The efficacy and safety of peginterferon alfa-2a in patients with HCV-related cirrhosis or bridging fibrosis was examined by an international team.
271 patients with cirrhosis or bridging fibrosis were randomly assigned to receive subcutaneous treatment with 3 million units of interferon alfa-2a three times weekly (88 patients), 90 µg of peginterferon alfa-2a once weekly (96), or 180 µg of peginterferon alfa-2a once weekly (87).
Treatment lasted 48 weeks and was followed by a 24-week follow-up period.
Undetectable HCV RNA at 72 weeks:
Interferon alfa-2a 8%.
90 µg peginterferon alfa-2a 15%.
180 µg peginterferon alfa-2a 30%.
Efficacy was assessed by measuring HCV RNA and alanine aminotransferase and by evaluating liver-biopsy specimens. A histologic response was defined as a decrease of at least 2 points on the 22-point Histological Activity Index.
In an intention-to-treat analysis, HCV RNA was found to be undetectable at week 72 in 8 per cent, 15 per cent, and 30 per cent of the patients treated with interferon alfa-2a and with 90 µg and 180 µg of peginterferon alfa-2a, respectively.
At week 72, alanine aminotransferase concentrations had normalized in 15 per cent, 20 per cent, and 34 per cent of patients, respectively.
In the subgroup of 184 patients with paired liver-biopsy specimens, the rates of histologic response at week 72 were 31 per cent, 44 per cent, and 54 per cent, respectively. All three treatments were similarly tolerated.
Dr Jenny Heathcote concluded on behalf of the group that, "In patients with chronic hepatitis C and cirrhosis or bridging fibrosis, 180 µg of peginterferon alfa-2a administered once weekly is significantly more effective than 3 million units of standard interferon alfa-2a administered three times weekly."