TOPIC: G3 Dacla/Sofosbivir from Mylan in India

I am a G3 contracted 40 years ago . I am responder /relapser with Interferon/Ribavirin . I have Daclatasvir and
Sufosbivir from Mylan in India . My Hep doctor has concerns and suggests maybe waiting for EpClusa .
Has anyone had successful treatment with the drugs made under license in India ?

Hi Neil, welcome to the forum. Yes, hundreds here, likely thousands of people have successfully used the Indian generics.

First these points ... The meds from Mylan are the equivalent of the branded drugs. All of the Indian Sofosbuvir, Ledipasvir, and/or Daclatasvir producers are in fact having their medicines manufactured by either Hetero or Natco and they are all proving equally effective. The unlicensed drugs from the companies in Bangladesh are also being shown to be equal in effectiveness, and it is almost certain that the drugs coming from Morocco, Algeria and Pakistan are as well, although we don't have the data on those last three yet. In a couple months the results from 1,000,000 people that have been treated in Egypt with mostly Egyptian generics will be presented and the preliminary data indicate that again they are the equivalent of the branded drugs.

So the question of quality, branded vs generic, should not be your concern.

The issue your doctor is worried about is your genotype and your treatment experience. G3 treatment experienced people are having a harder time reaching SVR (sustained virologic response.) Additionally, people with higher levels of fibrosis/cirrhosis have a harder time getting the medicine into the scarred areas of their livers, where the virus can hide and then reappear after treatment. In such cases, it is generally advised to either lengthen treatment, change drugs, or add more drugs ... maybe ribivirin, maybe an NS3 inhibitor ... or two/three of these options.

You haven't told us your fibroscan score or viral load or any other blood test numbers, so it's going to be difficult to tell you whether you would be best served to simply lengthen treatment or add more meds/different meds. But our doctor here, Dr. James Freeman, is one of the top world authorities on this issue, so if you put your further data here in this thread he can probably answer your questions.

And if it turns out you should be taking Epclusa, (Sofosbuvir/Velpatasvir,) Beacon Pharmaceuticals in Bangladesh is already selling a generic form of this combination called Sofosvel. Beacon has provided meds for many, many people here and you can find their contact info in the top post of their thread in the Pharmas Market section of the forum ... or click here:

fixhepc.com/forum/daa-access/439-beacon-...c-sof-vel-combo.html

Again, welcome to the forum.

Edit: It might also be helpful to know where you live on the planet.

Hi Neil,

From the looks of your email address you're in the UK. As Kevin points out G3 is harder to cure so longer treatment with SOF+DCV and +/- Ribavirin (and even PEG Interferon in past responders based on BOSON trials) are current options.

Velpatasvir has an EC50 of 20 compared to Daclatasvir's EC50 of 500 making it about 25x as potent, although it is less well absorbed which almost certainly robs it of part of it's power outside of a test tube. It does probably have an edge although if you have a look at this:

www.hepctip.ca/drug-pipeline-2/sofosbuvi...patasvir-fact-sheet/

And the ASTRAL-4 results we see SVR rates of 50-84% in GT3 in decompensated cirrhotics. This actually looks worse than SOF+DCV but the reality is that it's probably similar and the data sets are just not big enough to be definitive.

The reality is that there will always be better drugs in the future. SOF+DCV is better than PEG/Riba. PEG/Riba + SOF produced 90% SVR in GT3 in BOSON so is about the same as SOF+DCV, and arguably adding DCV to that would have made it better. This is certainly seeing use in salvage treatment.

Treat now or wait a while is a very personal question that only you can really answer with stage of fibrosis and disease impact being important considerations of how long you can afford to, of might want to wait.

Happy to have an in depth chat online if you'd like.

Hi there ,

thanks so much for the informed responses. I am in London . I am about to start with Dacla and sufosbivir . My Fibrascan is 6.1 . I will add my Viral load scores after I get them on Monday . I took the view that the drugs may very well cure me ( 96%) and unless they are poison (!) I have nothing to lose . My Doctor is on NICE committee here so cannot recommend generics , but in the UK you have to have cirrhosis to get the drugs on the NHS .; or pay £45K . We agreed to do bloods at 2,4,12 weeks to keep a close eye on things .

Hi Neil,

It is good to know that even if your Dr is "officially" not allowed to do anything, he is still supporting you on the generic path. You will not regret it, and there is a very high probability that your Dr will be astonished by the results.

One more patient cured. One more Dr convinced.

Its progress Jim....

Cheers,

Thanks for super informed replies . Finally started my Dacla/Sofos 12 days ago .
got fairly strong flu like symptoms after about a week . I see this is "normal " but if it continues when do I get further medical advice ?

Hi Neil
I had 12 weeks sof/dac ( EOT 28/11/16). I did get some side effects....however the end result is that i have no Hep C virus
So any sleepless nights or headaches have been worth it... wishing you every success with this treatment...Donna x

Congratulations!!

I have just had my 24 week ( 12 weeks after 12 weeks of treatment on Dacla and sofosbivir ) results and I am clear . Done . Finished . I carried that virus for 40 years and had 6 months of Interferon and ribavirin that didn't work . My wife saw Fix HepC on the TV and I got my drugs from India . I did have a lousy 6 weeks of very bad flu like symptoms which we mustn't underestimate ( nothing like interferon/Ribavirin though) but it is a small price . UK NHS policy is still to wait for Cirrhosis, or you can pay £50 K privately . Thank you so much for setting up this organisation . It is literally changing people's lives .

Congratulations - that's great news neil.rogers8! I understand the absolute relief to be rid of something that we didn't want but had to carry with us for decades. Enjoy the lightness!