The U.S. Food and Drug Administration (FDA) announced today its approval for a new drug to treat chronic hepatitis C, including patients with moderate or severe kidney disease and those who are on dialysis. The drug, Mavyret, is manufactured by AbbVie Inc. and is intended for people without cirrhosis or mild cirrhosis.
The new drug was also approved for adult patients with HCV genotype 1 infection who have received treatment with an NS5A inhibitor or an NS3/4A protease inhibitor (but not both), according to a press release.
Mavyret aims to treat hepatitis C genotypes 1 through 6.
FDA approves Mavyret to treat all genotypes of hepatitis C
Hepatitis C is an infection caused by the Hepatitis C virus (HCV) mostly spread by sharing infected needles or other equipment to inject drugs among infected people, according to the Centers for Disease Control and Prevention. The CDC estimates that between 2.7 and 3.9 million people have hepatitis C in the United States.
Mavyret is the first eight-week treatment approved for all HCV genotypes in adult patients without cirrhosis lacking treatment for their disease. The FDA noted that standard treatment duration was previously 12 weeks or more.
“This approval provides a shorter treatment duration for many patients, and also a treatment option for certain patients with genotype 1 infection, the most common HCV genotype in the United States, who were not successfully treated with other direct-acting antiviral treatments in the past,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research.
Some patients who have chronic HCV infection over several years can get jaundice (yellowish skin or eyes) and complications such as infections, bleeding, fluid accumulation in the abdomen, liver cancer, and death.
Mavyret reportedly cured hepatitis C in almost all clinical subjects
There are six HCV genotypes –or strains– that are genetically distinct groups of the virus. The FDA estimates that about 75 percent of Americans with HCV have genotype 1, between 20 and 25 percent have genotypes 2 or 3, and the remaining percentage is shared by patients with genotypes 4, 5, and 6.
The CDC says that for some people hepatitis C is a short-term illness, but between 70 and 85 percent of those who become ill report long-term chronic infection. There is no vaccine for the disease, so the CDC recommends that the best way to prevent hepatitis C is by avoiding behaviors that can spread the disease, particularly injecting drugs and sharing needles.
The FDA noted that Mavyret’s safety and efficacy were tested during clinical trials enrolling about 2,300 adults with genotypes 1 through 6 without cirrhosis. Results of the tests showed that between 92 and 100 percent of patients who received the drug for eight, 12 or 16 weeks had no virus in their blood 12 weeks after finishing treatment.
The treatment duration with the new drug will depend on treatment history, viral genotype, and cirrhosis status. The FDA reported the most common adverse reactions in people taking Mavyret were fatigue, headache, and nausea.