title: Incidence and risk factors of severe adverse events with nevirapine-based antiretroviral therapy in HIV-infected women. MTCT-Plus program, Abidjan, Côte d'Ivoire.
abstract: BACKGROUND
  In resource-limited settings where nevirapine-containing regimen is the preferred regimen in women, data on severe adverse events (SAEs) according to CD4 cell count are limited. We estimated the incidence of SAEs according to CD4 cell count and identify their risk factors in nevirapine-treated women.
  
  
  METHODS
  All HIV-infected women who initiated nevirapine-containing regimen in the MTCT-Plus operational program in Abidjan, Côte d'Ivoire, were eligible for this study. Laboratory and clinical (rash) SAEs were classified as grade 3 and 4. Cox models were used to identify factors associated with the occurrence of SAEs.
  
  
  RESULTS
  From August 2003 to October 2006, 290 women initiated a nevirapine-containing regimen at a median CD4 cell count of 186 cells/mm3 (IQR 124-266). During a median follow-up on treatment of 25 months, the incidence of all SAEs was 19.5/100 patient-years. The 24-month probability of occurrence of hepatotoxicity or rash was not different between women with a CD4 cell count >250 cells/mm3 and women with a CD4 cell count </=250 cells/mm3 (8.3% vs. 9.9%, Log-rank test: p = 0.75). In a multivariate proportional hazard model, neither CD4 cell count >250 cells/mm3 at treatment initiation nor initiation NVP-based regimen initiated during pregnancy were associated with the occurrence of SAEs.
  
  
  CONCLUSIONS
  CD4 cell count >250 cells/mm3 was not associated with a higher risk of severe hepatotoxicity and/or rash, as well as initiation of ART during pregnancy. Pharmacovogilance data as well as meta-analysis on women receiving NVP in these settings are needed for better information about NVP toxicity.
authors.affiliation: Programme MTCT-Plus, ACONDA, BP: 1954 Abidjan 18, Abidjan, Côte d'Ivoire.
authors.forename: Patrick A
authors.initials: PA
authors.lastname: Coffie
authors.forename: Besigin
authors.initials: B
authors.lastname: Tonwe-Gold
authors.forename: Aristophane K
authors.initials: AK
authors.lastname: Tanon
authors.forename: Clarisse
authors.initials: C
authors.lastname: Amani-Bosse
authors.forename: Gédéon
authors.initials: G
authors.lastname: Bédikou
authors.forename: Elaine J
authors.initials: EJ
authors.lastname: Abrams
authors.forename: François
authors.initials: F
authors.lastname: Dabis
authors.forename: Didier K
authors.initials: DK
authors.lastname: Ekouevi
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects*; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects* / Q000379:methods; D056486:Chemical and Drug Induced Liver Injury; D007560:Cote d'Ivoire; D005076:Exanthema / Q000139:chemically induced; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D015994:Incidence; D019829:Nevirapine / Q000009:adverse effects*; D012307:Risk Factors; D012720:Severity of Illness Index
chemical_list: D019380:Anti-HIV Agents; D019829:Nevirapine