title: 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.
abstract: 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.
authors.affiliation: MEDCENTER Leipzig, Karl-Tauchnitz-Str. 3, DE-04107 Leipzig, Germany. waizmann@medizincenter.de
authors.forename: Michael
authors.initials: M
authors.lastname: Waizmann
authors.forename: Grit
authors.initials: G
authors.lastname: Ackermann
mesh_terms: D000328:Adult; D000928:Antidepressive Agents / Q000627:therapeutic use; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002047:Buprenorphine / Q000627:therapeutic use; D015283:Citalopram / Q000627:therapeutic use; D003863:Depression / Q000139:chemically induced / Q000517:prevention & control; D023801:Directly Observed Therapy / Q000379:methods; D004334:Drug Administration Schedule; D005260:Female; D006454:Hemoglobins / Q000187:drug effects / Q000378:metabolism; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000209:etiology / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008691:Methadone / Q000627:therapeutic use; D008875:Middle Aged; D009294:Narcotics / Q000627:therapeutic use; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D011994:Recombinant Proteins; D012189:Retrospective Studies; D012254:Ribavirin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D016320:Substance Abuse Treatment Centers; D015819:Substance Abuse, Intravenous / Q000150:complications* / Q000534:rehabilitation; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000928:Antidepressive Agents; D000998:Antiviral Agents; D006454:Hemoglobins; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D009294:Narcotics; D011994:Recombinant Proteins; D015283:Citalopram; D011092:Polyethylene Glycols; D002047:Buprenorphine; D012254:Ribavirin; C100416:peginterferon alfa-2a; D008691:Methadone