Bictegravir/emtricitabine/tenofovir alafenamide as initial treatment for HIV-1: five-year follow-up from two randomized trialsResearch in context
Summary: Background: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is a single-tablet regimen recommended for HIV-1 treatment. The safety and efficacy of B/F/TAF as initial therapy was established in two Phase 3 studies: 1489 (vs dolutegravir [DTG]/abacavir/lamivudine) and 1490 (vs DTG ...
| Main Authors: | , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2023-05-01
|
| Series: | EClinicalMedicine |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2589537023001682 |
| _version_ | 1797829059937304576 |
|---|---|
| author | Paul E. Sax José R. Arribas Chloe Orkin Adriano Lazzarin Anton Pozniak Edwin DeJesus Franco Maggiolo Hans-Jürgen Stellbrink Yazdan Yazdanpanah Rima Acosta Hailin Huang Jason T. Hindman Hal Martin Jared M. Baeten David Wohl |
| author_facet | Paul E. Sax José R. Arribas Chloe Orkin Adriano Lazzarin Anton Pozniak Edwin DeJesus Franco Maggiolo Hans-Jürgen Stellbrink Yazdan Yazdanpanah Rima Acosta Hailin Huang Jason T. Hindman Hal Martin Jared M. Baeten David Wohl |
| author_sort | Paul E. Sax |
| collection | DOAJ |
| description | Summary: Background: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is a single-tablet regimen recommended for HIV-1 treatment. The safety and efficacy of B/F/TAF as initial therapy was established in two Phase 3 studies: 1489 (vs dolutegravir [DTG]/abacavir/lamivudine) and 1490 (vs DTG + F/TAF). After 144 weeks of randomized follow-up, an open-label extension evaluated B/F/TAF to 240 weeks. Methods: Of 634 participants randomized to B/F/TAF, 519 completed the double-blinded treatment, and 506/634 (80%) chose the 96-week open-label B/F/TAF extension, which was completed by 444/506 (88%) participants. Efficacy was based on the secondary outcome of the proportion of participants with HIV-1 RNA <50 copies/mL at Week 240 by missing = excluded and missing = failure methods. All 634 participants who were randomized to B/F/TAF and received at least one dose of B/F/TAF were included in efficacy and safety analyses. (Study 1489: ClinicalTrials.gov NCT02607930; EudraCT 2015-004024-54. Study 1490: ClinicalTrials.gov NCT02607956; EudraCT 2015-003988-10). Findings: Of those with available virologic data, 98.6% (95% CI [97.0%–99.5%], 426/432) maintained HIV-1 RNA <50 copies/mL at Week 240 (missing = excluded); when missing virologic data were considered as failure, 67.2% (95% CI [63.4%–70.8%], 426/634) maintained HIV-1 RNA <50 copies/mL. Mean (SD) change in CD4+ count from baseline was +338 (236.2) cells/μL. No treatment-emergent resistance to B/F/TAF was detected. Adverse events led to drug discontinuation in 1.6% (n = 10/634) of participants (n = 5 with events considered drug-related). No discontinuations were due to renal adverse events. Median (IQR) total cholesterol increased 21 (1,42) mg/dL from baseline; the change in total cholesterol:HDL was 0.1 (−0.5,0.6). Median (IQR) weight change from baseline was +6.1 kg (2.0, 11.7) at Week 240. In Study 1489, hip and spine bone mineral density mean percent changes from baseline were ≤0.6%. Interpretation: Through 5 years of follow-up, B/F/TAF maintained high rates of virologic suppression with no treatment-emergent resistance and rare drug discontinuations due to adverse events. These results demonstrate the durability and safety of B/F/TAF in people with HIV. Funding: Gilead Sciences. |
| first_indexed | 2024-04-09T13:14:22Z |
| format | Article |
| id | doaj.art-3763c296832847b0809740fb61aeb872 |
| institution | Directory Open Access Journal |
| issn | 2589-5370 |
| language | English |
| last_indexed | 2024-04-09T13:14:22Z |
| publishDate | 2023-05-01 |
| publisher | Elsevier |
| record_format | Article |
| series | EClinicalMedicine |
