AbbVie announced that the European Commission (EC) has approved MAVIRET (glecaprevir/pibrentasvir), an oral pangenotypic Direct-Acting Antiviral (DAA) therapy for the treatment of acute Hepatitis C Virus (HCV) infection in adults and children aged 3 years and older. With this approval, MAVIRET is now the only treatment approved in the European Union (EU) for both acute and chronic HCV infection.

Roopal Thakkar, MD, Executive Vice President (EVP)—Research and Development (R&D), Chief Scientific Officer, AbbVie, said, "More than 12 million people in Europe live with Hepatitis C, underscoring the need for earlier treatment. Today's 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."

HCV is a highly infectious blood-borne disease that often goes undetected because people may not show symptoms. While HCV is curable, many people remain undiagnosed. If left untreated, HCV can progress to severe liver complications, including cirrhosis and end-stage liver disease. Current clinical guidance supports treating nearly all people with acute or chronic HCV infection.

Massimo Puoti, MD, Director of the Infectious Diseases Department, Niguarda Hospital, Milan, Italy, said, "People living with HCV infection frequently face delayed treatment, leading to loss to care and onward transmission. 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."

Globally, HCV poses a substantial health and economic burden, with more than 200,000 deaths each year from liver cancer. People living with HCV are up to 17 times more likely to develop liver cancer than those unaffected.

The approval was supported by data from the phase 3, multicenter, single-arm prospective study evaluating the safety and efficacy of MAVIRET 8-week treatment regimen in patients with acute HCV infection. The study results showed MAVIRET to be a highly efficacious treatment for people with acute HCV. The majority of the Adverse Events (AEs) reported were mild or moderate in severity. The most common AEs were fatigue, diarrhea, headache, and asthenia.

AbbVie continues to collaborate with global regulatory authorities to support access to MAVIRET for people living with acute HCV infection. MAVIRET is approved in the US, Saudi Arabia, New Zealand, Canada, Taiwan, Australia and Argentina for the treatment of acute and chronic HCV infection in adults and children aged 3 years and older.