FDA’s new hep C approval: A step closer to a cure?

October 13, 2014

FDA’s approval of ledipasvir 90 mg/sofosbuvir 400 mg (Harvoni, Gilead Sciences), the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults, may signal that industry is at the forefront of a cure for hepatitis C, according to one industry expert.

Lassen

FDA’s approval of ledipasvir 90 mg/sofosbuvir 400 mg (Harvoni, Gilead Sciences), the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults, may signal that industry is at the forefront of a cure for hepatitis C, according to one industry expert.

“There is a limited window of time left before hepatitis C is essentially eradicated in the not too distant future,” according to David Lassen, chief clinical officer, Prime Therapeutics. “Additionally, we are still at the point where manufacturer's can price products based on what the ‘market will bear.’ Even after significant scrutiny by the federal government over the Sovaldi price tag, we aren't seeing that market pressure driving down prices of new specialty agents coming to market, yet.”

Harvoni combines the NS5A inhibitor ledipasvir with the nucleotide analog polymerase inhibitor sofosbuvir (Sovaldi), which was approved in December 2013.

Drug Overview: Sovaldi (sofosbuvir)

“The approval of Harvoni is significant as the increased efficacy of this combo product will likely mean it will capture market share quickly,” Lassen said.

“The key for formulary managers is to make sure they are prepared to manage therapy at launch-meaning much of the work traditionally done after the product launch needs to happen further upstream,” he said.

 

Prime, according to Lassen, has taken proactive steps to put utilization management in place right away after the launch of the product for its Blue plans, to make sure that members get the drug that's most appropriate for their condition and to help control costs.

Harvoni’s efficacy has been established in patients with chronic hepatitis C virus (HCV) genotype 1 infection, with a treatment duration of 8, 12 or 24 weeks depending on prior treatment history, cirrhosis status and baseline viral load. Eight weeks of treatment with Harvoni can be considered for treatment-naïve patients without cirrhosis who have baseline HCV viral load below 6 million IU/mL.

“What's unique about Harvoni's approval is that the drug is a combination therapy that includes the current curative treatment, Sovaldi,” Lassen said. “So we won't see any competitive price point pressure yet. AbbVie is awaiting approval of their new hepatitis C drug later this year, so that could bring about some pricing competition. Additionally, it comes at a time when new starts of therapy with Sovaldi are decreasing. The big question will be how many individuals have been waiting for this new therapy [warehoused]. We believe that within the commercially insured population approximately half of the warehoused patients have been treated. This new approval will likely result in treatment beginning for many of the remaining warehoused patients.

The drug’s approval is supported by data from 3 phase 3 studies, ION-1, ION-2 and ION-3. These studies evaluated 8, 12 or 24 weeks of treatment with Harvoni, with or without ribavirin, among nearly 2,000 genotype 1 HCV patients with compensated liver disease. These studies included non-cirrhotic treatment-naïve patients (ION-3), cirrhotic and non-cirrhotic treatment-naïve patients (ION-1) and cirrhotic and non-cirrhotic patients who failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor (ION-2). The primary endpoint for each study was sustained virologic response (HCV undetectable) 12 weeks after completing therapy (SVR12).

Patients who achieve SVR12 are considered cured of HCV. In these studies, ribavirin was not shown to increase response rates. Trial participants in the ribavirin-free arms (n=863) achieved SVR12 rates of 94% to 99%.

Fatigue, headache, nausea, diarrhea and insomnia were the most common adverse reactions among patients treated with Harvoni.