AbbVie announces positive Phase III results in hepatitis C drug
pharmafile | April 14, 2016 | News story | Manufacturing and Production, Research and Development | AbbVie, hepatitis, phase III
AbbVie (NYSE: ABBV) has announced positive results from their Phase III evaluating the combination of Viekirax and Exviera, with or without ribavirin, in patients with chronic hepatitis C.
The company combined the data from five completed Phase III clinical trials and found that patients received sustained virologic response rates at 48 weeks post-treatment, when they received the recommended regimen of Viekirax (ombitasvir/paritaprevir/ritonavir) and Exviera (dasabuvir).
Regardless of where certain resistance-associated variants of the virus were present (called NS5A RAVs), 100% of patients with genotype 1b of the hepatitis C virus achieved a positive virologic response without ribavirin. Furthermore 97% of patients with genotype 1a also achieved positive results with ribavirin. The therapy benefitted both those new to therapy and treatment-experienced with pegylated interferon/ribavirin, as well as those with compensated cirrhosis.
Christoph Sarrazin, professor of medicine at J.W. Goethe University Hospital in Frankfurt, says: “These results show that high virologic cure rates were achieved in HCV genotype 1a and 1b infected patients no matter their NS5A RAV status when treated with Viekirax and Exviera with and without ribavirin as recommended, a regimen which contains the NS5A inhibitor ombitasvir.”
Rob Scott, chief medical officer at AbbVie, comments: “It’s important that we understand emerging issues in treating people with chronic HCV, including RAVs, so that we can meet the needs of patients and physicians. As we learn more about the role of resistance to direct-acting antiviral regimens, it is vital to further investigate treatment options that are not affected by baseline RAVs.”
However, the variability in treatment responses when the NS5A protein is produced has yet to be fully determined.
Sean Murray
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