Epclusa Receives FDA Approval for Broad-Scale Treatment of HCV

Gilead Sciences’ new combination medication, Epclusa, has just received the green light from the US Food and Drug Administration (FDA) for treatment of all major forms of HCV. The fixed-dose tablet is intended for use by adults with chronic hepatitis C virus infection, and is administered over a 12-week regimen. The medication, a combination of sofosbuvir and velpatasvir, is the first of its kind capable of treating all six major genotypes of the infection. Its broad coverage could be utilized at the primary care level, and reduce or eradicate the need for genotype testing before treatment. As Gilead Sciences President and CEO John Gilliland notes, genotype testing “can be a barrier to treatment in certain resource-constrained settings.”

“Gilead believes the pricing of Epclusa will facilitate access for the US population with the greatest unmet medical need—patients with genotypes 2 and 3 who previously required more complex and costly multi-tablet regimens. For genotype 3 patients in particular, the cost of Epclusa will be half the cost of the most commonly used regimen (sofosbuvir plus daclatasvir).”
-Cara Miller, Gilead Sciences Spokesperson

The new first-line of defense can be used by anyone with HCV, regardless of if they have cirrhosis. However, those with moderate to severe cirrhosis are encouraged to use Epclusa with the medication ribavirin. What is notable about this medication, besides it not requiring concomitant use of interferons, is that it provides a lower-cost treatment option for those with less-common types of HCV. The price for the 12-week regimen is roughly $75,000, whereas it’s counterparts that feature sofosbuvir alone can range from $85,000-$95,000. Those with genotypes 2 and 3 often require several different treatments together, which can add up to substantially more than Epclusa alone.

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

Epclusa received its approval after four clinical trials utilizing the sofosbuvir/velpatasvir combination proved it was both safe and incredibly effective. 1,558 individuals with mild to no cirrhosis were evaluated in the first three trials, and of those, 95-99% who received the new treatment showed no detectable signs of the virus in their bloodstream after 12 weeks. The last trial evaluated individuals that had moderate to severe cirrhosis accompanying their HCV. Of the 87 individuals who received concomitant treatment of Epclusa and ribavirin, 94% showed no detectable signs of the virus in their bloodstream after 12 weeks.

The medication’s label warns that it should not be taken with amiodaron (an antiarrhythmic agent), after pacemaker interventions and symptomatic bradycardia were observed. The only adverse side effects reported thus far are headache and fatigue. Overall, Epclusa is proving to be a great broad-range, first-line of treatment for those with all major forms of HCV.1,2

For more information regarding the approval of Epclusa, visit the FDA press release.

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