Safety and Antiviral Activity of Albinterferon Alfa-2b Dosed Every Four Weeks in Genotype 2/3 Chronic Hepatitis C Patients

Vincent G. Bain, Kelly D. Kaita, Paul Marotta, Eric M. Yoshida, Mark G. Swain, Robert J. Bailey, Keyur Patel, Patrick W. Cronin, Erik Pulkstenis, John G. McHutchison, G. Mani Subramanian

Research output: Contribution to journalArticle

Abstract

Background & Aims: A phase 2, randomized, multicenter, open-label study evaluated the safety and efficacy of albinterferon alfa-2b in interferon-α treatment-naïve patients with genotype 2/3, chronic hepatitis C virus infection. Methods: Forty-three patients were randomly assigned in a 1:1 ratio to receive subcutaneous albinterferon alfa-2b 1500 μg every 4 weeks (q4wk) or every 2 weeks (q2wk) with oral ribavirin 800 mg/day for 24 weeks. Primary efficacy end point was sustained virologic response (undetectable hepatitis C virus RNA 24 weeks after completion of treatment). Insulin resistance was also assessed. Results: The safety of albinterferon alfa-2b was acceptable, with a similar adverse event profile in both treatment arms. Discontinuation as a result of adverse events occurred in 4.5% and 14.3% of patients in the q4wk and q2wk arms, respectively. No dose reductions caused by adverse events were reported in the q4wk arm versus 9.5% in the q2wk arm. Rapid viral response rates at week 4 were 68.2% and 76.2% for the q4wk and q2wk arms, respectively; the corresponding sustained virologic response rates were 77.3% and 61.9%. Insulin resistance at baseline was significantly associated with lower sustained virologic response rates independent of body mass index. Conclusions: Albinterferon alfa-2b administered at 4-week intervals was safe and well-tolerated and demonstrated significant antiviral activity in patients with genotype 2/3, chronic hepatitis C virus. Insulin resistance appeared to have an independent effect on treatment response.

Original languageEnglish (US)
Pages (from-to)701-706
Number of pages6
JournalClinical Gastroenterology and Hepatology
Volume6
Issue number6
DOIs
StatePublished - Jun 2008
Externally publishedYes

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Chronic Hepatitis C
Antiviral Agents
Genotype
Hepacivirus
Insulin Resistance
Safety
Ribavirin
Virus Diseases
Therapeutics
Interferons
Body Mass Index
RNA
albinterferon alfa-2b
Sustained Virologic Response

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Safety and Antiviral Activity of Albinterferon Alfa-2b Dosed Every Four Weeks in Genotype 2/3 Chronic Hepatitis C Patients. / Bain, Vincent G.; Kaita, Kelly D.; Marotta, Paul; Yoshida, Eric M.; Swain, Mark G.; Bailey, Robert J.; Patel, Keyur; Cronin, Patrick W.; Pulkstenis, Erik; McHutchison, John G.; Subramanian, G. Mani.

In: Clinical Gastroenterology and Hepatology, Vol. 6, No. 6, 06.2008, p. 701-706.

Research output: Contribution to journalArticle

Bain, VG, Kaita, KD, Marotta, P, Yoshida, EM, Swain, MG, Bailey, RJ, Patel, K, Cronin, PW, Pulkstenis, E, McHutchison, JG & Subramanian, GM 2008, 'Safety and Antiviral Activity of Albinterferon Alfa-2b Dosed Every Four Weeks in Genotype 2/3 Chronic Hepatitis C Patients', Clinical Gastroenterology and Hepatology, vol. 6, no. 6, pp. 701-706. https://doi.org/10.1016/j.cgh.2008.02.056
Bain, Vincent G. ; Kaita, Kelly D. ; Marotta, Paul ; Yoshida, Eric M. ; Swain, Mark G. ; Bailey, Robert J. ; Patel, Keyur ; Cronin, Patrick W. ; Pulkstenis, Erik ; McHutchison, John G. ; Subramanian, G. Mani. / Safety and Antiviral Activity of Albinterferon Alfa-2b Dosed Every Four Weeks in Genotype 2/3 Chronic Hepatitis C Patients. In: Clinical Gastroenterology and Hepatology. 2008 ; Vol. 6, No. 6. pp. 701-706.
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T1 - Safety and Antiviral Activity of Albinterferon Alfa-2b Dosed Every Four Weeks in Genotype 2/3 Chronic Hepatitis C Patients

AU - Bain, Vincent G.

