adenine and Kidney Failure studies

Kidney Failure: A severe irreversible decline in the ability of kidneys to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism.

Research Excerpts

Excerpt	Relevance	Reference
"Treatment with tenofovir disoproxil fumarate has been associated with renal toxicity or reductions in bone mineral density, or both, in some patients with chronic hepatitis B virus (HBV) infection."	9.34	Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in virologically suppressed patients with chronic hepatitis B: a randomised, double-blind, phase 3, multicentre non-inferiority study. ( Agarwal, K; Ahn, SH; Bae, H; Buti, M; Chan, HLY; Chen, CY; Chuang, WL; Flaherty, JF; Fung, S; Gaggar, A; Lampertico, P; Lau, A; Lim, YS; Liu, Y; Ma, X; Ramji, A; Subramanian, GM; Suri, V; Tak, WY; Tam, E; Tan, SK; Trinh, H; Wu, G; Yoon, SK, 2020)
"80 patients with chronic hepatitis B received the antiviral therapy of adefovir dipivoxil (ADV, 10 mg/d)."	9.14	[Efficacy of the 96-week adefovir dipivoxil therapy in patients with chronic hepatitis B]. ( Cao, H; Chen, LB; Li, G; Shu, X; Xie, QF; Xu, QH; Xu, Z, 2010)
"Adefovir dipivoxil is safe for the treatment of chronic hepatitis B in patients with varying degrees of renal dysfunction and lamivudine-resistant HBV and results in biochemical and virological efficacy similar to that reported in the general population."	9.11	Efficacy and safety of adefovir dipivoxil in kidney recipients, hemodialysis patients, and patients with renal insufficiency. ( Brosgart, C; Chaix, ML; Currie, G; Fontaine, H; Morales, E; Nalpas, B; Pol, S; Serpaggi, J; Vallet-Pichard, A; Varaut, A; Verkarre, V, 2005)
"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)
"Previous studies have demonstrated that the treatment of chronic hepatitis B (CHB) infection with adefovir (ADV) can impair renal function."	7.80	Telbivudine protects renal function in patients with chronic hepatitis B infection in conjunction with adefovir-based combination therapy. ( Kim, HY; Kim, YJ; Lee, HJ; Lee, HS; Lee, JH; Lee, M; Oh, S; Yeum, TS; Yoon, JH; Yu, SJ, 2014)
"To investigate the effect of long-term tenofovir disoproxil fumarate (TDF) use on renal function, especially in patients with low body weight who are vulnerable to TDF nephrotoxicity."	7.80	Long-term exposure to tenofovir continuously decrease renal function in HIV-1-infected patients with low body weight: results from 10 years of follow-up. ( Aoki, T; Gatanaga, H; Honda, H; Kawasaki, Y; Kikuchi, Y; Kinai, E; Mizushima, D; Nishijima, T; Oka, S; Tanaka, N; Tanuma, J; Teruya, K; Tsukada, K; Watanabe, K; Yazaki, H, 2014)
"Nephrogenic systemic fibrosis (NSF) is a scleroderma-like disease associated with prior administration of certain gadolinium chelates (GCs)."	7.79	Nephrogenic systemic fibrosis-like effects of magnetic resonance imaging contrast agents in rats with adenine-induced renal failure. ( Bouzian, N; Bruneval, P; Corot, C; Daubiné, F; Factor, C; Fretellier, N; Hollenbeck, C; Idée, JM; Jestin, G; Laprévote, O; Mandet, C; Massicot, F; Parmentier, N; Port, M, 2013)
"Adefovir and tenofovir are nucleotide analogues used as long-term therapy of chronic hepatitis B."	7.78	Renal tubular dysfunction during long-term adefovir or tenofovir therapy in chronic hepatitis B. ( Chong, WH; Collins, MT; Gara, N; Ghany, MG; Hoofnagle, JH; Jake Liang, T; Kleiner, DE; Zhao, X, 2012)
"This was a retrospective study of human immunodeficiency virus (HIV)-infected patients at a university-affiliated HIV clinic who were prescribed tenofovir between July 1, 2001, and January 31, 2009."	7.77	A comparison of tenofovir-associated renal function changes in HIV-infected African Americans vs Caucasians. ( Cocohoba, J; Gruta, C; John, MD; Lao, CK, 2011)
"The study evaluated whether a liquid suspension of adefovir dipivoxil (ADV) is effective and safe when dose adjusted based on varying degrees of renal impairment in patients with chronic hepatitis B."	7.77	Efficacy and pharmacokinetics of adefovir dipivoxil liquid suspension in patients with chronic hepatitis B and renal impairment. ( Frederick, D; Pol, S; Rostaing, L; Rousseau, F; Schiff, E; Shiffman, ML; Thabut, D; Zeuzem, S; Zong, J, 2011)
"Combination therapy with adefovir dipivoxil (ADV) and lamivudine (LAM) is recommended for patients infected with LAM-refractory hepatitis B virus (HBV)."	7.76	Add-on combination therapy with adefovir dipivoxil induces renal impairment in patients with lamivudine-refractory hepatitis B virus. ( Enomoto, M; Habu, D; Imanishi, Y; Iwai, S; Kawada, N; Kobayashi, S; Morikawa, H; Sakaguchi, H; Shiomi, S; Tamori, A, 2010)
" A 40-year-old liver transplant recipient with hepatitis B virus reinfection, resistance to lamivudine, and fibrosing cholestatic hepatitis complicated by terminal renal impairment and spontaneous bacterial peritonitis was treated with adefovir dipivoxil 10 mg after every dialysis."	7.72	Successful treatment of fibrosing cholestatic hepatitis using adefovir dipivoxil in a patient with cirrhosis and renal insufficiency. ( Barg-Hock, H; Becker, T; Bleck, JS; Bock, CT; Böker, KH; Flemming, P; Klempnauer, J; Manns, MP; Rosenau, J; Tillmann, HL; Trautwein, C, 2003)
"Fanconi syndrome with osteomalacia can develop in patients with chronic hepatitis B infection being treated with adefovir at a conventional low dosage of 10 mg/day."	5.56	Osteomalacia and renal failure due to Fanconi syndrome caused by long-term low-dose Adefovir Dipivoxil: a case report. ( Cen, X; Cui, Y; Liu, Z; Mu, G; Xiang, Q; Xie, Q; Yu, Y; Zhang, H; Zhang, J, 2020)
"Renal failure was assessed by plasma and urinary markers."	5.43	The renal mitochondrial dysfunction in patients with vascular calcification is prevented by sodium thiosulfate. ( Krishnaraj, P; Kurian, GA; Ravindran, S, 2016)
"Adenine-treated animals experienced weight-loss, polyuria and polydipsia; however, these effects were significantly attenuated in adenine-treated Gunn rats."	5.42	Endogenously elevated bilirubin modulates kidney function and protects from circulating oxidative stress in a rat model of adenine-induced kidney failure. ( Benzie, IF; Boon, AC; Briskey, D; Bulmer, AC; Coombes, JS; Fassett, RG; Gopalan, V; Lam, AK, 2015)
"Treatment with tenofovir disoproxil fumarate has been associated with renal toxicity or reductions in bone mineral density, or both, in some patients with chronic hepatitis B virus (HBV) infection."	5.34	Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in virologically suppressed patients with chronic hepatitis B: a randomised, double-blind, phase 3, multicentre non-inferiority study. ( Agarwal, K; Ahn, SH; Bae, H; Buti, M; Chan, HLY; Chen, CY; Chuang, WL; Flaherty, JF; Fung, S; Gaggar, A; Lampertico, P; Lau, A; Lim, YS; Liu, Y; Ma, X; Ramji, A; Subramanian, GM; Suri, V; Tak, WY; Tam, E; Tan, SK; Trinh, H; Wu, G; Yoon, SK, 2020)
"80 patients with chronic hepatitis B received the antiviral therapy of adefovir dipivoxil (ADV, 10 mg/d)."	5.14	[Efficacy of the 96-week adefovir dipivoxil therapy in patients with chronic hepatitis B]. ( Cao, H; Chen, LB; Li, G; Shu, X; Xie, QF; Xu, QH; Xu, Z, 2010)
"Adefovir dipivoxil is safe for the treatment of chronic hepatitis B in patients with varying degrees of renal dysfunction and lamivudine-resistant HBV and results in biochemical and virological efficacy similar to that reported in the general population."	5.11	Efficacy and safety of adefovir dipivoxil in kidney recipients, hemodialysis patients, and patients with renal insufficiency. ( Brosgart, C; Chaix, ML; Currie, G; Fontaine, H; Morales, E; Nalpas, B; Pol, S; Serpaggi, J; Vallet-Pichard, A; Varaut, A; Verkarre, V, 2005)
"Tenofovir disoproxil fumarate (TDF), an ester prodrug of tenofovir (TFV), is one of the recommended drugs for chronic hepatitis B (CHB) patients."	4.98	Tenofovir alafenamide (TAF) treatment of HBV, what are the unanswered questions? ( Grossi, G; Lampertico, P; Loglio, A; Viganò, M, 2018)
"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)
"Renal anemia was induced by treatment with adenine (200 or 600 mg/kg/day, orally for 10 days) in non-diabetic Wistar-Kyoto or Wistar rats, respectively."	3.96	Failure to confirm a sodium-glucose cotransporter 2 inhibitor-induced hematopoietic effect in non-diabetic rats with renal anemia. ( Hitomi, H; Kittikulsuth, W; Kobara, H; Konishi, Y; Masaki, T; Morikawa, T; Nakano, D; Nishiyama, A; Osafune, K; Yamazaki, D, 2020)
"Previous studies have demonstrated that the treatment of chronic hepatitis B (CHB) infection with adefovir (ADV) can impair renal function."	3.80	Telbivudine protects renal function in patients with chronic hepatitis B infection in conjunction with adefovir-based combination therapy. ( Kim, HY; Kim, YJ; Lee, HJ; Lee, HS; Lee, JH; Lee, M; Oh, S; Yeum, TS; Yoon, JH; Yu, SJ, 2014)
"To investigate the effect of long-term tenofovir disoproxil fumarate (TDF) use on renal function, especially in patients with low body weight who are vulnerable to TDF nephrotoxicity."	3.80	Long-term exposure to tenofovir continuously decrease renal function in HIV-1-infected patients with low body weight: results from 10 years of follow-up. ( Aoki, T; Gatanaga, H; Honda, H; Kawasaki, Y; Kikuchi, Y; Kinai, E; Mizushima, D; Nishijima, T; Oka, S; Tanaka, N; Tanuma, J; Teruya, K; Tsukada, K; Watanabe, K; Yazaki, H, 2014)
"Nephrogenic systemic fibrosis (NSF) is a scleroderma-like disease associated with prior administration of certain gadolinium chelates (GCs)."	3.79	Nephrogenic systemic fibrosis-like effects of magnetic resonance imaging contrast agents in rats with adenine-induced renal failure. ( Bouzian, N; Bruneval, P; Corot, C; Daubiné, F; Factor, C; Fretellier, N; Hollenbeck, C; Idée, JM; Jestin, G; Laprévote, O; Mandet, C; Massicot, F; Parmentier, N; Port, M, 2013)
" We also found that co-infection with HCV and treatment by the antiretrovirat drug Tenofovir are significantly associated with the decline in renal function among our patients [p=0."	3.79	[Crucial risk factors for renal function deterioration of HIV-infected patients at the AIDS Clinic in Rambam Hospital]. ( Hassoun, G; Kedem, E; Mugrabi, F; Pollack, S; Shahar, E, 2013)
