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Albinterferon alfa‐2b dosed every two or four weeks in interferon‐naïve patients with genotype 1 chronic hepatitis C
Author(s) -
Zeuzem Stefan,
Yoshida Eric M.,
Benhamou Yves,
Pianko Stephen,
Bain Vincent G.,
Shouval Daniel,
Flisiak Robert,
Rehak Vratislav,
Grigorescu Mircea,
Kaita Kelly,
Cronin Patrick W.,
Pulkstenis Erik,
Subramanian G. Mani,
McHutchison John G.
Publication year - 2008
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.22403
Subject(s) - medicine , ribavirin , gastroenterology , discontinuation , adverse effect , interferon alfa , pegylated interferon , interferon , hepatitis c virus , alpha interferon , albumin , immunology , virus
The efficacy and safety of albinterferon alfa‐2b (alb‐IFN), a novel recombinant protein consisting of interferon alfa‐2b genetically fused to human albumin, was evaluated in a phase 2b, open‐label study of patients with genotype 1, chronic hepatitis C. In all, 458 IFN‐alfa treatment‐naïve patients were randomized to 48‐week treatment with peginterferon alfa (PEG‐IFNα)‐2a 180 μg one time per week (qwk), or alb‐IFN 900 or 1,200 μg once every two weeks (q2wk), or 1,200 μg once every four weeks (q4wk), administered subcutaneously, plus weight‐based oral ribavirin 1,000 or 1,200 mg/day. Hepatitis C virus RNA was measured by real‐time polymerase chain reaction (limit of detection: 10 IU/mL). The primary efficacy endpoint was sustained virologic response (hepatitis C virus RNA <10 IU/mL 24 weeks after the end of treatment). By intention‐to‐treat analysis, sustained virologic response rates were 58.5% (69/118) with alb‐IFN 900 μg q2wk, 55.5% (61/110) with 1,200 μg q2wk, and 50.9% (59/116) with 1,200 μg q4wk, and 57.9% (66/114) with PEG‐IFNα‐2a ( P = 0.64 for overall test). Discontinuation rates due to adverse events were 9.3% with alb‐IFN 900 μg q2wk, 18.2% with 1,200 μg q2wk and 12.1% with 1,200 μg q4wk, and 6.1% with PEG‐IFNα‐2a ( P = 0.04). Hematologic reductions were lowest in the q4wk group and comparable across other groups. At week 12, mean treatment‐associated missed workdays were significantly lower with alb‐IFN 900 μg q2wk versus PEG‐IFNα‐2a (1.1 versus 4.3 days; P = 0.006). Conclusion: Alb‐IFN administered q2wk or q4wk may offer comparable efficacy, with an improved dosing schedule, compared with PEG‐IFNα‐2a. (H EPATOLOGY 2008;48:407–417.)