Efficacy and side-effect profile of pegylated interferon (PEG-IFN) plus ribavirin (RBV) therapy in patients with chronic hepatitis C. Preliminary results

Introduction: Long-term treatment with PEG-IFNs combined with RBV is currently regarded as the best antiviral treatment for chronic hepatitis C (CHC). Aim: To survey our experience with this novel treatment modality.

Patients and methods: Since January 2004, the 48-week treatment of 83 CHC pts has been started with once-weekly injections of PEG-IFN combined with 1.0–1.2g RBV daily. Seventy-one had not participated in previous IFN treatment, 2 were relapsers to IFN monotherapy, 1 was a relapser to PEG-IFN monotherapy, and 9 had relapsed following previous standard IFN + RBV therapy. To date 67 pts have reached the 12th week of treatment, and 11 of them have completed the course of therapy, but no patients have as yet fulfilled the follow-up period.

Results: Fifty-three of the 67 pts (79.1%) gave an early virological response (EVR), and 6 of them displayed a negative HCV RNA test at the end of therapy. The treatment of 22 pts (26.5%) was stopped for various reasons (12 had no EVR, 2 were non-responders, 1 had hepatocellular carcinoma, 1 had a coronary intervention, 1 was hospitalized because of psychosis, 2 had side-effects of PEG-IFN and RBV, and 3 pts stopped the therapy on their own decision). A PEG-IFN dose reduction was necessary in 5 pts because of neutropenia and in 3 because of thrombopenia. An RBV dose reduction was needed in 22 pts because of anemia. A thyroid dysfunction appeared in 4 pts but required no changes in the dosing of PEG-IFN or RBV. Depression with therapeutic consequences was present in 22 pts; 9 of them had taken psychiatric drugs prior to the start of the treatment.

Conclusions: The data suggest that this novel treatment modality with PEG-IFN is more promising than the previous regimens with standard IFN. The side-effects are mostly tolerable, and an RBV dose reduction was necessary more often than that of PEG-IFN.