adenine and Pregnancy studies

Pregnancy: The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH.

Research Excerpts

Excerpt	Relevance	Reference
" Our data support the use of tenofovir disoproxil fumarate and emtricitabine in pregnancy and our reassuring findings can be used to allay safety concerns among pregnant women."	9.69	Pregnancy and neonatal safety outcomes of timing of initiation of daily oral tenofovir disoproxil fumarate and emtricitabine pre-exposure prophylaxis for HIV prevention (CAP016): an open-label, randomised, non-inferiority trial. ( Clark, R; Desmond, AC; Govender, V; Gray, G; Lombard, C; Mhlongo, O; Moodley, D; Naidoo, K; Naidoo, M; Newell, ML; Rooney, JF; Sebitloane, M, 2023)
"When started in pregnancy, dolutegravir-containing regimens had superior virological efficacy at delivery compared with the efavirenz, emtricitabine, and tenofovir disoproxil fumarate regimen."	9.41	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 ( 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)
"In the Promoting Maternal and Infant Survival Everywhere (PROMISE) trial, tenofovir disoproxil fumarate (TDF) use was associated with moderate or severe adverse pregnancy/neonatal outcomes."	9.34	Antenatal Intracellular Concentrations of Tenofovir Diphosphate and Emtricitabine Triphosphate and Associations Between Tenofovir Diphosphate and Severe Adverse Pregnancy Outcomes: IMPAACT-PROMISE (1077BF) Trial. ( Aizire, J; Brooks, KM; Butler, K; Cababasay, M; Fenton, T; Flynn, PM; Fowler, MG; Kiser, JJ; Mirochnick, M; Siberry, GK, 2020)
"Few data are available describing atazanavir exposure during pregnancy, especially when used in combination with tenofovir, whose coadministration with atazanavir results in decreased atazanavir exposure."	9.15	Atazanavir pharmacokinetics with and without tenofovir during pregnancy. ( Basar, M; Best, BM; Burchett, SK; Capparelli, EV; Hawkins, E; Hu, C; Mirochnick, M; Read, JS; Rossi, SS; Smith, E; Stek, AM, 2011)
"Tenofovir alafenamide (TAF) has recently been approved for chronic hepatitis B (CHB)."	8.95	Tenofovir alafenamide as compared to tenofovir disoproxil fumarate in the management of chronic hepatitis B with recent trends in patient demographics. ( Hsu, YC; Nguyen, MH; Wei, MT, 2017)
"Tenofovir disoproxil fumarate (TDF) safety during pregnancy has important public health implications."	8.89	Safety of tenofovir during pregnancy for the mother and fetus: a systematic review. ( Bulterys, M; Ellington, S; Kourtis, AP; Legardy-Williams, J; Wang, L, 2013)
" Further, the addition of single-dose TDF to single-dose nevirapine (SD-NVP) during delivery following maternal ZDV use during pregnancy significantly reduces the frequency of nonnucleoside reverse transcriptase inhibitor (NNRTI) resistance."	8.85	Tenofovir disoproxil fumarate in pregnancy and prevention of mother-to-child transmission of HIV-1: is it time to move on from zidovudine? ( Foster, C; Gibb, DM; Lyall, H; Olmscheid, B; Pearce, G; Zhang, S, 2009)
"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."	8.12	Tenofovir 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)
"Data on long-term tenofovir alafenamide (TAF) therapy for pregnant women with active chronic hepatitis B (CHB) (immune clearance and reactivation phases, currently and previously diagnosed) and their infants are lacking."	8.12	Tenofovir Alafenamide for Pregnant Chinese Women With Active Chronic Hepatitis B: A Multicenter Prospective Study. ( Chen, ZM; Cui, GL; Feng, YH; Huang, S; Li, GM; Li, GT; Li, J; Li, W; Li, WZ; Li, ZQ; Liang, HX; Lin, WB; Liu, N; Liu, YM; Lv, J; Pan, YJ; Song, N; Sun, CY; Wang, FS; Wang, M; Xu, GH; Xu, JH; Yu, ZJ; Zeng, QL; Zeng, YL; Zhang, DW; Zhang, GF; Zhang, GQ; Zhang, HX; Zhang, JY; Zhou, YH, 2022)
"There are few data on the utility of tenofovir diphosphate (TFV-DP) in dried blood spots (DBSs) to predict future viral load (VL) in postpartum women with HIV on antiretroviral therapy (ART)."	8.12	Use of Tenofovir Diphosphate Levels to Predict Viremia During the Postpartum Period in Women Living With Human Immunodeficiency Virus (HIV): A Nested Case-Control Study. ( Allerton, J; Castillo-Mancilla, J; Hsiao, NY; Hu, NC; Kabanda, S; Lesosky, M; Malaba, TR; Myer, L; Odayar, J; Orrell, C; Phillips, TK; Wiesner, L, 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."	8.12	Plasma 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)
"Entecavir (ETV) or adefovir dipivoxil (ADV) are not recommended during pregnancy because of embryotoxicity or teratogenicity found in animal studies; however, information on the safety of ETV or ADV in humans is limited."	8.12	Pregnancy outcomes for pregnant women with chronic hepatitis B exposing to entecavir or adefovir dipivoxil therapy before or in early pregnancy. ( Cai, H; Duan, X; Fu, D; Gao, X; Hu, Y; Kang, K; Liu, M; Yi, W; Zhou, M, 2022)
" These pregnant females developed lamivudine (LAM)- or telbivudine (LdT)-resistant chronic hepatitis B and received tenofovir (TDF) therapy (300 mg/d), and its curative effect, maternal and perinatal adverse events, fetal growth and development, and neonatal prognosis were evaluated."	7.81	Tenofovir rescue therapy in pregnant females with chronic hepatitis B. ( Cai, HD; Cao, YJ; Hu, YH; Liu, M; Yi, W, 2015)
"This is the first demonstration using an experimental model that maternal exposure to tenofovir DF during gestation results in overactivation of RAAS, up-regulation of renal sodium transporters and hypertension in the offspring."	7.81	Tenofovir during pregnancy in rats: a novel pathway for programmed hypertension in the offspring. ( Canale, D; Costa, Nde S; Gois, PH; Luchi, WM; Seguro, AC; Shimizu, MH; Veras, MM; Volpini, RA, 2015)
"To evaluate the effects of tenofovir disoproxil fumarate (TDF) use during late pregnancy to reduce hepatitis B virus (HBV) transmission in highly viremic mothers."	7.79	Efficacy and safety of tenofovir disoproxil fumarate in pregnancy for the prevention of vertical transmission of HBV infection. ( Ay, M; Ayaz, C; Barcin, T; Celen, MK; Dal, MS; Dal, T; Gulsun, S; Kalkanli, S; Kaya, S; Mert, D; Yildirim, N, 2013)
"To determine whether maternal use of tenofovir disoproxil fumarate for treatment of HIV in pregnancy predicts fetal and infant growth."	7.79	Infant growth outcomes after maternal tenofovir disoproxil fumarate use during pregnancy. ( Huo, Y; Livingston, EG; Patel, K; Ransom, CE; Scott, GB; Siberry, GK; Watts, HD; Williams, P, 2013)
"Recent studies have raised concerns about a change in rates of pregnancy among HIV-negative women exposed to tenofovir."	7.78	Tenofovir use and pregnancy among women initiating HAART. ( Firnhaber, C; Maskew, M; Sanne, I; Westreich, D, 2012)
"To evaluate the association of tenofovir disoproxil fumarate (TDF) use during pregnancy with early growth parameters in HIV-exposed, uninfected (HEU) infants."	7.78	Safety of tenofovir use during pregnancy: early growth outcomes in HIV-exposed uninfected infants. ( DiMeglio, LA; Griner, R; Hazra, R; Jacobson, DL; Kacanek, D; Mendez, H; Miller, T; Mofenson, LM; Rich, KC; Seage, GR; Siberry, GK; Tassiopoulos, K; Watts, DH; Williams, PL, 2012)
"According to the European AIDS Clinical Society, tenofovir disoproxil fumarate can be used in HIV-infected pregnant women if started prior to pregnancy, although no data are available on the pharmacokinetics of tenofovir (TFV) during pregnancy."	7.78	Pregnancy-related effects on tenofovir pharmacokinetics: a population study with 186 women. ( Benaboud, S; Bouazza, N; Chappuy, H; Firtion, G; Foissac, F; Hirt, D; Launay, O; Pannier, E; Rey, E; Tréluyer, JM; Urien, S, 2012)
"Tenofovir-related tubule damage characterized by Fanconi syndrome, renal insufficiency and nephrogenic diabetes insipidus has been reported in the adult HIV-infected population."	7.73	Nephrotoxicity in a child with perinatal HIV on tenofovir, didanosine and lopinavir/ritonavir. ( Hussain, S; Khayat, A; Rathore, MH; Tolaymat, A, 2006)
"International Maternal Pediatric Adolescent AIDS Clinical Trials Group 1026s is a prospective, nonblinded, pharmacokinetic study of HIV-infected pregnant women taking antiretrovirals for clinical indications, including 2 cohorts (with or without tenofovir) receiving atazanavir/ritonavir 300/100 mg once daily during the second trimester, 400/100 mg during the third trimester, and 300/100 mg postpartum (PP)."	6.78	Pharmacokinetics of an increased atazanavir dose with and without tenofovir during the third trimester of pregnancy. ( Best, BM; Burchett, SK; Byroads, M; Caparelli, E; Cressey, TR; Hawkins, E; Kreitchmann, R; Mirochnick, M; Rossi, S; Shapiro, DE; Smith, E; Stek, A; Wang, J; Watts, DH, 2013)
"During follow-up, no bone fractures were reported to have occurred; 12/368 creatinines and seven out of 305 phosphates were grade one (16) or two (three) in 14 children with no effect of in utero tenofovir (p>0."	6.77	Pregnancy and infant outcomes among HIV-infected women taking long-term ART with and without tenofovir in the DART trial. ( Chidziva, E; Gibb, DM; Gilks, CF; Grosskurth, H; Hakim, J; Kizito, H; Kyomugisha, H; Munderi, P; Musoke, P; Nalumenya, R; Nathoo, K; Russell, EC; Spyer, M; Tumukunde, D; Walker, AS; Zalwango, E, 2012)
" The median maternal peak concentration and cord blood TFV concentrations were 4."	6.76	Pharmacokinetics and placental transfer of single-dose tenofovir 1% vaginal gel in term pregnancy. ( Beigi, R; Chen, J; Hendrix, CW; Kunjara Na Ayudhya, RP; Macio, I; Mâsse, B; Noguchi, L; Parsons, T; Piper, J; Valentine, M; Watts, DH, 2011)
"Safety and efficacy data during pregnancy and up to 50 weeks post partum support the current recommendation of dolutegravir-based ART (particularly in combination with emtricitabine and tenofovir alafenamide) rather than efavirenz, emtricitabine, and tenofovir disoproxil fumarate, when started in pregnancy."	5.69	Efficacy and safety of three antiretroviral therapy regimens started in pregnancy up to 50 weeks post partum: a multicentre, open-label, randomised, controlled, phase 3 trial. ( Amico, KR; Boyce, C; Brummel, S; Cassim, H; Chakhtoura, N; Chinula, L; Coletti, A; Currier, JS; Fairlie, L; Frenkel, LM; Hoffman, R; Jean-Philippe, P; Johnston, B; Knowles, K; Korutaro, V; Krotje, C; Lockman, S; Masheto, G; McCarthy, K; Mmbaga, BT; Moyo, S; Patel, F; Purdue, L; Rooney, JF; Sax, PE; Shapiro, R; Stranix-Chibanda, L; Stringer, J; van Wyk, J; Ziemba, L, 2023)
" Our data support the use of tenofovir disoproxil fumarate and emtricitabine in pregnancy and our reassuring findings can be used to allay safety concerns among pregnant women."	5.69	Pregnancy and neonatal safety outcomes of timing of initiation of daily oral tenofovir disoproxil fumarate and emtricitabine pre-exposure prophylaxis for HIV prevention (CAP016): an open-label, randomised, non-inferiority trial. ( Clark, R; Desmond, AC; Govender, V; Gray, G; Lombard, C; Mhlongo, O; Moodley, D; Naidoo, K; Naidoo, M; Newell, ML; Rooney, JF; Sebitloane, M, 2023)
" Potentially, lower IFN-α and IP-10 levels as well as once-weekly intranasal dosing vs daily subcutaneous or intramuscular dosing with recombinant type I IFNs could explain the lack of pregnancy effects; however, there was an undesired impact on offspring immune function."	5.62	GSK2245035, a TLR7 agonist, Does Not Increase Pregnancy Loss in Cynomolgus Monkeys. ( Baker, A; Bray, M; Hillegas, AE; Maier, CC; Phadnis-Moghe, AS; Posobiec, LM; Price, MA; Stanislaus, DJ, 2021)
"When started in pregnancy, dolutegravir-containing regimens had superior virological efficacy at delivery compared with the efavirenz, emtricitabine, and tenofovir disoproxil fumarate regimen."	5.41	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 ( 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)
