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A robust* regimen delivering long-term efficacy with 0 treatment-emergent resistance§ in pivotalΩ randomised clinical trials*1–5

In ART naïve 1489 and 1490 studies, ≥97% efficacy (M=E analysis) after Week 48 through Week 2402

Study 1489 and Study 1490

Adapted from Sax P, et al. eClinicalMedicine 2023;59:101991.

 

Study populations included ART-naïve people with HIV with HIV-1 RNA ≥ 500 c/mL. For further details on the study designs for the 1489 and 1490 studies click here

 

Among those with baseline CD4 <200 cells/μL from the pooled studies, 98% (49/50) had HIV-1 RNA <50 copies/mL at Week 240. Efficacy defined as viral load <50 copies/mL and was calculated using US FDA Snapshot algorithm; includes only participants initially randomised to BIKTARVY®.

 

Median CD4 changes from B/F/TAF start to Week 240, cells/μL (IQR): Study 1489: +313 (179, 475); Study 1490: +331 (215, 467)19,20

Zero treatment emergent resistance through 5 years of follow up in the ART naïve 1489/1490 studies in any group of the final resistance analysis population††2

Participants table

Adapted from Sax P, et al. eClinicalMedicine 2023;59:101991.

 

††Final resistance analysis population included participants with confirmed HIV-1 RNA ≥200 copies/mL or ≥200 copies/mL at last visit, with no resuppression of HIV-1 RNA to <50 copies/mL while on study drug; includes only participants initially randomised to BIKTARVY®.2

 

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Footnotes:

*Robust: Defined as maintained efficacy, which is dependent on patient adherence. Adherence is impacted by tolerability and simplicity of treatment.21–24
 

§Efficacy: In RCTs in treatment-naïve participants, BIKTARVY® was non-inferior (VL <50 copies/mL) to ABC/3TC/DTG (Study 1489) and DTG + FTC/TAF (Study 1490) at Weeks 48 (primary endpoint), 96 and 144 (secondary endpoints).1 Pooled efficacy for BIKTARVY® (VL <50 copies/mL, n=634, M=F) at Weeks 48 and 144 was 91% and 82% respectively.1 After the optional 96 week open-label extension phase (from Weeks 144 through 240), participants taking BIKTARVY® since baseline achieved and maintained high rates of virologic suppression (VL <50 copies/mL: 99% [n=426/432] M=E, 67% [n=426/634] M=F).2 In RCTs in virologically suppressed participants, BIKTARVY® was non-inferior (VL≥50 copies/mL, M=F) at the Week 48 primary endpoint to comparator regimens of ABC/3TC/DTG (Study 1844) and ATV- or DRV-based regimens (Study 1878).1 BIKTARVY® efficacy at Week 48 (VL <50 copies/mL, M=F) was 94% in Study 1844 (n=282) and 92% in Study 1878 (n=290).1 Participants who switched to BIKTARVY® at baseline or from Week 48 in an optional open-label extension (Study 1844 total exposed to BIKTARVY® n=547, Study 1878 n=534) maintained high levels of viral suppression (VL <50 copies/mL, M=E) through 96 weeks in Study 1844 (100%, n=283/283)3 and Study 1878 (100%, n=318/318).4 

 

ΩPivotal: defined as the four registrational trials for BIKTARVY® (Studies 1489, 1490, 1844 and 1878).

Resistance: In pivotal (registrational) Phase 3 RCTs, there was 0 treatment-emergent resistance to the components of BIKTARVY® in the final resistance analysis populations.1–5

Abbreviations:

3TC, lamivudine; ABC, abacavir; ART, antiretroviral therapy; ATV, atazanavir; CD4, cluster of differentiation 4; DRV, darunavir; DTG, dolutegravir; eGFRCG; estimated glomerular filtration rate (Cockcroft-Gault); HBV, hepatitis B virus; HCV, hepatitis C virus; HIV, human immunodeficiency virus; INSTI, integrase strand transfer inhibitor; IQR, interquartile range; M=E, missing=excluded; M=F, missing=failure; NRTI, nucleoside reverse transcriptase inhibitor; PRT, proximal renal tubulopathy; RNA, ribonucleic acid; SmPC, Summary of Product Characteristics; VL, viral load.

References:

  1. BIKTARVY® Summary of Product Characteristics.
  2. Sax P, et al. eClinicalMedicine 2023;59:101991. 
  3. Brar I, et al. Infectious Diseases (ID) Week 2020, 21–25 October. Poster 1028. 
  4. Rockstroh JK, et al. HIV Glasgow 2020, 5–8 October; Glasgow, UK. Poster 036.
  5. Orkin C, et al. HIV Glasgow 2022, 23–28 October; Glasgow, UK. Poster P088.
  6. Gallant J, et al. Lancet 2017;390:2063–2072. 
  7. Sax PE, et al. Lancet 2017;390:2073–2082. 
  8. Kityo C, et al. International AIDS Society (IAS) 2019, 21–24 July; Mexico City, Mexico. Presentation MOAB0106. 
  9. Molina JM, et al. Lancet HIV 2018;5:e357–e365. 
  10. Daar ES, et al. Lancet HIV 2018;5:e347–e356.
  11. Podzamczer D, et al. HIV Glasgow 2018, 28–31 October: Glasgow, UK. Poster 119.
  12. Mills A, et al. Conference on Retroviruses and Opportunistic Infections (CROI) 2020, 8–11 March: Boston MA. Poster 2886.
  13. Maggiolo F, et al. HIV Med 2023;24:27−36. 
  14. Hagins D, et al. J Acquir Immune Defic Syndr 2021;88:86−95. 
  15. Natukunda E, et al. 13th International Workshop on HIV Pediatrics 2021. Virtual meeting. Available at: https://www.natap.org/2021/IAS/IAS_80.htm. Accessed February 2026. 
  16. Trottier B, et al. HIV Glasgow 2022, 23–26 October 2022; Glasgow, UK. Poster P067. 
  17. Gilead. Data on file HIV116. March 2022. 
  18. Post F, et al. Conference on Retroviruses and Opportunistic Infections (CROI) 2025, 9–13 March; San Francisco, United States. Poster 859. 
  19. Workowski K, et al. Conference on Retroviruses and Opportunistic Infections (CROI) 2021, 6–10 March. Abstract 415.
  20. Wohl D, et al. Conference on Retroviruses and Opportunistic Infections (CROI) 2022, 12–24 February: virtual. Abstract 494.
  21. US Department of Health and Human Services (DHHS). What to Start: Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV, March 2023. Available at: https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescentarv/guidelines-adult-adolescent-arv.pdf. Accessed February 2026.
  22. Cihlar T, et al. Curr Opin Virol 2016;18:50–56.
  23. Trottier B, et al. J Int AIDS Soc 2014;17(Suppl 3):19765.
  24. Orkin C, et al. HIV Med 2018;19:18–32.

UK-BVY-0703 Date of preparation February 2026