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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    • "Finally, the largest trial to date by Schaefer et al demonstrated a clear positive effect of escitalopram on the incidence and severity of depression during treatment in patients without prior psychiatric disorders [41]. Regarding PWID, results from few open-label studies conducted so far offer also positive results [46, 50]. In addition, methadone maintenance treatment has been described as an independent predictor of less long-term worsening of depressive symptoms [51]. "
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    ABSTRACT: Psychiatric comorbidity is a common problem in patients with substance use disorders. Patients with psychiatric diseases and/or substance abuse have an increased risk for hepatitis C virus (HCV) infection. Furthermore, psychiatric problems occur frequently during antiviral treatment and may be associated with the use of interferon alpha (IFN-α) but also with the primary psychiatric condition. As a consequence, substance abuse and/or acute psychiatric problems are still important reasons for nontreatment of chronic HCV infection. However, prospective and controlled data from recent years showed that if an interdisciplinary treatment is provided, patients with substance use disorders and/or psychiatric diseases do not differ regarding sustained virologic response or IFN-α–associated complications such as depression when compared with controls. Moreover, depression as the most important acute IFN-α–associated psychiatric adverse event can be acutely treated or even prevented by antidepressant pretreatment. Other, more rare but severe complications such as mania, psychotic symptoms, or delirium need individual psychiatric interventions.
    Full-text · Article · Jul 2013 · Clinical Infectious Diseases
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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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    ABSTRACT: Most methadone-maintained injection drug users (IDUs) have been infected with hepatitis C virus (HCV), but few initiate HCV treatment. Physicians may be reluctant to treat HCV in IDUs because of concerns about treatment adherence, psychiatric comorbidity, or ongoing drug use. Optimal HCV management approaches for IDUs remain unknown. We are conducting a randomized controlled trial in a network of nine methadone clinics with onsite HCV care to determine whether modified directly observed therapy (mDOT), compared to treatment as usual (TAU), improves adherence and virologic outcomes among opioid users. We plan to enroll 80 HCV-infected adults initiating care with pegylated interferon alfa-2a (IFN) plus ribavirin, and randomize them to mDOT (directly observed daily ribavirin plus provider-administered weekly IFN) or TAU (self-administered ribavirin plus provider-administered weekly IFN). Our outcome measures are: 1) self-reported and pill count adherence, and 2) end of treatment response (ETR) or sustained viral response (SVR). We will use mixed effects linear models to assess differences in pill count adherence between treatment arms (mDOT v. TAU), and we will assess differences between treatment arms in the proportion of subjects with ETR or SVR with chi square tests. Of the first 40 subjects enrolled: 21 have been randomized to mDOT and 19 to TAU. To date, the sample is 77% Latino, 60% HCV genotype-1, 38% active drug users, and 27% HIV-infected. Our overall retention rate at 24 weeks is 92%, 93% in the mDOT arm and 92% in the TAU arm. This paper describes the design and rationale of a randomized clinical trial comparing modified directly observed HCV therapy delivered in a methadone program to on-site treatment as usual. Our trial will allow rigorous evaluation of the efficacy of directly observed HCV therapy (both pegylated interferon and ribavirin) for improving adherence and clinical outcomes. This detailed description of trial methodology can serve as a template for the development of future DOT programs, and can also guide protocols for studies among HCV-infected drug users receiving methadone for opiate dependence.
    Full-text · Article · Nov 2011 · BMC Infectious Diseases

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