Expanded Approval for AbbVie's Mayvret Shortens Treatment Time for Some HCV Patients

AbbVie’s Mayvret won expanded approval from the U.S. Food and Drug Administration (FDA) to shorten the one-daily treatment duration from 12 to eight weeks in treatment-naïve hepatitis C patients without cirrhosis and with compensated cirrhosis.

The approval marks the first eight-week treatment approved for all treatment-naïve adult patients. The latest approval is aimed at all adults, as well as adolescent patients who are at least 12 years of age without cirrhosis and with compensated cirrhosis. Before Mayvret earned its latest approval, the standard treatment length for patients with compensated cirrhosis was previously 12 weeks or more.

Mayvret is a pan-genotypic, once-daily, ribavirin-free treatment that combines glecaprevir, an NS3/4A protease inhibitor, and pibrentasvir, an NS5A inhibitor. In 2017, Mayvret was the first drug approved by the FDA for all HCV genotypes 1-6 in adult patients without cirrhosis who have not been previously treated. Then, in May of this year, Mayvret was approved for treatment of hepatitis C in pediatric and adolescent patients.

Janet Hammond, head of general medicine and virology therapeutic area at AbbVie, said the latest approved provides more HCV patients with the ability to treat their disease in as little as eight weeks. Since Mayvret was approved, Hammond said more than 100,000 people have been prescribed the drug in the United States. Still, there have been patients who needed additional treatment options, which the latest approval can address.

The label expansion was based on data from the Phase IIIb EXPEDITION-8 study, a single-arm, open-label study evaluating the safety and efficacy of Mayvret in treatment-naïve adults with GT1-6 chronic HCV and compensated cirrhosis. In the study, an overall 98% of patients achieved a sustained virologic response 12 weeks after treatment. Over the course of the study, AbbVie said there was only a single relapse reported out of 336 patients treated. No patients discontinued treatment due to adverse events, the company added as it touted Mayvret’s strong safety profile.

In the Phase IIIb trial, there were two cohorts of patients. One cohort has genotype 1 through 6, while the second cohort has only treatment-naïve genotype 3 patients. Data from the first cohort has been presented at previous medical conferences and AbbVie noted that data from the second cohort will be presented at an upcoming medical meeting.

Worldwide, there are about 71 million people with chronic HCV, a disease that causes inflammation of the liver. The most common hepatitis viruses are A, B and C, with each type affecting the liver differently. It is estimated that approximately 75% to 85% of patients infected with the hepatitis C virus will develop a chronic infection. Hepatitis C is a major cause of liver cancer. The World Health Organization, which has a goal of eliminated HCV by 2030, estimated that in 2016, approximately 399 000 people died from hepatitis C, mostly from cirrhosis and hepatocellular carcinoma.