Tenofovir Alafenamide

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  • Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People with HIV Aged ≥ 65 Years: Week 48 Results of a Phase 3b, Open-Label Trial
    Infectious Diseases and Therapy, 2021
    Co-Authors: Franco Maggiolo, Federico Pulido, Giuliano Rizzardini, Jean Michel Molina, Stephane De Wit, Linos Vandekerckhove, Juan Berenguer, Michelle L. D’antoni, Christiana Blair, Susan K. Chuck
    Abstract:

    Introduction We report the 48-week results of an ongoing study to assess the efficacy and safety of switching older people with HIV to bictegravir/emtricitabine/Tenofovir Alafenamide (B/F/TAF). Methods This was a 96-week, phase 3b, open-label, single-arm study (GS-US-380-4449; NCT03405935). Virologically suppressed individuals aged ≥ 65 years receiving elvitegravir/cobicistat/emtricitabine/Tenofovir Alafenamide or a Tenofovir disoproxil fumarate-based regimen were switched to B/F/TAF. Primary endpoint was the percentage of participants with HIV-1 RNA 

  • emtricitabine and Tenofovir Alafenamide vs emtricitabine and Tenofovir disoproxil fumarate for hiv pre exposure prophylaxis discover primary results from a randomised double blind multicentre active controlled phase 3 non inferiority trial
    The Lancet, 2020
    Co-Authors: Jean Michel Molina, Melanie A Thompson, Edwin Dejesus, Kenneth H Mayer, Peter L Anderson, Karam Mounzer, Joss J De Wet, Heiko Jessen, Robert M Grant
    Abstract:

    Summary Background Tenofovir Alafenamide shows high antiviral efficacy and improved renal and bone safety compared with Tenofovir disoproxil fumarate when used for HIV treatment. Here, we report primary results from a blinded phase 3 study evaluating the efficacy and safety of pre-exposure prophylaxis (PrEP) with emtricitabine and Tenofovir Alafenamide versus emtricitabine and Tenofovir disoproxil fumarate for HIV prevention. Methods This study is an ongoing, randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial done at 94 community, public health, and hospital-associated clinics located in regions of Europe and North America, where there is a high incidence of HIV or prevalence of people living with HIV, or both. We enrolled adult cisgender men who have sex with men and transgender women who have sex with men, both with a high risk of acquiring HIV on the basis of their self-reported sexual behaviour in the past 12 weeks or their recent history (within 24 weeks of enrolment) of bacterial sexually transmitted infections. Participants with current or previous use of PrEP with emtricitabine and Tenofovir disoproxil fumarate were not excluded. We used a computer-generated random allocation sequence to randomly assign (1:1) participants to receive either emtricitabine (200 mg) and Tenofovir Alafenamide (25 mg) tablets daily, with matched placebo tablets (emtricitabine and Tenofovir Alafenamide group), or emtricitabine (200 mg) and Tenofovir disoproxil fumarate (300 mg) tablets daily, with matched placebo tablets (emtricitabine and Tenofovir disoproxil fumarate group). As such, all participants were given two tablets. The trial sponsor, investigators, participants, and the study staff who provided the study drugs, assessed the outcomes, and collected the data were masked to group assignment. The primary efficacy outcome was incident HIV infection, which was assessed when all participants had completed 48 weeks of follow-up and half of all participants had completed 96 weeks of follow-up. This full analysis set included all randomly assigned participants who had received at least one dose of the assigned study drug and had at least one post-baseline HIV test. Non-inferiority of emtricitabine and Tenofovir Alafenamide to emtricitabine and Tenofovir disoproxil fumarate was established if the upper bound of the 95·003% CI of the HIV incidence rate ratio (IRR) was less than the prespecified non-inferiority margin of 1·62. We prespecified six secondary bone mineral density and renal biomarker safety endpoints to evaluate using the safety analysis set. This analysis set included all randomly assigned participants who had received at least one dose of the assigned study drug. This trial is registered with ClinicalTrials.gov , NCT02842086 , and is no longer recruiting. Findings Between Sept 13, 2016, and June 30, 2017, 5387 (92%) of 5857 participants were randomly assigned and received emtricitabine and Tenofovir Alafenamide (n=2694) or emtricitabine and Tenofovir disoproxil fumarate (n=2693). At the time of the primary efficacy analysis (ie, when all participants had completed 48 weeks and 50% had completed 96 weeks) emtricitabine and Tenofovir Alafenamide was non-inferior to emtricitabine and Tenofovir disoproxil fumarate for HIV prevention, as the upper limit of the 95% CI of the IRR, was less than the prespecified non-inferiority margin of 1·62 (IRR 0·47 [95% CI 0·19–1·15]). After 8756 person-years of follow-up, 22 participants were diagnosed with HIV, seven participants in the emtricitabine and Tenofovir Alafenamide group (0·16 infections per 100 person-years [95% CI 0·06–0·33]), and 15 participants in the emtricitabine and Tenofovir disoproxil fumarate group (0·34 infections per 100 person-years [0·19–0·56]). Both regimens were well tolerated, with a low number of participants reporting adverse events that led to discontinuation of the study drug (36 [1%] of 2694 participants in the emtricitabine and Tenofovir Alafenamide group vs 49 [2%] of 2693 participants in the emtricitabine and Tenofovir disoproxil fumarate group). Emtricitabine and Tenofovir Alafenamide was superior to emtricitabine and Tenofovir disoproxil fumarate in all six prespecified bone mineral density and renal biomarker safety endpoints. Interpretation Daily emtricitabine and Tenofovir Alafenamide shows non-inferior efficacy to daily emtricitabine and Tenofovir disoproxil fumarate for HIV prevention, and the number of adverse events for both regimens was low. Emtricitabine and Tenofovir Alafenamide had more favourable effects on bone mineral density and biomarkers of renal safety than emtricitabine and Tenofovir disoproxil fumarate. Funding Gilead Sciences.

