A Future Without Hepatitis C?

The Liver Meeting 2014: American Association for the Study of Liver Diseases (AASLD)

William F. Balistreri, MD


December 16, 2014

In This Article

ABT-450/r, Ombitasvir, and Dasabuvir

Genotypes 1a and 1b

The IFN-free, all-oral, three direct-acting antivirals (3D) regimen of coformulated ABT-450, dosed with ritonavir and OMB with DAS, achieves high rates of SVR in patients infected with HCV genotype 1. Research presented further characterized the safety and efficacy of this regimen.

Everson and colleagues[14] reported the pooled data from four phase 3 clinical trials assessing the SVR12 rates of the 3D regimen with or without RBV in treatment-naive and peg-IFN/RBV-experienced genotype 1a patients, with or without cirrhosis. SVR12 rates were higher in treatment-naive patients without cirrhosis receiving 3D/ RBV (96%) compared with 3D alone (90%). High SVR12 rates were observed with both the 12- and 24-week regimens in patients with cirrhosis. However, in genotype 1a-infected patients with cirrhosis and a prior null response, a higher SVR12 rate was observed with longer treatment duration. Among patients receiving 3D/RBV, the rates of on-treatment virologic failure and relapse by posttreatment week 12 were low. Serious adverse events and discontinuations owing to adverse events occurred in < 3% of patients. Therefore, the 3D/RBV regimen achieved high SVR12 rates in historically difficult-to-cure subgroups of patients with prior null response and/or cirrhosis. Genotype 1a patients with cirrhosis and a prior null response may benefit from longer treatment duration.

Advanced Liver Disease

Efficacy of IFN-containing therapies in HCV-infected patients is affected by advanced liver disease, as clinically evidenced by hypoalbuminemia or thrombocytopenia.

Fried and colleagues[15] examined efficacy and safety of the all-oral 3D regimen with RBV (3D/RBV) in treatment-naive and experienced patients with HCV genotype 1 infection and compensated cirrhosis. Overall SVR12 rates were 92% and 96% for the 12- and 24-week arms, respectively. SVR12 rates did not differ substantially by sex, age, body mass index, or HCV RNA levels. SVR12 rates were 89%-97% in patients with platelet counts < 100 x 109/L and 84%-89% in patients with serum albumin levels < 35 g/L, indicating the efficacy of the 3D/RBV regimen across a broad range of subgroups, including patients with evidence of impaired hepatic synthetic function and/or evidence of portal hypertension.


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