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FDA Approves Sofosbuvir/Velpatasvir for Treatment of Chronic Hepatitis C Virus Infection

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On June 28, the U.S. Food and Drug Administration (FDA) approved a fixed-dose combination of sofosbuvir, 400 mg, plus velpatasvir, 100 mg (Epclusa) to treat adult patients with chronic hepatitis C virus (HCV) either with or without cirrhosis. For patients with moderate to severe cirrhosis (decompensated cirrhosis), sofosbuvir/velpatasvir is approved for use in combination with the drug ribavirin. Sofosbuvir was approved in 2013 as a single-agent tablet (Sovaldi), and velpatasvir is a new agent. The combination drug is the first to treat all six major forms of HCV.

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

Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. There are at least six distinct HCV genotypes. 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 a small number of patients are infected with genotypes 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 suffer from chronic HCV infection over many years may have complications such as bleeding, jaundice, fluid accumulation in the abdomen, infections, liver cancer, and death.

Supporting Research

The safety and efficacy of sofosbuvir/velpatasvir 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% to 99% of patients who received sofosbuvir/velpatasvir 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 was also evaluated in a clinical trial of 267 subjects with decompensated cirrhosis, of whom 87 subjects received sofosbuvir/velpatasvir in combination with ribavirin for 12 weeks. Of these patients, 94% had no virus detected in the blood 12 weeks after finishing treatment.

The most common side effects of sofosbuvir/velpatasvir include headache and fatigue. Sofosbuvir/velpatasvir–and-ribavirin combination regimens are contraindicated for patients for whom ribavirin is contraindicated.

Sofosbuvir/velpatasvir carries a warning for patients and health-care providers that symptomatic bradycardia and cases requiring pacemaker intervention have been reported when amiodarone is used with sofosbuvir in combination with another HCV direct-acting antiviral agent. Coadministration of amiodarone with sofosbuvir/velpatasvir is not recommended. Sofosbuvir/velpatasvir also carries a warning not to use with certain drugs that may reduce the amount of sofosbuvir/velpatasvir in the blood, which could lead to reduced efficacy of the combined agent.

Sofosbuvir/velpatasvir was reviewed under the FDA's priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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