" The likelihood of renal toxicity (proximal renal tubular dysfunction [PRTD]) correlated with plasma drug concentrations, which depended on the dosage regimen and age-related changes in drug clearance."	5.35	Chronic administration of tenofovir to rhesus macaques from infancy through adulthood and pregnancy: summary of pharmacokinetics and biological and virological effects. ( Abel, K; Bischofberger, N; Brignolo, LL; Cihlar, T; Durand-Gasselin, L; Jerome, C; Kearney, BP; Marthas, ML; Moore, J; Ray, AS; Reiser, H; Spinner, A; Van Rompay, KK, 2008)
"In the Promoting Maternal and Infant Survival Everywhere (PROMISE) trial, tenofovir disoproxil fumarate (TDF) use was associated with moderate or severe adverse pregnancy/neonatal outcomes."	5.34	Antenatal Intracellular Concentrations of Tenofovir Diphosphate and Emtricitabine Triphosphate and Associations Between Tenofovir Diphosphate and Severe Adverse Pregnancy Outcomes: IMPAACT-PROMISE (1077BF) Trial. ( Aizire, J; Brooks, KM; Butler, K; Cababasay, M; Fenton, T; Flynn, PM; Fowler, MG; Kiser, JJ; Mirochnick, M; Siberry, GK, 2020)
"Within a randomized, placebo-controlled trial of daily oral tenofovir disoproxil fumarate (TDF) and combination emtricitabine (FTC)/TDF PrEP for HIV-1 prevention conducted among heterosexual HIV-1-serodiscordant couples, we assessed the impact of TDF and FTC/TDF use on male fertility, measured as incident pregnancy in female partners of men assigned to PrEP vs."	5.19	Pre-exposure prophylaxis does not affect the fertility of HIV-1-uninfected men. ( Baeten, JM; Bukusi, EA; Celum, C; Heffron, R; Mugo, NR; Mujugira, A; Were, EO, 2014)
"Few data are available describing atazanavir exposure during pregnancy, especially when used in combination with tenofovir, whose coadministration with atazanavir results in decreased atazanavir exposure."	5.15	Atazanavir pharmacokinetics with and without tenofovir during pregnancy. ( Basar, M; Best, BM; Burchett, SK; Capparelli, EV; Hawkins, E; Hu, C; Mirochnick, M; Read, JS; Rossi, SS; Smith, E; Stek, AM, 2011)
"Tenofovir alafenamide (TAF) has recently been approved for chronic hepatitis B (CHB)."	4.95	Tenofovir alafenamide as compared to tenofovir disoproxil fumarate in the management of chronic hepatitis B with recent trends in patient demographics. ( Hsu, YC; Nguyen, MH; Wei, MT, 2017)
"Lamivudine and tenofovir disoproxil fumarate (TDF) are both active against hepatitis B virus (HBV)."	4.91	Breastfeeding while taking lamivudine or tenofovir disoproxil fumarate: a review of the evidence. ( Ehrhardt, S; Guo, N; Nelson, K; Thio, CL; Xie, C, 2015)
"Tenofovir disoproxil fumarate (TDF) safety during pregnancy has important public health implications."	4.89	Safety of tenofovir during pregnancy for the mother and fetus: a systematic review. ( Bulterys, M; Ellington, S; Kourtis, AP; Legardy-Williams, J; Wang, L, 2013)
" Further, the addition of single-dose TDF to single-dose nevirapine (SD-NVP) during delivery following maternal ZDV use during pregnancy significantly reduces the frequency of nonnucleoside reverse transcriptase inhibitor (NNRTI) resistance."	4.85	Tenofovir disoproxil fumarate in pregnancy and prevention of mother-to-child transmission of HIV-1: is it time to move on from zidovudine? ( Foster, C; Gibb, DM; Lyall, H; Olmscheid, B; Pearce, G; Zhang, S, 2009)
" The conference issued recommendations on the investigation and management of chronic hepatitis B, including the use of lamivudine, adefovir and interferon."	4.82	The management of chronic viral hepatitis: a Canadian consensus conference 2004. ( Bain, V; Cooper, C; Lowe, C; Martin, S; Myers, RP; Sherman, M; Villeneuve, JP, 2004)
"Data on long-term tenofovir alafenamide (TAF) therapy for pregnant women with active chronic hepatitis B (CHB) (immune clearance and reactivation phases, currently and previously diagnosed) and their infants are lacking."	4.12	Tenofovir Alafenamide for Pregnant Chinese Women With Active Chronic Hepatitis B: A Multicenter Prospective Study. ( Chen, ZM; Cui, GL; Feng, YH; Huang, S; Li, GM; Li, GT; Li, J; Li, W; Li, WZ; Li, ZQ; Liang, HX; Lin, WB; Liu, N; Liu, YM; Lv, J; Pan, YJ; Song, N; Sun, CY; Wang, FS; Wang, M; Xu, GH; Xu, JH; Yu, ZJ; Zeng, QL; Zeng, YL; Zhang, DW; Zhang, GF; Zhang, GQ; Zhang, HX; Zhang, JY; Zhou, YH, 2022)
"There are few data on the utility of tenofovir diphosphate (TFV-DP) in dried blood spots (DBSs) to predict future viral load (VL) in postpartum women with HIV on antiretroviral therapy (ART)."	4.12	Use of Tenofovir Diphosphate Levels to Predict Viremia During the Postpartum Period in Women Living With Human Immunodeficiency Virus (HIV): A Nested Case-Control Study. ( Allerton, J; Castillo-Mancilla, J; Hsiao, NY; Hu, NC; Kabanda, S; Lesosky, M; Malaba, TR; Myer, L; Odayar, J; Orrell, C; Phillips, TK; Wiesner, L, 2022)
"Tenofovir alafenamide (TAF) is a key component of HIV treatment, but pharmacokinetic data supporting the use of TAF during pregnancy are limited."	4.12	Pharmacokinetics 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."	4.12	Plasma 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)
"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."	4.12	Tenofovir 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)
"Entecavir (ETV) or adefovir dipivoxil (ADV) are not recommended during pregnancy because of embryotoxicity or teratogenicity found in animal studies; however, information on the safety of ETV or ADV in humans is limited."	4.12	Pregnancy outcomes for pregnant women with chronic hepatitis B exposing to entecavir or adefovir dipivoxil therapy before or in early pregnancy. ( Cai, H; Duan, X; Fu, D; Gao, X; Hu, Y; Kang, K; Liu, M; Yi, W; Zhou, M, 2022)
"To observe the clinical efficacy of combination therapy with peg-IFNalpha and adefovir (CPIA) in women who were hepatfis B virus (HBV) carriers and had just given birth and received telbivudine (LdT) during pregnancy for prevention of mother-to-child transmission."	3.81	[Efficacy of combination antiviral therapy following childbirth in pregnant HBV carriers receiving telbivudine for prevention of mother-to-child transmission]. ( Cao, ZH; Chen, XY; He, ZM; Jin, Y; Liu, YL; Lu, JF; Ma, LN; Zhang, SB, 2015)
"Chronic hepatitis B pregnant women with normal levels of ALT and high levels of HBV DNA were treated with Telbivudine during the third trimester of their pregnancy."	3.81	Effect of Peg-interferon α-2a combined with Adefovir in HBV postpartum women with normal levels of ALT and high levels of HBV DNA. ( Chen, X; Chen, Y; Du, X; Liu, Y; Lu, J; Ma, L; Ren, S; Shen, C; Zhang, H; Zhang, S, 2015)
"This is the first demonstration using an experimental model that maternal exposure to tenofovir DF during gestation results in overactivation of RAAS, up-regulation of renal sodium transporters and hypertension in the offspring."	3.81	Tenofovir during pregnancy in rats: a novel pathway for programmed hypertension in the offspring. ( Canale, D; Costa, Nde S; Gois, PH; Luchi, WM; Seguro, AC; Shimizu, MH; Veras, MM; Volpini, RA, 2015)
" These pregnant females developed lamivudine (LAM)- or telbivudine (LdT)-resistant chronic hepatitis B and received tenofovir (TDF) therapy (300 mg/d), and its curative effect, maternal and perinatal adverse events, fetal growth and development, and neonatal prognosis were evaluated."	3.81	Tenofovir rescue therapy in pregnant females with chronic hepatitis B. ( Cai, HD; Cao, YJ; Hu, YH; Liu, M; Yi, W, 2015)
"To determine whether maternal use of tenofovir disoproxil fumarate for treatment of HIV in pregnancy predicts fetal and infant growth."	3.79	Infant growth outcomes after maternal tenofovir disoproxil fumarate use during pregnancy. ( Huo, Y; Livingston, EG; Patel, K; Ransom, CE; Scott, GB; Siberry, GK; Watts, HD; Williams, P, 2013)
"Emerging international guidelines for the prevention of mother-to-child transmission of HIV infection across sub-Saharan Africa call for the initiation of a triple-drug antiretroviral regimen containing tenofovir, a potentially nephrotoxic agent, in all HIV-infected pregnant women at the first antenatal clinic visit."	3.79	Low prevalence of renal dysfunction in HIV-infected pregnant women: implications for guidelines for the prevention of mother-to-child transmission of HIV. ( Bekker, LG; Kamkuemah, M; Kaplan, R; Myer, L, 2013)
"To evaluate the effects of tenofovir disoproxil fumarate (TDF) use during late pregnancy to reduce hepatitis B virus (HBV) transmission in highly viremic mothers."	3.79	Efficacy and safety of tenofovir disoproxil fumarate in pregnancy for the prevention of vertical transmission of HBV infection. ( Ay, M; Ayaz, C; Barcin, T; Celen, MK; Dal, MS; Dal, T; Gulsun, S; Kalkanli, S; Kaya, S; Mert, D; Yildirim, N, 2013)
"To evaluate the association of tenofovir disoproxil fumarate (TDF) use during pregnancy with early growth parameters in HIV-exposed, uninfected (HEU) infants."	3.78	Safety of tenofovir use during pregnancy: early growth outcomes in HIV-exposed uninfected infants. ( DiMeglio, LA; Griner, R; Hazra, R; Jacobson, DL; Kacanek, D; Mendez, H; Miller, T; Mofenson, LM; Rich, KC; Seage, GR; Siberry, GK; Tassiopoulos, K; Watts, DH; Williams, PL, 2012)
"Recent studies have raised concerns about a change in rates of pregnancy among HIV-negative women exposed to tenofovir."	3.78	Tenofovir use and pregnancy among women initiating HAART. ( Firnhaber, C; Maskew, M; Sanne, I; Westreich, D, 2012)
"According to the European AIDS Clinical Society, tenofovir disoproxil fumarate can be used in HIV-infected pregnant women if started prior to pregnancy, although no data are available on the pharmacokinetics of tenofovir (TFV) during pregnancy."	3.78	Pregnancy-related effects on tenofovir pharmacokinetics: a population study with 186 women. ( Benaboud, S; Bouazza, N; Chappuy, H; Firtion, G; Foissac, F; Hirt, D; Launay, O; Pannier, E; Rey, E; Tréluyer, JM; Urien, S, 2012)
"To identify adverse effects of tenofovir use during pregnancy in HIV-infected women and their infants."	3.74	Adverse effects of tenofovir use in HIV-infected pregnant women and their infants. ( Hayes, E; Mondy, K; Nurutdinova, D; Onen, NF; Overton, ET, 2008)
"Tenofovir-related tubule damage characterized by Fanconi syndrome, renal insufficiency and nephrogenic diabetes insipidus has been reported in the adult HIV-infected population."	3.73	Nephrotoxicity in a child with perinatal HIV on tenofovir, didanosine and lopinavir/ritonavir. ( Hussain, S; Khayat, A; Rathore, MH; Tolaymat, A, 2006)
"Transgenic Mov-14 mice, which carry the provirus of Moloney murine leukemia virus (Mo-MuLV) in the germ line and begin to produce infectious virus on embryonic day 14, were used to evaluate the ability of 9-(2-phosphonylmethoxyethyl)adenine (PMEA) to cross the placenta and protect embryos from viremia."	3.68	Transplacental antiretroviral therapy with 9-(2-phosphonylmethoxyethyl)adenine is embryotoxic in transgenic mice. ( Balzarini, J; Bronson, R; De Clercq, E; Jaenisch, R; Lee, JS; Mullaney, S; Ruprecht, RM; Sharpe, AH, 1991)
"L-Alanosine [L-2-amino-3(N-hydroxy-N-nitrosamino)propionic acid], a tumor-inhibiting agent, induces pregnancy arrest after single or multiple SC or PO administration to rats and hamsters."	3.67	Contragestational profile of the tumor-inhibiting agent, L-alanosine, in the rat and the hamster. ( Assandri, A; Barone, D; Galliani, G; Grandi, M; Lancini, GC; Mistrello, G, 1985)