  • bone mineral density in virologically suppressed people aged 60 years or older with hiv 1 switching from a regimen containing Tenofovir disoproxil fumarate to an elvitegravir cobicistat emtricitabine and Tenofovir Alafenamide single tablet regimen a
    The Lancet HIV, 2019
    Co-Authors: Franco Maggiolo, David Piontkowsky, Maria Gracia Mateogarcia, Yongwu Shao, Ian Mcnicholl, Federico Pulido, Francois Raffi, Giuliano Rizzardini, Jean Michel Molina, Richard Haubrich
    Abstract:

    Summary Background Tenofovir Alafenamide is associated with less renal and bone toxicity than Tenofovir disoproxil fumarate and might improve the long-term safety of antiretroviral therapy. We aimed to investigate the effect on bone mineral density of switching from a regimen containing Tenofovir disoproxil fumarate to one containing Tenofovir Alafenamide in participants aged 60 years and older. Methods We did a prospective, open-label, multicentre, randomised trial in 36 European centres. Participants were virologically suppressed (HIV-1 RNA ClinicalTrials.gov , NCT02616783 . Findings Between Dec 22, 2015, and March 21, 2018, 167 participants were randomly assigned to elvitegravir, cobicistat, emtricitabine, and Tenofovir Alafenamide (n=111 [66%]) or Tenofovir disoproxil fumarate (n=56 [34%]). One participant in the elvitegravir, cobicistat, emtricitabine, and Tenofovir Alafenamide group did not receive treatment and was excluded from all analyses. At week 48, the mean percentage change in spine bone mineral density was 2·24% (SD 3·27) in the elvitegravir, cobicistat, emtricitabine, and Tenofovir Alafenamide group and −0·10% (3·39) in the Tenofovir disoproxil fumarate group (between-group difference 2·43% [95% CI 1·34–3·52]; p Interpretation The significantly improved bone mineral density, overall safety, and efficacy data show the feasibility of switching from a regimen containing Tenofovir disoproxil fumarate to elvitegravir, cobicistat, emtricitabine, and Tenofovir Alafenamide in virologically suppressed people living with HIV aged 60 years or older. Funding Gilead Sciences.

  • a week 48 randomized phase 3 trial of darunavir cobicistat emtricitabine Tenofovir Alafenamide in treatment naive hiv 1 patients
    AIDS, 2018
    Co-Authors: Joseph J. Eron, Erika Van Landuyt, Joel E Gallant, Jacques Reynes, Andrea Antinori, Chloe Orkin, Eugenia Negredo, Jean Michel Molina, Anthony Mills, Erkki Lathouwers
    Abstract:

    Objectives:To investigate efficacy and safety of a single-tablet regimen of darunavir/cobicistat/emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) 800/150/200/10 mg vs. darunavir/cobicistat plus emtricitabine/Tenofovir disoproxyl fumarate (TDF) (control) in antiretroviral-treatment-naive, HIV-1-infect

  • A week-48 randomized phase-3 trial of darunavir/cobicistat/emtricitabine/Tenofovir Alafenamide in treatment-naive HIV-1 patients
    AIDS, 2018
    Co-Authors: Joseph J. Eron, Erika Van Landuyt, Joel E Gallant, Jacques Reynes, Andrea Antinori, Chloe Orkin, Eugenia Negredo, Jean Michel Molina, Anthony Mills, Erkki Lathouwers
    Abstract:

    Objectives:To investigate efficacy and safety of a single-tablet regimen of darunavir/cobicistat/emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) 800/150/200/10 mg vs. darunavir/cobicistat plus emtricitabine/Tenofovir disoproxyl fumarate (TDF) (control) in antiretroviral-treatment-naive, HIV-1-infect

Anthony Mills - One of the best experts on this subject based on the ideXlab platform.

Edwin Dejesus - One of the best experts on this subject based on the ideXlab platform.

  • emtricitabine and Tenofovir Alafenamide vs emtricitabine and Tenofovir disoproxil fumarate for hiv pre exposure prophylaxis discover primary results from a randomised double blind multicentre active controlled phase 3 non inferiority trial
    The Lancet, 2020
    Co-Authors: Jean Michel Molina, Melanie A Thompson, Edwin Dejesus, Kenneth H Mayer, Peter L Anderson, Karam Mounzer, Joss J De Wet, Heiko Jessen, Robert M Grant
    Abstract:

    Summary Background Tenofovir Alafenamide shows high antiviral efficacy and improved renal and bone safety compared with Tenofovir disoproxil fumarate when used for HIV treatment. Here, we report primary results from a blinded phase 3 study evaluating the efficacy and safety of pre-exposure prophylaxis (PrEP) with emtricitabine and Tenofovir Alafenamide versus emtricitabine and Tenofovir disoproxil fumarate for HIV prevention. Methods This study is an ongoing, randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial done at 94 community, public health, and hospital-associated clinics located in regions of Europe and North America, where there is a high incidence of HIV or prevalence of people living with HIV, or both. We enrolled adult cisgender men who have sex with men and transgender women who have sex with men, both with a high risk of acquiring HIV on the basis of their self-reported sexual behaviour in the past 12 weeks or their recent history (within 24 weeks of enrolment) of bacterial sexually transmitted infections. Participants with current or previous use of PrEP with emtricitabine and Tenofovir disoproxil fumarate were not excluded. We used a computer-generated random allocation sequence to randomly assign (1:1) participants to receive either emtricitabine (200 mg) and Tenofovir Alafenamide (25 mg) tablets daily, with matched placebo tablets (emtricitabine and Tenofovir Alafenamide group), or emtricitabine (200 mg) and Tenofovir disoproxil fumarate (300 mg) tablets daily, with matched placebo tablets (emtricitabine and Tenofovir disoproxil fumarate group). As such, all participants were given two tablets. The trial sponsor, investigators, participants, and the study staff who provided the study drugs, assessed the outcomes, and collected the data were masked to group assignment. The primary efficacy outcome was incident HIV infection, which was assessed when all participants had completed 48 weeks of follow-up and half of all participants had completed 96 weeks of follow-up. This full analysis set included all randomly assigned participants who had received at least one dose of the assigned study drug and had at least one post-baseline HIV test. Non-inferiority of emtricitabine and Tenofovir Alafenamide to emtricitabine and Tenofovir disoproxil fumarate was established if the upper bound of the 95·003% CI of the HIV incidence rate ratio (IRR) was less than the prespecified non-inferiority margin of 1·62. We prespecified six secondary bone mineral density and renal biomarker safety endpoints to evaluate using the safety analysis set. This analysis set included all randomly assigned participants who had received at least one dose of the assigned study drug. This trial is registered with ClinicalTrials.gov , NCT02842086 , and is no longer recruiting. Findings Between Sept 13, 2016, and June 30, 2017, 5387 (92%) of 5857 participants were randomly assigned and received emtricitabine and Tenofovir Alafenamide (n=2694) or emtricitabine and Tenofovir disoproxil fumarate (n=2693). At the time of the primary efficacy analysis (ie, when all participants had completed 48 weeks and 50% had completed 96 weeks) emtricitabine and Tenofovir Alafenamide was non-inferior to emtricitabine and Tenofovir disoproxil fumarate for HIV prevention, as the upper limit of the 95% CI of the IRR, was less than the prespecified non-inferiority margin of 1·62 (IRR 0·47 [95% CI 0·19–1·15]). After 8756 person-years of follow-up, 22 participants were diagnosed with HIV, seven participants in the emtricitabine and Tenofovir Alafenamide group (0·16 infections per 100 person-years [95% CI 0·06–0·33]), and 15 participants in the emtricitabine and Tenofovir disoproxil fumarate group (0·34 infections per 100 person-years [0·19–0·56]). Both regimens were well tolerated, with a low number of participants reporting adverse events that led to discontinuation of the study drug (36 [1%] of 2694 participants in the emtricitabine and Tenofovir Alafenamide group vs 49 [2%] of 2693 participants in the emtricitabine and Tenofovir disoproxil fumarate group). Emtricitabine and Tenofovir Alafenamide was superior to emtricitabine and Tenofovir disoproxil fumarate in all six prespecified bone mineral density and renal biomarker safety endpoints. Interpretation Daily emtricitabine and Tenofovir Alafenamide shows non-inferior efficacy to daily emtricitabine and Tenofovir disoproxil fumarate for HIV prevention, and the number of adverse events for both regimens was low. Emtricitabine and Tenofovir Alafenamide had more favourable effects on bone mineral density and biomarkers of renal safety than emtricitabine and Tenofovir disoproxil fumarate. Funding Gilead Sciences.

