Combination tablet approved to treat chronic hepatitis C

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Food and Drug Administration approved a medication to treat adults who have chronic hepatitis C. The medication also is approved in combination with ribavirin to treat patients who have moderate-to-severe cirrhosis (advanced liver disease).

The medication, which is marketed as Epclusa by Gilead Sciences, is a fixed-dose combination tablet that contains sofosbuvir and velpatasvir and is the first to treat all six major forms of the hepatitis C virus (HCV).

Hepatitis C is a viral disease that causes inflammation of the liver that can lead to liver failure. According to Centers for Disease Control and Prevention, HCV infection becomes chronic in 75 percent to 85 percent of cases. People who have chronic hepatitis C might have complications over many years, such as bleeding, jaundice (yellowish skin or eyes), fluid that’s in the abdomen, infections, liver cancer and death.

FDA reports that a clinical trial of 1,558 patients who had hepatitis C without cirrhosis or with mild cirrhosis showed that at least 95 percent who received the tablet for 12 weeks had no HCV in their blood 12 weeks after they finished treatment, which suggests that the patients’ infections had been cured. A trial of 267 patients who had hepatitis C and moderate-to-severe cirrhosis and used the tablet along with ribavirin for 12 weeks showed that 94 percent had no HCV in their blood 12 weeks after they finished treatment, FDA says.

The tablet’s most common side effects in clinical trials included headache and fatigue. The tablet carries a warning for patients and health-care providers that serious slowing of the heart (symptomatic bradycardia) and cases that require pacemaker intervention have been reported when amiodarone, which is a medication that’s used to treat certain types of serious irregular heartbeats, is used with sofosbuvir. FDA doesn’t recommend taking the tablet with amiodarone. The tablet also has a warning that advises that the tablet shouldn’t be used with certain medications that might reduce the amount of the medication that’s in the blood, which might reduce the tablet’s efficacy.