FDA approvals

FDA approves Viekira Pak for treatment of HCV

The FDA today approved a treatment for patients with hepatitis C virus genotype 1 infection, including those with cirrhosis, according to a press release.

A combination of ombitasvir, paritaprevir and ritonavir tablets with dasabuvir tablets, Viekira Pak, (AbbVie) is the fourth chronic HCV drug product the FDA has approved in the past 14 months, and the 11th drug to have previously received the FDA’s breakthrough therapy designation. It can be used with or without ribavirin, but is not recommended for patients with decompensated cirrhosis.

“The new generation of therapeutics for hepatitis C virus is changing the treatment paradigm for Americans living with the disease,” Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in the 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.”

Edward Cox

Edward Cox

Viekira Pak was evaluated in six clinical trials that included 2,308 participants with chronic HCV infection, some of whom also had cirrhosis. In separate trials, participants were randomly assigned Viekira Pak or placebo; Viekira Pak with or without ribavirin; or Viekira Pak with ribavirin for 12 or 24 weeks.

The primary outcome for each trial was sustained virologic response at least 12 weeks after therapy completion. Ninety-one percent to 100% of participants who received the treatment at recommended dosages (two ombitasvir, paritaprevir, ritonavir 12.5 mg/75 mg/ 50 mg once daily and one dasabuvir 250-mg tablet twice daily) achieved SVR. The most commonly reported side effects were feeling tired, itching, lethargy, nausea and insomnia.

Other drugs approved by the FDA to treat chronic HCV infection include simeprevir (Olysio, Janssen Pharmaceuticals), sofosbuvir (Sovaldi, Gilead Sciences) and ledipasvir and sofosbuvir (Harvoni, Gilead Sciences).

The FDA today approved a treatment for patients with hepatitis C virus genotype 1 infection, including those with cirrhosis, according to a press release.

A combination of ombitasvir, paritaprevir and ritonavir tablets with dasabuvir tablets, Viekira Pak, (AbbVie) is the fourth chronic HCV drug product the FDA has approved in the past 14 months, and the 11th drug to have previously received the FDA’s breakthrough therapy designation. It can be used with or without ribavirin, but is not recommended for patients with decompensated cirrhosis.

“The new generation of therapeutics for hepatitis C virus is changing the treatment paradigm for Americans living with the disease,” Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in the 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.”

Edward Cox

Edward Cox

Viekira Pak was evaluated in six clinical trials that included 2,308 participants with chronic HCV infection, some of whom also had cirrhosis. In separate trials, participants were randomly assigned Viekira Pak or placebo; Viekira Pak with or without ribavirin; or Viekira Pak with ribavirin for 12 or 24 weeks.

The primary outcome for each trial was sustained virologic response at least 12 weeks after therapy completion. Ninety-one percent to 100% of participants who received the treatment at recommended dosages (two ombitasvir, paritaprevir, ritonavir 12.5 mg/75 mg/ 50 mg once daily and one dasabuvir 250-mg tablet twice daily) achieved SVR. The most commonly reported side effects were feeling tired, itching, lethargy, nausea and insomnia.

Other drugs approved by the FDA to treat chronic HCV infection include simeprevir (Olysio, Janssen Pharmaceuticals), sofosbuvir (Sovaldi, Gilead Sciences) and ledipasvir and sofosbuvir (Harvoni, Gilead Sciences).