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Virologic response rates of weight-based taribavirin versus ribavirin in treatment-naive patients with genotype 1 chronic hepatitis C.

Publication ,  Journal Article
Poordad, F; Lawitz, E; Shiffman, ML; Hassanein, T; Muir, AJ; Bacon, BR; Heise, J; Halliman, D; Chun, E; Hammond, J
Published in: Hepatology
October 2010

UNLABELLED: Ribavirin-induced hemolytic anemia can prompt dose reductions and lower sustained virologic response (SVR) rates in the treatment of patients with chronic hepatitis C. The study aimed to determine if weight-based dosing of taribavirin (TBV), an oral prodrug of ribavirin (RBV), demonstrated efficacy comparable to RBV while maintaining its previously demonstrated anemia advantage with fixed dose administration. A U.S. phase 2b randomized, open-label, active-controlled, parallel-group study was conducted in 278 treatment-naive patients infected with genotype 1 who were stratified by body weight and baseline viral load. Patients were randomized 1:1:1:1 to receive TBV (20, 25, or 30 mg/kg/day) or RBV (800-1400 mg/day) with pegylated interferon alfa-2b for 48 weeks. The SVR rates in this difficult-to-cure patient demographics (mean age, 49 years; 61% male; 30% African American or Latino; high viral load; advanced fibrosis; and mean weight, 82 kg) were 28.4%, 24.3%, 20.6%, and 21.4% in the 20, 25, and 30 mg/kg TBV groups and the RBV group, respectively. There were no statistical differences in the efficacy analyses. Anemia rates were significantly lower (P < 0.05) in the 20 and 25 mg/kg/day TBV treatment groups (13.4% and 15.7%, respectively) compared to RBV (32.9%). The most common adverse events in all groups were fatigue, diarrhea, and insomnia. Diarrhea, reported in 38% of TBV patients versus 21% of RBV patients, was generally mild and not dose-limiting. CONCLUSION: All TBV doses demonstrated efficacy and tolerability comparable to that of RBV; however, the 25 mg/kg dose demonstrated the optimal balance of safety and efficacy. Anemia rates were significantly lower for TBV given at 20-25 mg/kg than RBV. These data suggest weight-based dosing with TBV provides a safe and effective treatment alternative to RBV for chronic hepatitis C. American Association for the Study of Liver Diseases.

Duke Scholars

Published In

Hepatology

DOI

EISSN

1527-3350

Publication Date

October 2010

Volume

52

Issue

4

Start / End Page

1208 / 1215

Location

United States

Related Subject Headings

  • Viral Load
  • Treatment Outcome
  • Ribavirin
  • Recombinant Proteins
  • Polyethylene Glycols
  • Middle Aged
  • Male
  • Interferon-alpha
  • Interferon alpha-2
  • Humans
 

Citation

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Poordad, F., Lawitz, E., Shiffman, M. L., Hassanein, T., Muir, A. J., Bacon, B. R., … Hammond, J. (2010). Virologic response rates of weight-based taribavirin versus ribavirin in treatment-naive patients with genotype 1 chronic hepatitis C. Hepatology, 52(4), 1208–1215. https://doi.org/10.1002/hep.23827
Poordad, Fred, Eric Lawitz, Mitchell L. Shiffman, Tarek Hassanein, Andrew J. Muir, Bruce R. Bacon, Jamie Heise, Deanine Halliman, Eric Chun, and Janet Hammond. “Virologic response rates of weight-based taribavirin versus ribavirin in treatment-naive patients with genotype 1 chronic hepatitis C.Hepatology 52, no. 4 (October 2010): 1208–15. https://doi.org/10.1002/hep.23827.
Poordad F, Lawitz E, Shiffman ML, Hassanein T, Muir AJ, Bacon BR, et al. Virologic response rates of weight-based taribavirin versus ribavirin in treatment-naive patients with genotype 1 chronic hepatitis C. Hepatology. 2010 Oct;52(4):1208–15.
Poordad, Fred, et al. “Virologic response rates of weight-based taribavirin versus ribavirin in treatment-naive patients with genotype 1 chronic hepatitis C.Hepatology, vol. 52, no. 4, Oct. 2010, pp. 1208–15. Pubmed, doi:10.1002/hep.23827.
Poordad F, Lawitz E, Shiffman ML, Hassanein T, Muir AJ, Bacon BR, Heise J, Halliman D, Chun E, Hammond J. Virologic response rates of weight-based taribavirin versus ribavirin in treatment-naive patients with genotype 1 chronic hepatitis C. Hepatology. 2010 Oct;52(4):1208–1215.
Journal cover image

Published In

Hepatology

DOI

EISSN

1527-3350

Publication Date

October 2010

Volume

52

Issue

4

Start / End Page

1208 / 1215

Location

United States

Related Subject Headings

  • Viral Load
  • Treatment Outcome
  • Ribavirin
  • Recombinant Proteins
  • Polyethylene Glycols
  • Middle Aged
  • Male
  • Interferon-alpha
  • Interferon alpha-2
  • Humans