First Drug for All Major Hepatitis C Genotypes Approved by FDA

The FDA today approved Epclusa to treat patients with chronic hepatitis C virus (HCV) with and without cirrhosis.

Gilead's Epclusa is a combination of sofosbuvir and the new drug velpatasvir. This is the first treatment approved to treat the 6 major genotypes of HCV.

“The approval of Epclusa represents an important step forward in the global effort to control and potentially eliminate HCV as it provides a safe, simple and effective cure for the majority of HCV-infected patients, regardless of genotype,” Ira Jacobson, MD, principal investigator in the Epclusa clinical trials, said in a press release. “Building on the established backbone of sofosbuvir, Epclusa demonstrated consistently high cure rates across all genotypes, including among patients with genotype 2 and 3, who traditionally have required ribavirin or other multi-pill regimens.”

A phase 3 clinical trial that evaluated the treatment included 1558 patients without cirrhosis or with mild cirrhosis.

Researchers found that 95% to 99% of patients had viral suppression after 12 weeks. They also found that 94% of patients with moderate-to-severe cirrhosis had viral suppression after 12 weeks.

For patients with moderate-to-severe cirrhosis, Epclusa was approved in combination with ribavirin.

The most common side effects of the drug are headache and fatigue, according to the FDA.

“Today’s approval represents a significant advance for patients with HCV genotypes 2 and 3, who previously required more complex and costly regimens,” said John Milligan, PhD, president and CEO of Gilead. “As the first and only pan-genotypic cure for hepatitis C, Epclusa has the potential to eliminate the need for genotype testing, which can be a barrier to treatment in certain resource-constrained settings. We look forward to making Epclusa available to patients around the world as quickly as possible.”

Epclusa carries a warning for symptomatic bradycardia after incidents of pacemaker intervention were reported when amiodarone was administered with sofosbuvir in combination with another HCV direct-acting antiviral. The co-administration of amiodarone with Epclusa is not recommended.

Epclusa also carries a warning for use with certain drugs that may decrease the amount of Epclusa in the blood, leading to diminished efficacy.

“This approval offers a management and treatment option for a wider scope of patients with chronic hepatitis C,” said Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

Stay up to date on the latest news in specialty pharmacy by getting Specialty Pharmacy Times in your mailbox or inbox for free!

Click here to sign up for free for the bi-monthly Specialty Pharmacy Times print journal delivered to your address.

Click here to sign up for our email newsletters delivered every Monday, Wednesday, and Friday, in addition to breaking news alerts.

Click here to follow us on Facebook. 

Click here to follow us on Twitter. 

Click here to join our LinkedIn group. 

Related Articles

A recent study demonstrates the clinical benefit from the use of direct-acting antivirals for hepatitis C virus in patients with a history of liver cancer.
Top news of the day from across the health care landscape.
Top news of the day from across the health care landscape.
Company Profile >
Industry Guide >
Market News >
Peer Exchange >
Conferences >
Subscribe >
Specialty Times Resources
About Us
Contact Us
Terms & Conditions
MJH Associates >
Pharmacy Times
American Journal of Managed Care
MD Magazine
Targeted Oncology
Physicians' Education Resource
Pharmacy & Healthcare Communications, LLC
2 Clarke Drive
Suite 100
Cranbury, NJ 08512
P: 609-716-7777
F: 609-716-4747

Copyright Specialty Pharmacy Times 2006-2019
Pharmacy & Healthcare Communications, LLC. All Rights Reserved.