Bersoff-Matcha SJ, Miller WC, van der Horst C, Hamrick HJ JR, Gase D, Powderly WG, Mundy LM; Conference on Retroviruses and Opportunistic Infections.

Program Abstr 6th Conf Retrovir Oppor Infect Conf Retrovir Oppor Infect 6th 1999 Chic Ill. 1999 Jan 31-Feb 4; 6th: 196 (abstract no. 682).

Washington University School of Medicine, St. Louis, MO.

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.

Publication Types:

• Meeting Abstracts

Keywords:

• CD4 Lymphocyte Count
• Cohort Studies
• Exanthema
• Female
• HIV Infections
• Humans
• Male
• Nevirapine
• Retrospective Studies
• Sex Characteristics

Other ID:

• 20711916

UI: 102195446

From Meeting Abstracts