Is Ribavirin Necessary in HCV Treatment Regimens?
With or without ribavirin, combination therapy for hepatitis C virus (HCV) infection comprised of ABT-450/r plus ombitasvir and dasabuvir—the 3D regimen—significantly increases the chance of achieving sustained virologic response. Furthermore, treatment with ribavirin also normalizes liver chemistry in patients with cirrhosis, according to 2 studies presented at the annual meeting of the American College of Gastroenterology.
For the first study, researchers followed 599 patients infected with HCV genotype 1b without cirrhosis, and randomized to the 3D regimen (150 mg/100 mg/25 mg once daily ABT-450/r/ombitasvir and 250 mg twice daily dasabuvir) with or without 1000 mg to 1200 mg once daily ribavirin.
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Note: Previous studies have tested the efficacy of the 3D regimen with and without ribavirin, but this is the first study of its kind to allow patients previously treated with pegylated interferon/ribavirin into the group of participants.
After 12 weeks, 99.3% of the 301 patients not taking ribavirin and 98.7% of the 298 who were taking ribavirin achieved and maintained sustained virologic response.
Two patients did not achieve SVR due to missing the 12th week of treatment, 1 due to virologic breakthrough, and 2 (taking 3D plus ribavirin) due to discontinuation of drug treatment because of adverse events.
In the second study, researchers assessed the efficacy 3D regimen with ribavirin in 380 patients with Child-Pugh A cirrhosis and HCV infection. Participants were randomly assigned treatment for either 12 or 24 weeks and eligible for the study only if they had platelet counts of 60,000 cells/mm3 or higher, serum albumin of 2.8 g/dL or higher, and total bilirubin below 3 mg/dL.
Overall, 92% of those treated for 12 weeks and 96% of those treated for 24 weeks achieved SVR.
Alanine aminotransferase (ALT) levels fell from 99 U/L to 24 U/L and aminotransferase (AST) from 88 U/L to 27 U/L in patients treated for 12 weeks. In those treated for 24 weeks, ALT fell from 100 U/L to 19 U/L, while AST fell from 92 U/L to 24 U/L.
—Michael Potts
References:
Maieron A, Puoti M, Enejosa J, et al. SVR12 of 99% achieved with a ribavirin-free regimen of ABT-450/r/ombitasvir and dasabuvir in HCV genotype 1b-infected patients. Paper presented at the annual meeting of the American College of Gastroenterology, Philadelphia, PA; October 17, 2014.
Everson G, Lee S, Zeuzem S, et al. Normalization of liver-related laboratory parametersin HCV genotype 1-infected patients with cirrhosis after treatment with ABT-450/R/ombitasvir, dasabuvir and ribavirin. Paper presented at the annual meeting of the American College of Gastroenterology, Philadelphia, PA; October 17, 2014.