Triple Antiretroviral Compared with Zidovudine and Single-Dose Nevirapine Prophylaxis During Pregnancy and Breastfeeding for Prevention of Mother-To-Child Transmission of HIV-1 (Kesho Bora study): a Randomized Controlled Trial

Replication paper
Original publication: The Lancet Infectious Diseases
Original researchers: The Kesho Bora Study Group
Current status: Unable to Replicate

The Original Study

Antiretroviral therapy is beneficial for both maternal health and reducing the risk of mother-to-child transmission of HIV-1 during pregnancy, delivery and breastfeeding. This study assesses the impact of administering triple antiretroviral compared with zidovudine compared to single-dose nevirapine prophylaxis in pregnant women infected with HIV on several outcomes. Outcomes of interest include rates of HIV-free infant survival at 6 weeks and 12 months, HIV-free survival at 12 months in infants who were ever breastfed, AIDS-free survival in mothers at 18 months and serious adverse events in mothers and babies. 882 pregnant women from three countries (Burkina Faso, Kenya and South Africa) with WHO stage 1, 2 or 3 HIV-1 infection who had CD4 cell counts of 200–500 cells per μL were randomly assigned to either triple antiretroviral prophylaxis or zidovudine and single-dose nevirapine. In order to determine the impact of triple antiretroviral, the authors used Student’s t test and χ² test in combination with the Kaplan–Meier method. The study finds that triple antiretroviral prophylaxis during pregnancy and breastfeeding is safe and reduces the risk of mother-to-child HIV transmission.