Compounds > alanine
Page last updated: 2024-11-08

alanine and HIV Infections

alanine has been researched along with HIV Infections in 291 studies

Alanine: A non-essential amino acid that occurs in high levels in its free state in plasma. It is produced from pyruvate by transamination. It is involved in sugar and acid metabolism, increases IMMUNITY, and provides energy for muscle tissue, BRAIN, and the CENTRAL NERVOUS SYSTEM.
alanine : An alpha-amino acid that consists of propionic acid bearing an amino substituent at position 2.

HIV Infections: Includes the spectrum of human immunodeficiency virus infections that range from asymptomatic seropositivity, thru AIDS-related complex (ARC), to acquired immunodeficiency syndrome (AIDS).

Research Excerpts

ExcerptRelevanceReference
"When started in pregnancy, dolutegravir-containing regimens had superior virological efficacy at delivery compared with the efavirenz, emtricitabine, and tenofovir disoproxil fumarate regimen."9.41Efficacy and safety of dolutegravir with emtricitabine and tenofovir alafenamide fumarate or tenofovir disoproxil fumarate, and efavirenz, emtricitabine, and tenofovir disoproxil fumarate HIV antiretroviral therapy regimens started in pregnancy (IMPAACT 2 ( Amico, KR; Brummel, SS; Cassim, H; Chakhtoura, N; Chinula, L; Coletti, A; Currier, J; Fairlie, L; Frenkel, LM; Hanley, S; Hoffman, RM; Holmes, LB; Jean-Philippe, P; João, E; Johnston, B; Korutaro, V; Krotje, C; Lockman, S; Masheto, G; McCarthy, K; Mmbaga, BT; Momper, JD; Moyo, S; Purdue, L; Rooney, JF; Sax, PE; Shapiro, RL; Stranix-Chibanda, L; Stringer, JS; Thoofer, NK; Ziemba, L, 2021)
"Coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (E/C/F/TAF) has high efficacy and improved renal and bone safety in multiple phase 3 trials; TAF single agent is being studied in 2 phase 3 trials in patients with chronic hepatitis B."9.22Brief Report: Efficacy and Safety of Switching to a Single-Tablet Regimen of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in HIV-1/Hepatitis B-Coinfected Adults. ( Benson, P; Brinson, C; Brunetta, J; Cheng, A; Crofoot, G; Das, M; Fordyce, M; Gallant, J; Garner, W; McCallister, S; Mills, A; Oka, S, 2016)
"Integrase inhibitors, including dolutegravir (DTG), are associated with weight gain and obesity, especially when combined with tenofovir alafenamide (TAF)."9.12The predicted risk of adverse pregnancy outcomes as a result of treatment-associated obesity in a hypothetical population receiving tenofovir alafenamide/emtricitabine/dolutegravir, tenofovir disoproxil fumarate/emtricitabine/dolutegravir or tenofovir dis ( Asif, S; Baxevanidi, E; Chandiwana, N; Fairlie, L; Hill, A; Masenya, M; Serenata, C; Sokhela, S; Venter, WDF, 2021)
" This review aims to summarise the recent evidence investigating the associations between the use of integrase inhibitors and tenofovir alafenamide (TAF) with weight gain and the mechanisms by which this may occur."9.12Impact of Integrase inhibitors and tenofovir alafenamide on weight gain in people with HIV. ( Lake, JE; Trevillyan, J, 2021)
"We aimed to determine the reversibility of at least 7% weight gain within 12 months following tenofovir alafenamide (TAF) and/or integrase strand transfer inhibitor (INSTI) discontinuation in people with HIV (PWH) from the Dutch ATHENA cohort."8.31No evidence of rapid reversibility of tenofovir alafenamide and/or integrase strand transfer inhibitor-associated weight gain. ( Boyd, A; Reiss, P; Van der Valk, M; Verburgh, ML; Wit, FWNM, 2023)
"Tenofovir alafenamide (TAF), a prodrug of tenofovir (TFV), is included in the majority of the recommended first-line antiretroviral regimens for patients living with human immunodeficiency virus (HIV), but there are limited data on TAF use in pregnant women."8.12Tenofovir Alafenamide Plasma Concentrations Are Reduced in Pregnant Women Living With Human Immunodeficiency Virus (HIV): Data From the PANNA Network. ( Alba Alejandre, I; Bukkems, VE; Burger, D; Colbers, A; Garcia, C; Hidalgo Tenorio, C; Konopnicki, D; Lambert, JS; Necsoi, C; Richel, O; Te Brake, LHM; van der Meulen, E; van Hulzen, A; Weiss, F, 2022)
"Antenatal antiviral therapy (AVT) is effective in preventing mother-to-child transmission (MTCT) in chronic hepatitis B (CHB); tenofovir disoproxil fumarate (TDF) is the preferred agent."8.12Plasma and breast milk pharmacokinetics of tenofovir alafenamide in mothers with chronic hepatitis B infection. ( Cottrell, M; Crane, H; Di Girolamo, J; Dumond, J; Gane, E; Kashuba, A; Kayes, T; Levy, MT; Lim, TH; Manandhar, S; Symonds, A, 2022)
"As cardiovascular diseases represent the main cause of non-AIDS related death in people living with HIV (PLWH) with undetectable viral load, we evaluated lipid profile, weight gain and calculated cardiovascular risk change after switching from tenofovir disoproxil fumarate (TDF)-based regimens to tenofovir alafenamide (TAF)-based regimens."8.02Impact of switch from tenofovir disoproxil fumarate-based regimens to tenofovir alafenamide-based regimens on lipid profile, weight gain and cardiovascular risk score in people living with HIV. ( Darcis, G; Fombellida, K; Frippiat, F; Lecomte, M; Léonard, P; Maes, N; Meuris, C; Moutschen, M; Paquot, N; Plum, PE; Sauvage, AS; Uurlings, F; Vaira, D, 2021)
"Short-course preventive therapy with 1-month course of daily administration of isoniazid (300-mg) plus rifapentine (600-mg) (1HP) and 3-month course of weekly administration of isoniazid (900-mg) plus rifapentine (900-mg) (3HP) has higher completion rates than 9-month course of daily isoniazid (9H) for individuals with latent tuberculosis infection (LTBI)."8.02Short-course daily isoniazid and rifapentine for latent tuberculosis infection in people living with HIV who received coformulated bictegravir/emtricitabine/tenofovir alafenamide. ( Cheng, CN; Chuang, YC; Hung, CC; Kuo, CH; Lin, KY; Lin, SW; Lin, YJ; Lin, YT; Liou, BH; Liu, WC; Sun, HY, 2021)
"To investigate whether the switch from tenofovir disoproxil fumarate/emtricitabine/rilpivirine (TDF/FTC/RPV) to tenofovir alafenamide (TAF)/FTC/RPV is associated with weight gain in people living with HIV (PLWHIV)."7.96The switch from tenofovir disoproxil fumarate to tenofovir alafenamide determines weight gain in patients on rilpivirine-based regimen. ( Berruti, M; Briano, F; Di Biagio, A; Taramasso, L, 2020)
"A diagnosis of mild drug-related acute pancreatitis was made and BIC/FTC/TAF was immediately stopped."5.56Bictegravir/emtricitabine/tenofovir alafenamide-induced acute pancreatitis: a case report. ( Cattaneo, D; Filice, C; Gervasoni, C; Riva, A, 2020)
"Fatal lactic acidosis has been reported while on the treatment with Nucleoside/nucleotide analogues (NA) for the treatment of hepatitis B, C and HIV."5.48Tenofovir alafenamide associated fatal lactic acidosis in an autologous hematopoietic stem cell transplant recipient. ( Alsunaid, SR; Ashraf, H; Soubani, AO, 2018)
"When started in pregnancy, dolutegravir-containing regimens had superior virological efficacy at delivery compared with the efavirenz, emtricitabine, and tenofovir disoproxil fumarate regimen."5.41Efficacy and safety of dolutegravir with emtricitabine and tenofovir alafenamide fumarate or tenofovir disoproxil fumarate, and efavirenz, emtricitabine, and tenofovir disoproxil fumarate HIV antiretroviral therapy regimens started in pregnancy (IMPAACT 2 ( Amico, KR; Brummel, SS; Cassim, H; Chakhtoura, N; Chinula, L; Coletti, A; Currier, J; Fairlie, L; Frenkel, LM; Hanley, S; Hoffman, RM; Holmes, LB; Jean-Philippe, P; João, E; Johnston, B; Korutaro, V; Krotje, C; Lockman, S; Masheto, G; McCarthy, K; Mmbaga, BT; Momper, JD; Moyo, S; Purdue, L; Rooney, JF; Sax, PE; Shapiro, RL; Stranix-Chibanda, L; Stringer, JS; Thoofer, NK; Ziemba, L, 2021)
"Studies from different countries around the world have shown that integrase inhibitor (INSTI)-based regimens as well as tenofovir alafenamide (TAF) are associated with weight gain, with women and people of black race at especially high risk."5.22Metabolic Consequences of Antiretroviral Therapy. ( Diggins, CE; Lo, J; Russo, SC, 2022)
"Coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (E/C/F/TAF) has high efficacy and improved renal and bone safety in multiple phase 3 trials; TAF single agent is being studied in 2 phase 3 trials in patients with chronic hepatitis B."5.22Brief Report: Efficacy and Safety of Switching to a Single-Tablet Regimen of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in HIV-1/Hepatitis B-Coinfected Adults. ( Benson, P; Brinson, C; Brunetta, J; Cheng, A; Crofoot, G; Das, M; Fordyce, M; Gallant, J; Garner, W; McCallister, S; Mills, A; Oka, S, 2016)
"Recent evidence continues to contribute to the evidence for weight gain associated with INSTIs, especially when used with newer nucleoside reverse transcriptase inhibitor, tenofovir alafenamide (TAF)."5.12Risks of metabolic syndrome and diabetes with integrase inhibitor-based therapy. ( Hill, A; Shah, S, 2021)
"Integrase inhibitors, including dolutegravir (DTG), are associated with weight gain and obesity, especially when combined with tenofovir alafenamide (TAF)."5.12The predicted risk of adverse pregnancy outcomes as a result of treatment-associated obesity in a hypothetical population receiving tenofovir alafenamide/emtricitabine/dolutegravir, tenofovir disoproxil fumarate/emtricitabine/dolutegravir or tenofovir dis ( Asif, S; Baxevanidi, E; Chandiwana, N; Fairlie, L; Hill, A; Masenya, M; Serenata, C; Sokhela, S; Venter, WDF, 2021)
" This review aims to summarise the recent evidence investigating the associations between the use of integrase inhibitors and tenofovir alafenamide (TAF) with weight gain and the mechanisms by which this may occur."5.12Impact of Integrase inhibitors and tenofovir alafenamide on weight gain in people with HIV. ( Lake, JE; Trevillyan, J, 2021)
"The antiviral agent tenofovir is highly effective for the treatment of HIV and hepatitis B virus infections, and the older prodrug tenofovir disoproxil fumarate (TDF) is also a component of daily preexposure prophylaxis (PrEP) to reduce the risk of HIV infection in high-risk populations."4.98Potential kidney toxicity from the antiviral drug tenofovir: new indications, new formulations, and a new prodrug. ( Asriel, B; Chan, L; Eaton, EF; Wyatt, CM, 2018)
"A fixed-dose combination consisting of darunavir (Drv), cobicistat (Cobi), emtricitabine (2',3'-dideoxy-5-fluoro-3'-thiacytidine [FTC]), and tenofovir alafenamide (Taf) has been recently approved by the European Medicines Agency for the treatment of HIV infection, and is the first ever protease-inhibitor-based single-tablet regimen."4.98Darunavir-cobicistat-emtricitabine-tenofovir alafenamide: safety and efficacy of a protease inhibitor in the modern era. ( Bandera, A; Bozzi, G; Colella, E; Gori, A; Squillace, N, 2018)
"Tenofovir (TFV) is the cornerstone of the treatment and prophylaxis of HIV infections."4.98Role of tenofovir alafenamide (TAF) in the treatment and prophylaxis of HIV and HBV infections. ( De Clercq, E, 2018)
"We aimed to determine the reversibility of at least 7% weight gain within 12 months following tenofovir alafenamide (TAF) and/or integrase strand transfer inhibitor (INSTI) discontinuation in people with HIV (PWH) from the Dutch ATHENA cohort."4.31No evidence of rapid reversibility of tenofovir alafenamide and/or integrase strand transfer inhibitor-associated weight gain. ( Boyd, A; Reiss, P; Van der Valk, M; Verburgh, ML; Wit, FWNM, 2023)
" Efficacy against vaginal simian-HIV (SHIV) infection was investigated in six pigtailed macaques that received two tenofovir alafenamide implants (0."4.12Safety and efficacy of a biodegradable implant releasing tenofovir alafenamide for vaginal protection in a macaque model. ( Dobard, C; García-Lerma, JG; Gary, J; Gatto, G; Heneine, W; Holder, A; Johnson, L; Khalil, G; Krovi, A; Li, L; Luecke, E; Massud, I; Mills, P; Mitchell, J; Nishiura, K; Pan, Y; Ruone, S; van der Straten, A, 2022)
"Tenofovir alafenamide (TAF), a prodrug of tenofovir (TFV), is included in the majority of the recommended first-line antiretroviral regimens for patients living with human immunodeficiency virus (HIV), but there are limited data on TAF use in pregnant women."4.12Tenofovir Alafenamide Plasma Concentrations Are Reduced in Pregnant Women Living With Human Immunodeficiency Virus (HIV): Data From the PANNA Network. ( Alba Alejandre, I; Bukkems, VE; Burger, D; Colbers, A; Garcia, C; Hidalgo Tenorio, C; Konopnicki, D; Lambert, JS; Necsoi, C; Richel, O; Te Brake, LHM; van der Meulen, E; van Hulzen, A; Weiss, F, 2022)
"Tenofovir alafenamide (TAF) is a key component of HIV treatment, but pharmacokinetic data supporting the use of TAF during pregnancy are limited."4.12Pharmacokinetics of Tenofovir Alafenamide With Boosted Protease Inhibitors in Pregnant and Postpartum Women Living With HIV: Results From IMPAACT P1026s. ( Barr, E; Best, BM; Brooks, KM; Browning, R; Capparelli, EV; Chakhtoura, N; Deville, JG; Febo, IL; George, K; Knowles, K; Mirochnick, M; Paul, ME; Pinilla, M; Rungruengthanakit, K; Shapiro, DE; Stek, AM, 2022)
"Antenatal antiviral therapy (AVT) is effective in preventing mother-to-child transmission (MTCT) in chronic hepatitis B (CHB); tenofovir disoproxil fumarate (TDF) is the preferred agent."4.12Plasma and breast milk pharmacokinetics of tenofovir alafenamide in mothers with chronic hepatitis B infection. ( Cottrell, M; Crane, H; Di Girolamo, J; Dumond, J; Gane, E; Kashuba, A; Kayes, T; Levy, MT; Lim, TH; Manandhar, S; Symonds, A, 2022)
"As cardiovascular diseases represent the main cause of non-AIDS related death in people living with HIV (PLWH) with undetectable viral load, we evaluated lipid profile, weight gain and calculated cardiovascular risk change after switching from tenofovir disoproxil fumarate (TDF)-based regimens to tenofovir alafenamide (TAF)-based regimens."4.02Impact of switch from tenofovir disoproxil fumarate-based regimens to tenofovir alafenamide-based regimens on lipid profile, weight gain and cardiovascular risk score in people living with HIV. ( Darcis, G; Fombellida, K; Frippiat, F; Lecomte, M; Léonard, P; Maes, N; Meuris, C; Moutschen, M; Paquot, N; Plum, PE; Sauvage, AS; Uurlings, F; Vaira, D, 2021)
" However, emerging data from clinical trials has identified excessive weight gain possibly due to INSTI alone or with tenofovir alafenamide as a new and possible long-term complication of combination antiretroviral therapy (cART)."4.02Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide discontinuation and return to normal weight. ( DeMarais, P; Max, B, 2021)
"Although weight gain has been reported with the use of integrase strand transfer inhibitors (InSTI), concurrent use of tenofovir alafenamide (TAF) has been implicated in recent studies."4.02Weight gain before and after switch from TDF to TAF in a U.S. cohort study. ( Beyer, AP; Brunet, L; Fusco, GP; Fusco, JS; Hsu, RK; Mallon, PW; Mounzer, KC; Prajapati, G; Wohlfeiler, MB, 2021)
"Short-course preventive therapy with 1-month course of daily administration of isoniazid (300-mg) plus rifapentine (600-mg) (1HP) and 3-month course of weekly administration of isoniazid (900-mg) plus rifapentine (900-mg) (3HP) has higher completion rates than 9-month course of daily isoniazid (9H) for individuals with latent tuberculosis infection (LTBI)."4.02Short-course daily isoniazid and rifapentine for latent tuberculosis infection in people living with HIV who received coformulated bictegravir/emtricitabine/tenofovir alafenamide. ( Cheng, CN; Chuang, YC; Hung, CC; Kuo, CH; Lin, KY; Lin, SW; Lin, YJ; Lin, YT; Liou, BH; Liu, WC; Sun, HY, 2021)
"To investigate whether the switch from tenofovir disoproxil fumarate/emtricitabine/rilpivirine (TDF/FTC/RPV) to tenofovir alafenamide (TAF)/FTC/RPV is associated with weight gain in people living with HIV (PLWHIV)."3.96The switch from tenofovir disoproxil fumarate to tenofovir alafenamide determines weight gain in patients on rilpivirine-based regimen. ( Berruti, M; Briano, F; Di Biagio, A; Taramasso, L, 2020)
"Tenofovir alafenamide (TAF) is the latest agent approved for chronic hepatitis B virus (HBV) treatment."3.96Potential Benefits of Switching Liver Transplant Recipients to Tenofovir Alafenamide Prophylaxis. ( Kim, WR; Kwo, PY; Mannalithara, A; Sripongpun, P, 2020)
" We used a macaque model of repeated exposures to simian human immunodeficiency virus (SHIV) to investigate whether TAF alone or the combination of TAF and emtricitabine (FTC) can prevent vaginal infection."3.91Efficacy of Oral Tenofovir Alafenamide/Emtricitabine Combination or Single-Agent Tenofovir Alafenamide Against Vaginal Simian Human Immunodeficiency Virus Infection in Macaques. ( Babusis, D; Callebaut, C; Cong, ME; Deyounks, F; Dinh, C; García-Lerma, JG; Heneine, W; Holder, A; Johnson, R; Khalil, G; Lipscomb, J; Massud, I; McCallister, S; Nishiura, K; Pan, Y; Park, Y; Rooney, JF; Ruone, S, 2019)
"We describe a patient with two recent episodes of tenofovir disoproxil fumarate (TDF)-associated acute kidney injury and six-class drug-resistant HIV infection who achieved and maintained viral suppression without worsening kidney function on a regimen including tenofovir alafenamide (TAF) through 48 weeks of therapy."3.83Tenofovir alafenamide as part of a salvage regimen in a patient with multi-drug resistant HIV and tenofovir-DF-associated renal tubulopathy. ( Dewar, RL; Kopp, JB; Lane, HC; Maldarelli, F; Manion, MM; Mikula, JM; Norman-Wheeler, JF; Ober, AG; Pau, AK; Suarez, LM, 2016)
"Most (85%) women received highly active antiretroviral therapy (HAART) during pregnancy (mean duration: 31 weeks) and zidovudine during labor (93%)."3.72Hyperlactatemia in human immunodeficiency virus-uninfected infants who are exposed to antiretrovirals. ( Artuch, R; Fortuny, C; Jimenez, R; Muñoz-Almagro, C; Noguera, A; Pou, J; Sanchez, E; Vilaseca, MA, 2004)
" Safety was assessed by treatment-emergent adverse events (TEAEs)."3.30A phase I study to assess safety, pharmacokinetics, and pharmacodynamics of a vaginal insert containing tenofovir alafenamide and elvitegravir. ( Anderson, PL; Bushman, LR; Clark, M; Doncel, GF; Fang, X; Hanif, H; Ouattara, LA; Singh, O; Thurman, AR; Yousefieh, N, 2023)
" Drug-related adverse events were more frequent with DTG/3TC (15%; leading to discontinuation in 4%) than TAF-based regimens (5%; leading to discontinuation in 1%) through week 144, but rates were comparable after week 48 (4%; leading to discontinuation in 1% in both groups)."3.11Efficacy and Safety of Switching to Dolutegravir/Lamivudine Versus Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Results Through Week 144 F ( Aboud, M; Ait-Khaled, M; Ajana, F; Bisshop, F; De Wit, S; George, N; Leone, P; Osiyemi, O; Pappa, KA; Portilla, J; Routy, JP; Smith, KY; van Wyk, J; Wang, R; Wright, J; Wyen, C; Wynne, B, 2022)
"A crossover, randomized trial in healthy adults (NCT04244448) investigated the bioavailability of two off-label uses of BIC/TAF/FTC (50/200/25 mg), dissolved in water or crushed in apple compote, compared with the solid tablet."3.11Bioavailability of dissolved and crushed single tablets of bictegravir, emtricitabine, tenofovir alafenamide in healthy adults: the SOLUBIC randomized crossover study. ( Alix, A; Bois, J; Brucato, S; Dargere, S; Fournel, F; Fournier, A; Got, L; Gregoire, N; Hocqueloux, L; Lefeuvre, S; McNicholl, I; Parienti, JJ; Peyro-Saint-Paul, L; Prazuck, T; Valentin, C, 2022)
" Week 48 virologic suppression (HIV-1 RNA <50 copies/mL), resistance, adverse events (AEs), and laboratory parameters were assessed."3.01Brief Report: Efficacy and Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Females Living With HIV: An Integrated Analysis of 5 Trials. ( Ajana, F; Brainard, D; Chuck, SK; Collins, SE; Gandhi-Patel, B; Kityo, C; Koenig, E; Liu, Y; Makadzange, T; McNicholl, I; Natukunda, E; Orkin, C; Pikora, C; Wang, H; Wei, X; White, K, 2021)
" This phase I, open-label, 2-period, 1-way study assessed potential pharmacokinetic (PK) interactions between GSK3640254 and tenofovir alafenamide/emtricitabine (TAF/FTC; including the metabolite tenofovir [TFV]) in healthy volunteers."3.01A Phase I Evaluation of the Pharmacokinetics and Tolerability of the HIV-1 Maturation Inhibitor GSK3640254 and Tenofovir Alafenamide/Emtricitabine in Healthy Participants. ( Butcher, L; Davidson, AM; Johnson, M; Joshi, SR; Lataillade, M; Min, S; Pene Dumitrescu, T; Webster, L; Xu, J; Zhan, J; Zimmerman, E, 2021)
"Emtricitabine and tenofovir alafenamide is safe and effective for longer-term pre-exposure prophylaxis in cisgender men and transgender women who have sex with men."3.01Long-term safety and efficacy of emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV-1 pre-exposure prophylaxis: week 96 results from a randomised, double-blind, placebo-controlled, phase 3 trial. ( Asmuth, DM; Baeten, JM; Brainard, DM; Brunetta, JM; Carter, C; Cox, S; Das, M; Ebrahimi, R; Gilson, R; Henry, K; Kintu, A; Kronborg, G; Ogbuagu, O; Podzamczer, D; Ruane, PJ; Salazar, LC; Shao, Y; Spinner, CD; Whitlock, G; Wohl, D, 2021)
" No studies have yet compared TFV-DP in PBMC from lower than daily dosing between prodrugs, which has potential implications for event-driven preexposure prophylaxis and pharmacologic forgiveness."3.01Tenofovir-diphosphate in peripheral blood mononuclear cells during low, medium and high adherence to emtricitabine/ tenofovir alafenamide vs. emtricitabine/ tenofovir disoproxil fumarate. ( Anderson, PL; Brooks, KM; Bushman, L; Castillo-Mancilla, JR; Ibrahim, M; Kiser, JJ; MaWhinney, S; Morrow, M; Nemkov, C; Peterson, S; Yager, JL, 2021)
"TAF-DBS was a randomized, crossover clinical study of TFV-DP in DBS, following directly observed dosing of 33%, 67%, or 100% of daily TAF (25 mg)/FTC (200 mg)."2.94Intracellular Tenofovir-Diphosphate and Emtricitabine-Triphosphate in Dried Blood Spots Following Tenofovir Alafenamide: The TAF-DBS Study. ( Anderson, PL; Brooks, KM; Bushman, LR; Castillo-Mancilla, J; Ibrahim, ME; Kiser, JJ; MaWhinney, S; McCallister, S; McHugh, C; Morrow, M; Yager, J, 2020)
" Drug-related grade ≥2 adverse events and withdrawals due to adverse events occurred in 17 (4."2.94Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Phas ( Aboud, M; Ait-Khaled, M; Ajana, F; Bisshop, F; De Wit, S; Gartland, MJ; Nascimento, MC; Osiyemi, O; Pappa, KA; Portilla Sogorb, J; Routy, JP; Smith, KY; Tenorio, AR; van Wyk, J; Wang, R; Wright, J; Wyen, C; Wynne, B, 2020)
" At baseline (pre-switch) and at 12 weeks post-switch, we measured HIV-1 RNA in seminal plasma (SP) and blood plasma (BP), tenofovir (TFV) in SP and BP, and TFV-diphosphate (dp) in peripheral blood mononuclear cells (PBMCs) and seminal mononuclear cells (SMCs) at the end of the dosing interval (C24h)."2.90Seminal Tenofovir Concentrations, Viral Suppression, and Semen Quality With Tenofovir Alafenamide, Compared With Tenofovir Disoproxil Fumarate (Spanish HIV/AIDS Research Network, PreEC/RIS 40). ( Cottrell, ML; Garcia, B; Imaz, A; Kashuba, ADM; Morenilla, S; Niubó, J; Perez, E; Podzamczer, D; Tiraboschi, JM, 2019)
" Few discontinued due to adverse events (2% D/C/F/TAF arm)."2.90Week 96 efficacy and safety results of the phase 3, randomized EMERALD trial to evaluate switching from boosted-protease inhibitors plus emtricitabine/tenofovir disoproxil fumarate regimens to the once daily, single-tablet regimen of darunavir/cobicistat/ ( Brown, K; Cunningham, D; De Wit, S; Eron, JJ; Hufkens, V; Jezorwski, J; Lathouwers, E; Opsomer, M; Orkin, C; Petrovic, R; Post, FA; Pulido, F; Van Landuyt, E, 2019)
" The overall incidence and severity of adverse events was similar between groups, although headache occurred more frequently in the bictegravir group than in the boosted protease inhibitor group."2.87Efficacy and safety of switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from boosted protease inhibitor-based regimens in virologically suppressed adults with HIV-1: 48 week results of a randomised, open-label, multicentre, ph ( Andreatta, K; Cheng, A; Creticos, C; Crofoot, G; Custodio, J; Daar, ES; DeJesus, E; Graham, H; Koenig, E; Liu, YP; Martin, H; Molina, JM; Oguchi, G; Quirk, E; Rockstroh, JK; Ruane, P, 2018)
"Bictegravir is a novel, potent INSTI with a high in-vitro barrier to resistance and low potential as a perpetrator or victim of clinically relevant drug-drug interactions."2.84Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial. ( Brar, I; Cheng, A; Custodio, J; Daar, ES; Gallant, J; Girard, PM; Lazzarin, A; Martin, H; Mills, A; Orkin, C; Podzamczer, D; Quirk, E; Rockstroh, J; Tebas, P; Wei, X; White, K; Wohl, D, 2017)
" However, tenofovir disoproxil fumarate is associated with renal and bone toxic effects; the novel prodrug tenofovir alafenamide achieves 90% lower plasma tenofovir concentrations."2.82Efficacy and safety of tenofovir alafenamide versus tenofovir disoproxil fumarate given as fixed-dose combinations containing emtricitabine as backbones for treatment of HIV-1 infection in virologically suppressed adults: a randomised, double-blind, activ ( Abram, ME; Brinson, C; Cheng, AK; Clumeck, N; Daar, ES; DeJesus, E; Gallant, JE; Johnson, M; Morales-Ramirez, J; Osiyemi, O; Plummer, A; Raffi, F; Rhee, MS; Ruane, P; Ward, D; Yan, M, 2016)
" The regimen was well tolerated and no discontinuations related to adverse events occurred."2.82Safety, efficacy, and pharmacokinetics of a single-tablet regimen containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in treatment-naive, HIV-infected adolescents: a single-arm, open-label trial. ( Batra, J; Chakraborty, R; Gaur, AH; Kizito, H; Kosalaraksa, P; Luesomboon, W; Myers, M; Porter, D; Prasitsueubsai, W; Quirk, E; Rakhmanina, N; Rassool, M; Rhee, MS; SenGupta, D; Shao, Y; Ting, L, 2016)
" The most commonly observed adverse events were headache, nausea and flatulence, which occurred similarly across the three groups."2.79Phase I/II study of the pharmacokinetics, safety and antiretroviral activity of tenofovir alafenamide, a new prodrug of the HIV reverse transcriptase inhibitor tenofovir, in HIV-infected adults. ( Coakley, D; Kearney, B; Lee, WA; Markowitz, M; Miller, MD; Ruane, P; Squires, K; Wulfsohn, M; Zhong, L; Zolopa, A, 2014)
"73 log10 copies per milliliter, including a dose-response relationship for viral load decrease up to 25 mg."2.78Antiviral activity, safety, and pharmacokinetics/pharmacodynamics of tenofovir alafenamide as 10-day monotherapy in HIV-1-positive adults. ( Berger, D; Bredeek, UF; Callebaut, C; DeJesus, E; Fordyce, MW; Markowitz, M; Ramanathan, S; Rhee, MS; Ruane, PJ; Yale, K; Zhong, L, 2013)
" Both treatments were safe and well-tolerated, and most adverse events were similar as mild to moderate in severity."2.66Efficacy and safety of the regimens containing tenofovir alafenamide versus tenofovir disoproxil fumarate in fixed-dose single-tablet regimens for initial treatment of HIV-1 infection: A meta-analysis of randomized controlled trials. ( Chen, Y; Lu, Y; Tao, X; Zhang, L; Zhou, Y, 2020)
" BIC has demonstrated a high genetic barrier to resistance development in vitro, can be administered with or without food, and has a bioavailability of > 70%."2.61Bictegravir, a novel integrase inhibitor for the treatment of HIV infection. ( Bhatia, R; Rizza, S; Temesgen, Z; Zeuli, J, 2019)
"Proteinuria is also now recognized as a common finding in individuals living with HIV."2.55Renal effects of novel antiretroviral drugs. ( Jones, R; Levy, JB; Milburn, J, 2017)
"TAF has a similar tolerability, safety, and effectiveness to TDF and probably less adverse events related to renal and bone density outcomes in the treatment of naive and experienced patients with HIV-1."2.53The efficacy and safety of tenofovir alafenamide versus tenofovir disoproxil fumarate in antiretroviral regimens for HIV-1 therapy: Meta-analysis. ( Lu, X; Wang, H; Xu, N; Yang, X, 2016)
" Model-based simulations revealed 294% and 515% increases of median tenofovir Cmin in patients with CLCR of 15-29 mL/min (CKD stage 3), and less than 15 mL/min (stage 4), respectively, compared with normal renal function (CLCR = 90-149 mL/min)."1.91Population pharmacokinetic modelling to characterize the effect of chronic kidney disease on tenofovir exposure after tenofovir alafenamide administration. ( Alves Saldanha, S; Andre, P; Buclin, T; Cavassini, M; Courlet, P; Decosterd, LA; Desfontaine, V; Guidi, M; Kusejko, K; Thoueille, P, 2023)
"Dolutegravir is a comparatively recent molecular entity that represents an advance over previous products."1.91Preliminary Evaluation of Stability Data for Dolutegravir-Containing Triple Active Formulations Intended for PEPFAR. Degradation of Tenofovir Disoproxil Fumarate and Tenofovir Alafenamide as the Limiting Factor. ( Lunn, G, 2023)
" Our existing PK model, supported by an intravenous (IV) dosing dog study, was adapted to analyze mechanistic aspects underlying implant TAF delivery."1.91Preclinical Considerations for Long-acting Delivery of Tenofovir Alafenamide from Subdermal Implants for HIV Pre-exposure Prophylaxis. ( Baum, MM; Beliveau, M; Fanter, R; Gallay, PA; Gunawardana, M; Kuo, J; Marzinke, MA; Moss, JA; Ramirez, CM; Remedios-Chan, M; Sanchez, D; Trinh, M; Webster, P; Webster, S, 2023)
" Systemic drug disposition during TAF implant dosing was explained by a multi-compartment pharmacokinetic (PK) model."1.72Fundamental aspects of long-acting tenofovir alafenamide delivery from subdermal implants for HIV prophylaxis. ( Baum, MM; Beliveau, M; Buser, C; Caprioli, RM; Castonguay, AE; Gallay, PA; Gunawardana, M; Hendrix, CW; Kuo, J; Marzinke, MA; Moss, JA; Remedios-Chan, M; Reyzer, ML; Sanchez, D; Trinh, M; Tuck, M; Webster, P; Webster, S, 2022)
" Tenofovir is an important component of management, but the associated risk of nephrotoxicity makes dosing a challenge in patients with impaired kidney function."1.72Tenofovir alafenamide: An initial experience at Groote Schuur Hospital, Cape Town, South Africa. ( Barday, Z; Geragotellis, A; Naicker, V; Patel, S; Sanglay, L; Sonderup, M; Spearman, CW; Wearne, N, 2022)
"In individuals with a history of PRT on TDF, 96 weeks of TAF was not associated with recurrent PRT or adverse effects on renal tubular function, bone turnover, or BMD."1.62Safety of Tenofovir Alafenamide in People With HIV Who Experienced Proximal Renal Tubulopathy on Tenofovir Disoproxil Fumarate. ( Barbini, B; Burling, K; Campbell, L; Cromarty, B; Hamzah, L; Johnson, M; Jones, R; Post, FA; Samarawickrama, A; Williams, D; Winston, A, 2021)
" Treatment-related adverse events occurred in 51 (15%) patients (all Grade 1-2) and led to 8 discontinuations."1.62Real-world efficacy and safety of switching to bictegravir/emtricitabine/tenofovir alafenamide in older people living with HIV. ( Cruz, D; DeJesus, E; Hinestrosa, F; Nguyen, V; Patel, K; Rolle, CP, 2021)
" Adverse events were reported in 8 (7%) patients."1.62[Effectiveness, safety, and economic impact of the bictegravir/emtricitabine/tenofovir alafenamide regimen in real clinical practice cohort of HIV-1 infected adult patients]. ( Gutiérrez-Lorenzo, M; Rubio-Calvo, D; Urda-Romacho, J, 2021)
" However, the changes in renal function under long-term use of TAF are not known."1.62Renal function in Japanese HIV-1-positive patients who switch to tenofovir alafenamide fumarate after long-term tenofovir disoproxil fumarate: a single-center observational study. ( Abe, K; Goto, T; Imamura, J; Ito, T; Kamio, S; Kondo, A; Obara, T; Sato, H; Takahashi, N, 2021)
" Because TDF can lead to renal impairment and a decrease in bone mineral density (BMD), the prodrug tenofovir alafenamide (TAF) may be considered a viable alternative with fewer adverse effects."1.62Safety and efficacy of tenofovir alafenamide in liver transplant recipients: A single center experience. ( Achterfeld, A; Herzer, K; Rashidi-Alavijeh, J; Straub, K; Wedemeyer, H; Willuweit, K, 2021)
"Pregnant women receiving TAF 10 mg with cobicistat or TAF 25 mg without boosting as part of clinical care had intensive pharmacokinetic assessments performed during the second and third trimesters, and 6-12 weeks postpartum."1.62Pharmacokinetics of tenofovir alafenamide with and without cobicistat in pregnant and postpartum women living with HIV. ( Barr, E; Best, BM; Brooks, KM; Capparelli, EV; Chakhtoura, N; Cielo, M; Denson, K; Deville, JG; Espina, R; Febo, IL; George, K; Haubrich, R; Mirochnick, M; Momper, JD; Pinilla, M; Rooney, JF; Rungruengthanakit, K; Shapiro, DE; Smith, E; Stek, AM; Weinberg, A, 2021)
"6%) patients because of adverse effects."1.62Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide as Maintenance Treatment in HIV/HBV-Coinfected Patients. ( Cheng, CY; Cheng, SH; Ho, MW; Huang, SH; Huang, YS; Hung, CC; Lee, CH; Lee, YT; Lin, SP; Liou, BH; Liu, CE; Lu, PL; Sun, HY; Tang, HJ; Tsai, HC; Yang, CJ, 2021)
" In rats, systemic and local findings were considered not adverse due to their low severity and reversibility; therefore, the "no observed adverse effect level" (NOAEL) was set at 1,000 μg/kg/day."1.62A 28-Day Toxicity Study of Tenofovir Alafenamide Hemifumarate by Subcutaneous Infusion in Rats and Dogs. ( Alessi, T; Feldman, PL; Felx, M; Jain, R; Roller, S; Shelton, J; Singh, R; Wang, Y; Yang, B; Zane, D, 2021)
" These findings provide reassurance that the combination of TAF, boosted PIs and ledipasvir/sofosbuvir is safe in HIV/HCV-coinfected populations."1.56Pharmacokinetics and renal safety of tenofovir alafenamide with boosted protease inhibitors and ledipasvir/sofosbuvir. ( Anderson, PL; Blum, J; Brooks, KM; Bushman, LR; Castillo-Mancilla, JR; Cendali, F; Choi, YJ; Gomez, J; Haas, H; Ibrahim, ME; Johnson, B; Kiser, JJ; MaWhinney, S; Morrow, M; Roon, L; Rowan, SE; Wyles, DL; Zheng, JH, 2020)
"A diagnosis of mild drug-related acute pancreatitis was made and BIC/FTC/TAF was immediately stopped."1.56Bictegravir/emtricitabine/tenofovir alafenamide-induced acute pancreatitis: a case report. ( Cattaneo, D; Filice, C; Gervasoni, C; Riva, A, 2020)
"Conclusions: The patients were generally satisfied with the change in medication and well nformed about the dosage and advantages of TAF over TDF, but less well informed about the possible adverse effects of TAF."1.56Satisfaction and knowledge among patients with HIV after switching from tenofovir to tenofovir alafenamide in regimens containing emtricitabine and rilpivirine ( Bermejo-Vicedo, T; Gramage-Caro, T; Montero-Llorente, B; Rodríguez-Sagrado, MÁ; Vélez-Díaz-Pallarés, M, 2020)
"Acute pancreatitis has also been reported recently with another INSTI, dolutegravir."1.56Severe rhabdomyolysis and acute asymptomatic pancreatitis following the concomitant use of Biktarvy in the setting of hyperosmolar diabetic crisis. ( Goffard, JC; Henrard, S; Noure, L; Simeni Njonnou, SR, 2020)
"No cases of Fanconi syndrome have been reported in clinical trials of TAF."1.56Renal proximal tubulopathy in an HIV-infected patient treated with tenofovir alafenamide and gentamicin: a case report. ( Bloch, M; Gracey, DM; Heron, JE; Saunders, J; Vanguru, V, 2020)
"A reversible acute renal failure with no proximal tubulopathy and neuropsychiatric issues are discussed."1.51Overdose of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide in an HIV-1-infected subject with attempted suicide. ( Álvarez, H; Díaz-Cambre, H; García-González, J; Llibre, JM; Mariño, A; Valcarce, N, 2019)
"High urine FTC and TFV concentrations could provide an indication of adherence to daily oral dosing with TDF or TAF-based regimens used for treatment and prevention."1.51Brief Report: Urine Emtricitabine and Tenofovir Concentrations Provide Markers of Recent Antiretroviral Drug Exposure Among HIV-Negative Men Who Have Sex With Men. ( Conway-Washington, C; Dinh, C; Fountain, J; Haaland, RE; Hall, L; Holder, A; Kelley, CF; Livermont, T; Lupo, LD; Martin, A, 2019)
" Using a murine model, we compared the plasma and tissue pharmacokinetics of TFV and various TFV prodrugs, including tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), and hexadecyloxypropyl tenofovir (CMX157), after dosing as enema formulations with varying osmolality and ion content."1.51Development of rectal enema as microbicide (DREAM): Preclinical progressive selection of a tenofovir prodrug enema. ( Bensouda, S; Cone, RA; Date, AA; Ensign, LM; Fuchs, EJ; Gumber, S; Hanes, J; Hendrix, C; Hoang, T; Marzinke, M; Ortiz, JO; Rohan, L; Villinger, F; Xiao, P; Young, TW, 2019)
" Population pharmacokinetic models were developed using measured intracellular metabolite, endogenous nucleotide competitors, and extracellular parent drug concentrations."1.48A Pharmacokinetic/Pharmacodynamic Model to Predict Effective HIV Prophylaxis Dosing Strategies for People Who Inject Drugs. ( Chen, J; Cottrell, ML; Dumond, JB; Garrett, KL; Maas, BM; Prince, HA; Schauer, AP; Sykes, C; White, N, 2018)
"Fatal lactic acidosis has been reported while on the treatment with Nucleoside/nucleotide analogues (NA) for the treatment of hepatitis B, C and HIV."1.48Tenofovir alafenamide associated fatal lactic acidosis in an autologous hematopoietic stem cell transplant recipient. ( Alsunaid, SR; Ashraf, H; Soubani, AO, 2018)
"A single-arm, prospective, nonrandomized, cross-over, pharmacokinetic study in patients receiving a TDF-containing regimen (TDF 300 mg/FTC 200 mg/EVG 150 mg/COBI 150 mg) switched to a TAF-containing FDC regimen (TAF 10 mg/FTC 200 mg/EVG 150 mg/COBI 150 mg)."1.48Plasma and intracellular pharmacokinetics of tenofovir in patients switched from tenofovir disoproxil fumarate to tenofovir alafenamide. ( Bares, SH; Dyavar, SR; Fletcher, CV; Havens, J; Lee, S; O'Neill, J; Podany, AT; Scarsi, KK; Swindells, S, 2018)
"Dapivirine was also impacted by microbiota, as drug bound irreversibly to bacteria, resulting in decreased antiviral activity."1.48Vaginal microbiome modulates topical antiretroviral drug pharmacokinetics. ( Cameron, SA; Cheshenko, N; Frank, B; Fredricks, D; Herold, BC; Keller, MJ; Mesquita, PM; Reagle, K; Sinclair, S; Srinivasan, S; Taneva, E; Weinrick, B, 2018)
"Fanconi syndrome is a rare adverse effect of tenofovir disoproxil fumarate (TDF)."1.46Short Communication: Resolution of Tenofovir Disoproxil Fumarate Induced Fanconi Syndrome with Switch to Tenofovir Alafenamide Fumarate in a HIV-1 and Hepatitis B Coinfected Patient. ( Karris, MY, 2017)
" There were no discontinuations due to adverse events."1.43Pharmacokinetics and Safety of Tenofovir Alafenamide in HIV-Uninfected Subjects with Severe Renal Impairment. ( Custodio, JM; Fordyce, M; Garner, W; Kearney, BP; Ling, KH; Ramanathan, S; Vimal, M, 2016)
" Adherence to the dosing regimen has emerged as a critical factor determining efficacy outcomes of clinical trials."1.42Pharmacokinetics of long-acting tenofovir alafenamide (GS-7340) subdermal implant for HIV prophylaxis. ( Baum, MM; Beliveau, M; Fanter, R; Gunawardana, M; Hendrix, CW; Marzinke, MA; Miller, CS; Moss, JA; Remedios-Chan, M; Smith, TJ; Yang, F, 2015)

Research

Studies (291)

TimeframeStudies, this research(%)All Research%
pre-19901 (0.34)18.7374
1990's0 (0.00)18.2507
2000's8 (2.75)29.6817
2010's111 (38.14)24.3611
2020's171 (58.76)2.80

Authors

AuthorsStudies
Yager, JL1
Brooks, KM6
Castillo-Mancilla, JR2
Nemkov, C1
Morrow, M3
Peterson, S1
Ibrahim, M1
Bushman, L1
Kiser, JJ3
MaWhinney, S3
Anderson, PL5
Plum, PE1
Maes, N1
Sauvage, AS2
Frippiat, F1
Meuris, C1
Uurlings, F1
Lecomte, M1
Léonard, P1
Paquot, N1
Fombellida, K1
Vaira, D1
Moutschen, M2
Darcis, G2
Orkin, C10
Ajana, F5
Kityo, C3
Koenig, E6
Natukunda, E1
Gandhi-Patel, B1
Wang, H7
Liu, Y2
Wei, X6
White, K5
Makadzange, T4
Pikora, C1
McNicholl, I4
Collins, SE8
Brainard, D5
Chuck, SK1
Campbell, L2
Barbini, B2
Burling, K2
Cromarty, B1
Hamzah, L2
Johnson, M3
Jones, R3
Samarawickrama, A1
Williams, D2
Winston, A1
Post, FA5
Gelé, T1
Chéret, A2
Castro Gordon, A1
Nkam, L1
Furlan, V1
Pallier, C1
Becker, PH1
Catalan, P1
Goujard, C1
Taburet, AM1
Gasnault, J1
Gouget, H1
Barrail-Tran, A1
Cobb, DA1
Smith, N1
Deodhar, S1
Bade, AN1
Gautam, N1
Shetty, BLD1
McMillan, J1
Alnouti, Y1
Cohen, SM1
Gendelman, HE1
Edagwa, B1
Brunet, L2
Mallon, P2
Fusco, JS2
Wohlfeiler, MB2
Prajapati, G2
Beyer, A1
Fusco, GP2
Rolle, CP1
Nguyen, V1
Patel, K1
Cruz, D1
DeJesus, E15
Hinestrosa, F2
Xia, H1
Huang, XJ1
Hu, Y1
Gao, LY1
Wu, Y1
Wu, H2
Yan, ZF1
Ma, P1
Teng, J1
Zhu, C1
Lyu, J1
Pan, L1
Zhang, M1
Zhang, F1
Roa, PE1
Bazzi, R1
Liou, BH5
Cheng, CN1
Lin, YT1
Lin, YJ1
Chuang, YC3
Lin, KY2
Liu, WC2
Lin, SW1
Kuo, CH1
Sun, HY7
Hung, CC7
Bukkems, VE1
Necsoi, C1
Hidalgo Tenorio, C1
Garcia, C1
Alba Alejandre, I1
Weiss, F1
Lambert, JS2
van Hulzen, A1
Richel, O1
Te Brake, LHM1
van der Meulen, E1
Burger, D1
Konopnicki, D1
Colbers, A1
Calza, L1
Borderi, M1
Colangeli, V1
Miani, T1
Nuti, B1
Bon, I1
Lazzarotto, T1
Viale, P1
Abe, K1
Obara, T1
Kamio, S1
Kondo, A1
Imamura, J1
Goto, T1
Ito, T1
Sato, H1
Takahashi, N1
Hikasa, S2
Shimabukuro, S2
Hideta, K2
Higasa, S2
Sawada, A2
Tokugawa, T2
Tanaka, K2
Yanai, M2
Kimura, T2
D'Antoni, ML2
Andreatta, K5
Acosta, R6
Martin, H18
Chang, S5
Martin, R5
White, KL5
De Clercq, E4
Mayer, KH3
Gelman, M1
Holmes, J1
Kraft, J1
Melbourne, K1
Mimiaga, MJ1
Gengiah, TN1
Abdool Karim, Q1
Harkoo, I1
Mansoor, L1
Zuma, NY1
Radebe, P1
Samsunder, N1
Baxter, C1
Maharaj, B1
Baum, MM7
Moss, JA7
Pozzetto, B1
Hankins, C1
Abdool Karim, S1
Sevenler, D1
Niu, X1
Dossantos, S1
Toner, M1
Cressey, TR1
Sandlin, RD1
Drain, PK1
Ambrosioni, J1
Rojas Liévano, J1
Berrocal, L1
Inciarte, A1
de la Mora, L1
González-Cordón, A1
Martínez-Rebollar, M1
Laguno, M1
Torres, B1
Ugarte, A1
Chivite, I2
Leal, L1
de Lazzari, E1
Miró, JM1
Blanco, JL1
Martinez, E1
Mallolas, J1
Osiyemi, O4
De Wit, S3
Bisshop, F2
Portilla, J2
Routy, JP2
Wyen, C2
Ait-Khaled, M3
Leone, P1
Pappa, KA2
Wang, R2
Wright, J3
George, N1
Wynne, B3
Aboud, M2
van Wyk, J4
Smith, KY2
Ma, J1
Nance, RM2
Delaney, JAC2
Whitney, BM2
Bamford, L1
Gravett, RM1
Moore, RD2
Napravnik, S1
Jacobson, JM1
Christopoulos, K1
Burkholder, GA2
Keruly, J1
Eron, JJ5
Martin, J1
Cachay, ER1
Saag, MS3
Crane, HM2
Kitahata, MM2
Geragotellis, A1
Patel, S1
Sonderup, M1
Wearne, N1
Barday, Z1
Sanglay, L1
Naicker, V1
Spearman, CW1
Pinilla, M2
Stek, AM2
Shapiro, DE2
Barr, E2
Febo, IL2
Paul, ME1
Deville, JG2
George, K2
Knowles, K1
Rungruengthanakit, K2
Browning, R1
Chakhtoura, N3
Capparelli, EV2
Mirochnick, M3
Best, BM2
Yap, SH1
Lee, CS1
Furusho, A1
Ishii, C1
Shaharudin, S1
Zulhaimi, NS1
Kamarulzaman, A1
Kamaruzzaman, SB1
Mita, M1
Leong, KH1
Hamase, K1
Rajasuriar, R1
Diggins, CE1
Russo, SC1
Lo, J1
Sax, PE11
Molina, JM7
Daar, ES4
Hagins, D6
Liu, H3
Blair, C2
Gallant, J4
Martin, C1
Unal, G1
Plantier, JC1
Alessandri-Gradt, E1
Lee, WA2
Cheng, AK4
Rowe, SM1
Clary, JC1
Drummond, M1
Derrick, C1
Sanasi, K1
Bookstaver, PB1
Gunawardana, M6
Remedios-Chan, M5
Sanchez, D4
Webster, S4
Castonguay, AE1
Webster, P4
Buser, C1
Trinh, M4
Beliveau, M5
Hendrix, CW2
Marzinke, MA6
Tuck, M1
Caprioli, RM1
Reyzer, ML1
Kuo, J4
Gallay, PA4
Kayes, T1
Crane, H1
Symonds, A1
Dumond, J1
Cottrell, M1
Di Girolamo, J1
Manandhar, S1
Lim, TH1
Gane, E1
Kashuba, A1
Levy, MT1
de Gea Grela, A1
Martín Carbonero, L1
Micán, R1
Bernardino, JI1
Ramos, L1
Valencia, ME1
Schafer, JJ2
Zimmerman, M1
Walshe, C1
Cerankowski, J1
Shimada, A1
Keith, SW1
Kauppinen, KJ1
Aho, I1
Sutinen, J1
Papatheodoridis, GV1
Mimidis, K1
Manolakopoulos, S1
Gatselis, N1
Goulis, J1
Kapatais, A1
Manesis, E1
Vasiliadis, T1
Triantos, C1
Samonakis, D1
Sevastianos, V1
Karatapanis, S1
Elefsiniotis, I1
Deutsch, M1
Mylopoulou, T1
Papatheodoridi, M1
Kranidioti, H1
Agorastou, P1
Karaoulani, T1
Kyriazidou, A1
Zisimopoulos, K1
Dalekos, GN1
Ranzenigo, M1
Gianotti, N2
Galli, L1
Poli, A1
Mastrangelo, A1
Bruzzesi, E1
Chiurlo, M1
Nozza, S1
Bossolasco, S1
Spagnuolo, V1
Mancusi, D1
Termini, R1
Carini, E1
Lazzarin, A4
Castagna, A3
Chen, GJ2
Chen, LY1
Hsieh, SM1
Sheng, WH1
Liu, WD1
Huang, YS2
Wu, PY1
Chang, HY1
Luo, YZ1
Su, YC1
Chang, SF2
Chang, SY2
Parveen, S1
Tiwari, A1
Singh, J1
Shah, A1
Armenia, D1
Forbici, F1
Bertoli, A1
Berno, G1
Malagnino, V2
Gagliardini, R1
Borghi, V1
Gennari, W1
Cicalini, S2
Buonomini, A1
Teti, E2
Lanini, S1
Latini, A1
Sarmati, L2
Mussini, C3
Andreoni, M2
Antinori, A4
Perno, CF1
Ceccherini-Silberstein, F1
Santoro, MM1
Lee, MH1
Betancor, G1
Bangham, M1
Jeon, JK1
Shah, K1
Lynham, S1
Jimenez-Guardeño, JM1
Malim, MH1
Massud, I3
Krovi, A1
Nishiura, K2
Ruone, S2
Li, L1
Holder, A4
Gary, J1
Mills, P1
Mitchell, J2
Khalil, G2
Pan, Y3
Luecke, E1
Gatto, G1
Heneine, W3
García-Lerma, JG4
Johnson, L1
van der Straten, A2
Dobard, C2
Liu, W1
Yu, S1
Yan, B1
Sun, L1
He, Y1
Xu, L1
Zhao, F1
Zhou, Y3
Zhang, L2
Peng, Q1
Zhang, H1
Zhang, Q2
Cao, T1
Song, Y1
Wang, S1
Rao, M1
Jia, X1
Liu, X1
Zhou, J1
Ju, B1
Liu, J1
Johnson, KA2
Okochi, H2
Arreguin, M1
Watabe, J1
Glidden, DV2
Chattopadhyay, A1
Imbert, E1
Hickey, MD1
Gandhi, M3
Spinelli, M2
Sarowar, A1
Coffin, CS1
Fung, S1
Wong, A1
Doucette, K1
Truong, D1
Conway, B1
Haylock-Jacobs, S1
Ramji, A1
Hansen, BE1
Janssen, HLA1
Cooper, C1
Hocqueloux, L1
Lefeuvre, S1
Bois, J1
Brucato, S1
Alix, A1
Valentin, C1
Peyro-Saint-Paul, L1
Got, L1
Fournel, F1
Dargere, S1
Prazuck, T1
Fournier, A1
Gregoire, N1
Parienti, JJ1
Makarova, N1
Singletary, T1
Peet, MM2
Dinh, C3
Agrahari, V1
Mendoza, M1
Clark, MR1
Smith, JM1
Doncel, GF2
Tsai, MS3
Chen, CP3
Lee, CH5
Lee, CY3
Liu, CE4
Tang, HJ5
Hung, TC3
Li, CW3
Lee, YT4
Yang, CJ4
Fanter, R4
Ramirez, CM3
Bachelard, A2
Isernia, V2
Charpentier, C2
Benalycherif, A1
Mora, M1
Donadille, C1
Duvivier, C1
Lacombe, K1
El Mouhebb, M1
Spire, B1
Landman, R2
Descamps, D2
Peytavin, G3
Assoumou, L1
Ghosn, J2
Lunn, G1
Ritou, E1
Satta, S1
Petcherski, A1
Daskou, M1
Sharma, M1
Vasilopoulos, H1
Murakami, E1
Shirihai, OS1
Kelesidis, T1
Perrone, V1
Dovizio, M1
Sangiorgi, D1
Andretta, M1
Bartolini, F1
Cavaliere, A1
Ciaccia, A1
Chinellato, A1
Costantini, A1
Dell'Orco, S1
Ferrante, F1
Gentile, S1
Lavalle, A1
Moscogiuri, R1
Mosele, E1
Procacci, C1
Re, D1
Santoleri, F1
Roccia, A1
Maggiolo, F5
Degli Esposti, L1
Thoueille, P1
Alves Saldanha, S1
Desfontaine, V1
Kusejko, K1
Courlet, P1
Andre, P1
Cavassini, M6
Decosterd, LA1
Buclin, T1
Guidi, M1
Mateza, S1
Bradford, Y1
Maartens, G3
Sokhela, S3
Chandiwana, NC1
Venter, WDF4
Ritchie, MD1
Haas, DW1
Sinxadi, P1
Pons-Faudoa, FP2
Di Trani, N1
Capuani, S1
Hernandez, N1
Wood, AM1
Nehete, B1
Niles, J1
Shelton, KA1
Kezar, S1
Bushman, LR4
Chua, CYX1
Ittmann, MM1
Nehete, PN1
Arduino, RC1
Nichols, JE1
Grattoni, A2
Thurman, AR1
Ouattara, LA1
Yousefieh, N1
Fang, X1
Hanif, H1
Clark, M1
Singh, O1
Cox, S6
Margot, N5
Callebaut, C13
Penner, J1
Ombajo, LA1
Otieno, D1
Nkuranga, J1
Mburu, M1
Wahome, S1
Pozniak, A3
Bhagani, S1
Verburgh, ML1
Wit, FWNM1
Boyd, A1
Reiss, P1
Van der Valk, M1
Squillace, N2
Ricci, E1
Maggi, P1
Taramasso, L2
Menzaghi, B1
De Socio, GV1
Piconi, S1
Maurizio Celesia, B1
Orofino, G1
Sarchi, E1
Pellicanò, GF1
Simeone, F1
Valsecchi, L1
Bandera, A2
Cenderello, G1
Attala, L1
Angioni, G1
Falasca, K1
Cascio, A1
Bargiacchi, O1
Di Biagio, A2
Bonfanti, P1
Huliciak, M1
Lhotska, I1
Kocova-Vlckova, H1
Halodova, V1
Dusek, T1
Cecka, F1
Staud, F1
Vokral, I1
Cerveny, L1
Podzamczer, D9
Imaz, A3
Lopez-Lirola, A1
Knobel, H1
Masiá, M1
Fanciulli, C1
Hernández, C1
Lagarde, M1
Gutierrez, A1
Curran, A1
Morano, L1
Montero-Alonso, M1
Troya, J1
Rigo, R1
Casadellà, M1
Navarro-Alcaraz, A1
Ardila, F1
Parera, M1
Bernal, E1
Echeverria, P1
Estrada, V1
Hidalgo-Tenorio, C1
Macias, J1
Prieto, P1
Valencia, E1
Vivancos, MJ1
Rivero, A1
Mendoza, I1
Lázaro, A1
Espinosa, A1
Sánchez, L1
Horta, AM1
Torralba, M1
Willkom, M2
Wei, L1
Liu, YP4
Graham, H2
Quirk, E11
Huhn, GD4
Girard, PM3
Petrovic, R2
Luo, D3
Van Landuyt, E5
Lathouwers, E5
Nettles, RE2
Brown, K3
Wong, EY1
Coelho, LE1
Torres, TS1
Veloso, VG1
Landovitz, RJ1
Grinsztejn, B1
Ma, Q1
Ocque, AJ1
Morse, GD1
Sanders, C1
Burgi, A1
Little, SJ1
Letendre, SL1
Rizzardini, G3
Raffi, F4
Pulido, F3
Mateo-Garcia, MG1
Ong, E1
Shao, Y4
Piontkowsky, D3
Das, M11
Haubrich, R3
Surial, B5
Calmy, A4
Fehr, J2
Stöckle, M4
Bernasconi, E5
Roth, B1
Fux, CA2
Kovari, H3
Furrer, H4
Rauch, A5
Wandeler, G5
Avihingsanon, A3
Chetchotisakd, P1
Supparatpinyo, K1
Gankina, N1
Pokrovsky, V1
Voronin, E1
Stephens, JL4
Acosta, RK3
Cao, H6
Lee, MSL1
Kishore, S1
Hollenbeck, BL1
Padival, S1
Goldstein, RH1
Walensky, RP2
Bailey, AC1
Ibrahim, F1
Musso, CG1
Moorthy, GS1
Lalley-Chareczko, L1
Koenig, HC1
Zuppa, AF1
Nishida, S1
Milinkovic, A1
Berger, F1
Arenas-Pinto, A1
Mauss, S1
Gantner, P1
Hessamfar, M1
Souala, MF1
Valin, N1
Simon, A2
Bouvet, E1
Rouveix, E1
Cotte, L1
Bani-Sadr, F1
Hustache-Mathieu, L1
Lebrette, MG1
Truchetet, F1
Galempoix, JM1
Piroth, L1
Pellissier, G1
Muret, P2
Rey, D1
Turner, D1
Drak, D1
O'Connor, CC1
Templeton, DJ1
Gracey, DM3
Hermansson, L1
Yilmaz, A2
Price, RW1
Nilsson, S1
McCallister, S13
Zetterberg, H1
Blennow, K1
Gisslen, M2
Rockstroh, J3
Esser, S3
Vandekerckhove, L1
Hufkens, V2
Jezorwski, J4
Opsomer, M2
Zeuli, J2
Rizza, S2
Bhatia, R1
Temesgen, Z2
Shafran, SD2
Di Perri, G4
Su, JT1
Simpson, SM1
Sung, S1
Tfaily, EB1
Veazey, R1
Marzinke, M2
Qiu, J1
Watrous, D1
Widanapathirana, L1
Pearson, E1
Karunakaran, D1
Grasperge, B1
Dobek, G1
Cain, CM1
Hope, T1
Kiser, PF1
Crofoot, G8
Ramgopal, M4
Gathe, J2
Bolan, R1
Simonson, RB2
Benson, C1
Dunn, K2
Noe, S1
Jonsson-Oldenbuettel, C1
Jaeger, H1
Portilla Sogorb, J1
Nascimento, MC2
Tenorio, AR2
Gartland, MJ1
Krakower, DS2
Daskalakis, DC2
Feinberg, J2
Marcus, JL2
Lozano, AB1
Chueca, N1
de Salazar, A1
Fernández-Fuertes, E1
Collado, A1
Fernández, JM1
Álvarez, M1
García, F1
Tao, X1
Lu, Y1
Chen, Y1
Jain, MK1
Asmuth, DM2
Slim, J2
Goldstein, D1
Applin, S1
Ryu, JH1
Jiang, S2
Nguyen-Cleary, T1
Guyer, B1
Rossaro, L1
Haubrich, RH1
Stellbrink, HJ5
Woolley, I1
Llibre, JM3
Moore, SE1
Huesgen, E1
Howe, Z1
Biagi, MJ1
Schriever, CA1
Chiampas, TD1
Michienzi, SM1
Patel, MC1
Young, JD1
Badowski, ME1
Schwarze-Zander, C1
Piduhn, H1
Boesecke, C1
Schlabe, S1
Stoffel-Wagner, B1
Wasmuth, JC1
Strassburg, CP1
Rockstroh, JK3
Eke, AC1
Gebreyohannes, RD1
Sheffield, JS1
Dooley, KE1
Li, G1
Del Rio, C1
Armstrong, WS1
Ledergerber, B3
Günthard, HF3
Schmid, P4
Fulco, PP1
Berruti, M1
Briano, F1
Lacey, A1
Savinelli, S1
Barco, EA1
Macken, A1
Cotter, AG1
Sheehan, G1
Muldoon, E1
Feeney, E1
Mallon, PW2
Tinago, W1
Fletcher, CV2
Podany, AT3
Thorkelson, A1
Winchester, LC1
Mykris, T1
Anderson, J1
Jorstad, S1
Baker, JV1
Schacker, TW1
Morales, A1
Danziger, J1
Vélez-Díaz-Pallarés, M1
Gramage-Caro, T1
Rodríguez-Sagrado, MÁ1
Montero-Llorente, B1
Bermejo-Vicedo, T1
André-Garnier, E1
Hingrat, QL1
Marcelin, AG1
Reliquet, V1
Malet, I1
Leducq, V1
Rodallec, A1
Ferré, V1
Hill, A6
Arribas, JR5
Gupta, SK1
Martorell, C1
Wohl, D6
Thompson, MA2
Flamm, JA2
Brinson, C6
Clarke, A5
Huang, H2
Brainard, DM4
Petrakis, V1
Panagopoulos, P1
Papachristou, S1
Papanas, N1
Terzi, I1
Trypsianis, G1
Papazoglou, D1
Yager, J1
Castillo-Mancilla, J1
Ibrahim, ME2
McHugh, C1
Parsons, TL1
Gwenden, KN1
Adachi, E1
Saito, M1
Ikeuchi, K1
Hoshina, T1
Yotsuyanagi, H1
Simeni Njonnou, SR1
Henrard, S1
Noure, L1
Goffard, JC1
Luetkemeyer, AF1
Yazdanpanah, Y3
Ward, D3
Trottier, B2
Rieger, A1
Iwuji, CC1
Churchill, D1
Bremner, S1
Perry, N1
To, Y1
Lambert, D1
Bruce, C1
Waters, L2
Geretti, AM1
Riva, A1
Cattaneo, D2
Filice, C1
Gervasoni, C2
Spiegel, HML1
Lee, YL1
Cheng, CY2
Tsai, HC2
Huang, SH2
Lee, YC1
Hsieh, MH1
Su, LS1
Blum, J1
Wyles, DL1
Rowan, SE1
Zheng, JH1
Johnson, B1
Gomez, J1
Choi, YJ1
Cendali, F1
Haas, H1
Roon, L1
Heron, JE1
Bloch, M1
Vanguru, V1
Saunders, J1
Ferrández, JS1
García, AL1
Alonso-Vega, GG1
González, AO1
García, TM1
Kay, AW1
Ness, TE1
Martinez, L1
Mandalakas, AM1
Béguelin, C1
Chave, JP1
Boillat-Blanco, N1
Doco-Lecompte, T1
Walti, LN1
Horn, T1
McCann, NC1
Freedberg, KA1
Paltiel, AD1
Ting, J1
Shreay, S1
Bush, S1
Tiraboschi, JM2
Niubó, J2
Martinez-Picado, J1
Cottrell, ML3
Domingo, P2
Negredo, E2
Schauer, A1
Van Horne, B1
Morenilla, S2
Urrea, V1
Silva-Klug, A1
Scévola, S1
Garcia, B2
Kashuba, ADM3
Martin, TCS1
Hill, LA2
Tang, ME1
Balcombe, SM1
Li, M1
Zhou, L1
Dorsey, HG1
Musoff, C1
Jnr, DA1
Schoen, N1
Djan, K1
Paintsil, E1
Simmons, B1
Moorhouse, M1
Fairlie, L3
Mashabane, N1
Serenata, C2
Akpomiemie, G1
Masenya, M2
Qavi, A1
Chandiwana, N2
McCann, K2
Norris, S1
Chersich, M1
Lalla-Edward, S1
Vos, A1
Clayden, P1
Abrams, E1
Arulappan, N1
Pilkington, V1
Hughes, SL1
Pepperrell, T1
Gotham, D2
Pozniak, AL2
Gazzola, L1
Tagliaferri, G1
De Bona, A1
Mondatore, D1
Borsino, C1
Bini, T1
Marchetti, G1
d'Arminio Monforte, A1
Ruderman, SA1
Harding, BN1
Geng, E1
Mathews, WC1
Rodriguez, B1
Willig, AL1
Lindström, S1
Wood, BR2
Collier, AC1
Vannappagari, V1
Henegar, C1
Curtis, L1
Max, B1
DeMarais, P1
Bekerman, E1
Babusis, D2
Campigotto, F1
Barouch, DH1
Cihlar, T1
Robles, G1
Sauermilch, D1
Starks, TJ1
Rashidi-Alavijeh, J1
Straub, K1
Achterfeld, A1
Wedemeyer, H1
Willuweit, K1
Herzer, K1
Hung, A1
Sinclair, M1
Hemmersbach-Miller, M1
Edmonston, D1
Wyatt, C2
Momper, JD2
Weinberg, A1
Cielo, M1
Denson, K1
Smith, E1
Rooney, JF3
Espina, R1
Lu, PL1
Cheng, SH1
Lin, SP1
Ho, MW1
Ma, R1
Zhang, YS1
Xu, B1
Tong, ZW1
Zhao, CS1
Zhao, RG1
Shah, S1
Weinsteiger, S1
Baugh, B2
Ghys, A1
Mohsine, EG1
De Meyer, S1
Perez-Valero, I1
Temme, L1
McNicholl, IR1
Wilkin, A1
Spinner, CD2
El Ghazi, M1
Santos, J1
Scholten, S1
Wohlfeiler, M1
Jones, B1
Smith, DE2
Mesplède, T2
Kanda, N1
Okamoto, K2
Okumura, H1
Mieno, M1
Sakashita, K1
Sasahara, T1
Hatakeyama, S1
Mugglin, C1
Tarr, PE2
Pontolillo, M1
Piscitani, L1
Ucciferri, C1
Di Liberato, L1
Bonomini, M1
Vecchiet, J1
Pene Dumitrescu, T1
Joshi, SR1
Xu, J1
Zhan, J1
Butcher, L1
Zimmerman, E1
Webster, L1
Davidson, AM1
Lataillade, M1
Min, S1
Lake, JE1
Trevillyan, J1
Lockman, S1
Brummel, SS1
Ziemba, L1
Stranix-Chibanda, L1
McCarthy, K1
Coletti, A1
Jean-Philippe, P1
Johnston, B1
Krotje, C1
Hoffman, RM1
Moyo, S1
Stringer, JS1
Masheto, G1
Korutaro, V1
Cassim, H1
Mmbaga, BT1
João, E1
Hanley, S1
Purdue, L1
Holmes, LB1
Shapiro, RL1
Thoofer, NK1
Frenkel, LM1
Amico, KR1
Chinula, L1
Currier, J1
Hsu, RK1
Mounzer, KC1
Beyer, AP1
Yeoh, DK1
Campbell, AJ1
Bowen, AC1
Chen, GQ1
Wang, X1
Romano, JW1
Demkovich, ZR1
Diana, F1
Feldman, PL2
Ho, DK1
Hope, TJ1
Milad, M1
Roller, S2
Srinivasan, S2
Veazey, RS1
Zane, D2
Rogers, R1
Sheng, S1
Kassam, PT1
Seyedkazemi, S1
Hardy, H1
Gutiérrez-Lorenzo, M1
Rubio-Calvo, D1
Urda-Romacho, J1
Ikeda, M1
Wakabayashi, Y1
Yanagimoto, S1
Okugawa, S1
Moriya, K1
Touizer, E1
Alrubayyi, A1
Rees-Spear, C1
Fisher-Pearson, N1
Griffith, SA1
Muir, L1
Pellegrino, P1
Burns, F1
Kinloch, S1
Rowland-Jones, S1
Gupta, RK1
Gilson, R2
Peppa, D1
McCoy, LE1
Vallois, D1
Le Gac, S1
Chalal, L1
Damond, F1
Lagoutte-Renosi, J1
Flammang, M1
Ducloux, D1
Bamoulid, J1
Royer, PY1
Lepiller, Q1
Clairet, AL1
Davani, S1
Shelton, J1
Singh, R1
Jain, R1
Wang, Y1
Yang, B1
Felx, M1
Alessi, T1
Ogbuagu, O1
Ruane, PJ2
Salazar, LC1
Henry, K2
Ebrahimi, R1
Kintu, A1
Carter, C1
Baeten, JM2
Whitlock, G1
Brunetta, JM1
Kronborg, G1
Asif, S1
Baxevanidi, E1
D'Angelo, AB1
Westmoreland, DA1
Carneiro, PB1
Johnson, J1
Grov, C1
Kumar, P1
Saag, M3
Wurapa, AK1
Brar, I4
Berger, D2
Hileman, CO1
Ramgopal, MN3
McDonald, C3
Ueaphongsukkit, T1
Gatechompol, S1
Surintrspanont, J1
Iampenkhae, K1
Avihingsanon, Y1
Udomkarnjananun, S1
Ding, Y1
Lin, H1
Chen, X1
Zhu, B1
Xu, X2
Shen, W1
Gao, M1
He, N1
Sjaarda, A1
Bernstein, A1
Sparks, A1
Saber, S1
Siegel, M1
Darnell, J1
Jain, S1
Sun, X1
Qin, H1
Reynolds, T1
Karris, MY2
Tempestilli, M1
D'Avolio, A1
De Nicolò, A1
Agrati, C1
Ram, R1
Johnson, A1
Miller, M2
Boffito, M2
Flexner, CW1
Margot, NA2
Wong, P1
Kulkarni, R2
Porter, D4
Abram, ME3
Miller, MD3
Gallagher, A1
Quan, D1
Mills, A8
Tebas, P2
Custodio, J4
Cheng, A13
Montes, ML1
Workowski, K1
Reynes, J1
Garner, W5
SenGupta, D5
Ouyang, B1
Zhou, F1
Zhen, L1
Peng, Y1
Sun, J1
Chen, Q1
Jin, X1
Wang, G1
Zhang, J1
Novick, TK1
Choi, MJ1
Rosenberg, AZ1
McMahon, BA1
Fine, D1
Atta, MG1
Minisci, D1
Baldelli, S1
Mazzali, C1
Giacomelli, A1
Milazzo, L1
Meraviglia, P1
Resnati, C1
Clementi, E1
Galli, M1
Tartaglia, A1
Ferrara, SM1
Sica, S1
Santantonio, T1
Guaraldi, G1
Reinke, T1
Shen, Z2
Rodriguez-Garcia, M2
Patel, MV2
Bodwell, J2
Wira, CR2
Chan, L1
Asriel, B1
Eaton, EF1
Wyatt, CM1
Bares, SH2
Havens, J1
Dyavar, SR1
O'Neill, J1
Lee, S1
Swindells, S2
Scarsi, KK2
Ma, B1
Barth, A1
McHale, CM1
Lai, MT1
Haas, B2
Segal-Maurer, S1
Hodder, S1
Squires, K2
Kido, A1
Liu, D1
Yamamoto, M1
Song, J1
Zhang, R1
Du, Q1
Kawaguchi, Y1
Inoue, JI1
Matsuda, Z1
Tom, M1
Bowden, BH1
Satsangi, S1
Clotet, B1
Hoang, T1
Date, AA1
Ortiz, JO1
Young, TW1
Bensouda, S1
Xiao, P1
Rohan, L1
Fuchs, EJ1
Hendrix, C1
Gumber, S1
Villinger, F1
Cone, RA1
Hanes, J1
Ensign, LM1
Deeks, ED2
Harris, M1
Ruane, P5
Oguchi, G1
Creticos, C2
Laouri, M1
Alsunaid, SR1
Ashraf, H1
Soubani, AO1
Lee, SS1
Havens, JP1
Sayles, HR1
O'Neill, JL1
Taneva, E1
Sinclair, S1
Mesquita, PM1
Weinrick, B1
Cameron, SA1
Cheshenko, N1
Reagle, K1
Frank, B1
Fredricks, D1
Keller, MJ1
Herold, BC1
Njenda, DT1
Aralaguppe, SG1
Singh, K1
Rao, R1
Sönnerborg, A2
Sarafianos, SG1
Neogi, U1
Álvarez, H1
Mariño, A1
Valcarce, N1
García-González, J1
Díaz-Cambre, H1
Garrett, KL1
Chen, J2
Maas, BM1
Prince, HA1
Sykes, C2
Schauer, AP2
White, N1
Dumond, JB2
Mateo, MG1
Gutierrez, MDM1
Vidal, F1
Cid-Silva, P1
Fernández-Bargiela, N1
Margusino-Framiñán, L1
Balboa-Barreiro, V1
Mena-De-Cea, Á1
López-Calvo, S1
Vázquez-Rodríguez, P1
Martín-Herranz, I1
Míguez-Rey, E1
Poveda, E1
Castro-Iglesias, Á1
Bozzi, G1
Colella, E1
Gori, A1
Cerva, C1
Maffongelli, G1
Perez, E1
Giacomet, V1
Cossu, MV1
Capetti, AF1
Zuccotti, G1
Bahr, NC1
Yarlagadda, SG1
Pham, HT1
Lutz, J1
Majeed, S1
Greene, SA1
Prince, HMA1
Blake, K1
Nelson, JAE1
Gay, CL1
Cohen, MS1
Wohl, DA3
Baumgarten, A1
Barber, TJ1
Albrecht, H1
Martorell, CT2
Lelièvre, JD1
Parczewski, M1
Sripongpun, P1
Mannalithara, A1
Kwo, PY1
Kim, WR1
Cunningham, D1
Kaplun, O1
Psevdos, G1
Haaland, RE1
Martin, A1
Livermont, T1
Fountain, J1
Lupo, LD1
Hall, L1
Conway-Washington, C1
Kelley, CF1
Cong, ME1
Lipscomb, J1
Johnson, R1
Deyounks, F1
Park, Y1
Markowitz, M2
Bredeek, UF1
Zhong, L4
Ramanathan, S2
Rhee, MS4
Fordyce, MW5
Yale, K1
Zolopa, A2
Coakley, D1
Kearney, B1
Wulfsohn, M1
Elion, R2
Ortiz, R1
Post, F2
Bolduan, S1
Reif, T1
Schindler, M1
Schubert, U1
García-Broncano, P1
Berenguer, J1
Fernández-Rodríguez, A1
Pineda-Tenor, D1
Jiménez-Sousa, MÁ1
García-Alvarez, M1
Miralles, P1
Aldámiz-Echevarria, T1
López, JC1
Micheloud, D1
Resino, S1
Shalit, P1
Scribner, A1
Shamblaw, D2
Thomas, A1
Liu, HC3
Yan, M3
Yin, MT1
Thompson, M2
Oka, S3
Andrade-Villanueva, J2
Custodio, JM2
Plummer, A4
Miller, CS1
Yang, F1
Smith, TJ1
DiPerri, G1
Van Lunzen, J1
Madruga, JV1
Brunetta, J3
Huhn, G1
Ray, AS1
Hitchcock, MJ1
Clumeck, N2
Stephens, J1
Tashima, K1
Rashbaum, B1
Fordyce, M4
Kitrinos, KM1
Antela, A1
Aguiar, C1
Compston, J1
Hendry, BM1
Pourcher-Martinez, V1
Mikula, JM1
Manion, MM1
Maldarelli, F1
Suarez, LM1
Norman-Wheeler, JF1
Ober, AG1
Dewar, RL1
Kopp, JB1
Lane, HC1
Pau, AK1
Warpakowski, A1
Gallant, JE1
Morales-Ramirez, J1
Gazzard, B1
Garcia, M1
Le Moal, G1
Godet, C1
Beraud, G1
Chagneau-Derrode, C1
Roblot, F1
Benson, P2
Greig, SL1
Milburn, J1
Levy, JB1
Vimal, M1
Ling, KH1
Kearney, BP1
Bischoff, M1
Gibson, AK1
Shah, BM1
Nambiar, PH1
Lu, X1
Yang, X1
Xu, N1
Funderburg, NT1
McComsey, GA1
Kulkarni, M1
Bannerman, T1
Mantini, J1
Thornton, B1
Zhang, Y1
Song, Q1
Fang, L1
Dinoso, J1
Gaur, AH1
Kizito, H1
Prasitsueubsai, W1
Rakhmanina, N1
Rassool, M1
Chakraborty, R1
Batra, J1
Kosalaraksa, P1
Luesomboon, W1
Myers, M1
Ting, L1
Eriksen, J1
Albert, J1
Blaxhult, A1
Carlander, C1
Flamholc, L1
Josephson, F1
Karlström, O1
Navér, L1
Svedhem, V1
Snopková, S1
Havlíčková, K1
Husa, P1
Sampath, R1
Mandal, S1
Prathipati, PK1
Kang, G1
Yuan, Z1
Fan, W1
Li, Q1
Destache, CJ1
Dretler, R1
Peloquin, J1
LaMarca, A2
de Wet, J2
Valero, IP1
Vandercam, B1
Rijnders, B1
Thalme, A1
Stoeckle, M1
Slama, L1
Daar, E1
Santana-Bagur, J1
Stein, DK1
Bellos, N1
Scarsella, A1
Clarke, AE1
Guo, S1
Hammer, D1
Wild, J1
Ludwig, C1
Asbach, B1
Notka, F1
Wagner, R1
Hohenstein, E1
Rady, PL1
Hergersberg, M1
Huber, AR1
Tyring, SK1
Bregenzer, T1
Streit, M1
Itin, P1
Okazaki, T1
Pendleton, CD1
Lemonnier, F1
Berzofsky, JA1
Haugaard, SB1
Andersen, O1
Storgaard, H1
Dela, F1
Holst, JJ1
Iversen, J1
Nielsen, JO1
Madsbad, S1
Noguera, A1
Fortuny, C1
Muñoz-Almagro, C1
Sanchez, E1
Vilaseca, MA1
Artuch, R1
Pou, J1
Jimenez, R1
Mulky, A1
Vu, BC1
Conway, JA1
Hughes, SH1
Kappes, JC1
Friedman, RS1
Frankel, FR1
Xu, Z1
Lieberman, J1
Delaugerre, C1
Mouroux, M1
Yvon-Groussin, A1
Angleraud, F1
Huraux, JM1
Agut, H1
Katlama, C1
Calvez, V1
Norrby, E1
Parks, DE1
Utter, G1
Houghten, RA1
Lerner, RA1

