Safety of HIV-1 Perinatal Transmission Prophylaxis With Zidovudine and Nevirapine in Rural South India

Abstract

Background: The authors assessed acceptance and safety of, and adherence to, perinatal HIV-1 transmission prophylaxis at 2 public hospitals in rural Tamil Nadu, India.

Methods: Eligible HIV-1-infected women were offered zidovudine (ZDV) beginning at 28-weeks gestation until delivery. Their infants received ZDV for 6 weeks. A subsequent revision to the protocol added 1 dose of nevirapine (NVP) for mother and infant.

Results: Sixty of 67 women (90%) met inclusion criteria for the cohort study. Thirty-four of 36 eligible women and all 19 eligible live born infants received prophylaxis on study. Infant, but not maternal, adherence to ZDV varied by antiretroviral prophylaxis group (those receiving combined prophylaxis with ZDV and NVP had lower median adherence) (P = .02). Neutropenia (usually transient) was the most common severe adverse event. Only 1 of 5 women with neutropenia possibly related to ZDV permanently discontinued ZDV. ZDV was not discontinued for any infant.

Conclusion: With the exception of neutropenia, usually transient and always without clinical consequences, long-term ZDV (with or without NVP prophylaxis) is well tolerated.