Injectable Extended-Release Naltrexone Is Not Associated with Liver Enzyme Elevation in Patients with HCV, HIV
Injectable extended-release naltrexone (XR-NTX) is approved for treatment of opioid and alcohol dependence. Patients with drug and alcohol problems are more likely to have HCV and/or HIV infection, which may place them at greater risk for XR-NTX hepatotoxicity. This secondary analysis of data from a randomized controlled trial assessed the safety and efficacy of XR-NTX for treatment of opioid dependence in a sample of Russian adults without decompensated liver disease* (N=250). The prevalence of HCV and HIV in the sample was high (89% and 42%, respectively). Participants (88% men, 100% white) were followed for 6 months and underwent liver chemistry tests for ALT, AST, and GGT at monthly visits. Longitudinal analysis of the frequency with which patients had liver enzyme elevations >3 times the upper limit of normal (ULN) was conducted using generalized estimating equations. At 6 months,
- ALT was elevated >3 times ULN in 20% of XR-NTX patients versus 13% of placebo patients (p=0.88).
- AST was elevated in 14% of XR-NTX patients versus 11% of placebo patients (p=0.71).
- GGT was elevated in 23% of XR-NTX patients versus 21% of placebo patients (p=0.81).
- elevations were not more common in patients with HIV than in patients with HCV.
*Patients were excluded if they had evidence of ascites, jaundice, encephalopathy, esophageal varices, or AST/ALT >3 times ULN at baseline.