Hepatic safety of injectable extended-release naltrexone in patients with chronic
hepatitis C and HIV infection.
Author(s): Mitchell MC, Memisoglu A, Silverman BL.
Affiliation(s): Division of Gastroenterology, Johns Hopkins Bayview Medical Center, Baltimore,
Maryland. mack.mitchell@utsouthwestern.edu
Publication date & source: 2012, J Stud Alcohol Drugs. , 73(6):991-7
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 (HC V) 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.
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