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Higher doses of peginterferon alpha‐2b administered twice weekly improve sustained virological response in difficult‐to‐treat patients with chronic hepatitis C: results of a pilot randomized study
Author(s) -
Lodato F.,
Azzaroli F.,
Brillanti S.,
Colecchia A.,
Tamé M. R.,
Montagnani M.,
Muratori R.,
Giovanelli S.,
Feletti V.,
Bacchi Reggiani M. L.,
Roda E.,
Mazzella G.
Publication year - 2005
Publication title -
journal of viral hepatitis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.329
H-Index - 100
eISSN - 1365-2893
pISSN - 1352-0504
DOI - 10.1111/j.1365-2893.2005.00638.x
Subject(s) - medicine , ribavirin , discontinuation , gastroenterology , tolerability , genotype , chronic hepatitis , peginterferon alfa 2a , randomized controlled trial , immunology , adverse effect , virus , biology , biochemistry , gene
Summary. Beside substantial progress in treatment of chronic hepatitis C (CHC) particular patients (genotype 1/4, high viral load, previous nonresponse, cirrhosis) remain difficult to treat. The aim of our pilot randomized study was to compare efficacy and tolerability of standard doses of Peginterferon alpha‐2b + ribavirin with higher doses of Peginterferon alpha‐2b administered twice weekly + ribavirin. Sixty‐five outpatients with CHC were subsequently enrolled. Group A ( n = 22) received recommended doses of Peginterferon alpha‐2b and group B ( n = 43), received high doses twice weekly. Groups were comparable for baseline characteristics. All genotype 1/4 patients had high baseline viraemia. Sustained virological response (SVR) was significantly higher in group B among naïve patients (72% vs 25%, P = 0.024). A significantly higher rate of SVR was observed in group B both considering only genotype 1/4 patients, (46% vs 13%, P = 0.03) and grouping together genotype 1/4 naive and relapsers (57% vs 11%, P = 0.039). Discontinuation rate was 32% (7 of 22) in group A and 19% (8 of 43) in group B. Our response rates are the highest reported for genotype 1/4 with high viraemia. Our pilot study supports the need of randomized studies to evaluate both viral kinetics and efficacy of high dose and twice weekly administration of Peginterferon alpha‐2b in genotype 1/4 patients with high viraemia who may need personalized treatment schedules.