  • fixed dose combination bictegravir emtricitabine and Tenofovir Alafenamide versus dolutegravir containing regimens for initial treatment of hiv 1 infection week 144 results from two randomised double blind multicentre phase 3 non inferiority trials
    The Lancet HIV, 2020
    Co-Authors: Chloe Orkin, Franco Maggiolo, Hans Jurgen Stellbrink, Carlos Martorell, David A Wohl, Jeffrey L Stephens, Samir K. Gupta, Jose R. Arribas, Edwin Dejesus, Melanie A Thompson
    Abstract:

    Summary Background In the primary week-48 analyses of two phase 3 studies, coformulated bictegravir, emtricitabine, and Tenofovir Alafenamide was non-inferior to a dolutegravir-containing regimen in treatment-naive people with HIV. We report week-144 efficacy and safety results from these studies. Methods We did two double-blind, active-controlled studies (now in open-label extension phase). Study 1 randomly assigned (1:1) HLA-B*5701-negative adults without hepatitis B virus co-infection to receive coformulated bictegravir 50 mg, emtricitabine 200 mg, and Tenofovir Alafenamide 25 mg, or coformulated dolutegravir 50 mg, abacavir 600 mg, and lamivudine 300 mg once daily. Study 2 randomly assigned (1:1) adults to bictegravir, emtricitabine, and Tenofovir Alafenamide, or dolutegravir 50 mg given with coformulated emtricitabine 200 mg and Tenofovir Alafenamide 25 mg. We previously reported non-inferiority at the primary endpoint. Here, we report the week-144 secondary outcome of proportion of participants with plasma HIV-1 RNA less than 50 copies per mL at week 144, by US Food and Drug Administration Snapshot algorithm, analysed in the same manner. These studies were registered with ClinicalTrials.gov , NCT02607930 and NCT02607956 . Findings 629 participants were randomly assigned and treated in study 1 (314 to bictegravir, emtricitabine, and Tenofovir Alafenamide, and 315 to dolutegravir, abacavir, and lamivudine) and 645 in study 2 (327 to bictegravir, emtricitabine, and Tenofovir Alafenamide, 325 to dolutegravir, emtricitabine, Tenofovir Alafenamide). At week 144, bictegravir, emtricitabine, and Tenofovir Alafenamide was non-inferior to both dolutegravir-containing regimens for efficacy. In study 1, 256 (82%) of 314 participants had plasma HIV-1 RNA less than 50 copies per mL in the bictegravir, emtricitabine, and Tenofovir Alafenamide group and 265 (84%) of 315 in the dolutegravir, abacavir, and lamivudine group (difference −2·6%, 95% CI −8·5 to 3·4). In study 2, 262 (82%) of 320 participants had plasma HIV-1 RNA less than 50 copies per mL in the bictegravir, emtricitabine, and Tenofovir Alafenamide group and 273 (84%) of 325 in the dolutegravir, emtricitabine, and Tenofovir Alafenamide group (difference −1·9%, −7·8 to 3·9). In both studies, no participant had treatment-emergent resistance to study drugs up to week 144. All treatment regimens were well tolerated with additional exposure. Adverse events that led to study drug discontinuation were reported for no participants in the bictegravir, emtricitabine, and Tenofovir Alafenamide group versus five (2%) of 315 in the dolutegravir, abacavir, and lamivudine group (study 1), and six (2%) of 320 in the bictegravir, emtricitabine, and Tenofovir Alafenamide versus six (2%) of 325 in the dolutegravir, emtricitabine, and Tenofovir Alafenamide group (study 2). In study 1, statistically significant differences were observed in median changes from baseline in fasting total cholesterol (14 mg/dL vs 10 mg/dL; p=0·034), direct LDL (21 mg/dL vs 14 mg/dL; p=0·004), and total cholesterol to HDL ratio (−0·1 vs −0·3; p=0·007) at week 144; no differences were observed between groups in study 2. Weight gain was seen across all treatment groups in both studies, with no differences in median changes from baseline in weight at week 144 for either study. Interpretation These long-term data support the use of bictegravir, emtricitabine, and Tenofovir Alafenamide as a safe, well tolerated, and durable treatment for people with HIV, with no emergent resistance. Funding Gilead Sciences.

