AbbVie and Gilead Sciences have secured European Union approval for their next-generation hepatitis C combination therapies, marking a significant advancement in treating patients who have failed previous direct-acting antiviral regimens. The European Commission approved AbbVie's Maviret (glecaprevir+pibrentasvir) and Gilead's Vosevi (sofosbuvir+velpatasvir+voxilepravir), both designed to cover all six major hepatitis C genotypes.
Enhanced Treatment Options for Difficult Cases
Both therapies received accelerated regulatory review as they represent substantial improvements over existing treatments. Maviret offers a patient-friendly eight-week dosing schedule for patients without cirrhosis, while Vosevi provides a 12-week treatment regimen for patients with any genotype who have previously failed on other direct-acting antiviral regimens. For previously untreated patients without cirrhosis, Vosevi can be administered as an eight-week course.
The new approvals specifically target patients who cannot be cured with established regimens, addressing a critical gap in hepatitis C treatment. AbbVie noted that Maviret can be used in difficult-to-treat patients, including those with compensated cirrhosis across all major genotypes, and those who previously had limited treatment options such as patients with severe chronic kidney disease or those with genotype 3 disease.
Expanded Access for Adolescent Patients
In a parallel development, the European Commission extended the use of Gilead's established combination drug Harvoni (ledipasvir+sofosbuvir) to include adolescents aged 12-18 years with genotypes 1, 4, 5, and 6. This expansion makes Harvoni the first hepatitis C cure approved in the EU to include use in adolescents, previously having been limited to adults with all genotypes except genotype 2.
Market Impact and Patient Population
The approvals come as companies compete for market share in the hepatitis C treatment landscape. AbbVie estimates that approximately 214,000 people are still living with hepatitis C in the UK, many of whom have not been treated and do not yet have cirrhosis. The NHS has been rationing use of hepatitis C drugs to more serious cases, suggesting these new treatments could benefit patients who previously had limited options.
Regulatory Status and Pricing Considerations
While both drugs have secured EU approval, their regulatory status varies globally. AbbVie's Maviret remains under review in the US and Japan, while the FDA approved Gilead's Vosevi in the US in mid-July. No European pricing has been announced, though in the US, Vosevi has been priced at the same level as Gilead's already-approved combination, Epclusa.
The pricing of hepatitis C cures has proven controversial in health systems worldwide. When first-generation treatments like Gilead's Sovaldi entered the UK market, NICE deemed them cost-effective despite high prices because they cured patients of the disease, though this created budget challenges for the NHS when considering treatment for all eligible patients.
Clinical Efficacy and Competitive Landscape
Previous Phase III trial data demonstrated the effectiveness of these combination approaches. AbbVie's fixed-dose combination regimen showed a 99% sustained virologic response over 12 weeks in genotype 1 patients, with studies including 2,308 patients representing the largest conducted on genotype 1 patients at the time. Both AbbVie's and Gilead's regimens have achieved sustained viral responses well over 90%, with market differentiation likely to depend on compliance factors and pricing strategies.