"Adefovir and tenofovir are nucleotide analogues used as long-term therapy of chronic hepatitis B."	3.78	Renal tubular dysfunction during long-term adefovir or tenofovir therapy in chronic hepatitis B. ( Chong, WH; Collins, MT; Gara, N; Ghany, MG; Hoofnagle, JH; Jake Liang, T; Kleiner, DE; Zhao, X, 2012)
" Factors associated with elevated cystatin C included hepatitis C coinfection, hypertension, current smoking, older age, current tenofovir use, detectable plasma HIV RNA, and elevated microalbuminuria."	3.78	Cystatin C and baseline renal function among HIV-infected persons in the SUN Study. ( Brooks, JT; Bush, T; Conley, L; Hammer, J; Henry, K; Kojic, EM; Mondy, K; Overton, ET; Patel, P; Rhame, F, 2012)
"This was a retrospective study of human immunodeficiency virus (HIV)-infected patients at a university-affiliated HIV clinic who were prescribed tenofovir between July 1, 2001, and January 31, 2009."	3.77	A comparison of tenofovir-associated renal function changes in HIV-infected African Americans vs Caucasians. ( Cocohoba, J; Gruta, C; John, MD; Lao, CK, 2011)
"The study evaluated whether a liquid suspension of adefovir dipivoxil (ADV) is effective and safe when dose adjusted based on varying degrees of renal impairment in patients with chronic hepatitis B."	3.77	Efficacy and pharmacokinetics of adefovir dipivoxil liquid suspension in patients with chronic hepatitis B and renal impairment. ( Frederick, D; Pol, S; Rostaing, L; Rousseau, F; Schiff, E; Shiffman, ML; Thabut, D; Zeuzem, S; Zong, J, 2011)
"Combination therapy with adefovir dipivoxil (ADV) and lamivudine (LAM) is recommended for patients infected with LAM-refractory hepatitis B virus (HBV)."	3.76	Add-on combination therapy with adefovir dipivoxil induces renal impairment in patients with lamivudine-refractory hepatitis B virus. ( Enomoto, M; Habu, D; Imanishi, Y; Iwai, S; Kawada, N; Kobayashi, S; Morikawa, H; Sakaguchi, H; Shiomi, S; Tamori, A, 2010)
" A 40-year-old liver transplant recipient with hepatitis B virus reinfection, resistance to lamivudine, and fibrosing cholestatic hepatitis complicated by terminal renal impairment and spontaneous bacterial peritonitis was treated with adefovir dipivoxil 10 mg after every dialysis."	3.72	Successful treatment of fibrosing cholestatic hepatitis using adefovir dipivoxil in a patient with cirrhosis and renal insufficiency. ( Barg-Hock, H; Becker, T; Bleck, JS; Bock, CT; Böker, KH; Flemming, P; Klempnauer, J; Manns, MP; Rosenau, J; Tillmann, HL; Trautwein, C, 2003)
"The adenine-containing diet caused renal failure, characterized by crystal deposits, cystic dilatation of tubules, and micro-abscesses."	3.01	Functional and histological effects of Anthurium schlechtendalii Kunth extracts on adenine-induced kidney damage of adult Wistar rats. ( Ajibola, OO; Barradas-Dermitz, DM; Calderón-Garcidueñas, AL; Carvajal-Zarrabal, O; López-Amador, N; Nolasco-Hipolito, C, 2023)
" Although no dosage adjustment is needed for Oral Nirmatrelvir/Ritonavir in patients with mild renal impairment and coronavirus disease 2019, the dosage is reduced to twice daily in those with moderate renal impairment."	3.01	Medication safety in chronic kidney disease. ( Singh, S, 2023)
"As expected for a renally eliminated drug, subjects with and without hepatic impairment displayed similar tenofovir systemic exposures without evidence of substantial alterations in drug disposition, and therefore no dosage adjustments were warranted in these patients."	2.72	Pharmacokinetics and dosing recommendations of tenofovir disoproxil fumarate in hepatic or renal impairment. ( Flaherty, JF; Kearney, BP; Shah, J; Yale, K; Zhong, L, 2006)
"We pooled clinical renal safety data across 26 treatment-naive and antiretroviral switch studies to compare the incidence of proximal renal tubulopathy and discontinuation due to renal adverse events between participants taking TAF-containing regimens vs."	2.61	Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials. ( Arribas, JR; Brainard, D; Carter, C; Clarke, AE; Das, M; Elion, RA; Eron, JJ; Esser, S; Guo, S; Gupta, SK; Martin, H; Mudrikova, T; Negredo, E; Orkin, C; Podzamczer, D; Post, FA; Pozniak, AL; Rockstroh, JK; Sax, PE; SenGupta, D; Stellbrink, HJ; Waters, L; Wohl, DA; Zhong, L, 2019)
" The most common drugs given with tenofovir were ritonavir or lopinavir-ritonavir (21 of 27 patients), atazanavir (5 of 27 patients), and didanosine (9 of 27 patients)."	2.43	Tenofovir-associated acute and chronic kidney disease: a case of multiple drug interactions. ( Bedford, J; Braden, G; Hoffman, R; Morris, A; Pizzoferrato, T; Zimmermann, AE, 2006)
" Intracellular activation of a small fraction (< 10%) of the dose by cellular kinases leads to prolonged antiviral effects that are not easily predicted from conventional pharmacokinetic studies."	2.40	Clinical pharmacokinetics of the antiviral nucleotide analogues cidofovir and adefovir. ( Cundy, KC, 1999)
"Kidney failure was induced chemically with an adenine-rich diet (0."	1.72	Polyphenol-rich açaí seed extract exhibits reno-protective and anti-fibrotic activities in renal tubular cells and mice with kidney failure. ( Borges, NA; Daleprane, JB; de Castro Resende, Â; Monteiro, EB; Monteiro, M; Soulage, CO, 2022)
"Renal failure was induced by adding 0."	1.62	Safety and Gadolinium Distribution of the New High-Relaxivity Gadolinium Chelate Gadopiclenol in a Rat Model of Severe Renal Failure. ( Bocanegra, J; Corot, C; Factor, C; Fretellier, N; Idée, JM; Rasschaert, M; Robert, P; Seron, A, 2021)
"Limited published real-world data describe adverse events (AEs) among patients treated for mantle-cell lymphoma (MCL)."	1.62	Adverse Events and Economic Burden Among Patients Receiving Systemic Treatment for Mantle Cell Lymphoma: A Real-World Retrospective Cohort Study. ( Byfield, SD; Kabadi, SM; LE, L; Olufade, T, 2021)
"Fanconi syndrome with osteomalacia can develop in patients with chronic hepatitis B infection being treated with adefovir at a conventional low dosage of 10 mg/day."	1.56	Osteomalacia and renal failure due to Fanconi syndrome caused by long-term low-dose Adefovir Dipivoxil: a case report. ( Cen, X; Cui, Y; Liu, Z; Mu, G; Xiang, Q; Xie, Q; Yu, Y; Zhang, H; Zhang, J, 2020)
"A reversible acute renal failure with no proximal tubulopathy and neuropsychiatric issues are discussed."	1.51	Overdose of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide in an HIV-1-infected subject with attempted suicide. ( Álvarez, H; Díaz-Cambre, H; García-González, J; Llibre, JM; Mariño, A; Valcarce, N, 2019)
"Renal failure was assessed by plasma and urinary markers."	1.43	The renal mitochondrial dysfunction in patients with vascular calcification is prevented by sodium thiosulfate. ( Krishnaraj, P; Kurian, GA; Ravindran, S, 2016)
"Adenine-treated animals experienced weight-loss, polyuria and polydipsia; however, these effects were significantly attenuated in adenine-treated Gunn rats."	1.42	Endogenously elevated bilirubin modulates kidney function and protects from circulating oxidative stress in a rat model of adenine-induced kidney failure. ( Benzie, IF; Boon, AC; Briskey, D; Bulmer, AC; Coombes, JS; Fassett, RG; Gopalan, V; Lam, AK, 2015)
"HIV-infected women (n = 101) on tenofovir-based therapy underwent intensive 24-h pharmacokinetic sampling."	1.40	Common clinical conditions - age, low BMI, ritonavir use, mild renal impairment - affect tenofovir pharmacokinetics in a large cohort of HIV-infected women. ( Anastos, K; Bacchetti, P; Baxi, SM; Cohen, M; Gandhi, M; Gange, SJ; Greenblatt, RM; Huang, Y; Minkoff, H; Scherzer, R; Shlipak, MG; Young, M, 2014)
"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)
"Overall, the incidence of acute renal failure was 0."	1.37	Renal impairment in HIV-1 infected patients receiving antiretroviral regimens including tenofovir in a resource-limited setting. ( Chimsuntorn, S; Manosuthi, W; Nilkamhang, S; Prasithsirikul, W; Sungkanuparph, S; Tantanathip, P, 2011)
"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)
" Renal biopsy revealed toxic acute tubular necrosis, with distinctive proximal tubular eosinophilic inclusions representing giant mitochondria visible by light microscopy."	1.36	Tenofovir nephrotoxicity: acute tubular necrosis with distinctive clinical, pathological, and mitochondrial abnormalities. ( D'Agati, VD; Herlitz, LC; Markowitz, GS; Mohan, S; Radhakrishnan, J; Stokes, MB, 2010)
"Rats with renal failure induced by an adenine diet exhibited severe abnormality of Ca dynamics, including Ca shortage and ectopic accumulation of Ca."	1.36	Systemic disorders of calcium dynamics in rats with adenine-induced renal failure: implication for chronic kidney disease-related complications. ( Ikeda, R; Imai, Y; Maruyama, W; Mizoguchi, K, 2010)
"In this study, we present a case of renal failure in a patient who was on a tenofovir-containing regimen, resulting in extremely high tenofovir exposure and prolonged tenofovir monotherapy."	1.35	Prolonged exposure to tenofovir monotherapy 1 month after treatment discontinuation because of tenofovir-related renal failure. ( Beijnen, JH; Huitema, AD; Jansen, RS; Mulder, JW; Smits, PH; Ter Heine, R; van Gorp, EC; Wagenaar, JF, 2009)
"Renal failure is associated with aortic valve calcification (AVC)."	1.35	Uraemic hyperparathyroidism causes a reversible inflammatory process of aortic valve calcification in rats. ( Abedat, S; Beeri, R; Ben-Dov, IZ; Danenberg, HD; Lotan, C; Meir, K; Planer, D; Shuvy, M; Sosna, J, 2008)
"We report a biopsy-proven case of acute renal failure that developed within weeks of initiating a HAART regimen containing tenofovir, and review the literature with specific attention to cases of renal failure occurring within 8 weeks of tenofovir initiation."	1.34	Early onset of tenofovir-induced renal failure: case report and review of the literature. ( Ahya, SN; Kanwar, YS; Palella, F; Patel, SM; Zembower, TR, 2007)