  • Coformulated bictegravir, emtricitabine, Tenofovir Alafenamide after initial treatment with bictegravir or dolutegravir and emtricitabine/Tenofovir Alafenamide.
    AIDS (London England), 2018
    Co-Authors: Paul E. Sax, Gordon Crofoot, Cynthia Brinson, Anthony Mills, Edwin Dejesus, Douglas J. Ward, Paul Benson, Robin Dretler, Xuelian Wei, Sean E Collins
    Abstract:

    : A phase 2, randomized, active-controlled study of initial antiretroviral therapy with bictegravir or dolutegravir in combination with emtricitabine and Tenofovir Alafenamide showed excellent efficacy. After 60 weeks of blinded treatment, participants switched to a single-tablet regimen of bictegravir, emtricitabine, and Tenofovir Alafenamide. Switching maintained viral suppression in all participants who remained on the study through 12 weeks in the open-label phase, and was safe and well tolerated.

  • superior efficacy and improved renal and bone safety after switching from a Tenofovir disoproxil fumarate to a Tenofovir Alafenamide based regimen through 96 weeks of treatment
    AIDS Research and Human Retroviruses, 2018
    Co-Authors: Edwin Dejesus, Anthony Mills, Moti Ramgopal, Bernard Haas, Sorana Segalmaurer, Nicolas A Margot, Yapei Liu, Tariro Makadzange, Scott Mccallister
    Abstract:

    Abstract We previously demonstrated superior efficacy and safety advantages in HIV-infected, virologically suppressed adults switched to a regimen containing Tenofovir Alafenamide (TAF) as compared...

  • coformulated bictegravir emtricitabine and Tenofovir Alafenamide versus dolutegravir with emtricitabine and Tenofovir Alafenamide for initial treatment of hiv 1 infection gs us 380 1490 a randomised double blind multicentre phase 3 non inferiority tr
    The Lancet, 2017
    Co-Authors: Anton Pozniak, Jacques Reynes, Andrea Antinori, Hans Jurgen Stellbrink, Edwin Dejesus, Luisa M Montes, Ellen Koenig, Kimberly A Workowski, Jihad Slim, Will Garner
    Abstract:

    Summary Background Integrase strand transfer inhibitors (INSTIs) coadministered with two nucleoside or nucleotide reverse transcriptase inhibitors (NRTIs) are recommended as first-line treatment for HIV, and coformulated fixed-dose combinations are preferred to facilitate adherence. We report 48-week results from a study comparing initial HIV-1 treatment with bictegravir—a novel INSTI with a high in-vitro barrier to resistance and low potential as a perpetrator or victim of clinically relevant drug interactions—coformulated with the NRTI combination emtricitabine and Tenofovir Alafenamide as a fixed-dose combination to dolutegravir administered with coformulated emtricitabine and Tenofovir Alafenamide. Methods In this randomised, double-blind, multicentre, placebo-controlled, non-inferiority trial, HIV-infected adults were screened and enrolled at 126 outpatient centres in 10 countries in Australia, Europe, Latin America, and North America. Participants were previously untreated adults (HIV-1 RNA ≥500 copies per mL) with estimated glomerular filtration rate of at least 30 mL/min. Chronic hepatitis B virus or hepatitis C co-infection was allowed. We randomly assigned participants (1:1) to receive oral fixed-dose combination bictegravir 50 mg, emtricitabine 200 mg, and Tenofovir Alafenamide 25 mg or dolutegravir 50 mg with coformulated emtricitabine 200 mg and Tenofovir Alafenamide 25 mg, with matching placebo, once a day for 144 weeks. Investigators, participants, study staff, and those assessing outcomes were masked to treatment group. All participants who received at least one dose of study drug were included in primary efficacy and safety analyses. The primary endpoint was the proportion of participants with plasma HIV-1 RNA of less than 50 copies per mL at week 48 (US Food and Drug Administration snapshot algorithm), with a prespecified non-inferiority margin of −12%. This study is registered with ClinicalTrials.gov, number NCT02607956. Findings Between Nov 11, 2015, and July 15, 2016, 742 participants were screened for eligibility, of whom 657 were randomly assigned to treatment (327 with bictegravir, emtricitabine, and Tenofovir Alafenamide fixed-dose combination [bictegravir group] and 330 with dolutegravir plus emtricitabine and Tenofovir Alafenamide [dolutegravir group]). 320 participants who received the bictegravir regimen and 325 participants who received the dolutegravir regimen were included in the primary efficacy analyses. At week 48, HIV-1 RNA vs 83 [26%] of 325, p=0·022). Interpretation At 48 weeks, virological suppression with the bictegravir regimen was achieved and was non-inferior to the dolutegravir regimen in previously untreated adults. There was no emergent resistance to either regimen. The fixed-dose combination of bictegravir, emtricitabine, and Tenofovir Alafenamide was safe and well tolerated compared with the dolutegravir regimen. Funding Gilead Sciences Inc.

Franco Maggiolo - One of the best experts on this subject based on the ideXlab platform.

  • Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People with HIV Aged ≥ 65 Years: Week 48 Results of a Phase 3b, Open-Label Trial
    Infectious Diseases and Therapy, 2021
    Co-Authors: Franco Maggiolo, Federico Pulido, Giuliano Rizzardini, Jean Michel Molina, Stephane De Wit, Linos Vandekerckhove, Juan Berenguer, Michelle L. D’antoni, Christiana Blair, Susan K. Chuck
    Abstract:

    Introduction We report the 48-week results of an ongoing study to assess the efficacy and safety of switching older people with HIV to bictegravir/emtricitabine/Tenofovir Alafenamide (B/F/TAF). Methods This was a 96-week, phase 3b, open-label, single-arm study (GS-US-380-4449; NCT03405935). Virologically suppressed individuals aged ≥ 65 years receiving elvitegravir/cobicistat/emtricitabine/Tenofovir Alafenamide or a Tenofovir disoproxil fumarate-based regimen were switched to B/F/TAF. Primary endpoint was the percentage of participants with HIV-1 RNA 

  • fixed dose combination bictegravir emtricitabine and Tenofovir Alafenamide versus dolutegravir containing regimens for initial treatment of hiv 1 infection week 144 results from two randomised double blind multicentre phase 3 non inferiority trials
    The Lancet HIV, 2020
    Co-Authors: Chloe Orkin, Franco Maggiolo, Hans Jurgen Stellbrink, Carlos Martorell, David A Wohl, Jeffrey L Stephens, Samir K. Gupta, Jose R. Arribas, Edwin Dejesus, Melanie A Thompson
    Abstract:

