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Dolutegravir-based or low-dose efavirenz–based regimen for the treatment of HIV#6;1

New England Journal of Medicine Jul 29, 2019

Kouanfack C, et al. - Given concerns about side effects related to an efavirenz-based regimen (600-mg dose of efavirenz [EFV600]), the World Health Organization’s preferred first-line treatment for HIV type 1 (HIV-1) infection until June 2018, researchers undertook an open-label, multicenter, randomized, phase 3 noninferiority trial in Cameroon to assess dolutegravir-based and low-dose efavirenz–based combinations that have been considered as possible first-line treatments for HIV-1 in resource-limited settings. Random assignment of a total of 613 HIV-1 infected adults who had not received antiretroviral therapy and had an HIV-1 RNA level (viral load) of at least 1,000 copies per milliliter was done to receive either dolutegravir or the reference treatment of low-dose efavirenz (a 400-mg dose, known as EFV400), combined with tenofovir and lamivudine. Concerning viral suppression at week 48, dolutegravir-based regimen was identified as noninferior to an EFV400-based reference regimen in these patients. Viral suppression was achieved in fewer participants than expected among participants who had a viral load of at least 100,000 copies per milliliter when antiretroviral therapy was initiated.

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