Clinical Trials (53)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase IV Open-label Evaluation of Safety, Tolerability, and Acceptability of a Fixed-dose Formulation of Bictegravir, Emtricitabine/Tenofovir Alafenamide (B/F/TAF) for Non-occupational Prophylaxis Following Potential Exposure to HIV-1[NCT03499483]Phase 452 participants (Actual)Interventional2019-01-24Completed
A Phase I Randomized, Placebo-controlled, Double-blind Study to Assess Safety, Pharmacokinetics, and Modeled Pharmacodynamics of a Vaginal Insert Containing Tenofovir Alafenamide and Elvitegravir[NCT06087913]Phase 160 participants (Anticipated)Interventional2023-11-08Recruiting
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of GS-9883/F/TAF in HIV-1 Infected Subjects Who Are Virologica[NCT02603120]Phase 3567 participants (Actual)Interventional2015-11-11Completed
A Phase 3, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to GS-9883/Emtricitabine/Tenofovir Alafenamide [NCT02603107]Phase 3578 participants (Actual)Interventional2015-11-20Completed
A Phase 3, Randomized, Active-controlled, Open-label Study to Evaluate the Efficacy, Safety and Tolerability of Switching to a Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) Once-daily Single-tablet Regimen Versus Continuing the C[NCT02269917]Phase 31,149 participants (Actual)Interventional2015-03-31Completed
Elvitegravir (EVG) Cerebrospinal Fluid (CSF) Pharmacokinetics in HIV-Infected Individuals[NCT02251236]14 participants (Actual)Interventional2016-01-31Completed
A Phase 3b, Randomized, Open-Label Study to Evaluate Switching From a Tenofovir Disoproxil Fumarate (TDF) Containing Regimen to Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppress[NCT02616783]Phase 3167 participants (Actual)Interventional2015-12-22Completed
A Phase 3, Randomized, Open Label Study to Evaluate the Safety and Efficacy of Switching to a Fixed Dose Combination (FDC) of GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) From Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide (E/[NCT02652624]Phase 3472 participants (Actual)Interventional2016-02-19Completed
"Observational Study on Tolerability and Observance of Post-exposure Prophylaxis With Doravirine in HIV Viral Risk"[NCT05761509]200 participants (Anticipated)Observational2023-06-08Recruiting
Evaluation of Compliance With Treatment by Elvitegravir/Cobicistat/FTC/Tenofovir Alafenamide (E/C/F/TAF) in HIV Post-exposure Prophylaxis (to Infected Blood or Sexual Contact)[NCT02998320]Phase 3101 participants (Actual)Interventional2017-03-10Completed
A Phase 3, Open-Label Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically-Suppressed, HIV-1 Positive Subjects[NCT01815736]Phase 31,443 participants (Actual)Interventional2013-03-27Completed
A Phase 3, Randomized, Active-controlled, Double-blind Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Once Daily Fixed Dose Combination Regimen Versus a Regimen Consisting of Darunavir/Cobicis[NCT02431247]Phase 3725 participants (Actual)Interventional2015-07-06Completed
A Phase 3, Single-arm, Open-label Study to Evaluate the Efficacy and Safety of Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) Once Daily Fixed-dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naïve Human[NCT03227861]Phase 3109 participants (Actual)Interventional2017-07-31Completed
Efficacy and Safety of Dolutegravir + Lamivudine in Antiretroviral Treatment-naive Adults With HIV-1 Infection in a Multicenter Real-life Cohort Study[NCT04638686]185 participants (Actual)Observational2020-06-15Completed
A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Dolutegravir Plus Lamivudine in HIV-1 Infected Adults Who Are Virologically Suppressed[NCT03446573]Phase 3743 participants (Actual)Interventional2018-01-18Completed
Randomized, Open-label and Multicentric Trial Evaluating the Non-inferiority of Antiretroviral Dual Therapy Taken 4 Consecutive Days Per Week Versus Antiretroviral Dual Therapy 7/7 Days Per Week in HIV-1 Infected Patients With Controlled Viral Load Under [NCT04867083]Phase 3440 participants (Anticipated)Interventional2021-06-21Recruiting
A Phase 3b Randomized, Open-label, Controlled Study of the Efficacy, Safety and Tolerability of 12 Weeks of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Subjects Who Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamid[NCT02707601]Phase 3150 participants (Actual)Interventional2016-04-01Completed
Assessment of Netosis During COVID-19, Under Treatment With Anakinra, an Interleukin-1 Receptor Antagonist[NCT04594356]120 participants (Actual)Observational2020-11-19Completed
Use of cSVF For Residual Lung Damage (COPD/Fibrotic Lung Disease After Symptomatic COVID-19 Infection For Residual Pulmonary Injury or Post-Adult Respiratory Distress Syndrome Following Viral (SARS-Co-2) Infection[NCT04326036]Early Phase 110 participants (Anticipated)Interventional2020-03-25Enrolling by invitation
An Experimental Study on the Effect of Tenofovir Amibufenamide on Blood Lipid During Anti-HBV Treatment[NCT05398393]150 participants (Anticipated)Interventional2022-01-01Enrolling by invitation
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in HIV-1 Infected, Antiretroviral Treatment-Naive Adults[NCT02607930]Phase 3631 participants (Actual)Interventional2015-11-13Completed
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults[NCT02607956]Phase 3657 participants (Actual)Interventional2015-11-11Completed
The Cellular Pharmacology of F-TAF in Dried Blood Spots[NCT02962739]Phase 138 participants (Actual)Interventional2016-03-31Completed
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and Either Emtricitabine/Tenofovir Alafenamide or Emtricitabine/Tenofovir Disoproxil Fumarate to a Fixed Dose Combination of Bictegra[NCT03110380]Phase 3567 participants (Actual)Interventional2017-06-12Completed
Prospective Cohort Study to Assess the Safety and Efficacy of Replacing Tenofovir Disoproxil Fumarate by Tenofovir Alafenamide in HIV/HBV-coinfected Patients With Mild or Moderate Renal Dysfunction[NCT03115736]Phase 224 participants (Actual)Interventional2017-05-23Completed
WRHI 060 (ADVANCE): A Randomised, Phase 3 Non-inferiority Study of DTG + TAF + FTC Compared With DTG + TDF + FTC and EFV + TDF + FTC in Patients Infected With HIV-1 Starting First-line Antiretroviral Therapy - Extension to 192 Weeks[NCT03122262]Phase 31,110 participants (Actual)Interventional2017-01-16Completed
A Prospective Cohort Study of Tenofovir Alafenamide Switching Therapy in Kidney or Liver Transplant Recipients With Chronic Hepatitis B Virus Infection[NCT05410496]Phase 450 participants (Anticipated)Interventional2021-06-22Recruiting
Pharmacokinetic Properties of Antiretroviral and Related Drugs During Pregnancy and Postpartum[NCT00042289]1,578 participants (Actual)Observational2003-06-09Completed
Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (Genvoya) as Maintenance Treatment of HIV-1/Hepatitis B Virus (HBV)-Coinfected Patients: an Observational Study[NCT03425994]275 participants (Actual)Observational [Patient Registry]2018-02-06Active, not recruiting
A Phase 3b Open-Label Pilot Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) in Virologically-Suppressed HIV-1 Infected Adult Subjects Harboring the Archived Isolated NRTI [NCT02616029]Phase 366 participants (Actual)Interventional2015-12-17Completed
An Open-Label One-way Interaction Clinical Trial to Evaluate the Pharmacokinetic Interactions Between GSK3640254 and Tenofovir Alafenamide/Emtricitabine in Healthy Subjects[NCT03836729]Phase 116 participants (Actual)Interventional2019-02-11Completed
Phase III Study of the Virologic Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants[NCT03048422]Phase 3643 participants (Actual)Interventional2018-01-19Completed
A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At R[NCT02842086]Phase 35,399 participants (Actual)Interventional2016-09-02Active, not recruiting
A Phase 3b, Multicenter, Open-Label Study to Evaluate Switching From a Regimen of Two Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), [NCT03631732]Phase 3496 participants (Actual)Interventional2018-08-28Completed
A Multicenter Clinical Trial to Evaluate the Feasibility and Outcome of Same-day Antiretroviral Therapy With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) Among Patients Testing Positive by HIV Confirmatory Tests[NCT04712058]200 participants (Anticipated)Interventional2021-01-20Recruiting
Bictegravir in the Elderly Living With HIV: Impact of Polypharmacy and Multimorbidity (BICEP)[NCT05064020]162 participants (Anticipated)Observational2020-08-01Active, not recruiting
Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate to Bictegravir/ Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Virologically Suppressed Adults[NCT03532425]Phase 428 participants (Actual)Interventional2018-10-29Terminated (stopped due to Difficulties enrolling participants)
The Efficacy, Safety, and Tolerability of Switching to a Bictegravir (BIC)/Emtricitabine(FTC)/Tenofovir Alafenamide (TAF) Regimen in Virally Suppressed HIV-Positive Patients Post-Renal Transplant[NCT04530630]Phase 420 participants (Actual)Interventional2020-11-09Active, not recruiting
"Phase IV, Single-center, Open Study to Evaluate the Benefits of the Start of Immediate Treatment Without Immunovirological Data (Same Day Treatment) Compared to Conventional Treatment With BIC / FTC / TAF (Bictegravir/Emtricitabina/Tenofovir) in Naive Pa[NCT05606055]Phase 4100 participants (Actual)Interventional2020-12-01Completed
The Incidence and Severity of Drug Interactions Before and After Switching Antiretroviral Therapy to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Treatment Experienced Patients[NCT03789968]411 participants (Actual)Observational2019-09-01Completed
A Prospective Cohort Study of Tenofovir Alafenamide Switch Therapy in Chronic Hepatitis B Patients Who Are Unsatisfied to Entecavir Therapy[NCT05583006]60 participants (Anticipated)Observational2023-11-06Recruiting
Effects of Ledipasvir/Sofosbuvir Treatment on the Pharmacokinetics and Renal Safety of Tenofovir Alafenamide (TAF) in Patients With HIV.[NCT03126370]Phase 410 participants (Actual)Interventional2018-01-08Completed
Assessing Virologic Success and Metabolic Changes in Patients Switching From a TDF to TAF Containing Antiretroviral Therapy Regimen[NCT03646370]110 participants (Actual)Observational2018-07-25Completed
A Phase IIIB, Randomized Trial of Open-Label Efavirenz or Atazanavir With Ritonavir in Combination With Double-Blind Comparison of Emtricitabine/Tenofovir or Abacavir/Lamivudine in Antiretroviral-Naive Subjects[NCT00118898]Phase 31,864 participants (Actual)Interventional2005-09-30Completed
A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single Tablet Regimen Versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen in[NCT01497899]Phase 2279 participants (Actual)Interventional2011-12-28Completed
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Trea[NCT01780506]Phase 3872 participants (Actual)Interventional2012-12-26Completed
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treat[NCT01797445]Phase 3872 participants (Actual)Interventional2013-03-12Completed
Open Label, Randomized (1:1) Clinical Trial to Evaluate Switching From Dual Regimens Based on Dolutegravir Plus a Reverse Transcriptase Inhibitor to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed, HIV-1 Infected Pa[NCT03493568]Phase 3100 participants (Actual)Interventional2017-02-06Terminated (stopped due to The futility analysis on 24-week results estimated that there was only 2% probability of verifying the study hypothesis of a higher proportion pat. with no residual viremia through 48w in arm E/C/F/TAF)
A Phase 3, Randomized, Double-Blind, Switch Study to Evaluate F/TAF in HIV-1 Positive Subjects Who Are Virologically Suppressed on Regimens Containing FTC/TDF[NCT02121795]Phase 3668 participants (Actual)Interventional2014-05-06Completed
A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents a[NCT01854775]Phase 2/Phase 3129 participants (Actual)Interventional2013-05-06Active, not recruiting
A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of GS-9883 + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults[NCT02397694]Phase 298 participants (Actual)Interventional2015-03-23Completed
A Phase 3b, Randomized, Double-Blind Study to Evaluate Switching From a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/ Tenofovir Alafenamide (FTC/RPV/TAF[NCT02345226]Phase 3881 participants (Actual)Interventional2015-01-26Completed
A Phase 3b, Randomized, Double-Blind Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Subjects Who Are Virologically Suppressed on Emtricitabin[NCT02345252]Phase 3632 participants (Actual)Interventional2015-01-26Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Change From Baseline in CD4+ Cell Count at Week 48

(NCT02603120)
Timeframe: Baseline; Week 48

Interventioncells/µL (Mean)
B/F/TAF-31
ABC/DTG/3TC4

Hip Bone Mineral Density at Baseline

(NCT02603120)
Timeframe: Baseline

Interventiong/cm^2 (Mean)
B/F/TAF1.006
ABC/DTG/3TC0.996

Percentage Change From Baseline in Hip BMD at Week 48

(NCT02603120)
Timeframe: Baseline; Week 48

Interventionpercentage change (Mean)
B/F/TAF0.156
ABC/DTG/3TC0.299

Percentage Change From Baseline in Spine BMD at Week 48

(NCT02603120)
Timeframe: Baseline; Week 48

Interventionpercentage change (Mean)
B/F/TAF0.692
ABC/DTG/3TC0.416

Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Defined by the US FDA-defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02603120)
Timeframe: Week 48

Interventionpercentage of participants (Number)
B/F/TAF93.6
ABC/DTG/3TC95.0

Percentage of Participants With Virologic Failure (HIV-1 RNA ≥ 50 Copies/mL) as Defined by the Modified US FDA-defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02603120)
Timeframe: Week 48

Interventionpercentage of participants (Number)
B/F/TAF1.1
ABC/DTG/3TC0.4

Spine Bone Mineral Density (BMD) at Baseline

(NCT02603120)
Timeframe: Baseline

Interventiong/cm^2 (Mean)
B/F/TAF1.124
ABC/DTG/3TC1.103

Change From Baseline in CD4 Cell Count at Week 48

(NCT02603107)
Timeframe: Baseline to Week 48

Interventioncells/μL (Mean)
B/F/TAF25
Stay on Baseline Regimen (SBR)0

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02603107)
Timeframe: Week 48

Interventionpercentage of participants (Number)
B/F/TAF92.1
Stay on Baseline Regimen (SBR)88.9

Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm

The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02603107)
Timeframe: Week 48

Interventionpercentage of participants (Number)
B/F/TAF1.7
Stay on Baseline Regimen (SBR)1.7

Change From Reference in CD4+ Cell Count at Week 96

Change from reference in CD4+ cell count was assessed at Week 96. The change from reference in CD4+ count at a given time point is defined as: CD4+ at a given time point minus reference CD4+. For the D/C/F/TAF group, reference is the comparative treatment phase baseline as in Week 48 analysis (reference 1). For the Switch to D/C/F/TAF (late switch) group, the last value prior to the switch was used as reference (reference 2). (NCT02269917)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF+ F/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF (Comprising 44 weeks of D/C/F/TAF exposure [that is, from the switch to D/C/F/TAF at Week 52])

Interventioncells per cubic millimeter (cells/mm^3) (Least Squares Mean)
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])32.07
Switch to D/C/F/TAF13.07

Change From Reference in Estimated Glomerular Filtration Rate Based on Serum Creatinine (by CKD-EPI) at Week 96

Change from reference in eGFRcr (by CKD-EPI) was assessed at Week 96. eGFRcr per CKD-EPI formula - Female: 1) Serum creatinine (Scr) less than or equal to (<=)0.7 mg/dL: 144*(Scr/0.7)^-0.329*0.993^age; 2) Scr greater than (>)0.7 mg/dL: 144*(Scr/0.7)^-1.209*0.993^age. Male: 1) Scr <=0.9 mg/dL: 141*(Scr/0.9)^-0.411*0.993^age; 2) Scr >0.9 mg/dL: 141*(Scr/0.9)^-1.209*0.993^age. . For the D/C/F/TAF group, reference is the comparative treatment phase baseline as in Week 48 analysis (Reference 1). For the Switch to D/C/F/TAF (late switch) group, the last value prior to the switch was used as reference (reference 2). (NCT02269917)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF+ F/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

InterventionmL/min/1.73 m^2 (Median)
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])-1.3
Switch to D/C/F/TAF-0.7

Change From Reference in Estimated Glomerular Filtration Rate Based on Serum Creatinine (eGFRcr, by Cockcroft-Gault Formula [eGFRcg]) at Week 96

Change from reference in eGFRcr (by Cockcroft-Gault formula) was assessed at Week 96. eGFRcr according to the Cockcroft Gault formula- Male: (140 - age in years)*(weight in kilogram [kg])/72*(serum creatinine in milligram per deciliter [mg/dL])=eGFRcr (milliliter per minute [mL/min]); Female: (140 - age in years)*(weight in kg)/72*(serum creatinine in mg/dL)*0.85=eGFRcr (mL/min). For the D/C/F/TAF group, reference is the comparative treatment phase baseline as in Week 48 analysis (Reference 1). For the Switch to D/C/F/TAF (late switch) group, the last value prior to the switch was used as reference (reference 2). (NCT02269917)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF+ F/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

Interventionmilliliter per minute (mL/min) (Median)
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])-0.9
Switch to D/C/F/TAF0.0

Change From Reference in Estimated Glomerular Filtration Rate Based on Serum Cystatin C (by CKD-EPI) at Week 96

Change from reference in eGFRcyst (by CKD-EPI) was assessed at Week 96. eGFRcyst according to the CKD-EPI formula - 1) Serum Cystatin C (Scyst) <=0.8 mg/L: 133*(Scyst/0.8)^-0.499*0.996^age (*0.932 if female); 2) Scyst >0.8 mg/L: 133*(Scyst/0.8)^-1.328*0.996^age (*0.932 if female). For the D/C/F/TAF group, reference is the comparative treatment phase baseline as in Week 48 analysis (Reference 1). For the Switch to D/C/F/TAF (late switch) group, the last value prior to the switch was used as reference (reference 2). (NCT02269917)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF+ F/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

InterventionmL/min/1.73 m^2 (Median)
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])-0.9
Switch to D/C/F/TAF1.0

Change From Reference in Serum Creatinine Levels at Week 96

Change from reference in serum creatinine levels at Week 96 was assessed. For the D/C/F/TAF group, reference is the comparative treatment phase baseline as in Week 48 analysis (Reference 1). For the Switch to D/C/F/TAF (late switch) group, the last value prior to the switch was used as reference (reference 2). (NCT02269917)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF+ F/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

Interventionmicro mole per liter (Median)
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])0.0
Switch to D/C/F/TAF0.0

Change From Reference in UACR at Week 96

Change from reference in UACR was assessed at Week 96. For the D/C/F/TAF group, reference is the comparative treatment phase baseline as in Week 48 analysis (Reference 1). For the Switch to D/C/F/TAF (late switch) group, the last value prior to the switch was used as reference (reference 2). (NCT02269917)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF+ F/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

Interventionmilligram per gram (mg/g) (Median)
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])-0.63
Switch to D/C/F/TAF-0.93

Change From Reference in UB2MGCR at Week 96

Change from reference in UB2MGCR was assessed at Week 96. For the D/C/F/TAF group, reference is the comparative treatment phase baseline as in Week 48 analysis (Reference 1). For the Switch to D/C/F/TAF (late switch) group, the last value prior to the switch was used as reference (reference 2). (NCT02269917)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF+ F/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

Interventionmicrogram per gram (mcg/g) (Median)
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])-68.22
Switch to D/C/F/TAF-110.31

Change From Reference in UPCR at Week 96

Change from reference in UPCR was assessed at Week 96. For the D/C/F/TAF group, reference is the comparative treatment phase baseline as in Week 48 analysis (Reference 1). For the Switch to D/C/F/TAF (late switch) group, the last value prior to the switch was used as reference (reference 2). (NCT02269917)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF+ F/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

Interventionmilligram per gram (mg/g) (Median)
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])-22.23
Switch to D/C/F/TAF-12.81

Change From Reference in URBPCR at Week 96

Change from reference in URBPCR was assessed at Week 96. For the D/C/F/TAF group, reference is the comparative treatment phase baseline as in Week 48 analysis (Reference 1). For the Switch to D/C/F/TAF (late switch) group, the last value prior to the switch was used as reference (reference 2). (NCT02269917)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF+ F/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

Interventionmicrogram per gram (mcg/g) (Median)
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])-25.08
Switch to D/C/F/TAF-39.07

Number of Participants With Resistance to Study Drug

HIV-1 genotypes were analyzed from samples of participants with confirmed virologic rebound (virologic rebound was defined as: confirmed HIV-1 RNA >=50 copies/mL up to, and including the upper bound of the Week 48 window) and with HIV-1 RNA value >=400 copies/mL or who discontinued with last HIV-1 RNA >=400 copies/mL. Number of participants who developed resistance to any of the study drug was determined. (NCT02269917)
Timeframe: Up to Week 48

InterventionParticipants (Count of Participants)
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])1
Control (Baseline to Switch)3

Percent Change From Reference in FEPO4 at Week 96

Percent change from reference in FEPO4 at Week 96 was reported. For the D/C/F/TAF group, reference is the comparative treatment phase baseline as in Week 48 analysis (Reference 1). For the Switch to D/C/F/TAF (late switch) group, the last value prior to the switch was used as reference (reference 2). (NCT02269917)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF+ F/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

Interventionpercent change (Median)
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])4.15
Switch to D/C/F/TAF-3.19

Percent Change From Reference in Levels of 25-OH Vitamin D at Week 96

Percent change from reference in 25-OH Vitamin D at Week 96 were reported. For the D/C/F/TAF group, reference is the comparative treatment phase baseline as in Week 48 analysis (Reference 1). For the Switch to D/C/F/TAF (late switch) group, the last value prior to the switch was used as reference (reference 2). (NCT02269917)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF+ FTC/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

Interventionpercent change (Mean)
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])24.6
Switch to D/C/F/TAF-1.9

Percent Change From Reference in Levels of PTH at Week 96

Percent change from reference in PTH at Week 96 was reported. For the D/C/F/TAF group, reference is the comparative treatment phase baseline as in Week 48 analysis (Reference 1). For the Switch to D/C/F/TAF (late switch) group, the last value prior to the switch was used as reference (reference 2). (NCT02269917)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF+ FTC/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

Interventionpercent change (Mean)
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])-17.171
Switch to D/C/F/TAF-20.466

Percent Change From Reference in Levels of Serum CTX at Week 96

Percent change from reference in serum CTX at Week 96 was reported. For the D/C/F/TAF group, reference is the comparative treatment phase baseline as in Week 48 analysis (Reference 1). For the Switch to D/C/F/TAF (late switch) group, the last value prior to the switch was used as reference (reference 2). (NCT02269917)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF+ FTC/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

Interventionpercent change (Mean)
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])-10.192
Switch to D/C/F/TAF-21.755

Percent Change From Reference in Levels of Serum P1NP at Week 96

Percent change from reference in serum P1NP levels at Week 96 was reported. For the D/C/F/TAF group, reference is the comparative treatment phase baseline as in Week 48 analysis (Reference 1). For the Switch to D/C/F/TAF (late switch) group, the last value prior to the switch was used as reference (reference 2). (NCT02269917)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF+ FTC/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

Interventionpercent change (Mean)
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])-19.899
Switch to D/C/F/TAF-18.466

Percentage of Participants With Non-Virologic Rebound at Week 48 by Kaplan-Meier Estimates

Virologic rebound was defined as: confirmed plasma HIV-1 RNA >=50 copies/mL up to, and including the upper bound of the Week 48 window (ie, 54 weeks) and last available on-treatment (single) HIV-1 RNA >=50 copies/mL at premature discontinuation (irrespective of reason). Here Kaplan-Meier estimates percentage of participants with non-virologic rebound at week 48. (NCT02269917)
Timeframe: Baseline up to Week 48

Interventionpercentage of participants (Number)
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])97.7
Control (Baseline to Switch)97.8

Percentage of Participants With Non-Virologic Rebound at Week 96 by Kaplan-Meier Estimates

Here Kaplan-Meier estimates percentage of participants with non-virologic rebound at Week 96. (NCT02269917)
Timeframe: Baseline to Week 96 (D/C/F/TAF arm) and from Week 52 to Week 96 (Switch to D/C/F/TAF arm)

Interventionpercentage of participants (Number)
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])96.7
Switch to D/C/F/TAF97.8

Percentage of Participants With Treatment Adherence of >95 (Approach 1) Through Week 96

Treatment adherence (defined as adherence of >95%) was assessed by the drug accountability cumulative through Week 96 (Approach 1). (NCT02269917)
Timeframe: Through Week 96 (D/C/F/TAF arm) and from Week 52 to Week 96 (Switch to D/C/F/TAF arm)

Interventionpercentage of participants (Number)
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])91.6
Switch to D/C/F/TAF87.3

Percentage of Participants With Treatment Adherence of >95% (Approach 2) Through Week 48

Treatment adherence (defined as adherence of >95%) was assessed by the drug accountability cumulative treatment adherence up to time point where not more than one bottle was missing, or if available, through Week 48, whichever came sooner (Approach 2). (NCT02269917)
Timeframe: Through Week 48

Interventionpercentage of participants (Number)
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])82.7
Control (Baseline to Switch)77.2

Percentage of Participants With Treatment Adherence of >95% (Approach 2) Through Week 96

Treatment adherence (defined as adherence of >95%) was assessed by the drug accountability cumulative treatment adherence up to time point where not more than one bottle was missing, or if available, through Week 96, whichever came sooner (Approach 2). (NCT02269917)
Timeframe: Through Week 96 (D/C/F/TAF arm) and from Week 52 to Week 96 (Switch to D/C/F/TAF arm)

Interventionpercentage of participants (Number)
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])82.8
Switch to D/C/F/TAF80.9

Percentage of Participants With Treatment Adherence of >95% From Week 96 to End of Extension

Treatment adherence (defined as adherence of >95%) was assessed by the drug accountability and was calculated cumulative from start of treatment/switch to last study drug intake by determination of the cumulative treatment adherence in participants who returned all dispensed bottles prior to or at the last visit in the study from Week 96 to end of extension. (NCT02269917)
Timeframe: Week 96 to end of extension (up to 42 months)

Interventionpercentage of participants (Number)
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])89.5
Switch to D/C/F/TAF89.4

Percentage of Participants With Treatment Adherence of Greater Than (>)95 Percent (%) (Approach 1) Through Week 48

Treatment adherence (defined as adherence of >95%) was assessed by the drug accountability cumulative through Week 48 (Approach 1). (NCT02269917)
Timeframe: Through Week 48

InterventionPercentage of Participants (Number)
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])91.6
Control (Baseline to Switch)85.3

Percentage of Participants With Virologic Rebound (HIV-1 RNA >=20 Copies/mL) Cumulative Through Week 96

Virologic rebound was defined as: confirmed plasma HIV-1 RNA level >=20 copies/mL up to and including Week 96, last available on-treatment (single) HIV-1 RNA >=20 copies/mL at premature discontinuation (irrespective of reason), and last available on-treatment HIV-1 RNA >=20 copies/mL at the study cutoff of Week 96 (that is, any last viral load [re]test having occurred no later than 6 weeks after Week 96). Percentage of participants with virologic rebound were reported. (NCT02269917)
Timeframe: Through Week 96 (D/C/F/TAF arm) and from Week 52 to Week 96 (Switch to D/C/F/TAF arm)

Interventionpercentage of participants (Number)
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])13.8
Switch to D/C/F/TAF8.8

Percentage of Participants With Virologic Rebound (HIV-1 RNA >=200 Copies/mL) Cumulative Through Week 96

Virologic rebound was defined as: confirmed plasma HIV-1 RNA level >=200 copies/mL up to and including Week 96, last available on-treatment (single) HIV-1 RNA >=200 copies/mL at premature discontinuation (irrespective of reason), and last available on-treatment HIV-1 RNA >=200 copies/mL at the study cutoff of Week 96 (that is, any last viral load [re]test having occurred no later than 6 weeks after Week 96). Percentage of participants with virologic rebound were reported. (NCT02269917)
Timeframe: Through Week 96 (D/C/F/TAF arm) and from Week 52 to Week 96 (Switch to D/C/F/TAF arm)

Interventionpercentage of participants (Number)
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])0.5
Switch to D/C/F/TAF0.6

Percentage of Participants With Virologic Rebound (HIV-1 RNA >=50 Copies/mL) Cumulative Through Week 48

Virologic rebound was defined as: confirmed plasma human immunodeficiency virus - 1 (HIV-1) Ribonucleic Acid (RNA) level greater than or equal to (>=)50 copies per milliliter (copies/mL) up to, and including the upper bound of the Week 48 window (ie, 54 weeks) and last available on-treatment (single) HIV-1 RNA >=50 copies/mL at premature discontinuation (irrespective of reason). Percentage of participants with virologic rebound were reported. (NCT02269917)
Timeframe: Through Week 48

InterventionPercentage of participants (Number)
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])2.5
Control (Baseline to Switch)2.1

Percentage of Participants With Virologic Rebound (HIV-1 RNA >=50 Copies/mL) Cumulative Through Week 96

Virologic rebound was defined as: confirmed plasma HIV-1 RNA level >=50 copies/mL up to and including Week 96, last available on-treatment (single) HIV-1 RNA >=50 copies/mL at premature discontinuation (irrespective of reason), and last available on-treatment HIV-1 RNA >=50copies/mL at the study cutoff of Week 96 (that is, any last viral load [re]test having occurred no later than 6 weeks after Week 96). Percentage of participants with virologic rebound were reported. (NCT02269917)
Timeframe: Through Week 96 (D/C/F/TAF arm) and from Week 52 to Week 96 (Switch to D/C/F/TAF arm)

Interventionpercentage of participants (Number)
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])3.1
Switch to D/C/F/TAF2.3

Percentage of Participants With Virologic Rebound (Plasma HIV-1 RNA >=20 Copies/mL) Cumulative Through 48 Weeks

Virologic rebound was defined as: confirmed plasma HIV-1 RNA >=20 copies/mL up to, and including the upper bound of the Week 48 window (ie, 54 weeks) and last available on-treatment (single) HIV-1 RNA >=20 copies/mL at premature discontinuation (irrespective of reason). Percentage of participants with virologic rebound were reported. (NCT02269917)
Timeframe: Through 48 Weeks

InterventionPercentage of Participants (Number)
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])10.5
Control (Baseline to Switch)11.4

Percentage of Participants With Virologic Rebound (Plasma HIV-1 RNA >=200 Copies/mL) Cumulative Through 48 Weeks

Virologic rebound was defined as: confirmed plasma HIV-1 RNA >=200 copies/mL up to, and including the upper bound of the Week 48 window (ie, 54 weeks) and last available on-treatment (single) HIV-1 RNA >=200 copies/mL at premature discontinuation (irrespective of reason). Percentage of participants with virologic rebound were reported. (NCT02269917)
Timeframe: Through 48 Weeks

InterventionPercentage of Participants (Number)
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])0.4
Control (Baseline to Switch)0.0

CD4+ Cell Count Post-Week 96 to End of Extension

The immunologic change was determined by Cluster of CD4+ cell count. CD4+ cell count post-Week 96 to end of extension were assessed. (NCT02269917)
Timeframe: Week 96 to end of extension (up to 42 months)

,
Interventioncells/mm^3 (Mean)
Week 96 + 6 monthsWeek 96 + 12 monthsWeek 96 + 18 monthsWeek 96 + 24 monthsWeek 96 + 30 monthsWeek 96 + 36 monthsWeek 96 + 42 months
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])706.4707.6713.3712.7730.4732.0714.3
Switch to D/C/F/TAF681.3676.2686.1686.4685.8733.3705.6

Change From Baseline in Bone Mineral Density (BMD) T-Score at Weeks 24 and 48

Change from baseline in spine, hip, and femoral neck BMD T-Score was assessed at Week 24 and 48. T-score values >= -1.0 were considered normal, T-score values < -1.0 to -2.5 indicate osteopenia and T-score values < -2.5 indicate osteoporosis. (NCT02269917)
Timeframe: Baseline, Weeks 24 and 48

,
InterventionUnits on a scale (Mean)
Spine BMD T-score: BaselineSpine BMD T-score: Change at Week 24Spine BMD T-score: Change at Week 48Hip BMD T-score: BaselineHip BMD T-score: Change at Week 24Hip BMD T-score: Change at Week 48Femoral Neck BMD T-score: BaselineFemoral Neck BMD T-score: Change at Week 24Femoral Neck BMD T-score: Change at Week 48
Control (Baseline to Switch)-0.467-0.033-0.063-0.484-0.024-0.016-0.699-0.044-0.039
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])-0.7130.1020.132-0.5750.0370.095-0.7820.0190.039

Change From Baseline in Cluster of Differentiation 4 Plus (CD4+) Cell Count at Weeks 24 and 48

Change from baseline in CD4+ cell count was assessed at Weeks 24 and 48. (NCT02269917)
Timeframe: Baseline, Weeks 24 and 48

,
InterventionCells per cubic millimeter (cells/mm^3) (Mean)
BaselineChange at Week 24Change at Week 48
Control (Baseline to Switch)641.78.59.1
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])653.314.321.0

Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Creatinine (eGFRcr, by Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) at Weeks 24 and 48

Change from baseline in eGFRcr (by CKD-EPI) was assessed at Weeks 24 and 48. eGFRcr per CKD-EPI formula - Female: 1) Serum creatinine (Scr) less than or equal to (<=)0.7 mg/dL: 144*(Scr/0.7)^-0.329*0.993age; 2) Scr greater than (>)0.7 mg/dL: 144*(Scr/0.7)^-1.209*0.993age. Male: 1) Scr <=0.9 mg/dL: 141*(Scr/0.9)^-0.411*0.993age; 2) Scr >0.9 mg/dL: 141*(Scr/0.9)^-1.209*0.993age. (NCT02269917)
Timeframe: Baseline, Weeks 24 and 48

,
InterventionmL/min/1.73 m^2 (Least Squares Mean)
Change at Week 24Change at Week 48
Control (Baseline to Switch)-0.75-0.88
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])-1.67-1.97

Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Creatinine (eGFRcr, by Cockcroft-Gault Formula [eGFRcg]) at Weeks 24 and 48

Change from baseline in eGFRcr (by Cockcroft-Gault formula) was assessed at Weeks 24 and 48. eGFRcr according to the Cockcroft Gault formula- Male: (140 - age in years)*(weight in kilogram [kg])/72*(serum creatinine in milligram per deciliter [mg/dL])=eGFRcr (milliliter per minute [mL/min]); Female: (140 - age in years)*(weight in kg)/72*(serum creatinine in mg/dL)*0.85=eGFRcr (mL/min). (NCT02269917)
Timeframe: Baseline, Weeks 24 and 48

,
Interventionmilliliter per minute (mL/min) (Least Squares Mean)
Change at Week 24Change at Week 48
Control (Baseline to Switch)0.20-0.20
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])-0.38-0.94

Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Cystatin C (eGFRcyst, by Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) at Weeks 24 and 48

Change from baseline in eGFRcyst (by CKD-EPI) was assessed at Weeks 24 and 48. eGFRcyst according to the CKD-EPI formula - 1) Serum Cystatin C (Scyst) <=0.8 mg/L: 133*(Scyst/0.8)^-0.499*0.996age (*0.932 if female); 2) Scyst >0.8 mg/L: 133*(Scyst/0.8)^-1.328*0.996age (*0.932 if female). (NCT02269917)
Timeframe: Baseline, Weeks 24 and 48

,
InterventionmL/min/1.73 m^2 (Least Squares Mean)
eGFRcyst: Change at Week 24eGFRcyst: Change at Week 48
Control (Baseline to Switch)-0.93-1.76
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])0.21-0.42

Change From Baseline in Serum Creatinine Levels at Weeks 24 and 48

Change from baseline in serum creatinine levels at Weeks 24 and 48 was assessed. (NCT02269917)
Timeframe: Baseline and Weeks 24 and 48

,
Interventionmicro mole per liter (Least Squares Mean)
Change at Week 24Change at Week 48
Control (Baseline to Switch)0.880.65
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])1.221.27

Change From Baseline in Urine Albumin to Creatinine Ratio (UACR) and Urine Protein to Creatinine Ratio (UPCR) at Weeks 24 and 48

Change from baseline in UACR and UPCR was assessed at Weeks 24 and 48. Lower levels of albumin or protein in the urine indicates better proximal tubular function. (NCT02269917)
Timeframe: Baseline, Weeks 24 and 48

,
Interventionmilligram per gram (mg/g) (Median)
UACR: BaselineUACR: Change at Week 24UACR: Change at Week 48UPCR: BaselineUPCR: Change at Week 24UPCR: Change at Week 48
Control (Baseline to Switch)7.140.440.4062.900.07-7.37
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])6.20-0.78-0.7661.56-14.63-22.25

Change From Baseline in Urine Retinol Binding Protein to Creatinine Ratio (URBPCR) and Urine Beta-2 Microglobulin to Creatinine Ratio (UB2MGCR) at Weeks 24 and 48

Change from baseline in URBPCR and UB2MGCR was assessed at Weeks 24 and 48. Retinol binding protein is a marker of proximal tubular function. (NCT02269917)
Timeframe: Baseline, Weeks 24 and 48

,
Interventionmicrogram per gram (mcg/g) (Median)
URBPCR: BaselineURBPCR: Change at Week 24URBPCR: Change at Week 48UB2MGCR: BaselineUB2MGCR: Change at Week 24UB2MGCR: Change at Week 48
Control (Baseline to Switch)137.167.7619.66172.2512.0820.24
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])126.19-30.27-27.09156.85-72.64-67.02

Change From Reference in BMD T-score of Hip and Spine at Week 96

BMD status was assessed using BMD T-scores; normal bone status was defined by a BMD T-score >= -1, osteopenia by a T-score >= -2.5 to <-1.0, and osteoporosis by a T-score <-2.5. For the D/C/F/TAF group, reference is the comparative treatment phase baseline as in Week 48 analysis (Reference 1). For the Switch to D/C/F/TAF (late switch) group, the last value prior to the switch was used as reference (reference 2). (NCT02269917)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF+ FTC/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

,
Interventionunits on a scale (Mean)
Hip region BMDSpine region BMD
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])0.1220.176
Switch to D/C/F/TAF0.0770.255

Number of Participants With Resistance to Study Drug Through Week 96

HIV-1 genotypes were analyzed from samples of participants with confirmed virologic rebound in case they had HIV-1 RNA values >=400 copies/mL at failure or at later time points, including participants who discontinued with last HIV-1 RNA >=400 copies/mL. Virologic rebound was defined as: confirmed plasma HIV-1 RNA level >=20 copies/mL up to and including Week 96, last available on-treatment (single) HIV-1 RNA >=20 copies/mL at premature discontinuation (irrespective of reason), and last available on-treatment HIV-1 RNA >=20 copies/mL at the study cutoff of Week 96 (that is, any last viral load [re]test having occurred no later than 6 weeks after Week 96). Number of participants who developed resistance to any of the study drug (DRV, FTC, and TFV/TAF) were reported. (NCT02269917)
Timeframe: Through Week 96 (D/C/F/TAF arm), up to Week 48 (Control arm) and from Week 52 to Week 96 (Switch to D/C/F/TAF arm)

,,
InterventionParticipants (Count of Participants)
DRV resistance-associated mutations (RAMs)TFV RAMsFTC RAMs
Control (Baseline to Switch)000
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])000
Switch to D/C/F/TAF001

Percent Change From Baseline in 25-hydroxy Vitamin D at Weeks 24 and 48

Percent change from baseline in bone biomarker: 25-hydroxy vitamin D was assessed at Weeks 24 and 48. (NCT02269917)
Timeframe: Baseline, Weeks 24 and 48

,
InterventionPercent change (Mean)
Percent change at Week 24Percent change at Week 48
Control (Baseline to Switch)4.224.9
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])-3.025.2

Percent Change From Baseline in Parathyroid Hormone (PTH) at Weeks 24 and 48

Percent change from baseline in bone biomarker: PTH was assessed at Weeks 24 and 48. (NCT02269917)
Timeframe: Baseline, Weeks 24 and 48

,
InterventionPercent change (Mean)
Percent change at Week 24Percent change at Week 48
Control (Baseline to Switch)12.0349.436
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])-3.092-4.510

Percent Change From Baseline in Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Collagen Type 1 Beta Carboxy Telopeptide (CTX) Levels at Weeks 24 and 48

Percent change from baseline in bone biomarkers: P1NP and CTX was assessed at Weeks 24 and 48. (NCT02269917)
Timeframe: Baseline, Weeks 24 and 48

,
InterventionPercent Change (Mean)
P1NP: Percent change at Week 24P1NP: Percent change at Week 48CTX: Percent change at Week 24CTX: Percent change at Week 48
Control (Baseline to Switch)-0.027-3.75116.3125.433
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])-22.971-26.752-16.772-10.517

Percent Change From Baseline in Spine and Hip Bone Mineral Density (BMD) at Weeks 24 and 48

Percent change from baseline in spine and hip BMD was assessed at Weeks 24 and 48. (NCT02269917)
Timeframe: Baseline, Weeks 24 and 48

,
InterventionPercent change (Least Squares Mean)
Spine BMD: Percent change at Week 24Spine BMD: Percent change at Week 48Hip BMD: Percent change at Week 24Hip BMD: Percent change at Week 48
Control (Baseline to Switch)0.180.010.00-0.08
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])1.552.060.911.62

Percent Change From Baseline in Urine Fractional Excretion of Phosphate (FEPO4) at Weeks 24 and 48

Percent change from baseline in urine FEPO4 was assessed at Weeks 24 and 48. (NCT02269917)
Timeframe: Baseline, Weeks 24 and 48

,
InterventionPercent change (Median)
Percent change at Week 24Percent change at Week 48
Control (Baseline to Switch)8.558.57
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])3.588.42

Percent Change From Reference in Hip and Spine BMD at Week 96

"The BMD is the amount of mineral in gram per square centimeter of bone, which was assessed by DXA scan. Positive values are best values and negative values are worst values of change. Percent change from reference in hip and spine BMD was assessed. For the D/C/F/TAF group, reference is the comparative treatment phase baseline as in Week 48 analysis (Reference 1). For the Switch to D/C/F/TAF (late switch) group, the last value prior to the switch was used as reference (reference 2)." (NCT02269917)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF+ FTC/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

,
Interventionpercent change (Mean)
Hip region BMD-T scoreSpine region BMD-T score
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])0.01730.0193
Switch to D/C/F/TAF0.01080.0279

Percentage of Participants Experiencing Grade 3 and 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and Premature Discontinuation Due to AEs Through Week 48

An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 (Severe) events were symptoms causing inability to perform usual social & functional activities. Grade 4 (Life-threatening) events were symptoms causing inability to perform basic self-care functions or medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death. (NCT02269917)
Timeframe: Up to Week 48

,
InterventionPercentage of Participants (Number)
Grade 3 AEsGrade 4 AEsSAEsPremature discontinuations due to AEs
Control (Baseline to Switch)6.31.94.81.3
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])5.61.24.61.4

Percentage of Participants Experiencing Grade 3 and 4 AEs, Serious Adverse Events (SAEs), and Premature Discontinuation Due to AEs Post-Week 96 to End of Extension

AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 (Severe) events were symptoms causing inability to perform usual social & functional activities. Grade 4 (Life-threatening) events were symptoms causing inability to perform basic self-care functions or medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. (NCT02269917)
Timeframe: From Week 96 to end of extension (up to 42 months)

,
Interventionpercentage of participants (Number)
Grade 3 AEsGrade 4 AEsSAEsPremature discontinuations due to AEs
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])5.72.17.31.1
Switch to D/C/F/TAF5.01.57.72.1

Percentage of Participants Experiencing Grade 3 and Grade 4 AEs, SAEs, and Premature Discontinuation Due to AEs Through Week 96

AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 (Severe) events were symptoms causing inability to perform usual social & functional activities. Grade 4 (Life-threatening) events were symptoms causing inability to perform basic self-care functions or medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. (NCT02269917)
Timeframe: Through Week 96 (D/C/F/TAF arm) and from Week 52 to Week 96 (Switch to D/C/F/TAF arm)

,
Interventionpercentage of participants (Number)
Grade 3 AEsGrade 4 AEsSAEsPremature discontinuations due to AEs
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])10.52.48.72.2
Switch to D/C/F/TAF6.31.16.02.0

Percentage of Participants With HIV RNA <50, <20, <200 Copies/mL Post Week 96 to End of Extension

Percentage of participants with HIV RNA <50, <20, <200 copies/mL post Week 96 to end of extension were reported. (NCT02269917)
Timeframe: Week 96 to end of extension (up to 42 months)

,
Interventionpercentage of participants (Number)
Week 96 + 6 months (<50 copies/mL)Week 96 + 12 months (<50 copies/mL)Week 96 + 18 months (<50 copies/mL)Week 96 + 24 months (<50 copies/mL)Week 96 + 30 months (<50 copies/mL)Week 96 + 36 months (<50 copies/mL)Week 96 + 42 months (<50 copies/mL)Week 96 + 6 months (<200 copies/mL)Week 96 + 12 months (<200 copies/mL)Week 96 + 18 months (<200 copies/mL)Week 96 + 24 months (<200 copies/mL)Week 96 + 30 months (<200 copies/mL)Week 96 + 36 months (<200 copies/mL)Week 96 + 42 months (<200 copies/mL)Week 96 + 6 months (<20 copies/mL)Week 96 + 12 months (<20 copies/mL)Week 96 + 18 months (<20 copies/mL)Week 96 + 24 months (<20 copies/mL)Week 96 + 30 months (<20 copies/mL)Week 96 + 36 months (<20 copies/mL)Week 96 + 42 months (<20 copies/mL)
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])97.898.499.699.399.398.110099.199.310099.610010010091.493.996.196.195.694.293.8
Switch to D/C/F/TAF97.997.498.798.510010010099.798.799.199.310010010093.491.492.995.592.296.2100

Percentage of Participants With Non-Treatment Failure by Kaplan-Meier Estimates

Percentage of participants with non-treatment failure by Kaplan-Meier Estimates were reported. Treatment failure was defined as having either protocol-defined virologic rebound or having discontinued for reasons other than alternate access to D/C/F/TAF (or other antiretroviral [ARV]). (NCT02269917)
Timeframe: Week 96 to end of extension (up to 42 months)

Interventionpercentage of participants (Number)
Week 96Week 96 + 6 monthsWeek 96 + 12 monthsWeek 96 + 18 monthsWeek 96 + 24 monthsWeek 96 + 30 monthsWeek 96 + 36 months
Switch to D/C/F/TAF10098.595.492.289.788.182.6

Percentage of Participants With Non-Treatment Failure by Kaplan-Meier Estimates

Percentage of participants with non-treatment failure by Kaplan-Meier Estimates were reported. Treatment failure was defined as having either protocol-defined virologic rebound or having discontinued for reasons other than alternate access to D/C/F/TAF (or other antiretroviral [ARV]). (NCT02269917)
Timeframe: Week 96 to end of extension (up to 42 months)

Interventionpercentage of participants (Number)
Week 96Week 96 + 6 monthsWeek 96 + 12 monthsWeek 96 + 18 monthsWeek 96 + 24 monthsWeek 96 + 30 monthsWeek 96 + 36 monthsWeek 96 + 42 months
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])10098.194.391.689.487.084.981.7

Percentage of Participants With Non-Virologic Rebound by Kaplan-Meier Estimates

Virologic rebound is defined as participants who show confirmed HIV-1 RNA >=50 copies/mL, or for which the last available (single) HIV-1 RNA value on treatment was >=50 copies/mL. Here, Kaplan-Meier estimates (%) of non-virologic rebound at every 6 months interval are presented. (NCT02269917)
Timeframe: Week 96 to end of extension (at every 6 months, up to 42 months)

Interventionpercentage of participants (Number)
Week 96Week 96 + 6 monthsWeek 96 + 12 monthsWeek 96 + 18 monthsWeek 96 + 24 monthsWeek 96 + 30 monthsWeek 96 + 36 months
Switch to D/C/F/TAF10010098.598.196.596.596.5

Percentage of Participants With Non-Virologic Rebound by Kaplan-Meier Estimates

Virologic rebound is defined as participants who show confirmed HIV-1 RNA >=50 copies/mL, or for which the last available (single) HIV-1 RNA value on treatment was >=50 copies/mL. Here, Kaplan-Meier estimates (%) of non-virologic rebound at every 6 months interval are presented. (NCT02269917)
Timeframe: Week 96 to end of extension (at every 6 months, up to 42 months)

Interventionpercentage of participants (Number)
Week 96Week 96 + 6 monthsWeek 96 + 12 monthsWeek 96 + 18 monthsWeek 96 + 24 monthsWeek 96 + 30 monthsWeek 96 + 36 monthsWeek 96 + 42 months
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])10099.498.097.697.195.392.492.4

Percentage of Participants With Virologic Failure Based on HIV-1 RNA >=20, >=50, and >=200 Copies/mL Threshold at Week 96 as Defined by the FDA Snapshot Approach

Percentage of participants with virologic failure based on HIV-1 RNA >=20, >=50, and >=200 copies/mL threshold were analyzed at Week 96 using FDA snapshot approach. FDA Snapshot approach analysis was based on the last observed viral load data: virologic failure was defined by the FDA snapshot approach as having last available HIV-1 RNA >=20/50/200 copies/mL at Week 96; virologic failure - leading to discontinuation; virologic failure - discontinued due to other reason and last available HIV-1 RNA >=20/50/200 copies/mL. (NCT02269917)
Timeframe: Week 96 (Comprising up to Week 96 for D/C/F/TAF and 44 weeks of D/C/F/TAF exposure [that is, from the switch to D/C/F/TAF at Week 52 up to Week 96])

,
Interventionpercentage of participants (Number)
>=20 copies/mL>=50 copies/mL>=200 copies/mL
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])6.81.20.3
Switch to D/C/F/TAF6.01.70

Percentage of Participants With Virologic Response Based on HIV-1 RNA <20, <50, and <200 Copies/mL Threshold at Week 48 as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm

Percentage of participants with virologic response based on HIV-1 RNA <20, <50, and <200 copies/mL threshold were analyzed at Week 48 using TLOVR algorithm approach. TLOVR was defined as sustained HIV-1 RNA <20/50/200 copies/mL. (NCT02269917)
Timeframe: Week 48

