We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Switching to DTG/3TC Is non-inferior to continuing current antiretroviral regimen at week 48: SALSA subgroup analyses.
- Authors
Taylor, Stephen; Federico Andrade-Villanueva, Jaime; Kaplan, Richard; Nahass, Ronald; Hocqueloux, Laurent; Scholten, Stefan; Di Giambenedetto, Simona; Galera, Carlos; Blair, Libby; Wynne, Brian; Oyee, James; Underwood, Mark; Curtis, Lloyd; Bontempo, Gilda; Kwon, Sungshin; van Wyk, Jean
- Abstract
배경 In the SALSA study (ClinicalTrials.gov identifier, NCT04021290), switching to DTG/3TC was non-inferior to continuing a virologically suppressive current antiretroviral regimen (CAR) in maintaining virologic suppression at Week 48, with a safety profile consistent with the DTG and 3TC labels. We evaluated Snapshot virologic response at Week 48 by baseline regimen third agent class and disease and demo- graphic characteristics in SALSA. 방법 SALSA is a phase 3, randomized, controlled, open-label study of participants with HIV-1 RNA <50 c/mL for >6 months on a stable 3- or 4-drug regimen for ≥3 months, without prior virologic failure or NRTI or DTG resistance-associated mutations. Participants were randomized 1:1 (stratified by baseline third agent class) to switch to DTG/3TC or continue CAR for 52 weeks. Primary endpoint was proportion of participants with plasma HIV-1 RNA ≥50 c/mL at Week 48 (Snapshot algorithm, intention-to-treat-ex- posed [ITT-E] population, 5% non-inferiority margin). 결과 Overall, 493 participants were randomized to receive DTG/3TC (N=246) or CAR (N=247). Among all participants, 59% were White; 39% were women; 39% were aged ≥50 years; and 50%, 40%, and 10% were taking NNRTIs, INSTIs, and PIs at baseline, respectively. DTG/3TC was non-inferior to continuing CAR at Week 48 using Snapshot virologic failure (DTG/3TC, 0.4%; CAR, 1.2%; adjusted treatment difference [95% CI], −0.8% [−2.4%, 0.8%]), and results were consistent with the Snapshot virologic response analysis (DTG/3TC, 94.3%; CAR, 92.7%; adjusted treatment difference [95% CI], 1.6% [−2.8%, 5.9%]). Snapshot virologic response rates across subgroups were generally consistent with the overall analysis and were similar between treatment groups (Figure). No confirmed virologic withdrawals or observed resistance occurred in either group. 결론 Switching to DTG/3TC from prior suppressive CAR is effective at maintaining virologic suppression in individuals across a broad spectrum of demographic and disease characteristics regardless of baseline regimen. Data included in this abstract have previously been presented in full at 18th European AIDS Conference; October 27-30, 2021; Virtual and London, UK; Poster PE2/72.
- Subjects
LONDON (England); SUBGROUP analysis (Experimental design); DEMOGRAPHIC characteristics; AIDS; HIV
- Publication
Infection & Chemotherapy, 2022, Vol 54, pS298
- ISSN
2093-2340
- Publication type
Article