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BACKGROUND: Adverse effects of combination antiretroviral therapy (CART) commonly result in treatment modification and poor adherence. METHODS: We investigated predictors of toxicity-related treatment modification during the first year of CART in 1318 antiretroviral-naive human immunodeficiency virus (HIV)-infected individuals from the Swiss HIV Cohort Study who began treatment between January 1, 2005, and June 30, 2008. RESULTS: The total rate of treatment modification was 41.5 (95% confidence interval CI, 37.6-45.8) per 100 person-years. Of these, switches or discontinuations because of drug toxicity occurred at a rate of 22.4 (95% CI, 19.5-25.6) per 100 person-years. The most frequent toxic effects were gastrointestinal tract intolerance (28.9%), hypersensitivity (18.3%), central nervous system adverse events (17.3%), and hepatic events (11.5%). In the multivariate analysis, combined zidovudine and lamivudine (hazard ratio HR, 2.71 95% CI, 1.95-3.83; P < .001), nevirapine (1.95 1.01-3.81; P = .050), comedication for an opportunistic infection (2.24 1.19-4.21; P = .01), advanced age (1.21 1.03-1.40 per 10-year increase; P = .02), female sex (1.68 1.14-2.48; P = .009), nonwhite ethnicity (1.71 1.18-2.47; P = .005), higher baseline CD4 cell count (1.19 1.10-1.28 per 100/microL increase; P < .001), and HIV-RNA of more than 5.0 log(10) copies/mL (1.47 1.10-1.97; P = .009) were associated with higher rates of treatment modification. Almost 90% of individuals with treatment-limiting toxic effects were switched to a new regimen, and 85% achieved virologic suppression to less than 50 copies/mL at 12 months compared with 87% of those continuing CART (P = .56). CONCLUSIONS: Drug toxicity remains a frequent reason for treatment modification; however, it does not affect treatment success. Close monitoring and management of adverse effects and drug-drug interactions are crucial for the durability of CART.
Luigia Elzi (Mon,) studied this question.