Once-daily dolutegravir versus darunavir plus cobicistat in adults at the time of primary HIV-1 infection: the OPTIPRIM2-ANRS 169 randomized, open-label, Phase 3 trial

• Published in: Journal of antimicrobial chemotherapy 2022-08, Vol.77 (9), p.2506-2515
• Main Authors: Chéret, Antoine, Bauer, Rebecca, Meiffrédy, Vincent, Lopez, Pauline, Ajana, Faïza, Lacombe, Karine, Morlat, Philippe, Lascoux, Caroline, Reynes, Jacques, Calin, Ruxandra, Abel, Sylvie, Goujard, Cécile, Rouzioux, Christine, Avettand-Fenoel, Véronique, Meyer, Laurence
• Format: Article
• Language: English
• Subjects: Life Sciences
• ISSN: 0305-7453; 1460-2091
• DOI: 10.1093/jac/dkac207

BACKGROUNDWhether integrase strand transfer inhibitors (INSTIs) can decrease HIV-1 DNA levels more rapidly than boosted PIs during primary HIV-1 infection (PHI) is unknown. We hypothesized that once-daily dolutegravir/tenofovir/emtricitabine could reduce the viral reservoir through rapid viral replication control further than once-daily darunavir/cobicistat/tenofovir/emtricitabine. METHODSThe OPTIPRIM2-ANRS 169 study was a randomized (1:1), open-label, multicentre trial in adults with ≤5 or ≤3 HIV antibodies detected, respectively, by western blot or immunoblot in the last 10 days. The primary endpoint was total HIV-1 DNA levels in PBMCs at Week 48 (W48) adjusted for baseline levels. The main secondary endpoint was HIV-1 RNA level decrease. RESULTSBetween April 2017 and August 2018, 101 patients were included from 31 hospitals. Most patients were men (93%), the median age was 36 years and 17% were Fiebig stage ≤3. The median (IQR) plasma HIV-1 RNA and DNA levels were, respectively, 5.8 (5.0-6.6) and 3.87 (3.52-4.15) log10 copies/million PBMCs. The median (IQR) decreases in HIV-1 DNA levels at W48 were -1.48 (-1.74 to -1.06) and -1.39 (-1.55 to -0.98) log10 copies/million PBMCs in the dolutegravir and darunavir/cobicistat groups, respectively (P = 0.52). Plasma HIV-1 RNA levels were