| spelling | doaj.art-3763c296832847b0809740fb61aeb8722023-05-12T04:17:01ZengElsevierEClinicalMedicine2589-53702023-05-0159101991Bictegravir/emtricitabine/tenofovir alafenamide as initial treatment for HIV-1: five-year follow-up from two randomized trialsResearch in contextPaul E. Sax0José R. Arribas1Chloe Orkin2Adriano Lazzarin3Anton Pozniak4Edwin DeJesus5Franco Maggiolo6Hans-Jürgen Stellbrink7Yazdan Yazdanpanah8Rima Acosta9Hailin Huang10Jason T. Hindman11Hal Martin12Jared M. Baeten13David Wohl14Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA; Corresponding author. Brigham and Women's Hospital, Boston, MA, USA.Infectious Diseases Unit, Hospital Universitario La Paz, IdiPaz, CIBERINFEC, Madrid, SpainBarts Health NHS Trust, Royal London Hospital, Ambrose King Centre, London, United KingdomSan Raffaele Scientific Institute, Milan, ItalyChelsea & Westminster Hospital NHS Foundation Trust and LSHTM, London, United KingdomOrlando Immunology Center, Orlando, FL, USAUnit of HIV-related Diseases and Experimental Therapies, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, ItalyDepartment of Internal Medicine, Infectious Diseases, University of Hamburg, Hamburg, GermanyUniversité Paris Diderot and Hôpital Bichat-Claude Bernard, Paris, FranceGilead Sciences, Foster City, CA, USAGilead Sciences, Foster City, CA, USAGilead Sciences, Foster City, CA, USAGilead Sciences, Foster City, CA, USAGilead Sciences, Foster City, CA, USAUniversity of North Carolina School of Medicine, Chapel Hill, NC, USASummary: Background: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is a single-tablet regimen recommended for HIV-1 treatment. The safety and efficacy of B/F/TAF as initial therapy was established in two Phase 3 studies: 1489 (vs dolutegravir [DTG]/abacavir/lamivudine) and 1490 (vs DTG + F/TAF). After 144 weeks of randomized follow-up, an open-label extension evaluated B/F/TAF to 240 weeks. Methods: Of 634 participants randomized to B/F/TAF, 519 completed the double-blinded treatment, and 506/634 (80%) chose the 96-week open-label B/F/TAF extension, which was completed by 444/506 (88%) participants. Efficacy was based on the secondary outcome of the proportion of participants with HIV-1 RNA <50 copies/mL at Week 240 by missing = excluded and missing = failure methods. All 634 participants who were randomized to B/F/TAF and received at least one dose of B/F/TAF were included in efficacy and safety analyses. (Study 1489: ClinicalTrials.gov NCT02607930; EudraCT 2015-004024-54. Study 1490: ClinicalTrials.gov NCT02607956; EudraCT 2015-003988-10). Findings: Of those with available virologic data, 98.6% (95% CI [97.0%–99.5%], 426/432) maintained HIV-1 RNA <50 copies/mL at Week 240 (missing = excluded); when missing virologic data were considered as failure, 67.2% (95% CI [63.4%–70.8%], 426/634) maintained HIV-1 RNA <50 copies/mL. Mean (SD) change in CD4+ count from baseline was +338 (236.2) cells/μL. No treatment-emergent resistance to B/F/TAF was detected. Adverse events led to drug discontinuation in 1.6% (n = 10/634) of participants (n = 5 with events considered drug-related). No discontinuations were due to renal adverse events. Median (IQR) total cholesterol increased 21 (1,42) mg/dL from baseline; the change in total cholesterol:HDL was 0.1 (−0.5,0.6). Median (IQR) weight change from baseline was +6.1 kg (2.0, 11.7) at Week 240. In Study 1489, hip and spine bone mineral density mean percent changes from baseline were ≤0.6%. Interpretation: Through 5 years of follow-up, B/F/TAF maintained high rates of virologic suppression with no treatment-emergent resistance and rare drug discontinuations due to adverse events. These results demonstrate the durability and safety of B/F/TAF in people with HIV. Funding: Gilead Sciences.http://www.sciencedirect.com/science/article/pii/S2589537023001682Antiretroviral therapyIntegrase strand transfer inhibitorLong-termRenal safetyBone safety |
