EC approves expanded use of Daklinza (daclatasvir) for patients with chronic HCV and HIV co-infection

Daclatasvir formerly BMS-790052, trade name Daklinza) is a drug for the treatment of hepatitis C (HCV). It was developed by Bristol-Myers Squibb and was approved in Europe on 22 August 2014. Daklinza gained its FDA approval on July 24, 2015 in the United States; it is approved for Hepatitis C genotype 3 infections.  

A generic version of daclatasvir is expected to be approved in India before the end of 2015. 

Daclatasvir inhibits the HCV nonstructural protein NS5A.  Recent research suggests that it targets two steps of the viral replication process, enabling rapid decline of HCV RNA. Daclatasvir has been tested in combination regimens with pegylated interferon and ribavirin,  as well as with other direct-acting antiviral agents including asunaprevir and sofosbuvir....

Now....

EC approves expanded use of Daklinza (daclatasvir) for patients with chronic HCV and HIV co-infection: Bristol-Myers Squibb today announced that the European Commission has approved the expanded use of Daklinza, a first-in-class oral, once-a-day pill used in combination with other treatments as an option for adult patients with chronic hepatitis C virus infection who are co-infected with HIV or who have had a prior liver transplant.

AWMSG recommends Daklinza (daclatasvir) for treatment of adult patients with chronic HCV infection

In continuation of my update on daclatasvir 

The All Wales Medicines Strategy Group (AWMSG) has recommended Daklinza®(daclatasvir) for the treatment of adult patients with chronic hepatitis C virus (HCV) infection. The recommendation is specifically for patients with advanced liver disease, for whom treatment options can be limited. Daclatasvir is used in combination with other agents to treat adult patients with chronic HCV genotypes 1, 3 and 4 (which include most of the cases seen in Wales). This decision could enable some of the most ‘at-risk’ patients in Wales with chronic HCV to access a new, first-in-class treatment which has been shown, when used with other agents, to clear the viral infection in most of these patients after 12 or 24 weeks of therapy.

AWMSG recommends Daklinza (daclatasvir) for treatment of adult patients with chronic HCV infection

FDA Approves Expanded Use of Daklinza (daclatasvir) for Additional Challenging-to-treat Patients with Genotype 1 or Genotype 3 Chronic Hepatitis C

In continuation  of my update on Daclatasvir

Bristol-Myers Squibb Company (NYSE:BMY) announced today that Daklinza (daclatasvir, 60 mg), an NS5A replication complex inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) in combination with sofosbuvir (with or without ribavirin) in genotypes 1 and 3. The expanded label includes data in three additional challenging-to-treat patient populations: chronic hepatitis C virus (HCV) patients with HIV-1 coinfection, advanced cirrhosis, or post-liver transplant recurrence of HCV. The Daklinza plus sofosbuvir regimen is already available for the treatment of chronic HCV genotype 3, and is currently the only 12-week, once-daily all-oral treatment option for these patients. Sustained virologic response (SVR) rates are reduced in genotype 3 patients with cirrhosis receiving Daklinza and sofosbuvir for 12 weeks without ribavirin. The recommended dosage of Daklinza is 60 mg in combination with sofosbuvir with or without (+/-) ribavirin for 12 weeks..

“The expanded indication for Daklinza offers an additional treatment option for multiple subsets of patients who have genotype 1 or 3 chronic HCV,” said Chris Boerner, Head of U.S. Commercial, Bristol-Myers Squibb. “HCV/HIV-coinfected patients and patients with advanced cirrhosis or post-transplant recurrence of HCV still pose a treatment challenge to physicians. As part of our commitment to the HCV community, we have sought to make new treatment options available for these and other targeted populations that have not yet been able to fully benefit from currently available next-generation medicines.”

