AbbVie Receives Positive CHMP Opinion for Glecaprevir/Pibrentasvir in Acute HCV Patients

AbbVie Advances Treatment for Acute Hepatitis C with Glecaprevir/Pibrentasvir

AbbVie, a global leader in immunology, neuroscience, and specialized care, has taken a significant step forward in the battle against hepatitis C. Recently, the company announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding the oral pan-genotypic direct-acting antiviral (DAA) combination of Glecaprevir and Pibrentasvir for the treatment of acute hepatitis C virus (HCV) infection in adults and children aged 3 years and older. This promising recommendation is based on the results from the phase III study M20-350, which evaluated the safety and efficacy of this treatment in adults.

Significance of the Recommendation

Acute HCV infection often remains asymptomatic, complicating early diagnosis and treatment initiatives. The CHMP's positive opinion underscores the critical necessity for timely intervention to curb virus transmission and mitigate long-term liver-related complications. Additionally, the anticipated approval provides a new treatment avenue for both acute and chronic HCV infections across the European Union.

Dr. Primal Kaur, AbbVie’s Senior Vice President of Global Development, highlighted the importance of this development by stating, "This positive CHMP opinion represents a vital step toward enabling earlier treatment for acute hepatitis C, a stage often overlooked due to the absence of symptoms. This recognition aligns with global clinical guidelines advocating for the treatment of patients with acute or chronic HCV infection, potentially addressing unmet medical needs and contributing to the global eradication efforts for HCV."

Understanding Acute HCV Infection

HCV is a serious virus transmitted through blood that can lead to chronic liver diseases if left untreated. Early identification and treatment are vital, yet many individuals remain unaware of their infection until significant liver damage has occurred. The 2026 WHO Global Hepatitis Report emphasizes the ongoing gap in diagnosis and treatment rates, advocating for rapid testing and immediate care for those infected.

The positive sentiment from the CHMP is founded on the data from the M20-350 study, which demonstrated a remarkable 96% cure rate (sustained virologic response at week 12, or SVR12) among adults treated for 8 weeks with Glecaprevir/Pibrentasvir. The safety profile was consistent with previous experiences, with the most commonly reported side effects being fatigue, diarrhea, headache, and malaise.

Professor Christoph Sarrazin, Chief Physician at St. Josef's Hospital Wiesbaden and head of the Wiesbaden Liver Center, remarked on the clinical challenges presented by acute HCV infection. "Often discovered incidentally, managing acute HCV infections can be complicated, particularly when patients drop out of follow-up before treatment begins. This new treatment option has the potential to facilitate timely care, significantly impacting patient outcomes and broader public health initiatives."

Next Steps for AbbVie

AbbVie aims to ensure that those suffering from acute HCV infections can access Glecaprevir/Pibrentasvir as swiftly as possible, maintaining close collaboration with global regulatory authorities. The drug is already approved in various jurisdictions, including Canada, Australia, the United States under the brand name MAVYRET®, and several other countries for both acute and chronic HCV therapy in patients aged 3 years and older.

Details on M20-350 Study

The multicenter, single-group, phase III clinical trial (M20-350) assessed the safety and efficacy of Glecaprevir/Pibrentasvir in adults and adolescents aged 12 years or older with acute HCV infection. A total of 286 treatment-naive adult patients were enrolled from 70 global sites, receiving the therapy for 8 weeks and undergoing follow-up for 12 weeks. Findings confirmed a 96.2% SVR12 rate, affirming the treatment's effectiveness.

About Glecaprevir/Pibrentasvir

Glecaprevir/Pibrentasvir is a once-daily oral, pan-genotypic, and ribavirin-free DAA regimen for the treatment of chronic HCV infection. It combines the NS3/4A protease inhibitor Glecaprevir with the NS5A inhibitor Pibrentasvir, administered with food. According to EU guidelines, it is approved for adults and children above 3 years of age with chronic HCV infections.

AbbVie's Commitment

AbbVie is dedicated to addressing significant health issues by developing innovative pharmaceuticals and solutions. The company focuses on improving treatment standards and enhancing patient outcomes for those affected by HCV. By partnering with healthcare professionals globally, AbbVie aims to drive forward solutions in the quest for HCV eradication. For more information, visit AbbVie.