Aa
Aa
A
A
A
Close
1084115 tn?1385228589

European Commission Approves Daklinza (daclatasvir)


Daklinza, when used in combination with sofosbuvir, is an all-oral, once daily regimen that yields cure rates of up to 100%

Daklinza + sofosbuvir offers potential cure for a broad range of EU HCV patients, including those with advanced liver disease, genotype 3 and protease inhibitor failures




http://news.bms.com/press-release/rd-news/european-commission-approves-bristol-myers-squibbs-daklinza-daclatasvir-across&t=635447138542904738
6 Responses
Sort by: Helpful Oldest Newest
Avatar universal
I read the above article and have copied an exerpt to post here, if it is acceptable to do that.  Excitting news!

Web Manager:  Is that permissible?
Helpful - 0
1797925 tn?1341096204
Hope when daclatasvir (Daklinza) is approved here in November, many knowledgeable doctors will prescribe it 'off-label' with Sovaldi (sofosbuvir) for their patients.  Gilead is so far off from completing studies of their NS5A inhibitor GS-5816, it could be another year at the very least before it reaches the market.

If Gilead would have pursued those trials with Bristol back in 2012... if only...big sigh!  Oh well, you can't change history.  So onward my Hep C friends, onward!

Rexx - thanks for the article.
Helpful - 0
446474 tn?1446347682
Daclatasvir plus Sofosbuvir for Previously Treated or Untreated Chronic HCV Infection

BACKGROUND
All-oral combination therapy is desirable for patients with chronic hepatitis C virus (HCV) infection. We evaluated daclatasvir (an HCV NS5A replication complex inhibitor) plus sofosbuvir (a nucleotide analogue HCV NS5B polymerase inhibitor) in patients infected with HCV genotype 1, 2, or 3.

METHODS
In this open-label study, we initially randomly assigned 44 previously untreated patients with HCV genotype 1 infection and 44 patients infected with HCV genotype 2 or 3 to daclatasvir at a dose of 60 mg orally once daily plus sofosbuvir at a dose of 400 mg orally once daily, with or without ribavirin, for 24 weeks. The study was expanded to include 123 additional patients with genotype 1 infection who were randomly assigned to daclatasvir plus sofosbuvir, with or without ribavirin, for 12 weeks (82 previously untreated patients) or 24 weeks (41 patients who had previous virologic failure with telaprevir or boceprevir plus peginterferon alfa–ribavirin). The primary end point was a sustained virologic response (an HCV RNA level of <25 IU per milliliter) at week 12 after the end of therapy.

RESULTS
Overall, 211 patients received treatment. Among patients with genotype 1 infection, 98% of 126 previously untreated patients and 98% of 41 patients who did not have a sustained virologic response with HCV protease inhibitors had a sustained virologic response at week 12 after the end of therapy. A total of 92% of 26 patients with genotype 2 infection and 89% of 18 patients with genotype 3 infection had a sustained virologic response at week 12. High rates of sustained virologic response at week 12 were observed among patients with HCV subtypes 1a and 1b (98% and 100%, respectively) and those with CC and non-CC IL28B genotypes (93% and 98%, respectively), as well as among patients who received ribavirin and those who did not (94% and 98%, respectively). The most common adverse events were fatigue, headache, and nausea.

CONCLUSIONS
Once-daily oral daclatasvir plus sofosbuvir was associated with high rates of sustained virologic response among patients infected with HCV genotype 1, 2, or 3, including patients with no response to prior therapy with telaprevir or boceprevir.

(Funded by Bristol-Myers Squibb and Pharmasset (Gilead); A1444040 ClinicalTrials.gov number, NCT01359644.)

Presented in part at the 48th annual meeting of the European Association for the Study of the Liver, Amsterdam, April 24–28, 2013; the 63rd annual meeting of the American Association for the Study of Liver Diseases, Boston, November 9–13, 2012; and the 47th annual meeting of the European Association for the Study of the Liver, Barcelona, April 18–22, 2012.


Hector
Helpful - 0
Avatar universal
This is fantastic news.  I wonder what a 12 week course of this drug will cost?  
dointime  
Helpful - 0
2114131 tn?1399240871
I just started the combination treatment with Sovaldi (sofosbuvir) and Daklinza(daclatasvir) for 24 weeks. Total costs are 240.000 euro. (which is about 250.000 dollar) Im so glad my insurance pays for it!!  (-:
One month treatment with only Sovaldi costs 23.000 euro.
Mind boggling numbers.
Helpful - 0
142841 tn?1201975052
" ... as well as among patients who received ribavirin and those who did not (94% and 98%, respectively). "

Wow!  If I'm reading this correctly, the addition of ribavirin *reduced* the likelihood of SVR. That's unexpected...
Helpful - 0
Have an Answer?

You are reading content posted in the Hepatitis C Community

Top Hepatitis Answerers
317787 tn?1473358451
DC
683231 tn?1467323017
Auburn, WA
Learn About Top Answerers
Didn't find the answer you were looking for?
Ask a question
Answer a few simple questions about your Hep C treatment journey.

Those who qualify may receive up to $100 for their time.
Explore More In Our Hep C Learning Center
image description
Learn about this treatable virus.
image description
Getting tested for this viral infection.
image description
3 key steps to getting on treatment.
image description
4 steps to getting on therapy.
image description
What you need to know about Hep C drugs.
image description
How the drugs might affect you.
image description
These tips may up your chances of a cure.
Popular Resources
Herpes sores blister, then burst, scab and heal.
Herpes spreads by oral, vaginal and anal sex.
STIs are the most common cause of genital sores.
Condoms are the most effective way to prevent HIV and STDs.
PrEP is used by people with high risk to prevent HIV infection.
Can I get HIV from surfaces, like toilet seats?