Research

Studies (92)

Authors

Clinical Trials (14)

Trial Overview

Trial Outcomes

Change From Baseline in eGFR-CG at Week 96

Timeframe	Studies, this research(%)	All Research%
pre-1990	1 (1.09)	18.7374
1990's	5 (5.43)	18.2507
2000's	25 (27.17)	29.6817
2010's	49 (53.26)	24.3611
2020's	12 (13.04)	2.80

Authors	Studies
Ho, HJ	1
Kikuchi, K	1
Oikawa, D	1
Watanabe, S	1
Kanemitsu, Y	1
Saigusa, D	1
Kujirai, R	1
Ikeda-Ohtsubo, W	1
Ichijo, M	1
Akiyama, Y	1
Aoki, Y	1
Mishima, E	1
Ogata, Y	1
Oikawa, Y	2
Matsuhashi, T	1
Toyohara, T	1
Suzuki, C	1
Suzuki, T	1
Mano, N	1
Kagawa, Y	1
Owada, Y	1
Katayama, T	1
Nakayama, T	1
Tomioka, Y	1
Abe, T	1
Sato, H	3
Goto, M	3
Nishimura, G	3
Morimoto, N	3
Tokushima, H	3
Horii, Y	3
Takahashi, N	4
Monteiro, EB	3
Borges, NA	3
Monteiro, M	3
de Castro Resende, Â	3
Daleprane, JB	3
Soulage, CO	3
Singh, S	1
Calderón-Garcidueñas, AL	1
Barradas-Dermitz, DM	1
Nolasco-Hipolito, C	1
López-Amador, N	1
Ajibola, OO	1
Carvajal-Zarrabal, O	1
Shuvy, M	3
Abedat, S	3
Eliaz, R	1
Abu-Rmeileh, I	1
Abu-Snieneh, A	1
Ben-Dov, IZ	2
Meir, K	2
Pereg, D	1
Beeri, R	3
Lotan, C	3
Yamazaki, D	1
Konishi, Y	1
Morikawa, T	1
Kobara, H	1
Masaki, T	1
Hitomi, H	1
Osafune, K	1
Nakano, D	1
Kittikulsuth, W	1
Nishiyama, A	1
Lampertico, P	2
Buti, M	1
Fung, S	1
Ahn, SH	1
Chuang, WL	1
Tak, WY	1
Ramji, A	1
Chen, CY	1
Tam, E	1
Bae, H	1
Ma, X	1
Flaherty, JF	2
Gaggar, A	1
Lau, A	1
Liu, Y	2
Wu, G	1
Suri, V	1
Tan, SK	1
Subramanian, GM	1
Trinh, H	1
Yoon, SK	1
Agarwal, K	1
Lim, YS	1
Chan, HLY	1
Xiang, Q	1
Liu, Z	2
Yu, Y	1
Zhang, H	1
Xie, Q	1
Mu, G	1
Zhang, J	1
Cen, X	1
Cui, Y	1
Awad, AM	1
Saleh, MA	1
Abu-Elsaad, NM	1
Ibrahim, TM	1
Kumakura, S	1
Sato, E	1
Sekimoto, A	1
Hashizume, Y	1
Yamakage, S	1
Miyazaki, M	1
Ito, S	1
Harigae, H	1
Kabadi, SM	1
Byfield, SD	1
LE, L	1
Olufade, T	1
Fretellier, N	2
Rasschaert, M	1
Bocanegra, J	1
Robert, P	1
Factor, C	2
Seron, A	1
Idée, JM	2
Corot, C	2
Hsu, YC	1
Wei, MT	1
Nguyen, MH	1
Viganò, M	1
Loglio, A	1
Grossi, G	1
Álvarez, H	1
Mariño, A	1
Valcarce, N	1
García-González, J	1
Díaz-Cambre, H	1
Llibre, JM	1
Lv, Y	1
Li, X	1
Liang, S	1
Liang, D	1
Xu, F	1
Zhu, X	1
Zeng, C	1
Gupta, SK	2
Post, FA	2
Arribas, JR	1
Eron, JJ	1
Wohl, DA	1
Clarke, AE	1
Sax, PE	1
Stellbrink, HJ	1
Esser, S	1
Pozniak, AL	1
Podzamczer, D	1
Waters, L	1
Orkin, C	1
Rockstroh, JK	1
Mudrikova, T	1
Negredo, E	1
Elion, RA	1
Guo, S	1
Zhong, L	2
Carter, C	1
Martin, H	1
Brainard, D	1
SenGupta, D	1
Das, M	1
Shahar, E	1
Mugrabi, F	1
Kedem, E	1
Hassoun, G	1
Pollack, S	1
Tourret, J	1
Deray, G	1
Isnard-Bagnis, C	1
Wu, M	1
Tang, RN	1
Liu, H	1
Xu, M	1
Pan, MM	1
Liu, BC	1
Baxi, SM	1
Greenblatt, RM	1
Bacchetti, P	1
Scherzer, R	1
Minkoff, H	1
Huang, Y	1
Anastos, K	1
Cohen, M	1
Gange, SJ	1
Young, M	1
Shlipak, MG	1
Gandhi, M	1
Mi, D	1
Moe, SM	1
Dubé, MP	1
Lee, M	1
Oh, S	1
Lee, HJ	1
Yeum, TS	1
Lee, JH	1
Yu, SJ	1
Kim, HY	1
Yoon, JH	1
Lee, HS	1
Kim, YJ	1
Mulenga, L	2
Musonda, P	1
Mwango, A	1
Vinikoor, MJ	2
Davies, MA	1
Mweemba, A	2
Calmy, A	1
Stringer, JS	1
Keiser, O	1
Chi, BH	2
Wandeler, G	2
Estrella, MM	1
Moosa, MR	1
Nachega, JB	1
Zanolini, A	1
Emge, D	1
Nishijima, T	2
Kawasaki, Y	2
Tanaka, N	2
Mizushima, D	1
Aoki, T	1
Watanabe, K	1
Kinai, E	1
Honda, H	1
Yazaki, H	1
Tanuma, J	1
Tsukada, K	1
Teruya, K	1
Kikuchi, Y	1
Gatanaga, H	2
Oka, S	2
Kamkuemah, M	1
Kaplan, R	1
Bekker, LG	1
Little, F	1
Myer, L	1
Winston, J	1
Andrade-Villanueva, JF	1
Fisher, M	1
Beraud, C	1
Abram, ME	1
Graham, H	1
Rhee, MS	1
Cheng, AK	1
Szwarcberg, J	1
Rokx, C	1
Van der Ende, ME	1
Rijnders, BJ	1
Ueno, K	1
Shimizu, M	1
Kubo, T	1
Igarashi, N	1
Hatasaki, K	1
Aguiar, CF	1
Naffah-de-Souza, C	1
Castoldi, A	1
Corrêa-Costa, M	1
Braga, TT	1
Naka, ÉL	1
Amano, MT	1
Abate, DT	1
Hiyane, MI	1
Cenedeze, MA	1
Pacheco e Silva Filho, A	1
Câmara, NO	1
Boon, AC	1
Lam, AK	1
Gopalan, V	1
Benzie, IF	1
Briskey, D	1
Coombes, JS	1
Fassett, RG	1
Bulmer, AC	1
Peng, YH	1
Sweet, DH	1
Lin, SP	1
Yu, CP	1
Lee Chao, PD	1
Hou, YC	1
Krishnaraj, P	1
Ravindran, S	1
Kurian, GA	1
Wood, SM	1
Shah, SS	1
Steenhoff, AP	1
Meyers, KE	1
Kaplan, BS	1
Rutstein, RM	1
Matsui, I	1
Hamano, T	1
Mikami, S	1
Fujii, N	1
Takabatake, Y	1
Nagasawa, Y	1
Kawada, N	2
Ito, T	1
Rakugi, H	1
Imai, E	1
Isaka, Y	1
Rodríguez-Nóvoa, S	1
Labarga, P	1
Soriano, V	1
Egan, D	1
Albalater, M	1
Morello, J	1
Cuenca, L	1
González-Pardo, G	1
Khoo, S	1
Back, D	1
Owen, A	1
Ter Heine, R	1
Huitema, AD	1
Jansen, RS	1
Smits, PH	1
van Gorp, EC	1
Wagenaar, JF	1
Beijnen, JH	1
Mulder, JW	1
Tamori, A	1
Enomoto, M	1
Kobayashi, S	1
Iwai, S	1
Morikawa, H	1
Sakaguchi, H	1
Habu, D	1
Shiomi, S	1
Imanishi, Y	1
O'Neill, WC	1
Déti, EK	1
Thiébaut, R	1
Bonnet, F	1
Lawson-Ayayi, S	1
Dupon, M	1
Neau, D	1
Pellegrin, JL	1
Malvy, D	1
Tchamgoué, S	1
Dabis, F	1
Morlat, P	1
Nyska, A	1
Gal-Moscovici, A	1
Rajamannan, NM	1
Ikeda, R	1
Imai, Y	1
Maruyama, W	1
Mizoguchi, K	1
Ali, BH	1
Al-Salam, S	1
Al Husseni, I	1
Kayed, RR	1
Al-Masroori, N	1
Al-Harthi, T	1
Al Zaabi, M	1
Nemmar, A	1
Herlitz, LC	1
Mohan, S	1
