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Virological Response and Safety Outcomes in Chronic Hepatitis C Patients Treated with Pegylated Interferon plus Taribavirin (Viramidine)

Pegylated interferon plus ribavirin is standard therapy for chronic hepatitis C virus (HCV) infection, but ribavirin can cause hemolytic anemia that sometimes necessitates dose reduction or drug discontinuation.

In an attempt to overcome this limitation, researchers have studied a ribavirin pro-drug, taribavirin (Viramidine), which appears to cause less red blood cell destruction.

In a study published in the July 2007 Journal of Hepatology, researchers sought to determine the efficacy and safety of taribavirin versus ribavirin combined with pegylated interferon in patients with chronic hepatitis C.

In this Phase 2 open-label study, 180 participants were randomly assigned to receive 180 mcg/week pegylated interferon alfa-2a (Pegasys) plus either taribavirin at doses of 800, 1200, or 1600 mg or ribavirin at doses of 1000 or 1200 mg once daily.

Results

The proportions of patients with undetectable HCV RNA at 12 weeks did not differ significantly between the taribavirin and ribavirin arms:

- taribavirin 800 mg: 38%;
- taribavirin 1200 mg: 42%;
- taribavirin 1600 mg: 49%;
- ribavirin: 49%.

The highest proportions of patients with undetectable HCV RNA at end of treatment occurred in the taribavirin 1200 mg and ribavirin groups (63% and 62%, respectively).

The same held true for sustained virological response (SVR) rates (37% and 44%, respectively).

SVR rates were 23%, 37%, and 29% in the 3 taribavirin dose groups, compared with 44% for ribavirin.

Significantly fewer patients taking any dose of taribavirin had severe anemia (hemoglobin <10 g/dL) compared with those taking ribavirin (4% vs 27%).

Conclusion

In conclusion, the authors wrote, "Given with interferon, taribavirin produced SVR rates comparable to those of ribavirin, with a lower occurrence of anemia."

Departments of Medicine and Transplantation, Division of Hepatology and Complex GI, Physicians Foundation, California Pacific Medical Center, San Francisco, CA, USA.

08/10/07

Reference
RG Gish, S Arora, KR Reddy, and others. Virological response and safety outcomes in therapy-naive patients treated for chronic hepatitis C with taribavirin or ribavirin in combination with pegylated interferon alfa-2a: A randomized, phase 2 study. Journal of Hepatology 47(1): 51-59. July 2007.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 




FDA-approved
Monotherapies for HCV
Intron A
Roferon

Infergen

Pegasys

PEG-Intron

FDA-approved
Combination
Therapies
for HCV
Pegasys + Copegus
PEG-Intron + Rebetol
Intron A + Rebetol
Roferon A + Ribavirin