Focus on each HIV patient
HIV Drug Resistance
Emergent resistance-associated mutations at first- or second-line HIV-1 virologic failure with second-generation InSTIs in two- and three-drug regimens: the Virostar-1 study
The Virostar-1 study is a French multicenter, retrospective analysis designed to evaluate across a 3 year period, among 5986 people living with HIV (PWH) the real-world rates of virological failure (VF) on second-generation Integrase strand transfer inhibitors (InSTIs) treatments, and the fraction of those who experience emerged resistance-associated mutations (RAMs) while on first- or second-line regimen.
The study highlights that while second-generation InSTIs (DTG and BIC) maintain a high barrier to resistance in randomized clinical trials, at the real-world settings – where adherence is often suboptimal (average mean frequently < 80%)² – may show higher rates of resistance development than previously reported in Randomized controlled Phase 3 studies. The findings suggest that BIC-based 3-drug regimen may provide the highest barrier to resistance at the time of failure in a real-world setting.
Virostar-1: BIC/FTC/TAF vs DTG/3TC
Risk of VF with emergent M184V while on first line of therapy1
Adapted from Marcelin A-G, et al. J Antimicrob Chemotherapy, 2024.
*VF was defined as two consecutive HIV-1 Plasma viral load >50 c/ml.
References
1. Marcelin A-G et al. J Antimicrob Chemother 2024 https://doi.org/10.1093/jac/dkae377
2. McComsey GA, Lingohr-Smith M, Rogers R et al. Real-world adherence to antiretroviral therapy among HIV-1 patients across the United States. Adv Ther 2021; 38: 4961–74. 10.1007/s12325-021-01883-8
eP158 Publication from the recent EACS 2025 conference, an analysis that analyzes the entire existing treatments based on second-generation integrase inhibitors including LA injections.
Selection of antiretroviral resistance in treatment-experienced PWH with virological failure while on B/F/TAF, DTG/3TC or CAB+RPV LA: Virostar 2.0 study
Integrase strand transfer inhibitors (InSTIs) have potent antiretroviral activity and a high barrier to resistance hence are recommended as components of both 2- and 3-drug regimens as initial or switch options. In phase 3 studies of BIC/FTC/TAF or DTG/3TC or CAB+RPV LA IM the rate of virological failure was very low, with various rates of resistance emergence. This study aims to evaluate the incident of resistance-associated mutations (RAMs) rates over 3 years in an observational cohort of treatment experienced (TE) PWH who experienced a virological failure on BIC/FTC/TAF or DTG/3TC or CAB+RPV LA IM after receiving at least one prior regimen.
Virostar-2.0: BIC/FTC/TAF vs DTG/3TC vs CAB+RPV
Risk of VF with emergent M184 while on subsequent lines of therapy1
Adapted from Marcelin A-G, et al. EACS 2025, eP158.
*VF was defined as two consecutive HIV-1 Plasma viral load >50 c/ml.
References
1. Marcelin A-G et al. EACS 2025, eP158
Women with HIV
Women and girls with HIV account for 53% of people with HIV globally1and a third people with HIV in the WHO European region2, UK3, and in Israel4, each. In the US, 20% of new HIV diagnoses annually are in women5. Despite this, women are underrepresented in clinical trials. Women with HIV have specific clinical needs throughout their life course from contraception to pregnancy through to menopause, which is increasingly important as more women age with HIV.
Guidelines update their treatment recommendations for pregnant women with HIV or trying to conceive
Current guidelines emphasize the importance of effective antiretroviral therapy (ART) during pregnancy to protect maternal health and prevent perinatal transmission, yet treatment options remain limited due to concerns about toxicity, drug exposure, and teratogenicity. This underscores the need for safe, well-tolerated, and convenient regimens for pregnant women with HIV or women with HIV trying to conceive.
During 2025 the DHHS and EACS guidelines updated their recommendations for the preferred regimens during pregnancy and when trying to conceive, with BIC/FTC/TAF now being the only fixed-dose combination (FDC) that is recommended as “preferred” by both guidelines6,7.
These updates are based on existing data that demonstrates sufficient pharmacokinetics, efficacy and safety during pregnancy when treated with BIC/FTC/TAF8-10.
Breaking Boundaries: A Spotlight on Women with HIV Webinar
Women have unique medical and social needs. This is true for all women, and even more so for women with HIV.
During 2025 we held a webinar solely focusing on the needs of women with HIV with an emphasis on menopause, an issue often neglected.
We invite you to watch again as Prof. Hila Elinav (Hadassah MC), Dr. Shema Tariq (University College London’s Institute for Global Health), Dr. Karen Olshtain Pops (Hadassah MC) and Dr. Noa Hovav (Community Menopause Center, Nes Ziona) discuss recently publications and the specific needs of women with HIV
- gov. The Global HIV and AIDS Epidemic. Global Statistics. February 7, 2025 2025. https://www.hiv.gov/hiv-basics/overview/data-and-trends/global-statistics (accessed April 2025).