Stokes, MB	1
Radhakrishnan, J	1
D'Agati, VD	1
Markowitz, GS	1
De Beaudrap, P	1
Diallo, MB	1
Landman, R	1
Guèye, NF	1
Ndiaye, I	1
Diouf, A	1
Kane, CT	1
Etard, JF	1
Girard, PM	2
Sow, PS	1
Delaporte, E	1
Shiffman, ML	1
Pol, S	2
Rostaing, L	1
Schiff, E	1
Thabut, D	1
Zeuzem, S	1
Zong, J	1
Frederick, D	1
Rousseau, F	1
Thurairajah, P	1
Khanna, A	1
Mutimer, D	1
Chaisiri, K	1
Bowonwatanuwong, C	1
Kasettratat, N	1
Kiertiburanakul, S	1
Perazella, MA	2
Xu, Z	1
Chen, LB	1
Cao, H	1
Shu, X	1
Xu, QH	1
Li, G	1
Xie, QF	1
O'Donnell, EP	1
Scarsi, KK	1
Darin, KM	1
Gerzenshtein, L	1
Postelnick, MJ	1
Palella, FJ	1
Overton, ET	1
Patel, P	1
Mondy, K	1
Bush, T	1
Conley, L	1
Rhame, F	1
Kojic, EM	1
Hammer, J	1
Henry, K	1
Brooks, JT	1
Brennan, A	1
Evans, D	1
Maskew, M	1
Naicker, S	1
Ive, P	1
Sanne, I	1
Maotoe, T	1
Fox, M	1
Manosuthi, W	1
Prasithsirikul, W	1
Tantanathip, P	1
Chimsuntorn, S	1
Nilkamhang, S	1
Sungkanuparph, S	1
Ohi, A	1
Hanabusa, E	1
Ueda, O	1
Segawa, H	1
Horiba, N	1
Kaneko, I	1
Kuwahara, S	1
Mukai, T	1
Sasaki, S	1
Tominaga, R	1
Furutani, J	1
Aranami, F	1
Ohtomo, S	1
Kawase, Y	1
Wada, NA	1
Tachibe, T	1
Kakefuda, M	1
Tateishi, H	1
Matsumoto, K	1
Tatsumi, S	1
Kido, S	1
Fukushima, N	1
Jishage, K	1
Miyamoto, K	1
Lao, CK	1
Gruta, C	1
John, MD	1
Cocohoba, J	1
Gara, N	1
Zhao, X	1
Collins, MT	1
Chong, WH	1
Kleiner, DE	1
Jake Liang, T	1
Ghany, MG	1
Hoofnagle, JH	1
Johnson, DC	1
Chasela, C	1
Maliwichi, M	1
Mwafongo, A	1
Akinkuotu, A	1
Moses, A	1
Jamieson, DJ	1
Kourtis, AP	1
King, CC	1
van der Horst, C	1
Hosseinipour, MC	1
Bouzian, N	1
Parmentier, N	1
Bruneval, P	1
Jestin, G	1
Mandet, C	1
Daubiné, F	1
Massicot, F	1
Laprévote, O	1
Hollenbeck, C	1
Port, M	1
Buster, EH	1
Baak, BC	1
Bakker, CM	1
Beuers, UH	1
Brouwer, JT	1
Drenth, JP	1
van Erpecum, KJ	1
van Hoek, B	1
Honkoop, P	1
Kerbert-Dreteler, MJ	1
Koek, GH	1
van Nieuwkerk, KM	1
van Soest, H	1
van der Spek, BW	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Switching From Tenofovir Disoproxil Fumarate (TDF) 300 mg QD to Tenofovir Alafenamide (TAF) 25 mg QD in Subjects With Chronic Hepatitis B Who Are Virologically Suppressed[NCT02979613]	Phase 3	490 participants (Actual)	Interventional	2016-12-29	Completed
A Prospective Cohort Study of Tenofovir Alafenamide Switching Therapy in Kidney or Liver Transplant Recipients With Chronic Hepatitis B Virus Infection[NCT05410496]	Phase 4	50 participants (Anticipated)	Interventional	2021-06-22	Recruiting
A Phase 3b, Randomized, Double-Blind, Switch Study to Evaluate F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed on Regimens Containing ABC/3TC[NCT02469246]	Phase 3	567 participants (Actual)	Interventional	2015-06-29	Completed
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults[NCT02607956]	Phase 3	657 participants (Actual)	Interventional	2015-11-11	Completed
A Phase 3, Open-Label Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically-Suppressed, HIV-1 Positive Subjects[NCT01815736]	Phase 3	1,443 participants (Actual)	Interventional	2013-03-27	Completed
Effects of Sofosbuvir/Ledipasvir Treatment on the Pharmacokinetics and Renal Safety of Tenofovir[NCT02588287]		14 participants (Actual)	Interventional	2015-11-30	Completed
Effects of Ledipasvir/Sofosbuvir Treatment on the Pharmacokinetics and Renal Safety of Tenofovir Alafenamide (TAF) in Patients With HIV.[NCT03126370]	Phase 4	10 participants (Actual)	Interventional	2018-01-08	Completed
CALVIH: Determination of Kidney Stone Risk Factors in Patients Infected With HIV[NCT02457494]		23 participants (Actual)	Observational	2015-05-31	Completed
Changes in Weight After Switch to Dolutegravir/Lamivudine or Doravirine/Tenofovir/Lamivudine Compared to Continued Treatment With Dolutegravir/Tenofovir/Lamivudine for Virologically Suppressed HIV Infection. AVERTAS-2[NCT04903847]	Phase 4	126 participants (Anticipated)	Interventional	2021-02-02	Recruiting
A Phase 3 Open-label Safety Study of Cobicistat-containing Highly Active Antiretroviral Regimens in HIV-1 Infected Patients With Mild to Moderate Renal Impairment[NCT01363011]	Phase 3	106 participants (Actual)	Interventional	2011-05-31	Completed
The Effects of Vitamin D and Calcium Supplementation to Parathyroid Hormone in CHB Patients Treated With Tenofovir Disoproxil Fumarate[NCT05313477]	Phase 4	64 participants (Anticipated)	Interventional	2022-05-01	Recruiting
Study to Understand the Natural History of HIV/AIDS in the Era of Effective Therapy (SUN Study)[NCT00146419]		699 participants (Actual)	Observational	2004-03-31	Completed
Open Label Study of Nucleus(t)Ide Treated Patients Randomised to Tenofovir, or Tenofovir + Telbivudine[NCT02774837]	Phase 4	146 participants (Actual)	Interventional	2016-04-30	Active, not recruiting
Impact of Drug Therapy and Co-Morbidities on the Development of Renal Impairment in HIV-Infected Patients[NCT00551655]		684 participants (Actual)	Observational	2007-05-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

