The FDA is taking into consideration a once-daily formulation of AbbVie's ombitasvir, paritaprevir, and ritonavir tablets co-packaged with dasabuvir tablets (Viekira Pak).
The FDA is taking into consideration a once-daily formulation of AbbVie’s ombitasvir, paritaprevir, and ritonavir tablets co-packaged with dasabuvir tablets (Viekira Pak).
The FDA’s acceptance of the new drug application for the genotype 1 chronic hepatitis C virus infection was based on data from 2 studies.
The original formulation was approved in 2014 with a recommended dosage of 2 ombitasvir, paritaprevir, ritonavir 12.5 milligrams (mg)/75 mg/50 mg tablets once daily and 1 dasabuvir 250 mg tablet twice daily.
"Nearly 1 year after the launch of Viekira Pak, AbbVie is pleased to announce the acceptance of a new drug application for a once-daily formulation for the treatment of patients with chronic genotype 1 hepatitis C," said Michael Severino, executive vice president of research and development and chief scientific officer at AbbVie, in a press release. "This milestone further underscores AbbVie's commitment to offer people living with hepatitis C optimized treatment options."
While the treatment can be used for patients with compensated cirrhosis, Viekira Pak should not be used in patients with advanced cirrhosis.
Adverse effects include fatigue, nausea, itching, and skin reactions.
Sleep problems, nausea, and itching may also occur when the drug is taken without ribavirin.
The FDA encourages health care providers and patients to report adverse effects to MedWatch.