- Organization WH. HIV/AIDS Surveillance in Europe. 2024. https://www.ecdc.europa.eu/sites/default/files/documents/HIV_Surveillance_Report_2024.pdf (accessed April 2025).
- National AIDS Trust. UK HIV Statistics. 2024. https://nat.org.uk/about-hiv/hiv-statistics/
- Ministry of Health TAD, Israel. HIV/AIDS in Israel: Periodic Epidemiological Report 1981-2023. November 2024 2024. https://www.gov.il/BlobFolder/reports/aids-periodicreport2024/he/files_publications_HIV_periodicreport_2024_EN.pdf (accessed April 2025).
- gov. The US Statistics on HIV. February 21, 2025 2025. https://www.hiv.gov/hiv-basics/overview/data-and-trends/statistics (accessed April 2025).
- Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States. Available at: https://clinicalinfo.hiv.gov/en/guidelines/perinatal/whats-new (Last accessed: Dec 2025).
- Pregnancy and HIV. Available at: https://eacs.sanfordguide.com/en/eacs-hiv/art/eacs-pregnancy-and-hiv (Last accessed: Dec 2025).
- Biktarvy (BIC/TFC/TAF) Israeli prescribing information. Available at: https://israeldrugs.health.gov.il/#!/byDrug
- Zhang H, et al. AIDS 2024; 38:F1–F9. 6. Jao J, et al. AIDS 2023; 37:883–893.
- The Antiretroviral Pregnancy Registry. The Antiretroviral Pregnancy Registry Interim Report (1 January 1989 through 31 July 2024). Available at: https://www.apregistry.com/forms/interim_report.pdf (Last accessed: Jul 2025).
Hope you enjoyed this edition of HIVPro,
HIV newsletter for health care providers.
Please share with us your thoughts and questions:
Karen Rothwell
Karen.Rothwell@gilead.com
Shimrit Refaeli
Shimrit.Refaeli@gilead.com
MA−UNB−EMEAC−IL−00020
1. Sax PE, et al. EClinicalMedicine 2023;59:101991; 2. Sax PE, et al. Lancet 2017;390:2073-2082; 3. Gallant J, et al. Lancet 2017;390:2063-2072; 4. Daar ES, et al. Lancet HIV 2018;5:e347-e356; 5. Molina JM, et al. Lancet HIV 2018;5:e357-e365; 6. Hagins D, et al. J Acquir Immune Defic Syndr 2021;88:86-95; 7. Maggiolo F, et al. Infect Dis Ther 2021;10:775-788; 8. Kityo C, et al. J Acquir Immune Defic Syndr 2019;82:321-328; 9. Zhang H, et al. AIDS 2024;38:F1-F9; 10. Gaur AH, et al. Lancet Child Adolesc Health 2021;5:642-651; 11. Natukunda E, et al. HIV Peds 2021, Oral O2; 12. Sax PE, et al. Clin Infect Dis 2021;73:e485-e493; 13. Biktarvy USPI, Gilead Sciences, April 2024. 14. Eron JJ, et al. Lancet HIV 2019;6:e15-e24; 15. Avihingsanon A, et al. Lancet 2023;10:e640-e652; 16. Esser S, et al. HIV Med 2024;25:440-453; 17. BIKTARVY USPI, Gilead Sciences, October 2022; 18. Data on file. Gilead Sciences, Inc.; 19. Sax P. AIDS March 2022, 36:1511-1520; 20. Liu A, et al. AIDS 2022, Oral OALBC0103; 21. Tan DHS, et al. CROI 2024, Poster 1134; 22. Camici M, et al. AIDS 2022, Poster EPB151; 23. BIC-Now Hidalgo-Tenorio C. et al. EACS 2023 18-21 Oct. Warsaw, Poland Poster 098; 24. Rainbow Camici M. et al. Int J Microb Agents 2024; 63:1-9; 25. FAST study-IMEA 055 Bachelard A. et al. J Antimicrob Chemother 2023; 78:769-778; 26. Naidoo A, et al. CROI 2024, Oral 211; 27. Hyatt AN, et al. CROI 2023, Poster 675, The (mo)BETTA Trial; 28. The Base study, Havens P. J. et al. Infec Dis Feb 2023; 29. The Laptop Study. Behrens GMN, et al. CROI 2025, Poster 0658; 30. Maggiolo F, et al. Sex Transm Infect. 2024; 31. Andreatta K, et al. Infectious Diseases (ID) Week 2023; 11–15 October; Boston, MA. 32. Data on file. Gilead Sciences, Inc.