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Increased risk of hepatotoxicity in HIV-infected pregnant women receiving antiretroviral therapy independent of nevirapine exposure

Ouyang, David Wa; Shapiro, David Eb; Lu, Mingc; Brogly, Susan Bb; French, Audrey Ld; Leighty, Robert Mc; Thompson, Brucec; Tuomala, Ruth Ea; Hershow, Ronald Ce

doi: 10.1097/QAD.0b013e32832e34b1
Clinical Science: Concise Communication

Objective: To estimate whether the association between nevirapine (NVP) and hepatotoxicity differs according to pregnancy status in HIV-infected women.

Methods: The present analysis included HIV-infected pregnant women on antiretroviral therapy (ART) from two multicenter, prospective cohorts – the Women and Infants Transmission Study and the International Maternal Pediatric Adolescent AIDS Clinical Trials protocol P1025 – and HIV-infected nonpregnant women from one multicenter, prospective cohort – the Women's Interagency HIV Study. Using multivariate Cox proportional hazards regression, the interaction between NVP and pregnancy status in terms of hepatotoxicity was investigated. NVP use was dichotomized as use or no use and was further categorized according to ART exposure history. We investigated two outcomes: any liver enzyme elevation (LEE; grade 1–4) and severe LEE (grade 3–4).

Results: Data on 2050 HIV-infected women taking ART were included: 1229 (60.0%) pregnant and 821 (40.0%) nonpregnant. Among the pregnant women, 174 (14.2%) developed any LEE and 15 (1.2%) developed severe LEE as compared with 75 (9.1%) and 5 (0.6%), respectively, of the nonpregnant women. In multivariate adjusted models, NVP was not significantly associated with risk of LEE, regardless of pregnancy status; however, pregnancy was associated with an increased risk of any LEE (relative risk 4.7, confidence interval = 3.4–6.5) and severe LEE (relative risk 3.8, confidence interval = 1.3–11.1). The association of pregnancy and LEE was seen, regardless of prior ART and NVP exposure history.

Conclusion: No significant association between NVP and LEE was observed, regardless of pregnancy status, but pregnancy was significantly associated with increased hepatotoxocity in HIV-infected women.

aDivision of Maternal-Fetal Medicine, Brigham and Women's Hospital, USA

bCenter for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts, USA

cClinical Trials and Surveys Corporation, Baltimore, Maryland, USA

dCORE Center/Stroger Hospital of Cook County, USA

eUniversity of Illinois at Chicago School of Public Health, Chicago, Illinois, USA.

Received 20 January, 2009

Revised 11 May, 2009

Accepted 14 May, 2009

Correspondence to David W. Ouyang, MD, Assistant Professor, NorthShore University HealthSystem, Northwestern University Feinberg School of Medicine, 2650 Ridge Avenue, Evanston, IL 60201, USA. Tel: +1 847 570 2286; fax: +1 847 570 2910; e-mail:

© 2009 Lippincott Williams & Wilkins, Inc.