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FDA Approves Sofosbuvir/Velpatasvir Combo (Epclusa) for Treatment of Chronic HCV Infection

First drug to treat all six major forms of HCV

The FDA has given the green light to Epclusa (Gilead Sciences) for the treatment of adult patients with chronic hepatitis C virus (HCV) infection with or without cirrhosis. For patients with decompensated (moderate-to-severe) cirrhosis, Epclusa is approved for use in combination with ribavirin. Epclusa is a fixed-dose combination tablet containing sofosbuvir, a drug approved in 2013, and velpatasvir, a new drug, and is the first to treat all six major forms of HCV.

The safety and efficacy of Epclusa were evaluated in three 12-week, phase 3 trials involving a total of 1,558 subjects with HCV infection and cirrhosis or compensated cirrhosis (mild cirrhosis). The results showed that 95% to 99% of patients who received Epclusa had no virus detected in the blood 12 weeks after finishing treatment, suggesting that the patients’ infections had been cured. The safety and efficacy of Epclusa were also evaluated in a trial of 267 subjects with decompensated (moderate-to-severe) cirrhosis. In this study, 87 subjects received Epclusa in combination with ribavirin for 12 weeks. No virus was detected in the blood after 12 weeks of treatment in 94% of the patients.

The most common adverse events associated with Epclusa included headache and fatigue. Epclusa and ribavirin combination regimens are contraindicated in patients for whom ribavirin is contraindicated.

The label for Epclusa includes a warning that symptomatic bradycardia and cases requiring pacemaker intervention have been reported when amiodarone was used with sofosbuvir in combination with another HCV direct-acting antiviral agent. The coadministration of amiodarone with Epclusa is not recommended. The Epclusa label also carries a warning not to use the product with certain drugs that may reduce the amount of Epclusa in the blood, which could lead to reduced efficacy of Epclusa.

HCV infection causes inflammation of the liver that can lead to diminished liver function or liver failure. At least six distinct HCV genotypes, or strains, are genetically distinct groups of the virus. Knowing the genotype helps inform treatment recommendations and the duration of treatment. Approximately 75% of Americans with HCV have genotype 1; 20% to 25% have genotypes 2 or 3; and small numbers of patients are infected with genotype 4, 5, or 6.

According to the Centers for Disease Control and Prevention, HCV infection becomes chronic in approximately 75% to 85% of cases. Patients who develop chronic HCV infections over many years may have complications, such as bleeding, jaundice, fluid accumulation in the abdomen, infections, liver cancer, and death.

Source: FDA; June 28, 2016.

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