Introducing Epclusa

The treatment options for hepatitis C infections just gained a member to the club. There are six genotypes (numbered 1-6) of the hepatitis C virus. Previously, hepatitis C medications generally worked best for only one or a few genotypes. Consequently, identifying a patient’s genotype was an important part of the treatment process in order to determine the best medication for each patient.

This all changed with last week’s FDA approval of Gilead’s Epclusa® (sofosbuvir/velpatasvir). Epclusa, a combination of Sovaldi® (sofosbuvir) with a new NS5A inhibitor called velpatasvir in one pill, has been shown in research to successfully treat all types of hepatitis C. Epclusa is approved to treat adult patients with hepatitis C, both with and without cirrhosis.

Epclusa gained FDA approval on Tuesday, June 28, 2016 after a priority review of its New Drug Application. Epclusa was approved after a series of four clinical trials demonstrated excellent safety and efficacy during 12-week treatment courses. Two of these studies indicated a 97-100% cure rate (measured by sustained virologic response) in patients with genotypes 1a, 1b, 2, 4, 5, or 6. Patients with the difficult-to-treat genotype 3 reached 95% sustained virologic response. Genotype 3 accounts for about 20% of hepatitis C cases in the U.S. The wholesale acquisition cost (WAC) for Epclusa is $74,760, which is nearly 50% lower than the previous treatment for genotype 3.

Another difficult-to-treat patient group – that of patients with cirrhosis or previous treatment failure – achieved sustained virologic responses in 89-91% of cases. In all patients, few serious adverse effects were noted (16-19%), generally headache and fatigue.

The HCV Treatment Path app version 4.0 from BioPlus Specialty Pharmacy assists prescribers in navigating the therapy options for patients, by providing guidelines and tools to streamline the selection of treatment that is best-suited to individual patients, based on criteria from experts such as the FDA and the AASLD (American Association for the Study of Liver Diseases). Click here to preview this app.

Sources

Curry MP, O’Leary JG, Bzowej N, et al. Sofosbuvir and velpatasvir for HCV in patients with decompensated cirrhosis. N Engl J Med 2015;373:2618-28.

Feld JJ, Jacobson IM, Hezode C, et al. Sofosbuvir and velpatasvir for HCV genotype 1, 2, 4, 5, and 6 infection. N Engl J Med 2015;373:2599-2607.

Foster GR, Afdhal N, Roberts SK, et al. Sofosbuvir and velpatasvir for HCV genotype 2 and 3 infection. N Engl J Med 2015;373:2608-17.

 

Stephen C. Vogt, Pharm.D.
President and CEO
BioPlus Specialty Pharmacy

www.bioplusrx.com


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