,
InterventionPercentage of Participants (Number)
<20 copies/mL<50 copies/mL<200 copies/mL
Control (Baseline to Switch)83.692.994.7
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])86.093.795.4

Percentage of Participants With Virologic Response Based on HIV-1 RNA <20, <50, and <200 Copies/mL Threshold at Week 96 as Defined by the FDA Snapshot Approach

Percentage of participants with virologic response based on HIV-1 RNA <20, <50, and <200 copies/mL threshold were analyzed at Week 96 using FDA snapshot approach. FDA Snapshot approach analysis was based on the last observed viral load data: virologic response was defined as having last available HIV-1 RNA <20/50/200 copies/mL (observed case). (NCT02269917)
Timeframe: Week 96 (Comprising up to Week 96 for D/C/F/TAF and 44 weeks of D/C/F/TAF exposure [that is, from the switch to D/C/F/TAF at Week 52 up to Week 96])

,
Interventionpercentage of participants (Number)
<20 copies/mL<50 copies/mL<200 copies/mL
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])85.390.791.2
Switch to D/C/F/TAF89.893.895.5

Percentage of Participants With Virologic Response Based on HIV-1 RNA <20, <50, and <200 Copies/mL Threshold at Week 96 as Defined by the TLOVR Algorithm

Percentage of participants with virologic response based on HIV-1 RNA <20, <50, and <200 copies/mL threshold were analyzed at Week 96 using TLOVR algorithm approach. TLOVR was defined as sustained HIV-1 RNA <20/50/200 copies/mL. (NCT02269917)
Timeframe: Week 96 (Comprising up to Week 96 for D/C/F/TAF and 44 weeks of D/C/F/TAF exposure [that is, from the switch to D/C/F/TAF at Week 52 up to Week 96])

,
Interventionpercentage of participants (Number)
<20 copies/mL<50 copies/mL<200 copies/mL
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])79.689.691.7
Switch to D/C/F/TAF88.194.395.7

Percentage of Participants With Virologic Response Based on HIV-1 RNA Less Than (<)20, <50, and <200 Copies/mL Threshold at Week 48 as Defined by the Food and Drug Administration (FDA) Snapshot Approach

Percentage of participants with virologic response based on HIV-1 RNA <20, <50, and <200 copies/mL threshold were analyzed at Week 48 using FDA snapshot approach. FDA Snapshot approach analysis was based on the last observed viral load data: virologic response was defined as HIV-1 RNA <20/50/200 copies/mL (observed case). (NCT02269917)
Timeframe: Week 48

,
InterventionPercentage of Participants (Number)
<20 copies/mL<50 copies/mL<200 copies/mL
Control (Baseline to Switch)88.493.794.2
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])89.894.995.0

Predose (Trough) Plasma Concentration (C0h) of Darunavir

Predose (trough) plasma concentration (C0h) of darunavir was determined. Pharmacokinetic (PK) data was only analyzed for participants in the D/C/F/TAF group as per planned analysis. (NCT02269917)
Timeframe: Predose at Weeks 2, 4, 8, 12, 24, 36, and 48

InterventionNanogram per milliliter (ng/mL) (Mean)
Week 2Week 4Week 8Week 12Week 24Week 36Week 48
D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])1775.291732.001910.301643.382022.991806.371899.79

Concentration of Elvitegravir in Cerebrospinal Fluid at Baseline

(NCT02251236)
Timeframe: Baseline

Interventionng/mL (Median)
Stribild Arm4.3
Genvoya Arm2.72

Concentration of Elvitegravir in Cerebrospinal Fluid at Week 24

(NCT02251236)
Timeframe: Week 24

Interventionng/mL (Median)
Stribild Arm5.90
Genvoya Arm3.09

Concentration of Tenofovir in Cerebrospinal Fluid at Baseline

(NCT02251236)
Timeframe: Baseline

Interventionng/mL (Median)
Stribild Arm3.03
Genvoya Arm0.49

Concentration of Tenofovir in Cerebrospinal Fluid at Week 24

(NCT02251236)
Timeframe: Week 24

Interventionng/mL (Median)
Stribild Arm0.507
Genvoya Arm0.481

Change From Baseline in CD4+ Cell Count at Week 24

(NCT02616783)
Timeframe: Baseline; Week 24

Interventioncells/μL (Mean)
E/C/F/TAF48
Stay on Baseline Regimen-4

Change in Baseline in CD4+ Cell Count at Week 48

(NCT02616783)
Timeframe: Baseline; Week 48

Interventioncells/μL (Mean)
E/C/F/TAF56
Stay on Baseline Regimen-1

Percent Change From Baseline to Week 24 in Hip BMD

(NCT02616783)
Timeframe: Baseline; Week 24

InterventionPercent change (Mean)
E/C/F/TAF0.808
Stay on Baseline Regimen-0.537

Percent Change From Baseline to Week 24 in Spine BMD

(NCT02616783)
Timeframe: Baseline; Week 24

InterventionPercent change (Mean)
E/C/F/TAF1.625
Stay on Baseline Regimen-0.027

Percent Change From Baseline to Week 48 in Hip BMD

(NCT02616783)
Timeframe: Baseline; Week 48

InterventionPercent change (Mean)
E/C/F/TAF1.330
Stay on Baseline Regimen-0.726

Percent Change From Baseline to Week 48 in Spine BMD

(NCT02616783)
Timeframe: Baseline; Week 48

InterventionPercent change (Mean)
E/C/F/TAF2.237
Stay on Baseline Regimen-0.104

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02616783)
Timeframe: Week 24

InterventionPercentage of participants (Number)
E/C/F/TAF94.5
Stay on Baseline Regimen100.0

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02616783)
Timeframe: Week 48

InterventionPercentage of participants (Number)
E/C/F/TAF93.6
Stay on Baseline Regimen94.5

Change From Baseline in CD4+ Cell Count at Week 48

(NCT02652624)
Timeframe: Baseline; Week 48

Interventioncells/µL (Mean)
B/F/TAF29
Stay on Baseline Regimen26

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-Defined Snapshot Algorithm

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02652624)
Timeframe: Week 48

Interventionpercentage of participants (Number)
B/F/TAF95.7
Stay on Baseline Regimen95.3

Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the US FDA-Defined Snapshot Algorithm

The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02652624)
Timeframe: Week 48

Interventionpercentage of participants (Number)
B/F/TAF1.7
Stay on Baseline Regimen1.7

Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96

The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT01815736)
Timeframe: Week 96

Interventionpercentage of participants (Number)
E/C/F/TAF90.6
Stay on Baseline Treatment Regimen (SBR)85.3

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT01815736)
Timeframe: Week 96

Interventionpercentage of participants (Number)
E/C/F/TAF92.8
Stay on Baseline Treatment Regimen (SBR)89.1

Change From Baseline in CD4 Cell Count at Weeks 96

The analysis of CD4 cell count included values up to 1 day after the last dose date of randomized study drug.The change from baseline in CD4 cell count for the full analysis set was based on observed data (ie, Missing = Excluded) for the total and by the prior treatment regimen. (NCT01815736)
Timeframe: Baseline; Week 96

,
Interventioncells/uL (Mean)
BaselineChange at Week 96
E/C/F/TAF70160
Stay on Baseline Treatment Regimen (SBR)68942

Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48

The analysis of CD4 cell count included values up to 1 day after the last dose date of randomized study drug.The change from baseline in CD4 cell count for the full analysis set was based on observed data (ie, Missing = Excluded) for the total and by the prior treatment regimen. (NCT01815736)
Timeframe: Baseline; Week 48

,
Interventioncells/uL (Mean)
Baseline (NDA Data Cut)Change at Week 48 (NDA Data Cut)Baseline (All Participants)Change at Week 48 (All Participants)
E/C/F/TAF7123370135
Stay on Baseline Treatment Regimen (SBR)6902768924

Change From Baseline in Serum Creatinine at Week 48

(NCT01815736)
Timeframe: Baseline; Week 48

,
Interventionmg/dL (Mean)
NDA Data CutAll Participants
E/C/F/TAF-0.010.00
Stay on Baseline Treatment Regimen (SBR)0.040.03

Change From Baseline in the Overall EFV-related Symptom Assessment Score at Week 48

"The mean (SD) change of the overall EFV-related symptom assessment score is presented. The overall symptom score (ranging from 0 to 20) is the sum of the individual symptom scores ranging from 0 (no symptoms) to 4 (most severe symptoms) from the 5 EFV-related symptom assessments (dizziness, trouble sleeping, impaired concentration, sleepiness, and abnormal or vivid dream). A negative change from baseline indicates improvement.~EFV-Related Symptom Analysis Set: participants who received EFV/FTC/TDF as prior treatment, received at least 1 dose of study drug, and completed EFV-related symptom assessments at the baseline visit and at least 1 postbaseline visit." (NCT01815736)
Timeframe: Baseline; Week 48

,
Interventionunits on a scale (Mean)
NDA Data CutAll Participants
E/C/F/TAF-1.6-1.5
Stay on Baseline Treatment Regimen (SBR)-0.1-0.1

Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48

Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan. BMD is calculated as grams per square centimeter (g/cm^2); the mean (SD) percentage change is presented. (NCT01815736)
Timeframe: Baseline; Week 48

,
Interventionpercentage change (Mean)
NDA Data CutAll Participants
E/C/F/TAF1.9491.468
Stay on Baseline Treatment Regimen (SBR)-0.136-0.340

Percent Change From Baseline in Spine BMD at Week 48

Spine BMD was assessed by DXA scan. BMD is calculated as g/cm^2; the mean (SD) percentage change is presented. (NCT01815736)
Timeframe: Baseline; Week 48

,
Interventionpercentage change (Mean)
NDA Data CutAll Participants
E/C/F/TAF1.8611.557
Stay on Baseline Treatment Regimen (SBR)-0.110-0.443

Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48

The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT01815736)
Timeframe: Week 48

,
Interventionpercentage of participants (Number)
NDA Data CutAll Participants
E/C/F/TAF92.293.5
Stay on Baseline Treatment Regimen (SBR)90.490.4

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT01815736)
Timeframe: Week 48

,
Interventionpercentage of participants (Number)
NDA Data CutAll Participants
E/C/F/TAF95.697.2
Stay on Baseline Treatment Regimen (SBR)92.993.1

Area Under the Plasma Concentration Time Curve Across the Dosing Interval (AUCtau) of Tenofovir Alafenamide

The AUCtau is the measure of the plasma drug concentration from time zero to end of dosing interval. It is used to characterize drug absorption. (NCT02431247)
Timeframe: 30 minutes to 4 hours postdose at Weeks 2, 4, 12, 24 and 48 and at 2 timepoints with at least 2.5 hours in between sampling at Week 8 and 36 (first sample between 1 and 4 hours postdose)

Interventionh*ng/mL (Mean)
Tenofovir Alafenamide 10 mg [D/C/F/TAF (Test)]132.3117

Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h) of Darunavir

AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours post-dose. (NCT02431247)
Timeframe: 0 to 24 hours post dose

Interventionhours*nanogram per milliliter (h*ng/mL) (Mean)
Darunavir 800 mg [D/C/F/TAF]87909.3282

Change From Baseline in Cluster of Differentiation-4 (CD4+) Cell Count at Week 48

The immunologic change was determined by changes in Cluster of CD4+ cell count. Change from baseline in CD4+ cell count at Week 48 were assessed. (NCT02431247)
Timeframe: Baseline and Week 48

InterventionCells per millimeter cube (cells/mm^3) (Least Squares Mean)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])190.49
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)172.01

Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Creatinine (eGFRcr) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Formula at Week 48

Change from baseline in eGFRcr was calculated using the CKD-EPI equation as per which Stage 1 (normal or high GFR [>=90 mL/min]); Stage 2 (Mild CKD [60 to 90 mL/min]); Stage 3 (Moderate CKD [30 to 59mL/min]); Stage 4 (Severe CKD [15 to 29 mL/min]); Stage 5 (End Stage CKD [<15 mL/min]). The eGFRcr was assessed by calculating serum creatinine (Scr) using the equation: eGFRcr milliliter per minute per 1.72 meter square (mL/min/1.73m^2) = 144*(Scr/0.7)^-0.329*0.993^age (Scr =< 0.7 mg/dL) and eGFRcr mL/min/1.73m^2 = 144*(Scr/0.7)^-1.209*0.993^age (Scr >0.7 mg/dL) for female participants and eGFRcr mL/min/1.73m^2 = 141*(Scr/0.9)^-0.411*0.993^age (Scr =<0.9 mg/dL) and eGFRcr mL/min/1.73m^2 = 141*(Scr/0.9)^-1.209*0.993^age (Scr >0.9 mg/dL) for male participants. (NCT02431247)
Timeframe: Baseline and Week 48

InterventionmL/min/1.73 m^2 (Least Squares Mean)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])-6.04
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)-9.16

Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Creatinine by (Cockcroft-Gault Formula) at Week 48

Change from baseline in eGFRcr by cockcroft-gault formula at Week 48. The eGFRcr was assessed by calculated creatinine clearance (CrCl) using the Cockcroft-Gault formula, and was assessed using CrCl [mL/min] = (140 - A) * W / (72 * C) * R. Where A is age at sample date [years], W is body weight at specific visit (kilogram [kg]), C is the serum concentration of creatinine [mg/dL], R = 1 if the participant is male and = 0.85 if female. (NCT02431247)
Timeframe: Baseline and Week 48

Interventionmilliliter per minute (mL/min) (Least Squares Mean)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])-5.16
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)-11.20

Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Cystatin C (eGFRcyst) by CKD-EPI Formula at Week 48

Change from baseline in eGFRcyst was calculated using the CKD-EPI equation as per which Stage 1 (normal or high GFR) >= 90 indicates normal kidney function; Stage 2 (Mild CKD): 60 to 89 mL/min indicates mildly reduced kidney function; Stage 3 (Moderate CKD): 30 to 59 mL/min indicates moderately reduced kidney function; Stage 4 (Severe CKD): 15 to 29 mL/min indicates severely reduced kidney function; Stage 5 (End Stage of CKD): <15 mL/min indicate very severe or end stage kidney failure. The eGFRcyst was assessed by calculated serum cystatin C (Scyst) using the equation: eGFRcyst mL/min/1.73m^2 = 133 * (Scyst/0,8)^-0.499 * 0.996^age [* 0.932 if female] (Scyst =<0.8 mg/L) and eGFRcr mL/min/1.73m^2 = 133 * (Scyst/0,8)^-1.328 * 0.996^age [* 0.932 if male] (Scyst >0.8 mg/L). (NCT02431247)
Timeframe: Baseline and Week 48

InterventionmL/min/1.73 m^2 (Least Squares Mean)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])5.32
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)2.92

Change From Baseline in log10 HIV-1 RNA Levels at Week 48

Change from baseline in log10 HIV-1 RNA levels were reported. (NCT02431247)
Timeframe: Baseline and Week 48

Interventionlog10 HIV-1 RNA copies per mL (Least Squares Mean)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])-2.95
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)-2.91

Change From Baseline in Serum Creatinine at Week 48

Change from baseline in serum creatinine at Week 48 was reported. (NCT02431247)
Timeframe: Baseline and Week 48

Interventionmilligram per deciliter (mg/dL) (Least Squares Mean)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])0.05
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)0.09

Change From Baseline in Urine Albumin to Creatinine Ratio (UACR) at Week 48

Change from baseline in UACR at Week 48 was reported. (NCT02431247)
Timeframe: Baseline and Week 48

Interventionmg/g (Median)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])-0.58
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)-0.15

Change From Baseline in Urine Beta-2 Microglobulin to Creatinine Ratio (UB2MGCR) at Week 48

Change from baseline in UB2MGCR at Week 48 were reported. (NCT02431247)
Timeframe: Baseline and Week 48

Interventionmcg/g (Median)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])-30.42
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)18.36

Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) at Week 48

Change from baseline in UPCR at Week 48 was reported. (NCT02431247)
Timeframe: Baseline and Week 48

Interventionmilligram per gram (mg/g) (Median)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])-15.72
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)-10.53

Change From Baseline in Urine Retinol Binding Protein To Creatinine Ratio (URBPCR) at Week 48

Change from baseline in URBPCR at Week 48 were reported. (NCT02431247)
Timeframe: Baseline and Week 48

Interventionmicrogram per gram (mcg/g) (Median)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])7.00
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)35.02

Change From Reference in ALP Levels

Change from reference in ALP levels at Week 96 was reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

InterventionU/L (Mean)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])-0.9
Switch to D/C/F/TAF-9.7

Change From Reference in CD4+ Cell Count at Week 96

The immunologic change was determined by changes in cluster of differentiation (CD4+) cell count. Change from reference in CD4+ cell count at Week 96 was assessed. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

Interventioncells/mm^3 (Least Squares Mean)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])228.85
Switch to D/C/F/TAF27.01

Change From Reference in eGFRcr by CKD-EPI Formula

Change from reference in eGFRcr was calculated using the CKD-EPI equation as per Stage 1 (normal or high GFR) to Stage 5 (End Stage of CKD). The eGFRcr was assessed by calculating serum creatinine (Scr) using the CKD-EPI equation: eGFRcr milliliter per minute per 1.72 meter square (mL/min/1.73m^2) = 144 * (Scr/0.7)^-0.329 * 0.993^age (Scr =< 0.7 mg/dL) and eGFRcr mL/min/1.73m^2 = 144 * (Scr/0.7)^-1.209 * 0.993^age (Scr >0.7 mg/dL) for female participants and eGFRcr mL/min/1.73m^2 = 141 x (Scr/0.9)^-0.411 x 0.993^age (Scr =<0.9 mg/dL) and eGFRcr mL/min/1.73m^2 = 141 * (Scr/0.9)^-1.209 x 0.993^age (Scr >0.9 mg/dL) for male participants. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

InterventionmL/min/1.73 m^2 (Median)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])-5.6
Switch to D/C/F/TAF2.3

Change From Reference in Estimated Glomerular Filtration Rate Based on Serum Creatinine by Cockcroft-Gault Formula

Change from reference in eGFRcr by cockcroft-gault formula was reported. The eGFRcr was assessed by calculated creatinine clearance (CrCl) using the Cockcroft-Gault formula, and was assessed using CrCl [mL/min] = (140 - A) * W / (72 * C) * R. Where A is age at sample date [years], W is body weight at specific visit (kilogram [kg]), C is the serum concentration of creatinine [mg/dL], R = 1 if the participant is male and = 0.85 if female. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

InterventionmL/min (Median)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])-5.2
Switch to D/C/F/TAF4.6

Change From Reference in Estimated Glomerular Filtration Rate Based on Serum Cystatin C (eGFRcyst) by CKD-EPI Formula

Change from reference in eGFRcyst was calculated using the CKD-EPI equation as per Stage 1 (normal or high GFR) to Stage 5 (End Stage of CKD): <15 mL/min indicate very severe or end stage kidney failure. The eGFRcyst was assessed by calculated serum cystatin C (Scyst) using the CKD-EPI equation: eGFRcyst mL/min/1.73m^2 = 133 * (Scyst/0,8)^-0.499 * 0.996^age [x 0.932 if female] (Scyst =<0.8 mg/L) and eGFRcr mL/min/1.73m^2 = 133 * (Scyst/0,8)^-1.328 * 0.996^age [* 0.932 if male] (Scyst >0.8 mg/L). Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

InterventionmL/min/1.73 m^2 (Median)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])4.4
Switch to D/C/F/TAF0

Change From Reference in Levels of 25-OH Vitamin D

Change from reference in 25-OH Vitamin D were reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

Interventionnmol/L (Mean)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])21.3
Switch to D/C/F/TAF-10.3

Change From Reference in Levels of PTH

Change from reference in PTH levels were reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

Interventionpmol/L (Mean)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])-0.290
Switch to D/C/F/TAF-1.283

Change From Reference in Levels of Serum CTX

Change from reference in serum CTX levels were reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

Interventionmcg/L (Mean)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])0.041
Switch to D/C/F/TAF-0.162

Change From Reference in Levels of Serum P1NP

Change from reference in serum P1NP levels were reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

Interventionmcg/L (Mean)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])2.817
Switch to D/C/F/TAF-11.963

Change From Reference in log10 HIV-1 RNA Levels at Week 96

Change from reference in log10 HIV-1 RNA levels were reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for Test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

Interventionlog10 HIV-1 RNA copies per mL (Least Squares Mean)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])-2.72
Switch to D/C/F/TAF-0.0027

Change From Reference in Serum Creatinine

Change from reference in serum creatinine was reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

Interventionmg/dL (Median)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])0.045
Switch to D/C/F/TAF-0.034

Change From Reference in UACR

Change from reference in UACR at Week 96 was reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

Interventionmg/g (Median)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])-0.70
Switch to D/C/F/TAF-0.49

Change From Reference in UB2MGCR

Change from reference in UB2MGCR was reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

Interventionmcg/g (Median)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])-27.04
Switch to D/C/F/TAF-40.53

Change From Reference in UPCR

Change from reference in UPCR was reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF+ FTC/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

Interventionmg/g (Median)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])-15.46
Switch to D/C/F/TAF-1.40

Change From Reference in URBPCR

Change from reference in URBPCR at Week 96 were reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

Interventionmcg/g (Median)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])13.70
Switch to D/C/F/TAF-35.53

Percent Change From Baseline in Urine Fractional Excretion of Phosphate (FEPO4) at Week 48

Percent change from baseline in FEPO4 at Week 48 was reported. (NCT02431247)
Timeframe: Baseline and Week 48

InterventionPercent change (Median)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])16.00
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)22.55

Percent Change From Reference in Urine FEPO4

Percent change from reference in FEPO4 at Week 96 were reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

InterventionPercent change in urine FEPO4 (Median)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])18.52
Switch to D/C/F/TAF-7.51

Percentage of Participants With HIV-1 RNA <50 Copies Per mL at Week 96 Defined by FDA Snapshot Approach

Percentage of participants with a HIV-1 RNA < 50 copies per mL were assessed using FDA snapshot approach which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. The snapshot approach classified participants into 3 outcome categories: 1) virologic success (HIV RNA < 20/50/200 copies per mL at Week 96), 2) virologic failure (HIV RNA greater than or equal to [>=] 20/50/200 copies per mL at Week 96), 3) no viral load data in the Week 96 visit window (discontinued due to adverse event/death/other reason). The missing HIV-1 RNA is considered as non-response. (NCT02431247)
Timeframe: At Week 96

Interventionpercentage of participants (Number)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])85.1
Switch to D/C/F/TAF94.2

Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Less Than (<) 50 Copies Per Milliliter (Copies Per mL) (Virologic Response) at Week 48 Defined by Food and Drug Administration (FDA) Snapshot Approach

Percentage of participants with a HIV-1 RNA < 50 copies per mL were assessed using FDA snapshot approach which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. The snapshot approach classified participants into 3 outcome categories: 1) virologic success (HIV RNA < 20/50/200 copies per mL at Week 48), 2) virologic failure (HIV RNA greater than or equal to [>=] 20/50/200 copies per mL at Week 48), 3) no viral load data in the Week 48 visit window (discontinued due to adverse event/death/other reason). The missing HIV-1 RNA is considered as non-response. (NCT02431247)
Timeframe: At Week 48

Interventionpercentage of participants (Number)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])91.4
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)88.4

Plasma Concentrations 2 Hours After Dosing (C0-2h) of Tenofovir Alafenamide

C0-2h is defined as the plasma concentrations 2 hours after dosing. (NCT02431247)
Timeframe: 0 to 2 hours post dose

Interventionng/mL (Mean)
Tenofovir Alafenamide 10 mg [D/C/F/TAF (Test)]11.9785

Predose (Trough) Plasma Concentration (C0h) of Darunavir

C0h is defined as the predose (trough) plasma concentration or concentration just prior to study drug administration. (NCT02431247)
Timeframe: 30 minutes to 4 hours postdose at Weeks 2, 4, 12, 24 and 48 and at 2 timepoints with at least 2.5 hours in between sampling at Week 8 and 36 (first sample between 1 and 4 hours postdose)

Interventionnanogram per milliliter (ng/mL) (Mean)
Darunavir 800 mg [D/C/F/TAF (Test)]1898.9100

CD4+ Cell Count Post-Week From 96 to End of Extension

The immunologic change was determined by Cluster of CD4+ cell count. CD4+ cell count post-Week 96 to end of extension were assessed. (NCT02431247)
Timeframe: Week 96 to end of extension (up to 3 years)

,
Interventioncells/mm^3 (Mean)
Week 96 + 6 monthsWeek 96 + 12 monthsWeek 96 + 18 monthsWeek 96 + 24 monthsWeek 96 + 30 monthsWeek 96 + 36 months
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])790.2779.4789.8781.9741.6784.7
Switch to D/C/F/TAF749.7774.3758.4784.1736.7778.4

Change From Baseline in Alkaline Phosphatase (ALP) Levels at Weeks 24 and 48

Change from baseline in ALP at Weeks 24 and 48 was reported. (NCT02431247)
Timeframe: Baseline, Weeks 24 and 48

,
InterventionUnits per liter (U/L) (Mean)
Week 24Week 48
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])-3.2-1.1
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)12.015.1

Change From Baseline in BMD T-score of Hip and Spine

BMD status was assessed using BMD T-scores; normal bone status was defined by a BMD T-score >= -1, osteopenia by a T-score >= -2.5 to <-1.0, and osteoporosis by a T-score <-2.5. (NCT02431247)
Timeframe: Baseline, Weeks 24 and 48

,
InterventionBMD T-score (Mean)
Hip region BMD T-score (Week 24)Spine region BMD T-score (Week 24)Hip region BMD T-score (Week 48)Spine region BMD T-score (Week 48)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])0.019-0.1210.015-0.061
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)-0.109-0.322-0.177-0.225

Change From Baseline in Levels of 25-Hydroxyvitamin D (25-OH Vitamin D), at Week 24 and 48

Change from baseline in 25-OH Vitamin D levels at Week 24 and 48 were reported. (NCT02431247)
Timeframe: Baseline, Weeks 24 and 48

,
Interventionnanomol per liter (nmol/L) (Mean)
Week 24Week 48
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])12.716.9
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)22.128.3

Change From Baseline in Levels of Parathyroid Hormone (PTH) at Weeks 24 and 48

Change from baseline in PTH at Weeks 24 and 48 were reported. (NCT02431247)
Timeframe: Baseline, Weeks 24 and 48

,
InterventionPicomol per liter (pmol/L) (Mean)
Week 24Week 48
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])0.113-0.004
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)0.7770.633

Change From Baseline in Levels of Serum Collagen Type 1 Beta Carboxy Telopeptide (CTX) at Weeks 24 and 48

Change from baseline in serum CTX at Weeks 24 and 48 were reported. (NCT02431247)
Timeframe: Baseline, Weeks 24 and 48

,
Interventionmcg/L (Mean)
Week 24Week 48
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])0.0470.046
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)0.2830.226

Change From Baseline in Levels of Serum Procollagen 1 N-Terminal Propeptide (P1NP) at Weeks 24 and 48

Change from baseline in serum P1NP at Weeks 24 and 48 were reported. (NCT02431247)
Timeframe: Baseline, Weeks 24 and 48

,
Interventionmicrogram per liter (mcg/L) (Mean)
Week 24Week 48
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])1.8920.065
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)24.67924.251

Change From Reference in BMD T-score of Hip and Spine at Week 96

BMD status was assessed using BMD T-scores; normal bone status was defined by a BMD T-score >= -1, osteopenia by a T-score >= -2.5 to <-1.0, and osteoporosis by a T-score <-2.5. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

,
InterventionBMD T-score (Mean)
Hip region BMD T-scoreSpine region BMD T-score
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])-0.016-0.090
Switch to D/C/F/TAF0.0250.034

Number of Participants With ARV Resistance

Number of participants with DRV, FTC, TDF/TAF resistance were reported. (NCT02431247)
Timeframe: Baseline to end of extension (up to 4 years)

,,
InterventionParticipants (Count of Participants)
DRV resistance-associated mutations (RAMs)TFV RAMsFTC RAMs
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])002
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)001
Switch to D/C/F/TAF002

Percent Change From Baseline in Hip and Spine Bone Mineral Density (BMD)

"The BMD is the amount of mineral in gram per square centimeter of bone, which was assessed by dual energy x-ray absorptiometry (DEXA) scan. Positive values are best values and negative values are worst values of change. Percent change from baseline in hip and spine BMD was assessed." (NCT02431247)
Timeframe: Baseline, Weeks 24 and 48

,
InterventionPercent change (Least Squares Mean)
Hip region BMD (Week 24)Spine region BMD (Week 24)Hip region BMD (Week 48)Spine region BMD (Week 48)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])0.29-1.340.17-0.68
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)-1.66-3.43-2.69-2.38

Percent Change From Reference in Hip and Spine BMD

"The BMD is the amount of mineral in gram per square centimeter of bone, which was assessed by DEXA scan. Positive values are best values and negative values are worst values of change. Percent change from reference in hip and spine BMD was assessed. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group." (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF

,
InterventionPercent change in BMD (Mean)
Hip region BMDSpine region BMD
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])-0.2565-0.9349
Switch to D/C/F/TAF0.54670.4829

Percentage of Participants With >95% Treatment Adherence Assessed by Drug Accountability

Treatment adherence assessed by drug accountability (based on pill count) from start of treatment/switch to last study drug intake by determination of the cumulative treatment adherence in participants who returned all dispensed bottles prior to or at the last visit in the study. Adherent participants were defined as having an adherence >95% as assessed by drug accountability. (NCT02431247)
Timeframe: Baseline to Switch and switch to EOE to Open-Label D/C/F/TAF (Up to 3 years)

Interventionpercentage of participants (Number)
Baseline to Switch (double-blind treatment)
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)82.6

Percentage of Participants With >95% Treatment Adherence Assessed by Drug Accountability

Treatment adherence assessed by drug accountability (based on pill count) from start of treatment/switch to last study drug intake by determination of the cumulative treatment adherence in participants who returned all dispensed bottles prior to or at the last visit in the study. Adherent participants were defined as having an adherence >95% as assessed by drug accountability. (NCT02431247)
Timeframe: Baseline to Switch and switch to EOE to Open-Label D/C/F/TAF (Up to 3 years)

Interventionpercentage of participants (Number)
Switch to End of Extension (open-label D/C/F/TAF)
Switch to D/C/F/TAF88.7

Percentage of Participants With >95% Treatment Adherence Assessed by Drug Accountability

Treatment adherence assessed by drug accountability (based on pill count) from start of treatment/switch to last study drug intake by determination of the cumulative treatment adherence in participants who returned all dispensed bottles prior to or at the last visit in the study. Adherent participants were defined as having an adherence >95% as assessed by drug accountability. (NCT02431247)
Timeframe: Baseline to Switch and switch to EOE to Open-Label D/C/F/TAF (Up to 3 years)

Interventionpercentage of participants (Number)
Baseline to Switch (double-blind treatment)Switch to End of Extension (open-label D/C/F/TAF)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])87.292.2

Percentage of Participants With Grade 3 and 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and Premature Discontinuations Due to Adverse Events Through Week 48

AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events. SAE is any adverse event (AE) that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. (NCT02431247)
Timeframe: Up to Weeks 48

,
Interventionpercentage of participants (Number)
Grade 3 AEsGrade 4 AEsSAEsPremature discontinuations due to AEs
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])4.70.64.71.9
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)4.41.75.84.4

Percentage of Participants With Grade 3 and 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and Premature Discontinuations Due to Adverse Events Through Week 96

AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events. SAE is any adverse event (AE) that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. (NCT02431247)
Timeframe: Up to Week 96

,
Interventionpercentage of participants (Number)
Grade 3 AEsGrade 4 AEsSAEsPremature discontinuations due to AEs
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])11.60.810.82.8
Switch to D/C/F/TAF3.71.42.70.3

Percentage of Participants With Grade 3 and 4 AEs, SAEs, and Premature Discontinuations Due to Adverse Events Post-Week 96 to End of Extension

AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events. SAE is any adverse event (AE) that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. (NCT02431247)
Timeframe: From Week 96 to end of extension (up to 3 years)

,
Interventionpercentage of participants (Number)
Grade 3 AEsGrade 4 AEsSAEsPremature discontinuations due to AEs
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])3.503.21.0
Switch to D/C/F/TAF5.21.34.81.3

Percentage of Participants With HIV RNA <50, <20, and <200 Copies/mL Post-week 96 to End of Extension

Percentage of participants with HIV RNA <50, <20, and <200 copies/mL post Week 96 to end of extension were reported. (NCT02431247)
Timeframe: Week 96 to end of extension (up to 3 years)

,
Interventionpercentage of participants (Number)
Week 96 + 6 months (<50 copies/mL)Week 96 + 12 months (<50 copies/mL)Week 96 + 18 months (<50 copies/mL)Week 96 + 24 months (<50 copies/mL)Week 96 + 30 months (<50 copies/mL)Week 96 + 36 months (<50 copies/mL)Week 96 + 6 months (<20 copies/mL)Week 96 + 12 months (<20 copies/mL)Week 96 + 18 months (<20 copies/mL)Week 96 + 24 months (<20 copies/mL)Week 96 + 30 months (<20 copies/mL)Week 96 + 36 months (<20 copies/mL)Week 96 + 6 months (<200 copies/mL)Week 96 + 12 months (<200 copies/mL)Week 96 + 18 months (<200 copies/mL)Week 96 + 24 months (<200 copies/mL)Week 96 + 30 months (<200 copies/mL)Week 96 + 36 months (<200 copies/mL)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])97.799.098.197.594.7100.085.889.792.490.189.594.799.7100.098.797.596.5100.0
Switch to D/C/F/TAF96.396.798.295.791.468.888.291.692.887.084.562.599.399.598.297.898.387.5

Percentage of Participants With HIV-1 RNA < 20, 50, and 200 Copies Per mL at Week 48 and 96 Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm

Percentage of participants with HIV-1 RNA less than (<) 20, 50, and 200 copies per mL at Weeks 48 and 96 based on TLOVR algorithm were assessed. TLOVR requires sustained HIV-1 RNA < 50 copies per mL; confirmed HIV-1 RNA >= 50 copies per mL is considered as non-response (rebound); participant is considered non-responder after permanent discontinuation. (NCT02431247)
Timeframe: At Week 48 and 96

Interventionpercentage of participants (Number)
At Week 48: < 20 Copies per mLAt Week 48: <50 Copies per mLAt Week 48: <200 Copies per mL
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)79.988.791.7

Percentage of Participants With HIV-1 RNA < 20, 50, and 200 Copies Per mL at Week 48 and 96 Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm

Percentage of participants with HIV-1 RNA less than (<) 20, 50, and 200 copies per mL at Weeks 48 and 96 based on TLOVR algorithm were assessed. TLOVR requires sustained HIV-1 RNA < 50 copies per mL; confirmed HIV-1 RNA >= 50 copies per mL is considered as non-response (rebound); participant is considered non-responder after permanent discontinuation. (NCT02431247)
Timeframe: At Week 48 and 96

Interventionpercentage of participants (Number)
At Week 96: <20 Copies per mLAt Week 96: <50 Copies per mLAt Week 96: <200 Copies per mL
Switch to D/C/F/TAF78.493.896.9

Percentage of Participants With HIV-1 RNA < 20, 50, and 200 Copies Per mL at Week 48 and 96 Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm

Percentage of participants with HIV-1 RNA less than (<) 20, 50, and 200 copies per mL at Weeks 48 and 96 based on TLOVR algorithm were assessed. TLOVR requires sustained HIV-1 RNA < 50 copies per mL; confirmed HIV-1 RNA >= 50 copies per mL is considered as non-response (rebound); participant is considered non-responder after permanent discontinuation. (NCT02431247)
Timeframe: At Week 48 and 96

Interventionpercentage of participants (Number)
At Week 48: < 20 Copies per mLAt Week 48: <50 Copies per mLAt Week 48: <200 Copies per mLAt Week 96: <20 Copies per mLAt Week 96: <50 Copies per mLAt Week 96: <200 Copies per mL
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])82.691.293.173.285.186.7

Percentage of Participants With HIV-1 RNA <20 and 200 Copies Per mL at Weeks 48 and 96 Defined by FDA Snapshot Approach

Percentage of participants with HIV-1 RNA < 20/200 copies per mL using FDA snapshot approach were reported. The snapshot approach classified participants into 3 outcome categories: 1) virologic success (HIV RNA < 20/50/200 copies per mL at Week 48 and 96), 2) virologic failure (HIV RNA >= 20/50/200 copies per mL at Week 48 and 96), 3) no viral load data in the Week 48 and 96 visit window (discontinued due to adverse event/death/other reason). The missing HIV-1 RNA is considered as non-response. (NCT02431247)
Timeframe: At Weeks 48 and 96

Interventionpercentage of participants (Number)
At week 48: <20 Copies per mLAt week 48: <200 Copies per mL
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)79.390.6

Percentage of Participants With HIV-1 RNA <20 and 200 Copies Per mL at Weeks 48 and 96 Defined by FDA Snapshot Approach

Percentage of participants with HIV-1 RNA < 20/200 copies per mL using FDA snapshot approach were reported. The snapshot approach classified participants into 3 outcome categories: 1) virologic success (HIV RNA < 20/50/200 copies per mL at Week 48 and 96), 2) virologic failure (HIV RNA >= 20/50/200 copies per mL at Week 48 and 96), 3) no viral load data in the Week 48 and 96 visit window (discontinued due to adverse event/death/other reason). The missing HIV-1 RNA is considered as non-response. (NCT02431247)
Timeframe: At Weeks 48 and 96

Interventionpercentage of participants (Number)
At week 96: <20 Copies per mLAt week 96: <200 Copies per mL
Switch to D/C/F/TAF83.596.9

Percentage of Participants With HIV-1 RNA <20 and 200 Copies Per mL at Weeks 48 and 96 Defined by FDA Snapshot Approach

Percentage of participants with HIV-1 RNA < 20/200 copies per mL using FDA snapshot approach were reported. The snapshot approach classified participants into 3 outcome categories: 1) virologic success (HIV RNA < 20/50/200 copies per mL at Week 48 and 96), 2) virologic failure (HIV RNA >= 20/50/200 copies per mL at Week 48 and 96), 3) no viral load data in the Week 48 and 96 visit window (discontinued due to adverse event/death/other reason). The missing HIV-1 RNA is considered as non-response. (NCT02431247)
Timeframe: At Weeks 48 and 96

Interventionpercentage of participants (Number)
At week 48: <20 Copies per mLAt week 48: <200 Copies per mLAt week 96: <20 Copies per mLAt week 96: <200 Copies per mL
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])82.692.876.286.2

Percentage of Participants With Non-PDVF by Kaplan-Meier Estimates

Percentage of participants with non-PDVF by Kaplan-Meier Estimates were reported. PDVF was defined as having virologic non-response (HIV-1 RNA <1 log10 reduction from baseline and >=50 copies/mL at the Week 8 visit, confirmed at the next visit), virologic rebound (confirmed HIV-1 RNA >=50 copies/mL after confirmed consecutive HIV-1 RNA <50 copies/mL or confirmed >1 log10 increase in HIV-1 RNA from nadir), or viremic at final time point (final available on treatment HIV-1 RNA >=400 copies/mL). (NCT02431247)
Timeframe: From Week 96 to end of extension (up to 2 years and 6 months)

,
Interventionpercentage of participants (Number)
Week 96Week 96 + 6 monthsWeek 96 + 12 monthsWeek 96 + 18 monthsWeek 96 + 24 monthsWeek 96 + 30 months
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])10099.699.698.697.397.3
Switch to D/C/F/TAF10099.299.297.897.892.5

Percentage of Participants With PDVF Post-week 96 to End of Extension

Percentage of participants with PDVF were reported. Protocol-defined virologic failure was defined as having virologic non-response (HIV-1 RNA <1 log10 reduction from baseline and >=50 copies/mL at the Week 8 visit, confirmed at the next visit), virologic rebound (confirmed HIV-1 RNA >=50 copies/mL after confirmed consecutive HIV-1 RNA <50 copies/mL or confirmed >1 log10 increase in HIV-1 RNA from nadir), or viremic at final time point (final available on treatment HIV-1 RNA >=400 copies/mL). (NCT02431247)
Timeframe: Week 96 to end of extension (up to 3 years)

,
Interventionpercentage of participants (Number)
Participants who met PDVFVirologic non-responseVirologic reboundViremic at final time point
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])1.001.00
Switch to D/C/F/TAF2.101.40.7

Percentage of Participants With Protocol-defined Virologic Failure (PDVF)

Percentage of participants with PDVF were reported. Protocol-defined virologic failure was defined as having virologic non-response (HIV-1 RNA <1 log10 reduction from baseline and >=50 copies/mL at the Week 8 visit, confirmed at the next visit), virologic rebound (confirmed HIV-1 RNA >=50 copies/mL after confirmed consecutive HIV-1 RNA <50 copies/mL or confirmed >1 log10 increase in HIV-1 RNA from nadir), or viremic at final time point (final available on treatment HIV-1 RNA >=400 copies/mL). (NCT02431247)
Timeframe: From Baseline up to Week 96

Interventionpercentage of participants (Number)
Participants who met PDVF (Baseline - Switch)Virologic non-response (Baseline - Switch)Virologic rebound (Baseline - Switch)Viremic at final time point (Baseline - Switch)
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)4.403.90.6

Percentage of Participants With Protocol-defined Virologic Failure (PDVF)

Percentage of participants with PDVF were reported. Protocol-defined virologic failure was defined as having virologic non-response (HIV-1 RNA <1 log10 reduction from baseline and >=50 copies/mL at the Week 8 visit, confirmed at the next visit), virologic rebound (confirmed HIV-1 RNA >=50 copies/mL after confirmed consecutive HIV-1 RNA <50 copies/mL or confirmed >1 log10 increase in HIV-1 RNA from nadir), or viremic at final time point (final available on treatment HIV-1 RNA >=400 copies/mL). (NCT02431247)
Timeframe: From Baseline up to Week 96

Interventionpercentage of participants (Number)
Participants who met PDVF (Baseline - Week 96)Virologic non-response (Baseline - Week 96)Virologic rebound (Baseline-Week 96)Viremic at final time point (Baseline-Week 96)
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])4.10.60.30.6

Percentage of Participants With Protocol-defined Virologic Failure (PDVF)

Percentage of participants with PDVF were reported. Protocol-defined virologic failure was defined as having virologic non-response (HIV-1 RNA <1 log10 reduction from baseline and >=50 copies/mL at the Week 8 visit, confirmed at the next visit), virologic rebound (confirmed HIV-1 RNA >=50 copies/mL after confirmed consecutive HIV-1 RNA <50 copies/mL or confirmed >1 log10 increase in HIV-1 RNA from nadir), or viremic at final time point (final available on treatment HIV-1 RNA >=400 copies/mL). (NCT02431247)
Timeframe: From Baseline up to Week 96

Interventionpercentage of participants (Number)
Participants who met PDVF (Switch - Week 96)Virologic non-response (Switch - Week 96)Virologic rebound (Switch - Week 96)Viremic at final time point (Switch - Week 96)
Switch to D/C/F/TAF1.101.10

Percentage of Participants With Time to Treatment Failure by Kaplan-Meier Estimates

Percentage of participants with time to treatment failure by Kaplan-Meier Estimates were reported. Treatment failure was defined as having either protocol-defined virologic failure or having discontinued for reasons other than alternate access to D/C/F/TAF (or other ARVs). (NCT02431247)
Timeframe: From Week 96 to end of extension (up to 3 years)

Interventionpercentage of participants (Number)
Week 96Week 96 + 6 monthsWeek 96 + 12 monthsWeek 96 + 18 monthsWeek 96 + 24 monthsWeek 96 + 30 months
Switch to D/C/F/TAF10097.494.189.586.479.1

Percentage of Participants With Time to Treatment Failure by Kaplan-Meier Estimates

Percentage of participants with time to treatment failure by Kaplan-Meier Estimates were reported. Treatment failure was defined as having either protocol-defined virologic failure or having discontinued for reasons other than alternate access to D/C/F/TAF (or other ARVs). (NCT02431247)
Timeframe: From Week 96 to end of extension (up to 3 years)

Interventionpercentage of participants (Number)
Week 96Week 96 + 6 monthsWeek 96 + 12 monthsWeek 96 + 18 monthsWeek 96 + 24 monthsWeek 96 + 30 monthsWeek 96 + 36 months
D/C/F/TAF (Test) (Baseline to End of Extension [EOE])10098.995.690.687.184.884.8

Duration of Hospitalizations

Duration of hospitalizations in days was reported for those participants hospitalized during the course of the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this OM. (NCT03227861)
Timeframe: Up to Week 48

InterventionDays (Median)
D/C/F/TAF: Main Study5.0

Number of Participants That Required Discontinuation After Enrollment Based on Safety Stopping Rules

Number of participants that required discontinuation after enrollment based on safety stopping rules were reported. Stopping rules include the following reasons: a). Estimated glomerular filtration rate (eGFR) according to the Modification of Diet in Renal Disease (MDRD) formula < 50 milliliter per minute (mL/min) b). Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than or equal to (>=) 2.5*upper limit of normal (ULN); c). Serum lipase >=1.5*ULN; d). Positive serum human chorionic gonadotropin pregnancy test (beta-hCG) for women of childbearing potential; e). Laboratory results that the investigator believes should result in discontinuation of study medication; f). Participants identified with active hepatitis C virus (HCV) infection that in the opinion of the investigator requires HCV treatment immediately or expected to be needed during the course of the study with agents not compatible with D/C/F/TAF FDC. (NCT03227861)
Timeframe: Up to Week 48

InterventionParticipants (Count of Participants)
D/C/F/TAF: Main Study3

Number of Participants With Emergency Room Visits

Number of participants with emergency room visits was reported. (NCT03227861)
Timeframe: Up to Week 48

InterventionParticipants (Count of Participants)
D/C/F/TAF: Main Study19

Number of Participants With Hospitalizations

Number of participants with hospitalizations (overnight) was reported. (NCT03227861)
Timeframe: Up to Week 48

InterventionParticipants (Count of Participants)
D/C/F/TAF: Main Study11

Percentage of Participants Developing Resistance-associated Mutation (RAMs) and Loss of Phenotypic Susceptibility, Upon Meeting Protocol-defined Virologic Failure (PDVF)

Percentage of participants developing RAMs and loss of phenotypic susceptibility, upon meeting PDVF were reported. Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA <1 log10 reduction from baseline, and HIV-1 RNA greater than or equal to (>=) 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA <50 copies/mL, a rebound in HIV 1 RNA to >= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a >1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result. (NCT03227861)
Timeframe: Up to Week 48

InterventionPercentage of participants (Number)
D/C/F/TAF: Main Study0

Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs)

Percentage of participants discontinuing therapy due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. (NCT03227861)
Timeframe: Up to Week 48

InterventionPercentage of participants (Number)
D/C/F/TAF: Main Study0.9

Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs) Through Week 96

Percentage of participants discontinuing therapy due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. (NCT03227861)
Timeframe: Up to Week 96

InterventionPercentage of participants (Number)
D/C/F/TAF: Extension Study1.3

Percentage of Participants Lost-to-Follow-up Throughout the 48 Weeks of Treatment

Percentage of participants lost-to-follow-up throughout the 48 Weeks of treatment were reported. (NCT03227861)
Timeframe: Up to Week 48

InterventionPercentage of participants (Number)
D/C/F/TAF: Main Study3.67

Percentage of Participants Meeting Resistance Stopping Rules, Requiring Discontinuation of Study Treatment Due to Baseline Resistance Findings

Percentage of participants meeting resistance stopping rules, requiring discontinuation of study treatment due to baseline resistance findings were reported. Investigator reviewed antiretroviral screening/baseline resistance data at Week 4, depending on availability of screening/baseline HIV genotypic drug resistance testing results from central laboratory. Participants who do not show full sensitivity to all drugs in the fixed-dose combination (FDC) study regimen according to the susceptibility assessment in the Genosure Prime report will be contacted to return to study site for early study treatment discontinuation (ESTD). Participants with identified resistance to lamivudine/Emtricitabine, attributed to the presence of the M184I/V mutation alone will be permitted to remain in the study. (NCT03227861)
Timeframe: Up to Day 35

InterventionPercentage of participants (Number)
D/C/F/TAF: Main Study0

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24

Percentage of participants with HIV-1 RNA < 50 copies/mL were reported. (NCT03227861)
Timeframe: Week 24

InterventionPercentage of Participants (Number)
D/C/F/TAF: Main Study81.7

Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Less Than (<) 50 Copies Per Milliliter (Copies/mL) (Virologic Response) at Week 48 Defined by Food and Drug Administration (FDA) Snapshot Approach

Percentage of participants with a HIV-1 RNA < 50 copies per mL were assessed using FDA snapshot approach which defines a participant's virologic response status using only the viral load at the predefined time point within a window of time, along with study drug discontinuation status. If HIV RNA level is < 50 copies per mL at Week 48, it is considered as virologic success as per the snapshot approach. (NCT03227861)
Timeframe: Week 48

InterventionPercentage of participants (Number)
D/C/F/TAF: Main Study84.4

Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 12, 24 and 48

The immunologic change was determined by changes in Cluster of CD4+ cell count. Change from baseline in CD4+ cell count at Weeks 12, 24 and 48 were assessed. (NCT03227861)
Timeframe: Baseline, Weeks 12, 24 and 48

InterventionCells per millimeter cube (cells/mm^3) (Mean)
Change at Week 12Change at Week 24Change at Week 48
D/C/F/TAF: Main Study149.56182.11222.60

Change From Baseline in log10 HIV-1 RNA Viral Load (<50/200 Copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48

Change from baseline in log10 HIV-1 RNA viral load (<50/200 copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48 were reported. (NCT03227861)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 48

Interventionlog10 HIV-1 RNA copies per mL (Mean)
Change at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 24Change at Week 36Change at Week 48
D/C/F/TAF: Main Study-1.65-2.02-2.43-2.78-3.08-3.14-3.14

Mean Total Scores for the HIV-Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4, 24, and 48

The HIV treatment satisfaction questionnaire (HIVTSQ) is based on a 10-item self-reported scale that measures overall satisfaction with treatment. The HIVTSQ items are summed up to produce a treatment satisfaction score (0 to 60) and an individual satisfaction rating for each item (0 to 6). The higher the score, the greater the treatment satisfaction. (NCT03227861)
Timeframe: Weeks 4, 24, and 48

InterventionUnits on a scale (Mean)
Week 4Week 24Week 48
D/C/F/TAF: Main Study56.5257.8757.88

Median Medical Costs of Care ((United States of America [USA] Dollars) Based on Healthcare Resource Utilization [HRU])

Median medical costs of care (United States of America [USA] dollars) based on healthcare resource utilization [HRU]) were reported. The cost of care specified for overnight hospitalization, hospital day care ward (without overnight), emergency room visit, general practitioner visit, specialist visit, nurse practitioner visit, physician assistant visit and Other visit. (NCT03227861)
Timeframe: Up to Week 48

InterventionUSA dollars (Median)
Overnight hospitalizationHospital day care ward (without overnight)Emergency room visitGeneral practitioner visitSpecialist visitNurse practitioner visitPhysician assistant visitOther visit
D/C/F/TAF: Main Study2035.0341.0212.0142.094.066.047.0148.0

Number of Participants With Outpatient Visits

Number of participants with outpatient visits (in addition to study visits, including General practitioner visit, Specialist visit, Nurse practitioner visit, Physician assistant visit, Home healthcare nurse visit and Other visit) was reported. (NCT03227861)
Timeframe: Up to Week 48

InterventionParticipants (Count of Participants)
General practitioner visitSpecialist visitNurse practitioner visitPhysician assistant visitHome healthcare nurse visitOther visit
D/C/F/TAF: Main Study3328166025

Percentage of Participants Experiencing Grade 3 and 4 Adverse Events

AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events. (NCT03227861)
Timeframe: Up to Week 48

InterventionPercentage of participants (Number)
Grade 3Grade 4
D/C/F/TAF: Main Study11.90.9

Percentage of Participants Experiencing Grade 3 and 4 Adverse Events Through Week 96

AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events. (NCT03227861)
Timeframe: Up to Week 96

InterventionPercentage of participants (Number)
Grade 3Grade 4
D/C/F/TAF: Extension Study7.52.5

Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities

Percentage of participants experiencing grade 3 and 4 laboratory abnormalities was assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Event (AE) Grading Table. Abnormal laboratory values with Grade 3 or higher (3=Severe; 4=potentially life-threatening) signifies an interruption of usual daily activity, requiring systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable. (NCT03227861)
Timeframe: Up to Week 48

InterventionPercentage of participants (Number)
ALT: Grade 3ALT: Grade 4AST: Grade 3AST: Grade 4Calcium: Grade 3Calcium: Grade 4Glucose: Grade 3Glucose: Grade 4Hyperbilirubinemia: Grade 3Hyperbilirubinemia: Grade 4Hypophosphatemia: Grade 3Hypophosphatemia: Grade 4Sodium: Grade 3Sodium: Grade 4Absolute Lymphocytes Count: Grade 3Absolute Lymphocytes Count: Grade 4Platelet Count: Grade 3Platelet Count: Grade 4
D/C/F/TAF: Main Study02.80.93.700.90.902.800.9000.90.90.900.9

Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities Through Week 96

Percentage of participants experiencing grade 3 and 4 laboratory abnormalities were assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Event (AE) Grading Table. Abnormal laboratory values with Grade 3 or higher (3=Severe; 4=potentially life-threatening) signifies an interruption of usual daily activity, requiring systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable. (NCT03227861)
Timeframe: Up to Week 96

InterventionPercentage of participants (Number)
Glucose: Grade 3Glucose: Grade 4Hypophosphatemia: Grade 3Hypophosphatemia: Grade 4
D/C/F/TAF: Extension Study2.501.30

Percentage of Participants With 100% Treatment Adherence Based on Participants Self-Report, Using a 4-Day Recall at Weeks 4, 8, 12, 24, 36, and 48

Percentage of participants with 100 % adherence based on participants self-report, using a 4-Day recall at Weeks 4, 8, 12, 24, 36, and 48 was reported. (NCT03227861)
Timeframe: Weeks 4, 8, 12, 24, 36, and 48

InterventionPercentage of participants (Mean)
Week 4Week 8Week 12Week 24Week 36Week 48
D/C/F/TAF: Main Study99.7699.5099.0298.0499.4999.48

Percentage of Participants With Baseline Protease (PI), Reverse Transcriptase (RT) and Integrase (INI)-Resistance-associated Mutation (RAMs)

Percentage of Participants with resistance-associated mutations present at baseline were reported and included mutations in the domain of PR, RT (including nucleoside reverse transcriptase inhibitor [NRTIs] and non-nucleoside/nucleotide reverse transcriptase inhibitor [NNRTIs]), INI, RAMs as determined by the GenoSure Prime assay. Genotypes were not available for 7 participants due to failed amplification of viral deoxyribo nucleic acid (DNA) (that is, low viral load (VL) [<500 copies/mL], reduced viral fitness, compromised sample collection/handling, primer incompatibility). (NCT03227861)
Timeframe: Baseline (Day 1)

InterventionPercentage of Participants (Number)
Primary PI RAMSecondary PI RAMDarunavir RAMEmtricitabine RAMNNRTI RAMPrimary INI RAMSecondary INI RAM
D/C/F/TAF: Main Study4.998.002.027.504.9

Percentage of Participants With Protocol-defined Virologic Failure (PDVF) at Week 24 and 48

Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA <1 log10 reduction from baseline, and HIV-1 RNA >= 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA <50 copies/mL, a rebound in HIV 1 RNA to >= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a >1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result. (NCT03227861)
Timeframe: Week 24 and 48

InterventionPercentage of participants (Number)
Week 24Week 48
D/C/F/TAF: Main Study00

Percentage of Participants With Protocol-defined Virologic Failure (PDVF) at Week 72 and 96

Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA <1 log10 reduction from baseline, and HIV-1 RNA >= 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA <50 copies/mL, a rebound in HIV 1 RNA to >= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a >1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result. (NCT03227861)
Timeframe: Weeks 72 and 96

InterventionPercentage of participants (Number)
Week 72Week 96
D/C/F/TAF: Extension Study10.69.1

Percentage of Participants With Retention in Care Completed and With Documented Clinical Visit

Percentage of participants with retention in care completed and with documented clinical visit (within 90 days of discontinuation) were reported. (NCT03227861)
Timeframe: Up to Week 48

InterventionPercentage of participants (Number)
Retention in care: CompletedDocumented Clinical Visit
D/C/F/TAF: Main Study63.685.7

Percentage of Participants With Treatment Adherence >95% Based on Pill Count at Weeks 4, 8, 12, 24, 36, and 48

Percentage of participants with treatment adherence >95% based on pill count at Weeks 4, 8, 12, 24, 36, and 48 were reported. Treatment adherence was defined as having a treatment adherence of greater than (>) 95 percent (%) by pill count. (NCT03227861)
Timeframe: Weeks 4, 8, 12, 24, 36, and 48

InterventionPercentage of participants (Number)
>95% at Week 4>95% at Week 8>95% at Week 12>95% at Week 24>95% at Week 36>95% at Week 48
D/C/F/TAF: Main Study83.584.579.476.575.865.6

Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen Who Discontinued the Treatment Due to AEs: Up to Week 48

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Number of participants who discontinued the treatment due to adverse events have been presented. (NCT03446573)
Timeframe: Up to Week 48

InterventionParticipants (Count of Participants)
Randomized to TBR But Received TDF-based Regimen (Early Switch)0

Number of Participants Who Discontinued the Treatment Due to AEs: Up to Week 144

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. (NCT03446573)
Timeframe: Up to Week 144

InterventionParticipants (Count of Participants)
DTG+3TC FDC (Early Switch)23
TAF-based Regimen (Early Switch)7

Number of Participants Who Discontinued the Treatment Due to AEs: Up to Week 48

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Number of participants who discontinued the treatment due to adverse events have been presented. (NCT03446573)
Timeframe: Up to Week 48

InterventionParticipants (Count of Participants)
DTG+3TC FDC (Early Switch)13
TAF Based Regimen (Early Switch)2

Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Week 24

Percentage of participants with plasma HIV-1 RNA <50 c/mL was evaluated using FDA snapshot algorithm at Week 24. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Percentage values are rounded off. (NCT03446573)
Timeframe: Week 24

InterventionPercentage of participants (Number)
DTG+3TC FDC (Early Switch)95
TAF Based Regimen (Early Switch)96

Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Week 48

Percentage of participants with plasma HIV-1 RNA <50 c/mL (virologic success) was evaluated using FDA snapshot algorithm at Week 48 to demonstrate the non-inferior antiviral activity of switching to DTG +3TC once daily compared to continuation of TBR over 48 weeks. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. (NCT03446573)
Timeframe: Week 48

InterventionPercentage of participants (Number)
DTG+3TC FDC (Early Switch)93.2
TAF Based Regimen (Early Switch)93.0

Percentage of Participants With Virologic Failure Endpoint as Per FDA Snapshot Category at Week 24

Percentage of participants with plasma HIV-1 RNA >=50 c/mL was evaluated using FDA snapshot algorithm at Week 24. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. (NCT03446573)
Timeframe: Week 24

InterventionPercentage of participants (Number)
DTG+3TC FDC (Early Switch)0.3
TAF Based Regimen (Early Switch)0.8

Percentage of Participants With Virologic Failure Endpoint as Per Food and Drug Administration (FDA) Snapshot Category at Week 48

Percentage of participants with virologic failure (plasma HIV-1 RNA >=50 c/mL) was evaluated using FDA snapshot algorithm at Week 48. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest. Intent-to-treat exposed (ITT-E) Population comprises of all randomized participants who received at least one dose of study treatment either DTG + 3TC or TBR. Participants were assessed according to the treatment to which the participant was randomized. Any participant receiving a treatment randomization number was considered to be randomized. (NCT03446573)
Timeframe: Week 48

InterventionPercentage of participants (Number)
DTG+3TC FDC (Early Switch)0.3
TAF Based Regimen (Early Switch)0.5

Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 24 and 48

"Serum samples were collected for analysis of 25-hydroxyvitamin D. Baseline value was latest pre-dose assessment (Day 1) with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for treatment, visit, Baseline third agent class, CD4+ cell count (continuous), age (continuous), sex, race, BMI (continuous), smoking status, vitamin D use, Baseline biomarker (continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor.One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 24 and 48

,
InterventionNanomoles per liter (Mean)
Week 24, n=351, 355Week 48, n=344, 343
DTG+3TC FDC (Early Switch)0.0-5.8
TAF Based Regimen (Early Switch)2.1-3.5

Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen

"Serum samples were collected for the analysis of 25-hydroxyvitamin D. Baseline value was the value from latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline values for serum 25-hydroxyvitamin D in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 24 and 48

InterventionNanomoles per liter (Number)
Week 24, n=1
Randomized to TBR But Received TDF-based Regimen (Early Switch)2

Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 96 and 144

"Serum samples were collected for analysis of 25-hydroxyvitamin D. Baseline value is latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen" (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 96 and 144

,
InterventionNanomoles per liter (Mean)
Week 96, n=315, 291Week 144, n=315, 303
DTG+3TC FDC (Early Switch)-11.5-7.5
TAF Based Regimen (Early Switch)-2.2-1.9

Change From Baseline in Bone Biomarkers-serum Bone-ALP, Osteocalcin, Serum P1NP and Serum Type 1 CTX-1 at Weeks 96 and 144

"Serum samples were collected for analysis of bone biomarkers. Baseline is latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen" (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 96 and 144

,
InterventionMicrograms per liter (Mean)
Bone-ALP, Week 96, n=316, 289Bone-ALP, Week 144, n=314, 301Osteocalcin, Week 96, n=315 , 288Osteocalcin, Week 144, n=315, 301P1NP, Week 96, n=316 ,290P1NP, Week 144, n=315, 302CTX-1, Week 96 ,n=315, 289CTX-1, Week 48, n=315, 300
DTG+3TC FDC (Early Switch)-0.62-0.27-1.97-0.746.73.90.02010.0022
TAF Based Regimen (Early Switch)-0.79-0.40-0.101.214.73.50.0050-0.0104

Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum P1NP and Serum CTX-1 in Participants Randomized to TBR Arm Receiving TDF-based Regimen at Weeks 24 and 48

"Serum samples were collected for analysis of bone biomarkers. Baseline was latest pre-dose assessment with a non-missing value (Day 1) . Change from Baseline is post-dose visit value minus Baseline value. Change from Baseline in bone biomarkers-serum bone-specific ALP (Bone-ALP), osteocalcin, serum P1NP and serum CTX-1 in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 24 and 48

InterventionMicrograms per liter (Number)
Bone-ALP, Week 24, n=1Osteocalcin, Week 24, n=1P1NP, Week24, n=1CTX-1, Week 24,n=1
Randomized to TBR But Received TDF-based Regimen (Early Switch)0.313.4110.045

Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Type 1 Collagen C-telopeptides (CTX-1) at Weeks 24 and 48

"Serum samples were collected for analysis of bone biomarkers. Baseline was latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for treatment, visit, Baseline third agent class, CD4+ cell count (continuous), age (continuous), sex, race, body mass index (BMI) (continuous), smoking status, vitamin D use, Baseline biomarker (continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor.One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 24 and 48

,
InterventionMicrograms per liter (Mean)
Bone-ALP, Week 24, n=350, 354Bone-ALP, Week 48, n=343, 342Osteocalcin, Week 24, n=350 ,353Osteocalcin, Week 48, n=343, 342P1NP, Week24, n=349 ,356P1NP, Week48, n=342, 343CTX-1, Week 24,n=350,356CTX-1, Week 48, n=343, 343
DTG+3TC FDC (Early Switch)-0.77-0.03-1.08-1.157.09.30.03500.0602
TAF-based Regimen (Early Switch)-1.05-0.340.260.695.06.4-0.00310.0310

Change From Baseline in CD4+ Cell Count at Weeks 24 and 48

"CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and was presented within the TBR (TAF-based regimen) arm as efficacy of TAF and TDF are comparable." (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 24 and 48

,
InterventionCells per cubic millimeter (Median)
Week 24, n=351, 359Week 48, n=344, 345
DTG+3TC FDC (Early Switch)21.022.5
TAF Based Regimen (Early Switch)6.011.0

Change From Baseline in CD4+ Cell Count at Weeks 96 and 144

"CD4+ cells are a type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+and evaluated by flow cytometry. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and was presented within the TBR (TAF-based regimen) arm as efficacy of TAF and TDF are comparable" (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 96 and 144

,
InterventionCells per cubic millimeter (Median)
Week 96, n=315, 295Week 144, n=309, 301
DTG+3TC FDC (Early Switch)61.036.0
TAF-based Regimen (Early Switch)45.035.0

Change From Baseline in CD4+/CD8+ Cell Count Ratio at Weeks 24 and 48

"Blood samples were collected at specified time points to assess CD4+/CD8+ cell count ratio. It was assessed by flow cyclometry to evaluate the immunologic activity of switching to DTG+3TC once daily compared to continuation of TBR over 48 Weeks. Baseline (Day 1) values were the actual CD4+ cell count ratio values at pre-dose Day 1. Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and was presented within the TBR (TAF-based regimen) arm as efficacy of TAF and TDF are comparable ." (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 24 and 48

,
InterventionRatio (Median)
Week 24, n=346, 358Week 48, n=342, 343
DTG+3TC FDC (Early Switch)0.0100.030
TAF Based Regimen (Early Switch)0.0400.050

