Safety and tolerability of nevirapine-based antiretroviral therapy in HIV-infected patients receiving fluconazole for cryptococcal prophylaxis: a retrospective cohort study.

BACKGROUND: To compare the adverse events after initiation of NVP-based ART among HIV-infected patients who did not receive fluconazole (group A), received fluconazole 400 mg/week (group B), and received fluconazole 200 mg/day (group C). METHODS: A retrospective cohort study was conducted among HIV-infected patients who began NVP-based ART between December 2003 and September 2004. Patients were followed up for 6 months. Clinical hepatitis, elevated aspartate aminotransferase (AST) and alanine aminotransferase (ALT) (> 3 times from baseline), and skin rashes were studied. RESULTS: There were 686 patients; 225, 392, and 69 patients in group A, B, and C, respectively. Baseline characteristics including age, previous opportunistic infections, use of antituberculous drugs, and baseline aminotransferase levels among the three groups were similar. Group C had a higher proportion of men (p = 0.016). Baseline median (IQR) CD4 cell counts were 85 (21-159), 18 (7-48), and 16 (5-35) cell/mm3 in group A, B, and C, respectively (p < 0.001). Of 2/225 (0.9%), 4/392 (1.0%), and 0/69 (0%) patients in group A, B, and C developed clinical hepatitis (p = 0.705). There were no significant difference of elevated AST or ALT among the three groups (p > 0.05). By logistic regression, receiving fluconazole was not predictive of clinical hepatitis, elevated aminotransferase, or skin rashes. At 6 months after initiating NVP, 174 (77.3%) patients in group A, 309 (78.8%) patients in group B, and 58 (84.1%) patients in group C remained on NVP. CONCLUSION: Initiation of NVP-based ART among Thais with advance HIV disease receiving fluconazole is safe and well-tolerated. NVP should not be contraindicated for patients receiving fluconazole for treatment or prophylaxis of cryptococcosis.