The European Commission has approved the use of Bristol-Myers Squibb’s Daklinza (daclatasvir) in combination with other drugs as a treatment for chronic hepatitis C (HCV).

According to B-MS, Daklinza, when used in combination with Gilead’s Sovaldi (sofosbuvir), provided an all-oral, interferon-free regimen with cure rates of up to 100% in clinical trials, including patients with advanced liver disease, the difficult-to-treat form genotype 3, and those who have previously failed treatment with protease inhibitors.

Clinical trials have also shown the drug to be well tolerated, with in low rates of discontinuation (<1%) due to side effects, and a low rate of serious adverse events (4.7%). 

The drug becomes the first NS5A complex inhibitor to win clearance in the EU, offering patients the chance of a shorter treatment duration (12 or 24 weeks) compared to 48 weeks of treatment with interferon- and ribavirin-based regimens.

“HCV is a challenging virus to overcome, requiring multiple modes of attack. With the approval of Daklinza, we have a new class of drug that disrupts the virus in two ways - by inhibiting both viral replication and assembly - and when combined with other compounds often results in cure among even the hardest-to-treat patients,” noted Michael Manns, Chairman of the Department of Gastroenterology, Hepatology, and Endocrinology at Hannover Medical School in Germany.

Concerns over access

Nevertheless, the Daklinza/Sovaldi regimen, for example, certainly won’t come cheap, given that a 12-week course of the latter drug alone comes in at $84,000.

Médecins Sans Frontières (MSF) says it is concerned about the potential lack of affordable access to Daklinza, noting that B-MS has not yet announced any access plans for low- and middle-income countries, where the majority of the HCV burden lies.

The group also stressed that “patent barriers that prevent affordable access to daclatasvir and the new DAAs [direct-acting antivirals] must be addressed by governments to promote robust generic competition, which will enable price reductions, facilitate the development of a pan-genotypic combination, and accelerate availability in all developing countries that are bearing the brunt of the hepatitis C epidemic”.

European regulators are the second to approve the anti-viral, after Japan issued its stamp of approval back in July.