Change From Baseline in CD4+/CD8+ Cell Count Ratio at Weeks 96 and 144

"Blood samples were collected at specified time points to assess CD4+/CD8+ cell count ratio and were evaluated by flow cyclometry to evaluate the immunologic activity of switching to DTG+3TC once daily compared to continuation of TBR over Weeks 96 and 144. Baseline (Day 1) values are the actual CD4+ cell count ratio values at pre-dose Day 1. Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and was presented within the TBR (TAF-based regimen) arm as efficacy of TAF and TDF are comparable" (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 96 and 144

,
InterventionRatio (Median)
Week 96, n=312, 292Week 144, n=307, 300
DTG+3TC FDC (Early Switch)0.0350.060
TAF-based Regimen (Early Switch)0.0800.100

Change From Baseline in EQ-5D-5L Thermometer Scores at Week 24 and 48

EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset. Baseline was the latest pre-dose assessment value with a non-missing value (Day 1) and change from Baseline is defined as post-dose value minus Baseline value. (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 24 and 48

,
InterventionScores on a scale (Mean)
Week 24Week 48
DTG+3TC FDC (Early Switch)1.21.1
TAF Based Regimen (Early Switch)1.31.7

Change From Baseline in EQ-5D-5L Thermometer Scores at Weeks 96 and 144

EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Baseline is defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 96 and 144

,
InterventionScores on a scale (Mean)
Week 96, n=364, 369Week 144, n=364, 368
DTG+3TC FDC (Early Switch)0.70.2
TAF Based Regimen (Early Switch)1.91.4

Change From Baseline in EQ-5D-5L Utility Score at Weeks 96 and 144

EQ-5D-5L questionnaire provides profile of participant function and global health state rating. Five-item measure has 1question assessing each of 5dimensions:mobility,self-care,usual activities,pain/discomfort,anxiety/depression and 5 levels for each dimension including 1=no problems,2=slight problems,3=moderate problems,4=severe problems,5=extreme problems. Health state is defined by combining levels of answers from each of 5 questions. Each health state is referred to in terms of a 5 digit code.Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state.EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health.Baseline is latest pre-dose assessment value with a non-missing value (Day 1).Change from Baseline is post-dose visit value minus Baseline value. (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 96 and 144

,
InterventionScores on a scale (Mean)
Week 96, n=364, 370Week 144, n=364, 369
DTG+3TC FDC (Early Switch)-0.0036-0.0151
TAF Based Regimen (Early Switch)-0.0038-0.0042

Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Utility Score at Week 24 and 48

EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 24 and 48

,
InterventionScores on a scale (Mean)
Week 24Week 48
DTG+3TC FDC (Early Switch)0.00290.0037
TAF Based Regimen (Early Switch)0.00460.0023

Change From Baseline in Fasting Lipids at Weeks 24 and 48

"Blood samples were collected at Baseline (Day 1), Week 24 and Week 48 to assess fasting lipids which included plasma cholesterol, plasma LDL cholesterol, plasma high density lipoprotein (HDL) cholesterol and plasma triglycerides. Baseline value was the value from the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at weeks 24 and 48

,
InterventionMillimoles per liter (Median)
Plasma cholesterol, Week 24, n=282, 264Plasma cholesterol, Week 48, n=275, 263Plasma LDL Cholesterol, Week 24, n=282, 264Plasma LDL Cholesterol, Week 48, n=275, 263Plasma Triglycerides, Week 24, n=282, 264Plasma Triglycerides, Week 48, n=275, 263Plasma HDL Cholesterol, Week 24, n=282, 264Plasma HDL Cholesterol, Week 48, n=275, 263
DTG+3TC FDC (Early Switch)-0.325-0.200-0.210-0.170-0.100-0.100-0.0500.000
TAF Based Regimen (Early Switch)0.0000.100-0.0600.0700.0600.1000.0500.050

Change From Baseline in Fasting Lipids at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen

"Blood samples were collected at Baseline (Day 1), weeks 24 and 48 visit (participant withdrew from the study at Week 36) to assess fasting lipids which included plasma cholesterol, plasma LDL cholesterol, plasma HDL cholesterol and plasma triglycerides. Baseline value was the value from the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline values for fasting lipids in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at weeks 24 and 48

InterventionMillimoles per liter (Number)
Plasma cholesterol, Week 24, n=1Plasma LDL Cholesterol, Week 24, n=1Plasma Triglycerides, Week 24, n=1Plasma HDL Cholesterol, Week 24, n=1
Randomized to TBR But Received TDF-based Regimen (Early Switch)0-0.671.360.05

Change From Baseline in Fasting Lipids at Weeks 96 and 144

"Blood samples were collected at Baseline (Day 1), Weeks 96 and 144 to assess fasting lipids which includes plasma cholesterol, plasma LDL cholesterol, plasma HDL cholesterol and plasma triglycerides. Baseline value is the value from the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 96 and 144

,
InterventionMillimoles per liter (Median)
Plasma cholesterol, Week 96, n=238, 213Plasma cholesterol, Week 144, n=243, 230Plasma LDL Cholesterol, Week 96, n=238, 213Plasma LDL Cholesterol, Week 144, n=243, 230Plasma Triglycerides, Week 96, n=238, 213Plasma Triglycerides, Week 144, n=243, 230Plasma HDL Cholesterol, Week 96, n=238, 213Plasma HDL Cholesterol, Week 144, n=243, 230
DTG+3TC FDC (Early Switch)-3.7-4.0-5.6-5.0-2.1-9.4-3.8-3.8
TAF Based Regimen (Early Switch)1.23.81.74.24.92.20.03.8

Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 24 and 48

"Serum samples assessed: renal inflammation biomarker serum creatinine.Baseline(Day 1)was value from latest pre-dose assessment with non-missing value. Change from Baseline is post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from repeated measures model adjusting for treatment, visit, Baseline third agent class, CD4+ cell count(continuous), age(continuous), sex, race, BMI(continuous), presence of diabetes mellitus, presence of hypertension, Baseline biomarker(continuous), treatment by visit interaction, Baseline value by visit interaction, with visit as repeated factor. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen" (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 24 and 48

,
InterventionMicromoles per liter (Mean)
Week 24, n=351, 359Week 48, n=344, 345
DTG+3TC FDC (Early Switch)7.476.67
TAF Based Regimen (Early Switch)3.112.18

Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen

"Serum samples were collected at Baseline, Week 24 and Week 48 to assess renal inflammation biomarker - serum creatinine. Baseline was defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline in serum creatinine in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 24 and 48

InterventionMicromoles per liter (Number)
Week 24, n=1
Randomized to TBR But Received TDF-based Regimen (Early Switch)-8

Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 96 and 144

"Serum samples were collected to assess renal inflammation biomarker - serum creatinine. Baseline is defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen" (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 96 and 144

,
InterventionMicromoles per liter (Mean)
Week 96, n=316, 294Week 144, n=311, 302
DTG+3TC FDC (Early Switch)5.539.25
TAF-based Regimen (Early Switch)0.585.17

Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 24 and 48

"Serum samples were collected to assess renal biomarker. Baseline was latest pre-dose assessment value with non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for following:treatment, visit, Baseline third agent class, CD4+ cell count(continuous), age(continuous), sex, race, BMI(continuous), presence of diabetes mellitus, presence of hypertension, Baseline biomarker(continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen" (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 24 and 48

,
InterventionMilligrams per liter (Mean)
Week 24, n=351, 357Week 48, n=344, 343
DTG+3TC FDC (Early Switch)-0.030.00
TAF Based Regimen (Early Switch)-0.020.01

Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen

"Serum samples were collected at Baseline, Week 24 and Week 48 to assess renal inflammation biomarker - cystatin C. Baseline was defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline values for serum cystatin -C biomarker in TDF based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 24 and 48

InterventionMilligrams per liter (Number)
Week 24, n=1
Randomized to TBR But Received TDF-based Regimen (Early Switch)0

Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 96 and 144

"Serum samples were collected to assess renal biomarker. Baseline is latest pre-dose assessment value with non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen" (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 96 and 144

,
InterventionMilligrams per liter (Mean)
Week 96, n=316, 290Week 144, n=315, 302
DTG+3TC FDC (Early Switch)0.070.13
TAF-based Regimen (Early Switch)0.100.14

Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24 and 48

"Serum samples assessed:serum GFR from cystatin C and from creatinine adjusted using CKD-EPI Baseline(Day 1) was value from latest pre-dose assessment with non-missing value. Change from Baseline is post-dose visit value minus Baseline value.Adjusted mean and standard error is presented.Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from repeated measures model adjusting for treatment, visit, Baseline third agent class,CD4+ cell count(continuous),age(continuous), sex, race, BMI(continuous),presence of diabetes mellitus, presence of hypertension, Baseline biomarker(continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen" (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 24 and 48

,
InterventionMilliliters/minute/1.73*meter square (Mean)
GFR from cystatin C CKD-EPI, Week 24, n=351, 357GFR from cystatin C CKD-EPI, Week 48, n=344, 343GFR from creatinine CKD-EPI, Week 24, n=351, 359GFR from creatinine CKD-EPI, Week 48, n=344, 345
DTG+3TC FDC (Early Switch)3.20.1-8.8-7.7
TAF Based Regimen (Early Switch)1.5-1.6-3.8-2.9

Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen

"Serum samples were collected at Baseline, Week 24 and Week 48 to assess renal inflammation biomarkers - serum GFR from cystatin C adjusted using CKD-EPI and serum GFR from creatinine adjusted using CKD-EPI. Baseline was defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline in serum GFR from cystatin C adjusted using CKD-EPI and serum GFR from creatinine adjusted using CKD-EPI in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 24 and 48

InterventionMilliliters/minute/1.73*meter square (Number)
GFR from cystatin C CKD-EPI, Week 24, n=1GFR from creatinine CKD-EPI, Week 24, n=1
Randomized to TBR But Received TDF-based Regimen (Early Switch)04

Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 96 and 144

"Serum samples were collected to assess serum GFR from cystatin C and from creatinine adjusted for BSA. Baseline is defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen" (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 96 and 144

,
InterventionMilliliters/minute/1.73*meter square (Mean)
GFR from cystatin C CKD-EPI, Week 96, n=316, 290GFR from cystatin C CKD-EPI, Week 144, n=315, 302GFR from creatinine adjusted for BSA, Week 96, n=315, 294GFR from creatinine adjusted for BSA, Week 144, n=311, 300
DTG+3TC FDC (Early Switch)-7.6-13.9-7.2-11.5
TAF Based Regimen (Early Switch)-11.7-15.8-1.9-7.0

Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 24 and 48 in Participants Randomized to TBR Receiving TDF-based Regimen

"Urine samples were collected at Baseline, Week 24 and Week 48 to assess renal biomarkers - urine albumin/creatinine ratio and urine protein/creatinine ratio. Baseline was defined as the latest pre-dose assessment value with a non-missing value. (Day 1). Change from Baseline in UA/C was calculated as UA/C ratio at post-Baseline visit minus UA/C ratio calculated at Baseline. Change from Baseline in UP/C was calculated as UP/C ratio at post-Baseline visit minus UP/C ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at weeks 24 and 48

InterventionRatio (Number)
UA/C, Week 24, n=1UP/C, Week 24, n=1
Randomized to TBR But Received TDF-based Regimen (Early Switch)00.3

Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 96 and 144

"Urine samples were collected at Baseline, Weeks 96 and 144. Baseline is defined as Day 1. Change from Baseline in UA/C is defined as UA/C ratio at post-Baseline visit minus UA/C ratio at Baseline. Change from Baseline in UP/C and UA/C is defined as UP/C and UA/C ratio at post-Baseline visit minus UP/C and UA/C ratio at Baseline, respectively. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 96 and 144

,
InterventionRatio (Geometric Mean)
UA/C, Week 96, n=208, 175UA/C, Week 144, n=202, 179UP/C, Week 96, n=245, 206UP/C, Week 144, n=237, 220
DTG+3TC FDC (Early Switch)1.0581.2031.0481.182
TAF-based Regimen (Early Switch)1.0751.2001.1051.188

Change From Baseline in Renal Biomarkers- Urine Albumin/Creatinine (UA/C) Ratio and Urine Protein/Creatinine (UP/C) Ratio at Weeks 24 and 48

"Urine samples were collected at Baseline, Week 24 and Week 48. Baseline is defined as Day 1. Change from Baseline in UA/C was calculated as UA/C ratio at post-Baseline visit minus UA/C ratio calculated at Baseline. Estimated geometric mean adjusted ratio (each visit over Baseline) and 95% CI have been presented. Change from Baseline in UP/C and UA/C was calculated as UP/C and UA/C ratio at post-Baseline visit minus UP/C and UA/C ratio calculated at Baseline, respectively. Estimated geometric mean adjusted ratio (each visit over Baseline) and 95% CI have been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at weeks 24 and 48

,
InterventionRatio (Geometric Mean)
UA/C, Week 24, n=235, 230UA/C, Week 48, n=230, 224UP/C, Week 24, n=267, 261UP/C, Week 48, n=261, 257
DTG+3TC FDC (Early Switch)1.0801.1250.9550.971
TAF Based Regimen (Early Switch)1.0221.0590.9761.016

Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 24 and 48

"Urine biomarker samples were collected at Baseline, Weeks 24 and 48 to assess urine beta-2 microglobulin/urine creatinine. Geometric mean ratio (visit divided by Baseline) and 95% CI of geometric mean ratio has been presented. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine beta-2-microglobulin/urine creatinine was calculated as urine beta-2-microglobulin/urine creatinine ratio at post-Baseline visit minus urine beta-2-microglobulin/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at weeks 24 and 48

,
InterventionRatio (Geometric Mean)
Week 24, n=136, 141Week 48, n=126, 141
DTG+3TC FDC (Early Switch)0.9910.973
TAF Based Regimen (Early Switch)1.0340.922

Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 96 and 144

"Urine biomarker samples were collected at Baseline, Weeks 96 and 144 to assess urine beta-2 microglobulin/urine creatinine. Baseline (Day 1) value is the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine beta-2-microglobulin/urine creatinine is defined as urine beta-2-microglobulin/urine creatinine ratio at post-Baseline visit minus urine beta-2-microglobulin/urine creatinine ratio at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 96 and 144

,
InterventionRatio (Geometric Mean)
Week 96, n=109, 107Week 144, n=101, 97
DTG+3TC FDC (Early Switch)1.0800.904
TAF-based Regimen (Early Switch)0.9860.958

Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 24 and 48

"Urine biomarker samples were collected at Baseline and at Weeks 24 and 48 to assess urine phosphate. Geometric mean ratio (visit divided by Baseline) and 95% CI of geometric mean ratio has been presented. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine phosphate was calculated as urine phosphate at post-Baseline visit minus urine phosphate calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at weeks 24 and 48

,
InterventionRatio (Geometric Mean)
Week 24, n=348, 352Week 48, n=342, 340
DTG+3TC FDC (Early Switch)0.9550.969
TAF Based Regimen (Early Switch)0.9400.970

Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen

"Urine biomarker samples were collected to assess urine phosphate. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine phosphate was calculated as urine phosphate at post-Baseline visit minus urine phosphate calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at weeks 24 and 48

InterventionRatio (Number)
Week 24, n=1
Randomized to TBR But Received TDF-based Regimen (Early Switch)2.9

Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 96 and 144

"Urine biomarker samples were collected at Baseline, Weeks 96 and 144 to assess urine phosphate. Baseline (Day 1) value is the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine phosphate is defined as urine phosphate at post-Baseline visit minus urine phosphate at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen" (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 96 and 144

,
InterventionRatio (Geometric Mean)
Week 96, n=312, 286Week 144, n=313, 298
DTG+3TC FDC (Early Switch)0.9600.890
TAF Based Regimen (Early Switch)0.9780.912

Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 24 and 48

"Urine biomarker samples were collected at Baseline, Weeks 24 and 48 to assess urine retinol binding protein 4/urine creatinine. Geometric mean ratio (visit divided by Baseline) and 95% CI of geometric mean ratio has been presented. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in Urine retinol binding protein 4/urine creatinine ratio was calculated as Urine retinol binding protein 4/urine creatinine ratio at post-Baseline visit minus Urine retinol binding protein 4/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at weeks 24 and 48

,
InterventionRatio (Geometric Mean)
Week 24, n=344, 343Week 48, n=340, 335
DTG+3TC FDC (Early Switch)0.8601.063
TAF Based Regimen (Early Switch)0.9201.068

Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen

"Urine biomarker samples were collected to assess urine retinol binding protein 4/urine creatinine. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine retinol binding protein 4/urine creatinine was calculated as urine retinol binding protein 4/urine creatinine ratio at post-Baseline visit minus urine retinol binding protein 4/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at weeks 24 and 48

InterventionRatio (Number)
Week 24, n=1
Randomized to TBR But Received TDF-based Regimen (Early Switch)1.04

Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 96 and 144

"Urine biomarker samples were collected at Baseline, Weeks 96 and 144 to assess urine retinol binding protein 4/urine creatinine. Baseline (Day 1) value is the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in Urine retinol binding protein 4/urine creatinine ratio is defined as Urine retinol binding protein 4/urine creatinine ratio at post-Baseline visit minus Urine retinol binding protein 4/urine creatinine ratio at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen" (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 96 and 144

,
InterventionRatio (Geometric Mean)
Week 96, n=310, 282Week 144, n=304, 288
DTG+3TC FDC (Early Switch)0.9261.188
TAF Based Regimen (Early Switch)0.8511.227

Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With AEs by Their Severity Grades: Up to Week 48

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the DAIDS toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of TDF-based regimen participants with adverse events by maximum grade have been presented. (NCT03446573)
Timeframe: Up to Week 48

InterventionParticipants (Count of Participants)
Grade 1Grade 2Grade 3Grade 4Grade 5
Randomized to TBR But Received TDF-based Regimen (Early Switch)01000

Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Any SAEs and Common (>=2%) Non-SAEs: Up to Week 48

An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other important medical event as per medical or scientific judgment . Number of TDF-based regimen participants with any SAE and common (>=2%) non-SAEs are presented. (NCT03446573)
Timeframe: Up to Week 48

InterventionParticipants (Count of Participants)
Any non-SAE (>=2%)Any SAE
Randomized to TBR But Received TDF-based Regimen (Early Switch)10

Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36

samples were collected up to the Week 36 visit for the analysis of clinical chemistry parameters: alanine aminotransferase (ALT), albumin, alkaline phosphate (ALP), aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase (CK), creatinine, direct bilirubin, glomerular filtration rate (GFR) from creatinine adjusted using chronic kidney disease-epidemiology collaboration (CKD-EPI), GFR from cystatin C adjusted using CKD-EPI, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol, phosphate and triglycerides. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. (NCT03446573)
Timeframe: Up to Week 36

InterventionParticipants (Count of Participants)
ALT, Grade 1ALT, Grade 2ALT, Grade 3ALT, Grade 4Albumin, Grade 1Albumin, Grade 2Albumin, Grade 3Albumin, Grade 4ALP, Grade 1ALP, Grade 2ALP, Grade 3ALP, Grade 4AST, Grade 1AST, Grade 2AST, Grade 3AST, Grade 4Bilirubin, Grade 1Bilirubin, Grade 2Bilirubin, Grade 3Bilirubin, Grade 4CO2, Grade 1CO2, Grade 2CO2, Grade 3CO2, Grade 4Cholesterol, Grade 1Cholesterol, Grade 2Cholesterol, Grade 3Cholesterol, Grade 4CK, Grade 1CK, Grade 2CK, Grade 3CK, Grade 4Creatinine, Grade 1Creatinine, Grade 2Creatinine, Grade 3Creatinine, Grade 4Direct bilirubin, Grade 1Direct bilirubin, Grade 2Direct bilirubin, Grade 3Direct bilirubin, Grade 4GFR from creatinine adjusted using CKD EPI,Grade 1GFR from creatinine adjusted using CKD EPI,Grade 2GFR from creatinine adjusted using CKD EPI,Grade 3GFR from creatinine adjusted using CKD EPI,Grade 4GFR from cystatin C adjusted using CKD-EPI,Grade 1GFR from cystatin C adjusted using CKD-EPI,Grade 2GFR from cystatin C adjusted using CKD-EPI,Grade 3GFR from cystatin C adjusted using CKD-EPI,Grade 4Hypercalcemia, Grade 1Hypercalcemia, Grade 2Hypercalcemia, Grade 3Hypercalcemia, Grade 4Hyperglycemia, Grade 1Hyperglycemia, Grade 2Hyperglycemia, Grade 3Hyperglycemia, Grade 4Hyperkalemia, Grade 1Hyperkalemia, Grade 2Hyperkalemia, Grade 3Hyperkalemia, Grade 4Hypernatremia, Grade 1Hypernatremia, Grade 2Hypernatremia, Grade 3Hypernatremia, Grade 4Hypocalcemia, Grade 1Hypocalcemia, Grade 2Hypocalcemia, Grade 3Hypocalcemia, Grade 4Hypoglycemia, Grade 1Hypoglycemia, Grade 2Hypoglycemia, Grade 3Hypoglycemia, Grade 4Hypokalemia, Grade 1Hypokalemia, Grade 2Hypokalemia, Grade 3Hypokalemia, Grade 4Hyponatremia, Grade 1Hyponatremia, Grade 2Hyponatremia, Grade 3Hyponatremia, Grade 4LDL cholesterol, Grade 1LDL cholesterol, Grade 2LDL cholesterol, Grade 3LDL cholesterol, Grade 4Phosphate, Grade 1Phosphate, Grade 2Phosphate, Grade 3Phosphate, Grade 4Triglycerides, Grade 1Triglycerides, Grade 2Triglycerides, Grade 3Triglycerides, Grade 4
Randomized to TBR But Received TDF-based Regimen (Early Switch)00000000000000000000000000000000000000000000000000000000000000000000000000000000000000001000

Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36

Blood samples were collected up to the Week 36 visit for the analysis of hematology parameters-platelet count, neutrophils, hemoglobin and leukocytes. Any abnormality in hematology parameters were evaluated according to the DAIDS toxicity scale from Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. Only those TDF-based regimen participants with maximum post-Baseline emergent hematology toxicities in any of the hematology parameters have been presented. (NCT03446573)
Timeframe: Up to Week 36

InterventionParticipants (Count of Participants)
Hemoglobin, Grade 1Hemoglobin, Grade 2Hemoglobin, Grade 3Hemoglobin, Grade 4Leukocytes, Grade 1Leukocytes, Grade 2Leukocytes, Grade 3Leukocytes, Grade 4Neutrophils, Grade 1Neutrophils, Grade 2Neutrophils, Grade 3Neutrophils, Grade 4Platelets, Grade 1Platelets, Grade 2Platelets, Grade 3Platelets, Grade 4
Randomized to TBR But Received TDF-based Regimen (Early Switch)0000000000000000

Number of Participants With AEs by Their Severity Grades: Up to Week 144

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented. (NCT03446573)
Timeframe: Up to Week 144

,
InterventionParticipants (Count of Participants)
Grade 1Grade 2Grade 3Grade 4Grade 5
DTG+3TC FDC (Early Switch)572175093
TAF Based Regimen (Early Switch)652085480

Number of Participants With AEs by Their Severity Grades: Up to Week 48

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented. (NCT03446573)
Timeframe: Up to Week 48

,
InterventionParticipants (Count of Participants)
Grade 1Grade 2Grade 3Grade 4Grade 5
DTG+3TC FDC (Early Switch)1021701931
TAF Based Regimen (Early Switch)941771560

Number of Participants With Any SAEs and Common (>=2%) Non-SAEs: Up to Week 148

An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other important medical event as per medical or scientific judgment (NCT03446573)
Timeframe: Up to Week 148

,
InterventionParticipants (Count of Participants)
Any non-SAE (>=2%)Any SAE
DTG+3TC FDC (Early Switch)30757
TAF-based Regimen (Early Switch)30444

Number of Participants With Any Serious Adverse Events (SAEs) and Common (>=2%) Non-serious Adverse Events (Non-SAEs): Up to Week 48

An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other important medical event as per medical or scientific judgment . Safety Population included all participants who received at least one dose of study treatment either DTG + 3TC or TBR. This population was based on the treatment the participant actually received. Number of participants with any SAE and common (>=2%) non-SAEs are presented. (NCT03446573)
Timeframe: Up to Week 48

,
InterventionParticipants (Count of Participants)
Any non-SAE (>=2%)Any SAE
DTG+3TC FDC (Early Switch)22221
TAF Based Regimen (Early Switch)20416

Number of Participants With Disease Progression at Weeks 24 and 48

HIV-associated conditions were recorded during the study and were assessed according to the 2014 CDC Classification System for HIV Infection in Adults. CDC classification for HIV were: Stage 1: No AIDS defining condition and CD4+ T-lymphocyte count: >=500 cells/mcL; Stage 2: No AIDS infection and CD4+ lymphocyte count: 200-499 cell/mcL and Stage 3:Documented AIDS defining condition or CD4+ T-lymphocye count <200 cells/mcL. Disease progression summarize participants who had HIV infection stage 3 associated conditions or death. Indicators of clinical disease progression were defined as: CDC Category Stage 1 at enrollment to Stage 3 event; CDC Category Stage 2 at enrollment to Stage 3 event; CDC Category Stage 3 at enrollment to New Stage 3 Event; CDC Category Stage 1, 2 or 3 at enrollment to Death. (NCT03446573)
Timeframe: At Weeks 24 and 48

,
InterventionParticipants (Count of Participants)
From CDC Stage 1 to CDC Stage 3 EventFrom CDC Stage 2 to CDC Stage 3 EventFrom CDC Stage 3 to new CDC Stage 3 EventFrom CDC Stage 1, 2 or 3 to DeathNo HIV-1 disease progression
DTG+3TC FDC (Early Switch)1001367
TAF Based Regimen (Early Switch)0000372

Number of Participants With Disease Progression at Weeks 96 and 144

HIV-associated conditions were recorded during the study and assessed according to the 2014 CDC Classification System for HIV Infection in Adults. CDC classification for HIV is: Stage 1: No AIDS defining condition and CD4+ T-lymphocyte count: >=500 cells/mcL; Stage 2: No AIDS infection and CD4+ lymphocyte count: 200-499 cell/mcL and Stage 3: Documented AIDS-defining condition or CD4+ T-lymphocye count <200 cells/mcL. Indicators of clinical disease progression is defined as: CDC Category Stage 1 at enrollment to Stage 3 event; CDC Category Stage 2 at enrollment to Stage 3 event; CDC Category Stage 3 at enrollment to New Stage 3 Event; CDC Category Stage 1, 2 or 3 at enrollment to Death. (NCT03446573)
Timeframe: At Weeks 96 and 144

,
InterventionParticipants (Count of Participants)
Week 96, From CDC Stage 1 to CDC Stage 3 EventWeek 96, From CDC Stage 2 to CDC Stage 3 EventWeek 96, From CDC Stage 3 to new CDC Stage 3 EventWeek 96, From CDC Stage 1, 2 or 3 to DeathWeek 96, No HIV-1 disease progressionWeek 144, From CDC Stage 1 to CDC Stage 3 EventWeek 144, From CDC Stage 2 to CDC Stage 3 EventWeek 144,From CDC Stage 3 to new CDC Stage 3 EventWeek 144, From CDC Stage 1, 2 or 3 to DeathWeek 144, No HIV-1 disease progression
DTG+3TC FDC (Early Switch)20023652003364
TAF-based Regimen (Early Switch)00003720100371

Number of Participants With Genotypic Resistance: Up to Week 144

Plasma samples were collected for drug resistance testing. Number of participants, who meet CVW criteria (one plasma HIV-1 RNA >=200 c/mL after Day 1 with immediate prior HIV RNA >=50 c/mL), with genotypic resistance to INSTI, NRTI, NNRTI and PI are summarized. (NCT03446573)
Timeframe: Up to Week 144

InterventionParticipants (Count of Participants)
INSTINRTINNRTIPI
TAF Based Regimen (Early Switch)0000

Number of Participants With Genotypic Resistance: Up to Week 48

Plasma samples were collected for drug resistance testing. Number of participants, who met confirmed virologic withdrawal (CVW) criteria (one plasma HIV-1 RNA >=200 c/mL after Day 1 with immediate prior HIV RNA >=50 c/mL), with genotypic resistance to INSTI, nucleoside reverse transcriptase inhibitor (NRTI), NNRTI and PI was summarized. (NCT03446573)
Timeframe: Up to Week 48

InterventionParticipants (Count of Participants)
INSTINRTINNRTIPI
TAF Based Regimen (Early Switch)0000

Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144

Blood samples were collected up to Week 144 for the analysis of clinical chemistry parameters: ALT, albumin, ALP, AST, bilirubin, CO2, cholesterol, CK, creatinine, direct bilirubin, GFR from creatinine adjusted for BSA, GFR from cystatin C adjusted using CKD-EPI, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, LDL cholesterol, phosphate triglycerides and lactate dehydrogenase. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. (NCT03446573)
Timeframe: Up to Week 144

,
InterventionParticipants (Count of Participants)
ALT, Grade 1ALT, Grade 2ALT, Grade 3ALT, Grade 4Albumin, Grade 1Albumin, Grade 2Albumin, Grade 3Albumin, Grade 4ALP, Grade 1ALP, Grade 2ALP, Grade 3ALP, Grade 4AST, Grade 1AST, Grade 2AST, Grade 3AST, Grade 4Bilirubin, Grade 1Bilirubin, Grade 2Bilirubin, Grade 3Bilirubin, Grade 4CO2, Grade 1CO2, Grade 2CO2, Grade 3CO2, Grade 4Cholesterol, Grade 1Cholesterol, Grade 2Cholesterol, Grade 3Cholesterol, Grade 4CK, Grade 1CK, Grade 2CK, Grade 3CK, Grade 4Creatinine, Grade 1Creatinine, Grade 2Creatinine, Grade 3Creatinine, Grade 4Direct bilirubin, Grade 1Direct bilirubin, Grade 2Direct bilirubin, Grade 3Direct bilirubin, Grade 4GFR from creatinine adjusted using CKD EPI,Grade 1GFR from creatinine adjusted using CKD EPI,Grade 2GFR from creatinine adjusted using CKD EPI,Grade 3GFR from creatinine adjusted using CKD EPI,Grade 4GFR from cystatin C adjusted using CKD-EPI,Grade 1GFR from cystatin C adjusted using CKD-EPI,Grade 2GFR from cystatin C adjusted using CKD-EPI,Grade 3GFR from cystatin C adjusted using CKD-EPI,Grade 4Hypercalcemia, Grade 1Hypercalcemia, Grade 2Hypercalcemia, Grade 3Hypercalcemia, Grade 4Hyperglycemia, Grade 1Hyperglycemia, Grade 2Hyperglycemia, Grade 3Hyperglycemia, Grade 4Hyperkalemia, Grade 1Hyperkalemia, Grade 2Hyperkalemia, Grade 3Hyperkalemia, Grade 4Hypernatremia, Grade 1Hypernatremia, Grade 2Hypernatremia, Grade 3Hypernatremia, Grade 4Hypocalcemia, Grade 1Hypocalcemia, Grade 2Hypocalcemia, Grade 3Hypocalcemia, Grade 4Hypoglycemia, Grade 1Hypoglycemia, Grade 2Hypoglycemia, Grade 3Hypoglycemia, Grade 4Hypokalemia, Grade 1Hypokalemia, Grade 2Hypokalemia, Grade 3Hypokalemia, Grade 4Hyponatremia, Grade 1Hyponatremia, Grade 2Hyponatremia, Grade 3Hyponatremia, Grade 4LDL cholesterol, Grade 1LDL cholesterol, Grade 2LDL cholesterol, Grade 3LDL cholesterol, Grade 4Phosphate, Grade 1Phosphate, Grade 2Phosphate, Grade 3Phosphate, Grade 4Triglycerides, Grade 1Triglycerides, Grade 2Triglycerides, Grade 3Triglycerides, Grade 4Lactate Dehydrogenase Grade 1Lactate Dehydrogenase Grade 2Lactate Dehydrogenase Grade 3Lactate Dehydrogenase Grade 4
DTG+3TC FDC (Early Switch)551150120060003413332493011021042261041121210215100013001653800169461800073404032004100141009400103102100041198061300606640000
TAF Based Regimen (Early Switch)49931000000104590312410974007034203013121012210003001012410183581900077314021003000520010300700026200562490719007715521000

Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48

Blood samples were collected up to Week 48 for the analysis of clinical chemistry parameters: alanine aminotransferase (ALT), albumin, alkaline phosphate (ALP), aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase (CK), creatinine, direct bilirubin, glomerular filtration rate (GFR) from creatinine adjusted for body surface area (BSA), GFR from cystatin C adjusted using chronic kidney disease-epidemiology collaboration (CKD-EPI), hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol, phosphate and triglycerides. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. (NCT03446573)
Timeframe: Up to Week 48

,
InterventionParticipants (Count of Participants)
ALT, Grade 1ALT, Grade 2ALT, Grade 3ALT, Grade 4Albumin, Grade 1Albumin, Grade 2Albumin, Grade 3Albumin, Grade 4ALP, Grade 1ALP, Grade 2ALP, Grade 3ALP, Grade 4AST, Grade 1AST, Grade 2AST, Grade 3AST, Grade 4Bilirubin, Grade 1Bilirubin, Grade 2Bilirubin, Grade 3Bilirubin, Grade 4CO2, Grade 1CO2, Grade 2CO2, Grade 3CO2, Grade 4Cholesterol, Grade 1Cholesterol, Grade 2Cholesterol, Grade 3Cholesterol, Grade 4CK, Grade 1CK, Grade 2CK, Grade 3CK, Grade 4Creatinine, Grade 1Creatinine, Grade 2Creatinine, Grade 3Creatinine, Grade 4Direct bilirubin, Grade 1Direct bilirubin, Grade 2Direct bilirubin, Grade 3Direct bilirubin, Grade 4GFR from creatinine adjusted using CKD EPI,Grade 1GFR from creatinine adjusted using CKD EPI,Grade 2GFR from creatinine adjusted using CKD EPI,Grade 3GFR from creatinine adjusted using CKD EPI,Grade 4GFR from cystatin C adjusted using CKD-EPI,Grade 1GFR from cystatin C adjusted using CKD-EPI,Grade 2GFR from cystatin C adjusted using CKD-EPI,Grade 3GFR from cystatin C adjusted using CKD-EPI,Grade 4Hypercalcemia, Grade 1Hypercalcemia, Grade 2Hypercalcemia, Grade 3Hypercalcemia, Grade 4Hyperglycemia, Grade 1Hyperglycemia, Grade 2Hyperglycemia, Grade 3Hyperglycemia, Grade 4Hyperkalemia, Grade 1Hyperkalemia, Grade 2Hyperkalemia, Grade 3Hyperkalemia, Grade 4Hypernatremia, Grade 1Hypernatremia, Grade 2Hypernatremia, Grade 3Hypernatremia, Grade 4Hypocalcemia, Grade 1Hypocalcemia, Grade 2Hypocalcemia, Grade 3Hypocalcemia, Grade 4Hypoglycemia, Grade 1Hypoglycemia, Grade 2Hypoglycemia, Grade 3Hypoglycemia, Grade 4Hypokalemia, Grade 1Hypokalemia, Grade 2Hypokalemia, Grade 3Hypokalemia, Grade 4Hyponatremia, Grade 1Hyponatremia, Grade 2Hyponatremia, Grade 3Hyponatremia, Grade 4LDL cholesterol, Grade 1LDL cholesterol, Grade 2LDL cholesterol, Grade 3LDL cholesterol, Grade 4Phosphate, Grade 1Phosphate, Grade 2Phosphate, Grade 3Phosphate, Grade 4Triglycerides, Grade 1Triglycerides, Grade 2Triglycerides, Grade 3Triglycerides, Grade 4
DTG+3TC FDC (Early Switch)24610100020002171117510731002712102849616300008001352600525170005621200200100080005300710080002813603820034444
TAF Based Regimen (Early Switch)1841000000000294007210701005219001998571000010083130066403000641920200010001100620010001320035153047700481140

Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144

Blood samples were collected up to Week 144 for the analysis of hematology parameters-platelet count, neutrophils, hemoglobin and leukocytes. Any abnormality in hematology parameters are were evaluated according to the DAIDS toxicity scale from Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. (NCT03446573)
Timeframe: Up to Week 144

,
InterventionParticipants (Count of Participants)
Hemoglobin, Grade 1Hemoglobin, Grade 2Hemoglobin, Grade 3Hemoglobin, Grade 4Leukocytes, Grade 1Leukocytes, Grade 2Leukocytes, Grade 3Leukocytes, Grade 4Neutrophils, Grade 1Neutrophils, Grade 2Neutrophils, Grade 3Neutrophils, Grade 4Platelets, Grade 1Platelets, Grade 2Platelets, Grade 3Platelets, Grade 4
DTG+3TC FDC (Early Switch)7100211053028200
TAF Based Regimen (Early Switch)2200400058027100

Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48

Blood samples were collected up to Week 48 for the analysis of hematology parameters-platelet count, neutrophils, hemoglobin and leukocytes. Any abnormality in hematology parameters were evaluated according to the DAIDS toxicity scale from Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. Only those participants with maximum post-Baseline emergent hematology toxicities in any of the hematology parameters have been presented. (NCT03446573)
Timeframe: Up to Week 48

,
InterventionParticipants (Count of Participants)
Hemoglobin, Grade 1Hemoglobin, Grade 2Hemoglobin, Grade 3Hemoglobin, Grade 4Leukocytes, Grade 1Leukocytes, Grade 2Leukocytes, Grade 3Leukocytes, Grade 4Neutrophils, Grade 1Neutrophils, Grade 2Neutrophils, Grade 3Neutrophils, Grade 4Platelets, Grade 1Platelets, Grade 2Platelets, Grade 3Platelets, Grade 4
DTG+3TC FDC (Early Switch)3000110032016100
TAF Based Regimen (Early Switch)0000100044005100

Number of Participants With Phenotypic Resistance: Up to Week 144

Number of participants, who meet CVW criteria (one plasma HIV-1 RNA >=200 c/mL after Day 1 with immediate prior HIV RNA >=50 c/mL), with phenotypic resistance to INSTI,NNRT,NRTI and PI were summarized. Assessment of antiviral activity of anti-retroviral therapy (ART) using phenotypic test results was interpreted through a proprietary algorithm (from Monogram Biosciences), which provided the overall susceptibility of the drug. Partially sensitive and resistant calls were considered resistant in this analysis. The phenotypic resistance was calculated using binary scoring system, where 0 was considered as sensitive and 1 as resistance. Phenotypic Resistance data for the following INSTI, NNRTI, NRTI and PI drugs in participants Meeting CVW Criteria has been presented. (NCT03446573)
Timeframe: Up to Week 144

InterventionParticipants (Count of Participants)
INSTI, DTG, SensitiveINSTI, DTG, ResistantINSTI, Bictegravir (BIC), SensitiveINSTI, BIC, ResistantINSTI, Elvitegravir (EVG), SensitiveINSTI, EVG, ResistantINSTI, Raltegravir (RAL), SensitiveINSTI, RAL, ResistantNNRTI, Delavirdine (DLV), SensitiveNNRTI, DLV, ResistantNNRTI, Efavirenz (EFV), SensitiveNNRTI, EFV, ResistantNNRTI, Etravirine (ETR), SensitiveNNRTI, ETR, ResistantNNRTI, Nevirapine (NVP), SensitiveNNRTI, NVP, ResistantNNRTI, Rilpivirine (RPV), SensitiveNNRTI, RPV, ResistantNRTI, 3TC, SensitiveNRTI, 3TC, ResistantNRTI, Abacavir (ABC), SensitiveNRTI, ABC, ResistantNRTI, Zidovudine (AZT), SensitiveNRTI, AZT, ResistantNRTI, Stavudine (D4T), SensitiveNRTI, D4T, ResistantNRTI, Didanosine (DDI), SensitiveNRTI, DDI, ResistantNRTI, Emtricitabine (FTC), SensitiveNRTI, FTC, ResistantNRTI, Tenofovir (TDF), SensitiveNRTI, TDF, ResistantPI, Atazanavir (ATV), SensitivePI, ATV, ResistantPI, Darunavir (DRV), SensitivePI, DRV, ResistantPI, Fosamprenavir (FPV), SensitivePI, FPV, ResistantPI, Indinavir (IDV), SensitivePI, IDV, ResistantPI, Lopinavir (LPV), SensitivePI, LPV, ResistantPI, Nelfinavir (NFV), SensitivePI, NFV, ResistantPI, Ritonavir (RTV), SensitivePI, RTV, ResistantPI, Saquinavir (SQV), SensitivePI, SQV, ResistantPI, Tipranavir (TPV), SensitivePI, TPV, Resistant
TAF Based Regimen (Early Switch)20202020202020202020202020202020202020202020202020

Number of Participants With Phenotypic Resistance: Up to Week 48

Number of participants, who meet CVW criteria (one plasma HIV-1 RNA >=200 c/mL after Day 1 with immediate prior HIV RNA >=50 c/mL), with phenotypic resistance to INSTI, NNRTI,NRTI and PI were summarized. Assessment of antiviral activity of ART using phenotypic test results was interpreted through a proprietary algorithm (from Monogram Biosciences), which provided the overall susceptibility of the drug. Partially sensitive and resistant calls were considered resistant in this analysis. The phenotypic resistance was calculated using binary scoring system, where 0 was considered as sensitive and 1 as resistance. Phenotypic Resistance data for the following INSTI, NNRTI, NRTI and PI drugs in participants Meeting CVW Criteria has been presented. (NCT03446573)
Timeframe: Up to Week 48

InterventionParticipants (Count of Participants)
INSTI, DTG, SensitiveINSTI, DTG, ResistantINSTI, Bictegravir (BIC), SensitiveINSTI, BIC, ResistantINSTI, Elvitegravir (EVG), SensitiveINSTI, EVG, ResistantINSTI, Raltegravir (RAL), SensitiveINSTI, RAL, ResistantNNRTI, Delavirdine (DLV), SensitiveNNRTI, DLV, ResistantNNRTI, Efavirenz (EFV), SensitiveNNRTI, EFV, ResistantNNRTI, Etravirine (ETR), SensitiveNNRTI, ETR, ResistantNNRTI, Nevirapine (NVP), SensitiveNNRTI, NVP, ResistantNNRTI, Rilpivirine (RPV), SensitiveNNRTI, RPV, ResistantNRTI, 3TC, SensitiveNRTI, 3TC, ResistantNRTI, Abacavir (ABC), SensitiveNRTI, ABC, ResistantNRTI, Zidovudine (AZT), SensitiveNRTI, AZT, ResistantNRTI, Stavudine (D4T), SensitiveNRTI, D4T, ResistantNRTI, Didanosine (DDI), SensitiveNRTI, DDI, ResistantNRTI, Emtricitabine (FTC), SensitiveNRTI, FTC, ResistantNRTI, Tenofovir (TDF), SensitiveNRTI, TDF, ResistantPI, Atazanavir (ATV), SensitivePI, ATV, ResistantPI, Darunavir (DRV), SensitivePI, DRV, ResistantPI, Fosamprenavir (FPV), SensitivePI, FPV, ResistantPI, Indinavir (IDV), SensitivePI, IDV, ResistantPI, Lopinavir (LPV), SensitivePI, LPV, ResistantPI, Nelfinavir (NFV), SensitivePI, NFV, ResistantPI, Ritonavir (RTV), SensitivePI, RTV, ResistantPI, Saquinavir (SQV), SensitivePI, SQV, ResistantPI, Tipranavir (TPV), SensitivePI, TPV, Resistant
TAF Based Regimen (Early Switch)10101010101010101010101010101010101010101010101010

Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Weeks 96 and 144

Percentage of participants with plasma HIV-1 RNA <50 c/mL was evaluated using FDA snapshot algorithm at Weeks 96 and 144. (NCT03446573)
Timeframe: Weeks 96 and 144

,
InterventionPercentage of participants (Number)
Week 96Week 144
DTG+3TC FDC (Early Switch)85.985.9
TAF-based Regimen (Early Switch)79.081.7

Percentage of Participants With Virologic Failure Endpoint as Per FDA Snapshot Category at Weeks 96, 144

Percentage of participants with plasma HIV-1 RNA >=50 c/mL was evaluated using FDA snapshot algorithm at Weeks 96 and 144. (NCT03446573)
Timeframe: Weeks 96 and 144

,
InterventionPercentage of participants (Number)
Week 96Week 144
DTG+3TC FDC (Early Switch)0.30.3
TAF-based Regimen (Early Switch)1.11.3

Percentage of Participants Experiencing Grades 1 Through 4 Adverse Events After Switch to E/C/F/TAF or F/R/TAF Throughout the Study and During Coadministeration With LDV/SOF Treatment

(NCT02707601)
Timeframe: Up to 32 weeks plus 30 days

Interventionpercentage of participants (Number)
E/C/F/TAF + LDV/SOF (Co-administration: Week 8 to Week 20)62.5
F/R/TAF + LDV/SOF (Co-administration: Week 8 to Week 20)69.4
E/C/F/TAF + LDV/SOF (Whole Study: Day 1 to Post-HCV Week 12)83.8
F/R/TAF + LDV/SOF (Whole Study: Day 1 to Post-HCV to Week 12)79.7

Percentage of Participants With HCV RNA < LLOQ at 12 Weeks After Discontinuation of LDV/SOF Treatment (SVR12)

Sustained Virologic Response (SVR12) was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping LDV/SOF treatment. (NCT02707601)
Timeframe: HCV Posttreatment Week 12

Interventionpercentage of participants (Number)
E/C/F/TAF + LDV/SOF98.6
F/R/TAF + LDV/SOF95.8

Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of LDV/SOF Treatment (SVR4)

SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping LDV/SOF treatment. (NCT02707601)
Timeframe: HCV Posttreatment Week 4

Interventionpercentage of participants (Number)
E/C/F/TAF + LDV/SOF98.6
F/R/TAF + LDV/SOF98.6

Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL (Virologic Failure) 24 Weeks After Start of the F/TAF-Based Regimen Using Modified FDA Snapshot Algorithm

The percentage of participants with HIV-1 RNA ≥ 50 copies/mL 24 weeks after start of the F/TAF-based regimen were analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02707601)
Timeframe: 24 weeks after start of HIV treatment

Interventionpercentage of participants (Number)
E/C/F/TAF + LDV/SOF1.4
F/R/TAF + LDV/SOF1.4

Change From Baseline in CD4+ Cell Count at Week 144

(NCT02607930)
Timeframe: Baseline, Week 144

Interventioncells/µL (Mean)
B/F/TAF299
ABC/DTG/3TC317

Change From Baseline in CD4+ Cell Count at Week 48

(NCT02607930)
Timeframe: Baseline, Week 48

Interventioncells/µL (Mean)
B/F/TAF235
ABC/DTG/3TC228

Change From Baseline in CD4+ Cell Count at Week 48 Open-Label

(NCT02607930)
Timeframe: Baseline, open-label Week 48

Interventioncells/µL (Mean)
All B/F/TAF330
ABC/DTG/3TC to B/F/TAF-4

Change From Baseline in CD4+ Cell Count at Week 96

(NCT02607930)
Timeframe: Baseline, Week 96

Interventioncells/µL (Mean)
B/F/TAF287
ABC/DTG/3TC288

Change From Baseline in CD4+ Cell Count at Week 96 Open-Label

(NCT02607930)
Timeframe: Baseline, open-label Week 96

Interventioncell/µL (Mean)
All B/F/TAF339
ABC/DTG/3TC to B/F/TAF-15

Change From Baseline in log10 HIV-1 RNA at Week 144

(NCT02607930)
Timeframe: Baseline, Week 144

Interventionlog10 copies/mL (Mean)
B/F/TAF-3.11
ABC/DTG/3TC-3.10

Change From Baseline in log10 HIV-1 RNA at Week 48

(NCT02607930)
Timeframe: Baseline, Week 48

Interventionlog10 copies/mL (Mean)
B/F/TAF-3.11
ABC/DTG/3TC-3.07

Change From Baseline in log10 HIV-1 RNA at Week 96

(NCT02607930)
Timeframe: Baseline, Week 96

Interventionlog10 copies/mL (Mean)
B/F/TAF-3.09
ABC/DTG/3TC-3.10

Percentage Change From Baseline in Hip BMD at Week 144

(NCT02607930)
Timeframe: Baseline, Week 144

Interventionpercentage change (Mean)
B/F/TAF-1.020
ABC/DTG/3TC-1.291

Percentage Change From Baseline in Hip BMD at Week 48

(NCT02607930)
Timeframe: Baseline, Week 48

Interventionpercentage change (Mean)
B/F/TAF-0.802
ABC/DTG/3TC-1.148

Percentage Change From Baseline in Hip BMD at Week 96

(NCT02607930)
Timeframe: Baseline, Week 96

Interventionpercentage change (Mean)
B/F/TAF-1.128
ABC/DTG/3TC-1.262

Percentage Change From Baseline in Spine BMD at Week 144

(NCT02607930)
Timeframe: Baseline, Week 144

Interventionpercentage change (Mean)
B/F/TAF-0.371
ABC/DTG/3TC0.035

Percentage Change From Baseline in Spine BMD at Week 48

(NCT02607930)
Timeframe: Baseline, Week 48

Interventionpercentage change (Mean)
B/F/TAF-0.772
ABC/DTG/3TC-0.552

Percentage Change From Baseline in Spine BMD at Week 96

(NCT02607930)
Timeframe: Baseline, Week 96

Interventionpercentage change (Mean)
B/F/TAF-0.705
ABC/DTG/3TC-0.219

Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 144 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02607930)
Timeframe: Week 144

Interventionpercentage of participants (Number)
B/F/TAF78.0
ABC/DTG/3TC82.2

Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02607930)
Timeframe: Week 48

Interventionpercentage of participants (Number)
B/F/TAF87.6
ABC/DTG/3TC87.3

Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02607930)
Timeframe: Week 96

Interventionpercentage of participants (Number)
B/F/TAF83.4
ABC/DTG/3TC84.8

Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 144 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02607930)
Timeframe: Week 144

Interventionpercentage of participants (Number)
B/F/TAF81.5
ABC/DTG/3TC84.1

Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02607930)
Timeframe: Week 48

Interventionpercentage of participants (Number)
B/F/TAF92.4
ABC/DTG/3TC93.0

Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Excluded Algorithm

The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Excluded for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). The denominator for percentages at a visit was the number of participants in the all B/F/TAF analysis set with non-missing HIV-1 RNA value at that visit. (NCT02607930)
Timeframe: Baseline, open-label Week 48

Interventionpercentage of participants (Number)
All B/F/TAF99.2
ABC/DTG/3TC to B/F/TAF100

Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Failure Algorithm

The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Failure for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was treated as HIV-1 RNA ≥ 50 copies/mL. The denominator for percentages was the number of participants in all B/F/TAF analysis set. (NCT02607930)
Timeframe: Baseline, open-label Week 48

Interventionpercentage of participants (Number)
All B/F/TAF74.8
ABC/DTG/3TC to B/F/TAF83.5

Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02607930)
Timeframe: Week 96

Interventionpercentage of participants (Number)
B/F/TAF87.9
ABC/DTG/3TC89.8

Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Excluded Algorithm

The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Excluded for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). The denominator for percentages at a visit was the number of participants in the all B/F/TAF analysis set with non-missing HIV-1 RNA value at that visit. (NCT02607930)
Timeframe: Baseline, open-label Week 96

Interventionpercentage of participants (Number)
All B/F/TAF97.7
ABC/DTG/3TC to B/F/TAF99.5

Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Failure Algorithm

The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Failure for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was treated as HIV-1 RNA ≥ 50 copies/mL. The denominator for percentages was the number of participants in all B/F/TAF analysis set. (NCT02607930)
Timeframe: Baseline, open-label Week 96

Interventionpercentage of participants (Number)
All B/F/TAF66.2
ABC/DTG/3TC to B/F/TAF85.4

Change From Baseline in CD4+ Cell Count at Week 144

(NCT02607956)
Timeframe: Baseline, Week 144

Interventioncells/μL (Mean)
B/F/TAF278
DTG + F/TAF289

Change From Baseline in CD4+ Cell Count at Week 48

(NCT02607956)
Timeframe: Baseline, Week 48

Interventioncells/μL (Mean)
B/F/TAF180
DTG + F/TAF201

Change From Baseline in CD4+ Cell Count at Week 48 Open-Label

(NCT02607956)
Timeframe: Baseline, open-label Week 48

Interventioncells/μL (Mean)
All B/F/TAF304
DTG + F/TAF to B/F/TAF9

Change From Baseline in CD4+ Cell Count at Week 96

(NCT02607956)
Timeframe: Baseline, Week 96

Interventioncells/μL (Mean)
B/F/TAF237
DTG + F/TAF281

Change From Baseline in CD4+ Cell Count at Week 96 Open-Label

(NCT02607956)
Timeframe: Baseline, open-label Week 96

Interventioncells/µL (Mean)
All B/F/TAF336
DTG + F/TAF to B/F/TAF-10

Change From Baseline in log10 HIV-1 RNA at Week 144

(NCT02607956)
Timeframe: Baseline, Week 144

Interventionlog10 copies/mL (Mean)
B/F/TAF-3.06
DTG + F/TAF-3.11

Change From Baseline in log10 HIV-1 RNA at Week 48

(NCT02607956)
Timeframe: Baseline, Week 48

Interventionlog10 copies/mL (Mean)
B/F/TAF-3.07
DTG + F/TAF-3.12

Change From Baseline in log10 HIV-1 RNA at Week 96

(NCT02607956)
Timeframe: Baseline, Week 96

Interventionlog10 copies/mL (Mean)
B/F/TAF-3.08
DTG + F/TAF-3.10

Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 144 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02607956)
Timeframe: Week 144

Interventionpercentage of participants (Number)
B/F/TAF77.5
DTG + F/TAF79.1

Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02607956)
Timeframe: Week 48

Interventionpercentage of participants (Number)
B/F/TAF82.2
DTG + F/TAF87.1

Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02607956)
Timeframe: Week 96

Interventionpercentage of participants (Number)
B/F/TAF77.5
DTG + F/TAF80.3

Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 144 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02607956)
Timeframe: Week 144

Interventionpercentage of participants (Number)
B/F/TAF81.9
DTG + F/TAF84.0

Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02607956)
Timeframe: Week 48

Interventionpercentage of participants (Number)
B/F/TAF89.4
DTG + F/TAF92.9

Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Excluded Algorithm

The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Excluded for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set for the all B/F/TAF analysis. All missing data was excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). The denominator for percentages at a visit was the number of participants in the all B/F/TAF analysis set with nonmissing HIV-1 RNA value at that visit. (NCT02607956)
Timeframe: Baseline, open-label Week 48

Interventionpercentage of participants (Number)
All B/F/TAF99.2
DTG + F/TAF to B/F/TAF99.6

Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Failure Algorithm

The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Failure for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set for the all B/F/TAF analysis. All missing data was treated as HIV-1 RNA ≥ 50 copies/mL. The denominator for percentages was the number of participants in all B/F/TAF analysis set. (NCT02607956)
Timeframe: Baseline, open-label Week 48

Interventionpercentage of participants (Number)
All B/F/TAF75.3
DTG + F/TAF to B/F/TAF84.5

Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02607956)
Timeframe: Week 96

Interventionpercentage of participants (Number)
B/F/TAF84.1
DTG + F/TAF86.5

Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Excluded Algorithm

The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Excluded for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set for the all B/F/TAF analysis. All missing data was excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). The denominator for percentages at a visit was the number of participants in the all B/F/TAF analysis set with nonmissing HIV-1 RNA value at that visit. (NCT02607956)
Timeframe: Baseline, open-label Week 96

Interventionpercentage of participants (Number)
All B/F/TAF99.5
DTG + F/TAF to B/F/TAF99.1

Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Failure Algorithm

The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Failure for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set for the all B/F/TAF analysis. All missing data was treated as HIV-1 RNA ≥ 50 copies/mL. The denominator for percentages was the number of participants in all B/F/TAF analysis set. (NCT02607956)
Timeframe: Baseline, open-label Week 96

Interventionpercentage of participants (Number)
All B/F/TAF68.1
DTG + F/TAF to B/F/TAF87.5

Steady State Concentrations of TFV-DP for Different Dosing Patterns of Descovy

Tenofovir diphosphate (TFV-DP) concentrations in dried blood spots (DBS) respective to dosing regimens of 33%, 67%, 100% of daily dosing. (NCT02962739)
Timeframe: Assessed weekly for 9 months

Interventionfmol/punch (Mean)
DOT 33%657
DOT 67%1451
DOT 100%2381

Change From Baseline in CD4+ Cell Count at Week 48

(NCT03110380)
Timeframe: Baseline; Week 48

Interventioncells/µL (Mean)
B/F/TAF18
DTG + F/TAF36

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT03110380)
Timeframe: Week 48

Interventionpercentage of participants (Number)
B/F/TAF93.3
DTG + F/TAF91.1

Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm

The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT03110380)
Timeframe: Week 48

Interventionpercentage of participants (Number)
B/F/TAF0.4
DTG + F/TAF1.1

Pharmacokinetic (PK) Parameter: Infant Plasma Washout Half-life (T1/2) of ARVs and TB Drugs

Infant plasma concentrations were collected and measured during the first 9 days of life. Half-life is defined as 0.693/k, where k, the elimination rate constant, is the slope of the decline in concentrations. (NCT00042289)
Timeframe: Infant plasma samples at 2-10, 18-28, 36-72 hours and 5-9 days after birth.

Interventionhour (Median)
DTG 50mg q.d.32.8
EVG/COBI 150/150mg q.d.7.6
DRV/COBI 800/150 mg q.d.NA
EFV 600 mg q.d. (Outside THA)65.6

PK Parameter: Cord/Maternal Blood Concentration Ratio With Median (IQR) for ARVs and TB Drugs

Cord blood and maternal plasma concentrations were collected and measured at delivery, and compared as a ratio. (NCT00042289)
Timeframe: Measured at time of delivery with single cord blood and single maternal plasma sample.

Interventionunitless (Median)
DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.0.15
DTG 50mg q.d.1.25
EVG/COBI 150/150mg q.d.0.91
DRV/COBI 800/150 mg q.d.0.07
ATV/COBI 300/150 mg q.d.0.07
TFV 300mg q.d.0.88

PK Parameter: Cord/Maternal Blood Concentration Ratio With Median (Range) for ARVs and TB Drugs

Cord blood and maternal plasma concentrations were collected and measured at delivery, and compared as a ratio. For arms with zero overall participants analyzed, samples were below the limit of quantification and ratios could not be calculated. (NCT00042289)
Timeframe: Measured at time of delivery with single cord blood and single maternal plasma sample.

Interventionunitless (Median)
TAF 10mg q.d. w/COBI0.97
EFV 600 mg q.d. (Outside THA)0.67
EFV 600mg q.d.0.49
LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d.0.2
RAL 400mg b.i.d.1.5
ETR 200mg b.i.d.0.52
MVC 150 or 300mg b.i.d.0.33
ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.0.14
TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.0.16
NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.0.19
IDV/RTV Arm 2: 400/100mg q.d. (Only THA)0.12
RPV 25mg q.d.0.55
ATV/RTV 300/100mg q.d. or TFV/ATV/RTV 300/300/100mg q.d.0.18
DRV/RTV 800/100mg q.d. or DRV/RTV 600/100mg b.i.d.0.18

Plasma Concentration for Contraceptives

Serum concentrations of the contraceptives. Note that no historical controls were provided by team pharmacologists and thus no comparisons were done for contraceptive concentrations in women using hormonal contraceptives and selected ARV drugs as compared to historical controls not using those ARV drugs. (NCT00042289)
Timeframe: Measured at 6-7 weeks after contraceptive initiation postpartum

Interventionpg/mL (Median)
ATV/RTV/TFV 300/100/300mg q.d. With ENG604
LPV/RTV 400/100 b.i.d. With ENG428
EFV 600mg q.d. With ENG125

Area Under the Curve From 0 to 12 Hours (AUC12) of ARVs for Contraceptive Arms

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC12h (area-under-the-curve from 0 to 12 hours) were determined using the linear trapezoidal rule. (NCT00042289)
Timeframe: Measured at 2-12 wks postpartum before contraceptive initiation and 6-7 wks after contraceptive initiation. Blood samples were drawn pre-dose and at 0, 1, 2, 6, 8 and 12 hours post dosing.

Interventionmcg*hr/mL (Median)
Before contraceptive initiationAfter contraceptive initiation
LPV/RTV 400/100 b.i.d. With ENG115.97100.20

Area Under the Curve From 0 to 24 Hours (AUC24) of ARVs for Contraceptive Arms

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24h (area-under-the-curve from 0 to 24 hours) were determined using the linear trapezoidal rule. (NCT00042289)
Timeframe: Measured at 2-12 wks postpartum before contraceptive initiation and 6-7 wks after contraceptive initiation. Blood samples were drawn pre-dose and at 0, 1, 2, 6, 8, 12, and 24 hours post dosing.

,
Interventionmcg*hr/mL (Median)
Before contraceptive initiationAfter contraceptive initiation
ATV/RTV/TFV 300/100/300mg q.d. With ENG53.9655.25
EFV 600mg q.d. With ENG53.6456.65

Number of Women Who Met PK Target of Area Under the Curve (AUC) for ARVs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC (area under the curve) were determined using the linear trapezoidal rule. See PK target in the Protocol Appendix V. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 (and 24) hours post dosing.

,
InterventionParticipants (Count of Participants)
3rd TrimesterPostpartum
EFV 600mg q.d.2021
MVC 150 or 300mg b.i.d.87

Number of Women Who Met PK Target of Area Under the Curve (AUC) for ARVs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC (area under the curve) were determined using the linear trapezoidal rule. See PK target in the Protocol Appendix V. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 (and 24) hours post dosing.

,,,,,,,,,,,,,,,,,,,,,,
InterventionParticipants (Count of Participants)
2nd Trimester3rd TrimesterPostpartum
ATV/RTV Arm 1: 300/100mg q.d.11212
DRV/COBI 800/150 mg q.d.3414
DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.71622
DRV/RTV 600/100mg b.i.d.71922
DRV/RTV 800/100mg q.d.91922
DTG 50mg q.d.92023
EFV 600 mg q.d. (Outside THA)123334
ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.82927
ETR 200mg b.i.d.5137
EVG/COBI 150/150mg q.d.81018
FPV/RTV 700/100mg b.i.d.82622
IDV/RTV Arm 2: 400/100mg q.d. (Only THA)101926
LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d.93027
ATV/COBI 300/150 mg q.d.125
NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.NA1514
RAL 400mg b.i.d.113330
RPV 25mg q.d.142625
TAF 10mg q.d. w/COBI152322
TAF 25mg q.d.132324
TAF 25mg q.d. w/COBI or RTV Boosting102418
TFV 300mg q.d.22727
TFV/ATV/RTV Arm 1: 300/300/100mg q.d.11112
TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.72332

Pharmacokinetic (PK) Parameter: Infant Plasma Washout Concentration of ARVs and TB Drugs

Infant plasma concentrations were collected and measured during the first 9 days of life. (NCT00042289)
Timeframe: Blood samples were collected at 2-10, 18-28, 36-72 hours and 5-9 days after birth.

,,,
Interventionmcg/mL (Median)
2-10 hours after birth18-28 hours after birth36-72 hours after birth5-9 days after birth
DRV/COBI 800/150 mg q.d.0.351.431.871.72
DTG 50mg q.d.1.731.531.000.06
EFV 600 mg q.d. (Outside THA)1.11.00.90.4
EVG/COBI 150/150mg q.d.0.1320.0320.0050.005

PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Geometric Mean (95% CI) for ARVs and TB Drugs

Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing. (NCT00042289)
Timeframe: Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.

Interventionng*hour/mL (Geometric Mean)
2nd Trimester3rd TrimesterPostpartum
MVC 150 or 300mg b.i.d.NA27173645

PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (IQR) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC12 (area under the curve from 0 to 12 hours) were determined using the linear trapezoidal rule. (NCT00042289)
Timeframe: Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.

,,,
Interventionmg*hour/L (Median)
2nd Trimester3rd TrimesterPostpartum
DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.55.151.879.6
DRV/RTV 600/100mg b.i.d.45.845.961.7
FPV/RTV 700/100mg b.i.d.43.5032.1551.60
NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.NA34.233.5

PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (Range) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC12 (area under the curve from 0 to 12 hours) were determined using the linear trapezoidal rule. (NCT00042289)
Timeframe: Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.

,,,
Interventionmg*hour/L (Median)
2nd Trimester3rd TrimesterPostpartum
ETR 200mg b.i.d.4.58.35.3
IDV/RTV Arm 2: 400/100mg q.d. (Only THA)14.916.127.1
LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d.7296133
RAL 400mg b.i.d.6.65.411.6

PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (IQR) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24 (area under the curve from 0 to 24 hours) were determined using the linear trapezoidal rule. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dosing.

,,,,,,,,,,,,,
Interventionmg*hour/L (Median)
2nd Trimester3rd TrimesterPostpartum
ATV/COBI 300/150 mg q.d.25.3318.8536.20
ATV/RTV Arm 1: 300/100mg q.d.88.241.957.9
ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.30.645.748.8
DRV/COBI 800/150 mg q.d.50.0042.0595.55
DRV/RTV 800/100mg q.d.64.663.5103.9
DTG 50mg q.d.47.649.265.0
EFV 600 mg q.d. (Outside THA)47.3060.0262.70
EVG/COBI 150/150mg q.d.15.314.021.0
TAF 10mg q.d. w/COBI0.1970.2060.216
TAF 25mg q.d.0.1710.2120.271
TAF 25mg q.d. w/COBI or RTV Boosting0.1810.2570.283
TFV 300mg q.d.1.92.43.0
TFV/ATV/RTV Arm 1: 300/300/100mg q.d.14.528.839.6
TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.26.237.758.7

PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (Range) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24h (area-under-the-curve from 0 to 24 hours) were determined using the trapezoidal rule. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dosing.

