The FDA today approved ombitasvir, paritaprevir, and ritonavir tablets copackaged with dasabuvir tablets to treat individuals with chronic hepatitis C virus genotype 1 infection, including patients with cirrhosis.
The FDA today approved ombitasvir, paritaprevir, and ritonavir tablets copackaged with dasabuvir tablets (Viekira Pak) to treat individuals with chronic hepatitis C virus (HCV) genotype 1 infection, including patients with cirrhosis.
This product contains 3 new drugs that work to inhibit the growth of HCV, while the ritonavir works to increase blood levels of paritaprevir. The FDA’s approval makes Viekira Pak the fourth drug product approved to treat chronic HCV in the past year.
AbbVie’s trials of Viekira Pak enrolled 2308 patients with chronic HCV infection with and without cirrhosis. The subjects took either Viekira Pak or placebo, Viekira Pak with or without ribavirin, or Viekira Pak with ribavirin for 12 or 24 weeks.
The results showed 91% to 100% of patients who received the recommended dosing of Viekira Pak achieved sustained virologic response (SVR), meaning they were considered cured of HCV, after at least 12 weeks, according to the FDA.
The recommended dosage for Viekira Pak is 2 ombitasvir, paritaprevir, ritonavir 12.5 milligrams (mg)/75 mg/50 mg tablets once daily and 1 dasabuvir 250 mg tablet twice daily.
According to the FDA, Viekira Pak can be used with or without ribavirin, but it is not recommended for patients with decompensated cirrhosis.
“The new generation of therapeutics for HCV is changing the treatment paradigm for Americans living with the disease,” said Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in a press release. “We continue to see the development of new all-oral treatments with very high virologic response rates and improved safety profiles compared to some of the older interferon-based drug regimens.”
Common side effects of Viekira Pak were fatigue, itching, feeling weak or lack of energy, nausea, and trouble sleeping.