Key European panel backs expansion of Maviret to treat acute hepatitis C
Recommendation under review; final decision expected in coming months
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The Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the approval of Abbvie’s oral therapy Maviret (glecaprevir/pibrentasvir) to cover its use for acute hepatitis C infection in patients ages 3 and older.
The CHMP is a part of the European Medicines Agency tasked with reviewing data on experimental therapies under review for approval in the European Union (EU). The CHMP’s recommendation will now be reviewed by the European Commission, which is expected to issue a final decision in the coming months. The Commission isn’t technically required to follow the CHMP’s recommendation, but it almost always does.
“The CHMP positive opinion for Maviret in acute hepatitis C represents an important step toward enabling earlier treatment, at a stage when the disease is often asymptomatic [without symptoms] and may go undiagnosed,” Primal Kaur, MD, senior vice president, global development of immunology, neuroscience, eye care, and specialty at Abbvie, said in a company press release.
Kaur added that the CHMP’s recommendation “aligns with global clinical guidance supporting treatment of suitable people with acute or chronic [hepatitis C] infection” and “has the potential to help address unmet need, reduce the risk of onward transmission, and support global [hepatitis C] elimination efforts.”
Maviret already approved in EU for treating chronic hepatitis C infection
Maviret is already approved in the EU for treating chronic hepatitis C infection in adults and children 3 years and older. It is also cleared for use to treat both acute and chronic hepatitis C in patients ages 3 and older in the U.S. (where it is sold under the brand name Mavyret), Canada, Australia, Saudi Arabia, New Zealand, Taiwan, and Argentina.
Hepatitis C is a liver infection caused by the hepatitis C virus (HCV), which is primarily spread through contact with infected blood. When the virus first enters the body, it causes an acute infection that often doesn’t cause noticeable symptoms.
Sometimes the body clears the virus after the acute infection, but in many cases the infection becomes chronic or long-lasting, which can set the stage for life-threatening complications like liver failure and cancer.
This treatment option could help streamline care pathways and support timely initiation of therapy once infection is confirmed, an important step for both individual patient outcomes and broader public health efforts.
Maviret is an oral, pan-genotypic, once-daily therapy containing a combination of two direct-acting antivirals, which are medications that suppress HCV’s growth in the body. Pan-genotypic refers to treatments that work equally well across all or most HCV strains.
“In clinical practice, acute [hepatitis C] can be challenging to manage, as it is often identified incidentally and patients may be lost to follow-up before treatment is initiated,” said Christoph Sarrazin, chief physician at St. Josef’s Hospital Wiesbaden in Germany, head of the Wiesbaden Liver Center, and a board member of the German Liver Foundation. “This treatment option could help streamline care pathways and support timely initiation of therapy once infection is confirmed, an important step for both individual patient outcomes and broader public health efforts.”
The CHMP’s recommendation to expand the approval of Maviret to include acute HCV infection was mainly supported by results from M20-350 (NCT04903626), a global Phase 3 clinical trial in which 286 adults with acute hepatitis C received Maviret as their first-line treatment.
Data showed that roughly 96% of patients achieved a sustained virologic response, defined as undetectable HCV genetic material three months after the eight-week treatment course. Safety data were consistent with the therapy’s known profile in chronic hepatitis C patients.
