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Randomized Controlled Trial
. 2021 Jul 15;73(2):e485-e493.
doi: 10.1093/cid/ciaa988.

Switching to Bictegravir, Emtricitabine, and Tenofovir Alafenamide in Virologically Suppressed Adults With Human Immunodeficiency Virus

Paul E Sax  1 , Jürgen K Rockstroh  2 , Anne F Luetkemeyer  3 , Yazdan Yazdanpanah  4 , Douglas Ward  5 , Benoit Trottier  6 , Armin Rieger  7 , Hui Liu  8 , Rima Acosta  8 , Sean E Collins  8 , Diana M Brainard  8 , Hal Martin  8 ; GS-US-380–4030 Investigators
Affiliations
Randomized Controlled Trial

Switching to Bictegravir, Emtricitabine, and Tenofovir Alafenamide in Virologically Suppressed Adults With Human Immunodeficiency Virus

Paul E Sax et al. Clin Infect Dis. .

Abstract

Background: Bictegravir (B)/emtricitabine (F)/tenofovir alafenamide (TAF) is guideline-recommended treatment for human immunodeficiency virus type 1 (HIV-1). We evaluated whether people receiving dolutegravir (DTG) plus F/TAF or F/TDF (tenofovir disoproxil fumarate) with viral suppression can switch to B/F/TAF without compromising safety or efficacy, regardless of preexisting nucleoside reverse transcriptase inhibitor (NRTI) resistance.

Methods: In this multicenter, randomized, double-blinded, active-controlled, noninferiority trial, we enrolled adults who were virologically suppressed for ≥6 months before screening (with documented/suspected NRTI resistance) or ≥3 months before screening (with no documented/suspected NRTI resistance) on DTG plus either F/TDF or F/TAF. We randomly assigned (1:1) participants to switch to B/F/TAF or DTG + F/TAF once daily for 48 weeks, each with matching placebo. The primary endpoint was proportion of participants with plasma HIV-1 RNA ≥50 copies/mL at week 48 (snapshot algorithm); the prespecified noninferiority margin was 4%.

Results: Five hundred sixty-seven adults were randomized; 565 were treated (284 B/F/TAF, 281 DTG + F/TAF). At week 48, B/F/TAF was noninferior to DTG + F/TAF, as 0.4% (1/284) vs 1.1% (3/281) had HIV-1 RNA ≥50 copies/mL (difference, -0.7% [95.001% confidence interval {CI}, -2.8% to 1.0%]). There were no significant differences in efficacy among participants with suspected or confirmed prior NRTI resistance (n = 138). No participant had treatment-emergent drug resistance. Median weight change from baseline at week 48 was +1.3 kg (B/F/TAF) vs +1.1 kg (DTG + F/TAF) (P = .46). Weight change differed by baseline NRTIs (+2.2 kg [F/TDF] and +0.6 kg [F/TAF], P < .001), with no differences between B/F/TAF and DTG + F/TAF.

Conclusions: The single-tablet regimen B/F/TAF is a safe, effective option for people virologically suppressed on DTG plus either F/TDF or F/TAF, including in individuals with preexisting resistance to NRTIs.

Clinical trials registration: NCT03110380.

Keywords: HIV; INSTI; bictegravir; dolutegravir; tenofovir alafenamide.

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Figures

Figure 1.
Figure 1.
Study profile through week 48. Abbreviations: B/F/TAF, bictegravir/emtricitabine/tenofovir alafenamide; DTG + F/TAF, dolutegravir plus emtricitabine/tenofovir alafenamide.
Figure 2.
Figure 2.
Virologic outcome at week 48. Abbreviations: B/F/TAF, bictegravir/emtricitabine/tenofovir alafenamide; c/mL, copies per milliliter; CI, confidence interval; DTG + F/TAF, dolutegravir plus emtricitabine/tenofovir alafenamide; HIV-1 human immunodeficiency virus type 1.
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