High rates of sustained virological response in hepatitis C virus-infected injection drug users receiving directly observed therapy with peginterferon alpha-2a (40KD) (PEGASYS) and once-daily ribavirin

MEDCENTER Leipzig, Karl-Tauchnitz-Str. 3, DE-04107 Leipzig, Germany.
Journal of substance abuse treatment (Impact Factor: 2.9). 03/2010; 38(4):338-45. DOI: 10.1016/j.jsat.2010.02.002
Source: PubMed


This retrospective study evaluated the efficacy and tolerability of directly observed therapy with peginterferon alfa-2a and once-daily ribavirin (RBV) for chronic hepatitis C in 49 opioid-addicted injection drug users (IDUs) participating in a drug treatment program at a specialized outpatient center. Patients also received prophylactic citalopram to minimize the risk of interferon-induced depression. Patients had daily access to and support from specialist physicians, nurses and counseling services at the center, and a 24-hour helpline. Sustained virological response was achieved by 48 of 49 patients (98%) overall, including 20 of 21 (95%) hepatitis C virus (HCV) Genotype 1/4-infected patients and 28 of 28 (100%) Genotype 2/3-infected patients. Treatment was well tolerated, and no unexpected side effects of peginterferon treatment were seen. The safety profile of once-daily RBV was not different from twice-daily dosing. Decline in hemoglobin levels was similar to those reported in clinical trials including once-daily RBV and did not lead to dose reduction or treatment withdrawal. Our data demonstrate that HCV-infected IDUs on stable L-polamidone (methadone) or buprenorphine maintenance can be successfully and safely treated with peginterferon alfa-2a and RBV in an optimal substitution setting.

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    • "Since methadone-maintained drug users attend opiate agonist treatment programs up to six days per week, it is feasible to observe oral ingestion of daily ribavirin, to which adherence may be particularly important for achieving sustained viral response [7-9]. However, DOT for HCV has only recently been evaluated [10,11], and, to our knowledge, no randomized trial has evaluated both directly observed pegylated interferon and directly observed ribavirin administered on-site in a methadone clinic. "
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