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Raltegravir vs efavirenz in antiretroviral-naive pregnant women living with HIV (NICHD P1081): An open-label, randomised, controlled, phase 4 trial

The Lancet HIV May 09, 2020

João EC, Morrison RL, Shapiro DE, et al. - Researchers investigated the safety and efficacy of antiretroviral therapy with raltegravir vs efavirenz in late pregnancy via performing an open-label, randomized controlled trial at 19 hospitals and clinics in Argentina, Brazil, South Africa, Tanzania, Thailand, and the USA. Enrollment of 408 women was done (206 raltegravir, 202 efavirenz); of these, 394 delivered on-study (200 raltegravir, 194 efavirenz); 307 were included in the primary efficacy analysis (153 raltegravir, 154 efavirenz). Findings support the US Perinatal HIV Guidelines Panel recommending the integrase inhibitors raltegravir and dolutegravir as preferred regimens for use during pregnancy due to their efficacy, tolerance, and pharmacokinetic profiles. Currently, the integrase inhibitor dolutegravir is a favored regimen for limiting perinatal HIV transmission with raltegravir recommended as a preferred or alternative integrase inhibitor for pregnant women living with HIV.

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