FDA Approves First Regimen to Treat All Six Major Forms of HCV

The US Food and Drug Administration just approved a new regimen to treat the six major forms of chronic hepatitis C (HCV).

The new regimen, Epclusa, from Gilead Sciences, Inc., is indicated to treat chronic hepatitis C in adult patients with or without cirrhosis. Epclusa is a fixed-dose combination therapy that contains sofosbuvir and velpatasvir. Epclusa is approved to be used in combination with ribavirin to treat those who suffer from moderate to severe cirrhosis.

According to the Centers for Disease Control and Prevention (CDC), between 75% to 85% of HCV patients suffer from chronic forms of the disease. Prolonged infection with chronic HCV causes bleeding, jaundice, accumulation of fluid in the abdomen, infections, liver cancer, and even death.

Epclusa underwent three Phase III clinical trials that tested the drug on more than 1,500 participants with compensated cirrhosis (mild cirrhosis), as well as without cirrhosis. The drug’s safety and efficacy were proved for 12-week regimens. After 12 weeks of treatment, between 95% and 99% of patients had no viremia, which suggested the patients were cured.

Another clinical trial testing the drug’s safety and efficacy included 267 participants with decompensated cirrhosis (moderate to severe cirrhosis). Of the participants, 87 received a 12-week regiment of Epclusa in combination with ribavirin. Zero viremia was detected in 94% of the treatment group after 12 weeks of drug administration.

Epclusa may cause headache and fatigue. Use of Epclusa in combination with ribavirin is contraindicated for those for whom ribavirin is contraindicated. Epclusa carries a warning that it may cause symptomatic bradycardia (slowing of the heart rate). Epclusa is not to be taken with amiodarone, or any other drug that may reduce the amount of Epclusa in the blood (which may cause reduced efficacy).

Charitha Gowda, MD, MPH, infectious diseases physician at Penn Presbyterian Medical Center told Contagion, "The approval of sofosbuvir/velpatasvir is truly exciting as it is the first pangenotypic treatment regimen in our growing arsenal of anti-HCV drugs. It will certainly help us treat more and more patients. However, in addition to newer drugs, we need to ensure there is adequate focus and attention on identifying patients who are infected, linking them into medical care, and obtaining access to affordable treatment for all of them."