Interventionmg*hour/L (Median)
3rd TrimesterPostpartum
EFV 600mg q.d.55.458.3

PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (Range) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24h (area-under-the-curve from 0 to 24 hours) were determined using the trapezoidal rule. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dosing.

Interventionmg*hour/L (Median)
2nd Trimester3rd TrimesterPostpartum
RPV 25mg q.d.1.9691.6692.387

PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (IQR) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.

Interventionmg/L (Median)
3rd TrimesterPostpartum
EFV 600mg q.d.5.445.10

PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (IQR) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.

,,,,,,,,,,,,,,
Interventionmg/L (Median)
2nd Trimester3rd TrimesterPostpartum
ATV/COBI 300/150 mg q.d.2.822.203.90
ATV/RTV Arm 1: 300/100mg q.d.NA3.64.1
ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.3.114.514.52
DRV/COBI 800/150 mg q.d.4.593.677.04
DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.6.226.558.96
DRV/RTV 600/100mg b.i.d.5.645.537.78
DRV/RTV 800/100mg q.d.6.775.788.11
DTG 50mg q.d.3.623.544.85
EFV 600 mg q.d. (Outside THA)3.875.134.41
FPV/RTV 700/100mg b.i.d.5.615.126.75
IDV/RTV Arm 2: 400/100mg q.d. (Only THA)3.893.625.37
NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.NA5.15.0
TFV 300mg q.d.0.2500.2450.298
TFV/ATV/RTV Arm 1: 300/300/100mg q.d.1.22.54.1
TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.2.733.565.43

PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (Range) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.

,,,
Interventionmg/L (Median)
2nd Trimester3rd TrimesterPostpartum
ETR 200mg b.i.d.0.701.010.63
LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d.8.410.714.6
RAL 400mg b.i.d.2.2501.7703.035
RPV 25mg q.d.0.1450.1340.134

PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (95% CI) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.

Interventionng/mL (Median)
3rd TrimesterPostpartum
MVC 150 or 300mg b.i.d.448647

PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (IQR) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.

,,,
Interventionng/mL (Median)
2nd Trimester3rd TrimesterPostpartum
EVG/COBI 150/150mg q.d.1447.11432.81713.1
TAF 10mg q.d. w/COBI80.491.298.2
TAF 25mg q.d.69.796133
TAF 25mg q.d. w/COBI or RTV Boosting87.8107141

PK Parameter: Trough Concentration (C12) With Geometric Mean (95% CI) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 12h post-dose sample after an observed dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 12 hrs after an observed dose.

Interventionng/mL (Geometric Mean)
3rd TrimesterPostpartum
MVC 150 or 300mg b.i.d.108128

PK Parameter: Trough Concentration (C12) With Median (IQR) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 12h post-dose sample after an observed dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum, depending on study arm. Trough concentration was measured 12 hrs after an observed dose.

,,,
Interventionmg/L (Median)
2nd Trimester3rd TrimesterPostpartum
DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.2.842.524.51
DRV/RTV 600/100mg b.i.d.2.122.222.51
FPV/RTV 700/100mg b.i.d.2.121.642.87
NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.NA0.470.52

PK Parameter: Trough Concentration (C12) With Median (Range) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 12h post-dose sample after an observed dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum, depending on study arm. Trough concentration was measured 12 hrs after an observed dose.

,,,
Interventionmg/L (Median)
2nd Trimester3rd TrimesterPostpartum
ETR 200mg b.i.d.0.360.480.38
IDV/RTV Arm 2: 400/100mg q.d. (Only THA)0.130.130.28
LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d.3.75.17.2
RAL 400mg b.i.d.0.06210.0640.0797

PK Parameter: Trough Concentration (C24) With Median (IQR) for ARVs and TB Drugs

"Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 24h post-dose sample after an observed dose.~For the TAF 25 mg q.d., 10 mg q.d. w/COBI, and 25 mg q.d. w/COBI or RTV boosting arms, samples were all below the limit of quantification and statistical analyses were not conducted." (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 24 hrs after an observed dose.

,,,,,,,,,,,,,
Interventionmg/L (Median)
2nd Trimester3rd TrimesterPostpartum
ATV/COBI 300/150 mg q.d.0.210.210.61
ATV/RTV Arm 1: 300/100mg q.d.2.00.71.2
ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.0.490.710.90
DRV/COBI 800/150 mg q.d.0.330.271.43
DRV/RTV 800/100mg q.d.0.991.172.78
DTG 50mg q.d.0.730.931.28
EFV 600 mg q.d. (Outside THA)1.491.481.94
EVG/COBI 150/150mg q.d.0.02580.04870.3771
TAF 10mg q.d. w/COBI0.001950.001950.00195
TAF 25mg q.d.0.001950.001950.00195
TAF 25mg q.d. w/COBI or RTV Boosting0.001950.001950.00195
TFV 300mg q.d.0.0390.0540.061
TFV/ATV/RTV Arm 1: 300/300/100mg q.d.0.30.50.8
TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.0.440.571.26

PK Parameter: Trough Concentration (C24) With Median (Range) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 24h post-dose sample after an observed dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 24 hrs after an observed dose.

Interventionmg/L (Median)
3rd TrimesterPostpartum
EFV 600mg q.d.1.602.05

PK Parameter: Trough Concentration (C24) With Median (Range) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 24h post-dose sample after an observed dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 24 hrs after an observed dose.

Interventionmg/L (Median)
2nd Trimester3rd TrimesterPostpartum
RPV 25mg q.d.0.0630.0560.081

Change From Baseline in CD4 % at Week 24

(NCT02616029)
Timeframe: Baseline (Day 1); Week 24

Interventionpercentage of CD4 cells (Mean)
Part 1: E/C/F/TAF0.1
Part 2: E/C/F/TAF1.1
Total E/C/F/TAF0.5

Change From Baseline in CD4 % at Week 48

(NCT02616029)
Timeframe: Baseline (Day 1); Week 48

Interventionpercentage of CD4 cells (Mean)
Part 1: E/C/F/TAF0.2
Part 2: E/C/F/TAF1.5
Total E/C/F/TAF0.8

Change From Baseline in CD4 Percentage (%) at Week 12

(NCT02616029)
Timeframe: Baseline (Day 1); Week 12

Interventionpercentage of CD4 cells (Mean)
Part 1: E/C/F/TAF-0.4
Part 2: E/C/F/TAF1.5
Total E/C/F/TAF0.4

Change From Baseline in CD4+ Cell Count at Week 24

(NCT02616029)
Timeframe: Baseline (Day 1); Week 24

Interventioncells/µL (Mean)
Part 1: E/C/F/TAF-40
Part 2: E/C/F/TAF28
Total E/C/F/TAF-10

Change From Baseline in CD4+ Cell Count at Week 48

(NCT02616029)
Timeframe: Baseline (Day 1); Week 48

Interventioncells/µL (Mean)
Part 1: E/C/F/TAF-6
Part 2: E/C/F/TAF27
Total E/C/F/TAF9

Change From Baseline in Cluster Determinant 4+ (CD4+) Cell Count at Week 12

(NCT02616029)
Timeframe: Baseline (Day 1); Week 12

Interventioncells/µL (Mean)
Part 1: E/C/F/TAF-47
Part 2: E/C/F/TAF-6
Total E/C/F/TAF-30

Percentage of Participants With Emergence of New Mutations in HIV-1 Reverse Transcriptase and Integrase

Development of new resistance mutations was assessed in participants who developed virologic failure, defined as 2 consecutive HIV-1 RNA result ≥ 50 copies/mL at any point in the study or with HIV-1 RNA ≥ 50 copies/mL at last visit. (NCT02616029)
Timeframe: Day 1 up to 48 weeks

Interventionpercentage of participants (Number)
Part 1: E/C/F/TAF0
Part 2: E/C/F/TAF0
Total E/C/F/TAF0

Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 12 Using the FDA Snapshot Analysis

The percentage of participants with HIV-1 RNA < 20 copies/mL at Week 12 was also analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 12 window was between Day 71 and 98 (inclusive). (NCT02616029)
Timeframe: Week 12

Interventionpercentage of participants (Number)
Part 1: E/C/F/TAF91.7
Part 2: E/C/F/TAF96.2
Total E/C/F/TAF93.5

Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 24 Using the FDA Snapshot Analysis

The percentage of participants with HIV-1 RNA < 20 copies/mL at Week 24 was also analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 24 window was between Day 141 and 210 (inclusive). (NCT02616029)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Part 1: E/C/F/TAF88.9
Part 2: E/C/F/TAF100.0
Total E/C/F/TAF93.5

Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 Using the FDA Snapshot Analysis

The percentage of participants with HIV-1 RNA < 20 copies/mL at Week 48 was also analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 12 window was between Day 295 and 378 (inclusive). (NCT02616029)
Timeframe: Week 48

Interventionpercentage of participants (Number)
Part 1: E/C/F/TAF88.9
Part 2: E/C/F/TAF96.2
Total E/C/F/TAF91.9

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 Using the FDA Snapshot Analysis

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 12 was also analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 12 window was between Day 71 and 98 (inclusive). (NCT02616029)
Timeframe: Week 12

Interventionpercentage of participants (Number)
Part 1: E/C/F/TAF91.7
Part 2: E/C/F/TAF96.2
Total E/C/F/TAF93.5

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 Using the Missing = Excluded (M = E) Approach

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 12 was also analyzed using the M = E approach. In this approach, all missing data was excluded in the computation of the proportions. (NCT02616029)
Timeframe: Week 12

Interventionpercentage of participants (Number)
Part 1: E/C/F/TAF100.0
Part 2: E/C/F/TAF96.2
Total E/C/F/TAF98.4

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 Using the Missing = Failure (M = F) Approach

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 12 was analyzed using the M = F approach. In this approach, all missing data was treated as HIV-1 RNA ≥ 50 copies/mL. (NCT02616029)
Timeframe: Week 12

Interventionpercentage of participants (Number)
Part 1: E/C/F/TAF97.2
Part 2: E/C/F/TAF96.2
Total E/C/F/TAF96.8

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using PVR

The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 24 was summarized. PVR was the percentage of participants who did not have a confirmed virologic rebound. Virologic rebound was defined as 2 consecutive HIV-1 RNA values ≥ 50 copies/mL or the last available HIV-1 RNA value ≥ 50 copies/mL during the study followed by premature discontinuation from the study. (NCT02616029)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Part 1: E/C/F/TAF100.0
Part 2: E/C/F/TAF100.0
Total E/C/F/TAF100.0

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the FDA Snapshot Analysis

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was also analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 24 window was between Day 141 and 210 (inclusive). (NCT02616029)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Part 1: E/C/F/TAF91.7
Part 2: E/C/F/TAF100.0
Total E/C/F/TAF95.2

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the M = E Approach

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was also analyzed using the M = E approach. In this approach, all missing data was excluded in the computation of the proportions. (NCT02616029)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Part 1: E/C/F/TAF100.0
Part 2: E/C/F/TAF100.0
Total E/C/F/TAF100.0

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the M = F Approach

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the M = F approach. In this approach, all missing data was treated as HIV-1 RNA ≥ 50 copies/mL. (NCT02616029)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Part 1: E/C/F/TAF91.7
Part 2: E/C/F/TAF100.0
Total E/C/F/TAF95.2

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using PVR

The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 48 was summarized. PVR was the percentage of participants who did not have a confirmed virologic rebound. Virologic rebound was defined as 2 consecutive HIV-1 RNA values ≥ 50 copies/mL or the last available HIV-1 RNA value ≥ 50 copies/mL during the study followed by premature discontinuation from the study. (NCT02616029)
Timeframe: Week 48

Interventionpercentage of participants (Number)
Part 1: E/C/F/TAF100.0
Part 2: E/C/F/TAF100.0
Total E/C/F/TAF100.0

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the FDA Snapshot Analysis

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was also analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 12 window was between Day 295 and 378 (inclusive). (NCT02616029)
Timeframe: Week 48

Interventionpercentage of participants (Number)
Part 1: E/C/F/TAF88.9
Part 2: E/C/F/TAF96.2
Total E/C/F/TAF91.9

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the M = E Approach

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was also analyzed using the M = E approach. In this approach, all missing data was excluded in the computation of the proportions. (NCT02616029)
Timeframe: Week 48

Interventionpercentage of participants (Number)
Part 1: E/C/F/TAF100.0
Part 2: E/C/F/TAF100.0
Total E/C/F/TAF100.0

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the M = F Approach

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the M = F approach. In this approach, all missing data was treated as HIV-1 RNA ≥ 50 copies/mL. (NCT02616029)
Timeframe: Week 48

Interventionpercentage of participants (Number)
Part 1: E/C/F/TAF91.7
Part 2: E/C/F/TAF96.2
Total E/C/F/TAF93.5

Percentage of Participants With Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) < 50 Copies/mL at Week 12 as Defined by Pure Virologic Response (PVR)

The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 12 was summarized. PVR was the percentage of participants who did not have a confirmed virologic rebound. Virologic rebound was defined as 2 consecutive HIV-1 RNA values ≥ 50 copies/mL or the last available HIV-1 RNA value ≥ 50 copies/mL during the study followed by premature discontinuation from the study. (NCT02616029)
Timeframe: Week 12

Interventionpercentage of participants (Number)
Part 1: E/C/F/TAF100.0
Part 2: E/C/F/TAF100.0
Total E/C/F/TAF100.0

Period 1: Area Under the Plasma Concentration-time Curve From Time 0 to the End of the Dosing Interval at Steady State (AUC [0-tau]) of TAF

Blood samples were collected at indicated time-points for analysis of AUC (0-tau). Pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis. PK Parameter Population included all participants who underwent plasma PK sampling and had evaluable PK parameters estimated. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

InterventionHours*nanogram per milliliter (Geometric Mean)
TAF/FTC250.4

Period 1: AUC (0-tau) of FTC

Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

InterventionHours*nanogram per milliliter (Geometric Mean)
TAF/FTC9787.5

Period 1: AUC (0-tau) of Tenofovir (TFV)

Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

InterventionHours*nanogram per milliliter (Geometric Mean)
TAF/FTC221.9

Period 1: Cmax of TFV

Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

InterventionNanogram per milliliter (Geometric Mean)
TAF/FTC13.14

Period 1: Ctau of TFV

Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

InterventionNanogram per milliliter (Geometric Mean)
TAF/FTC7.688

Period 1: Maximum Observed Concentration (Cmax) of TAF

Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

InterventionNanogram per milliliter (Geometric Mean)
TAF/FTC203.4

Period 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of FTC

Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

InterventionNanogram per milliliter (Geometric Mean)
TAF/FTC71.81

Period 1: Tmax of FTC

Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

InterventionHours (Median)
TAF/FTC1.500

Period 1: Tmax of TAF

Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

InterventionHours (Median)
TAF/FTC1.00

Period 1: Tmax of TFV

Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

InterventionHours (Median)
TAF/FTC3.000

Period 1:Cmax of FTC

Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

InterventionNanogram per milliliter (Geometric Mean)
TAF/FTC1811

Period 2: AUC (0-tau) of FTC

Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

InterventionHours*nanogram per milliliter (Geometric Mean)
TAF/FTC+GSK36402549421.0

Period 2: AUC (0-tau) of GSK3640254

Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 1 and 2hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

InterventionHours*nanogram per milliliter (Geometric Mean)
TAF/FTC+GSK364025424.53

Period 2: AUC (0-tau) of TAF

Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

InterventionHours*nanogram per milliliter (Geometric Mean)
TAF/FTC+GSK3640254215.4

Period 2: AUC (0-tau) of TFV

Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

InterventionHours*nanogram per milliliter (Geometric Mean)
TAF/FTC+GSK3640254229.1

Period 2: Cmax of GSK3640254

Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 1 and 2hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

InterventionNanogram per milliliter (Geometric Mean)
TAF/FTC+GSK36402541.411

Period 2: Cmax of TAF

Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

InterventionNanogram per milliliter (Geometric Mean)
TAF/FTC+GSK3640254175.1

Period 2: Cmax of TFV

Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

InterventionNanogram per milliliter (Geometric Mean)
TAF/FTC+GSK364025413.30

Period 2: Ctau of FTC

Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

InterventionNanogram per milliliter (Geometric Mean)
TAF/FTC+GSK364025482.92

Period 2: Ctau of GSK3640254

Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 1 and 2 hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

InterventionNanogram per milliliter (Geometric Mean)
TAF/FTC+GSK36402540.7883

Period 2: Ctau of TFV

Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

InterventionNanogram per milliliter (Geometric Mean)
TAF/FTC+GSK36402548.244

Period 2: Time of Maximum Observed Concentration (Tmax) of GSK3640254

Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 1 and 2hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

InterventionHours (Median)
TAF/FTC+GSK36402545.000

Period 2: Tmax of FTC

Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

InterventionHours (Median)
TAF/FTC+GSK36402541.500

Period 2: Tmax of TAF

Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

InterventionHours (Median)
TAF/FTC+GSK36402541.000

Period 2: Tmax of TFV

Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

InterventionHours (Median)
TAF/FTC+GSK36402543.000

Period 2:Cmax of FTC

Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

InterventionNanogram per milliliter (Geometric Mean)
TAF/FTC+GSK36402541701

Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAE)

An adverse events (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before (NCT03836729)
Timeframe: Up to Day 24

,
InterventionParticipants (Number)
Non-SAEsSAEs
TAF/FTC90
TAF/FTC+GSK364025430

Period 1: Absolute Values of Blood Pressure

SBP and DBP was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7

InterventionMillimeters of mercury (Mean)
SBP, BaselineSBP, Day 2SBP, Day 3SBP, Day 4SBP, Day 5SBP, Day 7DBP, BaselineDBP, Day 2DBP, Day 3DBP, Day 4DBP, Day 5DBP, Day 7
TAF/FTC123.3124.7121.5120.6121.0124.175.375.473.875.473.978.2

Period 1: Absolute Values of Chemistry Parameters of Lipase and Amylase

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionUnits per Liter (Mean)
Amylase, BaselineAmylase, Day 7Amylase, Day 14Lipase, BaselineLipase, Day 7Lipase, Day 14
TAF/FTC56.454.153.622.218.216.9

Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionInternational units per Liter (Mean)
Alkaline phosphatase, BaselineAlkaline phosphatase, Day 7Alkaline phosphatase, Day 14AST, BaselineAST, Day 7AST, Day 14ALT, BaselineALT, Day 7ALT, Day 14GGT BaselineGGT Day 7GGT Day 14LDH, BaselineLDH, Day 7LDH, Day 9CK, BaselineCK, Day 7CK, Day 14
TAF/FTC60.958.363.424.618.417.626.624.420.41.761.912.40138.0123.4126.0219.6116.6120.4

Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus

Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionMillimoles per Liter (Mean)
Glucose, BaselineGlucose, Day 7Glucose, Day 14Cholesterol, BaselineCholesterol, Day 7Cholesterol, Day 14Anion gap, BaselineAnion gap, Day 7Anion gap, Day 14Calcium, BaselineCalcium, Day 7Calcium, Day 14CO2, BaselineCO2, Day 7CO2, Day 14Chloride, BaselineChloride, Day 7Chloride, Day 14Phosphate, BaselinePhosphate, Day 7Phosphate, Day 14Potassium, BaselinePotassium, Day 7Potassium, Day 14Sodium, BaselineSodium, Day 7Sodium, Day 14Triglycerides, BaselineTriglycerides, Day 7Triglycerides, Day 14BUN, BaselineBUN, Day 7BUN, Day 14
TAF/FTC5.1114.9514.7914.2534.2493.8648.710.610.92.3592.3872.38731.730.130.8103.3102.2101.31.0781.0941.1034.254.284.22139.4138.8138.81.0761.1681.0334.4414.4234.246

Period 1: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionMicromoles per liter (Mean)
Creatinine, BaselineCreatinine, Day 7Creatinine, Day 14Total bilirubin, BaselineTotal bilirubin, Day 7Total bilirubin, Day 14Direct bilirubin, BaselineDirect bilirubin, Day 7Direct bilirubin, Day 14
TAF/FTC80.1685.8587.529.6411.8911.741.761.912.40

Period 1: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total protein, albumin and globulin. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionGrams per Liter (Mean)
Total Protein, BaselineTotal Protein, Day 7Total Protein, Day 14Globulin, BaselineGlobulin, Day 7Globulin, Day 14Albumin, BaselineAlbumin, Day 7Albumin, Day 14
TAF/FTC69.872.472.625.928.428.743.944.043.9

Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval

Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interval, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Day 1, 2 and 4 hours post-dose

InterventionMilliseconds (Mean)
PR Interval, BaselinePR Interval, Day 1, 2 hours post-dosePR Interval, Day 1, 4 hours post-doseQRS Duration, BaselineQRS Duration, Day 1, 2 hours post-doseQRS Duration, Day 1, 4 hours post-doseQT Interval, BaselineQT Interval, Day 1, 2 hours post-doseQT Interval, Day 1, 4 hours post-doseQTcF Interval, BaselineQTcF Interval, Day 1, 2 hours post-doseQTcF Interval, Day 1, 4 hours post-doseQTcB Interval, BaselineQTcB Interval, Day 1, 2 hours post-doseQTcB Interval, Day 1, 4 hours post-dose
TAF/FTC161.3162.8159.491.089.991.3377.8370.3383.6391.6386.7390.3398.8394.6393.3

Period 1: Absolute Values of Heart Rate

Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Day 1, 2 and 4 hours post-dose

InterventionBeats per minute (Mean)
BaselineDay 1, 2 hours post-doseDay 1, 4 hours post-dose
TAF/FTC67.669.164.4

Period 1: Absolute Values of pH of Urine

Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionpH (Mean)
BaselineDay 7Day 14
TAF/FTC6.225.886.03

Period 1: Absolute Values of Pulse Rate

Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7

InterventionBeats per minute (Mean)
BaselineDay 2Day 3Day 4Day 5Day 7
TAF/FTC73.972.870.169.972.366.3

Period 1: Absolute Values of Respiratory Rate

Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7

InterventionBreaths per minute (Mean)
BaselineDay 2Day 3Day 4Day 5Day 7
TAF/FTC14.012.513.513.515.314.6

Period 1: Absolute Values of Specific Gravity of Urine

Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionRatio (Mean)
BaselineDay 7Day 14
TAF/FTC1.01361.01431.0147

Period 1: Absolute Values of Temperature

Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7

InterventionDegree Celsius (Mean)
BaselineDay 2Day 3Day 4Day 5Day 7
TAF/FTC36.4936.3336.3436.4136.3436.25

Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils

Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, and 14

InterventionGiga cells per liter (Mean)
Basophils, Period 1 BaselineBasophils, Period 1 Day 7Basophils, Period 1 Day 14Eosinophils, Period 1 BaselineEosinophils, Period 1 Day 7Eosinophils, Period 1 Day 14Monocytes, Period 1 BaselineMonocytes, Period 1 Day 7Monocytes, Period 1 Day 14Leukocytes, Period 1 BaselineLeukocytes, Period 1 Day 7Leukocytes, Period 1 Day 14Lymphocytes, Period 1 BaselineLymphocytes, Period 1 Day 7Lymphocytes, Period 1 Day 14Neutrophils, Period 1 BaselineNeutrophils, Period 1 Day 7Neutrophils, Period 1 Day 14Platelets, Period 1 BaselinePlatelets, Period 1 Day 7Platelets, Period 1 Day 14
TAF/FTC0.0460.0410.0400.2250.2040.2050.5220.5360.5716.186.106.451.9451.6991.6833.4413.6283.954253.3256.6275.1

Period 1: Absolute Values of the Hematology Parameter: Erythrocytes

Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionTrillion cells per liter (Mean)
BaselineDay 7Day 14
TAF/FTC4.9775.1665.203

Period 1: Absolute Values of the Hematology Parameter: Hematocrit

Blood samples were collected at indicated time points for analysis for hematology parameter like hematocrit. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionProportion of red blood cells in blood (Mean)
BaselineDay 7Day 14
TAF/FTC0.42640.43840.4453

Period 1: Absolute Values of the Hematology Parameter: Hemoglobin

Blood samples were collected at indicated time-points for analysis for hematology parameter like hemoglobin. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionGrams per liter (Mean)
BaselineDay 7Day 14
TAF/FTC142.0148.1150.4

Period 1: Absolute Values of the Hematology Parameter: MCH

Blood samples were collected at indicated time-points for analysis for hematology parameter like MCH. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionPicograms (Mean)
BaselineDay 7Day 14
TAF/FTC28.6328.7528.98

Period 1: Absolute Values of the Hematology Parameter: MCV

Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionFemtoliters (Mean)
BaselineDay 7Day 14
TAF/FTC85.9285.0985.85

Period 1: Absolute Values of Urine Urobilinogen

Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionMicromoles per liter (Mean)
BaselineDay 7Day 14
TAF/FTC5.92553.38603.3860

Period 1: Change From Baseline in Blood Pressure

Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7

InterventionMillimeters of mercury (Mean)
SBP, Day 2SBP, Day 3SBP, Day 4SBP, Day 5SBP, Day 7DBP, Day 2DBP, Day 3DBP, Day 4DBP, Day 5DBP, Day 7
TAF/FTC1.4-1.8-2.7-2.30.80.1-1.60.1-1.42.9

Period 1: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH), Gamma-glutamyl Transferase (GGT), and Creatine Phosphokinase (CK)

Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter like alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionInternational units per Liter (Mean)
Alkaline phosphatase, Day 7Alkaline phosphatase, Day 14AST, Day 7AST, Day 14ALT, Day 7ALT, Day 14GGT Day 7GGT Day 14LDH, Day 7LDH, Day 14CK, Day 7CK, Day 14
TAF/FTC-2.62.4-6.2-6.9-2.1-6.20.2-1.7-14.6-12.0-103.0-99.2

Period 1: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), Carbon Dioxide (CO2), Chloride and Phosphorus

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionMillimoles per Liter (Mean)
Glucose, Day 7Glucose, Day 14Cholesterol, Day 7Cholesterol, Day 14Anion gap, Day 7Anion gap, Day 14Calcium, Day 7Calcium, Day 14CO2, Day 7CO2, Day 14Chloride, Day 7Chloride, Day 14Phosphate, Day 7Phosphate, Day 14Potassium, Day 7Potassium, Day 14Sodium, Day 7Sodium, Day 14Triglycerides, Day 7Triglycerides, Day 14BUN, Day 7BUN, Day 14
TAF/FTC-0.160-0.320-0.004-0.3891.92.20.0280.028-1.6-0.9-1.1-2.00.0170.0260.03-0.03-0.6-0.60.092-0.044-0.018-0.195

Period 1: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionUnits per Liter (Mean)
Amylase, Day 7Amylase, Day 14Lipase, Day 7Lipase, Day 14
TAF/FTC-2.3-2.8-4.0-5.3

Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionMicromoles per liter (Mean)
Creatinine, Day 7Creatinine, Day 14Total bilirubin, Day 7Total bilirubin, Day 14Direct bilirubin, Day 7Direct bilirubin, Day 14
TAF/FTC5.697.362.252.100.150.64

Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of of total protein, albumin and globulin. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionGrams per Liter (Mean)
Total Protein, Day 7Total Protein, Day 14Globulin, Day 7Globulin, Day 14Albumin, Day 7Albumin, Day 14
TAF/FTC2.62.92.52.80.10.1

Period 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF) Interval, and Bazett QT Correction Formula (QTcB) Interval

Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interal, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Day 1, 2 and 4 hours post-dose

InterventionMilliseconds (Mean)
PR Interval, Day 1, 2 hours post-dosePR Interval, Day 1, 4 hours post-doseQRS Duration, Day 1, 2 hours post-doseQRS Duration, Day 1, 4 hours post-doseQT Interval, Day 1, 2 hours post-doseQT Interval, Day 1, 4 hours post-doseQTcF Interval, Day 1, 2 hours post-doseQTcF Interval, Day 1, 4 hours post-doseQTcB Interval, Day 1, 2 hours post-doseQTcB Interval, Day 1, 4 hours post-dose
TAF/FTC1.5-1.9-1.10.3-7.55.8-4.9-1.3-4.1-5.4

Period 1: Change From Baseline in Heart Rate

Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Day 1, 2 and 4 hours post-dose

InterventionBeats per minute (Mean)
Day 1, 2 hours post-doseDay 1, 4 hours post-dose
TAF/FTC1.5-3.3

Period 1: Change From Baseline in Hematology Parameter of Erythrocytes

Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionTrillion cells per liter (Mean)
Day 7Day 14
TAF/FTC0.1890.226

Period 1: Change From Baseline in Hematology Parameter of Hematocrit

Blood samples were collected at indicated timepoints for analysis of hematology parameter like hematocrit. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionProportion of red blood cells in blood (Mean)
Day 7Day 14
TAF/FTC0.01210.0189

Period 1: Change From Baseline in Hematology Parameter of Hemoglobin

Blood samples were collected at indicated timepoints for analysis for hematology parameter like hemoglobin. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionGrams per liter (Mean)
Day 7Day 14
TAF/FTC6.18.4

Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Hemoglobin (MCH)

Blood samples were collected at indicated timepoints for analysis of hematology parameter like MCH. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionPicograms (Mean)
Day 7Day 14
TAF/FTC0.130.36

Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Volume (MCV)

Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionFemtoliters (Mean)
Day 7Day 14
TAF/FTC-0.83-0.07

Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils

Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, and 14

InterventionGiga cells per liter (Mean)
Basophils, Period 1 Day 7Basophils, Period 1 Day 14Eosinophils, Period 1 Day 7Eosinophils, Period 1 Day 14Monocytes, Period 1 Day 7Monocytes, Period 1 Day 14Leukocytes, Period 1 Day 7Leukocytes, Period 1 Day 14Lymphocytes, Period 1 Day 7Lymphocytes, Period 1 Day 14Neutrophils, Period 1 Day 7Neutrophils, Period 1 Day 14Platelets, Period 1 Day 7Platelets, Period 1 Day 14
TAF/FTC-0.005-0.006-0.021-0.0200.0140.049-0.080.27-0.246-0.2620.1880.5133.321.8

Period 1: Change From Baseline in Potential of Hydrogen (pH) of Urine

Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionpH (Mean)
Day 7Day 14
TAF/FTC-0.34-0.19

Period 1: Change From Baseline in Pulse Rate

Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7

InterventionBeats per minute (Mean)
Day 2Day 3Day 4Day 5Day 7
TAF/FTC-1.2-3.8-4.0-1.6-7.6

Period 1: Change From Baseline in Respiratory Rate

Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7

InterventionBreaths per minute (Mean)
Day 2Day 3Day 4Day 5Day 7
TAF/FTC-1.5-0.5-0.51.30.6

Period 1: Change From Baseline in Specific Gravity of Urine

Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionRatio (Mean)
Day 7Day 14
TAF/FTC0.00070.0011

Period 1: Change From Baseline in Temperature

Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7

InterventionDegree Celsius (Mean)
Day 2Day 3Day 4Day 5Day 7
TAF/FTC-0.16-0.15-0.09-0.15-0.24

Period 1: Change From Baseline in Urine Urobilinogen

Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14

InterventionMicromoles per liter (Mean)
Day 7Day 14
TAF/FTC-2.5395-2.5395

Period 2: Absolute Values of Blood Pressure

SBP and DBP was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Days 4, 7, 9, and 10

InterventionMillimeters of mercury (Mean)
SBP, Baseline, n= 16SBP, Day 4, n=15SBP, Day 7, n=15SBP, Day 9, n=15SBP, Day 10, n=15DBP, Baseline, n= 16DBP, Day 4, n= 15DBP, Day 7, n= 15DBP, Day 9, n= 15DBP, Day 10, n= 15
TAF/FTC+GSK3640254120.4119.3120.8117.9123.774.474.377.970.372.1

Period 2: Absolute Values of Chemistry Parameters of Lipase and Amylase

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionUnits per Liter (Mean)
Amylase, Baseline, n= 16Amylase, Day 3, n= 16Amylase, Day 7, n= 15Amylase, Day 9, n= 15Lipase, Baseline, n= 16Lipase, Day 3, n= 16Lipase, Day 7, n= 15Lipase, Day 9, n= 15
TAF/FTC+GSK364025453.656.852.755.716.924.617.521.0

Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionInternational units per Liter (Mean)
Alkaline phosphatase, Baseline Day 3, n= 16Alkaline phosphatase, Day 3, n= 16Alkaline phosphatase, Day 7, n= 15Alkaline phosphatase, Day 9, n= 15AST, Baseline, n= 16AST, Day 3, n= 16AST, Day 7, n= 15AST, Day 9, n= 15ALT, Baseline, n= 16ALT, Day 3, n= 16ALT, Day 7, n= 15ALT, Day 9, n= 15GGT, Baseline, n= 16GGT, Day 3, n= 16GGT, Day 7, n= 15GGT, Day 9, n= 15LDH, Baseline, n= 16LDH, Day 3, n= 16LDH, Day 7, n= 15LDH, Day 9, n= 15CK, Baseline, n= 16CK, Day 3, n= 16CK, Day 7, n= 15CK, Day 9, n= 15
TAF/FTC+GSK364025463.467.165.461.817.616.217.217.620.418.418.519.72.402.142.411.95126.0119.0118.0119.2120.4123.8135.8122.2

Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionMillimoles per Liter (Mean)
Glucose, Baseline, n= 16Glucose, Day 3, n= 15Glucose, Day 7, n= 15Glucose, Day 9, n= 15Cholesterol, Baseline, n= 16Cholesterol, Day 3, n=15Cholesterol, Day 7, n= 15Cholesterol, Day 9, n= 16Anion gap, Baseline, n= 16Anion gap, Day 3, n= 16Anion gap, Day 7, n= 15Anion gap, Day 9, n= 15Calcium, Baseline, n= 16Calcium, Day 3, n= 16Calcium, Day 7, n= 15Calcium, Day 9, n= 15CO2, Baseline, n= 16CO2, Day 3, n= 16CO2, Day 7, n= 15CO2, Day 9, n= 15Chloride, Baseline, n= 16Chloride, Day 3, n= 16Chloride, Day 7, n= 15Chloride, Day 9, n= 15Phosphate, Baseline, n= 16Phosphate, Day 3, n= 16Phosphate, Day 7, n= 15Phosphate, Day 9, n= 15Potassium, Baseline, n= 16Potassium, Day 3, n= 16Potassium, Day 7, n= 15Potassium, Day 9, n= 15Sodium, Baseline, n= 16Sodium, Day 3, n= 16Sodium, Day 7, n= 15Sodium, Day 9, n=15Triglycerides, Baseline, n= 16Triglycerides, Day 3, n= 16Triglycerides, Day 7, n= 15Triglycerides, Day 9, n= 15BUN, Baseline, n= 16BUN, Day 3, n= 16BUN, Day 7, n= 15BUN Day 9, n= 15
TAF/FTC+GSK36402544.7915.0275.1294.9503.8643.8753.8943.82210.910.510.310.52.3872.3992.4242.42130.830.330.730.5101.3103.6101.9102.71.1031.1651.1121.1174.224.234.214.35138.8140.2138.8139.31.0331.0291.1200.9614.2464.5584.2604.263

Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, creatinine and uric acid. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionMicromoles per liter (Mean)
Creatinine, Baseline, n= 16Creatinine, Day 3, n= 16Creatinine, Day 7, n= 15Creatinine, Day 9, n= 15Total bilirubin, Baseline, n= 16Total bilirubin, Day 3, n= 16Total bilirubin, Day 7, n= 15Total bilirubin, Day 9, n= 15Direct bilirubin, Baseline, n= 16Direct bilirubin, Day 3, n= 16Direct bilirubin, Day 7, n= 15Direct bilirubin, Day 9, n= 15
TAF/FTC+GSK364025487.5285.1891.5388.2711.4410.6211.339.682.402.142.411.95

Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, creatinine and uric acid. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionGrams per Liter (Mean)
Total Protein, Baseline, n= 16Total Protein, Day 3, n= 16Total Protein, Day 7, n= 15Total Protein, Day 9, n= 15Globulin, Baseline, n= 16Globulin, Day 3, n= 16Globulin, Day 7, n= 15Globulin, Day 9, n= 15Albumin, Baseline, n= 16Albumin, Day 3, n= 16Albumin, Day 7, n= 15Albumin, Day 9, n= 15
TAF/FTC+GSK364025472.672.875.773.328.728.930.928.843.943.944.844.5

Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval

Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interval, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose

InterventionMilliseconds (Mean)
PR Interval, Baseline, n= 16PR Interval, Day 1, 2 hours post-dose, n= 16PR Interval, Day 1, 4 hours post-dose, n= 16PR Interval, Day 4, Pre-dose, n= 15PR Interval, Day 4, 2 hours post-dose, n= 15PR Interval, Day 4, 4 hours post-dose, n= 15PR Interval, Day 7, Pre-dose, n= 15PR Interval, Day 7, 2 hours post-dose, n= 15PR Interval, Day 7, 4 hours post-dose, n= 15PR Interval, Day 9 post-dose, n= 15QRS Duration, Baseline, n= 16QRS Duration, Day 1, 2 hours post-dose, n= 16QRS Duration, Day 1, 4 hours post-dose, n= 16QRS Duration, Day 4, Pre-dose, n= 15QRS Duration, Day 4, 2 hours post-dose, n= 15QRS Duration, Day 4, 4 hours post-dose, n= 15QRS Duration, Day 7, Pre-dose, n= 15QRS Duration, Day 7, 2 hours post-dose, n= 15QRS Duration, Day 7, 4 hours post-dose, n= 15QRS Duration, Day 9 post-dose, n= 15QT Interval, Baseline, n= 16QT Interval, Day 1, 2 hours post-dose, n= 16QT Interval, Day 1, 4 hours post-dose, n= 16QT Interval, Day 4, Pre-dose, n= 15QT Interval, Day 4, 2 hours post-dose, n= 15QT Interval, Day 4, 4 hours post-dose, n= 15QT Interval, Day 7, Pre-dose, n= 15QT Interval, Day 7, 2 hours post-dose, n= 15QT Interval, Day 7, 4 hours post-dose, n= 15QT Interval, Day 9 post-dose, n= 15QTcF Interval, Baseline, n= 16QTcF Interval, Day 1, 2 hours, n= 16QTcF Interval, Day 1, 4 hours post-dose, n= 16QTcF Interval, Day 4, Pre-dose, n= 15QTcF Interval, Day 4, 2 hours post-dose, n= 15QTcF Interval, Day 4, 4 hours post-dose, n= 15QTcF Interval, Day 7, Pre-dose, n= 15QTcF Interval, Day 7, 2 hours post-dose, n= 15QTcF Interval, Day 7, 4 hours post-dose, n= 15QTcF Interval, Day 9 post-dose, n= 15QTcB Interval, Baseline, n= 16QTcB Interval, Day 1, 2 hours post-dose, n= 16QTcB Interval, Day 1, 4 hours post-dose, n= 16QTcB Interval, Day 4, Pre-dose, n= 15QTcB Interval, Day 4, 2 hours post-dose, n= 15QTcB Interval, Day 4, 4 hours post-dose, n= 15QTcB Interval, Day 7, Pre-dose, n= 15QTcB Interval, Day 7, 2 hours post-dose, n= 15QTcB Interval, Day 7, 4 hours post-dose, n= 15QTcB Interval, Day 9 post-dose, n= 15
TAF/FTC+GSK3640254167.3160.4163.6167.1160.7163.7164.9164.3163.9168.891.488.990.191.891.891.194.592.791.694.3377.7365.1375.9385.6371.5383.9381.7369.9384.1382.4390.0385.6392.4395.0388.3393.4393.0383.8389.5396.8395.7396.4400.4399.2396.2398.0398.3390.5391.9404.0

Period 2: Absolute Values of Heart Rate

Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose

InterventionBeats per minute (Mean)
Baseline, n= 16Day 1, 2 hours post-dose, n= 16Day 1, 4 hours post-dose, n= 16Day 4, Pre-dose, n= 15Day 4, 2 hours post-dose, n= 15Day 4, 4 hours post-dose, n= 15Day 7, Pre-dose, n= 15Day 7, 2 hours post-dose, n= 15Day 7, 4 hours post-dose, n= 15Day 9 post-dose, n= 15
TAF/FTC+GSK364025466.571.569.365.168.965.365.967.463.367.7

Period 2: Absolute Values of pH of Urine

Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionpH (Mean)
Baseline, n= 16Day 3, n= 16Day 7, n= 15Day 9, n= 15
TAF/FTC+GSK36402546.036.226.076.07

Period 2: Absolute Values of Pulse Rate

Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Days 4, 7, 9, and 10

InterventionBeats per minute (Mean)
Baseline, n= 16Day 4, n=15Day 7, n=15Day 9, n=15Day 10, n=15
TAF/FTC+GSK364025470.571.971.469.279.0

Period 2: Absolute Values of Respiratory Rate

Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Days 4, 7, 9, and 10

InterventionBreaths per minute (Mean)
Baseline, n= 16Day 4, n=15Day 7, n=15Day 9, n=15Day 10, n=15
TAF/FTC+GSK364025415.612.513.314.914.3

Period 2: Absolute Values of Specific Gravity of Urine

Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionRatio (Mean)
Baseline, n= 16Day 3, n= 16Day 7, n= 15Day 9, n= 15
TAF/FTC+GSK36402541.01471.01781.01701.0151

Period 2: Absolute Values of Temperature

Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Days 4, 7, 9, and 10

InterventionDegree Celsius (Mean)
Baseline, n= 16Day 4, n=15Day 7, n=15Day 9, n=15Day 10, n=15
TAF/FTC+GSK364025436.4936.3736.4036.4636.53

Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils

Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionGiga cells per liter (Mean)
Basophils, Period 2 Baseline, n= 16Basophils, Period 2 Day 3, n= 15Basophils, Period 2 Day 7, n= 15Basophils, Period 2 Day 9, n= 15Eosinophils, Period 2 Baseline, n= 16Eosinophils, Period 2 Day 3, n= 15Eosinophils, Period 2 Day 7, n= 15Eosinophils, Period 2 Day 9, n= 16Monocytes, Period 2 Baseline, n= 16Monocytes, Period 2 Day 3, n= 16Monocytes, Period 2 Day 7, n= 15Monocytes, Period 2 Day 9, n= 15Leukocytes, Period 2 Baseline, n= 16Leukocytes, Period 2 Day 3, n= 16Leukocytes, Period 2 Day 7, n= 15Leukocytes, Period 2 Day 9, n= 15Lymphocytes, Period 2 Baseline, n= 16Lymphocytes, Period 2 Day 3, n= 16Lymphocytes, Period 2 Day 7, n= 15Lymphocytes, Period 2 Day 9, n= 15Neutrophils, Period 2 Baseline, n= 16Neutrophils, Period 2 Day 3, n= 16Neutrophils, Period 2 Day 7, n= 15Neutrophils, Period 2 Day 9, n= 15Platelets, Period 2 Baseline, n= 16Platelets, Period 2 Day 3, n= 16Platelets, Period 2 Day 7, n= 15Platelets, Period 2 Day 9, n= 15
TAF/FTC+GSK36402540.0400.0360.0380.0430.2080.1850.1570.1530.5450.4920.4480.4216.205.145.395.511.7181.5601.5701.5633.7242.8573.1893.324274.3283.4294.0290.4

Period 2: Absolute Values of the Hematology Parameter: Erythrocytes

Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionTrillion cells per liter (Mean)
Baseline, n= 16Day 3, n= 16Day 7, n= 15Day 9, n= 15
TAF/FTC+GSK36402545.2035.0905.1905.001

Period 2: Absolute Values of the Hematology Parameter: Hematocrit

Blood samples were collected at indicated time-points for analysis for hematology parameter like hematocrit. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionProportion of red blood cells in blood (Mean)
Baseline, n= 16Day 3, n= 16Day 7, n= 15Day 9, n= 15
TAF/FTC+GSK36402540.44530.43060.44440.4247

Period 2: Absolute Values of the Hematology Parameter: Hemoglobin

Blood samples were collected at indicated time-points for analysis for hematology parameter like hemoglobin. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionGrams per liter (Mean)
Baseline, n= 16Day 3, n= 16Day 7, n= 15Day 9, n= 15
TAF/FTC+GSK3640254150.4146.4149.1143.9

Period 2: Absolute Values of the Hematology Parameter: MCH

Blood samples were collected at indicated time-points for analysis of hematology parameter like MCH. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionPicograms (Mean)
Baseline, n= 16Day 3, n= 16Day 7, n= 15Day 9, n= 15
TAF/FTC+GSK364025428.9828.8828.8328.87

Period 2: Absolute Values of the Hematology Parameter: MCV

Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionFemtoliters (Mean)
Baseline, n= 16Day 3, n= 16Day 7, n= 15Day 9, n= 15
TAF/FTC+GSK364025485.8584.8385.8585.20

Period 2: Absolute Values of Urine Urobilinogen

Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionMicromoles per liter (Mean)
Baseline, n= 16Day 3, n= 16Day 7, n= 15Day 9, n= 15
TAF/FTC+GSK36402543.38603.38603.38603.3860

Period 2: Change From Baseline in Blood Pressure

SBP and DBP was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 4, 7, 9, and 10

InterventionMillimeters of mercury (Mean)
SBP, Day 4SBP, Day 7SBP, Day 9SBP, Day 10DBP, Day 4DBP, Day 7DBP, Day 9DBP, Day 10
TAF/FTC+GSK3640254-0.31.1-1.74.10.13.7-4.0-2.1

Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionInternational units per Liter (Mean)
Alkaline phosphatase, Day 3, n= 16Alkaline phosphatase, Day 7, n= 15Alkaline phosphatase, Day 9, n= 15AST, Day 3, n= 16AST, Day 7, n= 15AST, Day 9, n= 15ALT, Day 3, n= 16ALT, Day 7, n= 15ALT, Day 9, n= 15GGT, Day 3, n= 16GGT, Day 7, n= 15GGT, Day 9, n= 15LDH, Day 3, n= 16LDH, Day 7, n= 15LDH, Day 9, n= 15CK, Day 3, n= 16CK, Day 7, n= 15CK, Day 9, n= 15
TAF/FTC+GSK36402543.72.6-1.0-1.4-0.5-0.1-2.0-1.9-0.7-0.9-1.4-1.9-7.0-8.2-7.03.411.3-2.3

Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionMillimoles per Liter (Mean)
Glucose, Day 3, n= 15Glucose, Day 7, n= 15Glucose, Day 9, n= 15Cholesterol, Day 3, n=15Cholesterol, Day 7, n= 15Cholesterol, Day 9, n= 16Anion gap, Day 3, n= 16Anion gap, Day 7, n= 15Anion gap, Day 9, n= 15Calcium, Day 3, n= 16Calcium, Day 7, n= 15Calcium, Day 9, n= 15CO2, Day 3, n= 16CO2, Day 7, n= 15CO2, Day 9, n= 15Chloride, Day 3, n= 16Chloride, Day 7, n= 15Chloride, Day 9, n= 15Phosphate, Day 3, n= 16Phosphate, Day 7, n= 15Phosphate, Day 9, n= 15Potassium, Day 3, n= 16Potassium, Day 7, n= 15Potassium, Day 9, n= 15Sodium, Day 3, n= 16Sodium, Day 7, n= 15Sodium, Day 9, n= 15Triglycerides, Day 3, n= 16Triglycerides, Day 7, n= 15Triglycerides, Day 9, n= 15BUN, Day 3, n= 16BUN, Day 7, n= 15BUN, Day 9, n= 15
TAF/FTC+GSK36402540.2360.3150.1360.0110.1020.030-0.4-0.5-0.30.0130.0370.033-0.5-0.1-0.42.30.61.30.0620.0020.0070.01-0.030.101.40.10.6-0.0030.111-0.0490.312-0.031-0.028

Period 2: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionUnits per Liter (Mean)
Amylase, Day 3, n= 16Amylase, Day 7, n= 15Amylase, Day 9, n= 15Lipase, Day 3, n= 16Lipase, Day 7, n= 15Lipase, Day 9, n= 15
TAF/FTC+GSK36402543.3-1.91.17.70.03.5

Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionMicromoles per liter (Mean)
Creatinine, Day 3, n= 16Creatinine, Day 7, n= 15Creatinine, Day 9, n= 15Total bilirubin, Day 3, n= 16Total bilirubin, Day 7, n= 15Total bilirubin, Day 9, n= 15Direct bilirubin, Day 3, n= 16Direct bilirubin, Day 7, n= 15Direct bilirubin, Day 9, n= 15
TAF/FTC+GSK3640254-2.343.530.28-0.82-0.26-1.91-0.26-0.03-0.49

Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin

Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total protein, albumin and globulin. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionGrams per Liter (Mean)
Total Protein, Day 3, n= 16Total Protein, Day 7, n= 15Total Protein, Day 9, n= 15Globulin, Day 3, n= 16Globulin, Day 7, n= 15Globulin, Day 9, n= 15Albumin, Day 3, n= 16Albumin, Day 7, n= 15Albumin, Day 9, n= 15
TAF/FTC+GSK36402540.13.10.80.22.30.2-0.10.90.6

Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval

Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interal, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose

InterventionMilliseconds (Mean)
PR Interval, Day 1, 2 hours post-dose, n= 16PR Interval, Day 1, 4 hours post-dose, n= 16PR Interval, Day 4, Pre-dose, n= 15PR Interval, Day 4, 2 hours post-dose, n= 15PR Interval, Day 4, 4 hours post-dose, n= 15PR Interval, Day 7, Pre-dose, n= 15PR Interval, Day 7, 2 hours post-dose, n= 15PR Interval, Day 7, 4 hours post-dose, n= 15PR Interval, Day 9 post-dose, n= 15QRS Duration, Day 1, 2 hours post-dose, n= 16QRS Duration, Day 1, 4 hours post-dose, n= 16QRS Duration, Day 4, Pre-dose, n= 15QRS Duration, Day 4, 2 hours post-dose, n= 15QRS Duration, Day 4, 4 hours post-dose, n= 15QRS Duration, Day 7, Pre-dose, n= 15QRS Duration, Day 7, 2 hours post-dose, n= 15QRS Duration, Day 7, 4 hours post-dose, n= 15QRS Duration, Day 9 post-dose, n= 15QT Interval, Day 1, 2 hours post-dose, n= 16QT Interval, Day 1, 4 hours post-dose, n= 16QT Interval, Day 4, Pre-dose, n= 15QT Interval, Day 4, 2 hours post-dose, n= 15QT Interval, Day 4, 4 hours post-dose, n= 15QT Interval, Day 7, Pre-dose, n= 15QT Interval, Day 7, 2 hours post-dose, n= 15QT Interval, Day 7, 4 hours post-dose, n= 15QT Interval, Day 9 post-dose, n= 15QTcF Interval, Day 1, 2 hours post-dose, n= 16QTcF Interval, Day 1, 4 hours post-dose, n= 16QTcF Interval, Day 4, Pre-dose, n= 15QTcF Interval, Day 4, 2 hours post-dose, n= 15QTcF Interval, Day 4, 4 hours post-dose, n= 15QTcF Interval, Day 7, Pre-dose, n= 15QTcF Interval, Day 7, 2 hours post-dose, n= 15QTcF Interval, Day 7, 4 hours post-dose, n= 15QTcF Interval, Day 9 post-dose, n= 15QTcB Interval, Day 1, 2 hours post-dose, n= 16QTcB Interval, Day 1, 4 hours post-dose, n= 16QTcB Interval, Day 4, Pre-dose, n= 15QTcB Interval, Day 4, 2 hours post-dose, n= 15QTcB Interval, Day 4, 4 hours post-dose, n= 15QTcB Interval, Day 7, Pre-dose, n= 15QTcB Interval, Day 7, 2 hours post-dose, n= 15QTcB Interval, Day 7, 4 hours post-dose, n= 15QTcB Interval, Day 9 post-dose, n= 15
TAF/FTC+GSK3640254-6.8-3.7-0.5-6.9-3.9-2.7-3.3-3.71.2-2.5-1.40.50.5-0.23.31.50.33.0-12.6-1.87.3-6.85.63.5-8.45.84.1-4.42.46.1-0.64.54.1-5.10.67.90.74.75.52.54.34.6-3.2-1.710.3

Period 2: Change From Baseline in Heart Rate

Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose

InterventionBeats per minute (Mean)
Day 1, 2 hours post-dose, n= 16Day 1, 4 hours post-dose, n= 16Day 4, Pre-dose, n= 15Day 4, 2 hours post-dose, n= 15Day 4, 4 hours post-dose, n= 15Day 7, Pre-dose, n= 15Day 7, 2 hours post-dose, n= 15Day 7, 4 hours post-dose, n= 15Day 9 post-dose, n= 15
TAF/FTC+GSK36402545.02.8-0.53.3-0.30.31.8-2.32.1

Period 2: Change From Baseline in Hematology Parameter of Erythrocytes

Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionTrillion cells per liter (Mean)
Day 3, n= 16Day 7, n= 15Day 9, n= 15
TAF/FTC+GSK3640254-0.1130.000-0.189

Period 2: Change From Baseline in Hematology Parameter of Hematocrit

Blood samples were collected at indicated time-points for analysis for hematology parameter like hematocrit. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionProportion of red blood cells in blood (Mean)
Day 3, n= 16Day 7, n= 15Day 9, n= 15
TAF/FTC+GSK3640254-0.0147-0.0007-0.0204

Period 2: Change From Baseline in Hematology Parameter of Hemoglobin

Blood samples were collected at indicated timepoints for analysis of hematology parameter like hemoglobin. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionGrams per liter (Mean)
Day 3, n= 16Day 7, n= 15Day 9, n= 15
TAF/FTC+GSK3640254-3.9-1.1-6.4

Period 2: Change From Baseline in Hematology Parameter of MCH

Blood samples were collected at indicated timepoints for analysis for hematology parameter like MCH. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionPicograms (Mean)
Day 3, n= 16Day 7, n= 15Day 9, n= 15
TAF/FTC+GSK3640254-0.11-0.21-0.17

Period 2: Change From Baseline in Hematology Parameter of MCV

Blood samples were collected at indicated timepoints for analysis for hematology parameter like MCV. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionFemtoliters (Mean)
Day 3, n= 16Day 7, n= 15Day 9, n= 15
TAF/FTC+GSK3640254-1.02-0.17-0.82

Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils

Blood samples were collected at indicated timepoints for analysis for hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionGiga cells per liter (Mean)
Basophils, Period 2 Day 3, n= 15Basophils, Period 2 Day 7, n= 15Basophils, Period 2 Day 9, n= 15Eosinophils, Period 2 Day 3, n=15Eosinophils, Period 2 Day 7, n=15Eosinophils, Period 2 Day 9, n=16Monocytes, Period 2 Day 3, n= 16Monocytes, Period 2 Day 7, n= 15Monocytes, Period 2 Day 9, n= 15Leukocytes, Period 2 Day 3, n= 16Leukocytes, Period 2 Day 7, n= 15Leukocytes, Period 2 Day 9, n= 15Lymphocytes, Period 2 Day 3, n= 16Lymphocytes, Period 2 Day 7, n= 15Lymphocytes, Period 2 Day 9, n= 15Neutrophils, Period 2 Day 3, n= 16Neutrophils, Period 2 Day 7, n= 15Neutrophils, Period 2 Day 9, n= 15Platelets, Period 2 Day 3, n= 16Platelets, Period 2 Day 7, n= 15Platelets, Period 2 Day 9, n= 15
TAF/FTC+GSK3640254-0.004-0.0020.003-0.023-0.039-0.043-0.053-0.077-0.104-1.06-0.61-0.49-0.158-0.105-0.111-0.868-0.417-0.2829.219.816.2

Period 2: Change From Baseline in pH of Urine

Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionpH (Mean)
Day 3, n= 16Day 7, n= 15Day 9, n= 15
TAF/FTC+GSK36402540.190.100.10

Period 2: Change From Baseline in Pulse Rate

Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 4, 7, 9, and 10

InterventionBeats per minute (Mean)
Day 4Day 7Day 9Day 10
TAF/FTC+GSK36402542.41.9-0.39.5

Period 2: Change From Baseline in Respiratory Rate

Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 4, 7, 9, and 10

InterventionBreaths per minute (Mean)
Day 4Day 7Day 9Day 10
TAF/FTC+GSK3640254-3.2-2.4-0.8-1.5

Period 2: Change From Baseline in Specific Gravity of Urine

Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionRatio (Mean)
Day 3, n= 16Day 7, n= 15Day 9, n= 15
TAF/FTC+GSK36402540.00310.00240.0005

Period 2: Change From Baseline in Temperature

Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 4, 7, 9, and 10

InterventionDegree Celsius (Mean)
Day 4Day 7Day 9Day 10
TAF/FTC+GSK3640254-0.10-0.07-0.010.07

Period 2: Change From Baseline in Urine Urobilinogen

Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9

InterventionMicromoles per liter (Mean)
Day 3, n= 16Day 7, n= 15Day 9, n= 15
TAF/FTC+GSK36402540.00000.00000.0000

Change in Maternal Weight Antepartum

Change in maternal antepartum weight per week based on generalized estimating equations (NCT03048422)
Timeframe: Baseline through before delivery (up to one day prior)

Interventionkg/week (Mean)
Arm 1: Maternal DTG+FTC/TAF0.378
Arm 2: Maternal DTG+FTC/TDF0.319
Arm 3: Maternal EFV/FTC/TDF0.291

Change in Maternal Weight Overall

Change in maternal weight per week based on generalized estimating equations (NCT03048422)
Timeframe: Baseline to 50 weeks postpartum

Interventionkg/week (Mean)
Arm 1: Maternal DTG+FTC/TAF-0.027
Arm 2: Maternal DTG+FTC/TDF-0.050
Arm 3: Maternal EFV/FTC/TDF-0.084

Change in Maternal Weight Postpartum

Change in maternal postpartum weight per week based on generalized estimating equations (NCT03048422)
Timeframe: Delivery to 50 weeks postpartum

Interventionkg/week (Mean)
Arm 1: Maternal DTG+FTC/TAF0.014
Arm 2: Maternal DTG+FTC/TDF-0.008
Arm 3: Maternal EFV/FTC/TDF-0.032

Count of Infants With HIV-1 Antiretroviral Drug Resistance Mutations at the Time of Infant HIV Diagnosis

Count of infants with HIV-1 antiretroviral drug resistance mutations (to any antiretroviral drug) at the time of infant HIV diagnosis, based on laboratory blood test results. (NCT03048422)
Timeframe: From birth through 50 weeks postpartum

InterventionParticipants (Count of Participants)
Arm 1 Infants1
Arm 2 Infants0
Arm 3 Infants1

Cumulative Probability of Infant Deaths

The Kaplan-Meier estimate of the cumulative probability of infant deaths from birth through 50 weeks after birth. (NCT03048422)
Timeframe: Birth through 50 weeks after birth

InterventionCumulative probability per 100 persons (Number)
Arm 1 Infants1.0
Arm 2 Infants2.0
Arm 3 Infants6.9

Cumulative Probability of Infant HIV-infection

The Kaplan-Meier estimate of the cumulative probability of infants acquiring HIV-1 infection from birth through 50 weeks after birth based on nucleic acid test results. (NCT03048422)
Timeframe: Birth through 50 weeks after birth

InterventionCumulative probability per 100 persons (Number)
Arm 1 Infants0.98
Arm 2 Infants0.50
Arm 3 Infants0.55

Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event

The Kaplan-Meier estimate of the cumulative probability of infants experiencing grade 3 or higher adverse events, including events resulting in death due to any cause. (NCT03048422)
Timeframe: Birth through Week 50 postpartum

InterventionCumulative probability per 100 persons (Number)
Arms 1 and 2 Infants26.8
Arm 3 Infants30.9

Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event

The Kaplan-Meier estimate of the cumulative probability of infants experiencing grade 3 or higher adverse events, including events resulting in death due to any cause. (NCT03048422)
Timeframe: From birth through Week 50 postpartum

InterventionCumulative probability per 100 persons (Number)
Arm 1 Infants25.3
Arm 2 Infants28.6
Arm 3 Infants30.9

Cumulative Probability of Women Experiencing Grade 3 or Higher Adverse Event

"The Kaplan-Meier estimate of the cumulative probability of women experiencing grade 3 or higher adverse events, including events resulting in death due to any cause.~Time to first maternal grade 3 or higher adverse event was defined as the first grade 3 or higher adverse event that occurred after randomization and before 74 weeks of follow-up. The timeframe of 74 weeks was determined by adding up 56 weeks of postpartum follow-up to the mean duration of antepartum follow-up, which was 18 weeks." (NCT03048422)
Timeframe: From randomization up to 74 weeks

,
InterventionCumulative probability per 100 persons (Number)
Arm 1: Maternal DTG+FTC/TAF25.1
Arm 2: Maternal DTG+FTC/TDF30.8
Arm 3: Maternal EFV/FTC/TDF27.9
Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF27.9
Arm 3: Maternal EFV/FTC/TDF27.9

Maternal Change in Creatinine Clearance

Maternal change in creatinine clearance per week based on generalized estimating equations (NCT03048422)
Timeframe: Baseline to 50 weeks postpartum

InterventionmL/min (Mean)
Arm 1: Maternal DTG+FTC/TAF-0.980
Arm 2: Maternal DTG+FTC/TDF-0.887
Arm 3: Maternal EFV/FTC/TDF-0.935

Percentage of Infants Born Small for Gestational Age

Percentage of infants born small for gestational age (<10th percentile adjusted for sex assigned at birth) based on Intergrowth 21st Standards (NCT03048422)
Timeframe: Birth

Interventionpercentage of participants (Number)
Arm 1 Infants16.3
Arm 2 Infants22.5
Arm 3 Infants20.5

Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome

Percentage of mother-infant pairs with an adverse pregnancy outcome. Adverse pregnancy outcome includes spontaneous abortion (<20 weeks gestation), stillbirth (≥20 weeks gestation), preterm delivery (<37 completed weeks), or small for gestational age (<10th percentile by INTERGROWTH 21st Standards) (NCT03048422)
Timeframe: Delivery

Interventionpercentage of mother-infant pairs (Number)
Arm 1: Maternal DTG+FTC/TAF24.1
Arm 2: Maternal DTG+FTC/TDF32.9
Arm 3: Maternal EFV/FTC/TDF32.7

Percentage of Mother-Infant Pairs With an Adverse Pregnancy Outcome

Percentage of mother-infant pairs with an adverse pregnancy outcome. Adverse pregnancy outcome includes spontaneous abortion (<20 weeks gestation), stillbirth (≥20 weeks gestation), preterm delivery (<37 completed weeks), or small for gestational age (<10th percentile per INTERGROWTH 21st Standards) (NCT03048422)
Timeframe: Delivery

Interventionpercentage of mother-infant pairs (Number)
Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF28.4
Arm 3: Maternal EFV/FTC/TDF32.7

Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome or Major Congenital Anomaly

Percentage of mother-infant pairs with an adverse pregnancy outcome or major congenital anomaly. Adverse pregnancy outcomes include spontaneous abortions (<20 weeks gestation), stillbirths (≥20 weeks gestation), preterm deliveries (<37 weeks gestation), and infants small for gestational age (<10th percentile per INTERGROWTH 21st Standards). Major congenital anomaly was defined consistent with the definition of malformation provided by Holmes and Westgate (i.e., a structural abnormality with surgical, medical, or cosmetic importance) and evaluated by an internal study team blinded to treatment arm. (NCT03048422)
Timeframe: Delivery through 50 weeks postpartum

Interventionpercentage of mother-infant pairs (Number)
Arm 1: Maternal DTG+FTC/TAF24.1
Arm 2: Maternal DTG+FTC/TDF32.9
Arm 3: Maternal EFV/FTC/TDF33.2

Percentage of Mother-Infant Pairs With Preterm Deliveries

Percentage of mother-infant pairs with preterm deliveries (<37 weeks gestation) resulting in live born infant (NCT03048422)
Timeframe: Delivery

Interventionpercentage of participants (Number)
Arm 1: Maternal DTG+FTC/TAF5.8
Arm 2: Maternal DTG+FTC/TDF9.4
Arm 3: Maternal EFV/FTC/TDF12.1

Percentage of Mothers With HIV-1 ARV Drug Resistance Mutations at the Time of Maternal Virologic Failure

Percentage of mothers with HIV-1 antiretroviral (ARV) drug resistance mutations at the time of maternal virologic failure. Virologic failure was defined as two consecutive plasma HIV-1 RNA viral loads <200 copies/mL on or after 24 weeks on study. Drug resistance mutations were assessed using the Stanford algorithm, and all ARV regimens were assessed for mutations. (NCT03048422)
Timeframe: From 24 weeks after randomization through Week 50 postpartum

Interventionpercentage of participants (Number)
Arm 1: Maternal DTG+FTC/TAF0.92
Arm 2: Maternal DTG+FTC/TDF1.86
Arm 3: Maternal EFV/FTC/TDF6.16

Percentage of Mothers With HIV-1 RNA Less Than 200 Copies/mL at 50 Weeks Postpartum

Percentage of mothers with HIV-1 RNA less than 200 copies/mL at 50 weeks postpartum using real-time test results obtained from site laboratories (NCT03048422)
Timeframe: 50 weeks postpartum

