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Switching to Fixed-Dose Bictegravir, Emtricitabine, and Tenofovir Alafenamide (B/F/TAF) in Virologically Suppressed HIV-1 Infected Women: A Randomized, Open-Label, Multicenter, Active-Controlled, Phase 3, Noninferiority Trial.
J Acquir Immune Defic Syndr 2019; 82(3):321-328JA

Abstract

BACKGROUND

Bictegravir, coformulated with emtricitabine/tenofovir alafenamide as a fixed-dose combination (B/F/TAF), is recommended for treatment of HIV-1-infection. Multiple studies of B/F/TAF in treatment-naive and virologically suppressed cohorts have shown high efficacy and tolerability with no treatment-emergent resistance through 48 weeks. Participants in these studies have been predominantly men. We report 48-week results from a phase 3 study evaluating switching to B/F/TAF, specifically in a globally distributed trial population of women.

METHODS

In this multicenter, randomized, open-label, active-controlled, noninferiority trial (ClinicalTrials.gov NCT02652624), women living with HIV who were virologically suppressed (HIV-1 RNA levels <50 copies/mL) on a regimen containing either TAF or tenofovir disoproxil fumarate were randomly assigned (1:1) to switch to B/F/TAF (50/200/25 mg) or stay on baseline regimen (SBR) once daily for 48 weeks. Primary endpoint was proportion of participants with plasma HIV-1 RNA ≥50 copies/mL at week 48 (U.S. Food and Drug Administration snapshot algorithm); prespecified noninferiority margin was 4%.

FINDINGS

We randomized 472 participants and treated 470 (234 B/F/TAF, 236 SBR). Switching to B/F/TAF was noninferior to SBR for the primary outcome, as 1.7% (4/234) vs 1.7% (4/236) had HIV-1 RNA ≥50 copies/mL at week 48 (difference 0.0%, 95.001% confidence interval: -2.9% to 2.9%). No individual receiving B/F/TAF developed treatment-emergent resistance. Both treatments were well-tolerated; no participant discontinued treatment because of an adverse event.

INTERPRETATION

Fixed-dose combination B/F/TAF provides a safe and efficacious option for ongoing treatment of HIV in women. This study contributes important data on safety, tolerability, and outcomes of antiretroviral therapy among women living with HIV.

Authors+Show Affiliations

Joint Clinical Research Centre, Kampala, Uganda.Georgia Department of Public Health, Coastal Health District, Chatham CARE Center, Savannah, GA.Zona Universitaria, Instituto Dominicano de Estudios Virológicos, Santo Domingo, Dominion Republic, Canada.HIV-NAT, Thai Red Cross AIDS Research Centre and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.Khon Kaen University, Khon Kaen, Thailand.Chiang Mai University, Chiang Mai, Thailand.Krasnoyarsk Territorial Center for Prevention and Control of AIDS and Infectious Diseases, Krasnoyarsk, Russia.Center for Prevention and Control of AIDS, Moscow, Russia.Federal Budgetary Institution "Republican Clinical Infectious Hospital" of the Ministry of Health of the Russian Federation, Saint-Petersburg, Russia.Mercer University School of Medicine, Macon, GA.Orlando Immunology Center, Orlando, FL.Gilead Sciences Inc., Foster City, CA.Gilead Sciences Inc., Foster City, CA.Gilead Sciences Inc., Foster City, CA.Gilead Sciences Inc., Foster City, CA.Gilead Sciences Inc., Foster City, CA.Gilead Sciences Inc., Foster City, CA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31609930