| spellingShingle | Paul E. Sax José R. Arribas Chloe Orkin Adriano Lazzarin Anton Pozniak Edwin DeJesus Franco Maggiolo Hans-Jürgen Stellbrink Yazdan Yazdanpanah Rima Acosta Hailin Huang Jason T. Hindman Hal Martin Jared M. Baeten David Wohl Bictegravir/emtricitabine/tenofovir alafenamide as initial treatment for HIV-1: five-year follow-up from two randomized trialsResearch in context EClinicalMedicine Antiretroviral therapy Integrase strand transfer inhibitor Long-term Renal safety Bone safety |
| title | Bictegravir/emtricitabine/tenofovir alafenamide as initial treatment for HIV-1: five-year follow-up from two randomized trialsResearch in context |
| title_full | Bictegravir/emtricitabine/tenofovir alafenamide as initial treatment for HIV-1: five-year follow-up from two randomized trialsResearch in context |
| title_fullStr | Bictegravir/emtricitabine/tenofovir alafenamide as initial treatment for HIV-1: five-year follow-up from two randomized trialsResearch in context |
| title_full_unstemmed | Bictegravir/emtricitabine/tenofovir alafenamide as initial treatment for HIV-1: five-year follow-up from two randomized trialsResearch in context |
| title_short | Bictegravir/emtricitabine/tenofovir alafenamide as initial treatment for HIV-1: five-year follow-up from two randomized trialsResearch in context |
| title_sort | bictegravir emtricitabine tenofovir alafenamide as initial treatment for hiv 1 five year follow up from two randomized trialsresearch in context |
| topic | Antiretroviral therapy Integrase strand transfer inhibitor Long-term Renal safety Bone safety |
| url | http://www.sciencedirect.com/science/article/pii/S2589537023001682 |
| work_keys_str_mv | AT paulesax bictegraviremtricitabinetenofoviralafenamideasinitialtreatmentforhiv1fiveyearfollowupfromtworandomizedtrialsresearchincontext AT joserarribas bictegraviremtricitabinetenofoviralafenamideasinitialtreatmentforhiv1fiveyearfollowupfromtworandomizedtrialsresearchincontext AT chloeorkin bictegraviremtricitabinetenofoviralafenamideasinitialtreatmentforhiv1fiveyearfollowupfromtworandomizedtrialsresearchincontext AT adrianolazzarin bictegraviremtricitabinetenofoviralafenamideasinitialtreatmentforhiv1fiveyearfollowupfromtworandomizedtrialsresearchincontext AT antonpozniak bictegraviremtricitabinetenofoviralafenamideasinitialtreatmentforhiv1fiveyearfollowupfromtworandomizedtrialsresearchincontext AT edwindejesus bictegraviremtricitabinetenofoviralafenamideasinitialtreatmentforhiv1fiveyearfollowupfromtworandomizedtrialsresearchincontext AT francomaggiolo bictegraviremtricitabinetenofoviralafenamideasinitialtreatmentforhiv1fiveyearfollowupfromtworandomizedtrialsresearchincontext AT hansjurgenstellbrink bictegraviremtricitabinetenofoviralafenamideasinitialtreatmentforhiv1fiveyearfollowupfromtworandomizedtrialsresearchincontext AT yazdanyazdanpanah bictegraviremtricitabinetenofoviralafenamideasinitialtreatmentforhiv1fiveyearfollowupfromtworandomizedtrialsresearchincontext AT rimaacosta bictegraviremtricitabinetenofoviralafenamideasinitialtreatmentforhiv1fiveyearfollowupfromtworandomizedtrialsresearchincontext AT hailinhuang bictegraviremtricitabinetenofoviralafenamideasinitialtreatmentforhiv1fiveyearfollowupfromtworandomizedtrialsresearchincontext AT jasonthindman bictegraviremtricitabinetenofoviralafenamideasinitialtreatmentforhiv1fiveyearfollowupfromtworandomizedtrialsresearchincontext AT halmartin bictegraviremtricitabinetenofoviralafenamideasinitialtreatmentforhiv1fiveyearfollowupfromtworandomizedtrialsresearchincontext AT jaredmbaeten bictegraviremtricitabinetenofoviralafenamideasinitialtreatmentforhiv1fiveyearfollowupfromtworandomizedtrialsresearchincontext AT davidwohl bictegraviremtricitabinetenofoviralafenamideasinitialtreatmentforhiv1fiveyearfollowupfromtworandomizedtrialsresearchincontext |