"Cockcroft-Gault formula is as follows:~For men: Glomerular filtration rate (GFR) = (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL)~For women: GFR = 0.85 * (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL).~Change from baseline was calculated as the value at Week 96 minus the value at Baseline." (NCT02979613)
Timeframe: Baseline; Week 96

Change From Baseline in Estimated Glomerular Filtration Rate Calculated Using the Cockcroft-Gault Equation (eGFR-CG) at Week 48

Intervention	mL/min (Median)
TAF 25 mg	1.626
TDF 300 mg	0.544

"Cockcroft-Gault formula is as follows:~For men: Glomerular filtration rate (GFR) = (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL)~For women: GFR = 0.85 * (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL).~Change from baseline was calculated as the value at Week 48 minus the value at Baseline." (NCT02979613)
Timeframe: Baseline; Week 48

Change From Baseline in FibroTest® Score at Week 48

Intervention	mL/min (Median)
TAF 25 mg	2.240
TDF 300 mg	-1.722

The FibroTest score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Change from baseline was calculated as the value at Week 48 minus the value at Baseline. (NCT02979613)
Timeframe: Baseline; Week 48

Change From Baseline in FibroTest® Score at Week 96

Intervention	scores on a scale (Mean)
TAF 25 mg	-0.02
TDF 300 mg	-0.01

The FibroTest score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Change from baseline was calculated as the value at Week 96 minus the value at Baseline. (NCT02979613)
Timeframe: Baseline; Week 96

Percent Change From Baseline in Hip BMD at Week 96

Intervention	scores on a scale (Mean)
TAF 25 mg	-0.03
TDF 300 mg	-0.03

Percent Change = Change from baseline at a postbaseline visit/baseline * 100%. (NCT02979613)
Timeframe: Baseline; Week 96

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

Intervention	percent change (Mean)
TAF 25 mg	1.157
TDF 300 mg	0.180

Percent Change = Change from baseline at a postbaseline visit/baseline * 100%. (NCT02979613)
Timeframe: Baseline; Week 48

Percent Change From Baseline in Spine BMD at Week 48

Intervention	percent change (Mean)
TAF 25 mg	0.659
TDF 300 mg	-0.507

Percent Change = Change from baseline at a postbaseline visit/baseline * 100%. (NCT02979613)
Timeframe: Baseline; Week 48

Percent Change From Baseline in Spine BMD at Week 96

Intervention	percent change (Mean)
TAF 25 mg	1.743
TDF 300 mg	-0.138

Percent Change = Change from baseline at a postbaseline visit/baseline * 100%. (NCT02979613)
Timeframe: Baseline; Week 96

Percentage of Participants With HBeAg Loss at Week 96

Intervention	percent change (Mean)
TAF 25 mg	2.330
TDF 300 mg	1.726

HBeAg loss was defined as HBeAg changing from positive at baseline to negative at a postbaseline visit with baseline HBeAb negative or missing. The M = F approach was used for this analysis. (NCT02979613)
Timeframe: Week 96

Percentage of Participants With HBeAg Seroconversion at Week 48

Intervention	percentage of participants (Number)
TAF 25 mg	17.9
TDF 300 mg	9.0

HBeAg seroconversion was defined as HBeAg loss and HBeAb changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis. (NCT02979613)
Timeframe: Week 48

Percentage of Participants With HBeAg Seroconversion at Week 96

Intervention	percentage of participants (Number)
TAF 25 mg	2.6
TDF 300 mg	0.0

Percentage of Participants With HBsAg Loss at Week 96

Intervention	percentage of participants (Number)
TAF 25 mg	5.1
TDF 300 mg	2.6

HBsAg loss was defined as HBsAg changing from positive at baseline to negative at a postbaseline visit with baseline HBsAb negative or missing. The M = F approach was used for this analysis. (NCT02979613)
Timeframe: Week 96

Percentage of Participants With HBsAg Seroconversion at Week 48

Intervention	percentage of participants (Number)
TAF 25 mg	1.6
TDF 300 mg	2.4

HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis. (NCT02979613)
Timeframe: Week 48

Percentage of Participants With HBsAg Seroconversion at Week 96

Intervention	percentage of participants (Number)
TAF 25 mg	0.0
TDF 300 mg	0.0

Percentage of Participants With HBV DNA Levels < 20 IU/mL at Week 48

Intervention	percentage of participants (Number)
TAF 25 mg	0.8
TDF 300 mg	0.4

Percentage of Participants With HBV DNA Levels < 20 IU/mL at Week 96

Intervention	percentage of participants (Number)
TAF 25 mg	96.3
TDF 300 mg	96.3

Percentage of Participants With HBV DNA Levels ≥ 20 IU/mL at Week 96, as Determined by the Modified US FDA-Defined Snapshot Algorithm

Intervention	percentage of participants (Number)
TAF 25 mg	94.7
TDF 300 mg	93.9

"The percentage of participants with HBV DNA ≥ 20 IU/mL at Week 96 was analyzed using the modified US FDA-defined snapshot algorithm, which included participants who:~Had the last available on-treatment HBV DNA ≥ 20 IU/mL in the Week 96 analysis window (from Day 589 to Day 840, inclusive), or~Did not have on-treatment HBV DNA data available in the Week 96 analysis window and~Discontinued study drug prior to or in the Week 96 analysis window due to lack of efficacy, or~Discontinued study drug prior to or in the Week 96 analysis window due to reason other than lack of efficacy and had the last available on-treatment HBV DNA ≥ 20 IU/mL" (NCT02979613)
Timeframe: Week 96

Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 48

Intervention	percentage of participants (Number)
TAF 25 mg	0.4
TDF 300 mg	0.4

Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48

Intervention	percentage of participants (Number)
TAF 25 mg	7.7
TDF 300 mg	6.4

Percentage of Participants With Hepatitis B Virus (HBV) DNA Levels ≥ 20 IU/mL at Week 48, as Determined by the Modified United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm

Intervention	percentage of participants (Number)
TAF 25 mg	0.0
TDF 300 mg	2.0

"The percentage of participants with HBV DNA ≥ 20 IU/mL at Week 48 was analyzed using the modified US FDA-defined snapshot algorithm, which included participants who:~Had the last available on-treatment HBV DNA ≥ 20 IU/mL in the Week 48 analysis window (from Day 295 to Day 378, inclusive), or~Did not have on-treatment HBV DNA data available in the Week 48 analysis window and~Discontinued study drug prior to or in the Week 48 analysis window due to lack of efficacy, or~Discontinued study drug prior to or in the Week 48 analysis window due to reason other than lack of efficacy and had the last available on-treatment HBV DNA ≥ 20 IU/mL" (NCT02979613)
Timeframe: Week 48

Percentage of Participants With HBV DNA Levels < 20 IU/mL (Target Detected/Not Detected) at Week 48

Intervention	percentage of participants (Number)
TAF 25 mg	0.4
TDF 300 mg	0.4

The percentage of participants with HBV DNA < 20 IU/mL at Week 48 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 48 analysis window. The method of determining percentage of participants with HBV DNA levels <20 IU/mL (target detected/not detected i.e., lower limit of detection) at Week 48, was handled by M = F, and Missing=Excluded (M = E) approaches. (NCT02979613)
Timeframe: Week 48

Percentage of Participants With HBV DNA Levels < 20 IU/mL (Target Detected/Not Detected) at Week 96

Intervention	percentage of participants (Number)
	M = F Approach: < 20 IU/mL Target Not Detected	M = F Approach: < 20 IU/mL Target Detected	M = E Approach: < 20 IU/mL Target Not Detected	M = E Approach: < 20 IU/mL Target Detected
TAF 25 mg	63.4	32.9	65.5	34.0
TDF 300 mg	62.0	34.3	64.1	35.4

The percentage of participants with HBV DNA < 20 IU/mL at Week 96 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 96 analysis window. The method of determining percentage of participants with HBV DNA levels <20 IU/mL (target detected/not detected i.e., lower limit of detection) at Week 96, was handled by Missing=Failure (M = F), and Missing=Excluded (M = E) approaches. (NCT02979613)
Timeframe: Week 96

Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 48 (by Central Laboratory and the American Association for the Study of Liver Diseases [AASLD] Criteria)

Intervention	percentage of participants (Number)
	M = F Approach: < 20 IU/mL Target Not Detected	M = F Approach: < 20 IU/mL Target Detected	M = E Approach: < 20 IU/mL Target Not Detected	M = E Approach: < 20 IU/mL Target Detected
TAF 25 mg	65.8	28.8	69.3	30.3
TDF 300 mg	66.1	27.8	70.1	29.4

Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis. (NCT02979613)
Timeframe: Week 48

Percentage of Participants With Normal ALT at Week 96 (by Central Laboratory and the AASLD Criteria)

Intervention	percentage of participants (Number)
	Central Laboratory Criteria	AASLD Criteria
TAF 25 mg	89.3	79.0
TDF 300 mg	84.9	75.1

Percentage of Participants With Normalized ALT at Week 48 (by Central Laboratory and AASLD Criteria)

Intervention	percentage of participants (Number)
	Central Laboratory Criteria	AASLD Criteria
TAF 25 mg	88.5	80.7
TDF 300 mg	91.4	86.5

ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis. (NCT02979613)
Timeframe: Week 48

Percentage of Participants With Normalized ALT at Week 96 (by Central Laboratory and AASLD Criteria)

Intervention	percentage of participants (Number)
	Central Laboratory Criteria	AASLD Criteria
TAF 25 mg	50.0	50.0
TDF 300 mg	36.8	26.4

