Evaluation of Real-World Antiviral Effectiveness and Sustainability of the 2-Drug Regimen Dolutegravir/Lamivudine Fixed-Dose Combination in Treatment-Naive and Pretreated People Living With HIV Who are Virologically Suppressed, in Routine Clinical Care in France: Results From the CARAVEL Study.

BACKGROUND: Despite demonstrated virological efficacy, real-world evidence on the long-term effectiveness of dolutegravir plus lamivudine (DTG/3TC) in people living with HIV (PLWH) remains limited; this study assessed effectiveness, examining immunological response, resistance and safety. METHODS: CARAVEL was a French, prospective, noninterventional, single-arm, multicenter, 3-year cohort study in treatment-naive PLWH (TN-PLWH) and pretreated PLWH (PT-PLWH) receiving DTG/3TC for the first time. RESULTS: Forty-nine centers enrolled 304 participants: 56 TN-PLWH and 248 PT-PLWH. Effectiveness was evaluable in 49 (87%) TN-PLWH and 234 (94%) PT-PLWH. Initial virological suppression was attained for 44 (89.8%) TN-PLWH after 6 months of initiating DTG/3TC, with a median time to virological suppression of 1.1 months (IQR 1.0 to 2.1), and no virological failure during the follow-up. After switching, 220 (94%) PT-PLWH maintained virological suppression. During the follow-up, 14 PT-PLWH did not maintain virological suppression: 5 due to intermittent viraemia, and 9 due to virological failure (VF). Among the 9 participants with VF, a genotypic resistance test was available for 3 participants of whom 1 developed 3TC resistance [M184V] in the context of nonadherence. DTG/3TC was discontinued in 63 participants, mainly at their request (N = 40, 64.5%), as well as tolerability and VF. The average change in body weight over the follow-up was +2.0 (±6.0) (P = .13) kg in TN-PLWH and -0.2 (±6.5) (P = .78) kg in PT-PLWH, among participants with available data (N = 156). CONCLUSIONS: These real-world data demonstrated high virological success and good safety after up to 3 years on DTG/3TC in both TN-PLWH and PT-PLWH populations.