" Pharmacokinetic sampling was performed on cohort 1 and 3 mothers and all infants."	2.79	Pharmacokinetics and safety of tenofovir in HIV-infected women during labor and their infants during the first week of life. ( Emel, L; Eshleman, SH; Fowler, MG; George, K; Herron, C; Hudelson, SE; Joao, E; Kearney, B; Kreitchmann, R; Kumwenda, N; Mirochnick, M; Mofenson, L; Nielsen-Saines, K; Parsons, T; Pinto, J; Richardson, P; Santos, B; Sato, P; Taha, T, 2014)
"International Maternal Pediatric Adolescent AIDS Clinical Trials Group 1026s is a prospective, nonblinded, pharmacokinetic study of HIV-infected pregnant women taking antiretrovirals for clinical indications, including 2 cohorts (with or without tenofovir) receiving atazanavir/ritonavir 300/100 mg once daily during the second trimester, 400/100 mg during the third trimester, and 300/100 mg postpartum (PP)."	2.78	Pharmacokinetics of an increased atazanavir dose with and without tenofovir during the third trimester of pregnancy. ( Best, BM; Burchett, SK; Byroads, M; Caparelli, E; Cressey, TR; Hawkins, E; Kreitchmann, R; Mirochnick, M; Rossi, S; Shapiro, DE; Smith, E; Stek, A; Wang, J; Watts, DH, 2013)
"Pregnancy was assessed with monthly urine tests."	2.78	Women with pregnancies had lower adherence to 1% tenofovir vaginal gel as HIV preexposure prophylaxis in CAPRISA 004, a phase IIB randomized-controlled trial. ( Bangsberg, DR; Karim, QA; Mansoor, LE; Matthews, LT; Sibeko, S; Yende-Zuma, N, 2013)
" Twenty-four-hour pharmacokinetic curves were recorded in the third trimester (preferably week 33) and postpartum (preferably week 4-6)."	2.78	The pharmacokinetics, safety and efficacy of tenofovir and emtricitabine in HIV-1-infected pregnant women. ( Burger, DM; Colbers, AP; Giaquinto, C; Gingelmaier, A; Hawkins, DA; Ivanovic, J; Kabeya, K; Moltó, J; Rockstroh, JK; Sadiq, ST; Taylor, GP; Weizsäcker, K; Wyen, C, 2013)
"During follow-up, no bone fractures were reported to have occurred; 12/368 creatinines and seven out of 305 phosphates were grade one (16) or two (three) in 14 children with no effect of in utero tenofovir (p>0."	2.77	Pregnancy and infant outcomes among HIV-infected women taking long-term ART with and without tenofovir in the DART trial. ( Chidziva, E; Gibb, DM; Gilks, CF; Grosskurth, H; Hakim, J; Kizito, H; Kyomugisha, H; Munderi, P; Musoke, P; Nalumenya, R; Nathoo, K; Russell, EC; Spyer, M; Tumukunde, D; Walker, AS; Zalwango, E, 2012)
" A one-compartment model was used for mothers and neonates; the absorption rate constants for mothers and neonates were 0."	2.76	Population pharmacokinetics of nevirapine in HIV-1-infected pregnant women and their neonates. ( Arrivé, E; Avit, D; Benaboud, S; Blanche, S; Dabis, F; Ekouévi, DK; Gray, G; Hirt, D; McIntyre, J; Nerrienet, E; Rey, E; Sim, KL; Tréluyer, JM; Urien, S, 2011)
" All regimens were safe and well tolerated."	2.76	Pharmacokinetics and safety of single-dose tenofovir disoproxil fumarate and emtricitabine in HIV-1-infected pregnant women and their infants. ( Bardeguez, A; Cotter, A; Fiscus, SA; Flynn, PM; Heckman, B; Huang, S; Jean-Philippe, P; Kearney, B; Mirochnick, M; Mofenson, LM; Purswani, M; Robbins, B; Rodman, J; Rooney, JF; Shapiro, DE; Thorpe, E; Van Rompay, KK; Watts, DH, 2011)
" The median maternal peak concentration and cord blood TFV concentrations were 4."	2.76	Pharmacokinetics and placental transfer of single-dose tenofovir 1% vaginal gel in term pregnancy. ( Beigi, R; Chen, J; Hendrix, CW; Kunjara Na Ayudhya, RP; Macio, I; Mâsse, B; Noguchi, L; Parsons, T; Piper, J; Valentine, M; Watts, DH, 2011)
" No increase in the overall adverse event rates was observed."	2.75	Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. ( Abdool Karim, Q; Abdool Karim, SS; Arulappan, N; Baxter, C; Frohlich, JA; Gengiah, TN; Grobler, AC; Kharsany, AB; Maarschalk, S; Mansoor, LE; Mlisana, KP; Mlotshwa, M; Morris, L; Omar, Z; Sibeko, S; Taylor, D, 2010)
"Increased risk of lactic acidosis has also been described for those with impaired liver and renal function taking entecavir."	2.50	Extrahepatic effects of nucleoside and nucleotide analogues in chronic hepatitis B treatment. ( Fung, J; Lai, CL; Seto, WK; Yuen, MF, 2014)
"Should treatment of chronic hepatitis B virus infection be necessary during pregnancy, tenofovir, listed by the FDA as pregnancy category B drug, is to be preferred."	2.49	[Interdisciplinary aspects of and new drugs for chronic hepatitis B]. ( Horváth, G, 2013)
"Specialized treatment of CHB in pregnancy, coinfection, decompensated cirrhosis, and posttransplant is safe and effective."	2.48	New advances in chronic hepatitis B. ( Lee, WM; Tujios, SR, 2012)
" More comprehensive in vivo pharmacokinetic data are required to justify the potential use of these agents as safe and effective options during pregnancy."	2.47	Pharmacokinetics of antiretroviral drugs in anatomical sanctuary sites: the fetal compartment (placenta and amniotic fluid). ( Back, DJ; Else, LJ; Khoo, SH; Taylor, S, 2011)
"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."	1.62	Pharmacokinetics 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)
" Potentially, lower IFN-α and IP-10 levels as well as once-weekly intranasal dosing vs daily subcutaneous or intramuscular dosing with recombinant type I IFNs could explain the lack of pregnancy effects; however, there was an undesired impact on offspring immune function."	1.62	GSK2245035, a TLR7 agonist, Does Not Increase Pregnancy Loss in Cynomolgus Monkeys. ( Baker, A; Bray, M; Hillegas, AE; Maier, CC; Phadnis-Moghe, AS; Posobiec, LM; Price, MA; Stanislaus, DJ, 2021)
"Preeclampsia is a devastating hypertensive disorder of pregnancy with unknown mechanism."	1.56	The Inhibition of Protein Kinase C β Contributes to the Pathogenesis of Preeclampsia by Activating Autophagy. ( Cui, Y; Gong, L; Jing, T; Li, X; Lu, H; Ma, D; Tang, Y; Wu, S; Xiao, X; Xu, H; Zhang, J; Zhao, H; Zhou, Q, 2020)
" Secondary assessments included maternal HBV DNA reduction at delivery, and maternal or infant adverse events during follow up."	1.56	Efficacy and safety of tenofovir alafenamide fumarate for preventing mother-to-child transmission of hepatitis B virus: a national cohort study. ( Cao, L; Chen, B; Chen, R; Ding, Y; Fan, J; Gan, W; Huang, Y; Lin, C; Liu, Y; Pan, CQ; Sheng, Q; Wang, S; Wang, Y; Zhu, L, 2020)
"Adenosine is an important neuromodulator, that has been indicated to be affected by acute and chronic exposure to ethanol."	1.56	Inhibition of ecto-5'-nucleotidase and adenosine deaminase is able to reverse long-term behavioural effects of early ethanol exposure in zebrafish (Danio rerio). ( Da Silva, RS; Lutte, AH; Majolo, JH, 2020)
"Pregnancy is a time of increased HIV acquisition risk and pregnancy reduces concentrations of antiretrovirals used for treatment."	1.48	Tenofovir and tenofovir-diphosphate concentrations during pregnancy among HIV-uninfected women using oral preexposure prophylaxis. ( Anderson, PL; Asiimwe, S; Baeten, JM; Bukusi, EA; Celum, C; Donnell, D; Haberer, JE; Heffron, R; Hendrix, CW; Katabira, E; Marzinke, MA; Mugo, NR; Mugwanya, K; Pyra, M; Thomas, KK, 2018)
"This retrospective investigation carried out in Guangdong Province indicated that not only are anti-HBV drugs efficacious for blocking vertical transmission of HBV but also are safe for both mothers and infants when taken by fathers or mothers during the reproduction phases of insemination and pregnancy."	1.40	[Retrospective analysis of the efficacy and safety of anti-hepatitis B virus drugs taken during pregnancy in women from the Guangdong Province]. ( Chen, X; Gao, W; Li, D; Peng, J; Wen, F; Xia, J; Xu, C; Xu, M; Yao, Z, 2014)
"Primary outcomes were major birth defects rates with exposure to all antivirals, individual classes, and drugs compared to population-based controls."	1.38	Hepatitis B virus and human immunodeficiency virus drugs in pregnancy: findings from the Antiretroviral Pregnancy Registry. ( Aguilar, C; Brown, RS; Buti, M; Fagan, EA; Leu, CS; Pereira, MR; Tilson, HH; Verna, EC, 2012)
"New insights into the treatment of chronic hepatitis B with relevance for clinical practice have been adopted in these concise, revised guidelines."	1.38	The 2012 revised Dutch national guidelines for the treatment of chronic hepatitis B virus infection. ( Baak, BC; Bakker, CM; Beuers, UH; Brouwer, JT; Buster, EH; Drenth, JP; Honkoop, P; Janssen, HL; Kerbert-Dreteler, MJ; Koek, GH; Tan, AC; van der Spek, BW; van Erpecum, KJ; van Hoek, B; van Nieuwkerk, KM; van Soest, H; Vrolijk, JM, 2012)
" To summarize, the pharmacokinetic profile of efavirenz remained similar in the pregnant and non-pregnant rats."	1.38	Pharmacokinetic profiling of efavirenz-emtricitabine-tenofovir fixed dose combination in pregnant and non-pregnant rats. ( Bhyrapuneni, G; Kandikere, V; Komarneni, P; Muddana, N; Mudigonda, K; Mukkanti, K; Nirogi, R; Saralaya, R, 2012)
"Npt2b(+/+) mice with adenine-induced renal failure had hyperphosphatemia and high plasma creatinine levels."	1.37	Inorganic phosphate homeostasis in sodium-dependent phosphate cotransporter Npt2b⁺/⁻ mice. ( Aranami, F; Fukushima, N; Furutani, J; Hanabusa, E; Horiba, N; Jishage, K; Kakefuda, M; Kaneko, I; Kawase, Y; Kido, S; Kuwahara, S; Matsumoto, K; Miyamoto, K; Mukai, T; Ohi, A; Ohtomo, S; Oikawa, Y; Sasaki, S; Segawa, H; Tachibe, T; Tateishi, H; Tatsumi, S; Tominaga, R; Ueda, O; Wada, NA, 2011)
"Risks of breast cancer associated with low-penetrance susceptibility polymorphisms do not vary significantly with these ten established environmental risk factors."	1.36	Gene-environment interactions in 7610 women with breast cancer: prospective evidence from the Million Women Study. ( Baker, K; Bell, J; Beral, V; Bull, D; Green, J; Lathrop, M; Peto, R; Reeves, GK; Tipper, SJ; Travis, RC; Zelenika, D, 2010)
"6-h half-life (30%)."	1.35	Population pharmacokinetics of emtricitabine in human immunodeficiency virus type 1-infected pregnant women and their neonates. ( Arrivé, E; Avit, D; Blanche, S; Coffié, P; Dabis, F; Ekouévi, DK; Hirt, D; Lalsab, S; Leang, SK; McIntyre, J; Nerrienet, E; Rey, E; Tréluyer, JM; Urien, S, 2009)
" The likelihood of renal toxicity (proximal renal tubular dysfunction [PRTD]) correlated with plasma drug concentrations, which depended on the dosage regimen and age-related changes in drug clearance."	1.35	Chronic administration of tenofovir to rhesus macaques from infancy through adulthood and pregnancy: summary of pharmacokinetics and biological and virological effects. ( Abel, K; Bischofberger, N; Brignolo, LL; Cihlar, T; Durand-Gasselin, L; Jerome, C; Kearney, BP; Marthas, ML; Moore, J; Ray, AS; Reiser, H; Spinner, A; Van Rompay, KK, 2008)
"Levcromakalim was equally effective in inhibiting contractions of rings from all 3 groups."	1.31	Role of nucleotide cyclases in the inhibition of pregnant rat uterine contractions by the openers of potassium channels. ( Chwalisz, K; Garfield, RE; Longo, M; Okawa, T; Saade, GR; Vedernikov, YP, 2000)
"Adenosine failed to inhibit hypoxanthine uptake."	1.30	Hypoxanthine uptake at the fetal side of human placenta proceeds through a nucleobase-preferring carrier and a non-saturable process. ( Acevedo, CG; Bravo, I; Ramírez, M; Rojas, S, 1997)
"Monensin prevented the increase in thromboplastin activity at 68 hr as well as at 90-96 hr."	1.27	Effect of some drugs on thromboplastin activity in mouse trophoblast cells in vitro and in vivo. ( Dalaker, K; Prydz, H, 1986)
"Adenine incorporation was an order of magnitude higher than that of formate in both first and third trimester cells, and significantly (P less than 0."	1.27	Pathways of purine nucleotide synthesis in the human trophoblast early and late in gestation. ( Vettenranta, K, 1988)

