Extended prophylaxis with nevirapine and cotrimoxazole among HIV-exposed uninfected infants is well tolerated

Jim Aizire, Mary Glenn Fowler, Jing Wang, Avinash K. Shetty, Lynda Stranix-Chibanda, Moreen Kamateeka, Elizabeth R. Brown, Steve G. Bolton, Philippa M. Musoke, Hoosen Coovadia

Research output: Contribution to journalArticlepeer-review

9 Citations (Scopus)

Abstract

Objective: Nevirapine and cotrimoxazole are associated with hematologic toxicities and skin-rash. Safety of their concurrent use for prophylaxis over extended periods among HIV-exposed uninfected infants has not been previously assessed. Design: Secondary data analysis of the 'HIV Prevention Trials Network-046 protocol' (version 2.0), a phase-III, randomized, placebo-controlled trial that assessed efficacy and safety of nevirapine prophylaxis against breast milk transmission of HIV-1. Methods: Trial infants received 6-month study nevirapine/placebo, and standard-of-care peripartum single-dose nevirapine+/- zidovudine 'tail', and cotrimoxazole prophylaxis from 6 weeks through breastfeeding cessation. Adverse events were monitored using United States Division of AIDS Toxicity Tables (2004). Risk of neutropenia, anemia and skin-rash in the cotrimoxazole+nevirapine and the cotrimoxazole+placebo groups were compared using negative-binomial regression. Results: Incidence of neutropenia and/or anemia, and skin-rash was highest during the first 6 weeks of life and declined, thereafter, regardless of study group. Time to first adverse event after 6 weeks was similar in cotrimoxazole+nevirapine and cotrimoxazole+placebo groups: hazard ratio (95% confidence interval) was 1.26 (0.96-1.66) for neutropenia and/or anemia (all grades), 1.27 (0.80-2.03) for neutropenia and/or anemia (grade ≥3) and 1.16 (0.46-2.90) for skin-rash (grade ≥2). There were no statistically significant differences in immediate (6 weeks-6 months) and long-term (6-12 months) adverse event risk among infants on cotrimoxazole+nevirapine versus cotrimoxazole+placebo. Conclusion: Extended nevirapine and cotrimoxazole prophylaxis through 6 months of age among HIV-exposed uninfected infants did not appear to increase the immediate or long-term risk of neutropenia, anemia or skin-rash. Concurrent use beyond 6 months, however, needs to be evaluated.

Original languageEnglish
Pages (from-to)325-333
Number of pages9
JournalAIDS
Volume26
Issue number3
DOIs
Publication statusPublished - 28-01-2012
Externally publishedYes

All Science Journal Classification (ASJC) codes

  • Immunology and Allergy
  • Immunology
  • Infectious Diseases

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