The U.S. Food and Drug Administration (FDA) has approved the anti-hepatitis C drug Epclusa for the treatment of chronic hepatitis C virus (HCV) infection in adults.
The safety evaluation of Epclusa was based on data from a Phase III clinical trial in patients with HCV infection of genotypes 1, 2, 3, 4, 5, or 6 (with or without compensated cirrhosis), including 1035 patients who received Epclusa treatment for 12 weeks.
Among patients who received Epclusa treatment for 12 weeks, the proportion of patients who permanently discontinued treatment due to adverse events was 0.2%, and the proportion of patients experiencing serious adverse events was 3.2%. In the clinical studies, headache, fatigue, and nausea were the most common (incidence ≥10%) sudden adverse events in patients treated with Epclusa. These and other adverse events occurred at a similar frequency in patients treated with placebo compared to patients treated with Epclusa.
The safety of Epclusa was evaluated in an open-label study in patients with CPTB-stage cirrhosis who received Epclusa for 12 weeks (n=90), Epclusa plus ribavirin for 12 weeks (n=87), or Epclusa for 24 weeks (n=90). Observed adverse events were consistent with sequelae of decompensated liver disease, or with toxicity associated with Epclusa plus ribavirin.
In the 87 patients who received Epclusa plus ribavirin for 12 weeks, 23% and 7% experienced a decrease in hemoglobin to below 10 g/dL and 8.5 g/dL, respectively, during treatment. Ribavirin was discontinued in 15% of patients who received Epclusa plus RBV for 12 weeks due to adverse events.
What are the most important things I should know about Epclusa?
A serious side effect that Epclusa may cause is bradycardia.
If you have previously been infected with hepatitis B virus, using Epclusa may reactivate the hepatitis B virus. Because the use of Epclusa in children and adolescents has not been studied, it should not be used by children and adolescents under the age of 18.
Epclusa is contraindicated if:
● You are allergic to sofosbuvir, velpatasvir, or any other component of this drug.
● You are currently taking any of the following medications:
1. Rifampin and rifabutin (antibiotics used to treat infections, including tuberculosis);
2. St. John's wort – an herbal remedy for depression;
3. Carbamazepine, phenobarbital, and phenytoin (medications used to treat epilepsy and prevent seizures);
