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This promotional website is developed and funded by Gilead Sciences Ltd and intended for healthcare professionals in the UK and Ireland.
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Prescribing information, details of adverse event reporting and indications can be found at the bottom of this page. BIKTARVY® is subject to additional monitoring ▼ in Great Britain; this requirement no longer applies in Ireland and Northern Ireland.

Pivotal studies in treatment-naïve people living with HIV

Study 14891,2

Study 1489 is a Phase 3, randomised, double-blind study designed to evaluate the efficacy and safety of BIKTARVY® versus a fixed dose combination containing dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) in treatment naïve-adults living with HIV-1.

Study 1489

Adapted from Wohl D, et al. CROI 2022, Abstract 494.1

 

* All participants rolled over to open-label extension phase at the same time after the last person reached Week 144. 

 

 

Pivotal studies in treatment-naïve people living with HIV

Study 14901,3,4

Study 1490 is a Phase 3, randomised, double-blind study designed to evaluate the efficacy and safety of BIKTARVY® versus dolutegravir (DTG) + a fixed dose combination containing emtricitabine/tenofovir alafenamide (F/TAF) in treatment naive-adults living with HIV-1.

Study 1490

Adapted from Wohl D, et al. CROI 2022, Abstract 494.1

 

* All participants rolled over to open-label extension phase at the same time after the last person reached Week 144. 

Pivotal studies in treatment-experienced people living with HIV

Study 18445,6

Study 1844 is a Phase 3, randomised, double-blind study designed to evaluate the efficacy and safety of switching from a regimen of dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) to a fixed dose combination of BIKTARVY® versus continuing DTG/ABC/3TC in virologically suppressed adults living with HIV-1.

Study 1844

Adapted from Brar I, et al. ID Week 2020 Poster 1028.6

Pivotal studies in treatment-experienced people living with HIV

Study 1878 7,8

Study 1878 is a Phase 3, multicentre, randomised, open-label, active-controlled study to evaluate the safety and efficacy of switching from a regimen of fixed dose combination of boosted atazanavir (ATV) or darunavir (DRV) + either emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) to BIKTARVY® in virologically suppressed adults living with HIV-1.

Study 1878

Adapted from Rockstroh JK, et al. HIV Glasgow 2020 Poster 036.7

Abbreviations:

3TC, lamivudine; ABC, abacavir; ART, antiretroviral therapy; DTG, dolutegravir; eGFRCG, estimated glomerular filtration rate by Cockcroft-Gault; FTC, emtricitabine; HBV, hepatitis B virus; HCV, hepatitis C virus; HIV-1, human immunodeficiency virus-1; HLA, human leukocyte antigen; NI, non-inferiority; OD, once daily; RNA, ribonucleic acid; TAF, tenofovir alafenamide fumarate.

References:

  1. Wohl D, et al. Conference on Retroviruses and Opportunistic Infection (CROI) 2022, 12–24 February; Virtual. Abstract 494. 
  2. Workowski K, et al. Conference on Retroviruses and Opportunistic Infection (CROI) 2021, 6–10 March. Abstract 415. 
  3. Gallant J, et al. Lancet 2017;390:2063–2072. 
  4. Sax PE, et al. Lancet 2017;390:2073–2082. 
  5. Molina JM, et al. Lancet HIV 2018;5:e357–e365. 
  6. Brar I, et al. Infectious Diseases (ID) Week 2020, 21–25 October. Poster 1028. 
  7. Rockstroh JK, et al. HIV Glasgow 2020, 5–8 October; Glasgow, UK. Poster 036.
  8. Daar ES, et al. Lancet HIV 2018;5:e347–e356.

UK-BVY-0703 Date of preparation August 2024