Résumé
Background: The updated WHO 2019 guidelines for ARV treatment recommend a Dolutegravir (DTG)-based regimen as the preferred first-line regimen and low-dose Efavirenz (EFV400) as an alternative option. The non-inferior efficacy of DTG compared with EFV400 was prevoiously reported at W48. We report here the W96 data.Methods: NAMSAL is a phase 3 randomized, open label, multicentre trial conducted in Yaoundé. HIV-1 infected ARV-naive adults with HIV-RNA viral load (VL) > 1000 copies/mL were randomized (1:1) to DTG 50 mg or EFV 400 mg once daily, both with tenofovir disoproxil fumarate (TDF)/lamivudine (3TC). Randomization was stratified by screening VL and by site. The primary endpoint was the proportion of patients with VL < 50 copies/mL at W48 and extended at W96 (10% non-inferiority margin).Results: 613 participants (DTG arm: 310; EFV400 arm: 303) received at least one dose of study medication. In the ITT analysis at W96, the proportion of patients with HIV RNA < 50 copies/mL was 73.5% (228/310) and 72.3% (219/303) respectively (difference, 1.3%; 95% CI, -5.8 to 8.3; p-value < 0.001). Figure 1 shows the viral suppression according to Baseline VL. The per-protocol analysis showed similar results. Virological failure (WHO definition) was observed in 27 participants (DTG: 8; EFV400: 19), three were switched from DTG to EFV600 (May 2018 WHO signal). No resistance mutations to DTG was observed, unlike the EFV400 with 18 resistances (NNRTINRTI) in the 19 confirmed failure cases. Weight gain was greater in DTG arm (median weight gain: 5.0/3.0 Kg; incidence of obesity 12.3%/5.4%). 18 AE were observed (DTG: 8; EFV400: 10); one single participant in DTG arm had missing data.Conclusions: W96 results confirm the non-inferior efficacy of the DTG-based regimen and the no emergence of resistance to DTG. Virological success rate remains lower in patients with a high initial VL in both arms. We observed a continuous weight gain in the DTG arm.