Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Adults Who Are Virologically Suppressed

Summary

The primary objective of this study is to evaluate the efficacy of switching from a regimen of either dolutegravir (DTG) and emtricitabine /tenofovir alafenamide (F/TAF) or DTG and emtricitabine/tenofovir disoproxil fumarate (F/TDF) to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus DTG+F/TAF in virologically suppressed HIV-1 infected adults with or without antiretroviral (ARV) resistance.

Timeline

Start

2017-06-12

Primary completion

2018-12-04

Completion

2021-02-10

Outcome

Met primary endpoint

registry analysis (non-inferiority test); B/F/TAF vs DTG + F/TAF; Difference in Percentages -0.7 (95.001% CI -2.8 to 1.0) NCT03110380 ↗

paper At week 48, B/F/TAF was noninferior to DTG + F/TAF, PMID 32668455 ↗

Publications

• Results Sax PE, Rockstroh JK, Luetkemeyer AF, Yazdanpanah Y, Ward D, Trottier B, Rieger A, Liu H, Acosta R, Collins SE, Brainard DM, Martin H; GS-US-380-4030 Investigators. Switching to Bictegravir, Emtricitabine, and Tenofovir Alafenamide in Virologically Suppressed Adults With Human Immunodeficiency Virus. Clin Infect Dis. 2021 Jul 15;73(2):e485-e493. doi: 10.1093/cid/ciaa988.
• Results Acosta RK, Willkom M, Andreatta K, Liu H, Martin R, Parvangada A, Martin H, Collins S, White KL. Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) From Dolutegravir (DTG)+F/TAF or DTG+F/Tenofovir Disoproxil Fumarate (TDF) in the Presence of Pre-existing NRTI Resistance. J Acquir Immune Defic Syndr. 2020 Nov 1;85(3):363-371. doi: 10.1097/QAI.0000000000002454.

Drugs

Evaluation	Drug	Modality	Dose	Route
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	DTG	Unknown	50 mg	Oral
Comparator	F/TAF	Unknown	25 mg	Oral
Comparator	F/TAF	Unknown	200 mg	Oral

Indications