Virological response and safety outcomes in therapy-nai{dotless}̈ve patients treated for chronic hepatitis C with taribavirin or ribavirin in combination with pegylated interferon alfa-2a: A randomized, phase 2 study>

Robert G. Gish, Sanjeev Arora, K. Rajender Reddy, David R. Nelson, Christopher O'Brien, Yi Xu, Brian Murphy

Research output: Contribution to journalArticlepeer-review

43 Scopus citations

Abstract

Background/Aims: Pegylated interferon plus ribavirin can cause dose-limiting anemia. Taribavirin, a ribavirin prodrug, has shown a lower incidence of anemia. We sought to determine the efficacy and safety of taribavirin vs. ribavirin combined with pegylated interferon in patients with chronic hepatitis C (CHC). Methods: This phase 2 open-label study randomized 180 patients with CHC to receive pegylated interferon alfa-2a 180 μg/week plus taribavirin 800, 1200 or 1600 mg QD or ribavirin 1000 or 1200 mg QD. Efficacy variables included proportions of patients with undetectable serum HCV RNA levels at end of treatment and after a 24-week follow-up. Results: The proportions of patients with undetectable HCV RNA at 12 weeks did not differ significantly between taribavirin (38%, 42%, and 49% for the 800, 1200, and 1600 mg groups) and ribavirin (49%). The highest proportion of patients with undetectable HCV RNA at end of treatment and at follow-up occurred in both the taribavirin 1200 mg QD (63% and 37%) and ribavirin groups (62% and 44%). SVR rates were 23%, 37% and 29% for taribavirin and 44% for ribavirin. Fewer patients on any dose of taribavirin had severe anemia (hemoglobin <10 g/dL) than on ribavirin (6/135 [4%] vs. 12/45 [27%]). Conclusions: Given with interferon, taribavirin produced SVR rates comparable to those of ribavirin, with a lower occurrence of anemia.

Original languageEnglish (US)
Pages (from-to)51-59
Number of pages9
JournalJournal of Hepatology
Volume47
Issue number1
DOIs
StatePublished - Jul 2007

Keywords

  • Anemia
  • Hepatitis C
  • Phase 2 study
  • Ribavirin
  • Safety
  • Taribavirin
  • Viramidine

ASJC Scopus subject areas

  • Gastroenterology

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