Albinterferon alfa-2b dosed every two or four weeks in interferon-naïve patients with genotype 1 chronic hepatitis C

Stefan Zeuzem, Eric M. Yoshida, Yves Benhamou, Stephen Pianko, Vincent G. Bain, Daniel Shouval, Robert Flisiak, Vratislav Rehak, Mircea Grigorescu, Kelly Kaita, Patrick W. Cronin, Erik Pulkstenis, G. Mani Subramanian, John G. McHutchison

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)407-417
Number of pages11
JournalHepatology
Volume48
Issue number2
DOIs
StatePublished - Aug 2008
Externally publishedYes

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Chronic Hepatitis C
Interferons
Genotype
interferon alfa-2b
Hepacivirus
RNA
Intention to Treat Analysis
Ribavirin
Therapeutics
Recombinant Proteins
Limit of Detection
Real-Time Polymerase Chain Reaction
Albumins
Appointments and Schedules
albinterferon alfa-2b
peginterferon alfa-2a
Safety
Weights and Measures
Sustained Virologic Response

ASJC Scopus subject areas

  • Hepatology

Cite this

Zeuzem, S., Yoshida, E. M., Benhamou, Y., Pianko, S., Bain, V. G., Shouval, D., ... McHutchison, J. G. (2008). Albinterferon alfa-2b dosed every two or four weeks in interferon-naïve patients with genotype 1 chronic hepatitis C. Hepatology, 48(2), 407-417. https://doi.org/10.1002/hep.22403

Albinterferon alfa-2b dosed every two or four weeks in interferon-naïve patients with genotype 1 chronic hepatitis C. / 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.

In: Hepatology, Vol. 48, No. 2, 08.2008, p. 407-417.

Research output: Contribution to journalArticle

Zeuzem, S, Yoshida, EM, Benhamou, Y, Pianko, S, Bain, VG, Shouval, D, Flisiak, R, Rehak, V, Grigorescu, M, Kaita, K, Cronin, PW, Pulkstenis, E, Subramanian, GM & McHutchison, JG 2008, 'Albinterferon alfa-2b dosed every two or four weeks in interferon-naïve patients with genotype 1 chronic hepatitis C', Hepatology, vol. 48, no. 2, pp. 407-417. https://doi.org/10.1002/hep.22403
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. / Albinterferon alfa-2b dosed every two or four weeks in interferon-naïve patients with genotype 1 chronic hepatitis C. In: Hepatology. 2008 ; Vol. 48, No. 2. pp. 407-417.
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abstract = "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-na{\"i}ve 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.",
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AU - Yoshida, Eric M.

AU - Benhamou, Yves

AU - Pianko, Stephen

AU - Bain, Vincent G.

AU - Shouval, Daniel

AU - Flisiak, Robert

AU - Rehak, Vratislav

AU - Grigorescu, Mircea

AU - Kaita, Kelly

AU - Cronin, Patrick W.

AU - Pulkstenis, Erik

AU - Subramanian, G. Mani

AU - McHutchison, John G.

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N2 - 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.

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