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HCV Drug Update: Daklinza Gets Europe Approval

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EU Approves Drug That Is Up to 100% Effective Against Hep C

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Boasting an excellent safety record and high success rates, daclatasvir is now approved in Europe to treat Hepatitis C.

Many Americans were prepping to celebrate Labor Day weekend while Europeans in the Hepatitis C community had something else to rejoice about. Instead of preparing for a barbeque or holiday sale, physicians, patients and researchers in Europe were ecstatic about the August 27, 2014 approval of daclatasvir, Bristol-Myers Squibb’s Hepatitis C virus NS5A inhibitor.

Hepatitis C Overview

Transmitted via blood-to-blood contact, Hepatitis C is a contagious, viral infection of the liver. Experts estimate that 150 million people are infected with chronic Hepatitis C worldwide, including about 3 to 4 million in the United States and 9 million in the European Union. According to the World Health Organization, about 20 percent of people with chronic Hepatitis C will develop cirrhosis – a severe and potentially lethal form of liver disease. Those with advanced Hepatitis C are also at risk of developing liver cancer and liver failure. Thus, effective treatments for this infection are in great demand.

For many years, treatment for Hepatitis C involved at least 48 weeks of interferon and ribavirin. This combination of drugs had an approximate success rate of 50 percent, and is associated with a long list of severe side effects. Boasting success rates up to 75 percent, the recent addition of protease inhibitors to interferon and ribavirin dramatically improved the odds of beating Hepatitis C. However, medications still in development are promising to cure an even greater percentage of Hepatitis C infections, in a shorter period of time, with fewer side effects.

Bristol-Myers Squibb’s Hepatitis C NS5A inhibitor, daclatasvir, is a top contender for the newest and best Hepatitis C drug.

About Daclatasvir

On August 27, 2014, the European Commission approved daclatasvir (Daklinza) to treat adults with chronic Hepatitis C in combination with other drugs. Made by Bristol-Myers Squibb, Daklinza blocks the action of NS5A, a protein essential for Hepatitis C replication.

In their news release, Bristol-Myers Squibb claim that oral daclatasvir in combination with oral sofosbuvir cured up to 100 percent of participants in clinical trials. This outstanding success rate even includes patients with advanced liver disease. The following treatment outline is:

  • Hepatitis C genotype 1 or 4 without cirrhosis – Daclatasvir and sofosbuvir for 12 weeks. For those who did prior treatment (including a protease inhibitor), treatment may be prolonged to 24 weeks.
  • Hepatitis C genotype 1 or 4 with compensated cirrhosis – Daclatasvir and sofosbuvir for 24 weeks. Treatment may be shortened to 12 weeks for treatment naïve patients with a positive prognosis (IL28B CC genotype or low baseline viral load). Ribavirin can be added for patients with advanced liver disease or previous non-responders.
  • Hepatitis C genotype 3 with compensated cirrhosis and/or previous non-responders – Daclatasvir and sofosbuvir and ribavirin for 24 weeks.
  • Hepatitis C genotype 4 – Daclatasvir for 24 weeks with 24 to 48 weeks of peginterferon alfa and ribavirin. If the Hepatitis C is undetectable at weeks 4 and 12, all three medications should continue for 24 weeks. If patient has undetectable Hepatitis C at only 4 or 12 weeks, daclatasvir should be discontinued at 24 weeks and peginterferon alfa and ribavirin continued for a total duration of 48 weeks.

Daclatasvir’s Study Results

Multiple studies support the use of daclatasvir for Hepatitis C. In a study of daclatasvir and sofosbuvir for genotypes 1, 2 and 3, results showed undetectable levels of Hepatitis C 12 weeks after treatment in:

  • 99 percent of treatment-naïve patients with Hepatitis C genotype 1
  • 100 percent of patients with Hepatitis C genotype 1 who had previously failed treatment with the protease inhibitor telaprevir or boceprevir
  • 96 percent of patients with Hepatitis C genotype 2
  • 89 percent of patients with Hepatitis C genotype 3

While these extremely high success rates are encouraging, the low rate of side effects is even more exciting. The daclatasvir/sofosbuvir combination had very low rates of discontinuation (less than 1 percent) due to serious adverse events. The most common adverse events were fatigue, headache and nausea.

While it is exciting that this potential cure is now available in 28 countries of the European Union, those in the U.S. still have to wait – but hopefully not for long. Applications for the daclatasvir dual regimen are currently under review by the U.S. Food and Drug Administration (FDA). The FDA granted priority review status and set a target review date of November 30, 2014 for daclatasvir.

Many people have been waiting for an interferon-free Hepatitis C drug regimen that is both effective and tolerable. It appears that Bristol-Myers Squibb may be ending that wait – at least in Europe. Hopefully, daclatasvir will continue to reveal a high safety and efficacy profile and gain approval by the FDA before year’s end so infected Americans have even more to celebrate in 2015., Bristol-Myers Squibb Submits NDAs for Daclatasvir and Asunaprevir to US FDA for the Treatment of Hepatitis C, Retrieved August 31, 2014, Bristol-Myers Squibb, Business Wire News HQ(SM) 2014., European Regulators Approve Daclatasvir for Hepatitis C, Retrieved August 31, 2014,, 2014., Daclatasvir (Daklinza) for Chronic Hepatitis C Cleared in EU, Megan Brooks, Retrieved August 31, 2014, WebMD, LLC, 2014., MSF urges BMS to make daclatasvir accessible in low-and middle-income countries, Ramesh Shankar, Retrieved August 31, 2014, Saffron Media, Pvt, Ltd, 2014.


HCV Drug Update: Daklinza Gets Europe Approval

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How Quickly Can HCV be Eradicated?

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