A Short Course of Pegylated Interferon-alfa in Acute HCV Hepatitis
A Short Course of Pegylated Interferon-alfa in Acute HCV Hepatitis
Acute hepatitis C virus (HCV) infection evolves to chronicity in 50–84% cases. Treatment with interferon-α (IFN-α) was repeatedly found to provide sustained cure rates higher than that in chronic HCV infection, but the optimal treatment strategy has not yet been defined. In a multicentre open-label study, we investigated the therapeutic performance of a short course of pegylated (peg) IFN-α in patients with acute HCV hepatitis. Peg IFN-α2b, 1.0–1.5 μg/kg weekly, was administered for 12 weeks. Forty-six patients were enrolled; 26 of them were intravenous drug users. Eleven patients had jaundice. Treatment was started within 1–90 days from the peak alanine aminotransferase. Treatment was well tolerated with a single dropout (2%). Thirty-three of 46 patients (72%) had a sustained virological response (SVR) after a 6 months post-treatment follow-up, 8 (17%) relapsed after treatment and 4 were nonresponders (9%). A lower peak viraemia, receiving at least 1.2 μg/kg of peg IFN-α, and a negative HCV-RNA at week 4 and week 12 were predictors of SVR. Thus, in patients with early (week 4) viral response, a short course of peg IFN-α at a weekly dose >1.2 μg/kg, may be a valuable option for the treatment of acute HCV hepatitis.
The progression of hepatitis C virus (HCV) infection to chronic disease ranges from 50% to 84% of cases following an asymptomatic acute phase in most cases. Although the treatment outcome of chronic disease has been significantly improved in the last years by the introduction of ribavirin and pegylated interferon-α (peg IFN-α), allowing a greater and prolonged drug exposure, no sustained virological response (SVR) is obtained in a proportion of patients approaching 50%.
In the last years, evidence has been provided on the higher response rate to IFN-α-based therapies of acute hepatitis C (AHC) when compared with chronic HCV-related liver disease, with SVR as high as 98%. Peg IFN-α with or without ribavirin for 24 weeks has been used by Kamal et al. with good results (85% and 80% 6-months SVR, respectively). However, compliance may be an issue with the 24-week duration, as evidenced by a recent multicentre German study where SVR was 71% in the whole study population and 89% in patients adherent to therapy. The progress towards standardization of the treatment of acute HCV infection proceeds slowly and no definitive answers are yet available on the most appropriate timing, drugs, schedule and duration. As a regional reference centre for infectious diseases, we established a region-wide surveillance system for acute HCV infection by relying upon outpatient sentinel sites where subjects at risk of acquiring HCV infection are monitored. In this framework, we undertook an open-label therapeutic trial of a 12-week course of peg IFN-α2b in AHC.
Summary and Introduction
Summary
Acute hepatitis C virus (HCV) infection evolves to chronicity in 50–84% cases. Treatment with interferon-α (IFN-α) was repeatedly found to provide sustained cure rates higher than that in chronic HCV infection, but the optimal treatment strategy has not yet been defined. In a multicentre open-label study, we investigated the therapeutic performance of a short course of pegylated (peg) IFN-α in patients with acute HCV hepatitis. Peg IFN-α2b, 1.0–1.5 μg/kg weekly, was administered for 12 weeks. Forty-six patients were enrolled; 26 of them were intravenous drug users. Eleven patients had jaundice. Treatment was started within 1–90 days from the peak alanine aminotransferase. Treatment was well tolerated with a single dropout (2%). Thirty-three of 46 patients (72%) had a sustained virological response (SVR) after a 6 months post-treatment follow-up, 8 (17%) relapsed after treatment and 4 were nonresponders (9%). A lower peak viraemia, receiving at least 1.2 μg/kg of peg IFN-α, and a negative HCV-RNA at week 4 and week 12 were predictors of SVR. Thus, in patients with early (week 4) viral response, a short course of peg IFN-α at a weekly dose >1.2 μg/kg, may be a valuable option for the treatment of acute HCV hepatitis.
Introduction
The progression of hepatitis C virus (HCV) infection to chronic disease ranges from 50% to 84% of cases following an asymptomatic acute phase in most cases. Although the treatment outcome of chronic disease has been significantly improved in the last years by the introduction of ribavirin and pegylated interferon-α (peg IFN-α), allowing a greater and prolonged drug exposure, no sustained virological response (SVR) is obtained in a proportion of patients approaching 50%.
In the last years, evidence has been provided on the higher response rate to IFN-α-based therapies of acute hepatitis C (AHC) when compared with chronic HCV-related liver disease, with SVR as high as 98%. Peg IFN-α with or without ribavirin for 24 weeks has been used by Kamal et al. with good results (85% and 80% 6-months SVR, respectively). However, compliance may be an issue with the 24-week duration, as evidenced by a recent multicentre German study where SVR was 71% in the whole study population and 89% in patients adherent to therapy. The progress towards standardization of the treatment of acute HCV infection proceeds slowly and no definitive answers are yet available on the most appropriate timing, drugs, schedule and duration. As a regional reference centre for infectious diseases, we established a region-wide surveillance system for acute HCV infection by relying upon outpatient sentinel sites where subjects at risk of acquiring HCV infection are monitored. In this framework, we undertook an open-label therapeutic trial of a 12-week course of peg IFN-α2b in AHC.
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