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Randomized trial of albinterferon alfa‐2b every 4 weeks for chronic hepatitis C virus genotype 2/3
Author(s) -
Pianko S.,
Zeuzem S.,
Chuang W.L.,
Foster G. R.,
Sarin S. K.,
Flisiak R.,
Lee C.M.,
Andreone P.,
Piratvisuth T.,
Shah S.,
Sood A.,
George J.,
Gould M.,
Komolmit P.,
Thongsawat S.,
Tanwandee T.,
Rasenack J.,
Li Y.,
Pang M.,
Yin Y.,
Feutren G.,
Jacobson I. M.
Publication year - 2012
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.1365-2893.2012.01586.x
Subject(s) - medicine , ribavirin , gastroenterology , adverse effect , hepatitis c virus , pegylated interferon , randomized controlled trial , immunology , virus
Summary. Albinterferon alfa‐2b (albIFN) is a fusion protein of recombinant human albumin/recombinant interferon (IFN)‐α‐2b, with ∼200‐h half‐life. Safety/efficacy of albIFN q4wk was evaluated in 391 treatment‐naive patients with chronic hepatitis C virus (HCV) genotype 2/3. Patients were randomized 3:4:4:4 to one of four open‐label treatment groups: pegylated IFN (Peg‐IFN)‐α‐2a 180 μg qwk or albIFN 900, 1200 or 1500 μg q4wk, plus oral ribavirin 800 mg/day, for 24 weeks. Primary efficacy endpoint was sustained virologic response (SVR; HCV RNA <20 IU/mL 24 weeks post‐treatment). SVR rates were as follows: 85%, 76%, 76% and 78% with Peg‐IFNα‐2a and albIFN 900, 1200 and 1500 μg, respectively ( P = NS); corresponding rapid virologic response rates (HCV RNA <43 IU/mL at week 4) were as follows: 78%, 49% ( P < 0.001), 60% ( P = 0.01) and 71%. SVR rates were not influenced by interleukin 28B genotype, although rapid virologic response rates were greater with interleukin 28B CC ( P = NS). Serious adverse event rates were as follows: 4%, 11%, 3% and 3% with Peg‐IFNα‐2a and albIFN 900, 1200 and 1500 μg, respectively. No increase in serious/severe respiratory events was noted with albIFN. Fewer absolute neutrophil count reductions <750/mm 3 occurred with albIFN ( P = 0.03), leading to fewer IFN dose reductions. Haemoglobin reductions <10 g/dL were less frequent with albIFN 900 and 1200 μg vs 1500 μg and Peg‐IFNα‐2a ( P = 0.02), leading to fewer ribavirin dose reductions. albIFN administered q4wk produced fewer haematologic reductions than Peg‐IFNα‐2a, but had numerically lower SVR rates ( P = NS) in patients with chronic HCV genotype 2/3.