AbbVie, Gilead target sick hepatitis C patients in EU

Competing hepatitis C combination drugs from AbbVie and Gilead are now approved in the EU, as the companies aim to treat patients who cannot be cured with established regimens.

AbbVie’s Maviret (glecaprevir+pibrentasvir) and Gilead’s Vosevi (sofosbuvir+velpatasvir+voxilepravir) cover all six major hepatitis C genotypes.

In patients without cirrhosis, Maviret also offers a patient-friendly eight-week dosing schedule.

Gilead’s drug offers a 12-week treatment regimen in patients with any genotype of the disease who have previously failed on other direct-acting antiviral regimens.

However it is taken as an eight-week course in previously untreated patients without cirrhosis.

Regulators had given the drugs an accelerated review as they represent an improvement over existing therapies, which in many cases involved use of ribavirin and associated unpleasant side effects.

Gilead, which is searching for ways to maintain market share following competition from AbbVie and Merck & Co, added that the European Commission had extended the use of its established combination drug, Harvoni (ledipasvir+sofosbuvir).

Previously used in adults with all genotypes except genotype 2 in adults, Harvoni can be used in adolescents aged 12-18 years with the same disease strains.

This makes it the first hepatitis C cure approved in the EU to include use in adolescents.

There is no word yet on pricing in Europe, although in the US the drug has been priced at the same level as Gilead’s already-approved combination, Epclusa.

Pricing of the hepatitis C cures has proved to be a controversial issue in health systems around the world.

When the first generation of hepatitis C cures such as Gilead’s Sovaldi (sofosbuvir) hit the UK market, NICE said it was cost-effective despite its high price because it cured patients of the disease.

But this left the NHS with the dilemma about how to fund a drug that could add billions of pounds to the health service’s budget if it were to be used in all eligible patients.

AbbVie estimates that there are still around 214,000 people living with hepatitis C in the UK, many of whom have not been treated and do not yet have cirrhosis.

AbbVie noted that its drug can be used in difficult-to-treat patients, including those with compensated cirrhosis in 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.

The NHS has been rationing use of the drug to the more serious cases, so these patients could be among the first treated should the new treatments get through NICE.

AbbVie’s regimen is still under review in the US and Japan, while the FDA approved Gilead’s Vosevi in the US in mid-July.