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Gender Differences in Nevirapine Rash
SJ BERSOFF-MATCHA*1, WC MILLER2, C VAN DER HORST2, HJ HAMRICK JR2, D GASE1, WG POWDERLY1, LM MUNDY1 1Washington University School of Medicine, St. Louis, MO and 2University of North Carolina, Chapel Hill, NC
Background: Severe rash was observed in 3% of patients taking nevirapine in clinical trials, but the majority of these participants were men (85%). In our clinics, we observed more frequent severe adverse events (SAEs) in women treated with nevirapine. The purpose of this study was to determine if there is a gender difference in SAEs with this drug. Methods: We conducted a retrospective cohort study using medical records for all patients who received nevirapine at two institutions between 9/93 and 8/98. Demographic data, CD4 counts, concurrent medical therapies, and SAEs were extracted. All rashes observed within the first 90 days of nevirapine initiation were recorded and graded according to the ACTG scale. Results: The study population (N=264) included 85 women (32%) and 179 men (68%). Women were younger (mean age 34 years for women vs. 40 years for men) and more likely to be African American (women 81%; men 50%). Women had higher mean CD4 counts 316/mm3 (range 3-1413/mm3) compared to 203/mm3 (range 1-1360/mm3) for the men and were less likely to be taking opportunistic infection (OI) prophylaxis (women 55% vs. men 82%). Overall, 26 patients (9.8%) developed a rash while taking nevirapine, of whom 12 were women (14%) and 14 were men (8%), p=0.12. Mild rashes (Grades 1-2) were seen in 4 women and 13 men, p=0.43, whereas severe rashes (Grades 3-4) were seen in 8 women and 1 man (RR=16.8, 99% CI 2.1 - 132.5, p=0.0006). In other bivariate analyses, severe rash was also associated with higher CD4 counts (p=0.03), but was not associated with age, race or other medications. Conclusions: Although this study is limited by sample size, SAEs to nevirapine were significantly more frequent in the women in this cohort. These results emphasize the importance of analyzing gender differences in the evaluation of new medications for HIV infection.
Key Words: Nevirapine, Rash, Gender