Interventionpercentage of participants (Number)
Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF96.3
Arm 3: Maternal EFV/FTC/TDF96.4

Percentage of Mothers With HIV-1 RNA Less Than 50 Copies/mL at Delivery Measured at Central Laboratory

Percentage of mothers with HIV-1 RNA less than 50 copies/mL at delivery using batched test results obtained from central laboratory (NCT03048422)
Timeframe: Delivery

Interventionpercentage of participants (Number)
Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF94.4
Arm 3: Maternal EFV/FTC/TDF78.8

Percentage of Mothers With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL at 50 Weeks Postpartum Based on FDA Snapshot Algorithm

Percentage of mothers with virologic success of HIV-1 RNA less than 200 copies/mL at 50 weeks postpartum based on FDA snapshot algorithm using real-time test results obtained from site laboratories (NCT03048422)
Timeframe: 50 weeks postpartum

Interventionpercentage of participants (Number)
Arm 1: Maternal DTG+FTC/TAF75.6
Arm 2: Maternal DTG+FTC/TDF77.7
Arm 3: Maternal EFV/FTC/TDF76.3

Percentage of Mothers With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL at Delivery Based on FDA Snapshot Algorithm

Percentage of mothers with virologic success of HIV-1 RNA less than 200 copies/mL at delivery based on FDA snapshot algorithm using real-time test results obtained from site laboratories (NCT03048422)
Timeframe: Delivery

Interventionpercentage of participants (Number)
Arm 1: Maternal DTG+FTC/TAF88.9
Arm 2: Maternal DTG+FTC/TDF92.6
Arm 3: Maternal EFV/FTC/TDF81.0

Time to First HIV-1 RNA Less Than 200 Copies/mL Through Delivery

Time to first viral HIV-1 RNA less than 200 copies/mL through delivery, determined using real-time results obtained from site laboratories (NCT03048422)
Timeframe: Randomization to delivery

Interventionweeks (Mean)
Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF4.26
Arm 3: Maternal EFV/FTC/TDF6.49

Infant Creatinine Clearance

Infant creatinine clearance based on Schwartz formula (NCT03048422)
Timeframe: Delivery and 26 weeks postpartum

,,
InterventionmL/min (Mean)
Delivery26 Weeks Postpartum
Arm 1 Infants52.7134.8
Arm 2 Infants53.1123.6
Arm 3 Infants49.0135.0

Percentage of Mothers With HIV-1 RNA Viral Load Less Than 200 Copies/mL at Delivery

Percentage of mothers with plasma HIV-1 RNA viral load less than 200 copies/mL at delivery determined using real-time test results obtained at site laboratories. This outcome was evaluated in the non-inferiority (primary outcome) and superiority (secondary outcome) analyses. The intention-to-treat analysis included all randomized women who had viral load data available. The per-protocol analysis excluded women who modified randomized treatment (stopped, paused, switched, added any treatment) before viral load evaluation at delivery, with the exception of women who modified randomized treatment for use of a concomitant medication. (NCT03048422)
Timeframe: Delivery

,
InterventionPercentage of participants (Number)
Intention-to-Treat AnalysisPer-Protocol Analysis
Arm 3: Maternal EFV/FTC/TDF91.091.4
Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF97.597.5

Change From Baseline in Serum Creatinine at Week 48 in the Blinded Phase

(NCT02842086)
Timeframe: Baseline, Week 48

Interventionmg/dL (Mean)
Descovy (DVY)-0.01
Truvada (TVD)0.01

Change From Baseline in Serum Creatinine at Week 96 in the Blinded Phase

(NCT02842086)
Timeframe: Baseline, Week 96

Interventionmg/dL (Mean)
Descovy (DVY)0.01
Truvada (TVD)0.03

Incidence of HIV-1 Infection Per 100 Person Years (PY)

"The incidence of HIV-1 infection rate per 100 PY was calculated as the number of participants who became HIV infected during the study after the first dose of study drug divided by the sum of all participants' years (where a year is 365.25 days) of follow-up while at risk of HIV infection during the study.~HIV-1 infection is defined by one or more of the following criteria of contributing HIV tests performed via central lab or local lab:~Serologic evidence of seroconversion (reactive screening HIV Antigen/Antibody or Antibody test, confirmed by reactive HIV-1/HIV-2 differentiation assay), excluding HIV vaccinated participants, or~Virologic evidence of HIV-1 infection (positive qualitative HIV-1 RNA test or any detectable quantitative HIV-1 RNA test), or~Evidence of acute HIV-1 infection (reactive p24 Antigen or positive qualitative or quantitative RNA, in the absence of reactive HIV-1 Antibody results)" (NCT02842086)
Timeframe: When all participants completed minimum follow-up of 48 weeks and at least 50% of the participants completed 96 weeks of follow-up after randomization or permanently discontinued from the study (maximum 125 weeks)

InterventionHIV-1 infections per 100 PY (Number)
Descovy (DVY)0.160
Truvada (TVD)0.342

Incidence of HIV-1 Infection Per 100 PY

"The incidence of HIV-1 infection rate per 100 PY was calculated as the number of participants who became HIV infected during the study after the first dose of study drug divided by the sum of all participants' years (where a year is 365.25 days) of follow-up while at risk of HIV infection during the study.~HIV-1 infection is defined by one or more of the following criteria of contributing HIV tests performed via central lab or local lab:~Serologic evidence of seroconversion (reactive screening HIV Antigen/Antibody or Antibody test, confirmed by reactive HIV-1/HIV-2 differentiation assay), excluding HIV vaccinated participants, or~Virologic evidence of HIV-1 infection (positive qualitative HIV-1 RNA test or any detectable quantitative HIV-1 RNA test), or~Evidence of acute HIV-1 infection (reactive p24 Antigen or positive qualitative or quantitative RNA, in the absence of reactive HIV-1 Antibody results)" (NCT02842086)
Timeframe: When all participants have 96 weeks of follow-up after randomization or permanently discontinued from the study (maximum 157 weeks)

InterventionHIV-1 infections per 100 PY (Number)
Descovy (DVY)0.159
Truvada (TVD)0.297

Percent Change From Baseline in Hip BMD at Week 96 in the Blinded Phase

Percent Change = Change from baseline at Week 96 visit/value at baseline * 100%. (NCT02842086)
Timeframe: Baseline, Week 96

InterventionPercent Change (Mean)
Descovy (DVY)0.565
Truvada (TVD)-1.048

Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 in the Blinded Phase

Percent Change = Change from baseline at Week 48 visit/value at baseline * 100%. (NCT02842086)
Timeframe: Baseline, Week 48

InterventionPercent Change (Mean)
Descovy (DVY)0.218
Truvada (TVD)-0.968

Percent Change From Baseline in Spine BMD at Week 48 in the Blinded Phase

Percent Change = Change from baseline at Week 48 visit/value at baseline * 100%. (NCT02842086)
Timeframe: Baseline, Week 48

InterventionPercent Change (Mean)
Descovy (DVY)0.512
Truvada (TVD)-1.061

Percent Change From Baseline in Spine BMD at Week 96 in the Blinded Phase

Percent Change = Change from baseline at Week 96 visit/value at baseline * 100%. (NCT02842086)
Timeframe: Baseline, Week 96

InterventionPercent Change (Mean)
Descovy (DVY)0.831
Truvada (TVD)-1.426

Percent Change From Baseline in Urine Beta-2-Microglobulin to Creatinine Ratio at Week 48 in the Blinded Phase

"Percent Change = Change from baseline at Week 48 visit/value at baseline * 100%.~For urine creatinine, value of < 1 was handled as a missing value in its summary and the calculation of related ratios." (NCT02842086)
Timeframe: Baseline, Week 48

InterventionPercent Change (Median)
Descovy (DVY)-10.6
Truvada (TVD)15.4

Percent Change From Baseline in Urine Beta-2-Microglobulin to Creatinine Ratio at Week 96 in the Blinded Phase

"Percent Change = Change from baseline at Week 96 visit/value at baseline * 100%.~For urine creatinine, value of < 1 was handled as a missing value in its summary and the calculation of related ratios." (NCT02842086)
Timeframe: Baseline, Week 96

InterventionPercent Change (Median)
Descovy (DVY)-14.5
Truvada (TVD)14.1

Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96 in the Blinded Phase

"Percent Change = Change from baseline at Week 96 visit/value at baseline * 100%.~For urine creatinine, value of < 1 was handled as a missing value in its summary and the calculation of related ratios." (NCT02842086)
Timeframe: Baseline, Week 96

InterventionPercent Change (Median)
Descovy (DVY)0.3
Truvada (TVD)21.4

Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48 in the Blinded Phase

"Percent Change = Change from baseline at Week 48 visit/value at baseline * 100%.~For urine creatinine, value of < 1 was handled as a missing value in its summary and the calculation of related ratios." (NCT02842086)
Timeframe: Baseline, Week 48

InterventionPercent Change (Median)
Descovy (DVY)0.1
Truvada (TVD)20.0

Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality

(NCT02842086)
Timeframe: First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks)

Interventionpercentage of participants (Number)
Descovy (DVY)76.1
Truvada (TVD)79.1

Percentage of Participants Experiencing Treatment-Emergent Adverse Events

(NCT02842086)
Timeframe: First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks)

Interventionpercentage of participants (Number)
Descovy (DVY)93.7
Truvada (TVD)93.6

Change From Baseline in CD4+ Cell Count at Week 24: Full Analysis Set

The analysis includes values up to 1 day after permanent discontinuation of study treatment. (NCT03631732)
Timeframe: Baseline to Week 24

Interventioncells/uL (Mean)
B/F/TAF13
Stay on Baseline Regimen (SBR)1

Change From Baseline in CD4+ Cell Count at Week 24: Week 24 Per Protocol Analysis Set

The analysis includes values up to 1 day after permanent discontinuation of study treatment. (NCT03631732)
Timeframe: Baseline to Week 24

Interventioncells/uL (Mean)
B/F/TAF13
Stay on Baseline Regimen (SBR)4

Change From Baseline in CD4+ Cell Count at Week 48: Full Analysis Set

The analysis includes values up to 1 day after permanent discontinuation of study treatment. By Week 48, participants in B/F/TAF had received 48 weeks of treatment with B/F/TAF, while those in the Delayed B/F/TAF group had received only 24 weeks of treatment with B/F/TAF. (NCT03631732)
Timeframe: Baseline to Week 48

Interventioncells/uL (Mean)
B/F/TAF7
Delayed B/F/TAF-8

Percentage of Participants Experiencing Treatment-Emergent Adverse Events

An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A treatment-emergent adverse event was defined as any adverse event with onset date on or after the study treatment start date and no later than 30 days after the study drug stop date; or any adverse event leading to study drug discontinuation. (NCT03631732)
Timeframe: First B/F/TAF dose date up to Week 72 plus 30 days

Interventionpercentage of participants (Number)
B/F/TAF83.3
Delayed B/F/TAF69.3

Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormalities

Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant. Severity grades were defined by 'Gilead Grading Scale for Severity of AEs and Laboratory Abnormalities'. (NCT03631732)
Timeframe: First B/F/TAF dose date up to Week 72 plus 30 days

Interventionpercentage of participants (Number)
B/F/TAF87.8
Delayed B/F/TAF80.4

Percentage of Participants Who Had HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set

The percentage of participants who had HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT03631732)
Timeframe: Week 24

Interventionpercentage of participants (Number)
B/F/TAF96.3
Stay on Baseline Regimen (SBR)94.5

Percentage of Participants Who Had HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Week 24 Per Protocol Analysis Set

The percentage of participants who had HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT03631732)
Timeframe: Week 24

Interventionpercentage of participants (Number)
B/F/TAF99.3
Stay on Baseline Regimen (SBR)98.0

Percentage of Participants Who Had HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set

The percentage of participants who had HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defined a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. By Week 48, participants in B/F/TAF had received 48 weeks of treatment with B/F/TAF, while those in the Delayed B/F/TAF group had received only 24 weeks of treatment with B/F/TAF. (NCT03631732)
Timeframe: Week 48

Interventionpercentage of participants (Number)
B/F/TAF94.5
Delayed B/F/TAF96.9

Percentage of Participants Who Had HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set

The percentage of participants who had HIV-1 RNA ≥ 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT03631732)
Timeframe: Week 24

Interventionpercentage of participants (Number)
B/F/TAF0.6
Stay on Baseline Regimen (SBR)1.8

Percentage of Participants Who Had HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set

The percentage of participants who had HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defined a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. By Week 48, participants in B/F/TAF had received 48 weeks of treatment with B/F/TAF, while those in the Delayed B/F/TAF group had received only 24 weeks of treatment with B/F/TAF. (NCT03631732)
Timeframe: Week 48

Interventionpercentage of participants (Number)
B/F/TAF0.9
Delayed B/F/TAF0

Change From Week 12 Plasma Tenofovir Area Under the Plasma Concentration vs. Time Curve From Time 0 to 24 Hours (AUC0-24) at 24 and 28 Weeks

Compare plasma tenofovir AUC0-24 between TAF with boosted PI vs. TDF with boosted PI (Phase 2 vs. 1), and between TAF with boosted PI and LDV/SOF vs. TDF with boosted PI (Phase 3 vs. 1) (NCT03126370)
Timeframe: 12 weeks and 24 weeks and 28 weeks

Interventionng*h/mL (Geometric Mean)
TDF With a Boosted PI3466
TAF With a Boosted PI743
TAF With a Boosted PI and LDV/SOF868

Change From Week 12 Tenofovir-diphosphate (TFV-DP) in Dried Blood Spots (DBS)

Compare tenofovir diphosphate (TFV-DP) in dried blood spots (DBS) between TAF with a boosted PI vs. TDF with a boosted PI (Phase 2 vs. 1), and TAF with a boosted PI and LDV/SOF vs. TDF with a boosted PI (Phase 3 vs. 1) (NCT03126370)
Timeframe: 12 weeks and 24 and 28 weeks

Interventionfmol/2x7mm punches (Geometric Mean)
TDF With a Boosted PI36014
TAF With a Boosted PI6735
TAF With a Boosted PI and LDV/SOF6100

Change From Week 12 Tenofovir-diphosphate (TFV-DP) in Peripheral Blood Mononuclear Cells (PBMCs) at 24 and 28 Weeks

Compare tenofovir-diphosphate (TFV-DP) in peripheral blood mononuclear cells (PBMCs) between TAF with a boosted PI vs. TDF with a boosted PI (Phase 2 vs. 1), and TAF with a boosted PI and LDV/SOF vs. TDF with a boosted PI (Phase 3 vs. 1). (NCT03126370)
Timeframe: 12 weeks, and 24 weeks and 28 weeks

Interventionfmol/10^6 cells (Geometric Mean)
TDF With a Boosted PI83.0
TAF With a Boosted PI926
TAF With a Boosted PI and LDV/SOF1129

Change in Estimated Glomerular Filtration Rate (eGFR) and Renal Biomarkers: eGFR

Change in estimated glomerular filtration rate (eGFR) (NCT03126370)
Timeframe: 12 weeks, 24 weeks, and 28 weeks

InterventionmL/min/1.73 m^2 (Geometric Mean)
TDF With a Boosted PI86.7
TAF With a Boosted PI91.0
TAF With a Boosted PI and LDV/SOF88.1

Change in Estimated Glomerular Filtration Rate (eGFR) and Renal Biomarkers: UPCR

Change in estimated glomerular filtration rate (eGFR) and renal biomarkers: Urine protein to creatinine ratio (UPCR) (NCT03126370)
Timeframe: 12 weeks, 24 weeks, and 28 weeks

Interventionmg/g (Geometric Mean)
TDF With a Boosted PI134
TAF With a Boosted PI118
TAF With a Boosted PI and LDV/SOF97.3

Change in Estimated Glomerular Filtration Rate (eGFR) and Renal Biomarkers: B2M/Cr Ratio, and RBP/Cr Ratio

Change in renal biomarkers: urinary beta-2 microglobulin (B2M)/creatinine (Cr) ratio, and urinary retinol binding protein (RBP)/Cr ratio (NCT03126370)
Timeframe: 12 weeks, 24 weeks, and 28 weeks

,,
Interventionug/g (Geometric Mean)
β2M:Cr ratioRBP:Cr ratio
TAF With a Boosted PI224242
TAF With a Boosted PI and LDV/SOF178146
TDF With a Boosted PI419436

Amount of Study Follow-up

Participants were to be followed for 96 weeks after the last enrollment. Accrual was expected to take 96 weeks, thus the planned follow-up time was 96 to 192 weeks, dependent on when in the study the participant enrolled. This outcome summarizes that total amount of actual follow-up in weeks from randomization to last contact. (NCT00118898)
Timeframe: Follow-up time was variable, median follow-up was 138 weeks

InterventionWeeks (Median)
EFV, FTC/TDF, and Placebo ABC/3TC141.4
EFV, Placebo FTC/TDF, and ABC/3TC133.3
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC141.6
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC137.3

Number of Participants With a Grade 3/4 Safety Event

Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded. (NCT00118898)
Timeframe: Over all study follow-up while on initially assigned treatment, median follow-up was 120 weeks

Interventionparticipants (Number)
EFV, FTC/TDF, and Placebo ABC/3TC145
EFV, Placebo FTC/TDF, and ABC/3TC182
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC137
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC156

Number of Participants With Regimen Failure

Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

Interventionparticipants (Number)
EFV, FTC/TDF, and Placebo ABC/3TC162
EFV, Placebo FTC/TDF, and ABC/3TC246
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC157
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC233

Number of Participants With Treatment Modification

Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

Interventionparticipants (Number)
EFV, FTC/TDF, and Placebo ABC/3TC152
EFV, Placebo FTC/TDF, and ABC/3TC239
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC138
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC216

Number of Participants With Virologic Failure

Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. (NCT00118898)
Timeframe: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

Interventionparticipants (Number)
EFV, FTC/TDF, and Placebo ABC/3TC57
EFV, Placebo FTC/TDF, and ABC/3TC72
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC57
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC83

Number of Participants With Virologic Failure and Emergence of Major Resistance

Emergence of resistant virus was assessed by genotypic testing performed at Stanford University for all participants who met criteria for virologic failure and retrospectively on baseline samples from these participants. Major mutations were defined by International AIDS Society-United States of America (2008), as well as T69D, L74I, G190C/E/Q/T/V for reverse transcriptase and L24I, F53L, I54V/A/T/S, G73C/S/T/A, N88D for protease. (NCT00118898)
Timeframe: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

Interventionparticipants (Number)
EFV, FTC/TDF, and Placebo ABC/3TC27
EFV, Placebo FTC/TDF, and ABC/3TC41
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC5
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC12

Change in CD4 Count (Cells/mm3) From Baseline

Change was calculated as the CD4 count at Week 48 (or at Week 96) minus the baseline CD4 count (mean of pre-entry and entry values). (NCT00118898)
Timeframe: At Weeks 48 and 96

,,,
InterventionCells/mm3 (Median)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC163220.5
EFV, Placebo FTC/TDF, and ABC/3TC188250.5
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC175251.5
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC177.5250.3

Change in Fasting High-density Lipoprotein (HDL) Cholesterol Level From Baseline

Only fasting results are included. The protocol did not require that samples be collected fasting. (NCT00118898)
Timeframe: At Weeks 48 and 96

,,,
Interventionmg/dL (Median)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC89
EFV, Placebo FTC/TDF, and ABC/3TC1011
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC54
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC87

Change in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Level From Baseline

Only fasting results are included. The protocol did not require that samples be collected fasting. (NCT00118898)
Timeframe: At Weeks 48 and 96

,,,
Interventionmg/dL (Median)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC1413.5
EFV, Placebo FTC/TDF, and ABC/3TC2318
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC810
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC2018

Change in Fasting Total Cholesterol Level From Baseline

Only fasting results are included. The protocol did not require that samples be collected fasting. (NCT00118898)
Timeframe: At Weeks 48 and 96

,,,
Interventionmg/dL (Median)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC2223
EFV, Placebo FTC/TDF, and ABC/3TC3533
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC1114
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC3025

Change in Fasting Triglyceride Level From Baseline

Only fasting results are included. The protocol did not require that samples be collected fasting. (NCT00118898)
Timeframe: At Weeks 48 and 96

,,,
Interventionmg/dL (Median)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC109
EFV, Placebo FTC/TDF, and ABC/3TC1514
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC1411
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC2433

Cumulative Probability of Not Experiencing a Grade 3/4 Safety Event

Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded. (NCT00118898)
Timeframe: At week 48 and 96

,,,
Interventionpercentage of participants (Number)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC7870
EFV, Placebo FTC/TDF, and ABC/3TC6458
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC7973
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC7366

Cumulative Probability of Not Experiencing Regimen Failure

Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: At week 48 and 96

,,,
Interventionpercentage of participants (Number)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC7970
EFV, Placebo FTC/TDF, and ABC/3TC6454
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC8073
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC6657

Cumulative Probability of Not Experiencing Treatment Modification

Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: At week 48 and 96

,,,
Interventionpercentage of participants (Number)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC8073
EFV, Placebo FTC/TDF, and ABC/3TC6756
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC8677
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC7362

Cumulative Probability of Not Experiencing Virologic Failure

Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. (NCT00118898)
Timeframe: At week 48 and 96

,,,
Interventionpercentage of participants (Number)
Week 48Week 96
EFV, FTC/TDF, and Placebo ABC/3TC9490
EFV, Placebo FTC/TDF, and ABC/3TC8885
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC9289
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC8883

Number of Participants Experiencing Certain Targeted Clinical Events, Including Death, AIDS-defining Illness, and HIV-1 Related Events.

"AIDS-defining illnesses were defined per CDC category C definition. HIV-1 related events were defined per CDC category B definition. Events underwent study chair review for classification. See link below for more details.~http://www.cdc.gov/mmwr/preview/mmwrhtml/00018871.htm" (NCT00118898)
Timeframe: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

,,,
InterventionParticipants (Number)
DeathAIDS-defining illnessHIV-1 relatated event
EFV, FTC/TDF, and Placebo ABC/3TC61456
EFV, Placebo FTC/TDF, and ABC/3TC112561
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC62057
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC82363

Number of Participants With HIV-1 RNA Levels Less Than 200 Copies/mL

(NCT00118898)
Timeframe: At Weeks 48 and 96

,,,
InterventionParticipants (Number)
Number of Participants with RNA data at Week 48Number with HIV-1 RNA <200 copies/ml at Week 48Number of Participants with RNA data at Week 96Number with HIV-1 RNA <200 copies/ml at Week 96
EFV, FTC/TDF, and Placebo ABC/3TC415398379362
EFV, Placebo FTC/TDF, and ABC/3TC400377361342
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC416391384368
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC411372374346

The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL

(NCT00118898)
Timeframe: At Weeks 48 and 96

,,,
InterventionParticipants (Number)
Number of Participants with RNA data at Week 48Number with HIV-1 RNA <50 copies/ml at Week 48Number of Participants with RNA data at Week 96Number with HIV-1 RNA <50 copies/ml at Week 96
EFV, FTC/TDF, and Placebo ABC/3TC415372379345
EFV, Placebo FTC/TDF, and ABC/3TC400346361328
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC416348384345
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC411322374317

Time From Randomization to Virologic Failure

Blood samples for determining virologic failure were obtained at visit weeks 16 and 24 , and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks after randomization and before 24 weeks, or >=200 copies/mL at or after 24 weeks. The 5th percentile for time to virologic failure is the time (in weeks) at which 5% of the participants have experienced virologic failure. (NCT00118898)
Timeframe: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

,,,
InterventionWeeks (Number)
5th percentile time to virologic failure10th percentile time to virologic failure
EFV, FTC/TDF, and Placebo ABC/3TC3696
EFV, Placebo FTC/TDF, and ABC/3TC2436
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC2484
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC2436

Time From Treatment Dispensation to a Grade 3/4 Safety Event

Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. (NCT00118898)
Timeframe: All follow-up while on initially assigned regimen; the median (25th, 75th percentile) follow-up while on initial regimen was 120 (54, 156) weeks and the range was 0 to 205 weeks.

,,,
InterventionWeeks (Number)
5th percentile time to a grade 3/4 safety event10th percentile time to a grade 3/4 safety event25th percentile time to a grade 3/4 safety event
EFV, FTC/TDF, and Placebo ABC/3TC2.67.959.3
EFV, Placebo FTC/TDF, and ABC/3TC1.32.016.0
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC3.08.181.4
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC1.33.944.4

Time From Treatment Dispensation to Regimen Failure (First Occurrence of Virologic Failure or Treatment Modification)

Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

,,,
InterventionWeeks (Number)
5th percentile time to regimen failure10th percentile time to regimen failure25th percentile time to regimen failure
EFV, FTC/TDF, and Placebo ABC/3TC41672
EFV, Placebo FTC/TDF, and ABC/3TC4424
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC41684
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC4436

Time From Treatment Dispensation to Treatment Modification

Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

,,,
InterventionWeeks (Number)
5th percentile time to treatment modification10th percentile time to treatment modification25th percentile time to treatment modification
EFV, FTC/TDF, and Placebo ABC/3TC3.415.083.7
EFV, Placebo FTC/TDF, and ABC/3TC1.42.127.4
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC7.924.9108.9
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC1.65.043.6

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT01497899)
Timeframe: Week 24

Interventionpercentage of participants (Number)
E/C/F/TAF88.4
E/C/F/TDF89.7

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT01497899)
Timeframe: Week 48

Interventionpercentage of participants (Number)
E/C/F/TAF88.4
E/C/F/TDF87.9

Change From Baseline in CD4+ Cell Count at Weeks 24 and 48

(NCT01497899)
Timeframe: Baseline; Weeks 24 and 48

,
Interventioncells/uL (Mean)
BaselineChange at Week 24Change at Week 48
E/C/F/TAF404165177
E/C/F/TDF394179204

Change From Baseline in log10 HIV-1 RNA at Weeks 24 and 48

(NCT01497899)
Timeframe: Baseline; Weeks 24 and 48

,
Interventionlog10 copies/mL (Mean)
BaselineChange at Week 24Change at Week 48
E/C/F/TAF4.63-3.20-3.22
E/C/F/TDF4.69-3.26-3.33

Change From Baseline in CD4+ Cell Count at Week 144

(NCT01780506)
Timeframe: Baseline; Week 144

Interventioncells/µL (Mean)
E/C/F/TAF323
E/C/F/TDF310

Change From Baseline in CD4+ Cell Count at Week 48

(NCT01780506)
Timeframe: Baseline; Week 48

Interventioncells/µL (Mean)
E/C/F/TAF235
E/C/F/TDF221

Change From Baseline in CD4+ Cell Count at Week 96

(NCT01780506)
Timeframe: Baseline; Week 96

Interventioncells/µL (Mean)
E/C/F/TAF285
E/C/F/TDF271

Change From Baseline in Serum Creatinine at Week 144

(NCT01780506)
Timeframe: Baseline; Week 144

Interventionmg/dL (Mean)
E/C/F/TAF0.04
E/C/F/TDF0.08

Change From Baseline in Serum Creatinine at Week 48

(NCT01780506)
Timeframe: Baseline; Week 48

Interventionmg/dL (Mean)
E/C/F/TAF0.08
E/C/F/TDF0.11

Change From Baseline in Serum Creatinine at Week 96

(NCT01780506)
Timeframe: Baseline; Week 96

Interventionmg/dL (Mean)
E/C/F/TAF0.05
E/C/F/TDF0.07

Percent Change From Baseline in Hip BMD at Week 144

Hip BMD was assessed by DXA scan. (NCT01780506)
Timeframe: Baseline; Week 144

Interventionpercent change (Mean)
E/C/F/TAF-0.826
E/C/F/TDF-3.475

Percent Change From Baseline in Hip BMD at Week 96

Hip BMD was assessed by DXA scan. (NCT01780506)
Timeframe: Baseline; Week 96

Interventionpercent change (Mean)
E/C/F/TAF-0.951
E/C/F/TDF-3.515

Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48

Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan. (NCT01780506)
Timeframe: Baseline; Week 48

Interventionpercent change (Mean)
E/C/F/TAF-0.865
E/C/F/TDF-3.200

Percent Change From Baseline in Spine BMD at Week 144

Spine BMD was assessed by DXA scan. (NCT01780506)
Timeframe: Baseline; Week 144

Interventionpercent change (Mean)
E/C/F/TAF-0.809
E/C/F/TDF-3.023

Percent Change From Baseline in Spine BMD at Week 48

Spine BMD was assessed by DXA scan. (NCT01780506)
Timeframe: Baseline; Week 48

Interventionpercent change (Mean)
E/C/F/TAF-1.337
E/C/F/TDF-2.956

Percent Change From Baseline in Spine BMD at Week 96

Spine BMD was assessed by DXA scan. (NCT01780506)
Timeframe: Baseline; Week 96

Interventionpercent change (Mean)
E/C/F/TAF-0.907
E/C/F/TDF-3.053

Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 144

Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury. (NCT01780506)
Timeframe: Baseline; Week 144

Interventionpercent change (Median)
E/C/F/TAF-24.6
E/C/F/TDF60.4

Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 48

Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury. (NCT01780506)
Timeframe: Baseline; Week 48

Interventionpercent change (Median)
E/C/F/TAF-32.8
E/C/F/TDF18.0

Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 96

Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury. (NCT01780506)
Timeframe: Baseline; Week 96

Interventionpercent change (Median)
E/C/F/TAF-33.5
E/C/F/TDF32.5

Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 144

Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury. (NCT01780506)
Timeframe: Baseline; Week 144

Interventionpercent change (Median)
E/C/F/TAF37.4
E/C/F/TDF106.9

Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96

Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury. (NCT01780506)
Timeframe: Baseline; Week 96

Interventionpercent change (Median)
E/C/F/TAF11.3
E/C/F/TDF75.0

Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48

Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury. (NCT01780506)
Timeframe: Baseline; Week 48

Interventionpercent change (Median)
E/C/F/TAF6.9
E/C/F/TDF51.2

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT01780506)
Timeframe: Week 48

Interventionpercentage of participants (Number)
E/C/F/TAF93.1
E/C/F/TDF92.8

Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 144

Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant. (NCT01780506)
Timeframe: Up to 144 weeks

,
Interventionpercentage of participants (Number)
Grade 1Grade 2Grade 3
E/C/F/TAF31.36.00.2
E/C/F/TDF37.17.00.2

Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 48

Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant. (NCT01780506)
Timeframe: Up to 48 weeks

,
Interventionpercentage of participants (Number)
Grade 1Grade 2Grade 3
E/C/F/TAF25.84.60
E/C/F/TDF32.34.90.2

Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 96

Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant. (NCT01780506)
Timeframe: Up to 96 weeks

,
Interventionpercentage of participants (Number)
Grade 1Grade 2Grade 3
E/C/F/TAF28.85.10.2
E/C/F/TDF33.95.80.2

Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48, 96, and 144

The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Weeks 48, 96, and 144 were analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT01780506)
Timeframe: Weeks 48, 96. and 144

,
Interventionpercentage of participants (Number)
Week 48Week 96Week 144
E/C/F/TAF86.484.484.6
E/C/F/TDF87.383.680.1

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 96 and 144

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Weeks 96 and 144 were analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT01780506)
Timeframe: Weeks 96 and 144

,
Interventionpercentage of participants (Number)
Week 96Week 144
E/C/F/TAF89.286.9
E/C/F/TDF88.283.1

Change From Baseline in CD4+ Cell Count at Week 48

(NCT01797445)
Timeframe: Baseline; Week 48

Interventioncells/µL (Mean)
E/C/F/TAF225
E/C/F/TDF200

Change From Baseline in CD4+ Cell Count at Week 96

(NCT01797445)
Timeframe: Baseline; Week 96

Interventioncells/µL (Mean)
E/C/F/TAF274
E/C/F/TDF260

Change From Baseline in Serum Creatinine at Week 48

(NCT01797445)
Timeframe: Baseline; Week 48

Interventionmg/dL (Mean)
E/C/F/TAF0.08
E/C/F/TDF0.12

Change From Baseline in Serum Creatinine at Week 96

(NCT01797445)
Timeframe: Baseline; Week 96

Interventionmg/dL (Mean)
E/C/F/TAF0.04
E/C/F/TDF0.07

Percent Change From Baseline in Hip BMD at Week 96

Hip BMD was assessed by DXA scan. (NCT01797445)
Timeframe: Baseline; Week 96

Interventionpercent change (Mean)
E/C/F/TAF-0.364
E/C/F/TDF-3.023

Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48

Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan. (NCT01797445)
Timeframe: Baseline; Week 48

Interventionpercent change (Mean)
E/C/F/TAF-0.420
E/C/F/TDF-2.603

Percent Change From Baseline in Spine BMD at Week 48

Spine BMD was assessed by DXA scan. (NCT01797445)
Timeframe: Baseline; Week 48

Interventionpercent change (Mean)
E/C/F/TAF-1.278
E/C/F/TDF-2.759

Percent Change From Baseline in Spine BMD at Week 96

Spine BMD was assessed by DXA scan. (NCT01797445)
Timeframe: Baseline; Week 96

Interventionpercent change (Mean)
E/C/F/TAF-1.017
E/C/F/TDF-2.516

Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 48

Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury. (NCT01797445)
Timeframe: Baseline; Week 48

Interventionpercent change (Median)
E/C/F/TAF-29.3
E/C/F/TDF32.3

Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 96

Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury. (NCT01797445)
Timeframe: Baseline; Week 96

Interventionpercent change (Median)
E/C/F/TAF-31.0
E/C/F/TDF35.2

Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96

Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury. (NCT01797445)
Timeframe: Baseline; Week 96

Interventionpercent change (Median)
E/C/F/TAF16.9
E/C/F/TDF73.7

Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48

Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury. (NCT01797445)
Timeframe: Baseline; Week 48

Interventionpercent change (Median)
E/C/F/TAF13.3
E/C/F/TDF51.7

Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 48

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT01797445)
Timeframe: Week 48

Interventionpercentage of participants (Number)
E/C/F/TAF91.6
E/C/F/TDF88.5

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT01797445)
Timeframe: Week 96

Interventionpercentage of participants (Number)
E/C/F/TAF84.0
E/C/F/TDF82.3

Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48 and 96

The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Weeks 48 and 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT01797445)
Timeframe: Weeks 48 and 96

,
Interventionpercentage of participants (Number)
Week 48Week 96
E/C/F/TAF82.478.7
E/C/F/TDF80.776.8

Percentage of Participants With Treatment-emergent Proteinuria Through Week 48

Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant. (NCT01797445)
Timeframe: Baseline to Week 48

,
Interventionpercentage of participants (Number)
Grade 1Grade 2Grade 3
E/C/F/TAF27.34.70
E/C/F/TDF31.64.60

Percentage of Participants With Treatment-emergent Proteinuria Through Week 96

Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant. (NCT01797445)
Timeframe: Baseline to Week 96

,
Interventionpercentage of participants (Number)
Grade 1Grade 2Grade 3
E/C/F/TAF31.85.40
E/C/F/TDF36.95.10

Change From Baseline in CD4+ Cell Count at Week 48

(NCT02121795)
Timeframe: Baseline; Week 48

Interventioncells/μL (Mean)
F/TAF + 3rd Agent20
FTC/TDF + 3rd Agent21

Change From Baseline in CD4+ Cell Count at Week 96

(NCT02121795)
Timeframe: Baseline; Week 96

Interventioncells/μL (Mean)
F/TAF + 3rd Agent50
FTC/TDF + 3rd Agent46

Percentage Change From Baseline in Hip BMD at Week 96

Hip BMD was assessed by DXA scan. (NCT02121795)
Timeframe: Baseline; Week 96

Interventionpercentage change (Mean)
F/TAF + 3rd Agent1.856
FTC/TDF + 3rd Agent-0.289

Percentage Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48

Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan. (NCT02121795)
Timeframe: Baseline; Week 48

Interventionpercentage change (Mean)
F/TAF + 3rd Agent1.236
FTC/TDF + 3rd Agent-0.071

Percentage Change From Baseline in Spine BMD at Week 48

Spine BMD was assessed by DXA scan. (NCT02121795)
Timeframe: Baseline; Week 48

Interventionpercentage change (Mean)
F/TAF + 3rd Agent1.662
FTC/TDF + 3rd Agent-0.109

Percentage Change From Baseline in Spine BMD at Week 96

Spine BMD was assessed by DXA scan. (NCT02121795)
Timeframe: Baseline; Week 96

Interventionpercentage change (Mean)
F/TAF + 3rd Agent2.159
FTC/TDF + 3rd Agent-0.109

Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the FDA Snapshot Analysis

The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02121795)
Timeframe: Week 48

Interventionpercentage of participants (Number)
F/TAF + 3rd Agent91.6
FTC/TDF + 3rd Agent90.9

Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the FDA Snapshot Analysis

The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02121795)
Timeframe: Week 96

Interventionpercentage of participants (Number)
F/TAF + 3rd Agent83.5
FTC/TDF + 3rd Agent86.1

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA Snapshot Analysis

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02121795)
Timeframe: Week 48

Interventionpercentage of participants (Number)
F/TAF + 3rd Agent94.3
FTC/TDF + 3rd Agent93.0

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 96 as Defined by the FDA Snapshot Analysis

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02121795)
Timeframe: Week 96

Interventionpercentage of participants (Number)
F/TAF + 3rd Agent88.6
FTC/TDF + 3rd Agent89.1

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis

The percentage of participants with HIV-1 RNA < 400 Copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT01854775)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg94.0

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses

The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 24 was analyzed based on missing = excluded analyses. (NCT01854775)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg97.9

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = failure analyses. (NCT01854775)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg94.0

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis

The percentage of participants with HIV-1 RNA < 400 Copies/mL at Weeks 24 and 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT01854775)
Timeframe: Week 48

Interventionpercentage of participants (Number)
Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg94.0

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses

The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed based on missing = excluded analyses. (NCT01854775)
Timeframe: Week 48

Interventionpercentage of participants (Number)
Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg97.9

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses

The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed based on missing = failure analyses. (NCT01854775)
Timeframe: Week 48

Interventionpercentage of participants (Number)
Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg94.0

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT01854775)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg90.0

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = excluded analyses. (NCT01854775)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg93.8

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = failure analyses. (NCT01854775)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg90.0

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT01854775)
Timeframe: Week 48

Interventionpercentage of participants (Number)
Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg92.0

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = excluded analyses. (NCT01854775)
Timeframe: Week 48

Interventionpercentage of participants (Number)
Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg95.8

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = failure analyses. (NCT01854775)
Timeframe: Week 48

Interventionpercentage of participants (Number)
Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg92.0

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Excluded Analyses

The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 24 was analyzed based on missing = excluded analyses. (NCT01854775)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg100.0

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses

The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 24 was analyzed based on missing = failure analyses. (NCT01854775)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg100.0

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Excluded Analyses

The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed based on missing = excluded analyses. (NCT01854775)
Timeframe: Week 48

Interventionpercentage of participants (Number)
Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg100.0

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48, Based on Missing = Failure Analyses

The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed based on missing = failure analyses. (NCT01854775)
Timeframe: Week 48

Interventionpercentage of participants (Number)
Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg100.0

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT01854775)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg100.0

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = excluded analyses. (NCT01854775)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg100.0

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = failure analyses. (NCT01854775)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg100.0

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT01854775)
Timeframe: Week 48

Interventionpercentage of participants (Number)
Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg98.1

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = excluded analyses. (NCT01854775)
Timeframe: Week 48

Interventionpercentage of participants (Number)
Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg100.0

Cohort 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = failure analyses. (NCT01854775)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg100.0

Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT01854775)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg96.3

Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Excluded Analyses

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = excluded analyses. (NCT01854775)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg96.3

Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 24, Based on Missing = Failure Analyses

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed based on missing = failure analyses. (NCT01854775)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg96.3

Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, as Defined by the FDA Snapshot Analysis

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT01854775)
Timeframe: Week 48

Interventionpercentage of participants (Number)
Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg96.3

Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Excluded Analyses

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = excluded analyses. (NCT01854775)
Timeframe: Week 48

Interventionpercentage of participants (Number)
Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg96.3

Cohort 3: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 48, Based on Missing = Failure Analyses

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed based on missing = failure analyses. (NCT01854775)
Timeframe: Week 48

Interventionpercentage of participants (Number)
Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg96.3

Pharmacokinetic (PK) Parameter: AUCtau of Elvitegravir (EVG) (Cohort 1)

AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). (NCT01854775)
Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4

Interventionhr*ng/mL (Mean)
Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg23840.1

PK Parameter: AUClast of TAF (Cohort 2)

AUClast is defined as the concentration of drug from time zero to the last observable concentration. (NCT01854775)
Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4

Interventionhr*ng/mL (Mean)
Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg332.9

PK Parameter: AUClast of Tenofovir Alafenamide (TAF) (Cohort 1)

AUClast is defined as the concentration of drug from time zero to the last observable concentration. (NCT01854775)
Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4

Interventionhr*ng/mL (Mean)
Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg188.9

PK Parameter: AUCtau of EVG (Cohort 2)

AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). (NCT01854775)
Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4

Interventionhr*ng/mL (Mean)
Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg33813.9

PK Parameter: AUCtau of EVG (Cohort 3)

AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). (NCT01854775)
Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2

Interventionhr*ng/mL (Mean)
Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg29666.6

PK Parameter: AUCtau of TAF (Cohort 3)

AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). (NCT01854775)
Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2

Interventionhr*ng/mL (Mean)
Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg366.4

Cohort 1: Change From Baseline in CD4+ Cell Count at Week 24

(NCT01854775)
Timeframe: Baseline, Week 24

Interventioncells/μL (Mean)
BaselineChange at Week 24
Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg471191

Cohort 1: Change From Baseline in CD4+ Cell Count at Week 48

(NCT01854775)
Timeframe: Baseline, Week 48

Interventioncells/μL (Mean)
BaselineChange at Week 48
Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg471224

Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 24

(NCT01854775)
Timeframe: Baseline, Week 24

Interventionpercentage of CD4+ cell (Mean)
BaselineChange at Week 24
Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg23.67.7

Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 48

(NCT01854775)
Timeframe: Baseline, Week 48

Interventionpercentage of CD4+ cell (Mean)
BaselineChange at Week 48
Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg23.69.3

Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 24

(NCT01854775)
Timeframe: Baseline, Week 24

Interventioncopies/mL (Mean)
BaselineChange at Week 24
Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg4.62-3.25

Cohort 1: Change From Baseline in Plasma log10 HIV-1 RNA at Week 48

(NCT01854775)
Timeframe: Baseline, Week 48

Interventioncopies/mL (Mean)
BaselineChange at Week 48
Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg4.62-3.26

Cohort 1: Percentage of Participants With All Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs)

"Treatment-emergent adverse events (TEAEs) were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the Gilead Sciences Grading Scale for Severity of Adverse Events. An AE that met one or more of the following outcomes was classified as serious:~Fatal~Life-threatening~Disabling/incapacitating~Results in hospitalization or prolongs a hospital stay~A congenital abnormality~Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above." (NCT01854775)
Timeframe: From first dose date up to Week 24

Interventionpercentage of participants (Number)
Any TEAEsSAEs
Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg81.38.3

Cohort 2: Change From Baseline in CD4+ Cell Count at Week 24

(NCT01854775)
Timeframe: Baseline, Week 24

Interventioncells/μL (Mean)
BaselineChange at Week 24
Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg961-118

Cohort 2: Change From Baseline in CD4+ Cell Count at Week 48

(NCT01854775)
Timeframe: Baseline, Week 48

Interventioncells/µL (Mean)
BaselineChange at Week 48
Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg961-66

Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 24

(NCT01854775)
Timeframe: Baseline, Week 24

Interventionpercentage of CD4+ cell (Mean)
BaselineChange at Week 24
Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg38.2-0.8

Cohort 2: Change From Baseline in CD4+ Cell Percentage at Week 48

(NCT01854775)
Timeframe: Baseline, Week 48

Interventionpercentage of CD4+ cell (Mean)
BaselineChange at Week 48
Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg38.2-0.6

Cohort 2: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs

"TEAEs were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the Gilead Sciences Grading Scale for Severity of Adverse Events. An AE that met one or more of the following outcomes was classified as serious:~Fatal~Life-threatening~Disabling/incapacitating~Results in hospitalization or prolongs a hospital stay~A congenital abnormality~Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above." (NCT01854775)
Timeframe: From first dose date up to Week 24

Interventionpercentage of participants (Number)
Any TEAEsSAEs
Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg73.90

Cohort 3: Change From Baseline in CD4+ Cell Count at Week 24

(NCT01854775)
Timeframe: Baseline, Week 24

Interventioncells/μL (Mean)
BaselineChange at Week 24
Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg1153-137

Cohort 3: Change From Baseline in CD4+ Cell Count at Week 48

(NCT01854775)
Timeframe: Baseline, Week 48

Interventioncells/µL (Mean)
BaselineChange at Week 48
Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg1153-179

Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 24

(NCT01854775)
Timeframe: Baseline, Week 24

Interventionpercentage of CD4+ cell (Mean)
BaselineChange at Week 24
Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg35.90.0

Cohort 3: Change From Baseline in CD4+ Cell Percentage at Week 48

(NCT01854775)
Timeframe: Baseline, Week 48

Interventionpercentage of CD4+ cell (Mean)
BaselineChange at Week 48
Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg35.90.2

Cohort 3: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs

"TEAEs were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the Gilead Sciences Grading Scale for Severity of Adverse Events. An AE that met one or more of the following outcomes was classified as serious:~Fatal~Life-threatening~Disabling/incapacitating~Results in hospitalization or prolongs a hospital stay~A congenital abnormality~Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above." (NCT01854775)
Timeframe: From first dose date up to Week 24

Interventionpercentage of participants (Number)
Any TEAEsSAEs
Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg70.43.7

PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 1)

AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). (NCT01854775)
Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4

Interventionhr*ng/mL (Mean)
FTCTFVCOBI
Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg14424.4287.68240.8

PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 2)

AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). (NCT01854775)
Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4

Interventionhr*ng/mL (Mean)
FTCTFVCOBI
Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg20629.2440.215890.7

PK Parameter: AUCtau of FTC, TFV, and COBI (Cohort 3)

AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). (NCT01854775)
Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2

Interventionhr*ng/mL (Mean)
FTCTFVCOBI
Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg19468.1334.914485.2

PK Parameter: CL of EVG and TAF (Cohort 1)

Clearance (CL) is defined as the systemic clearance of the drug following intravenous administration. (NCT01854775)
Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4

InterventionL/hr (Mean)
EVGTAF
Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg6.768.6

PK Parameter: CL of EVG and TAF (Cohort 2)

Clearance (CL) is defined as the systemic clearance of the drug following intravenous administration. (NCT01854775)
Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4

InterventionL/hr (Mean)
EVGTAF
Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg6.331.9

PK Parameter: CL of EVG and TAF (Cohort 3)

Clearance (CL) is defined as the systemic clearance of the drug following intravenous administration. (NCT01854775)
Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2

InterventionL/hr (Mean)
EVGTAF
Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg3.418.5

PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 1)

Cmax is defined as the maximum concentration of drug. (NCT01854775)
Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4

Interventionng/mL (Mean)
EVGTAFFTCTFVCOBI
Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg2229.6166.82265.017.61202.4

PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 2)

Cmax is defined as the maximum concentration of drug. (NCT01854775)
Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4

Interventionng/mL (Mean)
EVGTAFFTCTFVCOBI
Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg3055.2313.33397.426.12079.4

PK Parameter: Cmax of EVG, TAF, FTC, TFV, and COBI (Cohort 3)

Cmax is defined as the maximum concentration of drug. (NCT01854775)
Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2

Interventionng/mL (Mean)
EVGTAFFTCTFVCOBI
Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg3297.2286.63007.419.61525.5

PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 1)

Ctau is defined as the observed drug concentration at the end of the dosing interval. (NCT01854775)
Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4

Interventionng/mL (Mean)
EVGFTCTFVCOBI
Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg300.8102.410.025.0

PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 2)

Ctau is defined as the observed drug concentration at the end of the dosing interval. (NCT01854775)
Timeframe: (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4

Interventionng/mL (Mean)
EVGFTCTFVCOBI
Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg370.0114.915.196.0

PK Parameter: Ctau of EVG, FTC, TFV, and COBI (Cohort 3)

Ctau is defined as the observed drug concentration at the end of the dosing interval. (NCT01854775)
Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2

Interventionng/mL (Mean)
EVGFTCTFVCOBI
Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg277.582.511.423.0

PK Parameter: Vz of EVG and TAF (Cohort 1)

Vz is defined as the volume of distribution of the drug after intravenous administration. (NCT01854775)
Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at Week 4

Interventionliters (Mean)
EVGTAF
Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg60.549.7

PK Parameter: Vz of EVG and TAF (Cohort 2)

Vz is defined as the volume of distribution of the drug after intravenous administration. (NCT01854775)
Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose at Week 4

Interventionliters (Mean)
EVGTAF
Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg46.828.6

PK Parameter: Vz of EVG and TAF (Cohort 3)

Vz is defined as the volume of distribution of the drug after intravenous administration. (NCT01854775)
Timeframe: 0 (pre-dose, ≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose at Week 2

Interventionliters (Mean)
EVGTAF
Cohort 3: Age ≥ 2 Years and Weight ≥ 14 to < 25 kg28.516.3

Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 12

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 12 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02397694)
Timeframe: Week 12

Interventionpercentage of participants (Number)
BIC + F/TAF93.8
DTG + F/TAF93.9

Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 48

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02397694)
Timeframe: Week 48

Interventionpercentage of participants (Number)
BIC + F/TAF96.9
DTG + F/TAF90.9

Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm.

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02397694)
Timeframe: Week 24

Interventionpercentage of participants (Number)
BIC + F/TAF96.9
DTG + F/TAF93.9

Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) During Double-Blinded Randomized Phase

(NCT02397694)
Timeframe: First dose date up to last dose (maximum duration: 58 Weeks) plus 30 days (During Double-Blinded Randomized Phase)

Interventionpercentage of participants (Number)
BIC + F/TAF87.7
DTG + F/TAF72.7

Percentage of Participants With Treatment Emergent Laboratory Abnormalities During Double-Blind Randomized Phase

(NCT02397694)
Timeframe: First dose date up to last dose (maximum duration: 58 Weeks) plus 30 days (During Double-Blinded Randomized Phase)

Interventionpercentage of participants (Number)
BIC + F/TAF87.5
DTG + F/TAF87.5

The Change From Baseline in CD4+ Cell Count at Week 24

(NCT02397694)
Timeframe: Baseline; Week 24

InterventionCD4 Cell Count (/μL) (Mean)
BIC + F/TAF190
DTG + F/TAF155

The Change From Baseline in CD4+ Cell Count at Week 48

(NCT02397694)
Timeframe: Baseline; Week 48

InterventionCD4 Cell Count (/μL) (Mean)
BIC + F/TAF258
DTG + F/TAF188

The Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 12

(NCT02397694)
Timeframe: Baseline; Week 12

InterventionCD4 Cell Count (/μL) (Mean)
BIC + F/TAF170
DTG + F/TAF173

The Change From Baseline in log10 HIV-1 RNA at Week 12

(NCT02397694)
Timeframe: Baseline; Week 12

Interventionlog10 copies/mL (Mean)
BIC + F/TAF-3.03
DTG + F/TAF-3.15

The Change From Baseline in log10 HIV-1 RNA at Week 24

(NCT02397694)
Timeframe: Baseline; Week 24

Interventionlog10 copies/mL (Mean)
BIC + F/TAF-3.09
DTG + F/TAF-3.12

The Change From Baseline in log10 HIV-1 RNA at Week 48

(NCT02397694)
Timeframe: Baseline; Week 48

Interventionlog10 copies/mL (Mean)
BIC + F/TAF-3.09
DTG + F/TAF-3.11

PK Parameter: AUCtau for BIC, FTC, TAF, and TFV

AUCtau is defined as the area under the concentration-time curve of the drug over time. (NCT02397694)
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8

,
Interventionh*ng/mL (Mean)
BICFTCTAFTFV
BIC + F/TAF139778.811605.4247.4316.0
DTG + F/TAFNA14689.8245.6369.4

PK Parameter: Cmax for Bictegravir (BIC), Emtricitabine (FTC), Tenofovir Alafenamide (TAF) and Tenofavir (TFV) at Steady-State

Cmax is the maximum observed plasma concentration of the drug. (NCT02397694)
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8

,
Interventionng/mL (Mean)
BICFTCTAFTFV
BIC + F/TAF9344.31919.1249.119.1
DTG + F/TAFNA2157.1260.820.9

PK Parameter: t1/2 of BIC, FTC, TAF, and TFV

t1/2 was defined as the terminal elimination half-life of the drug (NCT02397694)
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8

,
Interventionhours (Median)
BICFTCTAFTFV
BIC + F/TAF16.735.460.3737.74
DTG + F/TAFNA5.700.4234.47

PK Parameter: Tmax for BIC, FTC, TAF, and TFV at Steady-State

Tmax was defined as the time to Cmax. (NCT02397694)
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8

,
Interventionhours (Median)
BICFTCTAFTFV
BIC + F/TAF2.001.501.001.50
DTG + F/TAFNA1.501.002.00

PK Parameter:Ctau for BIC, FTC and TFV

Ctau was defined as the observed drug concentration at the end of the dosing interval. (NCT02397694)
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8

,
Interventionng/mL (Mean)
BICFTCTFV
BIC + F/TAF3508.676.610.7
DTG + F/TAFNA102.612.2

Change From Baseline in CD4+ Cell Count at Week 48

(NCT02345226)
Timeframe: Baseline; Week 48

Interventioncells/µL (Mean)
FTC/RPV/TAF23
EFV/FTC/TDF12

Change From Baseline in CD4+ Cell Count at Week 96

(NCT02345226)
Timeframe: Baseline; Week 96

Interventioncells/µL (Mean)
FTC/RPV/TAF12
EFV/FTC/TDF6

Change From Baseline in HIV Symptoms Index Score (HIVSI) at Week 48

The HIV Symptoms Index was a 20-item, self-reported measure that addressed presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Twenty HIV symptoms including Fatigue, Fever, Dizziness, Hand/Foot Pain, Memory Loss, Nausea, Diarrhea, Sadness, Nervous/anxious, Sleep Trouble, Skin Problems, Cough, Headache, Appetite Loss, Stomach Pain, Muscle/Joint Pain, Sex Problems, Change in Fat Deposits, Weight Loss, and Hair Loss were assessed. There were 5 possible responses (0 = I don't have this symptom; 1 = It doesn't bother me; 2 = It bothers me a little; 3 = It bothers me; and 4 = It bothers me a lot) for each HIV symptom. Total HIV Symptoms Index Score was derived from all 20 HIV symptoms by counting the number of bothersome symptoms. Total score would be missing if any of the individual items were missing. (NCT02345226)
Timeframe: Baseline; Week 48

Interventionunits on a scale (Mean)
FTC/RPV/TAF0
EFV/FTC/TDF-1

Change From Baseline in HIVSI Score at Week 96

The HIV Symptoms Index was a 20-item, self-reported measure that addressed presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Twenty HIV symptoms including Fatigue, Fever, Dizziness, Hand/Foot Pain, Memory Loss, Nausea, Diarrhea, Sadness, Nervous/anxious, Sleep Trouble, Skin Problems, Cough, Headache, Appetite Loss, Stomach Pain, Muscle/Joint Pain, Sex Problems, Change in Fat Deposits, Weight Loss, and Hair Loss were assessed. There were 5 possible responses (0 = I don't have this symptom; 1 = It doesn't bother me; 2 = It bothers me a little; 3 = It bothers me; and 4 = It bothers me a lot) for each HIV symptom. Total HIV Symptoms Index Score was derived from all 20 HIV symptoms by counting the number of bothersome symptoms. Total score would be missing if any of the individual items were missing. (NCT02345226)
Timeframe: Baseline; Week 96

Interventionunits on a scale (Mean)
FTC/RPV/TAF0
EFV/FTC/TDF-1

Percent Change From Baseline in Hip BMD at Week 96

Hip BMD was assessed by DXA scan. (NCT02345226)
Timeframe: Baseline; Week 96

Interventionpercentage change (Mean)
FTC/RPV/TAF1.831
EFV/FTC/TDF-0.617

Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48

Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan. (NCT02345226)
Timeframe: Baseline; Week 48

Interventionpercentage change (Mean)
FTC/RPV/TAF1.279
EFV/FTC/TDF-0.134

Percent Change From Baseline in Spine BMD at Week 48

Spine BMD was assessed by DXA scan. (NCT02345226)
Timeframe: Baseline; Week 48

Interventionpercentage change (Mean)
FTC/RPV/TAF1.645
EFV/FTC/TDF-0.045

Percent Change From Baseline in Spine BMD at Week 96

Spine BMD was assessed by DXA scan. (NCT02345226)
Timeframe: Baseline; Week 96

Interventionpercentage change (Mean)
FTC/RPV/TAF1.701
EFV/FTC/TDF0.126

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02345226)
Timeframe: Week 48

Interventionpercentage of participants (Number)
FTC/RPV/TAF90.0
EFV/FTC/TDF92.0

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-defined Snapshot

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02345226)
Timeframe: Week 96

Interventionpercentage of participants (Number)
FTC/RPV/TAF85.2
EFV/FTC/TDF85.1

Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-defined Snapshot Algorithm

The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02345226)
Timeframe: Week 48

Interventionpercentage of participants (Number)
FTC/RPV/TAF1.1
EFV/FTC/TDF0.9

Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Defined by the US FDA-defined Snapshot Algorithm

The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02345226)
Timeframe: Week 96

Interventionpercentage of participants (Number)
FTC/RPV/TAF0.7
EFV/FTC/TDF0.9

Change From Baseline in CD4+ Cell Count at Week 48

(NCT02345252)
Timeframe: Baseline; Week 48

Interventioncells/µL (Mean)
FTC/RPV/TAF9
FTC/RPV/TDF-1

Change From Baseline in CD4+ Cell Count at Week 96

(NCT02345252)
Timeframe: Baseline; Week 96

Interventioncells/µL (Mean)
FTC/RPV/TAF12
FTC/RPV/TDF16

Percent Change From Baseline in Hip BMD at Week 96

Hip BMD was assessed by DXA scan. (NCT02345252)
Timeframe: Baseline; Week 96

Interventionpercentage change (Mean)
FTC/RPV/TAF1.623
FTC/RPV/TDF-0.613

Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48

Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan. (NCT02345252)
Timeframe: Baseline; Week 48

Interventionpercentage change (Mean)
FTC/RPV/TAF1.040
FTC/RPV/TDF-0.245

Percent Change From Baseline in Spine BMD at Week 48

Spine BMD was assessed by DXA scan. (NCT02345252)
Timeframe: Baseline; Week 48

Interventionpercentage change (Mean)
FTC/RPV/TAF1.613
FTC/RPV/TDF0.075

Percent Change From Baseline in Spine BMD at Week 96

Spine BMD was assessed by DXA scan. (NCT02345252)
Timeframe: Baseline; Week 96

Interventionpercentage change (Mean)
FTC/RPV/TAF2.039
FTC/RPV/TDF-0.250

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the US FDA-defined snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02345252)
Timeframe: Week 48

Interventionpercentage of participants (Number)
FTC/RPV/TAF93.7
FTC/RPV/TDF93.9

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02345252)
Timeframe: Week 96

Interventionpercentage of participants (Number)
FTC/RPV/TAF89.2
FTC/RPV/TDF88.5

Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm

The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02345252)
Timeframe: Week 48

Interventionpercentage of participants (Number)
FTC/RPV/TAF0.6
FTC/RPV/TDF0

Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm

The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02345252)
Timeframe: Week 96

Interventionpercentage of participants (Number)
FTC/RPV/TAF0.6
FTC/RPV/TDF1.0

Reviews

34 reviews available for alanine and HIV Infections

ArticleYear
Tribute to John C. Martin at the Twentieth Anniversary of the Breakthrough of Tenofovir in the Treatment of HIV Infections.
    Viruses, 2021, 12-02, Volume: 13, Issue:12

    Topics: Alanine; Anti-HIV Agents; Drug Therapy, Combination; Emtricitabine, Tenofovir Disoproxil Fumarate Dr

2021
Metabolic Consequences of Antiretroviral Therapy.
    Current HIV/AIDS reports, 2022, Volume: 19, Issue:2

    Topics: Alanine; Anti-HIV Agents; Female; Glucose; HIV Infections; HIV Integrase Inhibitors; Humans; Tenofov

2022
Increased viral load in a hospitalized patient on treatment with crushed bictegravir/emtricitabine/tenofovir alafenamide: A case report and review of the literature.
    American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists, 2022, 08-05, Volume: 79, Issue:16

    Topics: Adenine; Adult; Alanine; Amides; Anti-HIV Agents; Drug Combinations; Emtricitabine; Heterocyclic Com

2022
Pre-exposure prophylaxis 2.0: new drugs and technologies in the pipeline.
    The lancet. HIV, 2019, Volume: 6, Issue:11

    Topics: Adenine; Administration, Cutaneous; Administration, Oral; Alanine; Contraceptive Devices, Female; De

2019
Tenofovir Urine Assay to Monitor Adherence to HIV Pre-exposure Prophylaxis.
    Current clinical pharmacology, 2020, Volume: 15, Issue:2

    Topics: Alanine; Anti-HIV Agents; Chromatography, High Pressure Liquid; HIV Infections; Humans; Mass Spectro

2020
Bictegravir, a novel integrase inhibitor for the treatment of HIV infection.
    Drugs of today (Barcelona, Spain : 1998), 2019, Volume: 55, Issue:11

    Topics: Adenine; Alanine; Amides; Emtricitabine; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, 4 o

2019
Efficacy and safety of the regimens containing tenofovir alafenamide versus tenofovir disoproxil fumarate in fixed-dose single-tablet regimens for initial treatment of HIV-1 infection: A meta-analysis of randomized controlled trials.
    International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases, 2020, Volume: 93

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; CD4 Lymphocyte Count; HIV Infections; HIV Seropositivity;

2020
The potential role of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) single-tablet regimen in the expanding spectrum of fixed-dose combination therapy for HIV.
    HIV medicine, 2020, Volume: 21 Suppl 1

    Topics: Adenine; Alanine; Anti-HIV Agents; CD4 Lymphocyte Count; Comorbidity; Drug Combinations; Emtricitabi

2020
Tenofovir alafenamide use in pregnant and lactating women living with HIV.
    Expert opinion on drug metabolism & toxicology, 2020, Volume: 16, Issue:4

    Topics: Adenine; Alanine; Anti-HIV Agents; Female; HIV Infections; Humans; Lactation; Pregnancy; Pregnancy C

2020
Tenofovir alafenamide vs. tenofovir disoproxil fumarate: an updated meta-analysis of 14 894 patients across 14 trials.
    AIDS (London, England), 2020, 12-01, Volume: 34, Issue:15

    Topics: Adenine; Alanine; Anti-HIV Agents; Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as

2020
Risks of metabolic syndrome and diabetes with integrase inhibitor-based therapy.
    Current opinion in infectious diseases, 2021, 02-01, Volume: 34, Issue:1

    Topics: Alanine; Anti-HIV Agents; Diabetes Mellitus; HIV Infections; HIV Integrase Inhibitors; Humans; Metab

2021
Evaluating the combination of emtricitabine/ tenofovir alafenamide fumarate to reduce the risk of sexually acquired HIV-1-infection in at-risk adults.
    Expert opinion on pharmacotherapy, 2021, Volume: 22, Issue:10

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Emtricitabine; Female; Fumarates; HIV Infections; HIV-1; H

2021
Impact of Integrase inhibitors and tenofovir alafenamide on weight gain in people with HIV.
    Current opinion in HIV and AIDS, 2021, 05-01, Volume: 16, Issue:3

    Topics: Alanine; Anti-HIV Agents; HIV Infections; HIV Integrase Inhibitors; Humans; Tenofovir; Weight Gain

2021
Tenofovir Alafenamide for HIV Prevention: Review of the Proceedings from the Gates Foundation Long-Acting TAF Product Development Meeting.
    AIDS research and human retroviruses, 2021, Volume: 37, Issue:6

    Topics: Adenine; Adolescent; Alanine; Animals; Anti-HIV Agents; Female; HIV Infections; Humans; Pre-Exposure

2021
The predicted risk of adverse pregnancy outcomes as a result of treatment-associated obesity in a hypothetical population receiving tenofovir alafenamide/emtricitabine/dolutegravir, tenofovir disoproxil fumarate/emtricitabine/dolutegravir or tenofovir dis
    AIDS (London, England), 2021, 12-15, Volume: 35, Issue:Suppl 2

    Topics: Alanine; Alkynes; Anti-HIV Agents; Benzoxazines; Cyclopropanes; Emtricitabine; Female; Heterocyclic

2021
Tenofovir alafenamide nephrotoxicity: a case report and literature review.
    AIDS research and therapy, 2021, 08-21, Volume: 18, Issue:1

    Topics: Adenine; Alanine; Anti-HIV Agents; Emtricitabine; Female; HIV Infections; Humans; Middle Aged; Tenof

2021
Candidates for inclusion in a universal antiretroviral regimen: tenofovir alafenamide.
    Current opinion in HIV and AIDS, 2017, Volume: 12, Issue:4

    Topics: Adenine; Alanine; Anti-HIV Agents; HIV Infections; HIV-1; Humans; Male; Prodrugs; Randomized Control

2017
Compatibility of next-generation first-line antiretrovirals with rifampicin-based antituberculosis therapy in resource limited settings.
    Current opinion in HIV and AIDS, 2017, Volume: 12, Issue:4

    Topics: Adenine; Alanine; Alkynes; Anti-Retroviral Agents; Antitubercular Agents; Benzoxazines; Cyclopropane

2017
Role of tenofovir alafenamide (TAF) in the treatment and prophylaxis of HIV and HBV infections.
    Biochemical pharmacology, 2018, Volume: 153

    Topics: Adenine; Alanine; Antiviral Agents; Drug Resistance, Viral; Drug Therapy, Combination; Hepatitis B;

2018
Potential kidney toxicity from the antiviral drug tenofovir: new indications, new formulations, and a new prodrug.
    Current opinion in nephrology and hypertension, 2018, Volume: 27, Issue:2

    Topics: Adenine; Alanine; Antiviral Agents; Bone Density; Drug Interactions; Glomerular Filtration Rate; Hep

2018
Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide: A Review in HIV-1 Infection.
    Drugs, 2018, Volume: 78, Issue:10

    Topics: Adenine; Alanine; Anti-HIV Agents; Bone Density; Cobicistat; Darunavir; Dose-Response Relationship,

2018
Tolerability of Current Antiretroviral Single-Tablet Regimens
    AIDS reviews, 2018, Volume: 20, Issue:3

    Topics: Adenine; Alanine; Anti-Retroviral Agents; Cobicistat; Darunavir; Drug Combinations; Emtricitabine; H

2018
Darunavir-cobicistat-emtricitabine-tenofovir alafenamide: safety and efficacy of a protease inhibitor in the modern era.
    Drug design, development and therapy, 2018, Volume: 12

    Topics: Adenine; Alanine; Anti-HIV Agents; Cobicistat; Darunavir; Drug Combinations; Emtricitabine; HIV; HIV

2018
An evaluation of elvitegravir plus cobicistat plus tenofovir alafenamide plus emtricitabine as a single-tablet regimen for the treatment of HIV in children and adolescents.
    Expert opinion on pharmacotherapy, 2019, Volume: 20, Issue:3

    Topics: Adenine; Adolescent; Alanine; Anti-HIV Agents; Child; Cobicistat; Emtricitabine; HIV Infections; Hum

2019
Bictegravir in a fixed-dose tablet with emtricitabine and tenofovir alafenamide for the treatment of HIV infection: pharmacology and clinical implications.
    Expert opinion on pharmacotherapy, 2019, Volume: 20, Issue:4

    Topics: Adenine; Alanine; Amides; Animals; Anti-HIV Agents; Drug Combinations; Drug Interactions; Emtricitab

2019
Planning HIV therapy to prevent future comorbidities: patient years for tenofovir alafenamide.
    HIV medicine, 2019, Volume: 20 Suppl 7

    Topics: Adenine; Age Factors; Alanine; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Clinical Tria

2019
Tenofovir alafenamide: A novel prodrug of tenofovir for the treatment of Human Immunodeficiency Virus.
    Antiviral research, 2016, Volume: 125

    Topics: Adenine; Alanine; Animals; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Bone Density; Dru

2016
The role of tenofovir alafenamide in future HIV management.
    HIV medicine, 2016, Volume: 17 Suppl 2

    Topics: Adenine; Alanine; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Drug-Related Side Effects

2016
Tenofovir alafenamide (TAF) as the successor of tenofovir disoproxil fumarate (TDF).
    Biochemical pharmacology, 2016, Nov-01, Volume: 119

    Topics: Adenine; Alanine; Antiviral Agents; HIV Infections; Humans; Tenofovir

2016
Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide: A Review in HIV-1 Infection.
    Drugs, 2016, Volume: 76, Issue:9

    Topics: Adenine; Adolescent; Adult; Alanine; Anti-HIV Agents; Clinical Trials, Phase III as Topic; Cobicista

2016
Renal effects of novel antiretroviral drugs.
    Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2017, 03-01, Volume: 32, Issue:3

    Topics: Adenine; Alanine; Anti-HIV Agents; Atazanavir Sulfate; Cobicistat; Creatinine; Disease Progression;

2017
Tenofovir Alafenamide.
    The Annals of pharmacotherapy, 2016, Volume: 50, Issue:11

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Bone Density; Female; HIV Infections; HIV-1; Humans; Prodr

2016
The efficacy and safety of tenofovir alafenamide versus tenofovir disoproxil fumarate in antiretroviral regimens for HIV-1 therapy: Meta-analysis.
    Medicine, 2016, Volume: 95, Issue:41

    Topics: Adenine; Alanine; Anti-HIV Agents; HIV Infections; HIV-1; Humans; RNA, Viral; Tenofovir; Treatment O

2016
Tenofovir alafenamide fumarate for the treatment of HIV infection.
    Drugs of today (Barcelona, Spain : 1998), 2016, Volume: 52, Issue:11

    Topics: Adenine; Alanine; Anti-HIV Agents; Clinical Trials as Topic; Drug Interactions; Drug Resistance, Vir

2016

Trials

61 trials available for alanine and HIV Infections

ArticleYear
Tenofovir-diphosphate in peripheral blood mononuclear cells during low, medium and high adherence to emtricitabine/ tenofovir alafenamide vs. emtricitabine/ tenofovir disoproxil fumarate.
    AIDS (London, England), 2021, 12-01, Volume: 35, Issue:15

    Topics: Alanine; Anti-HIV Agents; Diphosphates; Emtricitabine; HIV Infections; Humans; Leukocytes, Mononucle

2021
Brief Report: Efficacy and Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Females Living With HIV: An Integrated Analysis of 5 Trials.
    Journal of acquired immune deficiency syndromes (1999), 2021, 12-01, Volume: 88, Issue:4

    Topics: Adenine; Adolescent; Adult; Aged; Alanine; Amides; Anti-HIV Agents; Child; Drug Combinations; Emtric

2021
Brief Report: Bictegravir/Emtricitabine/Tenofovir Alafenamide Efficacy in Participants With Preexisting Primary Integrase Inhibitor Resistance Through 48 Weeks of Phase 3 Clinical Trials.
    Journal of acquired immune deficiency syndromes (1999), 2022, 04-01, Volume: 89, Issue:4

    Topics: Alanine; Amides; Anti-HIV Agents; Emtricitabine; Heterocyclic Compounds, 3-Ring; HIV Infections; HIV

2022
CAPRISA 018: a phase I/II clinical trial study protocol to assess the safety, acceptability, tolerability and pharmacokinetics of a sustained-release tenofovir alafenamide subdermal implant for HIV prevention in women.
    BMJ open, 2022, Jan-06, Volume: 12, Issue:1

    Topics: Alanine; Anti-HIV Agents; Clinical Trials, Phase I as Topic; Clinical Trials, Phase II as Topic; Del

2022
Efficacy and Safety of Switching to Dolutegravir/Lamivudine Versus Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Results Through Week 144 F
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2022, 09-29, Volume: 75, Issue:6

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Heterocyclic Compounds, 3-Ring; HIV Infections; HIV-1; Hum

2022
Bioavailability of dissolved and crushed single tablets of bictegravir, emtricitabine, tenofovir alafenamide in healthy adults: the SOLUBIC randomized crossover study.
    The Journal of antimicrobial chemotherapy, 2022, 12-23, Volume: 78, Issue:1

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Biological Availability; Cross-Over Studies; Emtricitabine

2022
Blood immune cells from people with HIV on antiviral regimens that contain tenofovir alafenamide (TAF) and tenofovir disoproxil fumarate (TDF) have differential metabolic signatures.
    Metabolism: clinical and experimental, 2023, Volume: 141

    Topics: Adenine; Alanine; Anti-HIV Agents; HIV Infections; Humans; Leukocytes, Mononuclear; Tenofovir

2023
Pharmacogenetics of tenofovir renal toxicity in HIV-positive Southern Africans.
    Pharmacogenetics and genomics, 2023, 07-01, Volume: 33, Issue:5

    Topics: Adenine; Adult; African People; Alanine; Anti-HIV Agents; HIV Infections; HIV Seropositivity; Humans

2023
A phase I study to assess safety, pharmacokinetics, and pharmacodynamics of a vaginal insert containing tenofovir alafenamide and elvitegravir.
    Frontiers in cellular and infection microbiology, 2023, Volume: 13

    Topics: Alanine; Anti-HIV Agents; Female; HIV Infections; HIV-1; Humans; Tenofovir

2023
Switching to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) plus darunavir/cobicistat in heavily antiretroviral-experienced, virologically suppressed HIV-infected adults receiving complex regimens.
    The Journal of antimicrobial chemotherapy, 2023, 11-06, Volume: 78, Issue:11

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Anti-Retroviral Agents; Cobicistat; Darunavir; DNA; Emtric

2023
Switching to bictegravir/emtricitabine/tenofovir alafenamide maintained HIV-1 RNA suppression in participants with archived antiretroviral resistance including M184V/I.
    The Journal of antimicrobial chemotherapy, 2019, 12-01, Volume: 74, Issue:12

    Topics: Adenine; Adult; Alanine; Amides; Amino Acid Substitution; Anti-HIV Agents; Double-Blind Method; Drug

2019
Switching to bictegravir/emtricitabine/tenofovir alafenamide maintained HIV-1 RNA suppression in participants with archived antiretroviral resistance including M184V/I.
    The Journal of antimicrobial chemotherapy, 2019, 12-01, Volume: 74, Issue:12

    Topics: Adenine; Adult; Alanine; Amides; Amino Acid Substitution; Anti-HIV Agents; Double-Blind Method; Drug

2019
Switching to bictegravir/emtricitabine/tenofovir alafenamide maintained HIV-1 RNA suppression in participants with archived antiretroviral resistance including M184V/I.
    The Journal of antimicrobial chemotherapy, 2019, 12-01, Volume: 74, Issue:12

    Topics: Adenine; Adult; Alanine; Amides; Amino Acid Substitution; Anti-HIV Agents; Double-Blind Method; Drug

2019
Switching to bictegravir/emtricitabine/tenofovir alafenamide maintained HIV-1 RNA suppression in participants with archived antiretroviral resistance including M184V/I.
    The Journal of antimicrobial chemotherapy, 2019, 12-01, Volume: 74, Issue:12

    Topics: Adenine; Adult; Alanine; Amides; Amino Acid Substitution; Anti-HIV Agents; Double-Blind Method; Drug

2019
Darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-experienced, virologically suppressed patients with HIV-1: subgroup analyses of the phase 3 EMERALD study.
    AIDS research and therapy, 2019, 08-29, Volume: 16, Issue:1

    Topics: Adenine; Adult; Aged; Alanine; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Cobicistat; D

2019
Bone mineral density in virologically suppressed people aged 60 years or older with HIV-1 switching from a regimen containing tenofovir disoproxil fumarate to an elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide single-tablet regimen: a m
    The lancet. HIV, 2019, Volume: 6, Issue:10

    Topics: Adenine; Aged; Aged, 80 and over; Alanine; Anti-HIV Agents; Bone Density; Cobicistat; Emtricitabine;

2019
Switching to Fixed-Dose Bictegravir, Emtricitabine, and Tenofovir Alafenamide (B/F/TAF) in Virologically Suppressed HIV-1 Infected Women: A Randomized, Open-Label, Multicenter, Active-Controlled, Phase 3, Noninferiority Trial.
    Journal of acquired immune deficiency syndromes (1999), 2019, 11-01, Volume: 82, Issue:3

    Topics: Adenine; Adult; Alanine; Amides; Anti-HIV Agents; CD4 Lymphocyte Count; Emtricitabine; Female; Heter

2019
Early safety of tenofovir alafenamide in patients with a history of tubulopathy on tenofovir disoproxil fumarate: a randomized controlled clinical trial.
    HIV medicine, 2020, Volume: 21, Issue:3

    Topics: Adenine; Alanine; Creatinine; Drug Administration Schedule; Drug Therapy, Combination; Emtricitabine

2020
Elvitegravir-Cobicistat-Emtricitabine-Tenofovir Alafenamide Single-tablet Regimen for Human Immunodeficiency Virus Postexposure Prophylaxis.
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020, 02-14, Volume: 70, Issue:5

    Topics: Adenine; Alanine; Anti-HIV Agents; Cobicistat; Drug Combinations; Emtricitabine; HIV Infections; HIV

2020
Elvitegravir-Cobicistat-Emtricitabine-Tenofovir Alafenamide Single-tablet Regimen for Human Immunodeficiency Virus Postexposure Prophylaxis.
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020, 02-14, Volume: 70, Issue:5

    Topics: Adenine; Alanine; Anti-HIV Agents; Cobicistat; Drug Combinations; Emtricitabine; HIV Infections; HIV

2020
Elvitegravir-Cobicistat-Emtricitabine-Tenofovir Alafenamide Single-tablet Regimen for Human Immunodeficiency Virus Postexposure Prophylaxis.
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020, 02-14, Volume: 70, Issue:5

    Topics: Adenine; Alanine; Anti-HIV Agents; Cobicistat; Drug Combinations; Emtricitabine; HIV Infections; HIV

2020
Elvitegravir-Cobicistat-Emtricitabine-Tenofovir Alafenamide Single-tablet Regimen for Human Immunodeficiency Virus Postexposure Prophylaxis.
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020, 02-14, Volume: 70, Issue:5

    Topics: Adenine; Alanine; Anti-HIV Agents; Cobicistat; Drug Combinations; Emtricitabine; HIV Infections; HIV

2020
Plasma concentration of neurofilament light chain protein decreases after switching from tenofovir disoproxil fumarate to tenofovir alafenamide fumarate.
    PloS one, 2019, Volume: 14, Issue:12

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Central Nervous System Diseases; Creatinine; Drug Administ

2019
Week 96 results of a phase 3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients.
    AIDS (London, England), 2020, 04-01, Volume: 34, Issue:5

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Cobicistat; Darunavir; Double-Blind Method; Drug Combinati

2020
Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Phas
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020, 11-05, Volume: 71, Issue:8

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Heterocyclic Compounds, 3-Ring; HIV Infections; HIV-1; Hum

2020
Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Phas
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020, 11-05, Volume: 71, Issue:8

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Heterocyclic Compounds, 3-Ring; HIV Infections; HIV-1; Hum

2020
Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Phas
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020, 11-05, Volume: 71, Issue:8

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Heterocyclic Compounds, 3-Ring; HIV Infections; HIV-1; Hum

2020
Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Phas
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020, 11-05, Volume: 71, Issue:8

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Heterocyclic Compounds, 3-Ring; HIV Infections; HIV-1; Hum

2020
Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Phas
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020, 11-05, Volume: 71, Issue:8

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Heterocyclic Compounds, 3-Ring; HIV Infections; HIV-1; Hum

2020
Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Phas
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020, 11-05, Volume: 71, Issue:8

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Heterocyclic Compounds, 3-Ring; HIV Infections; HIV-1; Hum

2020
Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Phas
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020, 11-05, Volume: 71, Issue:8

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Heterocyclic Compounds, 3-Ring; HIV Infections; HIV-1; Hum

2020
Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Phas
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020, 11-05, Volume: 71, Issue:8

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Heterocyclic Compounds, 3-Ring; HIV Infections; HIV-1; Hum

2020
Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Phas
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020, 11-05, Volume: 71, Issue:8

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Heterocyclic Compounds, 3-Ring; HIV Infections; HIV-1; Hum

2020
HIV/HCV therapy with ledipasvir/sofosbuvir after randomized switch to emtricitabine-tenofovir alafenamide-based single-tablet regimens.
    PloS one, 2020, Volume: 15, Issue:1

    Topics: Adenine; Adult; Aged; Alanine; Benzimidazoles; Coinfection; Drug Combinations; Drug Resistance, Vira

2020
Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomised, double-blind, multicentre, phase 3, non-inferiority trials
    The lancet. HIV, 2020, Volume: 7, Issue:6

    Topics: Adenine; Adult; Aged; Alanine; Dideoxynucleosides; Double-Blind Method; Drug Administration Schedule

2020
Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomised, double-blind, multicentre, phase 3, non-inferiority trials
    The lancet. HIV, 2020, Volume: 7, Issue:6

    Topics: Adenine; Adult; Aged; Alanine; Dideoxynucleosides; Double-Blind Method; Drug Administration Schedule

2020
Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomised, double-blind, multicentre, phase 3, non-inferiority trials
    The lancet. HIV, 2020, Volume: 7, Issue:6

    Topics: Adenine; Adult; Aged; Alanine; Dideoxynucleosides; Double-Blind Method; Drug Administration Schedule

2020
Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomised, double-blind, multicentre, phase 3, non-inferiority trials
    The lancet. HIV, 2020, Volume: 7, Issue:6

    Topics: Adenine; Adult; Aged; Alanine; Dideoxynucleosides; Double-Blind Method; Drug Administration Schedule

2020
Intracellular Tenofovir-Diphosphate and Emtricitabine-Triphosphate in Dried Blood Spots Following Tenofovir Alafenamide: The TAF-DBS Study.
    Journal of acquired immune deficiency syndromes (1999), 2020, 07-01, Volume: 84, Issue:3

    Topics: Adenine; Adolescent; Adult; Alanine; Anti-HIV Agents; Cross-Over Studies; Drug Combinations; Emtrici

2020
Switching to Bictegravir, Emtricitabine, and Tenofovir Alafenamide in Virologically Suppressed Adults With Human Immunodeficiency Virus.
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021, 07-15, Volume: 73, Issue:2

    Topics: Adult; Alanine; Amides; Anti-HIV Agents; Emtricitabine; Heterocyclic Compounds, 3-Ring; HIV Infectio

2021
A phase IV randomised, open-label pilot study to evaluate switching from protease-inhibitor based regimen to Bictegravir/Emtricitabine/Tenofovir Alafenamide single tablet regimen in Integrase inhibitor-naïve, virologically suppressed HIV-1 infected adults
    BMC infectious diseases, 2020, Jul-20, Volume: 20, Issue:1

    Topics: Adenine; Adult; Alanine; Amides; Drug Combinations; Drug Resistance, Viral; Emtricitabine; Female; H

2020
Dolutegravir with emtricitabine and tenofovir alafenamide or tenofovir disoproxil fumarate versus efavirenz, emtricitabine, and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection (ADVANCE): week 96 results from a randomised, phase 3, n
    The lancet. HIV, 2020, Volume: 7, Issue:10

    Topics: Adenine; Adolescent; Adult; Alanine; Alkynes; Anti-HIV Agents; Antiretroviral Therapy, Highly Active

2020
Week 96 resistance analyses of the once-daily, single-tablet regimen (STR) darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in adults living with HIV-1 from the phase 3 randomized AMBER and EMERALD trials.
    Journal of medical virology, 2021, Volume: 93, Issue:6

    Topics: Alanine; Anti-HIV Agents; Cobicistat; Darunavir; Drug Combinations; Drug Resistance, Multiple, Viral

2021
Week 96 subgroup analyses of the phase 3, randomized AMBER and EMERALD trials evaluating the efficacy and safety of the once daily darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) single-tablet regimen in antiretroviral treatment (ART)
    HIV research & clinical practice, 2020, Volume: 21, Issue:6

    Topics: Adult; Alanine; Anti-HIV Agents; Cobicistat; Darunavir; Emtricitabine; HIV Infections; HIV-1; Humans

2020
Brief Report: Improvement in Metabolic Health Parameters at Week 48 After Switching From a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen to the 2-Drug Regimen of Dolutegravir/Lamivudine: The TANGO Study.
    Journal of acquired immune deficiency syndromes (1999), 2021, 06-01, Volume: 87, Issue:2

    Topics: Adult; Alanine; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Blood Glucose; Drug Therapy,

2021
A Phase I Evaluation of the Pharmacokinetics and Tolerability of the HIV-1 Maturation Inhibitor GSK3640254 and Tenofovir Alafenamide/Emtricitabine in Healthy Participants.
    Antimicrobial agents and chemotherapy, 2021, 05-18, Volume: 65, Issue:6

    Topics: Adenine; Alanine; Anti-HIV Agents; Emtricitabine; Healthy Volunteers; HIV Infections; HIV-1; Humans;

2021
Efficacy and safety of dolutegravir with emtricitabine and tenofovir alafenamide fumarate or tenofovir disoproxil fumarate, and efavirenz, emtricitabine, and tenofovir disoproxil fumarate HIV antiretroviral therapy regimens started in pregnancy (IMPAACT 2
    Lancet (London, England), 2021, 04-03, Volume: 397, Issue:10281

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Drug Therapy, Combination; Emtricitabine; Female; Gestatio

2021
Three-year study of pre-existing drug resistance substitutions and efficacy of bictegravir/emtricitabine/tenofovir alafenamide in HIV-1 treatment-naive participants.
    The Journal of antimicrobial chemotherapy, 2021, 07-15, Volume: 76, Issue:8

    Topics: Alanine; Amides; Anti-HIV Agents; Drug Combinations; Drug Resistance; Emtricitabine; Heterocyclic Co

2021
Three-year study of pre-existing drug resistance substitutions and efficacy of bictegravir/emtricitabine/tenofovir alafenamide in HIV-1 treatment-naive participants.
    The Journal of antimicrobial chemotherapy, 2021, 07-15, Volume: 76, Issue:8

    Topics: Alanine; Amides; Anti-HIV Agents; Drug Combinations; Drug Resistance; Emtricitabine; Heterocyclic Co

2021
Three-year study of pre-existing drug resistance substitutions and efficacy of bictegravir/emtricitabine/tenofovir alafenamide in HIV-1 treatment-naive participants.
    The Journal of antimicrobial chemotherapy, 2021, 07-15, Volume: 76, Issue:8

    Topics: Alanine; Amides; Anti-HIV Agents; Drug Combinations; Drug Resistance; Emtricitabine; Heterocyclic Co

2021
Three-year study of pre-existing drug resistance substitutions and efficacy of bictegravir/emtricitabine/tenofovir alafenamide in HIV-1 treatment-naive participants.
    The Journal of antimicrobial chemotherapy, 2021, 07-15, Volume: 76, Issue:8

    Topics: Alanine; Amides; Anti-HIV Agents; Drug Combinations; Drug Resistance; Emtricitabine; Heterocyclic Co

2021
Long-term safety and efficacy of emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV-1 pre-exposure prophylaxis: week 96 results from a randomised, double-blind, placebo-controlled, phase 3 trial.
    The lancet. HIV, 2021, Volume: 8, Issue:7

    Topics: Adenine; Adult; Aged; Alanine; Anti-HIV Agents; Double-Blind Method; Drug Therapy, Combination; Emtr

2021
Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Black Americans With HIV-1: A Randomized Phase 3b, Multicenter, Open-Label Study.
    Journal of acquired immune deficiency syndromes (1999), 2021, 09-01, Volume: 88, Issue:1

    Topics: Adenine; Adolescent; Adult; Aged; Alanine; Amides; Anti-HIV Agents; Black or African American; Drug

2021
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Dideoxynucleosides; Double-Blind Method; Dr

2017
Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380-1490): a randomised, double-blind, multicentre, phase 3, non-inferiori
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Double-Blind Method; Drug Combinations; Emt

2017
Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380-1490): a randomised, double-blind, multicentre, phase 3, non-inferiori
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Double-Blind Method; Drug Combinations; Emt

2017
Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380-1490): a randomised, double-blind, multicentre, phase 3, non-inferiori
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Double-Blind Method; Drug Combinations; Emt

2017
Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380-1490): a randomised, double-blind, multicentre, phase 3, non-inferiori
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Double-Blind Method; Drug Combinations; Emt

2017
Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380-1490): a randomised, double-blind, multicentre, phase 3, non-inferiori
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Double-Blind Method; Drug Combinations; Emt

2017
Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380-1490): a randomised, double-blind, multicentre, phase 3, non-inferiori
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Double-Blind Method; Drug Combinations; Emt

2017
Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380-1490): a randomised, double-blind, multicentre, phase 3, non-inferiori
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Double-Blind Method; Drug Combinations; Emt

2017
Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380-1490): a randomised, double-blind, multicentre, phase 3, non-inferiori
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Double-Blind Method; Drug Combinations; Emt

2017
Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380-1490): a randomised, double-blind, multicentre, phase 3, non-inferiori
    Lancet (London, England), 2017, Nov-04, Volume: 390, Issue:10107

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Double-Blind Method; Drug Combinations; Emt

2017
Superior Efficacy and Improved Renal and Bone Safety After Switching from a Tenofovir Disoproxil Fumarate- to a Tenofovir Alafenamide-Based Regimen Through 96 Weeks of Treatment.
    AIDS research and human retroviruses, 2018, Volume: 34, Issue:4

    Topics: Adenine; Alanine; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Bone Density; Cobicistat;

2018
Brief Report: Efficacy and Safety of Switching to Coformulated Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide (E/C/F/TAF) in Virologically Suppressed Women.
    Journal of acquired immune deficiency syndromes (1999), 2018, 06-01, Volume: 78, Issue:2

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Cobicistat; Double-

2018
Efficacy and safety of switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from boosted protease inhibitor-based regimens in virologically suppressed adults with HIV-1: 48 week results of a randomised, open-label, multicentre, ph
    The lancet. HIV, 2018, Volume: 5, Issue:7

    Topics: Adenine; Adult; Aged; Alanine; Amides; Anti-Retroviral Agents; Drug Substitution; Emtricitabine; Fem

2018
Patient-Reported Symptoms Over 48 Weeks Among Participants in Randomized, Double-Blind, Phase III Non-inferiority Trials of Adults with HIV on Co-formulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide versus Co-formulated Abacavir, Dolutegravir,
    The patient, 2018, Volume: 11, Issue:5

    Topics: Adenine; Adolescent; Adult; Aged; Alanine; Amides; Anti-HIV Agents; Cohort Studies; Emtricitabine; E

2018
Patient-Reported Symptoms Over 48 Weeks Among Participants in Randomized, Double-Blind, Phase III Non-inferiority Trials of Adults with HIV on Co-formulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide versus Co-formulated Abacavir, Dolutegravir,
    The patient, 2018, Volume: 11, Issue:5

    Topics: Adenine; Adolescent; Adult; Aged; Alanine; Amides; Anti-HIV Agents; Cohort Studies; Emtricitabine; E

2018
Patient-Reported Symptoms Over 48 Weeks Among Participants in Randomized, Double-Blind, Phase III Non-inferiority Trials of Adults with HIV on Co-formulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide versus Co-formulated Abacavir, Dolutegravir,
    The patient, 2018, Volume: 11, Issue:5

    Topics: Adenine; Adolescent; Adult; Aged; Alanine; Amides; Anti-HIV Agents; Cohort Studies; Emtricitabine; E

2018
Patient-Reported Symptoms Over 48 Weeks Among Participants in Randomized, Double-Blind, Phase III Non-inferiority Trials of Adults with HIV on Co-formulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide versus Co-formulated Abacavir, Dolutegravir,
    The patient, 2018, Volume: 11, Issue:5

    Topics: Adenine; Adolescent; Adult; Aged; Alanine; Amides; Anti-HIV Agents; Cohort Studies; Emtricitabine; E

2018
Patient-Reported Symptoms Over 48 Weeks Among Participants in Randomized, Double-Blind, Phase III Non-inferiority Trials of Adults with HIV on Co-formulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide versus Co-formulated Abacavir, Dolutegravir,
    The patient, 2018, Volume: 11, Issue:5

    Topics: Adenine; Adolescent; Adult; Aged; Alanine; Amides; Anti-HIV Agents; Cohort Studies; Emtricitabine; E

2018
Patient-Reported Symptoms Over 48 Weeks Among Participants in Randomized, Double-Blind, Phase III Non-inferiority Trials of Adults with HIV on Co-formulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide versus Co-formulated Abacavir, Dolutegravir,
    The patient, 2018, Volume: 11, Issue:5

    Topics: Adenine; Adolescent; Adult; Aged; Alanine; Amides; Anti-HIV Agents; Cohort Studies; Emtricitabine; E

2018
Patient-Reported Symptoms Over 48 Weeks Among Participants in Randomized, Double-Blind, Phase III Non-inferiority Trials of Adults with HIV on Co-formulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide versus Co-formulated Abacavir, Dolutegravir,
    The patient, 2018, Volume: 11, Issue:5

    Topics: Adenine; Adolescent; Adult; Aged; Alanine; Amides; Anti-HIV Agents; Cohort Studies; Emtricitabine; E

2018
Patient-Reported Symptoms Over 48 Weeks Among Participants in Randomized, Double-Blind, Phase III Non-inferiority Trials of Adults with HIV on Co-formulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide versus Co-formulated Abacavir, Dolutegravir,
    The patient, 2018, Volume: 11, Issue:5

    Topics: Adenine; Adolescent; Adult; Aged; Alanine; Amides; Anti-HIV Agents; Cohort Studies; Emtricitabine; E

2018
Patient-Reported Symptoms Over 48 Weeks Among Participants in Randomized, Double-Blind, Phase III Non-inferiority Trials of Adults with HIV on Co-formulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide versus Co-formulated Abacavir, Dolutegravir,
    The patient, 2018, Volume: 11, Issue:5

    Topics: Adenine; Adolescent; Adult; Aged; Alanine; Amides; Anti-HIV Agents; Cohort Studies; Emtricitabine; E

2018
Patient-Reported Symptoms Over 48 Weeks Among Participants in Randomized, Double-Blind, Phase III Non-inferiority Trials of Adults with HIV on Co-formulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide versus Co-formulated Abacavir, Dolutegravir,
    The patient, 2018, Volume: 11, Issue:5

    Topics: Adenine; Adolescent; Adult; Aged; Alanine; Amides; Anti-HIV Agents; Cohort Studies; Emtricitabine; E

2018
Patient-Reported Symptoms Over 48 Weeks Among Participants in Randomized, Double-Blind, Phase III Non-inferiority Trials of Adults with HIV on Co-formulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide versus Co-formulated Abacavir, Dolutegravir,
    The patient, 2018, Volume: 11, Issue:5

    Topics: Adenine; Adolescent; Adult; Aged; Alanine; Amides; Anti-HIV Agents; Cohort Studies; Emtricitabine; E

2018
Patient-Reported Symptoms Over 48 Weeks Among Participants in Randomized, Double-Blind, Phase III Non-inferiority Trials of Adults with HIV on Co-formulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide versus Co-formulated Abacavir, Dolutegravir,
    The patient, 2018, Volume: 11, Issue:5

    Topics: Adenine; Adolescent; Adult; Aged; Alanine; Amides; Anti-HIV Agents; Cohort Studies; Emtricitabine; E

2018
Patient-Reported Symptoms Over 48 Weeks Among Participants in Randomized, Double-Blind, Phase III Non-inferiority Trials of Adults with HIV on Co-formulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide versus Co-formulated Abacavir, Dolutegravir,
    The patient, 2018, Volume: 11, Issue:5

    Topics: Adenine; Adolescent; Adult; Aged; Alanine; Amides; Anti-HIV Agents; Cohort Studies; Emtricitabine; E

2018
Patient-Reported Symptoms Over 48 Weeks Among Participants in Randomized, Double-Blind, Phase III Non-inferiority Trials of Adults with HIV on Co-formulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide versus Co-formulated Abacavir, Dolutegravir,
    The patient, 2018, Volume: 11, Issue:5

    Topics: Adenine; Adolescent; Adult; Aged; Alanine; Amides; Anti-HIV Agents; Cohort Studies; Emtricitabine; E

2018
Patient-Reported Symptoms Over 48 Weeks Among Participants in Randomized, Double-Blind, Phase III Non-inferiority Trials of Adults with HIV on Co-formulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide versus Co-formulated Abacavir, Dolutegravir,
    The patient, 2018, Volume: 11, Issue:5

    Topics: Adenine; Adolescent; Adult; Aged; Alanine; Amides; Anti-HIV Agents; Cohort Studies; Emtricitabine; E

2018
Patient-Reported Symptoms Over 48 Weeks Among Participants in Randomized, Double-Blind, Phase III Non-inferiority Trials of Adults with HIV on Co-formulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide versus Co-formulated Abacavir, Dolutegravir,
    The patient, 2018, Volume: 11, Issue:5

    Topics: Adenine; Adolescent; Adult; Aged; Alanine; Amides; Anti-HIV Agents; Cohort Studies; Emtricitabine; E

2018
Seminal Tenofovir Concentrations, Viral Suppression, and Semen Quality With Tenofovir Alafenamide, Compared With Tenofovir Disoproxil Fumarate (Spanish HIV/AIDS Research Network, PreEC/RIS 40).
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2019, 09-27, Volume: 69, Issue:8

    Topics: Adenine; Adult; Alanine; Anti-Retroviral Agents; Cobicistat; Emtricitabine; HIV Infections; HIV-1; H

2019
Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial.
    The lancet. HIV, 2019, Volume: 6, Issue:6

    Topics: Adenine; Alanine; Amides; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; CD4 Lymphocyte Cou

2019
Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial.
    The lancet. HIV, 2019, Volume: 6, Issue:6

    Topics: Adenine; Alanine; Amides; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; CD4 Lymphocyte Cou

2019
Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial.
    The lancet. HIV, 2019, Volume: 6, Issue:6

    Topics: Adenine; Alanine; Amides; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; CD4 Lymphocyte Cou

2019
Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial.
    The lancet. HIV, 2019, Volume: 6, Issue:6

    Topics: Adenine; Alanine; Amides; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; CD4 Lymphocyte Cou

2019
Co-formulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-infer
    The lancet. HIV, 2019, Volume: 6, Issue:6

    Topics: Adenine; Adult; Alanine; Amides; Anti-Retroviral Agents; Antiretroviral Therapy, Highly Active; Drug

2019
Week 96 efficacy and safety results of the phase 3, randomized EMERALD trial to evaluate switching from boosted-protease inhibitors plus emtricitabine/tenofovir disoproxil fumarate regimens to the once daily, single-tablet regimen of darunavir/cobicistat/
    Antiviral research, 2019, Volume: 170

    Topics: Adenine; Adult; Aged; Alanine; Anti-HIV Agents; Cobicistat; Darunavir; Drug Combinations; Drug Subst

2019
Antiviral activity, safety, and pharmacokinetics/pharmacodynamics of tenofovir alafenamide as 10-day monotherapy in HIV-1-positive adults.
    Journal of acquired immune deficiency syndromes (1999), 2013, Aug-01, Volume: 63, Issue:4

    Topics: Adenine; Adult; Alanine; Anti-Retroviral Agents; Area Under Curve; Dose-Response Relationship, Drug;

2013
Phase I/II study of the pharmacokinetics, safety and antiretroviral activity of tenofovir alafenamide, a new prodrug of the HIV reverse transcriptase inhibitor tenofovir, in HIV-infected adults.
    The Journal of antimicrobial chemotherapy, 2014, Volume: 69, Issue:5

    Topics: Adenine; Adolescent; Adult; Aged; Alanine; Anti-HIV Agents; Area Under Curve; Female; HIV Infections

2014
Tenofovir alafenamide vs. tenofovir disoproxil fumarate in single tablet regimens for initial HIV-1 therapy: a randomized phase 2 study.
    Journal of acquired immune deficiency syndromes (1999), 2014, Sep-01, Volume: 67, Issue:1

    Topics: Absorptiometry, Photon; Adenine; Administration, Oral; Adult; Alanine; Bone Density; CD4 Lymphocyte

2014
Tenofovir alafenamide vs. tenofovir disoproxil fumarate in single tablet regimens for initial HIV-1 therapy: a randomized phase 2 study.
    Journal of acquired immune deficiency syndromes (1999), 2014, Sep-01, Volume: 67, Issue:1

    Topics: Absorptiometry, Photon; Adenine; Administration, Oral; Adult; Alanine; Bone Density; CD4 Lymphocyte

2014
Tenofovir alafenamide vs. tenofovir disoproxil fumarate in single tablet regimens for initial HIV-1 therapy: a randomized phase 2 study.
    Journal of acquired immune deficiency syndromes (1999), 2014, Sep-01, Volume: 67, Issue:1

    Topics: Absorptiometry, Photon; Adenine; Administration, Oral; Adult; Alanine; Bone Density; CD4 Lymphocyte

2014
Tenofovir alafenamide vs. tenofovir disoproxil fumarate in single tablet regimens for initial HIV-1 therapy: a randomized phase 2 study.
    Journal of acquired immune deficiency syndromes (1999), 2014, Sep-01, Volume: 67, Issue:1

    Topics: Absorptiometry, Photon; Adenine; Administration, Oral; Adult; Alanine; Bone Density; CD4 Lymphocyte

2014
Tenofovir alafenamide vs. tenofovir disoproxil fumarate in single tablet regimens for initial HIV-1 therapy: a randomized phase 2 study.
    Journal of acquired immune deficiency syndromes (1999), 2014, Sep-01, Volume: 67, Issue:1

    Topics: Absorptiometry, Photon; Adenine; Administration, Oral; Adult; Alanine; Bone Density; CD4 Lymphocyte

2014
Tenofovir alafenamide vs. tenofovir disoproxil fumarate in single tablet regimens for initial HIV-1 therapy: a randomized phase 2 study.
    Journal of acquired immune deficiency syndromes (1999), 2014, Sep-01, Volume: 67, Issue:1

    Topics: Absorptiometry, Photon; Adenine; Administration, Oral; Adult; Alanine; Bone Density; CD4 Lymphocyte

2014
Tenofovir alafenamide vs. tenofovir disoproxil fumarate in single tablet regimens for initial HIV-1 therapy: a randomized phase 2 study.
    Journal of acquired immune deficiency syndromes (1999), 2014, Sep-01, Volume: 67, Issue:1

    Topics: Absorptiometry, Photon; Adenine; Administration, Oral; Adult; Alanine; Bone Density; CD4 Lymphocyte

2014
Tenofovir alafenamide vs. tenofovir disoproxil fumarate in single tablet regimens for initial HIV-1 therapy: a randomized phase 2 study.
    Journal of acquired immune deficiency syndromes (1999), 2014, Sep-01, Volume: 67, Issue:1

    Topics: Absorptiometry, Photon; Adenine; Administration, Oral; Adult; Alanine; Bone Density; CD4 Lymphocyte

2014
Tenofovir alafenamide vs. tenofovir disoproxil fumarate in single tablet regimens for initial HIV-1 therapy: a randomized phase 2 study.
    Journal of acquired immune deficiency syndromes (1999), 2014, Sep-01, Volume: 67, Issue:1

    Topics: Absorptiometry, Photon; Adenine; Administration, Oral; Adult; Alanine; Bone Density; CD4 Lymphocyte

2014
Tenofovir alafenamide vs. tenofovir disoproxil fumarate in single tablet regimens for initial HIV-1 therapy: a randomized phase 2 study.
    Journal of acquired immune deficiency syndromes (1999), 2014, Sep-01, Volume: 67, Issue:1

    Topics: Absorptiometry, Photon; Adenine; Administration, Oral; Adult; Alanine; Bone Density; CD4 Lymphocyte

2014
Tenofovir alafenamide vs. tenofovir disoproxil fumarate in single tablet regimens for initial HIV-1 therapy: a randomized phase 2 study.
    Journal of acquired immune deficiency syndromes (1999), 2014, Sep-01, Volume: 67, Issue:1

    Topics: Absorptiometry, Photon; Adenine; Administration, Oral; Adult; Alanine; Bone Density; CD4 Lymphocyte

2014
Tenofovir alafenamide vs. tenofovir disoproxil fumarate in single tablet regimens for initial HIV-1 therapy: a randomized phase 2 study.
    Journal of acquired immune deficiency syndromes (1999), 2014, Sep-01, Volume: 67, Issue:1

    Topics: Absorptiometry, Photon; Adenine; Administration, Oral; Adult; Alanine; Bone Density; CD4 Lymphocyte

2014
Tenofovir alafenamide vs. tenofovir disoproxil fumarate in single tablet regimens for initial HIV-1 therapy: a randomized phase 2 study.
    Journal of acquired immune deficiency syndromes (1999), 2014, Sep-01, Volume: 67, Issue:1

    Topics: Absorptiometry, Photon; Adenine; Administration, Oral; Adult; Alanine; Bone Density; CD4 Lymphocyte

2014
Tenofovir alafenamide vs. tenofovir disoproxil fumarate in single tablet regimens for initial HIV-1 therapy: a randomized phase 2 study.
    Journal of acquired immune deficiency syndromes (1999), 2014, Sep-01, Volume: 67, Issue:1

    Topics: Absorptiometry, Photon; Adenine; Administration, Oral; Adult; Alanine; Bone Density; CD4 Lymphocyte

2014
Tenofovir alafenamide vs. tenofovir disoproxil fumarate in single tablet regimens for initial HIV-1 therapy: a randomized phase 2 study.
    Journal of acquired immune deficiency syndromes (1999), 2014, Sep-01, Volume: 67, Issue:1

    Topics: Absorptiometry, Photon; Adenine; Administration, Oral; Adult; Alanine; Bone Density; CD4 Lymphocyte

2014
Tenofovir alafenamide vs. tenofovir disoproxil fumarate in single tablet regimens for initial HIV-1 therapy: a randomized phase 2 study.
    Journal of acquired immune deficiency syndromes (1999), 2014, Sep-01, Volume: 67, Issue:1

    Topics: Absorptiometry, Photon; Adenine; Administration, Oral; Adult; Alanine; Bone Density; CD4 Lymphocyte

2014
Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate in the First Protease Inhibitor-Based Single-Tablet Regimen for Initial HIV-1 Therapy: A Randomized Phase 2 Study.
    Journal of acquired immune deficiency syndromes (1999), 2015, Aug-01, Volume: 69, Issue:4

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Female; HIV Infections; HIV-1; Humans; Male; Organophospho

2015
Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials.
    Lancet (London, England), 2015, Jun-27, Volume: 385, Issue:9987

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Arthralgia; Bone Density; Carbamates; CD4 Lymphocyte Count

2015
Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials.
    Lancet (London, England), 2015, Jun-27, Volume: 385, Issue:9987

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Arthralgia; Bone Density; Carbamates; CD4 Lymphocyte Count

2015
Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials.
    Lancet (London, England), 2015, Jun-27, Volume: 385, Issue:9987

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Arthralgia; Bone Density; Carbamates; CD4 Lymphocyte Count

2015
Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials.
    Lancet (London, England), 2015, Jun-27, Volume: 385, Issue:9987

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Arthralgia; Bone Density; Carbamates; CD4 Lymphocyte Count

2015
Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials.
    Lancet (London, England), 2015, Jun-27, Volume: 385, Issue:9987

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Arthralgia; Bone Density; Carbamates; CD4 Lymphocyte Count

2015
Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials.
    Lancet (London, England), 2015, Jun-27, Volume: 385, Issue:9987

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Arthralgia; Bone Density; Carbamates; CD4 Lymphocyte Count

2015
Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials.
    Lancet (London, England), 2015, Jun-27, Volume: 385, Issue:9987

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Arthralgia; Bone Density; Carbamates; CD4 Lymphocyte Count

2015
Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials.
    Lancet (London, England), 2015, Jun-27, Volume: 385, Issue:9987

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Arthralgia; Bone Density; Carbamates; CD4 Lymphocyte Count

2015
Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials.
    Lancet (London, England), 2015, Jun-27, Volume: 385, Issue:9987

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Arthralgia; Bone Density; Carbamates; CD4 Lymphocyte Count

2015
Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral regimens for virologically suppressed adults with HIV-1 infection: a randomised, active-controlled, multicentre, open-label, phase 3, non-inferiority study.
    The Lancet. Infectious diseases, 2016, Volume: 16, Issue:1

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; CD4 Lymphocyte Count; Drug Combinations; Female; HIV Infec

2016
Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral regimens for virologically suppressed adults with HIV-1 infection: a randomised, active-controlled, multicentre, open-label, phase 3, non-inferiority study.
    The Lancet. Infectious diseases, 2016, Volume: 16, Issue:1

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; CD4 Lymphocyte Count; Drug Combinations; Female; HIV Infec

2016
Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral regimens for virologically suppressed adults with HIV-1 infection: a randomised, active-controlled, multicentre, open-label, phase 3, non-inferiority study.
    The Lancet. Infectious diseases, 2016, Volume: 16, Issue:1

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; CD4 Lymphocyte Count; Drug Combinations; Female; HIV Infec

2016
Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral regimens for virologically suppressed adults with HIV-1 infection: a randomised, active-controlled, multicentre, open-label, phase 3, non-inferiority study.
    The Lancet. Infectious diseases, 2016, Volume: 16, Issue:1

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; CD4 Lymphocyte Count; Drug Combinations; Female; HIV Infec

2016
Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral regimens for virologically suppressed adults with HIV-1 infection: a randomised, active-controlled, multicentre, open-label, phase 3, non-inferiority study.
    The Lancet. Infectious diseases, 2016, Volume: 16, Issue:1

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; CD4 Lymphocyte Count; Drug Combinations; Female; HIV Infec

2016
Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral regimens for virologically suppressed adults with HIV-1 infection: a randomised, active-controlled, multicentre, open-label, phase 3, non-inferiority study.
    The Lancet. Infectious diseases, 2016, Volume: 16, Issue:1

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; CD4 Lymphocyte Count; Drug Combinations; Female; HIV Infec

2016
Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral regimens for virologically suppressed adults with HIV-1 infection: a randomised, active-controlled, multicentre, open-label, phase 3, non-inferiority study.
    The Lancet. Infectious diseases, 2016, Volume: 16, Issue:1

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; CD4 Lymphocyte Count; Drug Combinations; Female; HIV Infec

2016
Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral regimens for virologically suppressed adults with HIV-1 infection: a randomised, active-controlled, multicentre, open-label, phase 3, non-inferiority study.
    The Lancet. Infectious diseases, 2016, Volume: 16, Issue:1

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; CD4 Lymphocyte Count; Drug Combinations; Female; HIV Infec

2016
Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral regimens for virologically suppressed adults with HIV-1 infection: a randomised, active-controlled, multicentre, open-label, phase 3, non-inferiority study.
    The Lancet. Infectious diseases, 2016, Volume: 16, Issue:1

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; CD4 Lymphocyte Count; Drug Combinations; Female; HIV Infec

2016
Brief Report: A Randomized, Double-Blind Comparison of Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate, Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine for Initial HIV-1 Treatment: Week 96 Results.
    Journal of acquired immune deficiency syndromes (1999), 2016, May-01, Volume: 72, Issue:1

    Topics: Adenine; Alanine; Albuminuria; Anti-HIV Agents; Bone Density; CD4 Lymphocyte Count; Cobicistat; Doub

2016
Brief Report: A Randomized, Double-Blind Comparison of Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate, Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine for Initial HIV-1 Treatment: Week 96 Results.
    Journal of acquired immune deficiency syndromes (1999), 2016, May-01, Volume: 72, Issue:1

    Topics: Adenine; Alanine; Albuminuria; Anti-HIV Agents; Bone Density; CD4 Lymphocyte Count; Cobicistat; Doub

2016
Brief Report: A Randomized, Double-Blind Comparison of Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate, Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine for Initial HIV-1 Treatment: Week 96 Results.
    Journal of acquired immune deficiency syndromes (1999), 2016, May-01, Volume: 72, Issue:1

    Topics: Adenine; Alanine; Albuminuria; Anti-HIV Agents; Bone Density; CD4 Lymphocyte Count; Cobicistat; Doub

2016
Brief Report: A Randomized, Double-Blind Comparison of Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate, Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine for Initial HIV-1 Treatment: Week 96 Results.
    Journal of acquired immune deficiency syndromes (1999), 2016, May-01, Volume: 72, Issue:1

    Topics: Adenine; Alanine; Albuminuria; Anti-HIV Agents; Bone Density; CD4 Lymphocyte Count; Cobicistat; Doub

2016
Rare emergence of drug resistance in HIV-1 treatment-naïve patients after 48 weeks of treatment with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide.
    HIV clinical trials, 2016, Volume: 17, Issue:2

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; CD4 Lymphocyte Count; Cobicistat; Drug Resistance, Viral;

2016
Rare emergence of drug resistance in HIV-1 treatment-naïve patients after 48 weeks of treatment with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide.
    HIV clinical trials, 2016, Volume: 17, Issue:2

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; CD4 Lymphocyte Count; Cobicistat; Drug Resistance, Viral;

2016
Rare emergence of drug resistance in HIV-1 treatment-naïve patients after 48 weeks of treatment with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide.
    HIV clinical trials, 2016, Volume: 17, Issue:2

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; CD4 Lymphocyte Count; Cobicistat; Drug Resistance, Viral;

2016
Rare emergence of drug resistance in HIV-1 treatment-naïve patients after 48 weeks of treatment with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide.
    HIV clinical trials, 2016, Volume: 17, Issue:2

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; CD4 Lymphocyte Count; Cobicistat; Drug Resistance, Viral;

2016
Efficacy and safety of tenofovir alafenamide versus tenofovir disoproxil fumarate given as fixed-dose combinations containing emtricitabine as backbones for treatment of HIV-1 infection in virologically suppressed adults: a randomised, double-blind, activ
    The lancet. HIV, 2016, Volume: 3, Issue:4

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Antiviral Agents; Double-Blind Method; Emtricitabine; Fema

2016
Brief Report: Efficacy and Safety of Switching to a Single-Tablet Regimen of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in HIV-1/Hepatitis B-Coinfected Adults.
    Journal of acquired immune deficiency syndromes (1999), 2016, 11-01, Volume: 73, Issue:3

    Topics: Adenine; Alanine; Anti-HIV Agents; Cobicistat; Coinfection; Drug Combinations; Drug Substitution; Em

2016
Equivalent Decline in Inflammation Markers with Tenofovir Disoproxil Fumarate vs. Tenofovir Alafenamide.
    EBioMedicine, 2016, Volume: 13

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Biomarkers; Comorbi

2016
Equivalent Decline in Inflammation Markers with Tenofovir Disoproxil Fumarate vs. Tenofovir Alafenamide.
    EBioMedicine, 2016, Volume: 13

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Biomarkers; Comorbi

2016
Equivalent Decline in Inflammation Markers with Tenofovir Disoproxil Fumarate vs. Tenofovir Alafenamide.
    EBioMedicine, 2016, Volume: 13

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Biomarkers; Comorbi

2016
Equivalent Decline in Inflammation Markers with Tenofovir Disoproxil Fumarate vs. Tenofovir Alafenamide.
    EBioMedicine, 2016, Volume: 13

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Biomarkers; Comorbi

2016
Safety, efficacy, and pharmacokinetics of a single-tablet regimen containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in treatment-naive, HIV-infected adolescents: a single-arm, open-label trial.
    The lancet. HIV, 2016, Volume: 3, Issue:12

    Topics: Adenine; Adolescent; Alanine; Anti-HIV Agents; Area Under Curve; CD4 Lymphocyte Count; Child; Cobici

2016
Bictegravir versus dolutegravir, each with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection: a randomised, double-blind, phase 2 trial.
    The lancet. HIV, 2017, Volume: 4, Issue:4

    Topics: Adenine; Adolescent; Adult; Alanine; Amides; Double-Blind Method; Drug Therapy, Combination; Emtrici

2017
Bictegravir versus dolutegravir, each with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection: a randomised, double-blind, phase 2 trial.
    The lancet. HIV, 2017, Volume: 4, Issue:4

    Topics: Adenine; Adolescent; Adult; Alanine; Amides; Double-Blind Method; Drug Therapy, Combination; Emtrici

2017
Bictegravir versus dolutegravir, each with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection: a randomised, double-blind, phase 2 trial.
    The lancet. HIV, 2017, Volume: 4, Issue:4

    Topics: Adenine; Adolescent; Adult; Alanine; Amides; Double-Blind Method; Drug Therapy, Combination; Emtrici

2017
Bictegravir versus dolutegravir, each with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection: a randomised, double-blind, phase 2 trial.
    The lancet. HIV, 2017, Volume: 4, Issue:4

    Topics: Adenine; Adolescent; Adult; Alanine; Amides; Double-Blind Method; Drug Therapy, Combination; Emtrici

2017
Bictegravir versus dolutegravir, each with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection: a randomised, double-blind, phase 2 trial.
    The lancet. HIV, 2017, Volume: 4, Issue:4

    Topics: Adenine; Adolescent; Adult; Alanine; Amides; Double-Blind Method; Drug Therapy, Combination; Emtrici

2017
Bictegravir versus dolutegravir, each with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection: a randomised, double-blind, phase 2 trial.
    The lancet. HIV, 2017, Volume: 4, Issue:4

    Topics: Adenine; Adolescent; Adult; Alanine; Amides; Double-Blind Method; Drug Therapy, Combination; Emtrici

2017
Bictegravir versus dolutegravir, each with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection: a randomised, double-blind, phase 2 trial.
    The lancet. HIV, 2017, Volume: 4, Issue:4

    Topics: Adenine; Adolescent; Adult; Alanine; Amides; Double-Blind Method; Drug Therapy, Combination; Emtrici

2017
Bictegravir versus dolutegravir, each with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection: a randomised, double-blind, phase 2 trial.
    The lancet. HIV, 2017, Volume: 4, Issue:4

    Topics: Adenine; Adolescent; Adult; Alanine; Amides; Double-Blind Method; Drug Therapy, Combination; Emtrici

2017
Bictegravir versus dolutegravir, each with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection: a randomised, double-blind, phase 2 trial.
    The lancet. HIV, 2017, Volume: 4, Issue:4

    Topics: Adenine; Adolescent; Adult; Alanine; Amides; Double-Blind Method; Drug Therapy, Combination; Emtrici

2017
Switching from efavirenz, emtricitabine, and tenofovir disoproxil fumarate to tenofovir alafenamide coformulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomised, double-blind, multicentre, phase 3b, non-i
    The lancet. HIV, 2017, Volume: 4, Issue:5

    Topics: Adenine; Adult; Alanine; Alkynes; Anti-HIV Agents; Benzoxazines; Cyclopropanes; Drug Therapy, Combin

2017
Switching from tenofovir disoproxil fumarate to tenofovir alafenamide coformulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomised, double-blind, multicentre, phase 3b, non-inferiority study.
    The lancet. HIV, 2017, Volume: 4, Issue:5

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Drug Therapy, Combination; Emtricitabine; Female; HIV Infe

2017
Switching from tenofovir disoproxil fumarate to tenofovir alafenamide coformulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomised, double-blind, multicentre, phase 3b, non-inferiority study.
    The lancet. HIV, 2017, Volume: 4, Issue:5

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Drug Therapy, Combination; Emtricitabine; Female; HIV Infe

2017
Switching from tenofovir disoproxil fumarate to tenofovir alafenamide coformulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomised, double-blind, multicentre, phase 3b, non-inferiority study.
    The lancet. HIV, 2017, Volume: 4, Issue:5

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Drug Therapy, Combination; Emtricitabine; Female; HIV Infe

2017
Switching from tenofovir disoproxil fumarate to tenofovir alafenamide coformulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomised, double-blind, multicentre, phase 3b, non-inferiority study.
    The lancet. HIV, 2017, Volume: 4, Issue:5

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Drug Therapy, Combination; Emtricitabine; Female; HIV Infe

2017
Brief Report: Long-Term (96-Week) Efficacy and Safety After Switching From Tenofovir Disoproxil Fumarate to Tenofovir Alafenamide in HIV-Infected, Virologically Suppressed Adults.
    Journal of acquired immune deficiency syndromes (1999), 2017, 06-01, Volume: 75, Issue:2

    Topics: Adenine; Alanine; Anti-HIV Agents; CD4 Lymphocyte Count; Double-Blind Method; HIV Infections; HIV-1;

2017
Brief Report: Randomized, Double-Blind Comparison of Tenofovir Alafenamide (TAF) vs Tenofovir Disoproxil Fumarate (TDF), Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine (E/C/F) for Initial HIV-1 Treatment: Week 144 Results.
    Journal of acquired immune deficiency syndromes (1999), 2017, 06-01, Volume: 75, Issue:2

    Topics: Adenine; Alanine; Anti-HIV Agents; Bone Density; CD4 Lymphocyte Count; Cobicistat; Double-Blind Meth

2017
Brief Report: Randomized, Double-Blind Comparison of Tenofovir Alafenamide (TAF) vs Tenofovir Disoproxil Fumarate (TDF), Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine (E/C/F) for Initial HIV-1 Treatment: Week 144 Results.
    Journal of acquired immune deficiency syndromes (1999), 2017, 06-01, Volume: 75, Issue:2

    Topics: Adenine; Alanine; Anti-HIV Agents; Bone Density; CD4 Lymphocyte Count; Cobicistat; Double-Blind Meth

2017
Brief Report: Randomized, Double-Blind Comparison of Tenofovir Alafenamide (TAF) vs Tenofovir Disoproxil Fumarate (TDF), Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine (E/C/F) for Initial HIV-1 Treatment: Week 144 Results.
    Journal of acquired immune deficiency syndromes (1999), 2017, 06-01, Volume: 75, Issue:2

    Topics: Adenine; Alanine; Anti-HIV Agents; Bone Density; CD4 Lymphocyte Count; Cobicistat; Double-Blind Meth

2017
Brief Report: Randomized, Double-Blind Comparison of Tenofovir Alafenamide (TAF) vs Tenofovir Disoproxil Fumarate (TDF), Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine (E/C/F) for Initial HIV-1 Treatment: Week 144 Results.
    Journal of acquired immune deficiency syndromes (1999), 2017, 06-01, Volume: 75, Issue:2

    Topics: Adenine; Alanine; Anti-HIV Agents; Bone Density; CD4 Lymphocyte Count; Cobicistat; Double-Blind Meth

2017
Insulin secretion in lipodystrophic HIV-infected patients is associated with high levels of nonglucose secretagogues and insulin resistance of beta-cells.
    American journal of physiology. Endocrinology and metabolism, 2004, Volume: 287, Issue:4

    Topics: Adipose Tissue; Adult; Alanine; Anthropometry; Blood Glucose; Body Composition; Body Mass Index; C-P

2004

Other Studies

196 other studies available for alanine and HIV Infections

ArticleYear
Impact of switch from tenofovir disoproxil fumarate-based regimens to tenofovir alafenamide-based regimens on lipid profile, weight gain and cardiovascular risk score in people living with HIV.
    BMC infectious diseases, 2021, Sep-06, Volume: 21, Issue:1

    Topics: Alanine; Anti-HIV Agents; Cardiovascular Diseases; Heart Disease Risk Factors; HIV Infections; Human

2021
Safety of Tenofovir Alafenamide in People With HIV Who Experienced Proximal Renal Tubulopathy on Tenofovir Disoproxil Fumarate.
    Journal of acquired immune deficiency syndromes (1999), 2021, 10-01, Volume: 88, Issue:2

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Creatinine; Cystatin C; Female; HIV Infections; Humans; Ki

2021
Cerebrospinal fluid exposure to bictegravir/emtricitabine/tenofovir in HIV-1-infected patients with CNS impairment.
    The Journal of antimicrobial chemotherapy, 2021, 11-12, Volume: 76, Issue:12

    Topics: Adenine; Aged; Alanine; Amides; Anti-HIV Agents; Chromatography, Liquid; Emtricitabine; Female; Hete

2021
Transformation of tenofovir into stable ProTide nanocrystals with long-acting pharmacokinetic profiles.
    Nature communications, 2021, 09-16, Volume: 12, Issue:1

    Topics: Adenine; Alanine; Animals; Anti-HIV Agents; Drug Stability; Female; HIV Infections; HIV-1; Humans; M

2021
Switch from Tenofovir Disoproxil Fumarate to Tenofovir Alafenamide in People Living with HIV: Lipid Changes and Statin Underutilization.
    Clinical drug investigation, 2021, Volume: 41, Issue:11

    Topics: Alanine; Anti-HIV Agents; HIV Infections; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Li

2021
Real-world efficacy and safety of switching to bictegravir/emtricitabine/tenofovir alafenamide in older people living with HIV.
    Medicine, 2021, Sep-24, Volume: 100, Issue:38

    Topics: Aged; Aged, 80 and over; Alanine; Drug Combinations; Drug Substitution; Emtricitabine; Female; HIV I

2021
Switching from efavirenz to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide reduces central nervous system symptoms in people living with HIV.
    Chinese medical journal, 2021, Oct-13, Volume: 134, Issue:23

    Topics: Adenine; Adult; Alanine; Alkynes; Anti-HIV Agents; Benzoxazines; Central Nervous System; Cobicistat;

2021
Analytical Lifecycle Management (ALM) and Analytical Quality by Design (AQbD) for analytical procedure development of related substances in tenofovir alafenamide fumarate tablets.
    Journal of pharmaceutical and biomedical analysis, 2022, Jan-05, Volume: 207

    Topics: Adenine; Alanine; Anti-HIV Agents; Chromatography, Liquid; Fumarates; HIV Infections; Humans; Tablet

2022
Crushed bictegravir/emtricitabine/tenofovir alafenamide in a human immunodeficiency virus-positive patient with pancreatic cancer.
    International journal of STD & AIDS, 2022, Volume: 33, Issue:1

    Topics: Adenine; Aged; Alanine; Amides; Anti-HIV Agents; Emtricitabine; Heterocyclic Compounds, 3-Ring; HIV;

2022
Short-course daily isoniazid and rifapentine for latent tuberculosis infection in people living with HIV who received coformulated bictegravir/emtricitabine/tenofovir alafenamide.
    Journal of the International AIDS Society, 2021, Volume: 24, Issue:11

    Topics: Adenine; Alanine; Amides; Anti-HIV Agents; Emtricitabine; Heterocyclic Compounds, 3-Ring; HIV Infect

2021
Tenofovir Alafenamide Plasma Concentrations Are Reduced in Pregnant Women Living With Human Immunodeficiency Virus (HIV): Data From the PANNA Network.
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2022, 09-10, Volume: 75, Issue:4

    Topics: Adenine; Alanine; Anti-HIV Agents; Female; HIV; HIV Infections; Humans; Pregnancy; Pregnant Women; T

2022
Weight gain in treatment-naive HIV-1 infected patients starting abacavir/lamivudine/dolutegravir or tenofovir alafenamide/emtricitabine/bictegravir.
    AIDS (London, England), 2022, 01-01, Volume: 36, Issue:1

    Topics: Alanine; Amides; Anti-HIV Agents; Dideoxynucleosides; Emtricitabine; Heterocyclic Compounds, 3-Ring;

2022
Renal function in Japanese HIV-1-positive patients who switch to tenofovir alafenamide fumarate after long-term tenofovir disoproxil fumarate: a single-center observational study.
    AIDS research and therapy, 2021, 12-07, Volume: 18, Issue:1

    Topics: Alanine; Anti-HIV Agents; Fumarates; HIV Infections; HIV-1; Humans; Japan; Kidney; Tenofovir

2021
Effect of switching from tenofovir disoproxil fumarate to tenofovir alafenamide on estimated glomerular filtration rate slope in patients with HIV: A retrospective observational study.
    Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy, 2022, Volume: 28, Issue:3

    Topics: Alanine; Anti-HIV Agents; Fumarates; Glomerular Filtration Rate; HIV Infections; Humans; Retrospecti

2022
Safety and Tolerability of Once Daily Coformulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide for Postexposure Prophylaxis After Sexual Exposure.
    Journal of acquired immune deficiency syndromes (1999), 2022, 05-01, Volume: 90, Issue:1

    Topics: Adenine; Alanine; Amides; Anti-HIV Agents; Emtricitabine; Fatigue; Female; Heterocyclic Compounds, 3

2022
Point-of-care semi-quantitative test for adherence to tenofovir alafenamide or tenofovir disoproxil fumarate.
    The Journal of antimicrobial chemotherapy, 2022, 03-31, Volume: 77, Issue:4

    Topics: Adult; Alanine; Anti-HIV Agents; Emtricitabine; HIV Infections; HIV-1; Humans; Point-of-Care Systems

2022
Real-life experience with bictegravir/emtricitabine/tenofovir alafenamide in a large reference clinical centre.
    The Journal of antimicrobial chemotherapy, 2022, 03-31, Volume: 77, Issue:4

    Topics: Adult; Alanine; Amides; Anti-HIV Agents; Emtricitabine; Heterocyclic Compounds, 3-Ring; HIV Infectio

2022
Current Antiretroviral Treatment Among People With Human Immunodeficiency Virus in the United States: Findings from the Centers for AIDS Research Network of Integrated Clinic Systems Cohort.
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2022, 09-10, Volume: 75, Issue:4

    Topics: Acquired Immunodeficiency Syndrome; Alanine; Anti-HIV Agents; Anti-Retroviral Agents; Emtricitabine;

2022
Tenofovir alafenamide: An initial experience at Groote Schuur Hospital, Cape Town, South Africa.
    South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde, 2022, Feb-01, Volume: 112, Issue:2

    Topics: Adult; Alanine; Antiviral Agents; Female; Follow-Up Studies; Glomerular Filtration Rate; Hepatitis B

2022
Pharmacokinetics of Tenofovir Alafenamide With Boosted Protease Inhibitors in Pregnant and Postpartum Women Living With HIV: Results From IMPAACT P1026s.
    Journal of acquired immune deficiency syndromes (1999), 2022, 07-01, Volume: 90, Issue:3

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Antiviral Agents; Female; HIV Infections; Humans; Postpart

2022
Plasma d-amino acids are associated with markers of immune activation and organ dysfunction in people with HIV.
    AIDS (London, England), 2022, 06-01, Volume: 36, Issue:7

    Topics: Alanine; Amino Acids; Asparagine; Biomarkers; HIV Infections; Humans; Multiple Organ Failure; Prolin

2022
High efficacy of switching to bictegravir/emtricitabine/tenofovir alafenamide in people with suppressed HIV and preexisting M184V/I.
    AIDS (London, England), 2022, 09-01, Volume: 36, Issue:11

    Topics: Adenine; Adult; Alanine; Amides; Anti-HIV Agents; Clinical Trials as Topic; Drug Combinations; Emtri

