Bristol-Myers Squibb Gets Expanded Use for Hepatitis C Drug in Europe

The European Commission has approved expanded use of a Bristol-Myers Squibb hepatitis C drug to include patient populations with decompensated cirrhosis, HIV-1 coinfection and post-liver transplant recurrence of the virus.

Chronic infection of the hepatitis C virus inflames the liver and if left unchecked can cause longer-term damage that can lead to liver cancer or the need for a liver transplant. It is estimated that as many as 150 million people are infected with the disease worldwide.

“The European Commission’s approval of these new indications for Daklinza is an important step forward for a significant group of patients with chronic hepatitis C who are still in need of treatment options that can deliver high cure rates,” Douglas Manion, MD, head of Bristol-Myers Squibb said in a news release. “The complex clinical considerations for physicians treating HCV/HIV coinfected patients and patients with cirrhosis, decompensated cirrhosis or post-transplant recurrence of HCV reinforces the vast diversity of this disease, and we have worked hard to continue to identify and address those patients who require additional solutions for cure.”

Daklinza is a 60 mg, once-daily, oral antiviral medication that is already approved by the European Commission in combination with Sovaldi (made by Gilead Sciences) for 12 or 24 weeks to treat chronic infection of the hepatitis C virus across genotypes 1, 2, 3, and 4. Its active substance blocks the action of the NS5A protein which allows the hepatitis C virus RNA to replicate and thrive. The drug, which is generically daclatasvir, must not be administered as monotherapy and is contraindicated in combination with medicinal products that strongly induce CYP3A and P-glycoprotein transporter, according to the release.

The updated label adds use of Daklinza in combination with Sovaldi (with or without ribavirin, depending on the indication and genotype) in three other hepatitis C patient populations; those coinfected with HIV-1, difficult to treat patients with decompensated cirrhosis, and patients whose hepatitis C virus recurred after a liver transplant, according to the release. The change is effective in all 28 member states of the European Union.

Health officials estimate that between 0.4% and 3.5% of the population are infected with the hepatitis C virus in different European Union member states. The virus is the most common single cause of liver transplantation in the EU and it is considered a major public health challenge, according the European Medicines Agency.

Last year the U.S. Food and Drug Administration approved Daklinza in combination with Sovaldi for treatment of patients with genotype 3 hepatitis C chronic infection. The drug regimen has also been approved in other countries including the United Kingdom and Japan.

The added indications to the label are based on data from a clinical trial in post-transplant patients and patients with advanced cirrhosis and another trial that involved patients who were coinfected with HIV, the release states.

The most common side effects of Daklinza when used in combination with sofosbuvir include headache, tiredness, nausea and diarrhea.