The U.S. Food and Drug Administration has approved an expanded indication for AbbVie's MAVYRET (glecaprevir/pibrentasvir), making it the first and only direct acting antiviral therapy approved to treat patients with acute hepatitis C virus infection in eight weeks with a 96% cure rate. The approval allows healthcare providers to treat HCV patients immediately at the time of diagnosis, addressing a critical gap in acute infection management.
Breakthrough Therapy Designation Supports Approval
The FDA granted Breakthrough Therapy Designation for MAVYRET in treating acute HCV, a program designed to expedite development and review of medicines intended to treat serious conditions where preliminary clinical evidence indicates substantial improvement over existing therapies on clinically significant endpoints.
MAVYRET is now approved for treating adults and pediatric patients three years and older with acute or chronic hepatitis C virus infection without cirrhosis or with compensated cirrhosis. The drug targets all HCV genotypes 1, 2, 3, 4, 5, and 6, providing a pangenotypic treatment option.
Phase 3 Trial Demonstrates High Efficacy
The label expansion was supported by data from the Phase 3 M20-350 study, a multicenter, single-arm prospective clinical trial evaluating MAVYRET's safety and efficacy in adults with acute HCV infection. The study enrolled 286 treatment-naïve adult patients with acute HCV infection across 70 locations globally.
Patients received oral tablets of MAVYRET once daily for eight weeks and were followed for 12 weeks after treatment completion. The primary endpoint was the percentage of patients achieving sustained virological response 12 weeks post-treatment (SVR12) in the intention-to-treat population. Secondary endpoints included SVR12 rates in the modified intention-to-treat virologic failure population and rates of on-treatment virologic failure and post-treatment relapse.
The study results demonstrated MAVYRET as a highly efficacious treatment for people with acute HCV. The majority of adverse events reported were mild or moderate in severity, with the most common being fatigue, asthenia, headache, and diarrhea.
Addressing Global Health Elimination Goals
Current global clinical guidance calls for universal treatment of nearly all people with acute or chronic HCV infection. Widespread implementation of these guidelines has the potential to substantially reduce global disease spread. The World Health Organization leads public health community efforts to eliminate HCV as a public health problem by 2030.
However, approximately 80% of high-income countries, including the United States, are not on track to achieve this elimination goal until after 2050. The United States is expected to incur approximately $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, M.D., director of the 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."
Clinical Significance and Treatment Impact
HCV is a highly infectious blood-borne disease affecting the liver. People recently infected with acute HCV may not have symptoms. If left untreated, HCV could lead to liver-related complications such as cirrhosis or liver cancer. Acute HCV refers to people recently infected with the virus and can be a short-term illness, but for many people, acute infection leads to chronic infection.
"MAVYRET has treated more than one million patients with HCV, but we recognize that a significant need remains for patients with acute infection," said Roopal Thakkar, M.D., executive vice president of research and development and chief scientific officer at AbbVie. "The label expansion for MAVYRET, coupled with the implementation of test and treat models of care, serve as tools to support the public health community in treating more patients and bringing us closer to achieving the global 2030 elimination goal."
Safety Profile and Contraindications
MAVYRET carries important safety considerations, including the risk of hepatitis B virus reactivation in patients with prior HBV infection. The drug is contraindicated in patients with moderate or severe liver impairment or those taking atazanavir or rifampin. The most common side effects are headache and tiredness.
Healthcare providers must monitor patients for signs of worsening liver problems during treatment, particularly those with advanced liver disease before starting therapy. The drug formulation includes 50 mg glecaprevir and 20 mg pibrentasvir per packet for oral pellets.
