Mitchell MC, Memisoglu A, Silverman BL.Hepatic safety of injectable naltrexone in patients with chronic hepatitis C and HIV infection. J Stud Alcohol Drugs. 2012 Nov;73(6):991-7. Subgroup See Krupitsky Authors noted analysis (2011) another study of that showed Krupitsky oral (2011) naltrexone was associated with LETs > 3.5x BL values in 2 / 114 pts (1.8%) over a median of 49 d of tx in veterans with HIV infection, 57% of whom were with HCV (Tetrault and Fiellin, 2012). Alcohol use was not tracked. No use of INH, statins, or potentially toxic drugs except 8 pts taking APAP (NMT 4 g/d). Krupitsky E, Nunes EV, Ling W, Gastfriend DR, Memisoglu A, Silverman BL. Injectable extended-release naltrexone (XR-NTX) for opioid dependence: safety and effectiveness. Addiction. 2013 Sep;108(9):1628-37. doi: 10.1111/add.12208. Epub 2013 May 24. 52-wk 114 pts who ER-NTX 380 UDT qmo Funding: follow-on completed RCT mg i.m. Alkermes OL OS and entered the q4wk for up GRADE: OL phase; to 13 add’l Missing drug use LOW continued on doses UDS (Timeline (n = 67) or (including Pts who results switched from the DB entered the were PBO to ER-NTX doses, this OL phase imputed method) (n = 47). totals to 19 were similar as injections Addiction to those who positive; Excluded pts on Severity did not. LOCF oral naltrexone,
Mitchell MC, Memisoglu A, Silverman BL.Hepatic safety of injectable naltrexone in patients with chronic hepatitis C and HIV infection. J Stud Alcohol Drugs. 2012 Nov;73(6):991-7. Subgroup analysis of Krupitsky (2011) See Krupitsky (2011) Authors noted another study that showed oral naltrexone was associated with LETs > 3.5x BL values in 2 / 114 pts (1.8%) over a median of 49 d of tx in veterans with HIV infection, 57% of whom were with HCV (Tetrault and Fiellin, 2012). Alcohol use was not tracked. No use of INH, statins, or potentially toxic drugs except 8 pts taking APAP (NMT 4 g/d). Krupitsky E, Nunes EV, Ling W, Gastfriend DR, Memisoglu A, Silverman BL. Injectable extended-release naltrexone (XR-NTX) for opioid dependence: safety and effectiveness. Addiction. 2013 Sep;108(9):1628-37. doi: 10.1111/add.12208. Epub 2013 May 24. 52-wk follow-on OL OS Missing UDS results were imputed as positive; LOCF 114 pts who completed RCT and entered the OL phase; continued on (n = 67) or switched from PBO to ER-NTX (n = 47). Excluded pts on oral naltrexone, ER-NTX 380 mg i.m. q4wk for up to 13 add’l doses (including the DB doses, this totals to 19 injections UDT qmo drug use (Timeline method) Addiction Severity Funding: Alkermes GRADE: LOW Pts who entered the OL phase were similar to those who did not.