Virological response and safety outcomes in therapy–naïve patients treated for chronic hepatitis C with taribavirin or ribavirin in combination with pegylated interferon alfa-2a: A randomized, phase 2 study

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 hepatit...

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Bibliographic Details
Published in:Journal of hepatology 2007, Vol.47 (1), p.51-59
Main Authors: Gish, Robert G, Arora, Sanjeev, Rajender Reddy, K, Nelson, David R, O’Brien, Christopher, Xu, Yi, Murphy, Brian
Format: Article
Language:English
Subjects:
Anemia
Anemias. Hemoglobinopathies
Antibiotics. Antiinfectious agents. Antiparasitic agents
Antiviral agents
Biological and medical sciences
Diseases of red blood cells
Gastroenterology and Hepatology
Hematologic and hematopoietic diseases
Hepatitis C
Human viral diseases
Infectious diseases
Medical sciences
Pharmacology. Drug treatments
Phase 2 study
Ribavirin
Safety
Taribavirin
Viral diseases
Viral hepatitis
Viramidine
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Summary: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
ISSN:0168-8278
1600-0641
DOI:10.1016/j.jhep.2007.02.018