AU - Kaita, Kelly D.

AU - Marotta, Paul

AU - Yoshida, Eric M.

AU - Swain, Mark G.

AU - Bailey, Robert J.

AU - Patel, Keyur

AU - Cronin, Patrick W.

AU - Pulkstenis, Erik

AU - McHutchison, John G.

AU - Subramanian, G. Mani

PY - 2008/6

Y1 - 2008/6

N2 - Background & Aims: A phase 2, randomized, multicenter, open-label study evaluated the safety and efficacy of albinterferon alfa-2b in interferon-α treatment-naïve patients with genotype 2/3, chronic hepatitis C virus infection. Methods: Forty-three patients were randomly assigned in a 1:1 ratio to receive subcutaneous albinterferon alfa-2b 1500 μg every 4 weeks (q4wk) or every 2 weeks (q2wk) with oral ribavirin 800 mg/day for 24 weeks. Primary efficacy end point was sustained virologic response (undetectable hepatitis C virus RNA 24 weeks after completion of treatment). Insulin resistance was also assessed. Results: The safety of albinterferon alfa-2b was acceptable, with a similar adverse event profile in both treatment arms. Discontinuation as a result of adverse events occurred in 4.5% and 14.3% of patients in the q4wk and q2wk arms, respectively. No dose reductions caused by adverse events were reported in the q4wk arm versus 9.5% in the q2wk arm. Rapid viral response rates at week 4 were 68.2% and 76.2% for the q4wk and q2wk arms, respectively; the corresponding sustained virologic response rates were 77.3% and 61.9%. Insulin resistance at baseline was significantly associated with lower sustained virologic response rates independent of body mass index. Conclusions: Albinterferon alfa-2b administered at 4-week intervals was safe and well-tolerated and demonstrated significant antiviral activity in patients with genotype 2/3, chronic hepatitis C virus. Insulin resistance appeared to have an independent effect on treatment response.

AB - Background & Aims: A phase 2, randomized, multicenter, open-label study evaluated the safety and efficacy of albinterferon alfa-2b in interferon-α treatment-naïve patients with genotype 2/3, chronic hepatitis C virus infection. Methods: Forty-three patients were randomly assigned in a 1:1 ratio to receive subcutaneous albinterferon alfa-2b 1500 μg every 4 weeks (q4wk) or every 2 weeks (q2wk) with oral ribavirin 800 mg/day for 24 weeks. Primary efficacy end point was sustained virologic response (undetectable hepatitis C virus RNA 24 weeks after completion of treatment). Insulin resistance was also assessed. Results: The safety of albinterferon alfa-2b was acceptable, with a similar adverse event profile in both treatment arms. Discontinuation as a result of adverse events occurred in 4.5% and 14.3% of patients in the q4wk and q2wk arms, respectively. No dose reductions caused by adverse events were reported in the q4wk arm versus 9.5% in the q2wk arm. Rapid viral response rates at week 4 were 68.2% and 76.2% for the q4wk and q2wk arms, respectively; the corresponding sustained virologic response rates were 77.3% and 61.9%. Insulin resistance at baseline was significantly associated with lower sustained virologic response rates independent of body mass index. Conclusions: Albinterferon alfa-2b administered at 4-week intervals was safe and well-tolerated and demonstrated significant antiviral activity in patients with genotype 2/3, chronic hepatitis C virus. Insulin resistance appeared to have an independent effect on treatment response.

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