Federal health officials have green-lighted the first pill that can treat all major forms of hepatitis C, a liver infection caused by the blood-borne hepatitis C virus (HCV)
On Tuesday, the Food and Drug Administration (FDA) gave its approval to Gilead Sciences' combination pill Epclusa, the latest in a series of drug approvals that can reshape how the viral disease is treated.
The new drug combines sofosbuvir, which was green-lighted by federal regulators in 2013, and the new drug velpatasvir. It is the first drug capable of treating all major forms of HCV.
Six distinct HCV strains are currently known. Treatment recommendations and the duration of treatment often depend on knowing the particular genotype of the virus.
The pill's broad indication makes it easier to use compared with five other hepatitis drugs that were recently approved by the FDA, as each of these were tailored to different viral strains or stages of the liver disease.
Epclusa can be used by adult patients with or without liver damage. Patients with moderate to severe cirrhosis can take the drug in combination with the drug ribavirin.
"This approval offers a management and treatment option for a wider scope of patients with chronic hepatitis C," said Edward Cox, FDA's Center for Drug Evaluation and Research Office of Antimicrobial Products director.
Data from three clinical trials showed that the pill cleared the virus in 95 to 99 percent of 1,558 patients infected with HCV without cirrhosis or with mild cirrhosis after three months of treatment.
Another clinical trial showed that treatment with Epclusa in combination with ribavirin cured 94 percent of patients with moderate to severe cirrhosis. Among the drug's side effects include headache and fatigue.
"Building on the established backbone of sofosbuvir, Epclusa demonstrated consistently high cure rates across all genotypes, including among patients with genotype 2 and 3, who traditionally have required ribavirin or other multi-pill regimens," said Ira Jacobson, from Mount Sinai Beth Israel, who is principal investigator in the clinical trials.
The new drug, which needs to be taken daily, costs $74,760 for a 12-week course of treatment, or about $890 per pill. This makes the newly approved drug less expensive than Sovaldi, which costs about $1,000 per pill, and another Gilead hepatitis C treatment Harvoni, which costs $1,125 per pill.
California-based Gilead has been criticized for the cost of its hepatitis C drugs, but these remain to be top sellers. In 2015, Harvoni was the world's top-selling prescription drug with over $18 billion in global sales.
Data from the Centers for Disease Control and Prevention showed that hepatitis C affects at least 2.7 million people in United States. The disease killed more than 19,000 in 2014.