FDA Approves Viekira Pak for Hepatitis C

December 19, 2014

The US Food and Drug Administration (FDA) today approved a combination oral drug called Viekira Pak (AbbVie) for chronic hepatitis C virus (HCV) genotype 1 that, depending on its price, could give physicians and patients a less expensive alternative to sofosbuvir (Sovaldi) and ledipasvir/sofosbuvir (Harvoni), both from Gilead Sciences.

The new hepatitis C treatment consists of three new drugs (ombitasvir, paritaprevir, and dasabuvir), along with ritonavir, which boosts the blood level of paritaprevir, the agency announced. Similar to ledipasvir/sofosbuvir, Viekira Pak is an all-oral regimen without the need for interferon, which comes with harsh adverse events, plus ribavirin for HCV genotype 1, although adding the latter drug is optional. Stand-alone sofosbuvir should be used in combination with both interferon and ribavirin for HCV genotypes 1 and 4, and ribavirin only for HCV genotypes 2 and 3.

"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 news 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."

Viekira Pak is indicated for patients with chronic HCV genotype 1, whether or not they have cirrhosis.

The steep price of sofosbuvir — $84,000 for a 12-week course — has rankled the healthcare industry. Last week, the transportation authority of Philadelphia, Pennsylvania, filed a federal class-action lawsuit against Gilead Sciences for charging "exorbitant" prices. Ledipasvir/sofosbuvir is even more expensive, at an estimated $94,500 per course of treatment.

Earlier this fall, Express Scripts, the nation's largest pharmacy benefit manager, said it may revise its formulary to favor Viekira Pak over sofosbuvir and ledipasvir/sofosbuvir if the newest HCV drug is less expensive, but just as effective.

When asked what AbbVie would charge for Viekira Pak, or whether the price would substantially undercut that of sofosbuvir and ledipasvir/sofosbuvir, company spokesperson Morry Smulevitz told Medscape Medical News, "AbbVie is currently drafting an official statement that will be issued over the newswire in the near future."

The FDA determined that Viekira Pak was effective, based on six clinical trials involving 2308 participants with chronic HCV, some of whom had cirrhosis. The trials aimed to measure whether HCV was no longer detectable in the bloodstream at least 12 weeks after the end of treatment, indicating a cure. Depending on the study, participants were randomly assigned to receive Viekira Pak or a sugar pill, Viekira Pak with or without ribavirin, or the new drug with ribavirin for either 12 weeks or 24 weeks. Cure rates across the various groups ranged from 91% to 100%.

Fatigue, itching, feeling weak or unenergetic, nausea, and trouble sleeping were the most common adverse events reported during the clinical trials.

European drug regulators recommended approval of their version of Viekira Pak in November.

More information about today's announcement is available on the FDA website.


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