AbbVie Gains European Approval for New HCV Treatment in Acute Hepatitis C Patients

New Treatment for Acute Hepatitis C: Gracaprevir/Velpatasvir

AbbVie, a global biopharmaceutical company, announced on June 23, 2026, that the European Commission has approved its oral pan-genotypic direct-acting antiviral drug, Gracaprevir/Velpatasvir, for treating adults and children aged three and older suffering from acute Hepatitis C virus (HCV) infection. This new approval makes Gracaprevir/Velpatasvir the only therapy authorized in the European Union for both acute and chronic HCV infections, which is a significant milestone in the fight against this infectious disease.

HCV, which is primarily transmitted through blood, poses a significant public health threat, with over 12 million individuals living with Hepatitis C across Europe. The disease often goes unnoticed since many infected individuals do not show symptoms. Without appropriate treatment, HCV can lead to severe liver complications, including cirrhosis and end-stage liver disease. The need for immediate and effective intervention has been emphasized, and this newly approved therapy provides a timely option for early treatment.

Dr. Roopal Thakkar, AbbVie’s executive vice president of research and development and chief scientific officer, stated, “The European Commission’s approval of Gracaprevir/Velpatasvir is a crucial step in enabling healthcare providers to initiate treatment promptly after an acute diagnosis of HCV. This development holds promise for reducing the risk of liver disease progression, cirrhosis, and liver cancer.” By delivering a simplified treatment process, this medication aligns with global efforts to eliminate HCV.

The safety and efficacy of Gracaprevir/Velpatasvir were validated in a Phase 3 trial (M20-350), involving multiple centers and conducted with adult and adolescent patients diagnosed with acute HCV infection. The results indicated a high efficacy rate, with 96.2% of participants achieving sustained virologic response (SVR12) after an eight-week treatment regimen. The most commonly reported adverse effects were mild to moderate, including fatigue, diarrhea, headache, and malaise, confirming the treatment's tolerability.

Dr. Massimo Puoti, director of the Infectious Diseases Department at Niguarda Hospital in Milan, highlighted the importance of timely access to treatment and emphasized that delays in starting therapy could lead to lost treatment opportunities and increased transmission rates. With this approval, healthcare professionals across the EU now have an essential option available for early intervention in acute HCV cases.

The approval of Gracaprevir/Velpatasvir is not just an advancement in therapy but a significant contribution to public health efforts aimed at eradicating HCV. Globally, HCV poses serious health and economic burdens, contributing to over 200,000 deaths from liver cancer annually and increasing the risk of developing cancer by up to 17 times for infected individuals compared to those who are not infected.

AbbVie is committed to collaborating with global regulatory authorities to ensure that patients diagnosed with acute Hepatitis C can access Gracaprevir/Velpatasvir. The treatment has already received approvals in the United States, Saudi Arabia, New Zealand, Canada, Taiwan, Australia, and Argentina for managing acute and chronic HCV infection in both adults and children over three years of age.

In conclusion, AbbVie's approval of Gracaprevir/Velpatasvir marks a hopeful development for countless individuals affected by HCV in Europe and elsewhere. The new treatment not only enhances clinical options available to physicians but also represents a collective step forward in combating this public health challenge.

For more information about ongoing clinical trials related to Gracaprevir/Velpatasvir, visit clinicaltrials.gov.

For further inquiries about AbbVie’s commitment to addressing HCV and other health challenges, please check out their website at www.abbvie.com.