FDA Approves Supplemental NDA for AbbVie's Viekira Pak Hepatitis C Drug

The US Food and Drug Administration approved a supplemental New Drug Application submitted by drug maker AbbVie for Viekira Pak without ribavirin to treat patients with chronic hepatitis C genotype 1b and compensated cirrhosis.

Originally approved in 2014 for treatment of hepatitis C genotypes 1a and 1b, Viekira Pak contains ombitasvir, paritaprevir, and dasabuvir, three drugs that inhibit the growth of the hepatitis C virus, and the drug ritonavir, which is used to increase blood levels of paritaprevir. The sNDA approval allows for the use of Viekira Pak without ribavirin as a therapy for treating genotype 1b chronic hepatitis C patients both with and without compensated cirrhosis, according to a media spokesperson.

The supplemental application had been given FDA priority review status, which is granted to investigational drugs that treat serious conditions and could provide improved safety or effectiveness to what is already on the market, according to an AbbVie news release.

"We are constantly striving to advance clinical care for patients living with chronic hepatitis C," Michael Severino, MD, AbbVie’s executive vice president of research and development and chief scientific officer said in the release. "This approval is especially significant because patients with chronic HCV with compensated cirrhosis are among the tough to treat, and in our study Viekira Pak demonstrated 100 percent cure rates in GT1b patients without the use of ribavirin."

The Viekira Pak is among the new all oral regimens approved in recent years for the treatment of hepatitis C, a bloodborne virus that can seriously damage the liver over time. The newer drugs work faster and have higher cure rates than traditional treatment for chronic infection of the virus that often involved interferon injections.

Data submitted to the FDA included results from the TURQOISE-III clinical trial, a single-arm phase 3b study which evaluated 12 weeks of administration of Viekira Pak without ribavirin to treat hepatitis C genotype 1b patients with compensated liver cirrhosis (Child-Pugh A). Among the 60 patients who received the drug, 100% sustained virologic response at 12 weeks post treatment, a marker considered a cure for the virus, according to the release.

None of the patients in the trial stopped taking the drug because of adverse events. The most common AEs were fatigue, diarrhea, headache, arthralgia, dizziness, insomnia and pruritus.

Jordan Feld, MD, an AbbVie consultant and lead investigator in the trial, stated in the release that the approval provides a useful option for people infected with genotype 1b hepatitis C.

“The ability to cure these individuals with just 12 weeks of treatment and without the need for ribavirin is a great benefit," said Feld, the research director and clinician scientist for the Toronto Center for Liver Disease, Toronto, Canada. "The outstanding 100 percent cure rate from the study confirms that this is likely to be a very effective strategy."

Labeling information notes that the Viekira Pak is contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh B and C) due to risk of potential toxicity.