AbbVie Wins European Approval for Hepatitis C Treatment

Following similar approvals in the United States and Canada, AbbVie has been granted marketing authorization by the European Commission for an all-oral, interferon-free combination drug for the treatment of genotypes 1 and 4 chronic hepatitis C infection.

Called Viekirax + Exviera, the drug regimen blocks proteins that help replicate the hepatitis C virus. Viekirax is a fixed-dose combination of an NS3/4 protease inhibitor (paritaprevir), an NS5A inhibitor (ombitasvir) and ritonavir, a potent cytochrome P450 3A4 inhibitor used as a pharmacokinetic enhancer and Exviera is a nonnucleoside NS5B polymerase inhibitor (dasabuvir).

"The approval of AbbVie's hepatitis C treatment in the European Union, following the recent approvals in the U.S. and Canada, offers patients across Europe a new and effective treatment to cure this serious disease," AbbVie CEO Richard Gonzalez said in a news statement. "We are committed to working with local governments and healthcare systems to support broad access to VIEKIRAX + EXVIERA.”

Hepatitis C is a blood borne virus that if left unchecked can cause serious liver damage over time and possibly lead to liver cancer or the need for a liver transplant. Health officials estimate that as many as 150 million people are infected with the disease worldwide.

The Commission approved Viekirax + Exviera to be given with or without ribavirin for people with hepatitis C virus infection genotype 1, including patients with compensated liver cirrhosis, HIV-1 co-infection or those on opioid substitution therapy, as well as liver transplant recipients. Viekirax was also approved for use with ribavirin in patients with hepatitis C genotype 4, according to the AbbVie statement.

The 12-week regimen for genotype 1 hepatitis C patients calls for Viekirax once daily plus Exviera with or without ribavirin twice daily. The recommended treatment period is twice as long (24 weeks) for genotype 1a patients who have cirrhosis. For genotype 4 patients, the treatment period is 12 weeks of Viekirax once daily with ribavirin taken twice daily.

Prior to approval, the drug application was reviewed by the European Medicines Agency under accelerated assessment that is granted to speed up access to new medicine considered to be of major public health interest. An estimated nine million people in Europe are chronically infected with hepatitis C.

AbbVie’s latest all- oral drug treatment does not require interferon injections and is among a list of new hepatitis C treatments that offer higher cure rates with fewer serious side effects. In six pivotal phase 3 clinical trials, the treatment cured from 95% to 100% of patients with genotype 1 hepatitis C infection, AbbVie said. The most common adverse events were fatigue and nausea.The approval of Viekirax for genotype 4 patients was based on a phase 2 study that resulted in 100 percent sustained virologic response among study participants, according to the AbbVie statement.

AbbVie was granted a similar approval in December by the Food and Drug Administration for US patients with genotype 1 chronic hepatitis C. Called Viekira Pak, the US version is not approved to treat genotype 4 patients nor is it indicated for patients on opioid substitution therapy.