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


CONCLUSIONS
With the exception of neutropenia, usually transient and always without clinical consequences, long-term ZDV (with or without NVP prophylaxis) is well tolerated.
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Jennifer S
JS
Pediatric, Adolescent, and Maternal AIDS Branch, National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland 20892-7510, USA. jennifer_read@nih.gov
Samuel
N M
NM
Parameshwari
S
S
Dharmarajan
Shoba
S
Van Hook
Hannah M
HM
Jacob
S Mini
SM
Junankar
Viju
V
Bethel
James
J
Xu
Jiahong
J
Stoszek
Sonia K
SK
D019380:Anti-HIV Agents / Q000627:therapeutic use; D015331:Cohort Studies; D005260:Female; D015658:HIV Infections / Q000188:drug therapy; D015497:HIV-1; D006801:Humans; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control; D019829:Nevirapine / Q000627:therapeutic use; D011247:Pregnancy; D015215:Zidovudine / Q000627:therapeutic use
D019380:Anti-HIV Agents; D015215:Zidovudine; D019829:Nevirapine