Authorized Generics of Epclusa, Harvoni Will Soon Be Available for HCV Treatment

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The authorized generic versions are anticipated to launch in January 2019.
The authorized generic versions are anticipated to launch in January 2019.

Gilead Sciences announced that its subsidiary, Asegua Therapeutics, will launch authorized generic versions of Epclusa (sofosbuvir, velpatasvir) and Harvoni (ledipasvir, sofosbuvir), both indicated for the treatment of hepatitis C virus (HCV) infection.

Epclusa combines sofobsuvir, an HCV NS5B polymerase inhibitor, and velpatasvir, an HCV NS5A inhibitor. It is indicated to treat HCV genotype 1, 2, 3, 4, 5, or 6 infection in adults without cirrhosis or with compensated cirrhosis; or with decompensated cirrhosis for use in combination with ribavirin (RBV).

Harvoni combines ledipasvir, an HCV NS5A inhibitor, and sofosbuvir, an HCV NS5B polymerase inhibitor. It is indicated to treat HCV genotype 1, 4, 5, or 6 infection in patients without cirrhosis or with compensated cirrhosis; genotype 1 with decompensated cirrhosis, in combination with ribavirin; or genotype 1 or 4 who are liver transplant recipients without cirrhosis or with compensated cirrhosis, in combination with ribavirin. 

“Launching these authorized generics is the best solution available to us today to quickly introduce a lower-priced alternative to our HCV medications without significant disruption to the healthcare system and our business,” said John F. Milligan, PhD, President and CEO, Gilead Sciences.

Epclusa is currently available as 400mg/100mg strength tablets. Harvoni is available as 90mg/400mg strength tablets. 

The authorized generic versions are anticipated to launch in January 2019. The list price for the generics is $24,000 for the most common course of therapy, which the Company states reflects the discounts that health insurers and government payers receive today.

For more information call (800) 445-3235 or visit Gilead.com.

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