Citation

Kityo, Cissy, et al. "Switching to Fixed-Dose Bictegravir, Emtricitabine, and Tenofovir Alafenamide (B/F/TAF) in Virologically Suppressed HIV-1 Infected Women: a Randomized, Open-Label, Multicenter, Active-Controlled, Phase 3, Noninferiority Trial." Journal of Acquired Immune Deficiency Syndromes (1999), vol. 82, no. 3, 2019, pp. 321-328.
Kityo C, Hagins D, Koenig E, et al. Switching to Fixed-Dose Bictegravir, Emtricitabine, and Tenofovir Alafenamide (B/F/TAF) in Virologically Suppressed HIV-1 Infected Women: A Randomized, Open-Label, Multicenter, Active-Controlled, Phase 3, Noninferiority Trial. J Acquir Immune Defic Syndr. 2019;82(3):321-328.
Kityo, C., Hagins, D., Koenig, E., Avihingsanon, A., Chetchotisakd, P., Supparatpinyo, K., ... Makadzange, T. (2019). Switching to Fixed-Dose Bictegravir, Emtricitabine, and Tenofovir Alafenamide (B/F/TAF) in Virologically Suppressed HIV-1 Infected Women: A Randomized, Open-Label, Multicenter, Active-Controlled, Phase 3, Noninferiority Trial. Journal of Acquired Immune Deficiency Syndromes (1999), 82(3), pp. 321-328. doi:10.1097/QAI.0000000000002137.
Kityo C, et al. Switching to Fixed-Dose Bictegravir, Emtricitabine, and Tenofovir Alafenamide (B/F/TAF) in Virologically Suppressed HIV-1 Infected Women: a Randomized, Open-Label, Multicenter, Active-Controlled, Phase 3, Noninferiority Trial. J Acquir Immune Defic Syndr. 2019 Nov 1;82(3):321-328. PubMed PMID: 31609930.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Switching to Fixed-Dose Bictegravir, Emtricitabine, and Tenofovir Alafenamide (B/F/TAF) in Virologically Suppressed HIV-1 Infected Women: A Randomized, Open-Label, Multicenter, Active-Controlled, Phase 3, Noninferiority Trial. AU - Kityo,Cissy, AU - Hagins,Debbie, AU - Koenig,Ellen, AU - Avihingsanon,Anchalee, AU - Chetchotisakd,Ploenchan, AU - Supparatpinyo,Khuanchai, AU - Gankina,Natalya, AU - Pokrovsky,Vadim, AU - Voronin,Evgeny, AU - Stephens,Jeffrey L, AU - DeJesus,Edwin, AU - Wang,Hui, AU - Acosta,Rima K, AU - Cao,Huyen, AU - Quirk,Erin, AU - Martin,Hal, AU - Makadzange,Tariro, PY - 2019/10/15/entrez PY - 2019/10/15/pubmed PY - 2019/10/15/medline SP - 321 EP - 328 JF - Journal of acquired immune deficiency syndromes (1999) JO - J. Acquir. Immune Defic. Syndr. VL - 82 IS - 3 N2 - BACKGROUND: Bictegravir, coformulated with emtricitabine/tenofovir alafenamide as a fixed-dose combination (B/F/TAF), is recommended for treatment of HIV-1-infection. Multiple studies of B/F/TAF in treatment-naive and virologically suppressed cohorts have shown high efficacy and tolerability with no treatment-emergent resistance through 48 weeks. Participants in these studies have been predominantly men. We report 48-week results from a phase 3 study evaluating switching to B/F/TAF, specifically in a globally distributed trial population of women. METHODS: In this multicenter, randomized, open-label, active-controlled, noninferiority trial (ClinicalTrials.gov NCT02652624), women living with HIV who were virologically suppressed (HIV-1 RNA levels <50 copies/mL) on a regimen containing either TAF or tenofovir disoproxil fumarate were randomly assigned (1:1) to switch to B/F/TAF (50/200/25 mg) or stay on baseline regimen (SBR) once daily for 48 weeks. Primary endpoint was proportion of participants with plasma HIV-1 RNA ≥50 copies/mL at week 48 (U.S. Food and Drug Administration snapshot algorithm); prespecified noninferiority margin was 4%. FINDINGS: We randomized 472 participants and treated 470 (234 B/F/TAF, 236 SBR). Switching to B/F/TAF was noninferior to SBR for the primary outcome, as 1.7% (4/234) vs 1.7% (4/236) had HIV-1 RNA ≥50 copies/mL at week 48 (difference 0.0%, 95.001% confidence interval: -2.9% to 2.9%). No individual receiving B/F/TAF developed treatment-emergent resistance. Both treatments were well-tolerated; no participant discontinued treatment because of an adverse event. INTERPRETATION: Fixed-dose combination B/F/TAF provides a safe and efficacious option for ongoing treatment of HIV in women. This study contributes important data on safety, tolerability, and outcomes of antiretroviral therapy among women living with HIV. SN - 1944-7884 UR - https://www.unboundmedicine.com/medline/citation/31609930/Switching_to_Fixed-Dose_Bictegravir,_Emtricitabine,_and_Tenofovir_Alafenamide_(B/F/TAF)_in_Virologically_Suppressed_HIV-1_Infected_Women:_A_Randomized,_Open-Label,_Multicenter,_Active-Controlled,_Phase_3,_Noninferiority_Trial L2 - http://dx.doi.org/10.1097/QAI.0000000000002137 DB - PRIME DP - Unbound Medicine ER -