On July 24, 2015, the US Food and Drug Administration (FDA) approved two new orally administered drugs for use in patients with hepatitis C virus (HCV) infections. Bristol-Myers Squibb’s Daklinza™ (daclatasvir) is now approved for use in patients with genotype 3, in combination with sofosbuvir (Sovaldi®, Gilead). AbbVie Inc.’s Technivie™ was approved for use in patients with genotype 4, without scarring and poor liver function (cirrhosis), in combination with ribavirin.
The Daklinza™ approval was based in part on a safety and efficacy trial in which the drug was administered in combination with sofosbuvir to 152 treatment-naive and treatment-experienced participants with chronic HCV genotype 3 infection. Trial participants received Daklinza™ 60 milligrams (mg) with sofosbuvir 400 mg once daily for 12 weeks. They were then monitored for 24 weeks post treatment. Results showed that 98% of the treatment-naive participants with no cirrhosis of the liver and 58% of the treatment-naive participants with cirrhosis achieved sustained virologic response (SVR), meaning they no longer had detectable virus in their blood. Of the participants who were treatment-experienced, 92% with no cirrhosis of the liver and 69% with cirrhosis achieved SVR.
“Today’s approval provides a new option for patients with genotype 3 HCV, including those patients who cannot tolerate ribavirin,” said Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
Technivie™, a combination of the drugs ombitasvir, paritaprevir and ritonavir, was approved based on the findings of a safety/efficacy study that included 135 people with chronic HCV genotype 4 infections. These patients were not affected by cirrhosis. 91 of the trial participants received Technivie with ribavirin once-a-day for 12 weeks; 44 participants received Technivie™ once daily without ribavirin for 12 weeks. Results showed that 100% of the participants who received Technivie™ with ribavirin achieved SVR. Those who received Technivie™ without ribavirin, achieved an SVR of 91%.
“Today’s approval provides the first treatment option for patients with genotype 4 HCV infections without requiring use of interferon,” said Cox.
Source: FDA news releases, July 24, 2015
