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- Title
Efficacy and Safety of Switching to Dolutegravir/ Lamivudine by Baseline Regimen in Virologically Suppressed Adults: 48-Week Pooled Analysis.
- Authors
Scholten, Stefan; Cahn, Pedro; Ruane, Peter; Kaplan, Richard; Portilla, Joaquín; Hodder, Sally; Bisshop, Fiona; Wynne, Brian R.; Grove, Richard; Bontempo, Gilda; Moodley, Riya; Jones, Bryn; Ait-Khaled, Mounir; Okoli, Chinyere; Gyo-Seung Gu
- Abstract
Background: Dolutegravir/Lamivudine (DTG/3TC) has durable efficacy and a high barrier to resistance, supporting its inclusion in international guidelines as a recommended INSTI-based regimen. We present pooled efficacy and safety outcomes among virologically suppressed adults switching to DTG/3TC by baseline regimen. Methods: This analysis includes 48-week data from the phase 3 TANGO and SALSA trials of adults with HIV-1 RNA <50 c/mL randomized to switch to once-daily DTG/3TC fixed-dose combination or continue current antiretroviral regimen (CAR). Primary and key secondary endpoints were proportions with HIV-1 RNA ≥50 and <50 c/mL at Week 48, respectively (Snapshot, intention-to-treat exposed). Results: Among 1234 participants, the most commonly used baseline third agent class and NRTI backbone were INSTIs (63%) and TAF/FTC (74%), respectively. Overall, at Week 48, few participants had HIV-1 RNA ≥50 c/mL (adjusted difference, −0.5; 95% CI, −1.3, 0.4); results were consistent across baseline regimen subgroups. High proportions of participants maintained HIV-1 RNA <50 c/mL in the DTG/3TC and CAR groups across baseline regimen use (Table). No DTG/3TC participants had confirmed virologic withdrawal (CVW); 1 CAR participant had CVW (no resistance detected). In the overall analysis, proportions of any adverse events (AEs) and grade 2-5 AEs were similar between treatment groups, with few AEs leading to withdrawal or serious AEs; drug-related AEs were more frequent in the DTG/3TC group, as expected in stable switch studies. Similar results were observed by baseline regimen use. Conclusion: DTG/3TC maintained high proportions of virologic suppression, had a high barrier to resistance, and demonstrated a good safety and tolerability profile 1 year after switch regardless of prior 3-/4-drug regimen use, supporting this 2-drug regimen as a robust, well-tolerated switch option with fewer antiretrovirals.
- Subjects
LAMIVUDINE; ADULTS; HIV; RNA; DOLUTEGRAVIR
- Publication
Infection & Chemotherapy, 2022, Vol 54, p271
- ISSN
2093-2340
- Publication type
Article