EASL 2009: Early Treatment of Acute Hepatitis C with Pegylated Interferon Monotherapy Produces Better Results than Delayed Combination Therapy

In a late-breaker presentation at the 44th Annual Meeting of the European Association for the Study of the Liver (EASL 2009) last month in Copenhagen, K. Deterding and colleagues with the HEP-NET Acute HCV Study Group described findings from a randomized trial of early versus delayed treatment of acute hepatitis C.

Acute hepatitis C virus (HCV) infection-- within the first 6 months -- is much easier to treat with interferon-based therapy than chronic infection, but the optimal time for starting therapy, length of treatment, and need for ribavirin are not clearly established.

Early treatment of acute hepatitis C with interferon monotherapy is highly effective, producing sustained virological response (SVR) rates of 85% or higher, the investigators noted as background. An alternative strategy might be to delay treatment for 3 months, and only treat those patients who did not spontaneously clear the virus during that time.

The HEP-NET Acute HCV-III study was a prospective trial of patients with symptomatic or asymptomatic acute hepatitis C. Eligible individuals were either HCV antibody positive, had elevated ALT (> 10 x upper limit of normal), or were exposed to HCV within the past 4 months. None had hepatitis A, hepatitis B, or HIV coinfection.

A total of 108 participants at72 centers in Germany enrolled between 2004 and 2008. A majority (60%)were men, the mean age was 40years, about half had HCV genotype 1, and about 60% had jaundice (icterus). The present efficacy analysis included 89 patents; the other 19 dropped out for various reasons after randomization.

Participants were randomly assigned to receive either immediate treatment with pegylated interferon alfa-2b (PegIntron) monotherapy for 6 months (n = 52), or else delayed treatment with pegylated interferon alfa-2b plus ribavirin for 6 months starting 12 weeks after randomization in patients who remained HCV RNA positive (n = 20). All asymptomatic patients received early treatment with pegylated interferon monotherapy.



"This so far largest prospective and the first randomized European trial on acute hepatitis C confirmed that early immediate treatment with [pegylated interferon alfa-2b] is highly effective in both symptomatic and asymptomatic patients," the investigators concluded.

"Delayed [pegylated interferon alfa-2b] plus ribavirin treatment resulted in lower overall response rates in this real-life treatment setting," they added, "however, if adherence can be assured this strategy seems to be of similar efficacy in symptomatic patients."

Hannover Medical School, HEP-NET: German Network of Competence on Viral Hepatitis, Hannover, Germany; Ludwig-Maximillians-University, Munich, Germany; University of Leipzig, Hannover, Germany; University Hamburg-Eppendorf, Hamburg, Germany; Johannes-Gutenberg University Mainz, Mainz, Germany; University of Bonn, Bonn, Germany; University of Schleswig-Holstein, Campus Kiel, Kiel, Germany; Charité Berlin Campus Virchow-Klinikum, Berlin, Germany.



K Deterding, N Gruner, J Wiegand, and others. Early versus delayed treatment of acute hepatitis C: the German HEP-NET Acute HCV-III study -- a randomized controlled trial. 44th Annual Meeting of the European Association for the Study of the Liver (EASL 2009). Copenhagen, Denmark. April 22-26, 2009. Abstract 1047.