Liver Toxicity of Initial Antiretroviral Drug Regimens Including Two Nucleoside Analogs Plus One Non-Nucleoside Analog or One Ritonavir-Boosted Protease Inhibitor in HIV/HCV-Coinfected Patients

Objective: To evaluate the incidence and risk factors for grade 3 or 4 ALT or AST elevations (TE) and grade 4 total bilirubin elevations (TBE) among HIV/HCV-coinfected treatment-naive patients with an initial regimen including 2 nucleoside analogs plus efavirenz (EFV), nevirapine (NVP), or a ritonavir-boosted protease inhibitor (PI/r). Patients and Methods: This was a retrospective multicenter observational cohort study that recruited 745 HIV-infected drug-naive patients with detectable plasma HCV RNA who started a regimen including EFV, NVP, or PI/r. Results: EFV was prescribed in 323 (43%), NVP in 126 (17%), and a PI/r in 296 (40%) patients. Grade 3 or 4 TE were observed in 19 (5.9%) individuals receiving EFV compared with 14 (11%) on NVP (P = .056) and 31(10.5%) on PI/r (P = .036). Grade 4 TBE were identified in 7(2.2%) patients on EFV, 1(0.8%) on NVP, and 11(3.7%) on PI/r (P = .19). Therapy was discontinued due to liver toxicity in 13 (4%) patients on EFV, 16 (13%) on NVP, and 17 (6%) on PI/r (P = .003). Conclusions: Regimens including EFV, NVP, or PI/r are generally safe in treatment-na ve HIV/HCV-coinfected patients. Grade 3-4 TE are less commonly seen with EFV than with PI/r. Discontinuations due to hepatotoxicity were less frequent for patients receiving EFV than for those treated with NVP.