    Summary Background In the primary week-48 analyses of two phase 3 studies, coformulated bictegravir, emtricitabine, and Tenofovir Alafenamide was non-inferior to a dolutegravir-containing regimen in treatment-naive people with HIV. We report week-144 efficacy and safety results from these studies. Methods We did two double-blind, active-controlled studies (now in open-label extension phase). Study 1 randomly assigned (1:1) HLA-B*5701-negative adults without hepatitis B virus co-infection to receive coformulated bictegravir 50 mg, emtricitabine 200 mg, and Tenofovir Alafenamide 25 mg, or coformulated dolutegravir 50 mg, abacavir 600 mg, and lamivudine 300 mg once daily. Study 2 randomly assigned (1:1) adults to bictegravir, emtricitabine, and Tenofovir Alafenamide, or dolutegravir 50 mg given with coformulated emtricitabine 200 mg and Tenofovir Alafenamide 25 mg. We previously reported non-inferiority at the primary endpoint. Here, we report the week-144 secondary outcome of proportion of participants with plasma HIV-1 RNA less than 50 copies per mL at week 144, by US Food and Drug Administration Snapshot algorithm, analysed in the same manner. These studies were registered with ClinicalTrials.gov , NCT02607930 and NCT02607956 . Findings 629 participants were randomly assigned and treated in study 1 (314 to bictegravir, emtricitabine, and Tenofovir Alafenamide, and 315 to dolutegravir, abacavir, and lamivudine) and 645 in study 2 (327 to bictegravir, emtricitabine, and Tenofovir Alafenamide, 325 to dolutegravir, emtricitabine, Tenofovir Alafenamide). At week 144, bictegravir, emtricitabine, and Tenofovir Alafenamide was non-inferior to both dolutegravir-containing regimens for efficacy. In study 1, 256 (82%) of 314 participants had plasma HIV-1 RNA less than 50 copies per mL in the bictegravir, emtricitabine, and Tenofovir Alafenamide group and 265 (84%) of 315 in the dolutegravir, abacavir, and lamivudine group (difference −2·6%, 95% CI −8·5 to 3·4). In study 2, 262 (82%) of 320 participants had plasma HIV-1 RNA less than 50 copies per mL in the bictegravir, emtricitabine, and Tenofovir Alafenamide group and 273 (84%) of 325 in the dolutegravir, emtricitabine, and Tenofovir Alafenamide group (difference −1·9%, −7·8 to 3·9). In both studies, no participant had treatment-emergent resistance to study drugs up to week 144. All treatment regimens were well tolerated with additional exposure. Adverse events that led to study drug discontinuation were reported for no participants in the bictegravir, emtricitabine, and Tenofovir Alafenamide group versus five (2%) of 315 in the dolutegravir, abacavir, and lamivudine group (study 1), and six (2%) of 320 in the bictegravir, emtricitabine, and Tenofovir Alafenamide versus six (2%) of 325 in the dolutegravir, emtricitabine, and Tenofovir Alafenamide group (study 2). In study 1, statistically significant differences were observed in median changes from baseline in fasting total cholesterol (14 mg/dL vs 10 mg/dL; p=0·034), direct LDL (21 mg/dL vs 14 mg/dL; p=0·004), and total cholesterol to HDL ratio (−0·1 vs −0·3; p=0·007) at week 144; no differences were observed between groups in study 2. Weight gain was seen across all treatment groups in both studies, with no differences in median changes from baseline in weight at week 144 for either study. Interpretation These long-term data support the use of bictegravir, emtricitabine, and Tenofovir Alafenamide as a safe, well tolerated, and durable treatment for people with HIV, with no emergent resistance. Funding Gilead Sciences.

  • bone mineral density in virologically suppressed people aged 60 years or older with hiv 1 switching from a regimen containing Tenofovir disoproxil fumarate to an elvitegravir cobicistat emtricitabine and Tenofovir Alafenamide single tablet regimen a
    The Lancet HIV, 2019
    Co-Authors: Franco Maggiolo, David Piontkowsky, Maria Gracia Mateogarcia, Yongwu Shao, Ian Mcnicholl, Federico Pulido, Francois Raffi, Giuliano Rizzardini, Jean Michel Molina, Richard Haubrich
    Abstract:

    Summary Background Tenofovir Alafenamide is associated with less renal and bone toxicity than Tenofovir disoproxil fumarate and might improve the long-term safety of antiretroviral therapy. We aimed to investigate the effect on bone mineral density of switching from a regimen containing Tenofovir disoproxil fumarate to one containing Tenofovir Alafenamide in participants aged 60 years and older. Methods We did a prospective, open-label, multicentre, randomised trial in 36 European centres. Participants were virologically suppressed (HIV-1 RNA ClinicalTrials.gov , NCT02616783 . Findings Between Dec 22, 2015, and March 21, 2018, 167 participants were randomly assigned to elvitegravir, cobicistat, emtricitabine, and Tenofovir Alafenamide (n=111 [66%]) or Tenofovir disoproxil fumarate (n=56 [34%]). One participant in the elvitegravir, cobicistat, emtricitabine, and Tenofovir Alafenamide group did not receive treatment and was excluded from all analyses. At week 48, the mean percentage change in spine bone mineral density was 2·24% (SD 3·27) in the elvitegravir, cobicistat, emtricitabine, and Tenofovir Alafenamide group and −0·10% (3·39) in the Tenofovir disoproxil fumarate group (between-group difference 2·43% [95% CI 1·34–3·52]; p Interpretation The significantly improved bone mineral density, overall safety, and efficacy data show the feasibility of switching from a regimen containing Tenofovir disoproxil fumarate to elvitegravir, cobicistat, emtricitabine, and Tenofovir Alafenamide in virologically suppressed people living with HIV aged 60 years or older. Funding Gilead Sciences.

