Abbvie pulls 2 hepatitis treatments from EU market
EU withdraws marketing authorization at company’s request
Abbvie has decided to permanently discontinue the marketing of antiviral treatments Exviera (dasabuvir) and Viekirax (ombitasvir/paritaprevir/ritonavir) for adults with chronic hepatitis C in the European Union.
At the company’s request, the European Commission withdrew marketing authorization for the antiviral therapies on Sept. 25, a decision that extends to all EU nations, as well as Norway, Liechtenstein, and Iceland.
Abbvie’s decision was based on “commercial reasons,” according to the European Medicines Agency’s public statements for Exviera and Viekirax, a triple antiviral combination that was given alongside Exviera.
Exviera’s active ingredient, dasabuvir, used to be sold by Abbvie in the U.S. as part of a hepatitis C quadruple combination treatment, called Viekira Pak, that also included ombitasvir, paritaprevir, and ritonavir. An extended-release formulation of Viekira Pak, called Viekira XR, also became available in the country. Viekirax was sold in the U.S. under the brand name Technivie.
Abbvie voluntarily pulled Viekira XR and Technivie from the U.S. market in 2018 due to changes in treatment practices for chronic HCV in the U.S. Viekira Pak is no longer available in the U.S. market.
Hepatitis treatments and HCV
Hepatitis C is a viral form of hepatitis, or liver inflammation, caused by infection with the hepatitis C virus (HCV). More than half of infected people develop a chronic infection that can lead to serious problems such as irreversible liver scarring and damage (cirrhosis), liver cancer, or liver failure.
Current first-line treatment for hepatitis C involves direct-acting antivirals (DAAs), a class of oral medications that stops HCV’s ability to grow. Use of one or more of these medications is generally able to cure hepatitis C for up to 98% of people with few side effects.
Exviera is a DAA that stops HCV’s ability to replicate its DNA, preventing the virus from growing and infecting new cells. Viekirax is a combination of three other DAAs that work via different HCV-targeting mechanisms.
Both medications were approved in the EU in early 2015. They were intended to be used together for treating adults chronically infected with certain strains of HCV.
Hepatitis C patients in Europe have access to other antiviral therapies, including AbbVie’s Maviret (glecaprevir/pibrentasvir; sold as Mavyret in the U.S.)
Others include Gilead Sciences‘ Harvoni (ledipasvir/sofosbuvir), Epclusa (sofosbuvir/velpatasvir), Sovaldi (sofosbuvir), and Vosevi (sofosbuvir/velpatasvir/voxilaprevir), as well as Merck’s Zepatier (elbasvir/grazoprevir).
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