FDA Approves Expanded Use of Daklinza (daclatasvir) for Additional Challenging-to-treat Patients with Genotype 1 or Genotype 3 Chronic Hepatitis C

FDA Approves Expanded Use of Daklinza (daclatasvir) for Additional Challenging-to-treat Patients with Genotype 1 or Genotype 3 Chronic Hepatitis C

In continuation of my update on daclatasvir

Bristol-Myers Squibb Company (NYSE:BMY) announced today that Daklinza (daclatasvir, 60 mg), an NS5A replication complex inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) in combination with sofosbuvir (with or without ribavirin) in genotypes 1 and 3. The expanded label includes data in three additional challenging-to-treat patient populations: chronic hepatitis C virus (HCV) patients with HIV-1 coinfection, advanced cirrhosis, or post-liver transplant recurrence of HCV. The Daklinza plus sofosbuvir regimen is already available for the treatment of chronic HCV genotype 3, and is currently the only 12-week, once-daily all-oral treatment option for these patients. Sustained virologic response (SVR) rates are reduced in genotype 3 patients with cirrhosis receiving Daklinza and sofosbuvir for 12 weeks without ribavirin. The recommended dosage of Daklinza is 60 mg in combination with sofosbuvir with or without (+/-) ribavirin for 12 weeks.

FDA Approves Expanded Use of Daklinza (daclatasvir) for Additional Challenging-to-treat Patients with Genotype 1 or Genotype 3 Chronic Hepatitis C

Added benefit of daclatasvir drug not proven for chronic hepatitis C infection

In continuation of my update on daclatasvir 

The drug daclatasvir (trade name Daklinza) has been available since August 2014 for the treatment of adults with chronic hepatitis C (CHC) infection. The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment whether this new drug offers an added benefit over the appropriate comparator therapy.

The drug manufacturer presented data for patients without cirrhosis of the liver who are infected with hepatitis C virus (HCV) genotype 1, and for patients with HCV genotype 4. However, these data are unsuitable in various aspects to prove an added benefit.

The manufacturer dossier contained no data at all for three further patient groups with HCV genotype 1 infection (pretreated patients, untreated patients with cirrhosis of the liver, and patients with HIV coinfection) as well as for patients with HCV genotype 3 (with compensated cirrhosis and/or treatment-experienced).

Added benefit of daclatasvir drug not proven for chronic hepatitis C infection

Bristol-Myers Squibb and Tibotec partner to evaluate daclatasvir-TMC435 combination for HCV

Bristol-Myers Squibb and Tibotec partner to evaluate daclatasvir-TMC435 combination for HCV: Bristol-Myers Squibb Company announced today that it has entered into a clinical collaboration agreement with Tibotec Pharmaceuticals to evaluate the utility of daclatasvir (BMS-790052), Bristol-Myers Squibb's investigational NS5A replication complex inhibitor, in combination with Tibotec Pharmaceuticals' investigational NS3 protease inhibitor, TMC435, for the treatment of chronic hepatitis C virus (HCV).

New Drug Combo for Hepatitis C Shows Promise...

A new cocktail of two investigational drugs appears to have successfully cleared the hepatitis C virus in people who don't respond to standard treatment. What's more, the approach seems to work without the need for injections with interferon alpha, an onerous medication that causes serious side effects in many patients.

"We saw a sustained virologic response -- the virus was undetectable in the patients -- during treatment and remained undetectable after the drugs were stopped," said study author Dr. Anna Lok, director of clinical hepatology at the University of Michigan Medical School in Ann Arbor.

The study had two arms:  a group of 10 patients received four medications, including the two investigational drugs, the antivirals daclatasvir (see right structure)  and asunaprevir (see left structure-courtesy: ChemSpider), along with the standard treatment combination of interferon and ribavirin. The other arm of the study included 11 patients who received only the two investigational drugs. Both groups underwent treatment for 24 weeks.

The 10 patients on the four-drug regimen experienced a sustained virologic response with undetectable virus at the end of treatment and again at 12 weeks beyond their treatment, the researchers reported. In the two-drug group, four of the 11 patients also had undetectable levels of the hepatitis C virus in their blood 12 weeks after treatment ended.

"The four-drug arm was very impressive. These patients had not shown a response before and now we get a 90 to 100 percent rate of sustained response," said Lok....

Ref : http://www.nejm.org/doi/full/10.1056/NEJMoa1104430