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

Abstract

BACKGROUND & AIMS:

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.

METHODS:

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.

RESULTS:

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.

CONCLUSIONS:

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.

• Authors: Sanaa M Kamal, Amr E Fouly, Refaat R Kamel, Bridgette Hockenjos, Ahmed Al Tawil, Khalifa E Khalifa, Qi He, Margaret J Koziel, Khairy M El Naggar, Jens Rasenack, Nezam H Afdhal
• Journal: Gastroenterology (Gastroenterology) Vol. 130 Issue 3 Pg. 632-8 (Mar 2006) ISSN: 0016-5085 [Print] United States
• PMID: 16530503 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• Antiviral Agents
• Interferon alpha-2
• Interferon-alpha
• RNA, Viral
• Recombinant Proteins
• Polyethylene Glycols
• peginterferon alfa-2b

Topics

• Acute Disease
• Adult
• Antiviral Agents (therapeutic use)
• Female
• Hepatitis C (drug therapy, virology)
• Humans
• Interferon alpha-2
• Interferon-alpha (adverse effects, therapeutic use)
• Male
• Middle Aged
• Polyethylene Glycols
• Prospective Studies
• RNA, Viral (blood)
• Recombinant Proteins