Research

Studies (255)

Authors

Clinical Trials (33)

Trial Overview

Trial Outcomes

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

Timeframe	Studies, this research(%)	All Research%
pre-1990	60 (23.53)	18.7374
1990's	27 (10.59)	18.2507
2000's	39 (15.29)	29.6817
2010's	97 (38.04)	24.3611
2020's	32 (12.55)	2.80

Authors	Studies
Joseph, NT	1
Satten, GA	1
Williams, RE	1
Haddad, LB	1
Jamieson, DJ	2
Sheth, AN	1
Badell, ML	1
Bukkems, VE	1
Necsoi, C	1
Hidalgo Tenorio, C	1
Garcia, C	1
Alba Alejandre, I	1
Weiss, F	1
Lambert, JS	1
van Hulzen, A	1
Richel, O	1
Te Brake, LHM	1
van der Meulen, E	1
Burger, D	1
Konopnicki, D	1
Colbers, A	1
Abuogi, LL	1
Castillo-Mancilla, J	2
Hampanda, K	1
Owuor, K	1
Odwar, T	1
Onono, M	1
Helova, A	1
Turan, JM	1
Anderson, PL	3
Zeng, QL	1
Zhang, HX	1
Zhang, JY	1
Huang, S	4
Li, WZ	1
Li, GM	1
Pan, YJ	1
Feng, YH	1
Li, ZQ	1
Zhang, GF	1
Xu, JH	1
Lin, WB	1
Xu, GH	1
Liu, N	1
Zhang, GQ	1
Li, GT	1
Li, W	4
Zeng, YL	1
Song, N	1
Wang, M	1
Zhang, DW	1
Chen, ZM	1
Cui, GL	1
Li, J	8
Lv, J	1
Liu, YM	1
Liang, HX	1
Sun, CY	1
Zhou, YH	2
Yu, ZJ	1
Wang, FS	1
Odayar, J	1
Orrell, C	1
Phillips, TK	1
Hu, NC	1
Kabanda, S	1
Malaba, TR	1
Allerton, J	1
Wiesner, L	2
Hsiao, NY	1
Lesosky, M	1
Myer, L	2
Brooks, KM	4
Pinilla, M	2
Stek, AM	3
Shapiro, DE	4
Barr, E	2
Febo, IL	2
Paul, ME	1
Deville, JG	2
George, K	3
Knowles, K	2
Rungruengthanakit, K	2
Browning, R	1
Chakhtoura, N	5
Capparelli, EV	3
Mirochnick, M	8
Best, BM	4
Du, R	1
Bai, Y	1
Li, L	5
Kayes, T	1
Crane, H	1
Symonds, A	1
Dumond, J	1
Cottrell, M	1
Di Girolamo, J	1
Manandhar, S	1
Lim, TH	1
Gane, E	1
Kashuba, A	1
Levy, MT	3
Parveen, S	1
Tiwari, A	1
Singh, J	1
Shah, A	1
Kumar, M	1
Moodley, D	1
Lombard, C	1
Govender, V	1
Naidoo, M	1
Desmond, AC	1
Naidoo, K	1
Mhlongo, O	1
Sebitloane, M	1
Newell, ML	1
Clark, R	1
Rooney, JF	6
Gray, G	6
Chinula, L	2
Ziemba, L	2
Brummel, S	1
McCarthy, K	2
Coletti, A	2
Krotje, C	2
Johnston, B	3
Moyo, S	2
Stranix-Chibanda, L	3
Hoffman, R	1
Sax, PE	2
Stringer, J	1
Jean-Philippe, P	3
Korutaro, V	3
Cassim, H	2
Fairlie, L	3
Masheto, G	2
Boyce, C	1
Frenkel, LM	3
Amico, KR	4
Purdue, L	2
Shapiro, R	1
Mmbaga, BT	2
Patel, F	1
van Wyk, J	1
Currier, JS	2
Lockman, S	3
D'Andrea, S	1
Pallotti, F	1
Senofonte, G	1
Castellini, C	1
Paoli, D	1
Lombardo, F	1
Lenzi, A	1
Francavilla, S	1
Francavilla, F	1
Barbonetti, A	1
Aizire, J	1
Flynn, PM	2
Butler, K	1
Kiser, JJ	1
Siberry, GK	3
Fenton, T	1
Cababasay, M	1
Fowler, MG	2
Gao, X	1
Duan, X	1
Cai, H	1
Hu, Y	3
Liu, M	4
Kang, K	1
Zhou, M	1
Fu, D	1
Yi, W	2
Eke, AC	1
Gebreyohannes, RD	1
Sheffield, JS	1
Dooley, KE	1
Halim, AA	1
Alsayed, B	1
Embarak, S	1
Yaseen, T	1
Dabbous, S	1
Fontaine, O	1
Dueluzeau, R	1
Raibaud, P	1
Chabanet, C	1
Popoff, MR	1
Badoual, J	1
Gabilan, JC	1
Andremont, A	1
Gómez, L	1
Andrés, S	1
Sánchez, J	2
Alonso, JM	1
Rey, J	1
López, F	1
Jiménez, A	1
Yan, Z	1
Zhou, L	1
Zhao, Y	5
Wang, J	7
Huang, L	2
Hu, K	1
Liu, H	5
Wang, H	3
Guo, Z	1
Song, Y	1
Huang, H	4
Yang, R	1
Owen, TW	1
Al-Kaysi, RO	1
Bardeen, CJ	1
Cheng, Q	1
Wu, S	2
Cheng, T	1
Zhou, X	1
Wang, B	4
Zhang, Q	4
Wu, X	2
Yao, Y	3
Ochiai, T	1
Ishiguro, H	2
Nakano, R	2
Kubota, Y	2
Hara, M	1
Sunada, K	1
Hashimoto, K	1
Kajioka, J	1
Fujishima, A	1
Jiao, J	3
Gai, QY	3
Wang, W	2
Zang, YP	2
Niu, LL	2
Fu, YJ	3
Wang, X	6
Yao, LP	1
Qin, QP	1
Wang, ZY	1
Liu, J	5
Aleksic Sabo, V	1
Knezevic, P	1
Borges-Argáez, R	1
Chan-Balan, R	1
Cetina-Montejo, L	1
Ayora-Talavera, G	1
Sansores-Peraza, P	1
Gómez-Carballo, J	1
Cáceres-Farfán, M	1
Jang, J	1
Akin, D	1
Bashir, R	1
Yu, Z	1
Zhu, J	2
Jiang, H	1
He, C	2
Xiao, Z	1
Xu, J	2
Sun, Q	1
Han, D	1
Lei, H	1
Zhao, K	2
Zhu, L	2
Li, X	5
Fu, H	2
Wilson, BK	1
Step, DL	1
Maxwell, CL	1
Gifford, CA	1
Richards, CJ	1
Krehbiel, CR	1
Warner, JM	1
Doerr, AJ	1
Erickson, GE	1
Guretzky, JA	1
Rasby, RJ	1
Watson, AK	1
Klopfenstein, TJ	1
Sun, Y	4
Liu, Z	3
Pham, TD	1
Lee, BK	1
Yang, FC	1
Wu, KH	1
Lin, WP	1
Hu, MK	1
Lin, L	3
Shao, J	1
Sun, M	1
Xu, G	1
Zhang, X	6
Xu, N	1
Wang, R	1
Liu, S	1
He, H	1
Dong, X	2
Yang, M	2
Yang, Q	1
Duan, S	1
Yu, Y	2
Han, J	2
Zhang, C	4
Chen, L	2
Yang, X	1
Wang, T	2
Campbell, DA	1
Gao, K	1
Zager, RA	1
Johnson, ACM	1
Guillem, A	1
Keyser, J	1
Singh, B	1
Steubl, D	1
Schneider, MP	1
Meiselbach, H	1
Nadal, J	1
Schmid, MC	1
Saritas, T	1
Krane, V	1
Sommerer, C	1
Baid-Agrawal, S	1
Voelkl, J	1
Kotsis, F	1
Köttgen, A	1
Eckardt, KU	1
Scherberich, JE	1
Li, H	4
Yao, L	2
Sun, L	3
Zhu, Z	1
Naren, N	1
Zhang, XX	2
Gentile, GL	1
Rupert, AS	1
Carrasco, LI	1
Garcia, EM	1
Kumar, NG	1
Walsh, SW	1
Jefferson, KK	1
Guest, RL	1
Samé Guerra, D	1
Wissler, M	1
Grimm, J	1
Silhavy, TJ	1
Lee, JH	2
Yoo, JS	1
Kim, Y	1
Kim, JS	2
Lee, EJ	1
Roe, JH	1
Delorme, M	1
Bouchard, PA	1
Simon, M	1
Simard, S	1
Lellouche, F	1
D'Urzo, KA	1
Mok, F	1
D'Urzo, AD	1
Koneru, B	1
Lopez, G	1
Farooqi, A	1
Conkrite, KL	1
Nguyen, TH	1
Macha, SJ	1
Modi, A	1
Rokita, JL	1
Urias, E	1
Hindle, A	1
Davidson, H	1
Mccoy, K	1
Nance, J	1
Yazdani, V	1
Irwin, MS	1
Yang, S	1
Wheeler, DA	1
Maris, JM	1
Diskin, SJ	1
Reynolds, CP	1
Abhilash, L	1
Kalliyil, A	1
Sheeba, V	1
Hartley, AM	2
Meunier, B	2
Pinotsis, N	1
Maréchal, A	2
Xu, JY	1
Genko, N	1
Haraux, F	1
Rich, PR	1
Kamalanathan, M	1
Doyle, SM	1
Xu, C	2
Achberger, AM	1
Wade, TL	1
Schwehr, K	1
Santschi, PH	1
Sylvan, JB	1
Quigg, A	1
Leong, W	1
Xu, W	2
Gao, S	1
Zhai, X	1
Wang, C	2
Gilson, E	1
Ye, J	1
Lu, Y	1
Yan, R	1
Zhang, Y	8
Hu, Z	1
You, Q	1
Cai, Q	1
Yang, D	1
Gu, S	1
Dai, H	1
Zhao, X	2
Gui, C	1
Gui, J	1
Wu, PK	1
Hong, SK	1
Starenki, D	1
Oshima, K	1
Shao, H	1
Gestwicki, JE	1
Tsai, S	1
Park, JI	1
Wang, Y	9
Zhao, R	1
Gu, Z	1
Dong, C	2
Guo, G	1
Barrett, HE	1
Meester, EJ	1
van Gaalen, K	1
van der Heiden, K	1
Krenning, BJ	1
Beekman, FJ	1
de Blois, E	1
de Swart, J	1
Verhagen, HJ	1
Maina, T	1
Nock, BA	1
Norenberg, JP	1
de Jong, M	1
Gijsen, FJH	1
Bernsen, MR	1
Martínez-Milla, J	1
Galán-Arriola, C	1
Carnero, M	1
Cobiella, J	1
Pérez-Camargo, D	1
Bautista-Hernández, V	1
Rigol, M	1
Solanes, N	1
Villena-Gutierrez, R	1
Lobo, M	1
Mateo, J	1
Vilchez-Tschischke, JP	1
Salinas, B	1
Cussó, L	1
López, GJ	1
Fuster, V	1
Desco, M	1
Sanchez-González, J	1
Ibanez, B	1
van den Berg, P	1
Schweitzer, DH	1
van Haard, PMM	1
Geusens, PP	1
van den Bergh, JP	1
Zhu, X	1
Huang, X	4
Xu, H	3
Yang, G	2
Lin, Z	1
Salem, HF	1
Nafady, MM	1
Kharshoum, RM	1
Abd El-Ghafar, OA	1
Farouk, HO	1
Domiciano, D	1
Nery, FC	1
de Carvalho, PA	1
Prudente, DO	1
de Souza, LB	1
Chalfun-Júnior, A	1
Paiva, R	1
Marchiori, PER	1
Lu, M	2
An, Z	1
Jiang, J	2
Du, S	1
Zhou, H	1
Cui, J	1
Wu, W	1
Liu, Y	10
Song, J	1
Lian, Q	1
Uddin Ahmad, Z	1
Gang, DD	1
Konggidinata, MI	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Pharmacokinetic Properties of Antiretroviral and Related Drugs During Pregnancy and Postpartum[NCT00042289]		1,578 participants (Actual)	Observational	2003-06-09	Completed
Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for Primary HIV Prevention During Pregnancy and Postpartum in Adolescents and Young Women and Their Infants[NCT03386578]	Phase 2	390 participants (Actual)	Interventional	2018-07-03	Active, not recruiting
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 3	643 participants (Actual)	Interventional	2018-01-19	Completed
Changes in Weight and Body Composition After Switch to Dolutegravir/Lamivudine Compared to Continued Dolutegravir/Abacavir/Lamivudine for Virologically Suppressed HIV Infection: A Randomized Open-label Superiority Trial: AVERTAS-1[NCT04904406]	Phase 4	95 participants (Anticipated)	Interventional	2020-10-22	Recruiting
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 3	1,110 participants (Actual)	Interventional	2017-01-16	Completed
Can the Weight Gain Associated With Use of Integrase Strand Inhibitors be Halted or Reversed With a Switch to Doravirine/Lamivudine/Tenofovir DF in Patients Living With HIV? (DeLiTE)[NCT04665375]	Phase 4	25 participants (Anticipated)	Interventional	2021-04-26	Enrolling by invitation
Phase IIb Trial to Assess the Safety and Effectiveness of the Vaginal Microbicide 1% Tenofovir Gel for the Prevention of HIV Infection in Women in South Africa[NCT00441298]	Phase 2	889 participants (Actual)	Interventional	2007-05-31	Completed
Pre-Exposure Prophylaxis and Timed Intercourse for HIV-Discordant Couples[NCT02572505]		0 participants (Actual)	Interventional	2015-11-30	Withdrawn
Assessing the Feasibility and Acceptability of a Peer Outreach and Navigation Intervention to Increase Pre-exposure Prophylaxis Uptake Among Women at High Risk for HIV[NCT03226873]		66 participants (Actual)	Interventional	2017-11-16	Completed
Prevention of Mother-to-child Transmission of Hepatitis B Virus: a One Arm, Open Label Intervention Study to Estimate the Optimal Timing of Tenofovir (TDF) in Pregnancy[NCT02995005]	Phase 1/Phase 2	98 participants (Actual)	Interventional	2018-05-24	Completed
Pilot of an mHealth-enhanced, Safer Conception Intervention to Reduce HIV-1 Risk Among Kenyan HIV-1 Serodiscordant Couples[NCT03030768]		74 participants (Actual)	Observational	2016-02-29	Completed
Chronic HBV Infection in Pregnant Women Taking TAF to Prevent Mother-to-child Transmission in the Third Trimester: a Multicenter, Prospective Study[NCT04237376]		600 participants (Anticipated)	Observational	2019-04-09	Recruiting
Addition of Single-dose, Maternal Tenofovir and Emtricitabine to Reduce Non-nucleoside Reverse Transcriptase Inhibitor Resistance Mutations in the Setting of Zidovudine and Nevirapine for Prevention of Mother-to-child HIV Transmission[NCT00204308]	Phase 2	400 participants (Actual)	Interventional	2005-03-31	Completed
Phase 2 Expanded Safety Study of Tenofovir Gel in Pregnancy[NCT01490671]	Phase 2	0 participants (Actual)	Interventional		Withdrawn
Maternal and Infant Monitoring for Evidence of Toxicity Related to Tenofovir Exposure: The Bone and Kidney Health Substudy of the IMPAACT 1077 PROMISE Protocol (Promoting Maternal and Infant Survival Everywhere)[NCT01066858]		1,765 participants (Actual)	Observational	2011-03-22	Completed
Study of Placental Transfer of Tenofovir and Its Factors of Variability Using the Human Placental Perfusion Model[NCT02020083]		369 participants (Actual)	Observational	2013-02-28	Completed
Phase II Trial, Multicentre, Opened Label Evaluating the Pharmacokinetics and the Safety and Toxicity of the Tenofovir-Emtricitabine Combination in Pregnant Women and Infants in Africa and Asia[NCT00334256]	Phase 2	72 participants (Actual)	Interventional	2006-10-31	Completed
Assess the Performance of Metagenomic Sequencing in the Diagnosis of STI (NGS-IST)[NCT05581160]		332 participants (Anticipated)	Interventional	2022-07-11	Recruiting
Open Label Randomized Controlled Trial to Assess the Impact of Prophylactic Exposure to Tenofovir Gel on the Efficacy of Subsequent Tenofovir-containing Antiretroviral Therapy on Viral Suppression[NCT01387022]		59 participants (Actual)	Interventional	2011-06-30	Completed
Open-Label Randomized Controlled Trial to Assess the Implementation Effectiveness and Safety of 1% Tenofovir Gel Provision Through Family Planning Services in KwaZulu-Natal, South Africa[NCT01691768]	Phase 2/Phase 3	372 participants (Actual)	Interventional	2012-10-31	Completed
Optimal Combination Therapy After Nevirapine Exposure[NCT00089505]	Phase 3	745 participants (Actual)	Interventional	2006-11-30	Completed
Phase I Study of the Maternal Single-Dose Pharmacokinetics and Placental Transfer of Tenofovir 1% Vaginal Gel Among Healthy Term Gravidas[NCT00540605]	Phase 1	21 participants (Actual)	Interventional		Completed
Surveillance Monitoring for ART Toxicities Study in HIV Uninfected Children Born to HIV Infected Women[NCT01310023]		3,400 participants (Anticipated)	Observational	2007-03-31	Recruiting
A Multilevel Gaming Intervention for Persons on PrEP[NCT02611362]		82 participants (Actual)	Interventional	2015-04-30	Completed
Connecting Resources for Urban Sexual Health[NCT02183909]		380 participants (Actual)	Interventional	2013-05-31	Completed
Parallel Comparison of Tenofovir and Emtricitabine/Tenofovir Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples[NCT00557245]	Phase 3	4,758 participants (Actual)	Interventional	2008-05-31	Completed
Self-Test Strategies and Linkage Incentives to Improve ART and PrEP Uptake in Men[NCT04772469]		1,509 participants (Actual)	Interventional	2021-03-22	Completed
HPTN 076 - Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278 LA, for Pre-Exposure Prophylaxis (PrEP)[NCT02165202]	Phase 2	136 participants (Actual)	Interventional	2014-10-31	Completed
Immunogenetic Modulators of Mucosal Protection From HIV-1: The Kinga Study[NCT03701802]		812 participants (Actual)	Observational	2018-09-27	Completed
PC4PrEP: Integrating Pre-Exposure Prophylaxis (PrEP) Into Primary Care[NCT03617874]		22 participants (Actual)	Interventional	2020-02-28	Completed
Improving HIV Prevention Among Adolescent Girls and Young Women (AGYW) in Uganda[NCT05516602]		314 participants (Anticipated)	Interventional	2023-01-12	Recruiting
Comparative Effectiveness of Individual Versus Group-level Interventions to Reduce HIV Risk Among African Immigrant Women[NCT06022809]		424 participants (Anticipated)	Interventional	2023-10-25	Not yet recruiting
Study on Pharmacokinetics of Newly Developed ANtiretroviral Agents in HIV-infected pregNAnt Women (PANNA)[NCT00825929]		176 participants (Anticipated)	Observational	2009-02-28	Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

