A randomized, open-label, multicenter study evaluating the efficacy of peginterferon alfa-2a versus interferon alfa-2a, in combination with ribavirin, in naïve and relapsed chronic hepatitis C patients

• Published in: Acta gastro-enterologica belgica Vol. 73; no. 2; p. 223
• Main Authors: Nevens, F, Van Vlierberghe, H, D'Heygere, E, Delwaide, J, Adler, M, Henrion, J, Lenaerts, A, Hendlisz, A, Michielsen, P, Bastens, B, Brenard, R, Laureys, A
• Format: Journal Article
• Language: English
• Published: Belgium 01.04.2010
• Subjects: Antiviral Agents - administration & dosage; Drug Therapy, Combination; Female; Hepatitis C, Chronic - drug therapy; Humans; Interferon-alpha - administration & dosage; Logistic Models; Male; Middle Aged; Polyethylene Glycols - administration & dosage; Prospective Studies; Recombinant Proteins; Ribavirin - administration & dosage; RNA, Viral - analysis; Treatment Outcome
• ISSN: 1784-3227

A large multicenter trial to compare the efficacy of peginterferon alfa-2a with interferon alfa-2a, in combination with ribavirin, in chronic hepatitis C patients. Efficacy data for prior relapsers are reported because treatment recommendations for this patient population are not well defined. This study was a multicenter, prospective, randomized clinical trial. The primary efficacy endpoint was sustained virologic response in naive patients (n = 348) and relapsers (n = 95). Sustained virologic response rates were similar in naïve patients and relapsers, both for non-pegylated and pegylated interferon (respectively 27 and 26% and 54 and 43%). Pegylated interferon given for 48 weeks did not improved the relapse rate: 15.9 and 27.3% for non-pegylated and 16.7 and 30.4% for pegylated interferon, naïve vs relapsers respectively. Stepwise logistic regression analysis revealed a significant association between slow response (detectable HCV RNA at week 12 and undetectable at week 24) and relapse in patients with an end-of-treatment response (55% versus 13% respectively; p = 0.02; odds ratio = 6.07). This trial confirms the value of using peginterferon alfa-2a in both naïve and relapsed patients and provides support for a more tailored approach to treatment for relapsers and particulary for patients with a slow viral response.