Interferon alpha-2a Plus Ribavirin 1,000/1,200 mg versus Interferon alpha-2a Plus Ribavirin 600 mg for Chronic Hepatitis C Infection in Patients on Opiate Maintenance Treatment: An Open-Label Randomized Multicenter Trial

Abstract

In a small fraction of HCV-infected intravenous drug users in an opiate maintenance treatment program, antiviral therapy was feasible, safe, and effective. The success rate was comparable to that achieved in controlled studies that excluded drug users.

Swiss Multicenter Study Evaluating the Efficacy, Feasibility and Safety of Peginterferon-Alfa-2a and Ribavirin in Patients with Chronic Hepatitis C in Official Opiate Substitution Programs

“…In our earlier study [30], only 6% of all infected patients were eligible for treatment; indeed, a recently published study cited an even lower percentage [6]. Our study is therefore not able to answer the important question of whether treating a larger proportion of HCV infected IDU and using less stringent selection criteria would still be effective and safe.…”

“…Efficacy, measured as SVR, was 61% across all virus genotypes. Compared to an overall sustained viral response of 47% in an earlier study with standard interferon and ribavirin in the same setting [30], the treatment response rate with pegylated interferon-alfa-2a was clearly higher, as has been shown in studies using the same therapies but requiring cessation of opiate use [18]. Patients with genotype 2 or 3 had a sustained virologic response rate of 72%; those with genotype 1 or 4 had an SVR of 48%.…”

“…It has been shown [22, 23, 25,27,28,29,30] that in the setting of opiate maintenance treatment (OMT; with methadone, heroin, buprenorphine or other opiates), HCV treatment with interferon (IFN) and ribavirin is feasible and safe, at least in small, highly selected groups of patients.…”

Coevolution of the Hepatitis C Virus Polyprotein Sites in Patients on Combined Pegylated Interferon and Ribavirin Therapy

“…IFN-RBV therapy) (48,52). Because only 50% to 70% of chronically infected patients develop a sustained virologic response (SVR) to this treatment (48,52,55,80) and because patient intolerance to such therapy is common (61,68,120), the development and application of other therapeutic approaches using antiviral compounds that act against HCV more efficaciously and yet generate lower rates of adverse effects are major clinical management and public health objectives. Therapeutic failure presents in two forms: (i) complete resistance to treatment (no response [NR]) and (ii) unsustainable response (UR), which is characterized by an increase in HCV load observed during therapy after an initial period of decline in viral load (breakthrough) or observed after cessation of therapy (relapse) (52).…”

Treatment of Hepatitis C Virus Infection?Is There Progress?

“…So far, the impression was that treatment of HCV infection in intravenous drug users was not feasible due to the interference of the drug addiction with the relatively complex and long treatment schedule. The study by Huber et al [2] shows that this is true -but also not true. Of 420 patients with HCV infection who participated in an opiate maintenance treatment program in Switzerland, only 27 (6%) could be enrolled into the treatment protocol, which consisted of interferon alpha-2a plus ribavirin at either 1,000/1,200 or 600 mg. Interferon was administered daily for 28 days, then thrice weekly for another 5 or 11 months depending on genotype.…”