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.

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

Intervention	hour (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

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.

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

Intervention	unitless (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

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.

Plasma Concentration for Contraceptives

Intervention	unitless (Median)
TAF 10mg q.d. w/COBI	0.97
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

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

Area Under the Curve From 0 to 12 Hours (AUC12) of ARVs for Contraceptive Arms

Intervention	pg/mL (Median)
ATV/RTV/TFV 300/100/300mg q.d. With ENG	604
LPV/RTV 400/100 b.i.d. With ENG	428
EFV 600mg q.d. With ENG	125

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.

Area Under the Curve From 0 to 24 Hours (AUC24) of ARVs for Contraceptive Arms

Intervention	mcg*hr/mL (Median)
	Before contraceptive initiation	After contraceptive initiation
LPV/RTV 400/100 b.i.d. With ENG	115.97	100.20

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.

Number of Women Who Met PK Target of Area Under the Curve (AUC) for ARVs

Intervention	mcg*hr/mL (Median)
	Before contraceptive initiation	After contraceptive initiation
ATV/RTV/TFV 300/100/300mg q.d. With ENG	53.96	55.25
EFV 600mg q.d. With ENG	53.64	56.65

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.

Number of Women Who Met PK Target of Area Under the Curve (AUC) for ARVs

Intervention	Participants (Count of Participants)
	3rd Trimester	Postpartum
EFV 600mg q.d.	20	21
MVC 150 or 300mg b.i.d.	8	7

Pharmacokinetic (PK) Parameter: Infant Plasma Washout Concentration of ARVs and TB Drugs

Intervention	Participants (Count of Participants)
	2nd Trimester	3rd Trimester	Postpartum
ATV/RTV Arm 1: 300/100mg q.d.	1	12	12
DRV/COBI 800/150 mg q.d.	3	4	14
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.	7	16	22
DRV/RTV 600/100mg b.i.d.	7	19	22
DRV/RTV 800/100mg q.d.	9	19	22
DTG 50mg q.d.	9	20	23
EFV 600 mg q.d. (Outside THA)	12	33	34
ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.	8	29	27
ETR 200mg b.i.d.	5	13	7
EVG/COBI 150/150mg q.d.	8	10	18
FPV/RTV 700/100mg b.i.d.	8	26	22
IDV/RTV Arm 2: 400/100mg q.d. (Only THA)	10	19	26
LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d.	9	30	27
ATV/COBI 300/150 mg q.d.	1	2	5
NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.	NA	15	14
RAL 400mg b.i.d.	11	33	30
RPV 25mg q.d.	14	26	25
TAF 10mg q.d. w/COBI	15	23	22
TAF 25mg q.d.	13	23	24
TAF 25mg q.d. w/COBI or RTV Boosting	10	24	18
TFV 300mg q.d.	2	27	27
TFV/ATV/RTV Arm 1: 300/300/100mg q.d.	1	11	12
TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.	7	23	32

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.

PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Geometric Mean (95% CI) for ARVs and TB Drugs

Intervention	mcg/mL (Median)
	2-10 hours after birth	18-28 hours after birth	36-72 hours after birth	5-9 days after birth
DRV/COBI 800/150 mg q.d.	0.35	1.43	1.87	1.72
DTG 50mg q.d.	1.73	1.53	1.00	0.06
EFV 600 mg q.d. (Outside THA)	1.1	1.0	0.9	0.4
EVG/COBI 150/150mg q.d.	0.132	0.032	0.005	0.005

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.

PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (IQR) for ARVs and TB Drugs

Intervention	ng*hour/mL (Geometric Mean)
	2nd Trimester	3rd Trimester	Postpartum
MVC 150 or 300mg b.i.d.	NA	2717	3645

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.

PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (Range) for ARVs and TB Drugs

Intervention	mg*hour/L (Median)
	2nd Trimester	3rd Trimester	Postpartum
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.	55.1	51.8	79.6
DRV/RTV 600/100mg b.i.d.	45.8	45.9	61.7
FPV/RTV 700/100mg b.i.d.	43.50	32.15	51.60
NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.	NA	34.2	33.5

PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (IQR) for ARVs and TB Drugs

Intervention	mg*hour/L (Median)
	2nd Trimester	3rd Trimester	Postpartum
ETR 200mg b.i.d.	4.5	8.3	5.3
IDV/RTV Arm 2: 400/100mg q.d. (Only THA)	14.9	16.1	27.1
LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d.	72	96	133
RAL 400mg b.i.d.	6.6	5.4	11.6

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.

PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (Range) for ARVs and TB Drugs

Intervention	mg*hour/L (Median)
	2nd Trimester	3rd Trimester	Postpartum
ATV/COBI 300/150 mg q.d.	25.33	18.85	36.20
ATV/RTV Arm 1: 300/100mg q.d.	88.2	41.9	57.9
ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.	30.6	45.7	48.8
DRV/COBI 800/150 mg q.d.	50.00	42.05	95.55
DRV/RTV 800/100mg q.d.	64.6	63.5	103.9
DTG 50mg q.d.	47.6	49.2	65.0
EFV 600 mg q.d. (Outside THA)	47.30	60.02	62.70
EVG/COBI 150/150mg q.d.	15.3	14.0	21.0
TAF 10mg q.d. w/COBI	0.197	0.206	0.216
TAF 25mg q.d.	0.171	0.212	0.271
TAF 25mg q.d. w/COBI or RTV Boosting	0.181	0.257	0.283
TFV 300mg q.d.	1.9	2.4	3.0
TFV/ATV/RTV Arm 1: 300/300/100mg q.d.	14.5	28.8	39.6
TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.	26.2	37.7	58.7

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.

PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (Range) for ARVs and TB Drugs

Intervention	mg*hour/L (Median)
	3rd Trimester	Postpartum
EFV 600mg q.d.	55.4	58.3

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.

PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (IQR) for ARVs and TB Drugs

Intervention	mg*hour/L (Median)
	2nd Trimester	3rd Trimester	Postpartum
RPV 25mg q.d.	1.969	1.669	2.387

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.

PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (IQR) for ARVs and TB Drugs

Intervention	mg/L (Median)
	3rd Trimester	Postpartum
EFV 600mg q.d.	5.44	5.10

PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (Range) for ARVs and TB Drugs

Intervention	mg/L (Median)
	2nd Trimester	3rd Trimester	Postpartum
ATV/COBI 300/150 mg q.d.	2.82	2.20	3.90
ATV/RTV Arm 1: 300/100mg q.d.	NA	3.6	4.1
ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.	3.11	4.51	4.52
DRV/COBI 800/150 mg q.d.	4.59	3.67	7.04
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.	6.22	6.55	8.96
DRV/RTV 600/100mg b.i.d.	5.64	5.53	7.78
DRV/RTV 800/100mg q.d.	6.77	5.78	8.11
DTG 50mg q.d.	3.62	3.54	4.85
EFV 600 mg q.d. (Outside THA)	3.87	5.13	4.41
FPV/RTV 700/100mg b.i.d.	5.61	5.12	6.75
IDV/RTV Arm 2: 400/100mg q.d. (Only THA)	3.89	3.62	5.37
NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.	NA	5.1	5.0
TFV 300mg q.d.	0.250	0.245	0.298
TFV/ATV/RTV Arm 1: 300/300/100mg q.d.	1.2	2.5	4.1
TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.	2.73	3.56	5.43

PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (95% CI) for ARVs and TB Drugs

Intervention	mg/L (Median)
	2nd Trimester	3rd Trimester	Postpartum
ETR 200mg b.i.d.	0.70	1.01	0.63
LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d.	8.4	10.7	14.6
RAL 400mg b.i.d.	2.250	1.770	3.035
RPV 25mg q.d.	0.145	0.134	0.134

PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (IQR) for ARVs and TB Drugs

Intervention	ng/mL (Median)
	3rd Trimester	Postpartum
MVC 150 or 300mg b.i.d.	448	647

PK Parameter: Trough Concentration (C12) With Geometric Mean (95% CI) for ARVs and TB Drugs

Intervention	ng/mL (Median)
	2nd Trimester	3rd Trimester	Postpartum
EVG/COBI 150/150mg q.d.	1447.1	1432.8	1713.1
TAF 10mg q.d. w/COBI	80.4	91.2	98.2
TAF 25mg q.d.	69.7	96	133
TAF 25mg q.d. w/COBI or RTV Boosting	87.8	107	141

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.

PK Parameter: Trough Concentration (C12) With Median (IQR) for ARVs and TB Drugs

Intervention	ng/mL (Geometric Mean)
	3rd Trimester	Postpartum
MVC 150 or 300mg b.i.d.	108	128

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.

PK Parameter: Trough Concentration (C12) With Median (Range) for ARVs and TB Drugs

Intervention	mg/L (Median)
	2nd Trimester	3rd Trimester	Postpartum
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.	2.84	2.52	4.51
DRV/RTV 600/100mg b.i.d.	2.12	2.22	2.51
FPV/RTV 700/100mg b.i.d.	2.12	1.64	2.87
NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.	NA	0.47	0.52

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.

PK Parameter: Trough Concentration (C24) With Median (IQR) for ARVs and TB Drugs

Intervention	mg/L (Median)
	2nd Trimester	3rd Trimester	Postpartum
ETR 200mg b.i.d.	0.36	0.48	0.38
IDV/RTV Arm 2: 400/100mg q.d. (Only THA)	0.13	0.13	0.28
LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d.	3.7	5.1	7.2
RAL 400mg b.i.d.	0.0621	0.064	0.0797

"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.

PK Parameter: Trough Concentration (C24) With Median (Range) for ARVs and TB Drugs

Intervention	mg/L (Median)
	2nd Trimester	3rd Trimester	Postpartum
ATV/COBI 300/150 mg q.d.	0.21	0.21	0.61
ATV/RTV Arm 1: 300/100mg q.d.	2.0	0.7	1.2
ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.	0.49	0.71	0.90
DRV/COBI 800/150 mg q.d.	0.33	0.27	1.43
DRV/RTV 800/100mg q.d.	0.99	1.17	2.78
DTG 50mg q.d.	0.73	0.93	1.28
EFV 600 mg q.d. (Outside THA)	1.49	1.48	1.94
EVG/COBI 150/150mg q.d.	0.0258	0.0487	0.3771
TAF 10mg q.d. w/COBI	0.00195	0.00195	0.00195
TAF 25mg q.d.	0.00195	0.00195	0.00195
TAF 25mg q.d. w/COBI or RTV Boosting	0.00195	0.00195	0.00195
TFV 300mg q.d.	0.039	0.054	0.061
TFV/ATV/RTV Arm 1: 300/300/100mg q.d.	0.3	0.5	0.8
TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.	0.44	0.57	1.26

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.

PK Parameter: Trough Concentration (C24) With Median (Range) for ARVs and TB Drugs

Intervention	mg/L (Median)
	3rd Trimester	Postpartum
EFV 600mg q.d.	1.60	2.05

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.

Change in Maternal Weight Antepartum

Intervention	mg/L (Median)
	2nd Trimester	3rd Trimester	Postpartum
RPV 25mg q.d.	0.063	0.056	0.081

Change in maternal antepartum weight per week based on generalized estimating equations (NCT03048422)
Timeframe: Baseline through before delivery (up to one day prior)

Change in Maternal Weight Overall

Intervention	kg/week (Mean)
Arm 1: Maternal DTG+FTC/TAF	0.378
Arm 2: Maternal DTG+FTC/TDF	0.319
Arm 3: Maternal EFV/FTC/TDF	0.291

Change in maternal weight per week based on generalized estimating equations (NCT03048422)
Timeframe: Baseline to 50 weeks postpartum

Change in Maternal Weight Postpartum

Intervention	kg/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 postpartum weight per week based on generalized estimating equations (NCT03048422)
Timeframe: Delivery to 50 weeks postpartum

Count of Infants With HIV-1 Antiretroviral Drug Resistance Mutations at the Time of Infant HIV Diagnosis

Intervention	kg/week (Mean)
Arm 1: Maternal DTG+FTC/TAF	0.014
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 (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

Cumulative Probability of Infant Deaths

Intervention	Participants (Count of Participants)
Arm 1 Infants	1
Arm 2 Infants	0
Arm 3 Infants	1

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

Cumulative Probability of Infant HIV-infection

Intervention	Cumulative probability per 100 persons (Number)
Arm 1 Infants	1.0
Arm 2 Infants	2.0
Arm 3 Infants	6.9

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

Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event

Intervention	Cumulative probability per 100 persons (Number)
Arm 1 Infants	0.98
Arm 2 Infants	0.50
Arm 3 Infants	0.55

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

Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event

Intervention	Cumulative probability per 100 persons (Number)
Arms 1 and 2 Infants	26.8
Arm 3 Infants	30.9

Cumulative Probability of Women Experiencing Grade 3 or Higher Adverse Event

Intervention	Cumulative probability per 100 persons (Number)
Arm 1 Infants	25.3
Arm 2 Infants	28.6
Arm 3 Infants	30.9

"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

Maternal Change in Creatinine Clearance

Intervention	Cumulative probability per 100 persons (Number)
Arm 1: Maternal DTG+FTC/TAF	25.1
Arm 2: Maternal DTG+FTC/TDF	30.8
Arm 3: Maternal EFV/FTC/TDF	27.9
Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF	27.9
Arm 3: Maternal EFV/FTC/TDF	27.9

Maternal change in creatinine clearance per week based on generalized estimating equations (NCT03048422)
Timeframe: Baseline to 50 weeks postpartum

Percentage of Infants Born Small for Gestational Age

Intervention	mL/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 (<10th percentile adjusted for sex assigned at birth) based on Intergrowth 21st Standards (NCT03048422)
Timeframe: Birth

Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome

Intervention	percentage of participants (Number)
Arm 1 Infants	16.3
Arm 2 Infants	22.5
Arm 3 Infants	20.5

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

Percentage of Mother-Infant Pairs With an Adverse Pregnancy Outcome

Intervention	percentage of mother-infant pairs (Number)
Arm 1: Maternal DTG+FTC/TAF	24.1
Arm 2: Maternal DTG+FTC/TDF	32.9
Arm 3: Maternal EFV/FTC/TDF	32.7

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

Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome or Major Congenital Anomaly

Intervention	percentage of mother-infant pairs (Number)
Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF	28.4
Arm 3: Maternal EFV/FTC/TDF	32.7

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

Percentage of Mother-Infant Pairs With Preterm Deliveries

Intervention	percentage of mother-infant pairs (Number)
Arm 1: Maternal DTG+FTC/TAF	24.1
Arm 2: Maternal DTG+FTC/TDF	32.9
Arm 3: Maternal EFV/FTC/TDF	33.2

Percentage of mother-infant pairs with preterm deliveries (<37 weeks gestation) resulting in live born infant (NCT03048422)
Timeframe: Delivery

Percentage of Mothers With HIV-1 ARV Drug Resistance Mutations at the Time of Maternal Virologic Failure

Intervention	percentage of participants (Number)
Arm 1: Maternal DTG+FTC/TAF	5.8
Arm 2: Maternal DTG+FTC/TDF	9.4
Arm 3: Maternal EFV/FTC/TDF	12.1

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

Percentage of Mothers With HIV-1 RNA Less Than 200 Copies/mL at 50 Weeks Postpartum

Intervention	percentage of participants (Number)
Arm 1: Maternal DTG+FTC/TAF	0.92
Arm 2: Maternal DTG+FTC/TDF	1.86
Arm 3: Maternal EFV/FTC/TDF	6.16

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

Percentage of Mothers With HIV-1 RNA Less Than 50 Copies/mL at Delivery Measured at Central Laboratory

Intervention	percentage of participants (Number)
Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF	96.3
Arm 3: Maternal EFV/FTC/TDF	96.4

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

Percentage of Mothers With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL at 50 Weeks Postpartum Based on FDA Snapshot Algorithm

Intervention	percentage of participants (Number)
Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF	94.4
Arm 3: Maternal EFV/FTC/TDF	78.8

Percentage of mothers with virologic success of HIV-1 RNA less than 200 copies/mL at 50 weeks postpartum based on FDA snapshot algorithm using real-time test results obtained from site laboratories (NCT03048422)
Timeframe: 50 weeks postpartum

Percentage of Mothers With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL at Delivery Based on FDA Snapshot Algorithm

Intervention	percentage of participants (Number)
Arm 1: Maternal DTG+FTC/TAF	75.6
Arm 2: Maternal DTG+FTC/TDF	77.7
Arm 3: Maternal EFV/FTC/TDF	76.3

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

Time to First HIV-1 RNA Less Than 200 Copies/mL Through Delivery

Intervention	percentage of participants (Number)
Arm 1: Maternal DTG+FTC/TAF	88.9
Arm 2: Maternal DTG+FTC/TDF	92.6
Arm 3: Maternal EFV/FTC/TDF	81.0

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

Infant Creatinine Clearance

Infant creatinine clearance based on Schwartz formula (NCT03048422)
Timeframe: Delivery and 26 weeks postpartum

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

Change in CD4+ Cell Count From Randomisation to 12 Months Post-randomisation

Difference between 12 months and randomisation CD4+ count was calculated and then summarised (NCT01387022)
Timeframe: Measured at 12 months post ART initiation

Reported Adverse Events With Severity Grades 3 and 4 Based on the DAIDS Toxicity Grading Tables

(NCT01387022)
Timeframe: From randomisation until either time of termination or time of death

Tenofovir Resistance, Defined as Presence of K65R, K70E or Any of the TAMS Mutations

(NCT01387022)
Timeframe: From randomisation until either time of termination or time of death

The Antiretroviral Treatment Failure Rate at 12 Months.

