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. 2025 Apr 21;17(4):e82716.
doi: 10.7759/cureus.82716. eCollection 2025 Apr.

A Stable Switch From Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/FTC/TAF) to Dolutegravir/Lamivudine (DTG/3TC) in the Absence of Historical Resistance Records: Results From the Switch to Dovato in Patients Suppressed on Biktarvy (SOUND) Cohort

Jihad Slim  1 , Paul Bellafiore  1 , Masara Touza  2 , James P Fallon  3 , Rebecca A Borsi  4
Affiliations

A Stable Switch From Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/FTC/TAF) to Dolutegravir/Lamivudine (DTG/3TC) in the Absence of Historical Resistance Records: Results From the Switch to Dovato in Patients Suppressed on Biktarvy (SOUND) Cohort

Jihad Slim et al. Cureus. .

Abstract

Objective: This article aims to examine the safety and efficacy of switching from bictegravir/emtricitabine/tenofovir alafenamide (B/FTC/TAF) to dolutegravir and lamivudine (DTG/3TC) in the absence of prior resistance records.

Design: Switch to Dovato in patients suppressed on Biktarvy (SOUND) is an open-label, single-arm, pilot study of adult people with HIV who were virologically suppressed (HIV-1 <50 copies/mL) on B/FTC/TAF for >24 weeks, and switched to DTG/3TC in the absence of available resistance records.

Methods: The primary endpoint was the percentage of participants with HIV viral load (VL) ≥50 c/mL at week 48. Secondary endpoints at weeks 48 and 96 included the percentage of participants with HIV-VL <50 c/mL, incidence and severity of adverse events, laboratory abnormalities, change in baseline CD4 cell count, and retrospective proviral DNA resistance testing on banked baseline samples.

Results: Of the 40 individuals enrolled, 0% had VL ≥50 c/mL at week 48. No participants discontinued due to laboratory abnormalities or safety-related concerns. Three participants withdrew from the study while virologically suppressed. Among the 32 baseline samples available for retrospective proviral DNA resistance testing, six (19%) had nucleoside reverse transcriptase inhibitor resistance-associated mutations (RAMs), all with M184V. Two (6%) participants had integrase strand transfer inhibitor RAMs at baseline (S147S/G and Q148Q/R); neither conferred resistance to DTG. Nonnucleoside reverse transcriptase inhibitor and protease inhibitor RAMs were observed in eight (25%) and three (9%) participants, respectively. A significant decrease in weight was observed over the study period.

Conclusions: Results from SOUND support the efficacy and safety of switching to DTG/3TC for people living with HIV-1 who are virologically suppressed on B/FTC/TAF with unknown resistance history and may confer a weight advantage.

Keywords: b/ftc/taf; cohort; dtg/3tc; hiv; resistance.

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Conflict of interest statement

Human subjects: Consent for treatment and open access publication was obtained or waived by all participants in this study. Saint Michael's Medical Center Institutional Review Board issued approval 09/21. The design of this report was approved by local ethical communities. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: The study was supported by ViiV Healthcare under grant Viiv213578. Financial relationships: Jihad Slim declare(s) personal fees from GlaxoSmithKlein. Jihad Slim declare(s) personal fees from Gilead. Rebecca A. Borsi declare(s) employment from Viiv Healthcare. Jihad Slim declare(s) a grant and personal fees from ViiV Healthcare. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work.

Figures

Figure 1
Figure 1. Open-label, single-center, single-arm pilot study design
DTG: dolutegravir; 3TC: lamivudine; HBV: hepatitis B virus; VF: virologic failure; B/FTC/TAF: bictegravir, emtricitabine, and tenofovir alafenamide; ITT-E: intention to treat exposed; INSTI: integrase strand transfer inhibitor; ART: antiretroviral therapy
Figure 2
Figure 2. Results for secondary endpoints
VL: viral load
See this image and copyright information in PMC

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