Injectable extended-release naltrexone poses no hepatotoxicity signal in advanced ALD

The use of the injectable extended-release naltrexone for alcohol use disorder in patients with advanced alcohol-associated liver disease (ALD) does not appear to carry a substantial hepatotoxicity or liver decompensation risk, according to a study.

Researchers reviewed the medical records of adults with ALD who received at least one dose of XR-NTX 380 mg, administered via intramuscular injection at a tertiary care centre. They looked at clinical data and laboratory test results over a minimum follow-up of 12 weeks.

Safety was evaluated based on adverse events and liver biochemistry, while alcohol use was determined using phosphatidylethanol (PEth) levels.

Fourteen adults (median age 51 years, 64 percent male) with ALD were included in the analysis, including two with F3 fibrosis stage and nine with cirrhosis Child-Pugh class A–B. The median follow-up was 127 days.

Mild adverse effects occurred in four individuals (29 percent). These effects included injection site pain, nausea and vomiting, fatigue, and sexual side effects. There was no documented hepatotoxicity or hepatic decompensation in any of the individuals.

Furthermore, liver function tests and MELD/Child-Pugh scores did not significantly change during the follow-up period.

Alcohol consumption decreased in eight individuals (57 percent), with a nonsignificant decline in PEth levels.

Injectable extended-release naltrexone was developed to provide a safer alternative by avoiding first-pass hepatic metabolism, the researchers said. And the present data show evidence of its safety, tolerability, and impact on liver function and alcohol use in patients with advanced ALD, they added.