The FDA expanded the indication for glecaprevir-pibrentasvir (GLE/PIB; Mavyret, AbbVie) to treat adults and pediatric patients 36 months of age and older with acute or chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis. 

With this approval, GLE/PIB is the first and only direct-acting antiviral therapy approved to treat patients with acute HCV in eight weeks with a 96% cure rate, according to AbbVie.

The label expansion was supported by data from the phase 3, multicenter, single-arm prospective study evaluating the safety and efficacy of GLE/PIB eight-week treatment in adults with acute HCV infection. The study results showed GLE/PIB to be a highly efficacious treatment for people with acute HCV. 

The M20-350 clinical trial was designed to evaluate the safety and efficacy of GLE/PIB eight-week treatment in adults and children with acute HCV infection. The study enrolled 286 treatment-naive adults with acute HCV infection across 70 locations globally. Patients received oral tablets of GLE/PIB once daily for eight weeks and were followed for 12 weeks after the end of treatment. 

The primary end point was the percentage of patients with sustained virologic response 12 weeks post-treatment (SVR12) in the intention-to-treat (ITT) population. They found that 96.2% of patients had a sustained virologic response. Secondary end points included the percentage of patients achieving SVR12 in the modified ITT-virologic failure population, and the percentage of patients with on-treatment virologic failure and post-treatment relapse in the ITT population. In the ITT population, none of the patients experienced a treatment failure. 

SVR12 is defined as an HCV RNA level less than the lower limit of quantification 12 weeks after the last dose of study treatment. Efficacy was demonstrated if the lower bound of the two-sided 95% CI for the percentage of participants achieving SVR12 was greater than 90.5%.

More information on the study can be found on the trial’s website (ClinicalTrials.gov Identifier: NCT04903626).

HCV is a highly infectious bloodborne disease affecting the liver. People with acute HCV may be asymptomatic. If left untreated, HCV could lead to liver-related complications, such as cirrhosis or liver cancer. The United States is expected to incur about $120 billion in total medical costs over the next 10 years through 2035 linked to chronic liver disease and other related conditions caused by untreated HCV.

“The physical, emotional and economic burden of a curable condition like hepatitis C is far too great in the United States and around the world,” said John Ward, MD, the director, Coalition for Global Hepatitis Elimination. “If treated early with safe and effective therapies, providers can cure virtually all patients with hepatitis C before it escalates to chronic disease and eventually cirrhosis or liver cancer. The public health community now has a good opportunity to cure nearly all persons to support eliminating the toll of this deadly virus. No one should die of hepatitis C.”

The FDA granted Breakthrough Therapy designation for GLE/PIB for the treatment of acute HCV. 

—IDSE News Staff

From company press materials.

Originally published by our sister publication Infectious Disease Special Edition