Question about Daclatasvir/Sofosbuvir and some other

[mcmaklin]

Hi,

I found Hepatitis C accidently in my blood., genotype 1.
My liver is not in a bed condition F1 S3 (Fibroscan) - the good that I was never drinking and I don't smoke, I am 38 y.o., I had 3 blood transfusions after I was born.
 I would like to know something (there was a subject here but it is not updated) -
1. Are there any upcoming non interferon treatments that will be son in a phase 4 or 3B not listed at clinicaltrials web page?
2. What is the final thing with a famous Daclatasvir Sofosbuvir duo? It has been discontinued?
3. I think I can wait for a new treatment I hope

Thank you

[jberlin]

Hello,

Nice to meet you but sorry you have to be here.  Lots of new and promising treatments are being tested, so assuming your liver really is in good shape it is worth it to wait and see if the treatment time shortens and the side effects improve.  Dr Muir, Hepatologist from Duke and one of the leading liver docs, told me in 2011 I should think about waiting, but I decided for a couple of reasons to retreat (I was treated and relapsed in 2004-5) last year with the Incivek triple therapy and I am now considered cured.  But, it is now a year closer to possible new treatments, so you should see new options within 9-18 months.  Here is the current drug pipeline: 
http://hcvadvocate.blogspot.ca/p/quick-reference-guide_21.html

And his is Dr. Muir, just this last week, discussing the drug pipeline:
http://hepatitiscnewdrugs.blogspot.com/2013/05/watch-dr-andrew-muir-discuss-latest.html

Hope this helps!

[iana5252]

2. What is the final thing with a famous Daclatasvir Sofosbuvir duo? It has been discontinued?

Unfortunately there appears no hope of a phase III trial involving Sofosbuvir and Daclatasvir. Here is the latest news from the phase II trial. It was presented at the European Association for the Study of the Liver (EASL) conference in Amsterdam last month.

Sofosbuvir, Daclatasvir Combo Cures 100% in Hep C Trial
http://www.hepmag.com/articles/sofosbuvir_daclatasvir_2501_23846.shtml

"because of the fact that Gilead has opted not to work jointly with BMS on advanced studies of the two drugs in combination, preferring instead to set its sights on a single combination pill of sofosbuvir with the company’s own ledipasvir, it appears unlikely there will ever be a U.S. Food and Drug Administration approval of sofosbuvir and daclatasvir in combination."

[jberlin]

Just a quick update - my sources indicate that it looks like Daclatasvir will be delayed... but we should see some effective non-interferon treatment options in 2014.  -jack

[mcmaklin]

Only Daclatasvir? Not the second one from the coctail? So did they stop producing  or there is an agreement?
So will there be any phase 3 of clinical trials?
What are other non-interferon treatments?

[iana5252]

They have stopped testing daclatasvir and sofosbuvir together. Both drugs remain in development.

Here is Hep's latest report on the pipeline...
Hep C’s Blockbuster Season
http://www.hepmag.com/articles/blockbuster_season_2502_23937.shtml

Also a heads up that Gilead filed for FDA approval for sofosbuvir in April.

Gilead is seeking approval for the drug to be used with ribavirin for those with genotypes 2 or 3 of the virus, and to be used with ribavirin and pegylated interferon for treatment-naive people with genotypes 1, 4, 5 and 6.

The full story...
http://www.hepmag.com/articles/sofosbuvir_FDA_2501_23780.shtml

[jberlin]

What I was told by someone involved with clinical trials was:  "It also looks like Daclatasvir will be delayed.  Same issue will come up with simeprevir."  I believe this to be a reliable statement.  The drug pipeline I posted in my 1st response lays out what is in phase 2 or phase 3 trials, and that story iana posted seems to agree with the Dr. Muir video that we will see non interferon treatment options in under 2 years.  Perhaps sofosbuvir is the silver bullet?  I hope so!  -jack