The HCV saga goes on: Epclusa has been approved for treatment of chronic Hepatitis C virus (HCV) infection



Epclusa is a fixed-dose combination tablet containing sofosbuvir, a drug approved as Sovaldi in 2013, and velpatasvir, a new drug, and is the first to treat all six major forms of HCV. The safety and efficacy of Sofosbuvir/Velpatasvir (Epclusa) for 12 weeks was evaluated in three Phase III clinical trials of 1,558 subjects without cirrhosis or with compensated cirrhosis (mild cirrhosis). Results demonstrated that 95–99 percent of patients who received Sofosbuvir/Velpatasvir (Epclusa) had no virus detected in the blood 12 weeks after finishing treatment, suggesting the patients’ infections had been cured. The safety and efficacy of Sofosbuvir/Velpatasvir (Epclusa) was also evaluated in a clinical trial of 267 subjects with decompensated cirrhosis (moderate to severe cirrhosis), of whom 87 subjects received Sofosbuvir/Velpatasvir (Epclusa) in combination with ribavirin for 12 weeks, and 94 percent of these patients had no virus detected in the blood 12 weeks after finishing treatment.

The most common side effects of Sofosbuvir/Velpatasvir (Epclusa) include headache and fatigue. Sofosbuvir/Velpatasvir (Epclusa) and ribavirin combination regimens are contraindicated for patients for whom ribavirin is contraindicated.

Sofosbuvir/Velpatasvir (Epclusa) carries a warning for patients and health care providers that serious slowing of the heart rate (symptomatic bradycardia) and cases requiring pacemaker intervention have been reported when amiodarone is used with sofosbuvir in combination with another HCV direct-acting antiviral. Co-administration of amiodarone with Sofosbuvir/Velpatasvir (Epclusa) is not recommended. Sofosbuvir/Velpatasvir (Epclusa) also carries a warning not to use with certain drugs that may reduce the amount of Sofosbuvir/Velpatasvir (Epclusa) in the blood which could lead to reduced efficacy of Sofosbuvir/Velpatasvir (Epclusa).


Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.

Posted in New Drug Approval, Thasso Post, Theragenomic Medicine
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One comment on “The HCV saga goes on: Epclusa has been approved for treatment of chronic Hepatitis C virus (HCV) infection
  1. thassodotcom thassodotcom says:

    The European Medicines Agency (EMA) has adopted, as of End of May 2016, a positive opinion on Epclusa as well:

    This means that Epclusa will be available in the European Union in a short amount of time also.

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