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Safety and antiviral activity of albinterferon alfa-2b dosed every four weeks in genotype 2/3 chronic hepatitis C patients.

Publication ,  Journal Article
Bain, VG; Kaita, KD; Marotta, P; Yoshida, EM; Swain, MG; Bailey, RJ; Patel, K; Cronin, PW; Pulkstenis, E; McHutchison, JG; Subramanian, GM
Published in: Clin Gastroenterol Hepatol
June 2008

BACKGROUND & AIMS: A phase 2, randomized, multicenter, open-label study evaluated the safety and efficacy of albinterferon alfa-2b in interferon-alpha 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 microg 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.

Duke Scholars

Published In

Clin Gastroenterol Hepatol

DOI

EISSN

1542-7714

Publication Date

June 2008

Volume

6

Issue

6

Start / End Page

701 / 706

Location

United States

Related Subject Headings

  • Viral Load
  • Treatment Outcome
  • Ribavirin
  • Recombinant Proteins
  • RNA, Viral
  • Middle Aged
  • Male
  • Interferon-alpha
  • Interferon alpha-2
  • Injections, Subcutaneous
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Bain, V. G., Kaita, K. D., Marotta, P., Yoshida, E. M., Swain, M. G., Bailey, R. J., … Subramanian, G. M. (2008). Safety and antiviral activity of albinterferon alfa-2b dosed every four weeks in genotype 2/3 chronic hepatitis C patients. Clin Gastroenterol Hepatol, 6(6), 701–706. https://doi.org/10.1016/j.cgh.2008.02.056
Bain, Vincent G., Kelly D. Kaita, Paul Marotta, Eric M. Yoshida, Mark G. Swain, Robert J. Bailey, Keyur Patel, et al. “Safety and antiviral activity of albinterferon alfa-2b dosed every four weeks in genotype 2/3 chronic hepatitis C patients.Clin Gastroenterol Hepatol 6, no. 6 (June 2008): 701–6. https://doi.org/10.1016/j.cgh.2008.02.056.
Bain VG, Kaita KD, Marotta P, Yoshida EM, Swain MG, Bailey RJ, et al. Safety and antiviral activity of albinterferon alfa-2b dosed every four weeks in genotype 2/3 chronic hepatitis C patients. Clin Gastroenterol Hepatol. 2008 Jun;6(6):701–6.
Bain, Vincent G., et al. “Safety and antiviral activity of albinterferon alfa-2b dosed every four weeks in genotype 2/3 chronic hepatitis C patients.Clin Gastroenterol Hepatol, vol. 6, no. 6, June 2008, pp. 701–06. Pubmed, doi:10.1016/j.cgh.2008.02.056.
Bain VG, Kaita KD, Marotta P, Yoshida EM, Swain MG, Bailey RJ, Patel K, Cronin PW, Pulkstenis E, McHutchison JG, Subramanian GM. Safety and antiviral activity of albinterferon alfa-2b dosed every four weeks in genotype 2/3 chronic hepatitis C patients. Clin Gastroenterol Hepatol. 2008 Jun;6(6):701–706.
Journal cover image

Published In

Clin Gastroenterol Hepatol

DOI

EISSN

1542-7714

Publication Date

June 2008

Volume

6

Issue

6

Start / End Page

701 / 706

Location

United States

Related Subject Headings

  • Viral Load
  • Treatment Outcome
  • Ribavirin
  • Recombinant Proteins
  • RNA, Viral
  • Middle Aged
  • Male
  • Interferon-alpha
  • Interferon alpha-2
  • Injections, Subcutaneous