The IMPAACT Network is pleased to announce the antepartum results from the PROMISE Breastfeeding and Formula Feeding Versions (1077BF and 1077FF) were published in the New England Journal of Medicine (NEJM). This part of the PROMISE study demonstrated that triple antiretroviral (ARV) regimens evaluated in the study were superior to the single ARV based regimen for prevention of perinatal transmission during pregnancy and immediately postpartum. This manuscript expands on the early results presented at CROI 2015.
This part of the PROMISE study, which began in 2011 and completed follow-up in September 2016, aimed to determine how best to safely reduce the risk of HIV transmission from infected pregnant women to their babies during pregnancy. The study enrolled more than 3,500 HIV-infected pregnant or postpartum women who did not meet national criteria for receiving anti-HIV treatment and more than 3,200 HIV-exposed infants of these women in India, Malawi, South Africa, Tanzania, Uganda, Zambia and Zimbabwe. In the antepartum component, women were randomly assigned to one of three regimens: zidovudine plus intrapartum single-dose nevirapine with 6 to 14 days of tenofovir and emtricitabine postpartum (zidovudine alone); zidovudine, lamivudine, and lopinavir–ritonavir (zidovudine-based ART); or tenofovir, emtricitabine, and lopinavir–ritonavir (tenofovir-based ART). All regimens were continued through 6 to 14 days postpartum.
The results demonstrated efficacy of triple-drug ART for preventing transmission among HIV-infected pregnant women with high CD4 counts. All three regimens studied had a transmission rate of less than 2%, but the ART regimens had significantly lower rates of transmission than zidovudine alone (0.5% vs. 1.8%). However, both ART regimens were associated with higher rates of adverse events than zidovudine alone.
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Other results from the PROMISE studies presented at AIDS 2016 may be found here.