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Clinical Trial
. 2024 Sep 26;11(10):ofae560.
doi: 10.1093/ofid/ofae560. eCollection 2024 Oct.

Efficacy, Safety, and Tolerability of Switching From Bictegravir/Emtricitabine/Tenofovir Alafenamide to Dolutegravir/Lamivudine Among Adults With Virologically Suppressed HIV: The DYAD Study

Charlotte-Paige Rolle  1   2 , Jamie Castano  1 , Vu Nguyen  1 , Federico Hinestrosa  1   3 , Edwin DeJesus  1   3
Affiliations
Clinical Trial

Efficacy, Safety, and Tolerability of Switching From Bictegravir/Emtricitabine/Tenofovir Alafenamide to Dolutegravir/Lamivudine Among Adults With Virologically Suppressed HIV: The DYAD Study

Charlotte-Paige Rolle et al. Open Forum Infect Dis. .

Abstract

Background: In TANGO and SALSA, switching to dolutegravir/lamivudine (DTG/3TC) was noninferior to continuing a baseline regimen among adults who were treatment experienced, although few switched from bictegravir (B) / emtricitabine (F) / tenofovir alafenamide (TAF). Here, we present the efficacy and safety of switching to DTG/3TC as compared with continuing with B/F/TAF among adults with virologic suppression.

Methods: DYAD is an open-label clinical trial that randomized adults with HIV-1 RNA <50 copies/mL and no prior virologic failure (2:1) to switch to once-daily fixed-dose DTG/3TC or maintain B/F/TAF. The primary end point is the proportion with HIV-1 RNA ≥50 copies/mL at week 48 (Food and Drug Administration Snapshot algorithm, intention-to-treat exposed population, 6% noninferiority margin).

Results: Overall, 222 adults were randomized (16% women, 51% aged ≥50 years, 28% Black). At week 48, 6 (4%) with DTG/3TC and 5 (7%) with B/F/TAF had HIV-1 RNA ≥50 copies/mL (treatment difference, -2.8%; 95% CI, -11.4% to 3.1%), meeting noninferiority criteria. Through week 48, 18 participants (12 with DTG/3TC, 6 with B/F/TAF) met confirmed virologic withdrawal (CVW) criteria, and 2 of 18 had resistance: 1 with B/F/TAF developed M184M/I and G140G/S at week 12, and 1 with DTG/3TC had M184V at week 12. One participant with DTG/3TC and non-CVW developed M184V and K65R at week 12. Drug-related adverse events (AEs) and withdrawals due to AEs occurred in 31 (21%) and 6 (4%) participants with DTG/3TC and 2 (3%) and 0 participants with B/F/TAF, respectively.

Conclusions: Switching to DTG/3TC was noninferior to continuing B/F/TAF among adults with virologic suppression at week 48. Drug-related AEs and withdrawals were higher in the DTG/3TC arm, which is likely consistent with the open-label nature of this switch study.

Keywords: bictegravir/emtricitabine/tenofovir alafenamide; dolutegravir/lamivudine; randomized clinical trial; switch study; virologically suppressed.

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Conflict of interest statement

Potential conflicts of interest. C.-P. Rolle received research grants and honoraria from Gilead Sciences, ViiV Healthcare, and Janssen Infectious Diseases during the conduct of this study. F. H. received honoraria from Gilead Sciences, Merck, and AbbVie during the conduct of this study. E. D. received honoraria from Gilead Sciences during the conduct of this study. All other authors report no potential conflicts.

Figures

Figure 1.
Figure 1.
Study participant disposition. Abbreviations: 3TC, lamivudine; B, bictegravir; DTG, dolutegravir; F, emtricitabine; TAF, tenofovir alafenamide.
Figure 2.
Figure 2.
Virologic outcomes at week 48 by Food and Drug Administration Snapshot analysis. Abbreviations: 3TC, lamivudine; B, bictegravir; DTG, dolutegravir; F, emtricitabine; ITT-E, intention to treat exposed; TAF, tenofovir alafenamide.
Figure 3.
Figure 3.
Mean change from baseline in renal and metabolic parameters at week 48. Data are presented as mean change (standard deviation). Abbreviations: 3TC, lamivudine; B, bictegravir; DTG, dolutegravir; eGFR, estimated glomerular filtration rate; F, emtricitabine; HDL, high-density lipoprotein; LDL, low-density lipoprotein; ns, not significant; TAF, tenofovir alafenamide.
See this image and copyright information in PMC

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