  • co formulated bictegravir emtricitabine and Tenofovir Alafenamide versus dolutegravir with emtricitabine and Tenofovir Alafenamide for initial treatment of hiv 1 infection week 96 results from a randomised double blind multicentre phase 3 non inferio
    The Lancet HIV, 2019
    Co-Authors: Hans Jurgen Stellbrink, Franco Maggiolo, Helmut Albrecht, Catherine Creticos, Carlos Martorell, Rima Acosta, Sean E Collins, Jeffrey L Stephens, Jaime Rodriguez Arribas, Diana M Brainard
    Abstract:

    Summary Background The single-tablet regimen consisting of bictegravir, emtricitabine, and Tenofovir Alafenamide is recommended for treatment of HIV-1 infection on the basis of data from 48 weeks of treatment. Here, we examine the longer-term efficacy, safety, and tolerability of bictegravir, emtricitabine, and Tenofovir Alafenamide compared with dolutegravir plus co-formulated emtricitabine and Tenofovir Alafenamide at week 96. Methods This ongoing, randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial was done at 126 outpatient centres in ten countries. We enrolled treatment-naive adults (aged ≥18 years) with HIV-1 infection who had an estimated glomerular filtration rate of at least 30 mL/min and sensitivity to emtricitabine and Tenofovir. People with chronic hepatitis B or C infection, or both, and those who had used antivirals previously for prophylaxis were allowed. We randomly assigned participants (1:1) to receive treatment with either co-formulated bictegravir 50 mg, emtricitabine 200 mg, and Tenofovir Alafenamide 25 mg (the bictegravir group) or dolutegravir 50 mg with co-formulated emtricitabine 200 mg and Tenofovir Alafenamide 25 mg (the dolutegravir group), each with matching placebo, once daily for 144 weeks. Treatment allocation was masked to all participants and investigators. All participants who received at least one dose of study drug were included in primary efficacy and safety analyses. We previously reported the primary endpoint. Here, we report the week 96 secondary outcome of proportion of participants with plasma HIV-1 RNA less than 50 copies per mL at week 96 by US Food and Drug Administration snapshot algorithm, with a prespecified non-inferiority margin of −12%. This study was registered with ClinicalTrials.gov, number NCT02607956. Findings Between Nov 13, 2015, and July 14, 2016, we screened 742 individuals, of whom 657 were enrolled. 327 participants were assigned to the bictegravir group and 330 to the dolutegravir group. Of these, 320 in the bictegravir group and 325 in the dolutegravir group received at least one dose of study drug. At week 96, HIV-1 RNA less than 50 copies per mL was achieved by 269 (84%) of 320 participants in the bictegravir group and 281 (86%) of 325 in the dolutegravir group (difference −2·3%, 95% CI −7·9 to 3·2), demonstrating non-inferiority of the bictegravir regimen compared with the dolutegravir regimen. Both treatments continued to be well tolerated through 96 weeks; 283 (88%) of 320 participants in the bictegravir group and 288 (89%) of 325 in the dolutegravir group had any adverse event and 55 (17%), and 33 (10%) had any serious adverse event. The most common adverse events were diarrhoea (57 [18%] of 320 in the bictegravir group vs 51 [16%] of 325 in the dolutegravir group) and headache (51 [16%] of 320 vs 48 [15%] of 325). Deaths were reported for three (1%) individuals in each group (one cardiac arrest, one gastric adenocarcinoma, and one hypertensive heart disease and congestive cardiac failure in the bictegravir group and one unknown causes, one pulmonary embolism, and one lymphoma in the dolutegravir group); none were considered to be treatment related. Adverse events led to discontinuation in six (2%) participants in the bictegravir group and five (2%) in the dolutegravir group; one of these events in the bictegravir group versus four in the dolutegravir group occurred between weeks 48 and 96. Study drug-related adverse events were reported for 64 (20%) participants in the bictegravir group and 92 (28%) in the dolutegravir group. Interpretation These week 96 data support bictegravir, emtricitabine, and Tenofovir Alafenamide as a safe, well tolerated, and durable treatment for people living with chronic HIV. Funding Gilead Sciences, Inc.

  • Co-formulated bictegravir, emtricitabine, and Tenofovir Alafenamide versus dolutegravir with emtricitabine and Tenofovir Alafenamide for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-
    The lancet. HIV, 2019
    Co-Authors: Hans Jurgen Stellbrink, Franco Maggiolo, Helmut Albrecht, Catherine Creticos, Jeffrey L Stephens, Paul E. Sax, Jose R. Arribas, Xuelian Wei, Claudia T Martorell, Rima Acosta
    Abstract:

    The single-tablet regimen consisting of bictegravir, emtricitabine, and Tenofovir Alafenamide is recommended for treatment of HIV-1 infection on the basis of data from 48 weeks of treatment. Here, we examine the longer-term efficacy, safety, and tolerability of bictegravir, emtricitabine, and Tenofovir Alafenamide compared with dolutegravir plus co-formulated emtricitabine and Tenofovir Alafenamide at week 96. This ongoing, randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial was done at 126 outpatient centres in ten countries. We enrolled treatment-naive adults (aged ≥18 years) with HIV-1 infection who had an estimated glomerular filtration rate of at least 30 mL/min and sensitivity to emtricitabine and Tenofovir. People with chronic hepatitis B or C infection, or both, and those who had used antivirals previously for prophylaxis were allowed. We randomly assigned participants (1:1) to receive treatment with either co-formulated bictegravir 50 mg, emtricitabine 200 mg, and Tenofovir Alafenamide 25 mg (the bictegravir group) or dolutegravir 50 mg with co-formulated emtricitabine 200 mg and Tenofovir Alafenamide 25 mg (the dolutegravir group), each with matching placebo, once daily for 144 weeks. Treatment allocation was masked to all participants and investigators. All participants who received at least one dose of study drug were included in primary efficacy and safety analyses. We previously reported the primary endpoint. Here, we report the week 96 secondary outcome of proportion of participants with plasma HIV-1 RNA less than 50 copies per mL at week 96 by US Food and Drug Administration snapshot algorithm, with a prespecified non-inferiority margin of -12%. This study was registered with ClinicalTrials.gov, number NCT02607956. Between Nov 13, 2015, and July 14, 2016, we screened 742 individuals, of whom 657 were enrolled. 327 participants were assigned to the bictegravir group and 330 to the dolutegravir group. Of these, 320 in the bictegravir group and 325 in the dolutegravir group received at least one dose of study drug. At week 96, HIV-1 RNA less than 50 copies per mL was achieved by 269 (84%) of 320 participants in the bictegravir group and 281 (86%) of 325 in the dolutegravir group (difference -2·3%, 95% CI -7·9 to 3·2), demonstrating non-inferiority of the bictegravir regimen compared with the dolutegravir regimen. Both treatments continued to be well tolerated through 96 weeks; 283 (88%) of 320 participants in the bictegravir group and 288 (89%) of 325 in the dolutegravir group had any adverse event and 55 (17%), and 33 (10%) had any serious adverse event. The most common adverse events were diarrhoea (57 [18%] of 320 in the bictegravir group vs 51 [16%] of 325 in the dolutegravir group) and headache (51 [16%] of 320 vs 48 [15%] of 325). Deaths were reported for three (1%) individuals in each group (one cardiac arrest, one gastric adenocarcinoma, and one hypertensive heart disease and congestive cardiac failure in the bictegravir group and one unknown causes, one pulmonary embolism, and one lymphoma in the dolutegravir group); none were considered to be treatment related. Adverse events led to discontinuation in six (2%) participants in the bictegravir group and five (2%) in the dolutegravir group; one of these events in the bictegravir group versus four in the dolutegravir group occurred between weeks 48 and 96. Study drug-related adverse events were reported for 64 (20%) participants in the bictegravir group and 92 (28%) in the dolutegravir group. These week 96 data support bictegravir, emtricitabine, and Tenofovir Alafenamide as a safe, well tolerated, and durable treatment for people living with chronic HIV. Gilead Sciences, Inc. Copyright © 2019 Elsevier Ltd. All rights reserved.

