A group of international researchers investigated the efficacy and safety of peginterferon alfa-2a plus ribavirin in the initial treatment of chronic hepatitis C virus (HCV) infection.
A total of 1121 patients were randomly assigned to 1 of 3 treatment regimens.
The first treatment option was 180 µg of peginterferon alfa-2a once weekly plus daily ribavirin (1000 or 1200 mg, depending on body weight).
The other regimens were weekly peginterferon alfa-2a plus daily placebo, or 3 million units of interferon alfa-2b thrice weekly plus daily ribavirin.
Therapy was administered for 48 weeks.
The researchers found that a significantly higher proportion of patients who received peginterferon alfa-2a plus ribavirin had a sustained virologic response (56%).
Those who received interferon alfa-2b plus ribavirin or peginterferon alfa-2a alone had responses of 44% and 29%, respectively.
|Sustained virologic response:|
Peginterferon plus ribavirin: 56%
Interferon plus ribavirin: 44%
Peginterferon alone: 29%
| New England Journal of Medicine |
Sustained virologic response was defined as the absence of detectable HCV RNA 24 weeks after cessation of therapy.
The proportions of patients with HCV genotype 1 who had sustained virologic responses were 46%, 36%, and 21%, respectively, for the 3 regimens.
Among patients with HCV genotype 1 and high base-line levels of HCV RNA, the proportions of those with sustained virologic responses were 41%, 33%, and 13%, respectively.
The overall safety profiles of the 3 treatment regimens were similar.
However, the incidence of influenza-like symptoms and depression was lower in the groups receiving peginterferon alfa-2a than in the group receiving interferon alfa-2b plus ribavirin.
Dr Michael W. Fried, of the University of North Carolina, Chapel Hill, North Carolina, USA, concluded on behalf of his colleagues, "In patients with chronic hepatitis C, once-weekly peginterferon alfa-2a plus ribavirin was tolerated as well as interferon alfa-2b plus ribavirin.
"It also produced significant improvements in the rate of sustained virologic response, as compared with interferon alfa-2b plus ribavirin or peginterferon alfa-2a alone."