Change From Baseline in CD4 Cell Count at Week 48

Change From Baseline in CD4 Cell Count at Week 96

Percent Change From Baseline in Hip BMD at Week 96

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

Percent Change From Baseline in Spine BMD at Week 48

Percent Change From Baseline in Spine BMD at Week 96

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

Intervention	percentage of participants (Number)
	Central Laboratory Criteria	AASLD Criteria
TAF 25 mg	56.3	55.8
TDF 300 mg	78.9	73.6

Intervention	cells/µL (Mean)
F/TAF	-30
ABC/3TC	2

Intervention	cells/μL (Mean)
F/TAF	-29
ABC/3TC	10

Intervention	percent change (Mean)
F/TAF	0.169
ABC/3TC	0.021

Intervention	percent change (Mean)
F/TAF	0.246
ABC/3TC	0.086

Intervention	percent change (Mean)
F/TAF	0.081
ABC/3TC	-0.052

Intervention	percent change (Mean)
F/TAF	0.178
ABC/3TC	0.235

The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02469246)
Timeframe: Week 48

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

Intervention	percentage of participants (Number)
F/TAF	85.7
ABC/3TC	87.3

The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02469246)
Timeframe: Week 96

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

Intervention	percentage of participants (Number)
F/TAF	80.4
ABC/3TC	86.2

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02469246)
Timeframe: Week 48

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

Intervention	percentage of participants (Number)
F/TAF	88.6
ABC/3TC	92.4

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02469246)
Timeframe: Week 96

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

Intervention	percentage of participants (Number)
F/TAF	82.1
ABC/3TC	88.4

The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02469246)
Timeframe: Week 48

Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm

Intervention	percentage of participants (Number)
F/TAF	1.8
ABC/3TC	0.7

The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02469246)
Timeframe: Week 96

Change From Baseline in CD4+ Cell Count at Week 144

Change From Baseline in CD4+ Cell Count at Week 48

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

Change From Baseline in CD4+ Cell Count at Week 96

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

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

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

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

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

Intervention	percentage of participants (Number)
F/TAF	2.5
ABC/3TC	1.1

Intervention	cells/μL (Mean)
B/F/TAF	278
DTG + F/TAF	289

Intervention	cells/μL (Mean)
B/F/TAF	180
DTG + F/TAF	201

Intervention	cells/μL (Mean)
All B/F/TAF	304
DTG + F/TAF to B/F/TAF	9

Intervention	cells/μL (Mean)
B/F/TAF	237
DTG + F/TAF	281

Intervention	cells/µL (Mean)
All B/F/TAF	336
DTG + F/TAF to B/F/TAF	-10

Intervention	log10 copies/mL (Mean)
B/F/TAF	-3.06
DTG + F/TAF	-3.11

Intervention	log10 copies/mL (Mean)
B/F/TAF	-3.07
DTG + F/TAF	-3.12

Intervention	log10 copies/mL (Mean)
B/F/TAF	-3.08
DTG + F/TAF	-3.10

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Change From Baseline in CD4 Cell Count at Weeks 96

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

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

Change From Baseline in Serum Creatinine at Week 48

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

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

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

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

Percent Change From Baseline in Spine BMD at Week 48

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

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

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

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

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

Change From Week 12 Plasma Tenofovir Area Under the Plasma Concentration vs. Time Curve From Time 0 to 24 Hours (AUC0-24) at 24 and 28 Weeks

Compare plasma tenofovir AUC0-24 between TAF with boosted PI vs. TDF with boosted PI (Phase 2 vs. 1), and between TAF with boosted PI and LDV/SOF vs. TDF with boosted PI (Phase 3 vs. 1) (NCT03126370)
Timeframe: 12 weeks and 24 weeks and 28 weeks

Change From Week 12 Tenofovir-diphosphate (TFV-DP) in Dried Blood Spots (DBS)

Compare tenofovir diphosphate (TFV-DP) in dried blood spots (DBS) between TAF with a boosted PI vs. TDF with a boosted PI (Phase 2 vs. 1), and TAF with a boosted PI and LDV/SOF vs. TDF with a boosted PI (Phase 3 vs. 1) (NCT03126370)
Timeframe: 12 weeks and 24 and 28 weeks

Change From Week 12 Tenofovir-diphosphate (TFV-DP) in Peripheral Blood Mononuclear Cells (PBMCs) at 24 and 28 Weeks

Compare tenofovir-diphosphate (TFV-DP) in peripheral blood mononuclear cells (PBMCs) between TAF with a boosted PI vs. TDF with a boosted PI (Phase 2 vs. 1), and TAF with a boosted PI and LDV/SOF vs. TDF with a boosted PI (Phase 3 vs. 1). (NCT03126370)
Timeframe: 12 weeks, and 24 weeks and 28 weeks

Change in Estimated Glomerular Filtration Rate (eGFR) and Renal Biomarkers: eGFR

Change in estimated glomerular filtration rate (eGFR) (NCT03126370)
Timeframe: 12 weeks, 24 weeks, and 28 weeks

Change in Estimated Glomerular Filtration Rate (eGFR) and Renal Biomarkers: UPCR

Change in estimated glomerular filtration rate (eGFR) and renal biomarkers: Urine protein to creatinine ratio (UPCR) (NCT03126370)
Timeframe: 12 weeks, 24 weeks, and 28 weeks

Change in Estimated Glomerular Filtration Rate (eGFR) and Renal Biomarkers: B2M/Cr Ratio, and RBP/Cr Ratio

Change in renal biomarkers: urinary beta-2 microglobulin (B2M)/creatinine (Cr) ratio, and urinary retinol binding protein (RBP)/Cr ratio (NCT03126370)
Timeframe: 12 weeks, 24 weeks, and 28 weeks

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

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed in Cohort 1 (treatment-naive) using the FDA snapshot analysis algorithm. (NCT01363011)
Timeframe: Week 24

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (Cohort 2)

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed in Cohort 2 (treatment-experienced) using the FDA snapshot analysis algorithm. (NCT01363011)
Timeframe: Week 24

Change From Baseline in Actual Glomerular Filtration Rate (aGFR) at Weeks 2, 4, and 24 (Cohort 1)

Change from baseline in aGFR at Weeks 2, 4, and 24 was analyzed in Cohort 1 (treatment-naive). aGFR was calculated using iohexol plasma clearance. (NCT01363011)
Timeframe: Baseline; Weeks 2, 4, and 24

Change From Baseline in aGFR at Weeks 2, 4, and 24 (Cohort 2)

Change from baseline in aGFR at Weeks 2, 4, and 24 was analyzed in Cohort 2 (treatment-experienced). aGFR was calculated using iohexol plasma clearance. (NCT01363011)
Timeframe: Baseline; Weeks 2, 4, and 24

Change From Baseline in eGFR Using the Chronic Kidney Disease, Epidemiology Collaboration (CKD-EPI) Formula Based on Cystatin C Equation at Week 24 (Cohort 1)

Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area. (NCT01363011)
Timeframe: Baseline; Week 24

Change From Baseline in eGFR Using the Modification of Diet in Renal (MDRD) Equation at Week 24 (Cohort 1)

Change from baseline in eGFR-MDRD equation at Week 24 was analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area. (NCT01363011)
Timeframe: Baseline; Week 24

Change From Baseline in eGFR-CG at Week 24 (Cohort 2)

Change from baseline in eGFR-CG equation at Week 24 was analyzed in Cohort 2 (treatment-experienced). (NCT01363011)
Timeframe: Baseline; Week 24

Change From Baseline in eGFR-CG at Weeks 48 and 96 (Cohort 1)

Change from baseline in eGFR-CG at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive). This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters. (NCT01363011)
Timeframe: Baseline; Weeks 48 and 96

Change From Baseline in eGFR-CG at Weeks 48 and 96 (Cohort 2)

Change from baseline in eGFR-CG at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced). This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters. (NCT01363011)
Timeframe: Baseline; Week 48

Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation (Adjusted) at Weeks 48 and 96 (Cohort 1)

Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters. (NCT01363011)
Timeframe: Baseline; Weeks 48 and 96

Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation (Adjusted) at Weeks 48 and 96 (Cohort 2)

Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters. (NCT01363011)
Timeframe: Baseline; Weeks 48 and 96

Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation at Weeks 48 and 96 (Cohort 1)

Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters. (NCT01363011)
Timeframe: Baseline; Weeks 48 and 96

Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation at Weeks 48 and 96 (Cohort 2)

Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters. (NCT01363011)
Timeframe: Baseline; Weeks 48 and 96

Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation, Adjusted at Week 24 (Cohort 1)

Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area. (NCT01363011)
Timeframe: Baseline; Week 24

Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation, Adjusted at Week 24 (Cohort 2)

Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area. (NCT01363011)
Timeframe: Baseline; Week 24

Change From Baseline in eGFR-CKD-EPI Formula Based on Cystatin C Equation at Week 24 (Cohort 2)

Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area. (NCT01363011)
Timeframe: Baseline; Week 24

Change From Baseline in eGFR-MDRD at Week 24 (Cohort 2)

Change from baseline in eGFR-MDRD equation at Week 24 was analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area. (NCT01363011)
Timeframe: Baseline; Week 24

Change From Baseline in eGFR-MDRD at Weeks 48 and 96 (Cohort 1)

Change from baseline in eGFR-MDRD at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters. (NCT01363011)
Timeframe: Baseline; Weeks 48 and 96

Change From Baseline in eGFR-MDRD at Weeks 48 and 96 (Cohort 2)

Change from baseline in eGFR-MDRD at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters. (NCT01363011)
Timeframe: Baseline; Weeks 48 and 96

Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Cockcroft-Gault (CG) Equation at Week 24 (Cohort 1)

Change from baseline in eGFR-CG equation at Week 24 was analyzed in Cohort 1 (treatment-naive). (NCT01363011)
Timeframe: Baseline; Week 24

Percentage of Participants Who Experienced Adverse Events (Cohort 1)

Adverse events (AEs) occurring from baseline up to 30 days following the last dose of study drug were summarized for Cohort 1 (treatment-naive). A participant was counted once if they had a qualifying event. (NCT01363011)
Timeframe: Up to 147 weeks plus 30 days

Percentage of Participants Who Experienced Adverse Events (Cohort 2)

Adverse events (AEs) occurring from baseline up to 30 days following the last dose of study drug were summarized for Cohort 2 (treatment-experienced). A participant was counted once if they had a qualifying event. (NCT01363011)
Timeframe: Up to 166 weeks plus 30 days

Percentage of Participants Who Experienced Graded Laboratory Abnormalities (Cohort 1)

Laboratory abnormalities were summarized for Cohort 1 (treatment-naive) and were defined as values that increased at least one toxicity grade from baseline at any time postbaseline up to and including the date of last dose of study drug plus 30 days. A participant was counted once if they had a qualifying event. (NCT01363011)
Timeframe: Up to 147 weeks plus 30 days

Percentage of Participants Who Experienced Graded Laboratory Abnormalities (Cohort 2)

Laboratory abnormalities were summarized for Cohort 2 (treatment-experienced) and were defined as values that increased at least one toxicity grade from baseline at any time postbaseline up to and including the date of last dose of study drug plus 30 days. A participant was counted once if they had a qualifying event. (NCT01363011)
Timeframe: Up to 166 weeks plus 30 days

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 48 and 96 (Cohort 1)

The percentage of participants with HIV-1 RNA < 50 copies/mL at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive) using the FDA snapshot analysis algorithm. (NCT01363011)
Timeframe: Weeks 48 and 96

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 48 and 96 (Cohort 2)

The percentage of participants with HIV-1 RNA < 50 copies/mL at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced) using the FDA snapshot analysis algorithm. (NCT01363011)
Timeframe: Weeks 48 and 96

Plasma Pharmacokinetics of COBI: AUCtau (Cohort 1)

AUCtau was analyzed for Cohort 1 (treatment-naive) and was defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval). (NCT01363011)
Timeframe: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.

Plasma Pharmacokinetics of COBI: AUCtau (Cohort 2)

AUCtau was analyzed for Cohort 2 (treatment-experienced) and was defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval). (NCT01363011)
Timeframe: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.

Plasma Pharmacokinetics of COBI: Cmax (Cohort 1)

Cmax was analyzed for Cohort 1 (treatment-naive) and was defined as the maximum observed concentration of drug in plasma. (NCT01363011)
Timeframe: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.

Plasma Pharmacokinetics of COBI: Cmax (Cohort 2)

Cmax was analyzed for Cohort 2 (treatment-experienced) and was defined as the maximum observed concentration of drug in plasma. (NCT01363011)
Timeframe: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.

Plasma Pharmacokinetics of COBI: Ctau (Cohort 1)

Ctau was analyzed for Cohort 1 (treatment-naive) and was defined as the observed drug concentration at the end of the dosing interval. (NCT01363011)
Timeframe: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.

Plasma Pharmacokinetics of COBI: Ctau (Cohort 2)

Ctau was analyzed for Cohort 2 (treatment-experienced) and was defined as the observed drug concentration at the end of the dosing interval. (NCT01363011)
Timeframe: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.

Plasma Pharmacokinetics of COBI: t1/2 (Cohort 1)

t1/2 was analyzed for Cohort 1 (treatment-naive) and was defined as the estimate of the terminal elimination half-life of the drug. (NCT01363011)
Timeframe: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.

Plasma Pharmacokinetics of COBI: t1/2 (Cohort 2)

t1/2 was analyzed for Cohort 2 (treatment-experienced) and was defined as the estimate of the terminal elimination half-life of the drug. (NCT01363011)
Timeframe: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.

Plasma Pharmacokinetics of COBI: Tmax (Cohort 1)

Tmax was analyzed for Cohort 1 (treatment-naive) and was defined as the time of Cmax. (NCT01363011)
Timeframe: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.

Plasma Pharmacokinetics of COBI: Tmax (Cohort 2)

Tmax was analyzed for Cohort 2 (treatment-experienced) and was defined as the time of Cmax. (NCT01363011)
Timeframe: Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.

Intervention	cells/uL (Mean)
	Baseline	Change at Week 96
E/C/F/TAF	701	60
Stay on Baseline Treatment Regimen (SBR)	689	42

Intervention	cells/uL (Mean)
	Baseline (NDA Data Cut)	Change at Week 48 (NDA Data Cut)	Baseline (All Participants)	Change at Week 48 (All Participants)
E/C/F/TAF	712	33	701	35
Stay on Baseline Treatment Regimen (SBR)	690	27	689	24

Intervention	mg/dL (Mean)
	NDA Data Cut	All Participants
E/C/F/TAF	-0.01	0.00
Stay on Baseline Treatment Regimen (SBR)	0.04	0.03

Intervention	ng*h/mL (Geometric Mean)
TDF With a Boosted PI	3466
TAF With a Boosted PI	743
TAF With a Boosted PI and LDV/SOF	868

Intervention	fmol/2x7mm punches (Geometric Mean)
TDF With a Boosted PI	36014
TAF With a Boosted PI	6735
TAF With a Boosted PI and LDV/SOF	6100

Intervention	fmol/10^6 cells (Geometric Mean)
TDF With a Boosted PI	83.0
TAF With a Boosted PI	926
TAF With a Boosted PI and LDV/SOF	1129

Intervention	mL/min/1.73 m^2 (Geometric Mean)
TDF With a Boosted PI	86.7
TAF With a Boosted PI	91.0
TAF With a Boosted PI and LDV/SOF	88.1

Intervention	ug/g (Geometric Mean)
	β2M:Cr ratio	RBP:Cr ratio
TAF With a Boosted PI	224	242
TAF With a Boosted PI and LDV/SOF	178	146
TDF With a Boosted PI	419	436

Intervention	mL/min (Number)
	Baseline	Change at Week 2	Change at Week 4	Change at Week 24
E/C/F/TDF (Cohort 1)	81.6	-12.1	-7.3	-3.3

Intervention	mL/min (Median)
	Baseline	Change at Week 2 (n=13)	Change at Week 4 (n=13)	Change at Week 24 (n=11)
COBI+PI+2 NRTIs (Cohort 2)	82.5	1.6	7.0	-4.1

Intervention	mL/min/1.73 m^2 (Median)
	Baseline (n = 33)	Change at Week 24 (n = 30)
E/C/F/TDF (Cohort 1)	77.6	0.3

Intervention	mL/min (Median)
	Baseline (n = 73)	Change at Week 24 (n = 67)
COBI+PI+2 NRTIs (Cohort 2)	71.4	-3.7

Intervention	mL/min (Median)
	Change at Week 48 (n = 28)	Change at Week 96 (n = 25)
E/C/F/TDF (Cohort 1)	-7.6	-7.9

Intervention	mL/min (Median)
	Change at Week 48 (n = 63)	Change at Week 96 (n = 50)
COBI+PI+2 NRTIs (Cohort 2)	-3.8	-5.0

Intervention	percentage of participants (Number)
	Any AE	Drug-related AE	Grade 3 or higher AE	AE leading to drug discontinuation	Serious AE	AE of proximal renal tubulopathy
E/C/F/TDF (Cohort 1)	100.0	48.5	21.2	12.1	18.2	0

Intervention	percentage of participants (Number)
	Any laboratory abnormality	Grade 3 or 4 laboratory abnormality
E/C/F/TDF (Cohort 1)	100.0	39.4

Intervention	percentage of participants (Number)
	Week 48 (n = 33)	Week 96 (n = 27)
E/C/F/TDF (Cohort 1)	78.8	88.9

Intervention	percentage of participants (Number)
	Week 48 (n = 73)	Week 96 (n = 54)
COBI+PI+2 NRTIs (Cohort 2)	82.2	90.7

Intervention	h*ng/mL (Mean)
	Week 2 (n = 13)	Week 4 (n = 13)	Week 24 (n = 11)
COBI+PI+2 NRTIs (Cohort 2)	12458.0	11165.3	13980.5

Intervention	hours (Median)
	Week 2 (n = 13)	Week 4 (n = 12)	Week 24 (n = 10)
COBI+PI+2 NRTIs (Cohort 2)	4.37	3.98	3.77

