New Option for HCV / HIV Co-Infected Patients

The Food and Drug Administration (FDA) has approved a one-pill-a-day prescription regimen that works for all hepatitis C virus genotypes, and is compatible with widely-used antiretroviral regimens.

The updated labeling for Epclusa (sofosbuvir 400mg/velpatasvir 100mg), a once-daily single tablet regimen for the treatment of adults with chronic hepatitis C virus (HCV) infection, to include use in patients co-infected with HIV.

According to the Centers For Disease Control and Prevention (CDC), about one quarter of HIV-infected persons in the United States are also infected with Hepatitis C virus.

HCV is a bloodborne virus transmitted through direct contact with the blood of an infected person. HCV is one of the most important causes of chronic liver disease and may also impact the course and management of HIV infection.

Thus, coinfection with HIV and HCV is common (50%–90%) among HIV-infected injection drug users.

According to the CDC, an estimated 2.7-3.9 million people in the United States have chronic hepatitis C. After adjusting for under-reporting, an estimated 30,500 acute hepatitis C cases in 40 states occurred in 2014.

Because there are at least six known genotypes and more than 50 subtypes of HCV, genotype information is helpful in making recommendations regarding appropriate treatment regimen. The prevalence of HCV genotypes varies regionally, throughout the world.

Epclusa received FDA regulatory approval for the treatment of adults:

• with genotype 1-6 chronic HCV infection without cirrhosis,
• with compensated cirrhosis,
• with decompensated cirrhosis in combination with ribavirin.

“HCV co-infection remains a major cause of morbidity in HIV-infected individuals. With this expanded use, Epclusa provides co-infected patients with a much needed one-pill-a-day regimen that works across all HCV genotypes and is compatible with widely-used antiretroviral regimens,” said David Wyles, M.D., Chief, Division of Infectious Disease, Denver Health Medical Center; Associate Professor of Medicine,University of Colorado School of Medicine.

There is not a vaccine currently available for either hepatitis C or HIV.

To support these patients and their families, Gilead’s Epclusa Co-pay Coupon Program offers co-pay assistance for eligible patients with private insurance who need assistance paying for out-of-pocket medication costs.

Gilead has priced a 12-week regimen of Epclusa to cost $74,760. The cost of Epclusa is in-line with, if not a little less than, the other 12-week Hepatitis C medication regimens currently on the market.  The CDC price list can be found at this here.

Epclusa has a boxed warning in its product label regarding the risk of hepatitis B virus (HBV) reactivation in HCV/HBV co-infected patients. U.S. Full Prescribing Information for Epclusa, including BOXED WARNING, is available.