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12- Versus 24-week Treatment with Pegylated Interferon plus Ribavirin for Genotype 2 or 3 Chronic Hepatitis C Patients

By Liz Highleyman

In an effort to reduce the cost and side effects of treatment for chronic hepatitis C virus (HCV) infection, researchers have explored shorter courses of pegylated interferon plus ribavirin for individuals with easier-to-treat HCV genotypes 2 or 3.

The standard course of therapy for patients with these genotypes is 24 weeks (compared with 48 weeks for those with genotype 1). To date, previous trials looking at the efficacy of treatment durations shorter than 24 weeks for genotype 2 or 3 patients have yielded discordant results.

In the present study, reported in the June 2008 issue of Hepatology, Scandinavian researchers conducted a Phase III trial to compare the efficacy of 12 or 24 weeks of treatment, and to identify patients suitable for short-term therapy.

The study included 382 chronic hepatitis C patients with genotype 2 or 3 at 31 centers in Denmark, Finland, Norway, and Sweden. Participants were randomly assigned to receive 180 mcg/week pegylated interferon alpha-2a (Pegasys) plus 800 mg/day ribavirin for either 12 or 24 weeks.

Results

• Overall, 12 weeks of therapy was inferior to 24 weeks in the intent-to-treat population.

• Overall sustained viral response (SVR) rates were 59% for 12-week therapy versus 78% for 24-week therapy (P < 0.0001):

    - Genotype 2: 56% versus 82%, respectively (P = 0.006);
    - Genotype 3: 58% versus 78%, respectively (P = 0.0015).

• These differences were observed regardless of liver fibrosis stage.

• Age and rapid virological response on days 7 and 29 were independent predictors of SVR.

• Short-term treatment was useful in patients less than 40 years old, especially if HCV RNA was undetectable on day 29.

• For patients age 40 or older, 12-week therapy was effective if HCV RNA was below 1000 IU/mL on both day 7 and undetectable on day 29.

• If neither of these 2 criteria were met for patients age 40 or older, 24 weeks of therapy was superior (P < 0.0001).

Based on these findings, the investigators concluded that, "Peginterferon / ribavirin treatment for 12 weeks in HCV genotype 2/3 infection is overall inferior to 24 weeks of treatment but may be useful in some patients with a rapid initial clearance of virus."

As previously reported, the European Commission recently approved a short 16-week course of Pegasys plus ribavirin for genotype 2 or 3 patients with low baseline viral load and rapid virological response, or undetectable HCV RNA at week 4.

Department of Infectious Diseases, Göteborg University, Göteborg, Sweden; Department of Infectious Diseases, Haukeland University Hospital and Institute of Medicine, University of Bergen, Bergen, Norway; Department of Infectious Diseases, University of Southern Denmark, Southern Denmark, Denmark; Department of Gastroenterology, Helsinki University, Helsinki, Finland; Department of Infectious Diseases, Aarhus University, Aarhus, Denmark; Department of Histopathology, Royal Free Hospital, London, UK.

Reference
M Lagging, N Langeland, C Pedersen, and others. Randomized comparison of 12 or 24 weeks of peginterferon alpha-2a and ribavirin in chronic hepatitis C virus genotype 2/3 infection. Hepatology 47(6): 1837-1845. June 2008.
( Abstract )

 






 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


FDA-approved Combination Therapies for Chronic HCV Infection

Pegasys + Copegus
PEG-Intron + Rebetol
Intron A + Rebetol
Roferon A + Ribavirin
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