TAF (Vemlidy) Approved!

[Aduiski]

As just mentioned in another thread, but I decided we need a separate thread for it.
Here is the Gilead's announcement:

http://www.gilead.com/news/press-releases/2016/11/us-food-and-drug-administration-approves-gileads-vemlidy-tenofovir-alafenamide-for-the-treatment-of-chronic-hepatitis-b-virus-infection

Any idea of when it could become available on market? (I am in particular interested in availability in Germany and Australia)

[prom00]

What do you think about the price in EU, it will be similar as in US? For those of you that remember how Viread played out in the past, price wise, please share your opinion.

[bigmoviebuff]

my doctor knows about it and would perscribe it but he is worried the insurance company might not pay for it. If they stop selling viread that is a good sign.

[luckyman316]

This is the big worry with many doctors, as the medicine is too new and may not be on the approved list of many insurance companies. I suspect that's why those of us on clinical trials, like myself, will remain on it until insurance companies start to add it to the list. Once Viread is phased out, I believe this won't be an issue.

[Royal36]

But i really don't know how we should convince to our Dr's coz they are not very cooperative.

[Royal36]

I don't think so it is a cure but better than those already on market specially in Toxocity.

[SphereAj]

But, is this a cure for HBV?

[luckyman316]

Definitely not a cure, just a better formula for Tenofovir with less toxocity and sides. However, there are some that have reported a cure in a year or two on this... usually about 1 in every 10. So it's possible there's something in it that leads to a development of a potential cure down the line.

[sorte]

Seems interesting, it would be much better than interferon. Can you post any reliable info about it ? Or those are just gossips between doctors ?

[Aduiski]

Things are now moving fast:

European CHMP Adopts Positive Opinion for Gilead’s Vemlidy!
(http://www.gilead.com/news/press-releases/2016/11/european-chmp-adopts-positive-opinion-for-gileads-vemlidy-tenofovir-alafenamide-taf-for-the-treatment-of-chronic-hepatitis-b-virus-infection).

The CHMP’s recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union, Norway and Iceland.

[Aduiski]

I was told by a trustable source that Gilead will eventually stop delivering Viread and just replace it with Vemlidy. We'll see how this plays out....but in this case people insisting to stay on TDF will have to go for generics.

[chihep]

http://www.biocentury.com

...Gilead spokesperson Kelsey Grossman told BioCentury that Vemlidy will be available next week at a price of $997.77 for a 30-tablet bottle, "at parity" with the price of Gilead's HBV therapy Viread tenofovir disoproxil fumarate (TDF).

Vemlidy's label has a boxed warning noting risks of lactic acidosis or severe hepatomegaly with steatosis and post-treatment severe acute exacerbation of disease...

[luckyman316]

Sounds just a tad bit more than the current cost of Viread (approximate $25 per pill in the US). Not surprised here. Let's just hope insurance companies are able to cover this one, as I know they like to play games sometimes for a bit before the meds make it on the list.

[luckyman316]

Lovely.... on one hand I'm glad it's available for many who can't have this and it will be VERY helpful to all of them. On the other hand, I am worried for myself why? Why? Because I'm on the clinical trial and the last visit I went to this week, the doctor mentioned it'll be approved and it's possible they may pull the trial and I would not be given the drug for free any more (even though I signed on for 5 more years for research purposes).

At my last visit, 6 months ago, my doctor told me different that I'd still be on the trial and the drug would still be free as I finish the trial for the next 5 years. Naturally, the cost out of pocket for me after insurance is what will concern me (my original trial was up in Jan/Feb 2017 and now I have no idea if my insurance will approve this drug if I'm off).

I'm very torn on this news :( Can anyone offer some insight as to what I can expect now?

[Nmarius]

Does somebody know the price ?

[chihep]

$997.77 for a 30-tablet bottle in USA

[studyforhope]

It will be available in a few days in us pharmacies.I don't know the status of EU or Australia approvals.

[Aduiski]

thanks studyforhope!