title: Antiretroviral-associated toxicity among HIV-1-seropositive pregnant women in Mozambique receiving nevirapine-based regimens.
abstract: OBJECTIVE
  To assess toxicities associated with highly active antiretroviral therapy (HAART) among HIV-1-infected pregnant women treated with nevirapine-based regimens according to Mozambican national guidelines.
  
  
  METHODS
  Prospective cohort study.
  
  
  METHODS
  HIV-1-infected antiretroviral-naive pregnant women with CD4 counts < or =350 cells/microL were initiated on nevirapine, lamivudine, and stavudine or zidovudine and followed monthly. Severe hepatotoxicity was defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels > or =5-fold the upper limit of normal. Analyses were stratified by baseline CD4 count (<250 vs. 250-350 cells/microL).
  
  
  RESULTS
  Among 146 pregnant women, 75 (52%) began nevirapine, lamivudine, and zidovudine and 71 (48%) began nevirapine, lamivudine, and stavudine. Overall, 79 (54%) women had CD4 counts <250 cells/microL, 7 (5%) had grade II hepatotoxicity, and 4 (3%) had severe (grade III or IV) hepatotoxicity. All 4 women with severe hepatotoxicity had baseline CD4 counts > or =250 cells/microL (P = 0.02). Rates of skin toxicity, anemia, and peripheral neuropathy did not differ by CD4 cell count group. Overall, 12 (8%) women changed or discontinued HAART as a result of drug toxicity.
  
  
  CONCLUSIONS
  Severe hepatotoxicity from nevirapine-containing HAART in this cohort of pregnant women was more common at higher CD4 counts (6% vs. 0% among women with CD4 counts > or =250 cells/microL and CD4 counts <250 cells/microL, respectively), suggesting that laboratory monitoring is necessary when administering nevirapine-containing regimens to pregnant women with CD4 counts > or =250 cells/microL.
authors.affiliation: Ministry of Health, Maputo, Mozambique.
authors.forename: Lilia
authors.initials: L
authors.lastname: Jamisse
authors.forename: Jennifer
authors.initials: J
authors.lastname: Balkus
authors.forename: Jane
authors.initials: J
authors.lastname: Hitti
authors.forename: Steve
authors.initials: S
authors.lastname: Gloyd
authors.forename: Rolanda
authors.initials: R
authors.lastname: Manuel
authors.forename: Nafissa
authors.initials: N
authors.lastname: Osman
authors.forename: Martinho
authors.initials: M
authors.lastname: Djedje
authors.forename: Carey
authors.initials: C
authors.lastname: Farquhar
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000740:Anemia / Q000139:chemically induced; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects; D001219:Aspartate Aminotransferases / Q000097:blood; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy*; D006679:HIV Seropositivity / Q000188:drug therapy*; D015497:HIV-1 / Q000187:drug effects*; D006801:Humans; D007231:Infant, Newborn; D008099:Liver / Q000187:drug effects / Q000473:pathology; D009073:Mozambique; D019829:Nevirapine / Q000009:adverse effects / Q000627:therapeutic use*; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced; D011247:Pregnancy; D011446:Prospective Studies; D012867:Skin / Q000187:drug effects / Q000473:pathology; D016896:Treatment Outcome
chemical_list: D019380:Anti-HIV Agents; D019829:Nevirapine; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase