TY - JOUR
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
N1 - Funding Information:
This study was supported by Human Genome Sciences, Rockville, Maryland, and Novartis Pharma AG, Basel, Switzerland. Drs Bain, Kaita, Marotta, Yoshida, Swain, Bailey, Patel, and McHutchison have received research support from Human Genome Sciences, Inc, Rockville, Maryland, and Novartis Pharma AG, Basel, Switzerland. Drs Cronin, Pulkstenis, and Subramanian are employees of Human Genome Sciences. BioScience Communications, New York, NY, provided editorial support funded by Human Genome Sciences and Novartis Pharma AG.
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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U2 - 10.1016/j.cgh.2008.02.056
DO - 10.1016/j.cgh.2008.02.056
M3 - Article
C2 - 18467185
AN - SCOPUS:44749094657
SN - 1542-3565
VL - 6
SP - 701
EP - 706
JO - Clinical Gastroenterology and Hepatology
JF - Clinical Gastroenterology and Hepatology
IS - 6
ER -