Peginterferon alfa-2b therapy in acute hepatitis C: impact of onset of therapy on sustained virologic response

• Published in: Gastroenterology (New York, N.Y. 1943) Vol. 130; no. 3; p. 632
• Main Authors: Kamal, Sanaa M, Fouly, Amr E, Kamel, Refaat R, Hockenjos, Bridgette, Al Tawil, Ahmed, Khalifa, Khalifa E, He, Qi, Koziel, Margaret J, El Naggar, Khairy M, Rasenack, Jens, Afdhal, Nezam H
• Format: Journal Article
• Language: English
• Published: United States 01.03.2006
• Subjects: Acute Disease; Adult; Antiviral Agents - therapeutic use; Female; Hepatitis C - drug therapy; Hepatitis C - virology; Humans; Interferon-alpha - adverse effects; Interferon-alpha - therapeutic use; Male; Middle Aged; Polyethylene Glycols; Prospective Studies; Recombinant Proteins; RNA, Viral - blood
• ISSN: 0016-5085
• DOI: 10.1053/j.gastro.2006.01.034

Pegylated interferon therapy has not been adequately evaluated in acute hepatitis C virus (HCV) infection. This randomized trial assessed the efficacy, safety, and timing of pegylated interferon alfa-2b for treatment of acute hepatitis C. One hundred seventy-five patients acutely infected with HCV were screened. Patients whose infection did not spontaneously resolve by week 8 were randomized to once weekly peginterferon alfa-2b monotherapy (1.5 microg/kg per week) started at weeks 8, 12, or 20 for a duration of 12 weeks. The primary endpoint was undetectable HCV RNA 24 weeks after the end of treatment (sustained virologic response [SVR]). All patients were followed for 48 weeks after cessation of therapy. One hundred twenty-nine subjects started treatment at week 8 (group A, n = 43), week 12 (group B, n = 43), or week 20 (group C, n = 43). By using an intent-to-treat analysis, the overall SVR rate was 87%. The SVR rates were 95%, 92%, and 76% with treatment onset at 8, 12, and 20 weeks, respectively. Overall, SVR rates were better for patients infected with genotypes 2, 3, and 4 than those infected with genotype 1. Earlier initiation of therapy improved SVR rates for patients infected with genotype 1 with high viral load. Peginterferon alfa-2b was well tolerated. Subjects with SVR maintained undetectable HCV RNA 48 weeks after therapy. Peginterferon alfa-2b monotherapy in acute hepatitis C induces high sustained virologic response rates, prevents chronic evolution, and is well tolerated. Initiation of treatment at week 8 or 12 results in higher sustained virologic rates than initiation at week 20.