Treatment failure is defined as viral load > 50 copies/ml, antiretroviral regimen changes for treatment failure or death (NCT01387022)
Timeframe: 12 months post ART intiation or until time of death

HIV Incidence Rates

Time to HIV infection was calculated as the difference between estimated date of infection (midpoint between the last negative HIV test date and the first confirmed positive HIV test date) and enrolment date, plus one. Where a participant has a positive PCR and a negative rapid test on the same date, the date of infection is calculated as 14 days prior to this date. Women who do not become HIV positive before their last study visit will be censored on the day of their last negative HIV test. Their follow-up time will be calculated as the difference between date of censoring and enrolment date, plus one. (NCT01691768)
Timeframe: Between 2012 and 2015, up to 28 months

HIV Viral Load Among HIV Seroconverters

This is mean log transformed HIV viral load measured at the first visit post HIV infection. (NCT01691768)
Timeframe: Between 2012 and 2015, up to 28 months

Human Papillomavirus Incidence Rates

For the calculation of the incidence rate, seroconversion was assumed to have occurred at the midpoint between the first positive HPV test and the previous HPV negative test. (NCT01691768)
Timeframe: Between 2012 and 2015, up to 28 months

Percentage of Participants Achieving Adherence >80%.

Self-reported adherence to the tenofovir gel dosing strategy.Gel adherence was defined as the estimated proportion of reported sex acts covered by two gel doses and calculated for each woman by dividing half the number of returned used applicators each month by the number of reported sex acts that month.For participants attending 2-3 monthly clinic visits, their number of gels used in the last 30 days will be estimated as the total number of returned used gels, divided by the number of days between the current and the previous visit, times 30. (NCT01691768)
Timeframe: Between 2012 and 2015, up to 28 months

Percentage of Participants With Detectable Tenofovir Levels From Vaginal Samples at 12 Months of Follow-up

Percentage of participants with detectable tenofovir levels from vaginal samples at 12 months of follow-up. All drug levels below limit of quantification were considered to be undetectable. (NCT01691768)
Timeframe: All participants with drug levels at 12 months of follow-up

Pregnancy Incidence Rates

Time to pregnancy, was as the difference between the estimated date of conception and the enrolment date, plus one. The date of conception was defined as 14 days after the last normal menstrual period or the estimated date of delivery minus 40 weeks if the first date of last normal menstrual period is not available or the midpoint between the date of the first positive pregnancy test and the date of the previous negative pregnancy test. The censoring time for a woman who did not become pregnant during the study equals the difference between the calculated censoring date and the enrolment date, plus one. (NCT01691768)
Timeframe: Between 2012 and 2015, up to 28 months

Product Acceptability

This is the number of participants who reported that they liked the study product. The questionnaire was administered at study exit, therefore participants who were loss to follow-up and those who died could not complete the questionnaire. (NCT01691768)
Timeframe: At study completion, up to 28 months

Mean Number of Returned Used Applicators Per Month (i.e in 30 Days)

The primary endpoint is the mean number of returned used applicators per month. Since participants in the intervention arm followed two and three monthly schedule (as opposed to monthly in the intervention arm), the number of returned used applicators per month for each participant will be estimated as the total number of returned applicators at that visit divided by the number of days since the previous visit, multiplied by 30. Thus a uniform distribution of gel use will be assumed in participants whom we did not see monthly. Intent to treat and per protocol analyses were carried out of this outcome. Intent to treat population includes all participants who were randomized, met pre-randomization eligibility criteria and who have post-enrollment follow-up data. The per protocol population is a subset of the intent to treat population.The per-protocol analysis excluded visits where no gel had been dispensed for >120 days. (NCT01691768)
Timeframe: Between 2012 to 2015, up to 28 months

Number of Participants Who Experienced HIV-related Disease Progression or Death

Worsening to WHO stage III/IV (among subjects who had WHO stage I/II at baseline) and death were the composite secondary endpoint. WHO Disease Staging System for HIV Infection and Disease in Adults and Adolescents is an approach for use in resource limited settings in studies of progression to symptomatic HIV disease. There are 4 stages of disease staging, 1 being the least severe and 4 being the most severe disease stage based on the HIV related symptoms and diagnoses. Please refer to the following web page for detailed staging criteria: http://www.who.int/docstore/hiv/scaling/anex1.html (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r.

Number of Participants Who Experienced Treatment-related Toxicity That Led to Discontinuation of Randomized Regimen.

The outcome is defined as treatment-related toxicity (as evaluated by sites), regardless of grade, that led to discontinuation of randomized regimen. For NVP/NVP and NVP/LPV_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV_r arms, since the follow-up continued as planned, data through overall study were used. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r.

Number of Participants Who Experienced Virologic Failure or Died.

Virologic failure (VF) is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r.

Number of Participants Who Received NVP-containing Regimens at Randomization and Experienced NVP-associated Rash or Grade 2+ Liver Lab Abnormality

Any grade of rash or grade 2+ liver lab abnormality events that were claimed to be NVP associated (definitely, probably, or possibly) by site investigators were evaluated. Grade 2+ liver lab abnormality is defined as aspartate aminotransferase (AST)>=2.6 x ULN or alanine aminotransferase (ALT)>=2.6 x ULN. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP arm. Throughout study for NoNVP/NVP arm.

CD4 Count Change From Randomization

Change was calculated as the CD4 count at Week 48 (or at Week 96) minus the baseline CD4 count (last CD4 before/on treatment start date). For NVP/NVP and NVP/LPV_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV_r arms, since the follow-up continued as planned, data through overall study were used. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r. Week 48 and 96.

Percent of Participants Who Experienced Virologic Failure or Died

Results report cumulative percent of participants reaching virologic failure (VF) or death by week 48 and week 96 calculated using the Kaplan-Meier method. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r arms. Throughout study for NoNVP/NVP and NoNVP/LPV_r arms.

Percent of Participants Who Reported to Never Missed Any of the Study Drug Regimen in the Past Month

Self-reported adherence at week 48 and 96 while participants remained on randomized regimen. Adherence interviews for each antiretroviral drug drug the participant is taking was performed by site personnel every 24 weeks. For NVP/NVP and NVP/LPV_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV_r arms, since the follow-up continued as planned, data through overall study were used. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r arms. Throughout study for NoNVP/NVP and NoNVP/LPV_r arms.

Time From Randomization to Virologic Failure or Death for Participants Who Had SD NVP Exposure Prior to Study Entry

5th and 10th Percentiles in weeks from randomization to virologic failure (VF) or death. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) with median follow-up 72 weeks and range from 0 to 144 weeks.

Time From Randomization to Virologic Failure or Death for Participants Without SD NVP Exposure Prior to Study Entry

5th and 10th Percentiles in weeks from randomization to virologic failure (VF) or death. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF. (NCT00089505)
Timeframe: Throughout study with median follow-up 72 weeks and range from 0 to 180 weeks.

ARV (TFV-DP) Levels

Intracellular TFV-DP will be measured in red blood cells using dried blood spots. TFV-DP levels provide a measure of long-term adherence over the preceding month (like hemoglobin A1C). The level of intracellular TFV-DP can be used to estimate how many doses/week the participant is taking on average (e.g. 7/wk on average, 4-7/wk on average, 2-4/wk on average, <2/wk on average). (NCT02611362)
Timeframe: 24 weeks

HIV Knowledge at 24 Weeks

"The HIV Knowledge Scale assesses knowledge about issues such as risks for HIV, using 5 items with true, false, or do not know response options. Total scores range from 0 to 5. Higher scores indicate greater knowledge." (NCT02611362)
Timeframe: 24 weeks

Motivational Readiness for Adherence at 24 Weeks

Rollnick's Readiness Ruler will be used to assess motivation for adherence to medication and medical visits. Respondents rate how ready they are to take PrEP as prescribed on a scale from 1 (not ready) to 10 (ready to be consistent or already consistent) each month. (NCT02611362)
Timeframe: 24 weeks

Social Support for Medication Adherence

This six item measure assesses social support for taking medications, going to medical appointments and other tasks related to adherence using Likert style items with a four point scale. Scores range from 6 to 24 Higher scores indicate greater social support. (NCT02611362)
Timeframe: 24 weeks

Congenital Abnormalities Among Infants Born to Female Participants Taking Study Drug.

Infant outcomes measured as the number of live-born infants born to female participants taking study drug that had any congenital anomalies. (NCT00557245)
Timeframe: Up to 36 months

Head Circumference Among Infants Born to Female Participants Taking Study Drug

The slope of the linear model of the growth of infants (head circumference) during the entirety of follow-up. The head circumference of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month. (NCT00557245)
Timeframe: up to 12 months

Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants

The efficacy of once daily PrEP in preventing HIV-1 acquisition among uninfected heterosexuals in HIV-1 discordant partnerships, measured by calculating the HIV incidence per 100 person-years in each of three arms. (NCT00557245)
Timeframe: Up to 36 months

Length Among Infants Born to Female Participants Taking Study Drug

The slope of the linear model of the growth of infants (length) during the entirety of follow-up. The length of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month. (NCT00557245)
Timeframe: up to 12 months

Number of Participants With a Sexually Transmitted Infection (STI) During Follow-up

"Prevalence of STIs measured as the number of participants with a positive test result for N. gonorrhoeae, C. trachomatis, or T. vaginalis during follow-up. Participants were tested for STIs at annual follow-up visits and at intervening visits at which the participant presented with symptoms of an STI. Assessment for symptomatic sexually transmitted infections was conducted quarterly.~N. gonorrhoeae and C. trachomatis testing were by APTIMA Combo 2 (Gen-Probe) or COBAS Amplicor (Roche Diagnostics). T. vaginalis testing was by APTIMA TV TMA (Gen-Probe) or In Pouch TV (Biomed Diagnostics)." (NCT00557245)
Timeframe: Up to 36 months

Number of Participants With Serious Adverse Events (SAEs)

Safety of daily TDF or FTC/TDF among HIV-1 uninfected individuals randomized to TDF or FTC/TDF compared to those randomized to placebo measured as the number of participants with Serious Adverse Events (SAEs) during follow-up. (NCT00557245)
Timeframe: Up to 36 months

Number of Seroconverters With an HIV-1 Mutation Conferring Resistance to TDF or FTC

"HIV-1 resistance as measured by the number of seroconverters who had an HIV-1 reverse transcriptase mutation (K65R, K70E, M184I, or M184V) conferring resistance to TDF or FTC. These mutation types were pre-defined. Plasma samples for resistance testing were collected at the visit seroconversion was first detected and again at a visit within 1 month of seroconversion. Mutations detected at either of those visits are reported.~Both seroconverters found to have a resistance mutation had been HIV infected at enrollment (TDF arm: n=1; FTC-TDF arm: n=1)." (NCT00557245)
Timeframe: Up to 36 months

Prevalence of Unprotected Sex During Follow-up

Sexual risk behavior of participants, measured as the percentage of visits when participants reported having unprotected sex during follow-up. (NCT00557245)
Timeframe: Up to 36 months

Study Drug Adherence: Total Number of Study Drug Doses Taken of the Total Dispensed Doses.

Adherence to study medication as assessed by pill count at follow-up visits. We assessed the total number of doses taken of the total dispensed doses. (NCT00557245)
Timeframe: Up to 36 months

Weight Among Infants Born to Female Participants Taking Study Drug

The slope of the linear model of the growth of infants (weight) during the entirety of follow-up. The weight of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month. (NCT00557245)
Timeframe: up to 12 months

Study Drug Adherence: Self-reported Missed Doses of Study Drug

Adherence to study drug measured as the percentage of visits when participants reported missing 1) any dose of study drug in the prior month and 2) 2 or more consecutive doses of study drug. (NCT00557245)
Timeframe: Up to 36 months

Number of Participants Experiencing Any Grade 2 or Higher AEs During Injection Phase

Number of participants experiencing any Grade 2 or higher clinical and laboratory AEs to evaluate the safety of the injectable product, TMC278 LA (1200 mg dose administered at Weeks 4, 12, 20, 28, 36 and 44), through 48 weeks after initial injection (at Week 52) in women in SSA and the US. (NCT02165202)
Timeframe: Up to 52 weeks

Intervention	weeks (Mean)
Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF	4.26
Arm 3: Maternal EFV/FTC/TDF	6.49

Intervention	mL/min (Mean)
	Delivery	26 Weeks Postpartum
Arm 1 Infants	52.7	134.8
Arm 2 Infants	53.1	123.6
Arm 3 Infants	49.0	135.0

Intervention	Percentage of participants (Number)
	Intention-to-Treat Analysis	Per-Protocol Analysis
Arm 3: Maternal EFV/FTC/TDF	91.0	91.4
Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF	97.5	97.5

Intervention	Used gel applicators per month (Least Squares Mean)
	Intent to treat analyses	Per protocol analyses
Control	5.7	5.8
Intervention	5.2	5.5

Intervention	cells/mm^3 (Median)
	Week 48 CD4 count change from randomization	Week 96 CD4 count change from randomization
NoNVP/LPV_r	172	256
NoNVP/NVP	172	223
NVP/LPV_r	201	278
NVP/NVP	191	291

