Abstract
Zidovudine (ZDV) therapy during pregnancy and to the neonate reduced perinatal HIV transmission by nearly 70% in Pediatric AIDS Clinical Trials Group (PACTG) protocol 076. ZDV has been reported as positive in several in vitro carcinogenicity screening tests. We evaluated the short-term risk for tumors in 727 children with known ZDV exposure enrolled into the PACTG 076/219 and the Women and Infants Transmission Study (WITS). ZDV exposure in utero (antepartum) occurred in 97% and 99% of infants in PACTG 076/219 or WITS, respectively. Mean follow-up was 38.3 months with 366.9 person years follow-up for PACTG 076/219 and 14.5 months with 743.7 person years follow- up for WITS. No tumors of any nature were observed; relative risk was 0 (95% confidence interval [CI], 0-17.6). These data are reassuring regarding the short-term lack of tumors for ZDV-exposed infants observed to date. Longitudinal, standardized follow-up for infants with in utero antiretroviral exposure is necessary to assess long-term carcinogenicity.
Original language | English |
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Pages (from-to) | 463-467 |
Number of pages | 5 |
Journal | Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology |
Volume | 20 |
Issue number | 5 |
DOIs | |
State | Published - 15 Apr 1999 |
Keywords
- Carcinogenesis
- Perinatal HIV transmission
- Perinatal HIV transmission prophylaxis
- Zidovudine