Development of Resistance Mutations in Women Receiving Standard Antiretroviral Therapy Who Received Intrapartum Nevirapine to Prevent Perinatal Human Immunodeficiency Virus Type 1 Transmission: A Substudy of Pediatric AIDS Clinical Trials Group Protocol 316

• Published in: The Journal of infectious diseases Vol. 186; no. 2; pp. 181 - 188
• Main Authors: Cunningham, Coleen K., Chaix, Marie-Laure, Rekacewicz, Claire, Britto, Paula, Rouzioux, Christine, Gelber, Richard D., Dorenbaum, Alejandro, Delfraissy, Jean Francois, Bazin, Brigitte, Mofenson, Lynne, Sullivan, John L.
• Format: Journal Article
• Language: English
• Published: Chicago, IL The University of Chicago Press 15.07.2002; University of Chicago Press
• Subjects: Acquired Immunodeficiency Syndrome - drug therapy; Acquired Immunodeficiency Syndrome - prevention & control; AIDS; Anti-HIV Agents - therapeutic use; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antiretrovirals; Antiviral agents; Base Sequence; Biological and medical sciences; Disease transmission; Dosage; Drug Resistance, Viral - genetics; Female; Genetic mutation; HIV; HIV 1; HIV-1 - genetics; Human viral diseases; Humans; Infectious Disease Transmission, Vertical - prevention & control; Infectious diseases; Major Articles; Medical sciences; Molecular Sequence Data; Mutation; Nevirapine - therapeutic use; Pharmacology. Drug treatments; Phylogeny; Postpartum Period; Pregnancy; Pregnancy Complications, Infectious - drug therapy; Reverse Transcriptase Polymerase Chain Reaction; RNA; RNA, Viral - blood; Viral diseases; Viral diseases of the lymphoid tissue and the blood. Aids; Viruses; Women; Human; Immunopathology; Chemoprophylaxis; Nevirapine; HIV-1 virus; Non nucleoside compound; Transmission; Retroviridae; AIDS; Immune deficiency; Lentivirus; Infection; Virus; Pregnancy; Prevention; Resistance; Newborn; Viral disease; Antiviral; Female; Vertical transmission; Human immunodeficiency virus; Delivery; Mutation
• ISSN: 0022-1899; 1537-6613
• DOI: 10.1086/341300

Pediatric AIDS Clinical Trials Group protocol 316 was an international, multicenter, placebo-controlled trial comparing single-dose oral nevirapine (200 mg to mother and 2 mg/kg to infant) with placebo in human immunodeficiency virus (HIV)–infected pregnant women receiving standard antiretroviral therapy. This substudy evaluated the emergence of nevirapine-resistance mutations at 6 weeks postpartum in a subgroup of participants. Maternal risk factors for the emergence of nevirapine-resistance mutations were evaluated. Mutations associated with nevirapine resistance were detectable at delivery, prior to receipt of study drug, in 5 (2.3%) of 217 women. Fourteen (15%; 95% confidence interval, 8%–23%) of 95 women who received intrapartum nevirapine developed a nevirapine-resistance mutation 6 weeks postpartum. The most common mutation was K103N, which was present in 10 women. The risk for development of a new nevirapine-resistance mutation did not correlate with CD4 cell count or HIV-1 RNA load at delivery or with type of antepartum antiretroviral therapy. The risk of nevirapine resistance should be considered when determining the risks or benefits of intrapartum nevirapine in women receiving antepartum antiretroviral therapy