Article	Year
Medication safety in chronic kidney disease. Current opinion in nephrology and hypertension, 2023, 09-01, Volume: 32, Issue:5 Topics: Adenine; COVID-19; Humans; Kidney; Renal Insufficiency; Renal Insufficiency, Chronic; Tenofovir	2023
Functional and histological effects of Anthurium schlechtendalii Kunth extracts on adenine-induced kidney damage of adult Wistar rats. Toxicon : official journal of the International Society on Toxinology, 2023, Volume: 233 Topics: Adenine; Adult; Animals; Araceae; Humans; Inflammation; Kidney; Kidney Diseases; Plant Extracts; Rat	2023
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
Tenofovir alafenamide (TAF) treatment of HBV, what are the unanswered questions? Expert review of anti-infective therapy, 2018, Volume: 16, Issue:2 Topics: Adenine; Alanine; Antiviral Agents; Bone Density; Dose-Response Relationship, Drug; Hepatitis B, Chr	2018
Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials. AIDS (London, England), 2019, 07-15, Volume: 33, Issue:9 Topics: Adenine; Adolescent; Adult; Aged; Aged, 80 and over; Alanine; Anti-HIV Agents; Child; Female; Humans	2019
Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials. AIDS (London, England), 2019, 07-15, Volume: 33, Issue:9 Topics: Adenine; Adolescent; Adult; Aged; Aged, 80 and over; Alanine; Anti-HIV Agents; Child; Female; Humans	2019
Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials. AIDS (London, England), 2019, 07-15, Volume: 33, Issue:9 Topics: Adenine; Adolescent; Adult; Aged; Aged, 80 and over; Alanine; Anti-HIV Agents; Child; Female; Humans	2019
Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials. AIDS (London, England), 2019, 07-15, Volume: 33, Issue:9 Topics: Adenine; Adolescent; Adult; Aged; Aged, 80 and over; Alanine; Anti-HIV Agents; Child; Female; Humans	2019
Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials. AIDS (London, England), 2019, 07-15, Volume: 33, Issue:9 Topics: Adenine; Adolescent; Adult; Aged; Aged, 80 and over; Alanine; Anti-HIV Agents; Child; Female; Humans	2019
Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials. AIDS (London, England), 2019, 07-15, Volume: 33, Issue:9 Topics: Adenine; Adolescent; Adult; Aged; Aged, 80 and over; Alanine; Anti-HIV Agents; Child; Female; Humans	2019
Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials. AIDS (London, England), 2019, 07-15, Volume: 33, Issue:9 Topics: Adenine; Adolescent; Adult; Aged; Aged, 80 and over; Alanine; Anti-HIV Agents; Child; Female; Humans	2019
Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials. AIDS (London, England), 2019, 07-15, Volume: 33, Issue:9 Topics: Adenine; Adolescent; Adult; Aged; Aged, 80 and over; Alanine; Anti-HIV Agents; Child; Female; Humans	2019
Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials. AIDS (London, England), 2019, 07-15, Volume: 33, Issue:9 Topics: Adenine; Adolescent; Adult; Aged; Aged, 80 and over; Alanine; Anti-HIV Agents; Child; Female; Humans	2019
Tenofovir effect on the kidneys of HIV-infected patients: a double-edged sword? Journal of the American Society of Nephrology : JASN, 2013, Volume: 24, Issue:10 Topics: Adenine; Antirheumatic Agents; Clinical Trials as Topic; HIV Infections; Humans; Incidence; Kidney;	2013
Tenofovir effect on the kidneys of HIV-infected patients: a double-edged sword? Journal of the American Society of Nephrology : JASN, 2013, Volume: 24, Issue:10 Topics: Adenine; Antirheumatic Agents; Clinical Trials as Topic; HIV Infections; Humans; Incidence; Kidney;	2013
Tenofovir effect on the kidneys of HIV-infected patients: a double-edged sword? Journal of the American Society of Nephrology : JASN, 2013, Volume: 24, Issue:10 Topics: Adenine; Antirheumatic Agents; Clinical Trials as Topic; HIV Infections; Humans; Incidence; Kidney;	2013
Tenofovir effect on the kidneys of HIV-infected patients: a double-edged sword? Journal of the American Society of Nephrology : JASN, 2013, Volume: 24, Issue:10 Topics: Adenine; Antirheumatic Agents; Clinical Trials as Topic; HIV Infections; Humans; Incidence; Kidney;	2013
Tenofovir effect on the kidneys of HIV-infected patients: a double-edged sword? Journal of the American Society of Nephrology : JASN, 2013, Volume: 24, Issue:10 Topics: Adenine; Antirheumatic Agents; Clinical Trials as Topic; HIV Infections; Humans; Incidence; Kidney;	2013
Tenofovir effect on the kidneys of HIV-infected patients: a double-edged sword? Journal of the American Society of Nephrology : JASN, 2013, Volume: 24, Issue:10 Topics: Adenine; Antirheumatic Agents; Clinical Trials as Topic; HIV Infections; Humans; Incidence; Kidney;	2013
Tenofovir effect on the kidneys of HIV-infected patients: a double-edged sword? Journal of the American Society of Nephrology : JASN, 2013, Volume: 24, Issue:10 Topics: Adenine; Antirheumatic Agents; Clinical Trials as Topic; HIV Infections; Humans; Incidence; Kidney;	2013
Tenofovir effect on the kidneys of HIV-infected patients: a double-edged sword? Journal of the American Society of Nephrology : JASN, 2013, Volume: 24, Issue:10 Topics: Adenine; Antirheumatic Agents; Clinical Trials as Topic; HIV Infections; Humans; Incidence; Kidney;	2013
Tenofovir effect on the kidneys of HIV-infected patients: a double-edged sword? Journal of the American Society of Nephrology : JASN, 2013, Volume: 24, Issue:10 Topics: Adenine; Antirheumatic Agents; Clinical Trials as Topic; HIV Infections; Humans; Incidence; Kidney;	2013
Tenofovir-associated nephrotoxicity in two HIV-infected adolescent males. AIDS patient care and STDs, 2009, Volume: 23, Issue:1 Topics: Adenine; Adolescent; Age Factors; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Black or A	2009
Editorial comment: tenofovir nephrotoxicity--vigilance required. The AIDS reader, 2005, Volume: 15, Issue:7 Topics: Adenine; Fanconi Syndrome; Glycosuria; HIV Infections; Humans; Hypokalemia; Hypophosphatemia; Organo	2005
Tenofovir-associated acute and chronic kidney disease: a case of multiple drug interactions. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2006, Jan-15, Volume: 42, Issue:2 Topics: Adenine; Aged; Anti-HIV Agents; Creatinine; Drug Interactions; Humans; Male; Middle Aged; Organophos	2006
Realizing the potential of adenosine-receptor-based therapeutics. Proceedings of the Western Pharmacology Society, 1996, Volume: 39 Topics: Adenine; Animals; Clinical Trials as Topic; Humans; Norbornanes; Pain; Purinergic P1 Receptor Agonis	1996
Clinical pharmacokinetics of the antiviral nucleotide analogues cidofovir and adefovir. Clinical pharmacokinetics, 1999, Volume: 36, Issue:2 Topics: Adenine; Administration, Oral; Animals; Antiviral Agents; Cidofovir; Cytosine; Drug Interactions; Hu	1999

Article	Year
Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in virologically suppressed patients with chronic hepatitis B: a randomised, double-blind, phase 3, multicentre non-inferiority study. The lancet. Gastroenterology & hepatology, 2020, Volume: 5, Issue:5 Topics: Adenine; Alanine; Antiviral Agents; Bone Density; Creatinine; DNA, Viral; Double-Blind Method; Drug	2020
Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in virologically suppressed patients with chronic hepatitis B: a randomised, double-blind, phase 3, multicentre non-inferiority study. The lancet. Gastroenterology & hepatology, 2020, Volume: 5, Issue:5 Topics: Adenine; Alanine; Antiviral Agents; Bone Density; Creatinine; DNA, Viral; Double-Blind Method; Drug	2020
Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in virologically suppressed patients with chronic hepatitis B: a randomised, double-blind, phase 3, multicentre non-inferiority study. The lancet. Gastroenterology & hepatology, 2020, Volume: 5, Issue:5 Topics: Adenine; Alanine; Antiviral Agents; Bone Density; Creatinine; DNA, Viral; Double-Blind Method; Drug	2020
Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in virologically suppressed patients with chronic hepatitis B: a randomised, double-blind, phase 3, multicentre non-inferiority study. The lancet. Gastroenterology & hepatology, 2020, Volume: 5, Issue:5 Topics: Adenine; Alanine; Antiviral Agents; Bone Density; Creatinine; DNA, Viral; Double-Blind Method; Drug	2020
Effects of switching from efavirenz to raltegravir on endothelial function, bone mineral metabolism, inflammation, and renal function: a randomized, controlled trial. Journal of acquired immune deficiency syndromes (1999), 2013, Nov-01, Volume: 64, Issue:3 Topics: Adenine; Adult; Alkaline Phosphatase; Anti-HIV Agents; Biomarkers; Bone and Bones; C-Reactive Protei	2013
[Efficacy of the 96-week adefovir dipivoxil therapy in patients with chronic hepatitis B]. Zhonghua shi yan he lin chuang bing du xue za zhi = Zhonghua shiyan he linchuang bingduxue zazhi = Chinese journal of experimental and clinical virology, 2010, Volume: 24, Issue:3 Topics: Adenine; Adolescent; Adult; Antiviral Agents; DNA, Viral; Drug Resistance, Viral; Female; Genotype;	2010
Tenofovir use and renal insufficiency among pregnant and general adult population of HIV-infected, ART-naïve individuals in Lilongwe, Malawi. PloS one, 2012, Volume: 7, Issue:7 Topics: Adenine; Adolescent; Adult; Alkynes; Anti-HIV Agents; Benzoxazines; Body Mass Index; CD4 Lymphocyte	2012
Efficacy and safety of adefovir dipivoxil in kidney recipients, hemodialysis patients, and patients with renal insufficiency. Transplantation, 2005, Oct-27, Volume: 80, Issue:8 Topics: Adenine; Adult; Aged; Antiviral Agents; Drug Resistance, Viral; Female; Hepatitis B virus; Hepatitis	2005
Pharmacokinetics and dosing recommendations of tenofovir disoproxil fumarate in hepatic or renal impairment. Clinical pharmacokinetics, 2006, Volume: 45, Issue:11 Topics: Adenine; Adult; Aged; Drug Administration Schedule; Drug Monitoring; Female; Humans; Liver Diseases;	2006