2022
Bictegravir-based antiretroviral therapy in HIV-1 group O patients: data from real-life bictegravir/emtricitabine/tenofovir alafenamide switches.
    The Journal of antimicrobial chemotherapy, 2022, 07-28, Volume: 77, Issue:8

    Topics: Alanine; Amides; Anti-HIV Agents; Emtricitabine; Heterocyclic Compounds, 3-Ring; HIV Infections; HIV

2022
Tenofovir alafenamide fumarate.
    Antiviral therapy, 2022, Volume: 27, Issue:2

    Topics: Adenine; Alanine; Anti-HIV Agents; Fumarates; HIV Infections; HIV-1; Humans; Tenofovir

2022
Fundamental aspects of long-acting tenofovir alafenamide delivery from subdermal implants for HIV prophylaxis.
    Scientific reports, 2022, 05-17, Volume: 12, Issue:1

    Topics: Adenine; Alanine; Animals; Anti-HIV Agents; Female; HIV Infections; Mice; Tenofovir

2022
Plasma and breast milk pharmacokinetics of tenofovir alafenamide in mothers with chronic hepatitis B infection.
    Alimentary pharmacology & therapeutics, 2022, Volume: 56, Issue:3

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Female; Hepatitis B; Hepatitis B, Chronic; HIV Infections;

2022
[Real-world efficacy of switching to bictegravir/ emtricitabine/tenofovir alafenamide in pretreated patients with triple therapy containing rilpivirine].
    Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia, 2022, Volume: 35, Issue:4

    Topics: Adenine; Alanine; Amides; Anti-HIV Agents; Drug Combinations; Emtricitabine; Heterocyclic Compounds,

2022
Weight changes in patients with sustained viral suppression switching tenofovir disoproxil fumarate to tenofovir alafenamide.
    Obesity (Silver Spring, Md.), 2022, Volume: 30, Issue:6

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Cardiovascular Diseases; Cholesterol; Drug Substitution; F

2022
Switching from tenofovir alafenamide to tenofovir disoproxil fumarate improves lipid profile and protects from weight gain.
    AIDS (London, England), 2022, 08-01, Volume: 36, Issue:10

    Topics: Alanine; Anti-HIV Agents; Cholesterol, LDL; Drug Substitution; HIV Infections; Humans; Retrospective

2022
HERACLIS-TAF: a multi-centre prospective cohort study on 2-year safety and efficacy of tenofovir alafenamide in patients with chronic hepatitis B with renal and/or bone disorders or risks.
    Alimentary pharmacology & therapeutics, 2022, Volume: 56, Issue:4

    Topics: Adenine; Adult; Alanine; Hepatitis B, Chronic; HIV Infections; Humans; Phosphates; Prospective Studi

2022
Switching from a Non-Protease inhibitor-Based Regimen To the Fixed Dose Combination of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in Clinical Practice.
    Drug design, development and therapy, 2022, Volume: 16

    Topics: Alanine; Anti-HIV Agents; Cobicistat; Darunavir; Emtricitabine; Female; HIV Infections; HIV-1; Human

2022
Low-level viraemia and virologic failure among people living with HIV who received maintenance therapy with co-formulated bictegravir, emtricitabine and tenofovir alafenamide versus dolutegravir-based regimens.
    International journal of antimicrobial agents, 2022, Volume: 60, Issue:3

    Topics: Adenine; Alanine; Amides; Anti-HIV Agents; Emtricitabine; Heterocyclic Compounds, 3-Ring; Heterocycl

2022
HBV in pregnancy: time to consider tenofovir alafenamide (TAF).
    Hepatology international, 2022, Volume: 16, Issue:4

    Topics: Adenine; Alanine; Female; Hepatitis B virus; HIV Infections; Humans; Pregnancy; Tenofovir

2022
Bictegravir/emtricitabine/tenofovir alafenamide ensures high rates of virological suppression maintenance despite previous resistance in PLWH who optimize treatment in clinical practice.
    Journal of global antimicrobial resistance, 2022, Volume: 30

    Topics: Adenine; Alanine; Amides; Anti-HIV Agents; Drug Combinations; Emtricitabine; Heterocyclic Compounds,

2022
Plasma and breast milk pharmacokinetics of tenofovir alafenamide in mothers with chronic hepatitis B infection.
    Alimentary pharmacology & therapeutics, 2022, Volume: 56, Issue:3

    Topics: Adenine; Alanine; Antiviral Agents; Female; Hepatitis B, Chronic; HIV Infections; Humans; Milk, Huma

2022
MX2 Viral Substrate Breadth and Inhibitory Activity Are Regulated by Protein Phosphorylation.
    mBio, 2022, 08-30, Volume: 13, Issue:4

    Topics: Alanine; Animals; Antiviral Agents; Aspartic Acid; Capsid Proteins; DNA, Viral; HIV Infections; HIV-

2022
Safety and efficacy of a biodegradable implant releasing tenofovir alafenamide for vaginal protection in a macaque model.
    The Journal of antimicrobial chemotherapy, 2022, 10-28, Volume: 77, Issue:11

    Topics: Absorbable Implants; Alanine; Animals; Anti-HIV Agents; Emtricitabine; Female; HIV; HIV Infections;

2022
Effect of alcohol exposure on the efficacy and safety of tenofovir alafenamide fumarate, a major medicine against human immunodeficiency virus.
    Biochemical pharmacology, 2022, Volume: 204

    Topics: Adenine; Alanine; Alcohol Drinking; Anti-HIV Agents; Carboxylic Ester Hydrolases; Chromatography, Li

2022
Higher Risk of Dyslipidemia With Coformulated Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide than Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate Among Antiretroviral-Naive People Living With HIV in China.
    Journal of acquired immune deficiency syndromes (1999), 2022, 10-01, Volume: 91, Issue:S1

    Topics: Adenine; Alanine; Alkynes; Anti-HIV Agents; Anti-Retroviral Agents; Benzoxazines; Cholesterol, LDL;

2022
Urine Tenofovir Levels Strongly Correlate With Virologic Suppression in Patients With Human Immunodeficiency Virus on Tenofovir Alafenamide-Based Antiretroviral Therapy.
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2023, 03-04, Volume: 76, Issue:5

    Topics: Adenine; Alanine; Anti-HIV Agents; HIV Infections; HIV-1; Humans; Tenofovir

2023
Brief Report: Effect of Antiretroviral Switch From Tenofovir Disoproxil fumarate to Tenofovir Alafenamide on Alanine Aminotransferase, Lipid Profiles, and Renal Function in HIV/HBV-Coinfected Individuals in a Nationwide Canadian Study.
    Journal of acquired immune deficiency syndromes (1999), 2022, 12-01, Volume: 91, Issue:4

    Topics: Adenine; Alanine; Alanine Transaminase; Anti-Retroviral Agents; Canada; Cholesterol; Coinfection; He

2022
Pharmacokinetics and efficacy of topical inserts containing tenofovir alafenamide fumarate and elvitegravir administered rectally in macaques.
    EBioMedicine, 2022, Volume: 86

    Topics: Alanine; Animals; Anti-HIV Agents; Female; Fumarates; HIV Infections; Leukocytes, Mononuclear; Macac

2022
Switching to coformulated bictegravir, emtricitabine, and tenofovir alafenamide maintained viral suppression in adults with historical virological failures and K65N/R mutation.
    International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases, 2023, Volume: 126

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Drug Combinations; Emtricitabine; Heterocyclic Compounds,

2023
Switching to coformulated bictegravir, emtricitabine, and tenofovir alafenamide maintained viral suppression in adults with historical virological failures and K65N/R mutation.
    International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases, 2023, Volume: 126

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Drug Combinations; Emtricitabine; Heterocyclic Compounds,

2023
Switching to coformulated bictegravir, emtricitabine, and tenofovir alafenamide maintained viral suppression in adults with historical virological failures and K65N/R mutation.
    International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases, 2023, Volume: 126

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Drug Combinations; Emtricitabine; Heterocyclic Compounds,

2023
Switching to coformulated bictegravir, emtricitabine, and tenofovir alafenamide maintained viral suppression in adults with historical virological failures and K65N/R mutation.
    International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases, 2023, Volume: 126

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Drug Combinations; Emtricitabine; Heterocyclic Compounds,

2023
Switching to coformulated bictegravir, emtricitabine, and tenofovir alafenamide maintained viral suppression in adults with historical virological failures and K65N/R mutation.
    International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases, 2023, Volume: 126

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Drug Combinations; Emtricitabine; Heterocyclic Compounds,

2023
Switching to coformulated bictegravir, emtricitabine, and tenofovir alafenamide maintained viral suppression in adults with historical virological failures and K65N/R mutation.
    International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases, 2023, Volume: 126

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Drug Combinations; Emtricitabine; Heterocyclic Compounds,

2023
Switching to coformulated bictegravir, emtricitabine, and tenofovir alafenamide maintained viral suppression in adults with historical virological failures and K65N/R mutation.
    International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases, 2023, Volume: 126

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Drug Combinations; Emtricitabine; Heterocyclic Compounds,

2023
Switching to coformulated bictegravir, emtricitabine, and tenofovir alafenamide maintained viral suppression in adults with historical virological failures and K65N/R mutation.
    International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases, 2023, Volume: 126

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Drug Combinations; Emtricitabine; Heterocyclic Compounds,

2023
Switching to coformulated bictegravir, emtricitabine, and tenofovir alafenamide maintained viral suppression in adults with historical virological failures and K65N/R mutation.
    International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases, 2023, Volume: 126

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Drug Combinations; Emtricitabine; Heterocyclic Compounds,

2023
Preclinical Considerations for Long-acting Delivery of Tenofovir Alafenamide from Subdermal Implants for HIV Pre-exposure Prophylaxis.
    Pharmaceutical research, 2023, Volume: 40, Issue:7

    Topics: Adenine; Alanine; Animals; Anti-HIV Agents; Dogs; HIV Infections; Mice; Mice, Inbred C57BL; Pre-Expo

2023
Preclinical Considerations for Long-acting Delivery of Tenofovir Alafenamide from Subdermal Implants for HIV Pre-exposure Prophylaxis.
    Pharmaceutical research, 2023, Volume: 40, Issue:7

    Topics: Adenine; Alanine; Animals; Anti-HIV Agents; Dogs; HIV Infections; Mice; Mice, Inbred C57BL; Pre-Expo

2023
Preclinical Considerations for Long-acting Delivery of Tenofovir Alafenamide from Subdermal Implants for HIV Pre-exposure Prophylaxis.
    Pharmaceutical research, 2023, Volume: 40, Issue:7

    Topics: Adenine; Alanine; Animals; Anti-HIV Agents; Dogs; HIV Infections; Mice; Mice, Inbred C57BL; Pre-Expo

2023
Preclinical Considerations for Long-acting Delivery of Tenofovir Alafenamide from Subdermal Implants for HIV Pre-exposure Prophylaxis.
    Pharmaceutical research, 2023, Volume: 40, Issue:7

    Topics: Adenine; Alanine; Animals; Anti-HIV Agents; Dogs; HIV Infections; Mice; Mice, Inbred C57BL; Pre-Expo

2023
Preclinical Considerations for Long-acting Delivery of Tenofovir Alafenamide from Subdermal Implants for HIV Pre-exposure Prophylaxis.
    Pharmaceutical research, 2023, Volume: 40, Issue:7

    Topics: Adenine; Alanine; Animals; Anti-HIV Agents; Dogs; HIV Infections; Mice; Mice, Inbred C57BL; Pre-Expo

2023
Preclinical Considerations for Long-acting Delivery of Tenofovir Alafenamide from Subdermal Implants for HIV Pre-exposure Prophylaxis.
    Pharmaceutical research, 2023, Volume: 40, Issue:7

    Topics: Adenine; Alanine; Animals; Anti-HIV Agents; Dogs; HIV Infections; Mice; Mice, Inbred C57BL; Pre-Expo

2023
Preclinical Considerations for Long-acting Delivery of Tenofovir Alafenamide from Subdermal Implants for HIV Pre-exposure Prophylaxis.
    Pharmaceutical research, 2023, Volume: 40, Issue:7

    Topics: Adenine; Alanine; Animals; Anti-HIV Agents; Dogs; HIV Infections; Mice; Mice, Inbred C57BL; Pre-Expo

2023
Preclinical Considerations for Long-acting Delivery of Tenofovir Alafenamide from Subdermal Implants for HIV Pre-exposure Prophylaxis.
    Pharmaceutical research, 2023, Volume: 40, Issue:7

    Topics: Adenine; Alanine; Animals; Anti-HIV Agents; Dogs; HIV Infections; Mice; Mice, Inbred C57BL; Pre-Expo

2023
Preclinical Considerations for Long-acting Delivery of Tenofovir Alafenamide from Subdermal Implants for HIV Pre-exposure Prophylaxis.
    Pharmaceutical research, 2023, Volume: 40, Issue:7

    Topics: Adenine; Alanine; Animals; Anti-HIV Agents; Dogs; HIV Infections; Mice; Mice, Inbred C57BL; Pre-Expo

2023
Same-day initiation of bictegravir/emtricitabine/tenofovir alafenamide: Week 48 results of the FAST study-IMEA 055.
    The Journal of antimicrobial chemotherapy, 2023, 03-02, Volume: 78, Issue:3

    Topics: Adenine; Alanine; Anti-HIV Agents; Drug Combinations; Emtricitabine; Heterocyclic Compounds, 4 or Mo

2023
Preliminary Evaluation of Stability Data for Dolutegravir-Containing Triple Active Formulations Intended for PEPFAR. Degradation of Tenofovir Disoproxil Fumarate and Tenofovir Alafenamide as the Limiting Factor.
    Journal of pharmaceutical sciences, 2023, Volume: 112, Issue:6

    Topics: Adenine; Alanine; Anti-HIV Agents; HIV Infections; Humans; Hygroscopic Agents; Tablets; Tenofovir

2023
Healthcare Resource Consumption and Related Costs in Patients on Antiretroviral Therapies: Findings from Real-World Data in Italy.
    International journal of environmental research and public health, 2023, 02-21, Volume: 20, Issue:5

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Health Care Costs; Health Expenditures; HIV Infections; Hu

2023
Population pharmacokinetic modelling to characterize the effect of chronic kidney disease on tenofovir exposure after tenofovir alafenamide administration.
    The Journal of antimicrobial chemotherapy, 2023, 06-01, Volume: 78, Issue:6

    Topics: Adenine; Alanine; Anti-HIV Agents; HIV Infections; Humans; Renal Insufficiency, Chronic; Tenofovir

2023
Changes in local tissue microenvironment in response to subcutaneous long-acting delivery of tenofovir alafenamide in rats and non-human primates.
    Journal of controlled release : official journal of the Controlled Release Society, 2023, Volume: 358

    Topics: Adenine; Alanine; Animals; Anti-HIV Agents; HIV Infections; Macaca mulatta; Rats; Rats, Sprague-Dawl

2023
Antiviral activity of tenofovir alafenamide (TAF) against HIV-1 clinical isolates harboring K65R.
    Journal of medical virology, 2023, Volume: 95, Issue:4

    Topics: Alanine; Anti-HIV Agents; HIV Infections; HIV Seropositivity; HIV-1; Humans; Prodrugs; Reverse Trans

2023
High rates of kidney impairment among older people (≥ 60 years) living with HIV on first-line antiretroviral therapy at screening for a clinical trial in Kenya.
    PloS one, 2023, Volume: 18, Issue:6

    Topics: Adenine; Aged; Aged, 80 and over; Alanine; Anti-HIV Agents; Anti-Retroviral Agents; Emtricitabine; F

2023
No evidence of rapid reversibility of tenofovir alafenamide and/or integrase strand transfer inhibitor-associated weight gain.
    AIDS (London, England), 2023, 10-01, Volume: 37, Issue:12

    Topics: Adult; Alanine; Anti-Retroviral Agents; Drug Therapy, Combination; Female; HIV Infections; Humans; M

2023
Real-life safety of Emtricitabine/Tenofovir Alafenamide/Bictegravir.
    PloS one, 2023, Volume: 18, Issue:8

    Topics: Alanine; Anti-HIV Agents; Anti-Retroviral Agents; Emtricitabine; Female; Heterocyclic Compounds, 3-R

2023
Effect of P-glycoprotein and Cotreatment with Sofosbuvir on the Intestinal Permeation of Tenofovir Disoproxil Fumarate and Tenofovir Alafenamide Fumarate.
    Pharmaceutical research, 2023, Volume: 40, Issue:9

    Topics: Adenine; Alanine; Anti-HIV Agents; ATP Binding Cassette Transporter, Subfamily B; ATP Binding Casset

2023
Effectiveness, durability and safety of dolutegravir and lamivudine versus bictegravir, emtricitabine and tenofovir alafenamide in a real-world cohort of HIV-infected adults.
    PloS one, 2023, Volume: 18, Issue:9

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Emtricitabine; Heterocyclic Compounds, 3-Ring; Heterocycli

2023
Switching to Tenofovir Alafenamide in Elvitegravir-Based Regimens: Pharmacokinetics and Antiviral Activity in Cerebrospinal Fluid.
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020, 08-14, Volume: 71, Issue:4

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Emtricitabine; HIV Infections; Humans; Quinolones; Tenofov

2020
Switching antiretrovirals in older patients.
    The lancet. HIV, 2019, Volume: 6, Issue:10

    Topics: Adenine; Aged; Alanine; Bone Density; Cobicistat; Emtricitabine; HIV Infections; HIV-1; Humans; Midd

2019
Rates and predictors of switching to tenofovir alafenamide-containing ART in a nationwide cohort.
    BMC infectious diseases, 2019, Oct-10, Volume: 19, Issue:1

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; CD4 Lymphocyte Count; Cohort Studies; Drug Interactions; F

2019
Fevers and Night Sweats in a 35-year-old Man With Recent Travel to Southeast Asia.
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2019, 10-15, Volume: 69, Issue:9

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Asia, Southeastern; Cobicistat; Emtricitabine; HIV Infecti

2019
HIV 101: fundamentals of antiretroviral therapy.
    Topics in antiviral medicine, 2019, Volume: 27, Issue:3

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Anti-Retroviral Agents; Antiretroviral Therapy, Highly Act

2019
Where Were the Women? Gender Parity in Clinical Trials.
    The New England journal of medicine, 2019, Dec-26, Volume: 381, Issue:26

    Topics: Adenine; Alanine; Anti-HIV Agents; Clinical Trials as Topic; Drug Approval; Drug Combinations; Emtri

2019
Decreased levels of urinary liver-type fatty acid-binding protein after switching from tenofovir disoproxil fumarate to tenofovir alafenamide: a prospective observational study.
    International journal of STD & AIDS, 2019, Volume: 30, Issue:13

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Antiviral Agents; beta 2-Microglobulin; Biomarkers; CD4 Ly

2019
Reversible effect on lipids by switching from tenofovir disoproxil fumarate to tenofovir alafenamide and back.
    AIDS (London, England), 2019, 12-01, Volume: 33, Issue:15

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Cholesterol; Drug Substitution; Female; Germany; HIV Infec

2019
Renal function change after switching tenofovir disoproxil fumarate for tenofovir alafenamide in the HIV-positive patients of a metropolitan sexual health service.
    AIDS research and therapy, 2019, 12-07, Volume: 16, Issue:1

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Drug Substitution; Female; Glomerular Filtration Rate; HIV

2019
Response to Noe, Oldenbuettel and Jaeger.
    HIV medicine, 2020, Volume: 21, Issue:6

    Topics: Adenine; Alanine; HIV Infections; Humans; Tenofovir

2020
A Subcutaneous Implant of Tenofovir Alafenamide Fumarate Causes Local Inflammation and Tissue Necrosis in Rabbits and Macaques.
    Antimicrobial agents and chemotherapy, 2020, 02-21, Volume: 64, Issue:3

    Topics: Adenine; Alanine; Animals; Anti-HIV Agents; Delayed-Action Preparations; Drug Implants; Female; Fuma

2020
Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in a Rapid-Initiation Model of Care for Human Immunodeficiency Virus Type 1 Infection: Primary Analysis of the DIAMOND Study.
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020, 12-15, Volume: 71, Issue:12

    Topics: Adenine; Adolescent; Adult; Aged; Alanine; Anti-HIV Agents; Cobicistat; Darunavir; Diamond; Drug Com

2020
Not all is perfect with Tenofovir alafenamide.
    HIV medicine, 2020, Volume: 21, Issue:6

    Topics: Adenine; Alanine; HIV Infections; Humans; Tenofovir

2020
Tenofovir Alafenamide for HIV Preexposure Prophylaxis: What Can We DISCOVER About Its True Value?
    Annals of internal medicine, 2020, 02-18, Volume: 172, Issue:4

    Topics: Adenine; Alanine; Anti-HIV Agents; Female; HIV Infections; Humans; Male; Pre-Exposure Prophylaxis; T

2020
Failure to bictegravir and development of resistance mutations in an antiretroviral-experienced patient.
    Antiviral research, 2020, Volume: 179

    Topics: Adenine; Adult; Alanine; Amides; Anti-HIV Agents; Drug Resistance, Viral; Drug Therapy, Combination;

2020
Sustained virologic suppression with abacavir, emtricitabine, and crushed dolutegravir and tenofovir alafenamide in a patient with HIV and eosinophilic esophagitis.
    International journal of STD & AIDS, 2020, Volume: 31, Issue:3

    Topics: Adult; Alanine; Anti-HIV Agents; Deglutition Disorders; Dideoxynucleosides; Drug Therapy, Combinatio

2020
Development of gynecomastia following initiation of bictegravir/emtricitabine/tenofovir alafenamide.
    International journal of STD & AIDS, 2020, Volume: 31, Issue:4

    Topics: Adenine; Adult; Alanine; Amides; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; CD4 Lymphoc

2020
Switching tenofovir disoproxil fumarate to tenofovir alafenamide in a real life setting: what are the implications?
    HIV medicine, 2020, Volume: 21, Issue:6

    Topics: Age Factors; Alanine; Albuminuria; Cholesterol, LDL; Drug Substitution; Female; HIV Infections; Huma

2020
Therapeutic options for the 2019 novel coronavirus (2019-nCoV).
    Nature reviews. Drug discovery, 2020, Volume: 19, Issue:3

    Topics: Adenosine Monophosphate; Alanine; Antiviral Agents; Betacoronavirus; Coronavirus Infections; COVID-1

2020
Therapeutic options for the 2019 novel coronavirus (2019-nCoV).
    Nature reviews. Drug discovery, 2020, Volume: 19, Issue:3

    Topics: Adenosine Monophosphate; Alanine; Antiviral Agents; Betacoronavirus; Coronavirus Infections; COVID-1

2020
Therapeutic options for the 2019 novel coronavirus (2019-nCoV).
    Nature reviews. Drug discovery, 2020, Volume: 19, Issue:3

    Topics: Adenosine Monophosphate; Alanine; Antiviral Agents; Betacoronavirus; Coronavirus Infections; COVID-1

2020
Therapeutic options for the 2019 novel coronavirus (2019-nCoV).
    Nature reviews. Drug discovery, 2020, Volume: 19, Issue:3

    Topics: Adenosine Monophosphate; Alanine; Antiviral Agents; Betacoronavirus; Coronavirus Infections; COVID-1

2020
How Much Are We Willing to Pay for Preexposure Prophylaxis in the United States?
    Annals of internal medicine, 2020, 05-05, Volume: 172, Issue:9

    Topics: Adenine; Alanine; Anti-HIV Agents; Cost-Benefit Analysis; Decision Making, Shared; Emtricitabine, Te

2020
Changes in Renal Function After Switching From TDF to TAF in HIV-Infected Individuals: A Prospective Cohort Study.
    The Journal of infectious diseases, 2020, 07-23, Volume: 222, Issue:4

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Drug Substitution; Female; Glomerular Filtration Rate; HIV

2020
Crushed bictegravir/emtricitabine/tenofovir alafenamide in a human immunodeficiency virus-positive patient with esophageal cancer.
    American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists, 2020, 03-24, Volume: 77, Issue:7

    Topics: Adenine; Alanine; Anti-HIV Agents; Drug Combinations; Emtricitabine; Esophageal Neoplasms; Gastrosto

2020
The switch from tenofovir disoproxil fumarate to tenofovir alafenamide determines weight gain in patients on rilpivirine-based regimen.
    AIDS (London, England), 2020, 05-01, Volume: 34, Issue:6

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Emtricitabine; Female; Fumarates; HIV Infections; HIV-1; H

2020
Investigating the effect of antiretroviral switch to tenofovir alafenamide on lipid profiles in people living with HIV.
    AIDS (London, England), 2020, 07-01, Volume: 34, Issue:8

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Cholesterol; Cholesterol, LDL; Cohort Studies; Female; HIV

2020
The Lymphoid Tissue Pharmacokinetics of Tenofovir Disoproxil Fumarate and Tenofovir Alafenamide in HIV-Infected Persons.
    Clinical pharmacology and therapeutics, 2020, Volume: 108, Issue:5

    Topics: Adenine; Alanine; Anti-HIV Agents; CD4 Lymphocyte Count; Drug Monitoring; Drug Substitution; Drug Th

2020
Management Consideration in Drug-Induced Lactic Acidosis.
    Clinical journal of the American Society of Nephrology : CJASN, 2020, 10-07, Volume: 15, Issue:10

    Topics: Acidosis, Lactic; Acute Kidney Injury; Aged; Alanine; Continuous Renal Replacement Therapy; Diabetes

2020
Satisfaction and knowledge among patients with HIV after switching from tenofovir to tenofovir alafenamide in regimens containing emtricitabine and rilpivirine
    Biomedica : revista del Instituto Nacional de Salud, 2020, 05-01, Volume: 40, Issue:Supl. 1

    Topics: Adenine; Adult; Alanine; Antiviral Agents; Drug Combinations; Drug Substitution; Emtricitabine; Fema

2020
Previously unreported emergence of A265V substitution in the integrase gene in association with bictegravir virological failure.
    International journal of antimicrobial agents, 2020, Volume: 56, Issue:2

    Topics: Adenine; Aged; Alanine; Amides; Cell Line; Drug Resistance, Viral; Drug Therapy, Combination; Emtric

2020
Weighing considerations with newer antiretrovirals.
    The lancet. HIV, 2020, Volume: 7, Issue:6

    Topics: Adenine; Alanine; Amides; Double-Blind Method; Emtricitabine; Heterocyclic Compounds, 3-Ring; Hetero

2020
Tenofovir Alafenamide Fumarate Therapy for HIV Treatment: Cardiometabolic and Renal Safety.
    AIDS research and human retroviruses, 2020, Volume: 36, Issue:9

    Topics: Alanine; Anti-HIV Agents; Cardiovascular Diseases; Female; Fumarates; HIV Infections; Humans; Kidney

2020
Interspecies Differences in Tenofovir Alafenamide Fumarate Stability in Plasma.
    Antimicrobial agents and chemotherapy, 2020, 08-20, Volume: 64, Issue:9

    Topics: Adenine; Alanine; Animals; Anti-HIV Agents; Dogs; Fumarates; HIV Infections; Rabbits; Sheep; Tenofov

2020
Cases of coronavirus disease-2019 in HIV-infected transgender women.
    AIDS (London, England), 2020, 07-15, Volume: 34, Issue:9

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Antiviral Agents; Betacoronavirus; Coronavirus Infections;

2020
Severe rhabdomyolysis and acute asymptomatic pancreatitis following the concomitant use of Biktarvy in the setting of hyperosmolar diabetic crisis.
    BMJ case reports, 2020, Jul-01, Volume: 13, Issue:7

    Topics: Adenine; Alanine; Anti-HIV Agents; Cholangiopancreatography, Magnetic Resonance; Diabetes Mellitus;

2020
Tenofovir Alafenamide for HIV Preexposure Prophylaxis.
    Annals of internal medicine, 2020, 07-07, Volume: 173, Issue:1

    Topics: Adenine; Alanine; HIV Infections; Humans; Pre-Exposure Prophylaxis; Tenofovir

2020
Tenofovir Alafenamide for HIV Preexposure Prophylaxis.
    Annals of internal medicine, 2020, 07-07, Volume: 173, Issue:1

    Topics: Adenine; Alanine; HIV Infections; Humans; Pre-Exposure Prophylaxis; Tenofovir

2020
Bictegravir/emtricitabine/tenofovir alafenamide-induced acute pancreatitis: a case report.
    International journal of STD & AIDS, 2020, Volume: 31, Issue:10

    Topics: Acute Disease; Adenine; Adult; Alanine; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Drug

2020
DISCOVER: much accomplished, but not yet for all.
    Lancet (London, England), 2020, 07-25, Volume: 396, Issue:10246

    Topics: Adenine; Alanine; Double-Blind Method; Emtricitabine; HIV Infections; Humans; Pre-Exposure Prophylax

2020
Impact of archived M184V/I mutation on the effectiveness of switch to co-formulated elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide among virally suppressed people living with HIV.
    The Journal of antimicrobial chemotherapy, 2020, 10-01, Volume: 75, Issue:10

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Cobicistat; Emtricitabine; HIV Infections; HIV-1; Humans;

2020
Pharmacokinetics and renal safety of tenofovir alafenamide with boosted protease inhibitors and ledipasvir/sofosbuvir.
    The Journal of antimicrobial chemotherapy, 2020, 11-01, Volume: 75, Issue:11

    Topics: Adenine; Alanine; Anti-HIV Agents; Benzimidazoles; Fluorenes; HIV Infections; Humans; Protease Inhib

2020
Renal proximal tubulopathy in an HIV-infected patient treated with tenofovir alafenamide and gentamicin: a case report.
    BMC nephrology, 2020, 08-12, Volume: 21, Issue:1

    Topics: Acute Disease; Alanine; Anti-Bacterial Agents; Antineoplastic Combined Chemotherapy Protocols; Antiv

2020
Successful Bictegravir/Emtricitabine/Tenofovir Alafenamide Treatment in a HIV Patient With Swallowing Difficulties.
    The Annals of pharmacotherapy, 2021, Volume: 55, Issue:4

    Topics: Adenine; Alanine; Amides; Anti-HIV Agents; Deglutition; Drug Combinations; Emtricitabine; Female; Fr

2021
It Ain't Over Till It's Over: The Triple Threat of COVID-19, TB, and HIV.
    The American journal of tropical medicine and hygiene, 2020, Volume: 103, Issue:4

    Topics: Adenosine Monophosphate; Alanine; Antitubercular Agents; Antiviral Agents; Betacoronavirus; Coinfect

2020
Brief Report: Switching From TDF to TAF in HIV/HBV-Coinfected Individuals With Renal Dysfunction-A Prospective Cohort Study.
    Journal of acquired immune deficiency syndromes (1999), 2020, 10-01, Volume: 85, Issue:2

    Topics: Adenine; Aged; Alanine; Anti-HIV Agents; Female; Glomerular Filtration Rate; Hepatitis B; Hepatitis

2020
Comparative Pricing of Branded Tenofovir Alafenamide-Emtricitabine Relative to Generic Tenofovir Disoproxil Fumarate-Emtricitabine for HIV Preexposure Prophylaxis.
    Annals of internal medicine, 2020, 09-15, Volume: 173, Issue:6

    Topics: Adenine; Alanine; Cost-Benefit Analysis; Emtricitabine; Family; HIV Infections; Humans; Pre-Exposure

2020
Comparative Pricing of Branded Tenofovir Alafenamide-Emtricitabine Relative to Generic Tenofovir Disoproxil Fumarate-Emtricitabine for HIV Preexposure Prophylaxis.
    Annals of internal medicine, 2020, 09-15, Volume: 173, Issue:6

    Topics: Adenine; Alanine; Cost-Benefit Analysis; Emtricitabine; Family; HIV Infections; Humans; Pre-Exposure

2020
Dynamics of the Decay of Human Immunodeficiency Virus (HIV) RNA and Distribution of Bictegravir in the Genital Tract and Rectum in Antiretroviral-naive Adults Living With HIV-1 Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (Spanish HIV/AIDS
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021, 10-05, Volume: 73, Issue:7

    Topics: Adult; Alanine; Amides; Anti-HIV Agents; Emtricitabine; Female; Genitalia; Heterocyclic Compounds, 3

2021
Tenofovir alafenamide and rifabutin co-administration does not lead to loss of HIV-1 suppression: A retrospective observational study.
    International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases, 2020, Volume: 100

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Drug Therapy, Combination; Female; HIV Infections; HIV-1;

2020
Tenofovir alafenamide does not inhibit mitochondrial function and cholesterol biosynthesis in human T lymphoblastoid cell line.
    Antiviral research, 2020, Volume: 183

    Topics: Adenine; Alanine; Anti-HIV Agents; Cell Line; Cholesterol; DNA, Mitochondrial; HIV Infections; HIV-1

2020
Dyslipidaemia after switch to tenofovir alafenamide (TAF)-based cART regimens in a cohort of HIV-positive patients: what clinical relevance?
    HIV medicine, 2021, Volume: 22, Issue:2

    Topics: Alanine; Dyslipidemias; HIV Infections; Humans; Tenofovir

2021
Brief Report: Weight Gain Following ART Initiation in ART-Naïve People Living With HIV in the Current Treatment Era.
    Journal of acquired immune deficiency syndromes (1999), 2021, 03-01, Volume: 86, Issue:3

    Topics: Adult; Alanine; Alkynes; Anti-HIV Agents; Anti-Retroviral Agents; Benzoxazines; Cyclopropanes; Dideo

2021
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide discontinuation and return to normal weight.
    International journal of STD & AIDS, 2021, Volume: 32, Issue:1

    Topics: Adult; Alanine; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Cobicistat; Drug Combination

2021
Tenofovir alafenamide versus tenofovir disoproxil fumarate: integrating systematic review findings into practice and policy.
    AIDS (London, England), 2020, 12-01, Volume: 34, Issue:15

    Topics: Adenine; Alanine; HIV Infections; Humans; Policy; Tenofovir

2020
Two-dose emtricitabine/tenofovir alafenamide plus bictegravir prophylaxis protects macaques against SHIV infection.
    The Journal of antimicrobial chemotherapy, 2021, 02-11, Volume: 76, Issue:3

    Topics: Adenine; Alanine; Amides; Animals; Anti-HIV Agents; Emtricitabine; Heterocyclic Compounds, 3-Ring; H

2021
PrEP Demonstration Project Showed Superior Adherence with Tenofovir Alafenamide/Emtricitabine Compared to Tenofovir Disoproxil Fumarate/Emtricitabine in a Sample of Partnered Sexual Minority Men.
    AIDS and behavior, 2021, Volume: 25, Issue:4

    Topics: Adenine; Alanine; Anti-HIV Agents; Emtricitabine; HIV Infections; Humans; Male; Pre-Exposure Prophyl

2021
Safety and efficacy of tenofovir alafenamide in liver transplant recipients: A single center experience.
    Transplant infectious disease : an official journal of the Transplantation Society, 2021, Volume: 23, Issue:3

    Topics: Adenine; Alanine; HIV Infections; Humans; Liver Transplantation; Retrospective Studies; Tenofovir

2021
Prescribing rates and characteristics of recipients of tenofovir-containing regimens before and after market entry of tenofovir alafenamide.
    Journal of managed care & specialty pharmacy, 2020, Volume: 26, Issue:12

    Topics: Alanine; Anti-HIV Agents; Antiviral Agents; Comorbidity; Drug Approval; HIV Infections; Humans; Prac

2020
Pharmacokinetics of tenofovir alafenamide with and without cobicistat in pregnant and postpartum women living with HIV.
    AIDS (London, England), 2021, 03-01, Volume: 35, Issue:3

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Cobicistat; Emtricitabine; Female; HIV Infections; Humans;

2021
Tenofovir alafenamide revisited.
    Le infezioni in medicina, 2020, Dec-01, Volume: 28, Issue:4

    Topics: Alanine; Anti-HIV Agents; Anti-Retroviral Agents; Drug Substitution; HIV Infections; Humans; Tenofov

2020
Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide as Maintenance Treatment in HIV/HBV-Coinfected Patients.
    Journal of acquired immune deficiency syndromes (1999), 2021, 04-01, Volume: 86, Issue:4

    Topics: Adult; Alanine; Anti-HIV Agents; Cobicistat; Cohort Studies; Drug Combinations; Drug Substitution; E

2021
Preoperative rapid suppression of viral load by elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide regimen in human immunodeficiency virus-positive fracture patients significantly reduces postoperative complications.
    Chinese medical journal, 2020, Dec-05, Volume: 133, Issue:23

    Topics: Adenine; Alanine; Anti-HIV Agents; Cobicistat; Drug Combinations; Emtricitabine; HIV; HIV Infections

2020
Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in Adults With HIV and M184V/I Mutation.
    Journal of acquired immune deficiency syndromes (1999), 2021, 04-01, Volume: 86, Issue:4

    Topics: Adult; Aged; Alanine; Anti-HIV Agents; Cobicistat; Drug Combinations; Drug Resistance, Viral; Emtric

2021
Outcomes associated with treatment change from tenofovir disoproxil fumarate to tenofovir alafenamide in HIV-1-infected patients: a real-world study in Japan.
    HIV medicine, 2021, Volume: 22, Issue:6

    Topics: Adult; Alanine; Anti-HIV Agents; Fumarates; HIV Infections; HIV-1; Humans; Japan; Prospective Studie

2021
Summary for Patients: Weight and Metabolic Changes After Switching From Tenofovir Disoproxil Fumarate to Tenofovir Alafenamide in People Living With HIV.
    Annals of internal medicine, 2021, Volume: 174, Issue:6

    Topics: Adult; Alanine; Anti-HIV Agents; HIV Infections; Humans; Lipids; Obesity; Tenofovir; Weight Gain

2021
Weight and Metabolic Changes After Switching From Tenofovir Disoproxil Fumarate to Tenofovir Alafenamide in People Living With HIV : A Cohort Study.
    Annals of internal medicine, 2021, Volume: 174, Issue:6

    Topics: Adult; Alanine; Anti-HIV Agents; Blood Glucose; Cholesterol; Cholesterol, HDL; Cholesterol, LDL; Fem

2021
A rare case of acute tubular necrosis tenofovir alafenamide-related.
    Clinical nephrology, 2021, Volume: 95, Issue:6

    Topics: Adenine; Alanine; HIV Infections; Humans; Necrosis; Tenofovir

2021
Weight gain before and after switch from TDF to TAF in a U.S. cohort study.
    Journal of the International AIDS Society, 2021, Volume: 24, Issue:4

    Topics: Adult; Alanine; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Cohort Studies; Diabetes Mel

2021
Increase in Body Mass Index in Children With HIV, Switched to Tenofovir Alafenamide Fumarate or Dolutegravir Containing Antiretroviral Regimens.
    The Pediatric infectious disease journal, 2021, 05-01, Volume: 40, Issue:5

    Topics: Adolescent; Alanine; Anti-Retroviral Agents; Body Mass Index; Child; Cohort Studies; Female; Heteroc

2021
Changes in alanine aminotransferase levels after switching from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) in HIV-positive people without viral hepatitis in the Swiss HIV Cohort Study.
    HIV medicine, 2021, Volume: 22, Issue:7

    Topics: Alanine; Alanine Transaminase; Anti-HIV Agents; Cohort Studies; Fumarates; Hepatitis, Viral, Human;

2021
Brief Report: No Difference in Urine Tenofovir Levels in Patients Living With HIV on Unboosted Versus Dose-Adjusted Boosted Tenofovir Alafenamide.
    Journal of acquired immune deficiency syndromes (1999), 2021, 09-01, Volume: 88, Issue:1

    Topics: Adenine; Alanine; Antiretroviral Therapy, Highly Active; Antiviral Agents; Chromatography, Liquid; F

2021
Rapid initiation of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in acute and early HIV-1 infection: a DIAMOND subgroup analysis.
    HIV research & clinical practice, 2021, Volume: 22, Issue:2

    Topics: Adolescent; Adult; Alanine; Anti-HIV Agents; Cobicistat; Darunavir; Drug Combinations; Emtricitabine

2021
[Effectiveness, safety, and economic impact of the bictegravir/emtricitabine/tenofovir alafenamide regimen in real clinical practice cohort of HIV-1 infected adult patients].
    Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia, 2021, Volume: 34, Issue:4

    Topics: Adolescent; Adult; Alanine; Amides; Anti-HIV Agents; Emtricitabine; Heterocyclic Compounds, 3-Ring;

2021
Changing trends in lipid profile and biomarkers of renal function and bone metabolism before and after switching from tenofovir disoproxil fumarate to tenofovir alafenamide: a prospective observational study.
    AIDS research and therapy, 2021, 05-27, Volume: 18, Issue:1

    Topics: Alanine; Anti-HIV Agents; Biomarkers; Fumarates; HIV Infections; Humans; Kidney; Lipids; Prospective

2021
Failure to seroconvert after two doses of BNT162b2 SARS-CoV-2 vaccine in a patient with uncontrolled HIV.
    The lancet. HIV, 2021, Volume: 8, Issue:6

    Topics: Adenine; Adult; Alanine; Amides; Antiretroviral Therapy, Highly Active; BNT162 Vaccine; CD4 Lymphocy

2021
Efficacy and tolerability of combined antiretroviral treatment with bictegravir/emtricitabine/tenofovir alafenamide initiated at the time of primary HIV infection.
    The Journal of antimicrobial chemotherapy, 2021, 08-12, Volume: 76, Issue:9

    Topics: Alanine; Amides; Anti-HIV Agents; Anti-Retroviral Agents; Drug Combinations; Emtricitabine; Heterocy

2021
Bictegravir/emtricitabine/tenofovir alafenamide combination in the management of kidney transplant patients with HIV receiving immunosuppressants.
    Journal of chemotherapy (Florence, Italy), 2022, Volume: 34, Issue:3

    Topics: Adenine; Alanine; Amides; Anti-HIV Agents; Drug Combinations; Emtricitabine; Heterocyclic Compounds,

2022
A 28-Day Toxicity Study of Tenofovir Alafenamide Hemifumarate by Subcutaneous Infusion in Rats and Dogs.
    Microbiology spectrum, 2021, 09-03, Volume: 9, Issue:1

    Topics: Adenine; Alanine; Animals; Anti-HIV Agents; Dogs; Edema; HIV Infections; HIV-1; Infusions, Subcutane

2021
Why Are Patients Switching from Tenofovir Disoproxil Fumarate/Emtricitabine (Truvada) to Tenofovir Alafenamide/Emtricitabine (Descovy) for Pre-Exposure Prophylaxis?
    AIDS patient care and STDs, 2021, Volume: 35, Issue:8

    Topics: Adenine; Alanine; Anti-HIV Agents; Cohort Studies; Emtricitabine; Emtricitabine, Tenofovir Disoproxi

2021
Comprehensive metabolomics profiling reveals common metabolic alterations underlying the four major non-communicable diseases in treated HIV infection.
    EBioMedicine, 2021, Volume: 71

    Topics: Adolescent; Adult; Aged; Alanine; Aspartic Acid; Atherosclerosis; Cognitive Dysfunction; Female; Glu

2021
Comparison of weight gain after antiretroviral switch to integrase strand transfer inhibitor or tenofovir alafenamide-based therapy.
    Infection, 2022, Volume: 50, Issue:2

    Topics: Alanine; Anti-HIV Agents; Drug Substitution; HIV Infections; Humans; Integrase Inhibitors; Retrospec

2022
Impact of switching to tenofovir alafenamide on weight gain as compared to maintaining a non-tenofovir alafenamide containing regimen.
    Medicine, 2021, Aug-27, Volume: 100, Issue:34

    Topics: Alanine; Anti-HIV Agents; Body Mass Index; Case-Control Studies; Comorbidity; Female; HIV Infections

2021
Pharmacokinetics of bictegravir, emtricitabine and tenofovir alafenamide in a gastrectomized patient with HIV.
    The Journal of antimicrobial chemotherapy, 2021, 11-12, Volume: 76, Issue:12

    Topics: Alanine; Amides; Anti-HIV Agents; Emtricitabine; Heterocyclic Compounds, 3-Ring; HIV Infections; Hum

2021
Evolution of tenofovir-resistant HIV-1 isolates exposed to tenofovir alafenamide dose escalation.
    Antiviral research, 2017, Volume: 143

    Topics: Adenine; Alanine; Anti-HIV Agents; Cell Line; Dose-Response Relationship, Drug; Drug Resistance, Vir

2017
Short Communication: Resolution of Tenofovir Disoproxil Fumarate Induced Fanconi Syndrome with Switch to Tenofovir Alafenamide Fumarate in a HIV-1 and Hepatitis B Coinfected Patient.
    AIDS research and human retroviruses, 2017, Volume: 33, Issue:7

    Topics: Adenine; Alanine; Anti-HIV Agents; Coinfection; Fanconi Syndrome; Hepatitis B, Chronic; HIV Infectio

2017
Commonly Transmitted HIV-1 Drug Resistance Mutations in Reverse-Transcriptase and Protease in Antiretroviral Treatment-Naive Patients and Response to Regimens Containing Tenofovir Disoproxil Fumarate or Tenofovir Alafenamide.
    The Journal of infectious diseases, 2017, 03-15, Volume: 215, Issue:6

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Drug Resistance, Viral; Emtricitabine; Europe; Female; HIV

2017
[Update in HIV therapy: tenofovir alafenamide].
    Revue medicale suisse, 2016, Aug-24, Volume: 12, Issue:527

    Topics: Adenine; Alanine; Anti-HIV Agents; HIV Infections; Humans; Prodrugs; Tenofovir

2016
Improvement in renal function and resolution of proteinuria in an HIV-infected patient switched from tenofovir disoproxil fumarate to tenofovir alafenamide.
    Internal medicine journal, 2017, Volume: 47, Issue:7

    Topics: Adenine; Alanine; Antiviral Agents; Drug Substitution; Female; HIV Infections; Humans; Kidney Diseas

2017
Simultaneous determination of tenofovir alafenamide and its active metabolites tenofovir and tenofovir diphosphate in HBV-infected hepatocyte with a sensitive LC-MS/MS method.
    Journal of pharmaceutical and biomedical analysis, 2017, Nov-30, Volume: 146

    Topics: Adenine; Alanine; Anti-HIV Agents; Cell Line, Tumor; Chromatography, Liquid; DNA Replication; Half-L

2017
Tenofovir alafenamide nephrotoxicity in an HIV-positive patient: A case report.
    Medicine, 2017, Volume: 96, Issue:36

    Topics: Adenine; Alanine; Anti-HIV Agents; HIV Infections; Humans; Kidney Diseases; Male; Middle Aged; Mitoc

2017
Effect of Cobicistat on Tenofovir Disoproxil Fumarate (TDF): What Is True for TAF May Also Be True for TDF.
    Journal of acquired immune deficiency syndromes (1999), 2018, 01-01, Volume: 77, Issue:1

    Topics: Adenine; Adult; Aged; Alanine; Anti-HIV Agents; Cobicistat; Drug Combinations; Drug Interactions; Fe

2018
Successful treatment with tenofovir alafenamide of a HIV/hepatitis B virus coinfected patient with HIV and hepatitis B virus drug resistance, end-stage renal disease on haemodialysis.
    AIDS (London, England), 2017, 10-23, Volume: 31, Issue:16

    Topics: Adenine; Adult; Alanine; Antiviral Agents; Coinfection; Drug Resistance, Viral; Female; Hepatitis B,

2017
Role of tenofovir alafenamide in the jungle of antiretroviral prescription.
    The Journal of antimicrobial chemotherapy, 2018, 01-01, Volume: 73, Issue:1

    Topics: Adenine; Aged; Aged, 80 and over; Alanine; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; H

2018
Regimen Change: Gilead's TAF Drugs Toppling TDFs in HIV Treatment.
    Managed care (Langhorne, Pa.), 2017, Volume: 26, Issue:9

    Topics: Adenine; Alanine; Drug Therapy, Combination; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combi

2017
Hormonal Contraceptives Differentially Suppress TFV and TAF Inhibition of HIV Infection and TFV-DP in Blood and Genital Tract CD4+ T cells.
    Scientific reports, 2017, 12-18, Volume: 7, Issue:1

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Anti-Retroviral Agents; CD4-Positive T-Lymphocytes; Cells,

2017
Plasma and intracellular pharmacokinetics of tenofovir in patients switched from tenofovir disoproxil fumarate to tenofovir alafenamide.
    AIDS (London, England), 2018, 03-27, Volume: 32, Issue:6

    Topics: Adenine; Adult; Aged; Aged, 80 and over; Alanine; Anti-HIV Agents; Chromatography, Liquid; Cross-Ove

2018
Establishment of intracellular tenofovir-diphosphate as the key determinant for in vitro-in vivo translation of antiviral efficacy.
    Antiviral research, 2018, Volume: 151

    Topics: Adenine; Alanine; Anti-HIV Agents; Cytoplasm; Databases, Factual; Dose-Response Relationship, Drug;

2018
Six-helix bundle completion in the distal C-terminal heptad repeat region of gp41 is required for efficient human immunodeficiency virus type 1 infection.
    Retrovirology, 2018, 04-02, Volume: 15, Issue:1

    Topics: Alanine; Amino Acid Sequence; HIV Envelope Protein gp41; HIV Infections; HIV-1; Humans; Models, Biol

2018
Antiviral Activity of Tenofovir Alafenamide Against HIV-1 Subtypes and Emergence of K65R.
    AIDS research and human retroviruses, 2018, Volume: 34, Issue:5

    Topics: Adenine; Alanine; Anti-HIV Agents; Drug Resistance, Viral; HIV Infections; HIV-1; Humans; Mutation,

2018
Translation of clinical trial data to changes in clinical practice: rapid transition from tenofovir disoproxil fumarate to tenofovir alafenamide-based therapies in a Sydney HIV clinic.
    International journal of STD & AIDS, 2018, Volume: 29, Issue:10

    Topics: Adenine; Alanine; Ambulatory Care Facilities; Anti-HIV Agents; Antiviral Agents; Australia; HIV Infe

2018
To use entecavir, tenofovir disoproxil fumarate or tenofovir alafenamide: it's all about choosing the right patient!
    European journal of gastroenterology & hepatology, 2018, Volume: 30, Issue:6

    Topics: Adenine; Alanine; Anti-HIV Agents; Guanine; HIV Infections; Humans; Tenofovir

2018
Efficacy of single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alafenamide in the treatment of HIV-1.
    Expert opinion on pharmacotherapy, 2018, Volume: 19, Issue:8

    Topics: Adenine; Alanine; Anti-HIV Agents; Clinical Trials as Topic; Cobicistat; Darunavir; Drug Resistance,

2018
Development of rectal enema as microbicide (DREAM): Preclinical progressive selection of a tenofovir prodrug enema.
    European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V, 2019, Volume: 138

    Topics: Adenine; Administration, Rectal; Alanine; Animals; Anti-HIV Agents; Anti-Infective Agents; Enema; HI

2019
What did we learn from the bictegravir switch studies?
    The lancet. HIV, 2018, Volume: 5, Issue:7

    Topics: Adenine; Adult; Alanine; Amides; Emtricitabine; Heterocyclic Compounds, 3-Ring; Heterocyclic Compoun

2018
Tenofovir alafenamide associated fatal lactic acidosis in an autologous hematopoietic stem cell transplant recipient.
    Transplant infectious disease : an official journal of the Transplantation Society, 2018, Volume: 20, Issue:5

    Topics: Acidosis, Lactic; Adenine; Aged; Alanine; Antiviral Agents; Fatal Outcome; Hematopoietic Stem Cell T

2018
A pharmacist-led medication switch protocol in an academic HIV clinic: patient knowledge and satisfaction.
    BMC infectious diseases, 2018, 07-06, Volume: 18, Issue:1

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Cross-Sectional Studies; Elvitegravir, Cobicistat, Emtrici

2018
Vaginal microbiome modulates topical antiretroviral drug pharmacokinetics.
    JCI insight, 2018, 07-12, Volume: 3, Issue:13

    Topics: Actinobacteria; Adenine; Alanine; Anti-Retroviral Agents; Bacteria; Endocytosis; Female; Gardnerella

2018
Antiretroviral potency of 4'-ethnyl-2'-fluoro-2'-deoxyadenosine, tenofovir alafenamide and second-generation NNRTIs across diverse HIV-1 subtypes.
    The Journal of antimicrobial chemotherapy, 2018, 10-01, Volume: 73, Issue:10

    Topics: Adenine; Alanine; Anti-Retroviral Agents; Deoxyadenosines; Drug Resistance, Viral; HIV Infections; H

2018
Overdose of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide in an HIV-1-infected subject with attempted suicide.
    Infection, 2019, Volume: 47, Issue:1

    Topics: Adenine; Alanine; Anti-HIV Agents; Cobicistat; Drug Combinations; Drug Overdose; Emtricitabine; HIV

2019
A Pharmacokinetic/Pharmacodynamic Model to Predict Effective HIV Prophylaxis Dosing Strategies for People Who Inject Drugs.
    The Journal of pharmacology and experimental therapeutics, 2018, Volume: 367, Issue:2

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Emtricitabine; Female; HIV; HIV Infections; Humans; Middle

2018
Treatment with tenofovir alafenamide fumarate worsens the lipid profile of HIV-infected patients versus treatment with tenofovir disoproxil fumarate, each coformulated with elvitegravir, cobicistat, and emtricitabine.
    Basic & clinical pharmacology & toxicology, 2019, Volume: 124, Issue:4

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Cholesterol; Cholesterol, LDL; Elvitegravir, Cobicistat, E

2019
Abnormal elevation of international normalized ratio in a patient during the coadministration of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide and warfarin: a case report.
    AIDS (London, England), 2019, 02-01, Volume: 33, Issue:2

    Topics: Adenine; Alanine; Cobicistat; Emtricitabine; HIV Infections; Humans; International Normalized Ratio;

2019
Fanconi Syndrome and Tenofovir Alafenamide: A Case Report.
    Annals of internal medicine, 2019, 06-04, Volume: 170, Issue:11

    Topics: Adenine; Alanine; Antiviral Agents; Fanconi Syndrome; HIV Infections; Humans; Male; Middle Aged; Ten

2019
Epithelial Cells and Fibroblasts from the Human Female Reproductive Tract Accumulate and Release TFV and TAF to Sustain Inhibition of HIV Infection of CD4+ T cells.
    Scientific reports, 2019, 02-12, Volume: 9, Issue:1

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; CD4-Positive T-Lymphocytes; Cervix Uteri; Drug Resistance,

2019
Resistance Analysis of Bictegravir-Emtricitabine-Tenofovir Alafenamide in HIV-1 Treatment-Naive Patients through 48 Weeks.
    Antimicrobial agents and chemotherapy, 2019, Volume: 63, Issue:5

    Topics: Adenine; Alanine; Amides; Anti-HIV Agents; Antiviral Agents; Dideoxynucleosides; Drug Combinations;

2019
Resistance Analysis of Bictegravir-Emtricitabine-Tenofovir Alafenamide in HIV-1 Treatment-Naive Patients through 48 Weeks.
    Antimicrobial agents and chemotherapy, 2019, Volume: 63, Issue:5

    Topics: Adenine; Alanine; Amides; Anti-HIV Agents; Antiviral Agents; Dideoxynucleosides; Drug Combinations;

2019
Resistance Analysis of Bictegravir-Emtricitabine-Tenofovir Alafenamide in HIV-1 Treatment-Naive Patients through 48 Weeks.
    Antimicrobial agents and chemotherapy, 2019, Volume: 63, Issue:5

    Topics: Adenine; Alanine; Amides; Anti-HIV Agents; Antiviral Agents; Dideoxynucleosides; Drug Combinations;

2019
Resistance Analysis of Bictegravir-Emtricitabine-Tenofovir Alafenamide in HIV-1 Treatment-Naive Patients through 48 Weeks.
    Antimicrobial agents and chemotherapy, 2019, Volume: 63, Issue:5

    Topics: Adenine; Alanine; Amides; Anti-HIV Agents; Antiviral Agents; Dideoxynucleosides; Drug Combinations;

2019
Population Modeling Highlights Drug Disposition Differences Between Tenofovir Alafenamide and Tenofovir Disoproxil Fumarate in the Blood and Semen.
    Clinical pharmacology and therapeutics, 2019, Volume: 106, Issue:4

    Topics: Adenine; Adult; Alanine; Anti-Retroviral Agents; Cell Count; Emtricitabine; HIV Infections; HIV-1; H

2019
Bictegravir and dolutegravir: head to head at 96 weeks.
    The lancet. HIV, 2019, Volume: 6, Issue:6

    Topics: Adenine; Alanine; Amides; Dideoxynucleosides; Double-Blind Method; Emtricitabine; Heterocyclic Compo

2019
Potential Benefits of Switching Liver Transplant Recipients to Tenofovir Alafenamide Prophylaxis.
    Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2020, Volume: 18, Issue:3

    Topics: Adenine; Alanine; Hepatitis B, Chronic; HIV Infections; Humans; Liver Transplantation; Tenofovir

2020
Sustained HIV virologic suppression with crushed combination tablets containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide.
    American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists, 2019, 08-01, Volume: 76, Issue:16

    Topics: Adenine; Alanine; Anti-HIV Agents; Cobicistat; Drug Therapy, Combination; Emtricitabine; Enteral Nut

2019
Brief Report: Urine Emtricitabine and Tenofovir Concentrations Provide Markers of Recent Antiretroviral Drug Exposure Among HIV-Negative Men Who Have Sex With Men.
    Journal of acquired immune deficiency syndromes (1999), 2019, 11-01, Volume: 82, Issue:3

    Topics: Adenine; Administration, Oral; Adolescent; Adult; Alanine; Anti-HIV Agents; Anti-Retroviral Agents;

2019
Efficacy of Oral Tenofovir Alafenamide/Emtricitabine Combination or Single-Agent Tenofovir Alafenamide Against Vaginal Simian Human Immunodeficiency Virus Infection in Macaques.
    The Journal of infectious diseases, 2019, 10-22, Volume: 220, Issue:11

    Topics: Adenine; Alanine; Animals; Anti-HIV Agents; Chemoprevention; Disease Models, Animal; Disease Transmi

2019
HIV-1 Vpu mediated downregulation of CD155 requires alanine residues 10, 14 and 18 of the transmembrane domain.
    Virology, 2014, Volume: 464-465

    Topics: Alanine; Amino Acid Motifs; CD8-Positive T-Lymphocytes; Cell Membrane; Down-Regulation; HIV Infectio

2014
PPARγ2 Pro12Ala polymorphism was associated with favorable cardiometabolic risk profile in HIV/HCV coinfected patients: a cross-sectional study.
    Journal of translational medicine, 2014, Aug-27, Volume: 12

    Topics: Adult; Alanine; Amino Acid Substitution; Cardiovascular Diseases; Coinfection; Cross-Sectional Studi

2014
Tenofovir alafenamide for HIV infection: is less more?
    Lancet (London, England), 2015, Jun-27, Volume: 385, Issue:9987

    Topics: Adenine; Alanine; Anti-HIV Agents; Carbamates; Cobicistat; Deoxycytidine; Emtricitabine; Female; HIV

2015
Pharmacokinetics of long-acting tenofovir alafenamide (GS-7340) subdermal implant for HIV prophylaxis.
    Antimicrobial agents and chemotherapy, 2015, Volume: 59, Issue:7

    Topics: Adenine; Alanine; Animals; Anti-HIV Agents; Dogs; Drug Implants; Equipment Design; HIV Infections; H

2015
Tenofovir alafenamide as part of a salvage regimen in a patient with multi-drug resistant HIV and tenofovir-DF-associated renal tubulopathy.
    Antiviral therapy, 2016, Volume: 21, Issue:6

    Topics: Acute Kidney Injury; Adenine; Alanine; Anti-HIV Agents; Drug Resistance, Multiple, Viral; HIV Infect

2016
[New NRTI with optimized long-term tolerance].
    MMW Fortschritte der Medizin, 2015, Dec-14, Volume: 157, Issue:21-22

    Topics: Adenine; Alanine; Anti-HIV Agents; Drug Combinations; Drug Tolerance; HIV Infections; Humans; Tenofo

2015
Editorial.
    HIV medicine, 2016, Volume: 17 Suppl 2

    Topics: Adenine; Alanine; Anti-HIV Agents; Clinical Trials as Topic; Drug Approval; Drug-Related Side Effect

2016
First case report of renal improvement on tenofovir alafenamide in an HIV/hepatitis B virus-coinfected patient with adefovir-induced Fanconi's syndrome.
    AIDS (London, England), 2016, 06-01, Volume: 30, Issue:9

    Topics: Absorptiometry, Photon; Adenine; Alanine; Coinfection; Dose-Response Relationship, Drug; Fanconi Syn

2016
[Brief notes. Approval recommendation for fixed combination Descovy(R) in treatment of HIV].
    MMW Fortschritte der Medizin, 2016, Apr-14, Volume: 158, Issue:7

    Topics: Adenine; Adolescent; Adult; Alanine; Anti-HIV Agents; Child; Dose-Response Relationship, Drug; Drug

2016
Pharmacokinetics and Safety of Tenofovir Alafenamide in HIV-Uninfected Subjects with Severe Renal Impairment.
    Antimicrobial agents and chemotherapy, 2016, Volume: 60, Issue:9

    Topics: Adenine; Aged; Alanine; Anti-HIV Agents; Area Under Curve; Case-Control Studies; Female; Glomerular

2016
[Optimized therapy].
    MMW Fortschritte der Medizin, 2016, Jun-09, Volume: 158 Suppl 1

    Topics: Adenine; Alanine; Anti-HIV Agents; Dose-Response Relationship, Drug; Drug Substitution; Drug Therapy

2016
Antiretroviral treatment for HIV infection: Swedish recommendations 2016.
    Infectious diseases (London, England), 2017, Volume: 49, Issue:1

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; CD4 Lymphocyte Count; Dideoxynucleosides; Drug Combination

2017
[Tenofovir alafenamide fumarate - a new generation of tenofovir].
    Klinicka mikrobiologie a infekcni lekarstvi, 2016, Volume: 22, Issue:3

    Topics: Adenine; Alanine; Anti-HIV Agents; Drug Combinations; HIV Infections; Humans; Tenofovir

2016
Tenofovir alafenamide and elvitegravir loaded nanoparticles for long-acting prevention of HIV-1 vaginal transmission.
    AIDS (London, England), 2017, 02-20, Volume: 31, Issue:4

    Topics: Adenine; Alanine; Animals; Delayed-Action Preparations; Disease Transmission, Infectious; Female; HI

2017
Fusion of Epstein-Barr virus nuclear antigen-1-derived glycine-alanine repeat to trans-dominant HIV-1 Gag increases inhibitory activities and survival of transduced cells in vivo.
    Human gene therapy, 2008, Volume: 19, Issue:6

    Topics: AIDS Vaccines; Alanine; Animals; Cell Line; Cell Survival; Epstein-Barr Virus Nuclear Antigens; gag

2008
Epidermodysplasia verruciformis in a HIV-positive patient homozygous for the c917A-->T polymorphism in the TMC8/EVER2 gene.
    Dermatology (Basel, Switzerland), 2009, Volume: 218, Issue:2

    Topics: Adult; AIDS-Related Opportunistic Infections; Alanine; Epidermodysplasia Verruciformis; Female; HIV

2009
Epitope-enhanced conserved HIV-1 peptide protects HLA-A2-transgenic mice against virus expressing HIV-1 antigen.
    Journal of immunology (Baltimore, Md. : 1950), 2003, Sep-01, Volume: 171, Issue:5

    Topics: Adjuvants, Immunologic; Alanine; Amino Acid Substitution; Animals; Antigen Presentation; Cell Line;

2003
Hyperlactatemia in human immunodeficiency virus-uninfected infants who are exposed to antiretrovirals.
    Pediatrics, 2004, Volume: 114, Issue:5

    Topics: Alanine; Antiretroviral Therapy, Highly Active; Didanosine; Female; HIV Infections; HIV Seronegativi

2004
Analysis of amino acids in the beta7-beta8 loop of human immunodeficiency virus type 1 reverse transcriptase for their role in virus replication.
    Journal of molecular biology, 2007, Feb-02, Volume: 365, Issue:5

    Topics: Alanine; Amino Acid Sequence; Amino Acids; Asparagine; Dimerization; HIV Infections; HIV Protease; H

2007
Induction of human immunodeficiency virus (HIV)-specific CD8 T-cell responses by Listeria monocytogenes and a hyperattenuated Listeria strain engineered to express HIV antigens.
    Journal of virology, 2000, Volume: 74, Issue:21

    Topics: AIDS Vaccines; Alanine; Amino Acid Sequence; Animals; Antigen Presentation; CD8-Positive T-Lymphocyt

2000
Prevalence and conditions of selection of E44D/A and V118I human immunodeficiency virus type 1 reverse transcriptase mutations in clinical practice.
    Antimicrobial agents and chemotherapy, 2001, Volume: 45, Issue:3

    Topics: Alanine; Amino Acid Substitution; Anti-HIV Agents; Aspartic Acid; Drug Resistance, Microbial; Gene F

2001
Immunochemistry of the dominating antigenic region Ala582 to Cys604 in the transmembranous protein of simian and human immunodeficiency virus.
    Journal of immunology (Baltimore, Md. : 1950), 1989, Dec-01, Volume: 143, Issue:11

    Topics: Alanine; Amino Acid Sequence; Animals; Antibodies, Monoclonal; Antigens, Surface; Binding, Competiti

1989