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Third-Trimester Maternal Toxicity With Nevirapine Use in Pregnancy

From the ¹Department of Obstetrics and Gynecology, ²Pharmacy Practice and Administration, ³Department of Pediatrics, and ⁴Division of Infectious Diseases, Colleges of Medicine and Pharmacy, Ohio State University, Columbus, Ohio.

OBJECTIVE: Nevirapine-based therapy is associated with increased frequency of adverse events among women with CD4⁺ cell count of 250 cells/µL or greater. We evaluated the safety of nevirapine-based antiretroviral therapy in human immunodeficiency virus (HIV)-1-infected pregnant women.

METHODS: We retrospectively evaluated 23 pregnancies managed with nevirapine-based regimens from July 2001 to April 2005. The incidence of adverse events was determined and analyzed by CD4⁺ cell count of either less than or greater than or equal to 250 cells/µL, and gestational age when nevirapine was initiated. Liver function abnormality was graded according to the National Institute of Allergy and Infectious Diseases Division of AIDS toxicity guidelines.

RESULTS: Five of 23 patients (21.7%) started nevirapine-based therapy after 27 weeks of gestation. All 3 cases of adverse events occurred in this group within 6 weeks of initiating therapy and with CD4⁺ cell count greater than 250 cells/µL. A significant difference was noted in the proportion of patients who developed toxicity while starting nevirapine in the third trimester (3/5, 60%; 95% confidence interval 14.66–94.73) compared with those starting nevirapine earlier in pregnancy (0/18, 0%; 95% confidence interval 0.0–18.53; P < .006). Two patients developed rash, eosinophilia, and liver function abnormality, with one developing clinical hepatitis and renal failure. A third patient had abnormal elevation of liver enzymes but was asymptomatic.

CONCLUSION: The incidence of adverse events with nevirapine may be lower than previously reported (13% versus 29%) and may be primarily noted with initiating the drug late in pregnancy. Further study of nevirapine in larger cohorts of HIV-infected pregnant women is warranted to determine the relationship between nevirapine hepatotoxicity and trimester use.

LEVEL OF EVIDENCE: II-3