Lack of tumors in infants with perinatal HIV-1 exposure and fetal/neonatal exposure to zidovudine

• Published in: Journal of acquired immune deficiency syndromes and human retrovirology Vol. 20; no. 5; pp. 463 - 467
• Main Authors: HANSON, I. C, ANTONELLI, T. A, MOFENSON, L, SHAPIRO, D. E, SPERLING, R. S, OLESKE, J. M, COOPER, E, CULNANE, M, FOWLER, M. G, KALISH, L. A, LEE, S. S, MCSHERRY, G
• Format: Journal Article
• Language: English
• Published: New York, NY Raven Press 15-04-1999
• Subjects: Anti-HIV Agents - therapeutic use; Antimetabolites, Antineoplastic - therapeutic use; Antineoplastic agents; Biological and medical sciences; Chemotherapy; Female; Follow-Up Studies; HIV Infections - drug therapy; HIV Infections - physiopathology; HIV Infections - transmission; HIV-1; Human immunodeficiency virus; Human viral diseases; Humans; Infant; Infant, Newborn; Infectious Disease Transmission, Vertical; Infectious diseases; Male; Medical sciences; Neoplasms - prevention & control; Perinatal Care; Pharmacology. Drug treatments; Pregnancy; Prospective Studies; Reverse Transcriptase Inhibitors - therapeutic use; Viral diseases; Viral diseases of the lymphoid tissue and the blood. Aids; Zidovudine - therapeutic use; Antineoplastic agent; Human; Immunopathology; HIV-1 virus; Retroviridae; AIDS; Immune deficiency; Lentivirus; Biological activity; Infection; Virus; Pregnancy; Prevention; Chemotherapy; Newborn; Treatment; Viral disease; Dideoxynucleoside; Antiviral; Female; Vertical transmission; Human immunodeficiency virus; Pyrimidine nucleoside; Zidovudine
• ISSN: 1077-9450; 2331-6993
• DOI: 10.1097/00042560-199904150-00008

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.