AbbVie's Mavyret Approved for Hep C in Pediatric and Adolescent Patients

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The U.S. Food and Drug Administration (FDA) gave the nod to AbbVie’s Mavyret (glecaprevir and pibrentasvir) for all six strains of hepatitis C in children ages 12 to 17 years. The drug was approved for adults 18 years or older in 2017.

“Direct-acting antiviral drugs reduce the amount of HCV in the body by preventing the virus from multiplying, and in most cases, they cure HCV infection,” stated Jeffrey Murray, deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval represents another treatment option for children and adolescents with HCV infection, but for the first time, in all genotypes of HCV.”

The approval was based on clinical trials of 47 pediatric patients with genotype 1, 2, 3 or 4 HCV infection who didn’t have cirrhosis or had mild cirrhosis. In the studies, all patients who received Mavyret for 8 or 16 weeks showed no detectable virus in their blood 12 weeks after completion of treatment, which is to say, they were cured.

The dosing information indicates that Mavyret is now approved for adult or pediatric patients 12 years and older, or who weigh at least 99 pounds, who are infected with any of six known HCV genotypes without cirrhosis or with compensated cirrhosis. The side effects observed in the children were consistent with those observed in clinical trials on adults.

The drug isn’t recommended in patients with moderate cirrhosis and is contraindicated in severe cirrhosis cases. It is also contraindicated in patients taking atazanavir and rifampin.

This approval is timely, as there are currently national and global efforts to eradicate hepatitis C. NHS England, which leads the National Health Service (NHS) in England, has teamed up Gilead Sciences, Merck & Co., and AbbVie. NHS England will acquire hepatitis C drugs from the companies at competitive prices and work to identify patients around the country.

The program for hepatitis C is part of the NHS Long Term Plan, which will focus on addressing concerns over funding, staffing, and increasing inequalities and pressures from an aging population. The first step is to improve funding for the NHS, averaging 3.4% each year over the next five years, compared to the 2% increase the last five years; an identification of the changes needed based on meetings with the public and various organizations representing 3.5 million people; and taking the momentum created by the NHS Five Year Forward View and ensuring that it continues.

The Washington State Health Care Authority has struck a similar pact with AbbVie to supply hepatitis C drugs under a subscription-based payment model. This was announced on April 26. Under the terms of that deal, Washington State will pay a fixed dollar amount for an unlimited supply of hepatitis C drugs. It is part of the state’s goal of eliminating hepatitis C by 2030.

In March, Louisiana made a similar deal with Gilead. Both state’s plans will begin this summer.

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Hepatitis causes inflammation of the liver. The most common hepatitis viruses are A, B and C. They have similar symptoms but are spread in different ways and can affect the liver differently. Hepatitis A is typically a short-term infection. Both B and C can start as short-term infections, but often the virus stays in the body and causes chronic, lifelong infections. There are vaccines for hepatitis A and B, but none for hepatitis C.

About 75% to 85% of patients infected with the hepatitis C virus (HCV) will develop a chronic infection. About 15% to 25% infected will clear the virus without treatment. HCV is usually spread from blood contact or sexual contact. The Centers for Disease Control and Prevention (CDC) indicate that in the U.S., there were 18,153 deaths related to hepatitis C reported in 2016, but that figure is believed to be an underestimate.

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