MOAB0106
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Title
Longer-term (96-week) efficacy and safety of switching to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in women
Presenter
Cissy Kityo
Authors
C. Kityo1, D. Hagins2, E. Koenig3, A. Avihingsanon4, P. Chetchotisakd5, K. Supparatpinyo6, N. Gankina7, V. Pokrovsky8, E. Voronin9, J.L. Stephens10, E. Dejesus11, H. Wang12, R. Acosta12, D. Brainard12, H. Martin12, T. Makadzange12
Institutions
1Joint Clinical Research Centre, Kampala, Uganda, 2Chatham Care Center, Georgia Department of Public Health, Coastal Health District, Savannah, United States, 3Instituto Dominicano de Estudios Virologicos IDEV, Dr. Pineyro 211, Zona Universitaria, Santo Domingo, Dominican Republic, 4HIV Netherlands Australia Thailand Research Collaboration, The Thai Red Cross AIDS Research Centre, Bangkok, Thailand, 5Srinagarind Hospital, Khon Kaen, Thailand, 6Chiang Mai University, Chiang Mai, Thailand, 7Krasnoyarsk Territorial Center for Prevention and Control of AIDS and Infectious Diseases, Krasnoyarsk, Russian Federation, 8Center for Prevention and Control of AIDS, Moscow, Russian Federation, 9Federal State Institution 'Republican Clinical Infectious Hospital' of the Ministry of Health of the Russian Federation, Saint Petersburg, Russian Federation, 10Mercer University School of Medicine, Macon, United States, 11Orlando Immunology Center, Orlando, United States, 12Gilead Sciences, Foster City, United States

Background: Fixed-dose combination B/F/TAF is recommended regimen for HIV-1 treatment. We report week (W) 96 results from a phase 3 study evaluating switching to B/F/TAF in a globally distributed cohort of women. Primary outcome at W48 demonstrated noninferior virologic response, good tolerability, and no emergent resistance.
Methods: In the randomized phase of this multicenter, open-label trial, women living with HIV who were virologically suppressed (HIV-1 RNA < 50 copies/mL) on a baseline regimen (elvitegravir/cobicistat/F/TAF, E/C/F/tenofovir disoproxil fumarate [TDF], or atazanavir+ritonavir+F/TDF) were assigned (1:1) to switch to B/F/TAF (50/200/25 mg) or stay on baseline regimen (SBR) for 48W. At W48, women in the SBR arm switched to B/F/TAF; all participants received B/F/TAF through W96. Secondary efficacy endpoints included proportion with plasma HIV-1 RNA ≥50 copies/mL (missing=excluded [M=E]) at W96 (for those on B/F/TAF throughout the study) and W48 (for those switched to B/F/TAF after W48). Adverse events (AEs) and laboratory test results were assessed through W96.
Results: 470 women from the Dominican Republic, Russian Federation, Thailand, Uganda, and the US were treated in the randomized phase (234 B/F/TAF, 236 SBR); 231 continued on B/F/TAF and 228 in the SBR arm switched to B/F/TAF. At W96, virologic suppression (M=E) was maintained in 99.5% (95% CI 97.4%, 100.0%) of the women who received B/F/TAF throughout the study and in 98.5% (95% CI: 95.5%, 99.7%) of women who switched to B/F/TAF at W48. No individual who received B/F/TAF developed treatment-emergent resistance. Over a median exposure of 76.6W, B/F/TAF was well tolerated, with low frequencies of grade 3 or 4 AEs (6.7%), treatment-related AEs (5.8%), or serious AEs (5.2%). One participant who received B/F/TAF in the extension phase discontinued treatment due to drug-related AEs (grade 2 elevated ALT, AST, and GGT). Grade 3 or 4 laboratory abnormalities occurred in 22.1%; most were menses-associated urine RBCs.
Conclusions: B/F/TAF was safe and well tolerated through 96 weeks. Women who switched to B/F/TAF maintained high levels of virologic suppression without emergence of resistance. This analysis supports the efficacy and safety of B/F/TAF observed in other B/F/TAF studies and contributes important long-term data on safety, tolerability, and efficacy in women living with HIV.