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  • Estimated glomerular filtration rate slopes on Tenofovir Alafenamide.
    HIV medicine, 2020
    Co-Authors: Fowzia Ibrahim, Chloe Orkin, Margaret Johnson, L Campbell, Alexis Bailey, S Stockwell, Laura Waters, Mark Gompels, A De Burgh‐thomas, R Jones
    Abstract:

    OBJECTIVES The aim of the study was to analyse and compare estimated glomerular filtration rate (eGFR) slopes during exposure to Tenofovir disoproxil fumarate (TDF) and Tenofovir Alafenamide (TAF) in individuals who initiated TAF, regardless of prior regimen, before October 2016. METHODS An observational cohort study was conducted at 11 clinics in the UK and Ireland. Mixed effects models with random intercept and time terms fitted were used to generate and compare eGFR slopes while participants were exposed to TDF and TAF, with adjustment for age, eGFR at TDF/TAF initiation, gender, ethnicity, and time-updated CD4 cell count and HIV RNA measurements. RESULTS Data were available for 357 subjects (median age 50 years; 80% male; 82% white/other ethnicity; 51% men who have sex with men; median nadir CD4 count 216 cells/µL). The median duration of exposure to TAF was 2.0 (interquartile range 1.6, 2.3) years. At TAF initiation, the median CD4 count was 557 cells/µL, the median eGFR was 80 mL/min/1.73 m2, and 86% had suppressed HIV infection. The mean adjusted eGFR slope during TDF and TAF exposure was -2.08 [95% confidence interval (CI) -2.24, -1.92] and 1.18 (95% CI 0.20, 1.52) mL/min/1.73 m2/year, respectively (P   3 or 5 mL/min/1.73 m2/year) while receiving TDF experienced significant eGFR recovery while on TAF (P 

  • fixed dose combination bictegravir emtricitabine and Tenofovir Alafenamide versus dolutegravir containing regimens for initial treatment of hiv 1 infection week 144 results from two randomised double blind multicentre phase 3 non inferiority trials
    The Lancet HIV, 2020
    Co-Authors: Chloe Orkin, Franco Maggiolo, Hans Jurgen Stellbrink, Carlos Martorell, David A Wohl, Jeffrey L Stephens, Samir K. Gupta, Jose R. Arribas, Edwin Dejesus, Melanie A Thompson
    Abstract:

    Summary Background In the primary week-48 analyses of two phase 3 studies, coformulated bictegravir, emtricitabine, and Tenofovir Alafenamide was non-inferior to a dolutegravir-containing regimen in treatment-naive people with HIV. We report week-144 efficacy and safety results from these studies. Methods We did two double-blind, active-controlled studies (now in open-label extension phase). Study 1 randomly assigned (1:1) HLA-B*5701-negative adults without hepatitis B virus co-infection to receive coformulated bictegravir 50 mg, emtricitabine 200 mg, and Tenofovir Alafenamide 25 mg, or coformulated dolutegravir 50 mg, abacavir 600 mg, and lamivudine 300 mg once daily. Study 2 randomly assigned (1:1) adults to bictegravir, emtricitabine, and Tenofovir Alafenamide, or dolutegravir 50 mg given with coformulated emtricitabine 200 mg and Tenofovir Alafenamide 25 mg. We previously reported non-inferiority at the primary endpoint. Here, we report the week-144 secondary outcome of proportion of participants with plasma HIV-1 RNA less than 50 copies per mL at week 144, by US Food and Drug Administration Snapshot algorithm, analysed in the same manner. These studies were registered with ClinicalTrials.gov , NCT02607930 and NCT02607956 . Findings 629 participants were randomly assigned and treated in study 1 (314 to bictegravir, emtricitabine, and Tenofovir Alafenamide, and 315 to dolutegravir, abacavir, and lamivudine) and 645 in study 2 (327 to bictegravir, emtricitabine, and Tenofovir Alafenamide, 325 to dolutegravir, emtricitabine, Tenofovir Alafenamide). At week 144, bictegravir, emtricitabine, and Tenofovir Alafenamide was non-inferior to both dolutegravir-containing regimens for efficacy. In study 1, 256 (82%) of 314 participants had plasma HIV-1 RNA less than 50 copies per mL in the bictegravir, emtricitabine, and Tenofovir Alafenamide group and 265 (84%) of 315 in the dolutegravir, abacavir, and lamivudine group (difference −2·6%, 95% CI −8·5 to 3·4). In study 2, 262 (82%) of 320 participants had plasma HIV-1 RNA less than 50 copies per mL in the bictegravir, emtricitabine, and Tenofovir Alafenamide group and 273 (84%) of 325 in the dolutegravir, emtricitabine, and Tenofovir Alafenamide group (difference −1·9%, −7·8 to 3·9). In both studies, no participant had treatment-emergent resistance to study drugs up to week 144. All treatment regimens were well tolerated with additional exposure. Adverse events that led to study drug discontinuation were reported for no participants in the bictegravir, emtricitabine, and Tenofovir Alafenamide group versus five (2%) of 315 in the dolutegravir, abacavir, and lamivudine group (study 1), and six (2%) of 320 in the bictegravir, emtricitabine, and Tenofovir Alafenamide versus six (2%) of 325 in the dolutegravir, emtricitabine, and Tenofovir Alafenamide group (study 2). In study 1, statistically significant differences were observed in median changes from baseline in fasting total cholesterol (14 mg/dL vs 10 mg/dL; p=0·034), direct LDL (21 mg/dL vs 14 mg/dL; p=0·004), and total cholesterol to HDL ratio (−0·1 vs −0·3; p=0·007) at week 144; no differences were observed between groups in study 2. Weight gain was seen across all treatment groups in both studies, with no differences in median changes from baseline in weight at week 144 for either study. Interpretation These long-term data support the use of bictegravir, emtricitabine, and Tenofovir Alafenamide as a safe, well tolerated, and durable treatment for people with HIV, with no emergent resistance. Funding Gilead Sciences.

