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Hepatic Safety of Injectable Extended-Release Naltrexone in Patients With Chronic Hepatitis C and HIV Infection

Mack C. Mitchell, Asli Memisoglu, Bernard L. Silverman

Objective: Naltrexone (Revia, Vivitrol) is recognized as having the potential for hepatotoxicity. We evaluated the safety of intramuscular extended-release naltrexone (XR-NTX) in a cohort of patients with a high prevalence of chronic hepatitis C virus (HCV) and HIV infection undergoing treatment for opioid dependence. Method: A total of 250 (88% male) opioid-dependent patients were randomized to receive monthly injections of XR-NTX 380 mg or placebo. Of the 250 subjects, 222 (88.8%) had a history of HCV; 42% were positive for HIV. Liver chemistry tests for aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, gamma-glutamyl aminotransferase (GGT), alkaline phosphatase, serum albumin, and total protein were obtained at the screening visit, at baseline, and monthly for up to 6 months. Results: In a longitudinal analysis, the frequency of elevations in AST, ALT, and GGT greater than three times the upper limit of normal (ULN) was not statistically different in patients treated with XR-NTX compared with placebo (p = .71). Most of the elevations greater than three times the ULN occurred in patients with chronic HCV infection. In patients who had a treatment-emergent elevation in AST or ALT greater than three times the ULN, the aminotransferases improved and returned toward baseline in those patients with available follow-up data. No specific symptoms were associated with any of the elevations in ALT, AST, or GGT. The frequency of elevations in AST and ALT during treatment in patients with HIV infection was not significantly different compared with that in patients without HIV infection. Conclusions: XR-NTX can be used safely in eligible patients with opioid dependence, including those with underlying mild to moderate chronic HCV and/or HIV infections. (J. Stud. Alcohol Drugs, 73, 991997, 2012)