Maviret now approved in EU to treat acute hepatitis C virus infections
Label expansion gives adults, kids 3 and older new treatment option
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People in the European Union with acute hepatitis C virus (HCV) infections now have a new treatment option: Abbvie’s Maviret (glecaprevir/pibrentasvir).
EU regulators have expanded the therapy’s label to allow use of Maviret, sold in the U.S. as Mavyret, by adults and children ages 3 and older with HCV infections.
The decision, previously supported by a European Medicines Agency committee, makes Maviret the first therapy in the EU to be approved for both acute and chronic forms of hepatitis C.
To be eligible, patients must have compensated liver disease, meaning that despite some damage — which may include irreversible liver scarring, known as cirrhosis — the liver is still able to perform its usual functions.
“More than 12 million people in Europe live with hepatitis C, underscoring the need for earlier treatment,” Roopal Thakkar, MD, executive vice president, research and development, and chief scientific officer for Abbvie, said in a company press release announcing the regulatory decision.
“[The] European Commission approval of Maviret for acute hepatitis C infection enables earlier intervention, aiming to help more people access curative therapy at the time of diagnosis, while accelerating progress toward the goal of eliminating hepatitis C as a public health threat,” Thakkar said.
According to Abbvie, the expanded label improves the chances of curing the infection before it becomes a more serious long-term illness. Treatment also reduces the risk that a person will transmit the virus to others.
Maviret already approved for both uses in US, elsewhere
Maviret is similarly approved for acute and chronic HCV infections in the U.S. and Canada, as well as in Argentina, Australia, New Zealand, Saudi Arabia, and Taiwan.
Hepatitis C is a form of hepatitis, or liver inflammation, caused by an HCV infection. The virus, transmitted mainly through exposure to contaminated blood, can easily go undetected — and therefore untreated — because it often doesn’t cause noticeable symptoms until serious liver damage sets in.
Though a minority of people spontaneously clear HCV within the first six months, most people who are not treated ultimately develop a chronic infection, one defined as lasting more than six months. Chronic HCV infection is associated with an increased risk of complications such as liver failure or liver cancer.
Maviret is a combination of two direct-acting antiviral medications — pibrentasvir and glecaprevir — that work in different ways to prevent HCV from replicating in the body. It is pangenotypic, meaning it can target any major strain of the virus.
The medication is taken by mouth once daily for 8-16 weeks, or approximately two to four months. In the EU, the drug is available as oral tablets for adults and older children, with oral granules available for younger children.
Data from large trial supported label’s expansion in EU
The expanded approval was supported by data from the global Phase 3 M20-350 clinical trial (NCT04903626), in which nearly 300 adolescents and adults with acute hepatitis C and compensated liver disease received a first-line eight-week course of treatment with Maviret.
Data showed that more than 96% of participants achieved undetectable levels of HCV genetic material in the blood — with those results sustained for three months after treatment ended.
Adverse events reported during the study were mostly mild or moderate in severity. The most frequent events possibly related to Maviret were fatigue, headache, and lack of energy.
With this approval, healthcare professionals across the European Union now have an approved treatment option to treat patients at the earliest stage of infection, supporting prompt intervention and helping to reduce transmission, disease progression, and long-term complications for people living with hepatitis C.
Massimo Puoti, MD, director of the infectious diseases department at Niguarda Hospital in Milan, Italy, noted that “people living with HCV infection frequently face delayed treatment, leading to loss to care and onward transmission.”
This label expansion will allow earlier treatment for those with HCV infection, Pouti said.
“With this approval, healthcare professionals across the European Union now have an approved treatment option to treat patients at the earliest stage of infection, supporting prompt intervention and helping to reduce transmission, disease progression, and long-term complications for people living with hepatitis C,” Puoti said.
Pibrentasvir was developed by Abbvie, while glecaprevir was initially discovered by Enanta Pharmaceuticals and later developed by Abbvie.
Maviret’s expanded approval was also announced by Enanta in a separate company press release.
“We take pride in the role our discovery of glecaprevir has played in bringing forward a therapy that continues to benefit HCV patients worldwide,” said Jay R. Luly, PhD, president and CEO at Enanta. “We are pleased that AbbVie continues to collaborate with global regulatory authorities to support access to Maviret for people who have acute HCV infection.”
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