  • a week 48 randomized phase 3 trial of darunavir cobicistat emtricitabine Tenofovir Alafenamide in treatment naive hiv 1 patients
    AIDS, 2018
    Co-Authors: Joseph J. Eron, Erika Van Landuyt, Joel E Gallant, Jacques Reynes, Andrea Antinori, Chloe Orkin, Eugenia Negredo, Jean Michel Molina, Anthony Mills, Erkki Lathouwers
    Abstract:

    Objectives:To investigate efficacy and safety of a single-tablet regimen of darunavir/cobicistat/emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) 800/150/200/10 mg vs. darunavir/cobicistat plus emtricitabine/Tenofovir disoproxyl fumarate (TDF) (control) in antiretroviral-treatment-naive, HIV-1-infect

  • A week-48 randomized phase-3 trial of darunavir/cobicistat/emtricitabine/Tenofovir Alafenamide in treatment-naive HIV-1 patients
    AIDS, 2018
    Co-Authors: Joseph J. Eron, Erika Van Landuyt, Joel E Gallant, Jacques Reynes, Andrea Antinori, Chloe Orkin, Eugenia Negredo, Jean Michel Molina, Anthony Mills, Erkki Lathouwers
    Abstract:

    Objectives:To investigate efficacy and safety of a single-tablet regimen of darunavir/cobicistat/emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) 800/150/200/10 mg vs. darunavir/cobicistat plus emtricitabine/Tenofovir disoproxyl fumarate (TDF) (control) in antiretroviral-treatment-naive, HIV-1-infect

  • bictegravir emtricitabine and Tenofovir Alafenamide versus dolutegravir abacavir and lamivudine for initial treatment of hiv 1 infection gs us 380 1489 a double blind multicentre phase 3 randomised controlled non inferiority trial
    The Lancet, 2017
    Co-Authors: Joel E Gallant, Daniel Podzamczer, Pablo Tebas, Chloe Orkin, Anthony Mills, Eric S. Daar, Adriano Lazzarin, Pierre Marie Girard, Indira Brar, David A Wohl
    Abstract:

    Summary Background Integrase strand transfer inhibitors (INSTIs) are recommended components of initial antiretroviral therapy with two nucleoside reverse transcriptase inhibitors. Bictegravir is a novel, potent INSTI with a high in-vitro barrier to resistance and low potential as a perpetrator or victim of clinically relevant drug–drug interactions. We aimed to assess the efficacy and safety of bictegravir coformulated with emtricitabine and Tenofovir Alafenamide as a fixed-dose combination versus coformulated dolutegravir, abacavir, and lamivudine. Methods We did this double-blind, multicentre, active-controlled, randomised controlled non-inferiority trial at 122 outpatient centres in nine countries in Europe, Latin America, and North America. We enrolled HIV-1 infected adults (aged ≥18 years) who were previously untreated (HIV-1 RNA ≥500 copies per mL); HLA-B*5701 -negative; had no hepatitis B virus infection; screening genotypes showing sensitivity to emtricitabine, Tenofovir, lamivudine, and abacavir; and an estimated glomerular filtration rate of 50 mL/min or more. Participants were randomly assigned (1:1), via a computer-generated allocation sequence (block size of four), to receive coformulated bictegravir 50 mg, emtricitabine 200 mg, and Tenofovir Alafenamide 25 mg or coformulated dolutegravir 50 mg, abacavir 600 mg, and lamivudine 300 mg, with matching placebo, once daily for 144 weeks. Randomisation was stratified by HIV-1 RNA (≤100 000 copies per mL, >100 000 to ≤400 000 copies per mL, or >400 000 copies per mL), CD4 count ( Findings Between Nov 13, 2015, and July 14, 2016, we randomly assigned 631 participants to receive coformulated bictegravir, emtricitabine, and Tenofovir Alafenamide (n=316) or coformulated dolutegravir, abacavir, and lamivudine (n=315), of whom 314 and 315 patients, respectively, received at least one dose of study drug. At week 48, HIV-1 RNA less than 50 copies per mL was achieved in 92·4% of patients (n=290 of 314) in the bictegravir, emtricitabine, and Tenofovir Alafenamide group and 93·0% of patients (n=293 of 315) in the dolutegravir, abacavir, and lamivudine group (difference −0·6%, 95·002% CI −4·8 to 3·6; p=0·78), demonstrating non-inferiority of bictegravir, emtricitabine, and Tenofovir Alafenamide to dolutegravir, abacavir, and lamivudine. No individual developed treatment-emergent resistance to any study drug. Incidence and severity of adverse events was mostly similar between groups except for nausea, which occurred less frequently in patients given bictegravir, emtricitabine, and Tenofovir Alafenamide than in those given dolutegravir, abacavir, and lamivudine (10% [n=32] vs 23% [n=72]; p vs 40% [n=127]), the difference being driven by a higher incidence of drug-related nausea in the dolutegravir, abacavir, and lamivudine group (5% [n=17] vs 17% [n=55]; p Interpretation At 48 weeks, coformulated bictegravir, emtricitabine, and Tenofovir Alafenamide achieved virological suppression in 92% of previously untreated adults and was non-inferior to coformulated dolutegravir, abacavir, and lamivudine, with no treatment-emergent resistance. Bictegravir, emtricitabine, and Tenofovir Alafenamide was safe and well tolerated with better gastrointestinal tolerability than dolutegravir, abacavir, and lamivudine. Because coformulated bictegravir, emtricitabine, and Tenofovir Alafenamide does not require HLA B*5701 testing and provides guideline-recommended treatment for individuals co-infected with HIV and hepatitis B, this regimen might lend itself to rapid or same-day initiation of therapy in the clinical setting. Funding Gilead Sciences.

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