Dolutegravir-based or low-dose efavirenz–based regimen for the treatment of HIV 1
New England Journal of Medicine Sep 05, 2019
The NAMSAL ANRS 12313 Study Group - Through an open-label, multicenter, randomized, phase 3 noninferiority trial in Cameroon involving 613 individuals, researchers contrasted the efficiency and safety of a dolutegravir-based regimen with those of an efavirenz (400 mg; EFV400)-based regimen, with viral-load monitoring performed according to WHO recommendations. In 3 individuals in the dolutegravir group (with none acquiring drug-resistance mutations) and in 16 individuals in the EFV400 group, virologic failure (a viral load of > 1,000 copies per milliliter) was noted. More weight gain was observed in the dolutegravir group vs EFV400 group. Relative to viral suppression at week 48, a dolutegravir-based regimen was non-inferior to an EFV400-based reference regimen in HIV-1–infected adults in Cameroon. Moreover, among individuals with a viral load of at least 100,000 copies per milliliter when antiretroviral therapy was started, fewer participants than expected had viral suppression.
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