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FDA Approves New Hepatitis C Drug

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The US Food and Drug Administration approved on Thursday pharmaceutical company AbbVie Inc.’s drug to treat specific adults who have chronic hepatitis C.

The drug, called Mavyret, is set to treat hepatitis C genotypes 1 through 6 in adults who have not undergone any previous treatments, with or without mild cirrhosis, a kind of liver disease, Reuters reports. This includes patients suffering from moderate to severe kidney disease, and those undergoing dialysis.

According to the FDA, Mavyret is the only 8-week duration treatment approved for all hepatitis C genotypes. Standard treatments for the disease usually last 12 weeks or more.

Hepatitis C is a viral condition. The most common way to contract it is through contact with small amounts of infected blood. Hepatitis  C genotypes, or strains, are genetically distinctive kinds of the virus.

The Centers for Disease Control and Prevention state that an estimated 2.7 to 3.9 million Americans have chronic hepatitis C. Those who have suffered for years tend to have jaundiced eyes or skin, and other complications like bleeding, fluid accumulation in the stomach, liver cancer, infections, and in the worst cases, death.

Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said, “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.”

Mavyret was evaluated according to safety and efficiency, according to a statement released by the FDA. There were approximately 2,300 adults with genotype 1, 2, 3, 4, 5 or 6 HCV infections. The trial results showed that 92-100% of patients who received Mavyret as a treatment had no virus detected in their blood 12 weeks after completing the course.

The length of treatment with Mavyret depends according to patient history, viral genotype, and status of liver cirrhosis in a patient.



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