Cox- multivariate regression analysis showed that positive HCV Ab test (aHR = 4.4, 95% CI 1.5–13) and CD4 count < 50 cells/μL (aHR = 2, 95% CI 1.2–3.2) were independent predictors of grade 3 or 4 hepatotoxicity when adjusted for the study randomization week, sociodemographic variables, BMI and serum albumin levels. The gene discussed is CD4; the disease is hepatotoxicity.