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.
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.
Department of Pediatrics, State University of New York Upstate Medical University, Syracuse, Syracuse, NY 13210, USA. cunningc@mail.upstate.edu
Coleen K
CK
Cunningham
Marie-Laure
ML
Chaix
Claire
C
Rekacewicz
Paula
P
Britto
Christine
C
Rouzioux
Richard D
RD
Gelber
Alejandro
A
Dorenbaum
Jean Francois
JF
Delfraissy
Brigitte
B
Bazin
Lynne
L
Mofenson
John L
JL
Sullivan
D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy* / Q000517:prevention & control; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D001483:Base Sequence; D024882:Drug Resistance, Viral / Q000235:genetics*; D005260:Female; D015497:HIV-1 / Q000235:genetics*; D006801:Humans; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D008969:Molecular Sequence Data; D009154:Mutation; D019829:Nevirapine / Q000627:therapeutic use*; D010802:Phylogeny; D049590:Postpartum Period; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D012367:RNA, Viral / Q000097:blood; D020133:Reverse Transcriptase Polymerase Chain Reaction
D019380:Anti-HIV Agents; D012367:RNA, Viral; D019829:Nevirapine