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.

BACKGROUND: Though patients in opiate substitution programs are commonly infected with HCV, due to safety and efficacy concerns, they are rarely treated with interferon and ribavirin. METHODS: In a multicenter study, HCV-infected patients in opiate maintenance treatment programs received 180 microg pegylated interferon-alfa-2a once weekly, plus daily ribavirin for 24 weeks (genotypes 2, 3), or 48 weeks (genotypes 1, 4). RESULTS: Of the 67 patients enrolled, 31 (46%) had HCV genotypes 1 or 4, and 36 (54%) had genotypes 2 or 3. Intent-to-treat analysis showed end-of-treatment virologic response in 75% of patients (81% of genotypes 2 or 3; 65% of genotypes 1 or 4), and a sustained virologic response in 61% of patients (72% of genotypes 2 or 3; 48% of genotypes 1 or 4). Fifteen patients (22%) did not complete the study, in 5 (8%) cases because of severe adverse events. CONCLUSIONS: Drug users with chronic HCV infection, regularly attending an opiate maintenance program in which close collaboration between hepatologists/internists and addiction specialists is assured, can be treated effectively and safely with pegylated interferon-alfa-2a and ribavirin. Treatment results are very similar to those in other patient groups, and thus therapy should also be considered for this population.

Eligibility for and outcome of hepatitis C treatment of HIV-coinfected individuals in clinical practice: the Swiss HIV cohort study.

BACKGROUND: Morbidity and mortality of individuals co-infected with HIV and hepatitis C virus (HCV) is often determined by the course of their HCV infection. Only a selected proportion of those in need of HCV treatment are studied in randomized controlled trials (RCTs). We analysed the prevalence of HCV infection in a large cohort, the number of individuals requiring treatment, the eligibility for HCV treatment, and the outcome of the combination therapy with pegylated interferon-a and ribavirin in routine practice. METHODS: We analysed prescription patterns of HCV treatment and treatment outcomes among participants from the Swiss HIV Cohort Study with detectable hepatitis C viraemia (between January 2001 and October 2004). Efficacy was measured by the number of patients with undetectable HCV RNA at the end of therapy (EOTR) and at 6 months after treatment termination (SVR). Intention-to-continue-treatment principles were used. RESULTS: A total of 2150 of 7048 (30.5%) participants were coinfected with HCV; HCV RNA was detected in 60%, and not assessed in 26% of HCV-antibody-positive individuals. One hundred and sixty (12.5%) of HCV-RNA-positive patients started treatment. In patients infected with HCV genotypes 1/4 or 2/3, EOTR was achieved in 43.3% and 81.2% of patients, respectively, and SVR rates were 28.4% and 51.8%, respectively. More than 50% of the HCV-treated patients would have been excluded from two large published RCTs due to demographic, clinical and laboratory criteria. CONCLUSIONS: Despite clinical and psychosocial obstacles encountered in clinical practice, HCV treatment in HIV-coinfected individuals is feasible with results similar to those obtained in RCTs.

Barriers to interferon-alpha therapy are higher in intravenous drug users than in other patients with acute hepatitis C.

BACKGROUND/AIMS: Treatment with interferon-alpha (IFN-alpha) may eradicate HCV in most acute hepatitis C patients, thus preventing chronic hepatitis and avoiding less efficacious combination therapy. METHODS: In a prospective study, we evaluated the impact of barriers to successful start and completion of treatment of acute and subacute (<12 months from infection) hepatitis C with pegylated IFN-alpha2b, 1.5 microg/kg, QW, for 24 weeks. RESULTS: Out of 27 patients (22 were active intravenous drug users [IVDU]), 5 cleared HCV spontaneously. Antiviral treatment was indicated in 22 patients: six refused therapy for fear of side effects, whereas two others were lost to observation. Eight patients completed the treatment or received >80% of the scheduled drug: seven (88%) were sustained virological responders 24 weeks after the end of treatment. Six patients (all IVDU) stopped prematurely due to side effects: only one had a sustained virological response. Based on an intent-to-treat analysis, and considering all 14 patients in whom at least one dose of drug was administered, only 8 (57%) became sustained virological responders. CONCLUSIONS: Treatment of acute hepatitis C with pegylated IFN-alpha is highly beneficial, but its effectiveness is affected by a poor rate of acceptance and/or adherence to currently available regimens, especially in IVDU and women.