First-Ever Hep-C Drug Treatment For All Six Major Genotypes Approved By FDA

By John Lavitt 07/10/16

Though Epclusa may be a game changer for all chronic hep-C patients, the $74,000 price tag for a 12-week treatment regimen leaves much to be desired. 

First-Ever Hep-C Drug Treatment For All Six Major Genotypes Approved By FDA

The U.S. Food and Drug Administration has approved a new drug designed for the treatment of the chronic hepatitis C virus (HCV) in patients with advanced liver disease. Although Epclusa can be used to treat patients both with and without cirrhosis, the crucial role of the new drug is to help patients with serious liver damage. In addition, the new drug has the capability to treat all patients across the board.

Epclusa is a fixed-dose combination tablet containing sofosbuvir, one of the once notoriously expensive drugs approved in 2013, and velpatasvir, a new compound. Epclusa covers the treatment bases while also being the first truly effective treatment for people in dire straits. Developed by Gilead Sciences, Epclusa represents a major advancement in the treatment of HCV. 

As the first drug to treat all six major forms of the virus, Epclusa is a revolutionary step in the ability of doctors to treat all types of HCV. "This approval offers a management and treatment option for a wider scope of patients with chronic hepatitis C," Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a press release.

Though Gilead has been under fire for charging over $1,000 for a single Sovaldi pill, the company is taking a different tactic with Epclusa. The Big Pharma giant will price one pill of Epclusa at $890 a pill, which tallies about $74,760 for a 12-week treatment regimen

As a viral disease that causes inflammation of the liver that can lead to liver failure, hepatitis C historically has been difficult to treat because of the different strains of the virus. With at least six distinct HCV genotypes, which are genetically distinct groups of the virus, plus several mixed strains as well, reliable HCV treatment proved elusive for many years. Given the incredible advances in recent years brought on by applying HIV research to the hepatitis C virus, the playing field has been radically changed. 

According to the Centers for Disease Control and Prevention, HCV infection becomes chronic in about 80% of cases. Chronic HCV infection can lead to health complications in patients that include bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections, liver cancer and, ultimately, death. Despite these complications, HCV symptomatology usually does not become apparent without targeted testing until the infection is well-advanced and liver damage already has been done. 

As opposed to earlier treatments that combined interferon with ribavirin, which lead to numerous side effects and many poor treatment outcomes, Epclusa is a much easier drug regimen for patients to tolerate. The most common side effects of Epclusa alone are headache and fatigue, according to the FDA. Epclusa combined with ribavirin is an added regimen that also was approved in cases of severe liver damage. Approved under the FDA’s priority program, which provides for an expedited review of groundbreaking drugs that treat serious conditions, Epclusa was shown to offer a significant improvement in safety while offering the wider range of treatment applications.

Dr. Ira Jacobson, chairman of the department of medicine at Mount Sinai Beth Israel in New York City and the principal investigator in the Epclusa clinical trials, stated in a press release, “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.” 

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Growing up in Manhattan as a stutterer, John Lavitt discovered that writing was the best way to express himself when the words would not come. After graduating with honors from Brown University, he lived on the Greek island of Patmos, studying with his mentor, the late American poet Robert Lax. As a writer, John’s published work includes three articles in Chicken Soup For The Soul volumes and poems in multiple poetry journals and compilations. Active in recovery, John has been the Treatment Professional News Editor for The Fix. Since 2015, he has published over 500 articles on the addiction and recovery news website. Today, he lives in Los Angeles with his beautiful wife, trying his best to be happy and creative. Find John on Facebook, Twitter, and LinkedIn.