Ethnicity, race, and gender - Differences in serious adverse events among participants in an antiretroviral initiation trial: Results of CPCRA 058 (FIRST study)

Differences in adverse events by gender and race/ethnicity have not been described extensively in randomized clinical trials of HIV antiretroviral therapy (ART). Methods: Antiretroviral-naive HIV-infected participants enrolled in a long-term randomized clinical trial of 3 different initial ART strategies-protease inhibitor (PI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or PI plus NNRTI-based combinations with a median follow-up of 5 years, were compared by gender and race for 14 categories of grade 4 adverse events, discontinuation of initial antiretroviral regimen, and all-cause mortality. Multivariate analysis was used to identify predictors of events and death. Results: Among 1301 participants with complete data, there were 701 blacks, 225 Latinos, and 263 women. Several base line characteristics differed by gender and race, including age, HIV transmission risk, hepatitis B or C coinfection, viral load, diagnosis of AIDS, body mass index, and baseline hypertension. Grade 4 events occurred in 409 participants (rate: 8.9/100 person-years). There were 176 deaths (rate: 3.0/100 person-years) and 523 discontinuations of regimen for any toxicity (rate: 13/100 person-years). In the fully adjusted regressions, blacks had greater risk for cardiovascular (hazard ratio [HR] = 2.64, 95% confidence interval [CI]: 1.04 to 6.67) and renal (HR = 3.83, 95% Cl: 1.28 to 11.5) events. Black men had more psychiatric events (HR = 2.45, 95% CI: 1.13 to 5.30). Women had a higher risk for anemia (HR = 2.34, 95% CI: 1.09 to 4.99). Conclusion: Among HIV-infected participants initiating ART, there were significant risk-adjusted differences for specific adverse events by gender and race but not in the overall adverse event rates, all-cause mortality, or rates of toxicity-related treatment discontinuations.