Intervention	Percent of participants (Number)
	week 48 percent of virologic failure or death	week 96 percent of virologic failure or death
NoNVP/LPV_r	14	20
NoNVP/NVP	14	17
NVP/LPV_r	4	12
NVP/NVP	23	31

Intervention	percent of participants (Number)
	week 48 percent of full adherence in past month	week 96 percent of full adherence in past month
NoNVP/LPV_r	86	87
NoNVP/NVP	90	93
NVP/LPV_r	88	95
NVP/NVP	89	94

Intervention	weeks (Number)
	5th percentile	10th percentile	25th percentile
NVP/LPV_r	60	84	NA
NVP/NVP	12	12	60

Intervention	Number of live-born infants (Number)
Tenofovir Disoproxil Fumarate (TDF)	4
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	4
Placebo	5

Intervention	z-score difference per study month (Number)
Tenofovir Disoproxil Fumarate (TDF)	-0.057
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	-0.005
Placebo	-0.079

Authors	Studies
Joseph, NT	1
Satten, GA	1
Williams, RE	1
Haddad, LB	1
Jamieson, DJ	2
Sheth, AN	1
Badell, ML	1
Bukkems, VE	1
Necsoi, C	1
Hidalgo Tenorio, C	1
Garcia, C	1
Alba Alejandre, I	1
Weiss, F	1
Lambert, JS	1
van Hulzen, A	1
Richel, O	1
Te Brake, LHM	1
van der Meulen, E	1
Burger, D	1
Konopnicki, D	1
Colbers, A	1
Abuogi, LL	1
Castillo-Mancilla, J	2
Hampanda, K	1
Owuor, K	1
Odwar, T	1
Onono, M	1
Helova, A	1
Turan, JM	1
Anderson, PL	3
Zeng, QL	1
Zhang, HX	1
Zhang, JY	1
Huang, S	4
Li, WZ	1
Li, GM	1
Pan, YJ	1
Feng, YH	1
Li, ZQ	1
Zhang, GF	1

Intervention	events per 100 person years (Number)
Tenofovir Disoproxil Fumarate (TDF)	0.65
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	0.50
Placebo	1.99

Intervention	z-score difference per study month (Number)
Tenofovir Disoproxil Fumarate (TDF)	-0.006
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	0.036
Placebo	-0.033

Intervention	z-score difference per study month (Number)
Tenofovir Disoproxil Fumarate (TDF)	-0.021
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	0.009
Placebo	-0.056

Intervention	percentage of visits (Number)
	Missed any doses	Missed 2+ consecutive doses
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	15	4
Placebo	15	4
Tenofovir Disoproxil Fumarate (TDF)	15	4

Article	Year
Polymorphic Cytosine-Adenine-Guanine Repeat Length of Androgen Receptor Gene and Gender Incongruence in Trans Women: A Systematic Review and Meta-Analysis of Case-Control Studies. The journal of sexual medicine, 2020, Volume: 17, Issue:3 Topics: Adenine; Case-Control Studies; Cytosine; Female; Guanine; Humans; Male; Polymorphism, Genetic; Pregn	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
The Egyptian journal of chest diseases and tuberculosis, 2016, Volume: 65, Issue:1 Topics: A549 Cells; Acetylmuramyl-Alanyl-Isoglutamine; Acinetobacter baumannii; Acute Lung Injury; Adaptor P	2016
The Egyptian journal of chest diseases and tuberculosis, 2016, Volume: 65, Issue:1 Topics: A549 Cells; Acetylmuramyl-Alanyl-Isoglutamine; Acinetobacter baumannii; Acute Lung Injury; Adaptor P	2016
The Egyptian journal of chest diseases and tuberculosis, 2016, Volume: 65, Issue:1 Topics: A549 Cells; Acetylmuramyl-Alanyl-Isoglutamine; Acinetobacter baumannii; Acute Lung Injury; Adaptor P	2016
The Egyptian journal of chest diseases and tuberculosis, 2016, Volume: 65, Issue:1 Topics: A549 Cells; Acetylmuramyl-Alanyl-Isoglutamine; Acinetobacter baumannii; Acute Lung Injury; Adaptor P	2016
The Egyptian journal of chest diseases and tuberculosis, 2016, Volume: 65, Issue:1 Topics: A549 Cells; Acetylmuramyl-Alanyl-Isoglutamine; Acinetobacter baumannii; Acute Lung Injury; Adaptor P	2016
The Egyptian journal of chest diseases and tuberculosis, 2016, Volume: 65, Issue:1 Topics: A549 Cells; Acetylmuramyl-Alanyl-Isoglutamine; Acinetobacter baumannii; Acute Lung Injury; Adaptor P	2016
The Egyptian journal of chest diseases and tuberculosis, 2016, Volume: 65, Issue:1 Topics: A549 Cells; Acetylmuramyl-Alanyl-Isoglutamine; Acinetobacter baumannii; Acute Lung Injury; Adaptor P	2016
The Egyptian journal of chest diseases and tuberculosis, 2016, Volume: 65, Issue:1 Topics: A549 Cells; Acetylmuramyl-Alanyl-Isoglutamine; Acinetobacter baumannii; Acute Lung Injury; Adaptor P	2016
The Egyptian journal of chest diseases and tuberculosis, 2016, Volume: 65, Issue:1 Topics: A549 Cells; Acetylmuramyl-Alanyl-Isoglutamine; Acinetobacter baumannii; Acute Lung Injury; Adaptor P	2016
The Egyptian journal of chest diseases and tuberculosis, 2016, Volume: 65, Issue:1 Topics: A549 Cells; Acetylmuramyl-Alanyl-Isoglutamine; Acinetobacter baumannii; Acute Lung Injury; Adaptor P	2016
The Egyptian journal of chest diseases and tuberculosis, 2016, Volume: 65, Issue:1 Topics: A549 Cells; Acetylmuramyl-Alanyl-Isoglutamine; Acinetobacter baumannii; Acute Lung Injury; Adaptor P	2016
The Egyptian journal of chest diseases and tuberculosis, 2016, Volume: 65, Issue:1 Topics: A549 Cells; Acetylmuramyl-Alanyl-Isoglutamine; Acinetobacter baumannii; Acute Lung Injury; Adaptor P	2016
The Egyptian journal of chest diseases and tuberculosis, 2016, Volume: 65, Issue:1 Topics: A549 Cells; Acetylmuramyl-Alanyl-Isoglutamine; Acinetobacter baumannii; Acute Lung Injury; Adaptor P	2016
The Egyptian journal of chest diseases and tuberculosis, 2016, Volume: 65, Issue:1 Topics: A549 Cells; Acetylmuramyl-Alanyl-Isoglutamine; Acinetobacter baumannii; Acute Lung Injury; Adaptor P	2016
The Egyptian journal of chest diseases and tuberculosis, 2016, Volume: 65, Issue:1 Topics: A549 Cells; Acetylmuramyl-Alanyl-Isoglutamine; Acinetobacter baumannii; Acute Lung Injury; Adaptor P	2016
The Egyptian journal of chest diseases and tuberculosis, 2016, Volume: 65, Issue:1 Topics: A549 Cells; Acetylmuramyl-Alanyl-Isoglutamine; Acinetobacter baumannii; Acute Lung Injury; Adaptor P	2016
Tenofovir alafenamide as compared to tenofovir disoproxil fumarate in the management of chronic hepatitis B with recent trends in patient demographics. Expert review of gastroenterology & hepatology, 2017, Volume: 11, Issue:11 Topics: Adenine; Age Factors; Alanine; Antiviral Agents; Bone Density; Clinical Decision-Making; Female; Glo	2017
[Interdisciplinary aspects of and new drugs for chronic hepatitis B]. Orvosi hetilap, 2013, Jul-21, Volume: 154, Issue:29 Topics: Adenine; Antiviral Agents; Comorbidity; Drug Interactions; Drug Therapy, Combination; Female; Gastro	2013
Safety of tenofovir during pregnancy for the mother and fetus: a systematic review. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2013, Volume: 57, Issue:12 Topics: Adenine; Animals; Female; Fetal Development; HIV Infections; Humans; Infant, Newborn; Organophosphon	2013
Extrahepatic effects of nucleoside and nucleotide analogues in chronic hepatitis B treatment. Journal of gastroenterology and hepatology, 2014, Volume: 29, Issue:3 Topics: Acidosis, Lactic; Adenine; Administration, Oral; Antiviral Agents; Arabinofuranosyluracil; Dose-Resp	2014
Effects of hormonal contraception on antiretroviral drug metabolism, pharmacokinetics and pharmacodynamics. American journal of reproductive immunology (New York, N.Y. : 1989), 2014, Volume: 71, Issue:6 Topics: Adenine; Anti-HIV Agents; Contraception; Contraceptives, Oral, Hormonal; Cytochrome P-450 CYP3A; Cyt	2014
Breastfeeding while taking lamivudine or tenofovir disoproxil fumarate: a review of the evidence. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2015, Jan-15, Volume: 60, Issue:2 Topics: Adenine; Anti-HIV Agents; Breast Feeding; Disease Transmission, Infectious; Female; Hepatitis B; Hum	2015
Tenofovir disoproxil fumarate in pregnancy and prevention of mother-to-child transmission of HIV-1: is it time to move on from zidovudine? HIV medicine, 2009, Volume: 10, Issue:7 Topics: Adenine; Adult; Africa South of the Sahara; Animals; Anti-HIV Agents; Antiretroviral Therapy, Highly	2009
Systemic preexposure prophylaxis for human immunodeficiency virus infection. Pharmacotherapy, 2010, Volume: 30, Issue:10 Topics: Adenine; Animals; Anti-HIV Agents; Antiviral Agents; Deoxycytidine; Emtricitabine; Female; HIV; HIV	2010
Antiviral therapy for hepatitis B infection during pregnancy and breastfeeding. Antiviral therapy, 2011, Volume: 16, Issue:5 Topics: Adenine; Antiviral Agents; Breast Feeding; Female; Guanine; Hepatitis B; Hepatitis B virus; Hepatiti	2011
Pharmacokinetics of antiretroviral drugs in anatomical sanctuary sites: the fetal compartment (placenta and amniotic fluid). Antiviral therapy, 2011, Volume: 16, Issue:8 Topics: Adenine; Adult; Amniotic Fluid; Anti-HIV Agents; Cyclohexanes; Enfuvirtide; Female; Fetal Blood; Fet	2011
Drug delivery in multiple indication (multipurpose) prevention technologies: systems to prevent HIV-1 transmission and unintended pregnancies or HSV-2 transmission. Expert opinion on drug delivery, 2012, Volume: 9, Issue:4 Topics: Adenine; Administration, Intravaginal; Anti-Infective Agents; Antiviral Agents; Biopharmaceutics; Co	2012
New advances in chronic hepatitis B. Current opinion in gastroenterology, 2012, Volume: 28, Issue:3 Topics: Adenine; Antiviral Agents; Coinfection; Disease Progression; Drug Resistance, Viral; Female; Guanine	2012
The management of chronic viral hepatitis: a Canadian consensus conference 2004. Canadian journal of gastroenterology = Journal canadien de gastroenterologie, 2004, Volume: 18, Issue:12 Topics: Adenine; Adult; Antiviral Agents; Canada; Child; Child, Preschool; Drug Therapy, Combination; Enzyme	2004
Analysis of association between maternal tumor necrosis factor-alpha promoter polymorphism (-308), tumor necrosis factor concentration, and preterm birth. American journal of obstetrics and gynecology, 2006, Volume: 195, Issue:5 Topics: Adenine; Amniotic Fluid; Female; Genetic Predisposition to Disease; Guanine; Humans; Osmolar Concent	2006
The role of lipoproteins in steroidogenesis and cholesterol metabolism in steroidogenic glands. Endocrine reviews, 1982,Summer, Volume: 3, Issue:3 Topics: Adenine; Adrenal Cortex; Animals; Cattle; Cholesterol; Female; Humans; Hydroxymethylglutaryl CoA Red	1982
Immunosuppression and ablastin. Experimental parasitology, 1975, Volume: 38, Issue:3 Topics: Adenine; Animals; Antibodies; Antibody Formation; Antilymphocyte Serum; Cyclophosphamide; Dexamethas	1975
Nucleotide supply of the developing animal: role of the so-called 'salvage pathways'. Enzyme, 1973, Volume: 15, Issue:1 Topics: Adenine; Adenosine Monophosphate; Animals; Animals, Newborn; Brain; Cell Differentiation; Electropho	1973
Ocular virus disease. Annals of clinical research, 1973, Volume: 5, Issue:4 Topics: Adenine; Adolescent; Chickenpox; Child; Child, Preschool; Chorioretinitis; Conjunctivitis; Corneal U	1973