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Research Summary

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.

Comments:

In this sample of opioid-dependent patients—the majority with HCV infection and more than a third co-infected with HIV—treatment with XR-NTX was not significantly associated with increased elevation of liver enzymes. A limitation is the modest sample size, which should lead to cautious interpretation of results (particularly since slightly more elevations were observed in the XR-NTX group for each liver enzyme). Also, there was no comparison of the effect of XR-NTX on liver enzymes among participants with and without HCV. Nevertheless, results suggest XR-NTX is not strongly associated with hepatotoxicity, even among persons with HCV and HIV. Judith Tsui, MD, MPH

Reference:

Mitchell MC, Memisoglu A, Silverman BL. Hepatic safety of injectable extended-release naltrexone in patients with chronic hepatitis C and HIV infection. J Stud Alcohol Drugs. 2012;73(6):991–997.

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