Safety and Efficacy of Switching to a FDC of B/F/TAF From E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF in Virologically Suppressed HIV-1 Infected Women
Summary
The primary objective of this study is to evaluate the efficacy of switching to a fixed-dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing on a regimen consisting of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF), elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF), or atazanavir (ATV) + ritonavir (RTV) + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in virologically suppressed HIV-1 infected women.
Timeline
- Start
- 2016-02-19
- Primary completion
- 2017-10-09
- Completion
- 2018-11-26
Outcome
Met primary endpoint
paper Switching to B/F/TAF was noninferior to SBR for the primary outcome PMID 31609930 ↗
registry Difference in percentages 0.0 (95.001% CI -2.9 to 2.9) NCT02652624 ↗
release “The primary endpoint for this study conducted exclusively in women, was previously presented, and demonstrated noninferior maintained virologic suppression” gilead.com ↗
Publications
- Avihingsanon A, Chetchotisakd P, Kiertiburanakul S, Ratanasuwan W, Siripassorn K, Supparatpinyo K, Martin H, Wang H, Wong T, Wang HY. Efficacy and safety of switching to bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed Asian adults living with HIV: A pooled analysis from three international phase III randomized trials. HIV Med. 2023 Mar;24(3):290-300. doi: 10.1111/hiv.13386. Epub 2022 Aug 17.
- Kityo C, Hagins D, Koenig E, Avihingsanon A, Chetchotisakd P, Supparatpinyo K, Gankina N, Pokrovsky V, Voronin E, Stephens JL, DeJesus E, Wang H, Acosta RK, Cao H, Quirk E, Martin H, Makadzange T. 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. doi: 10.1097/QAI.0000000000002137.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ATV | Unknown | 300 mg | Oral |
| Subject | B/F/TAF | Unknown | 25 mg | Oral |
| Subject | B/F/TAF | Unknown | 50 mg | Oral |
| Subject | B/F/TAF | Unknown | 200 mg | Oral |
| Comparator | E/C/F/TAF | Unknown | 10 mg | Oral |
| Comparator | E/C/F/TAF | Unknown | 150 mg | Oral |
| Comparator | E/C/F/TAF | Unknown | 200 mg | Oral |
| Comparator | E/C/F/TDF | Unknown | 150 mg | Oral |
| Comparator | E/C/F/TDF | Unknown | 200 mg | Oral |
| Comparator | E/C/F/TDF | Unknown | 300 mg | Oral |
| Comparator | FTC/TDF | Unknown | 200 mg | Oral |
| Comparator | FTC/TDF | Unknown | 300 mg | Oral |
| Comparator | RTV | Unknown | 100 mg | Oral |