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Welcome VMP,
If you go to this page https://fixhepc.com/redemption-imagine-freedom-from-hepatitis-c and click on the blue highlighted “Redemption-2 (GT 1 2 3 4 5 6) is now open” label it will take you to the form.
Here is a direct link to the form https://fixhepc.com/r/root/redemption/2
Best wishes for a easy and successful treatment.
G3a since ’78 – Dx ’12 – F4 (2xHCC)
24wk Tx – PEG/Riba/Dac 2013 relapsed
24wk Tx – Generic Sof/Dac/Riba 2015/16 relapsed
16wk Tx – 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
SVR7 – 22/06/17 UND
SRV12 – 27/07/17 UND
SVR24 – 26/10/17 UND
Hi CD,
Great news to hear that you have found a doctor willing to help.
Just to clarify the situation a bit, as splitdog says this is the Sofosvel thread about Beacon Pharmacueticals new Velpatasvir/Sofosbuvir generic which is manufactured in Bangladesh. The prices are only the cost of the medication excluding shipping.
The Redemption eTrials details can be found here https://fixhepc.com/redemption-imagine-freedom-from-hepatitis-c along with current pricing. These trials use the Indian licenced manufacture version of the generics, either Harvoni® or Solvadi® + Daklinza® depending on genotype plus they include freight costs, delivery guarantee, etc (plus back up and medical support from MonkMed if required) thus the higher pricing.
An email to help@fixhepc.com should result in answers to any more detailed questions you have regarding Redemption.
G3a since ’78 – Dx ’12 – F4 (2xHCC)
24wk Tx – PEG/Riba/Dac 2013 relapsed
24wk Tx – Generic Sof/Dac/Riba 2015/16 relapsed
16wk Tx – 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
SVR7 – 22/06/17 UND
SRV12 – 27/07/17 UND
SVR24 – 26/10/17 UND
And as splitdog notes above the Velpatasvir/Sofosbuvir combination is quite an effective and recommended retreatment course for many relapsers. More info here http://www.hepatitisc.uw.edu/pdf/treatment-infection/treatment-genotype-3/core-concept/all
However it is less effective with “hard to treat” patients such as GT3a relapsers particularly where they have high fibrosis levels or cirrhosis which was why we were discussing the use of Voxilaprevir as one option even though it entails a wait.
vitrus wrote:Sofosvel needs to be tested by someone who is not the drug producer, like it was done for Twinvir.
Otherwise, personally I’m waiting for the Drug Controller General of India approval. They might ask for local trials though.Perhaps the question you should ask is “Has anyone other than the manufacturer tested Sofosvel and if so what was their finding?”
PS Welcome, I’m not always this grumpy and I wish you well for a swift resolution of your choice of treatment and success with it.
G3a since ’78 – Dx ’12 – F4 (2xHCC)
24wk Tx – PEG/Riba/Dac 2013 relapsed
24wk Tx – Generic Sof/Dac/Riba 2015/16 relapsed
16wk Tx – 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
SVR7 – 22/06/17 UND
SRV12 – 27/07/17 UND
SVR24 – 26/10/17 UND
vitrus wrote:I Agree
http://natap.org/2016/EASL/EASL_10.htm
http://www.gilead.com/news/press-releases/2016/4/gilead-announces-multiple-scientific-presentations-demonstrating-broad-utility-of-sofosbuvirbased-hepatitis-c-therapies
The last slideNausea plus diarhea vs no sides for vel.
But those are mild compared to ribavirin-related side effects. And the stomach usually recovers quickly.Slides also show it’s a stage 2 trial with small numbers for each combination. But 127/128 people were cured. So we’ll have more certainty in January.
Thanks,
Yes, early trial, small cohort and no placebo.
I went and had a quick look at just the diarrhoea results for Vox trials I could quickly access and the figures are all over the place. NCT02378935 was 9.6%, NC02378961 was 22.7% Both were non placebo trials. Interestingly I found an (admittedly phase 1) trial that used placebos NCT02185794. The placebo arm had 12.5% whereas the drug arm was only 5%.
The problem with quoting small scale trials which contain no placebo arm like you did is that anytime that you get a group of people together for a period of say 12 weeks and ask them to report adverse events, diarrhoea and nausea are going to show up fairly regularly whether those people have HCV or not and whether they are taking drugs, placebo or nothing at all. They are really common symptoms of everyday life that vary from location to location and season to season so you do need to be extremely cautious about attaching significance to them particularly if there is no placebo arm to the trial.I would also suggest you reconsider your “no sides for vel” statement. See p91 (onwards) below which shows them plus whether they were considered relevant. This is why we need placebo arms, to determine whether reported sides are related to the drugs or coincidental.
G3a since ’78 – Dx ’12 – F4 (2xHCC)
24wk Tx – PEG/Riba/Dac 2013 relapsed
24wk Tx – Generic Sof/Dac/Riba 2015/16 relapsed
16wk Tx – 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
SVR7 – 22/06/17 UND
SRV12 – 27/07/17 UND
SVR24 – 26/10/17 UND
hi vitrus,
“It is also widely known that vox causes diarhea and is otherwise bad for your stomach in the short term.(See links below)“
Again, citation please? There is nothing about adverse events relating to voxilaprevir in your claimed “links below”.
(And no, telling me to go and Google it doesn’t work. You are the one making these claims. Please back them up with some evidence.)
G3a since ’78 – Dx ’12 – F4 (2xHCC)
24wk Tx – PEG/Riba/Dac 2013 relapsed
24wk Tx – Generic Sof/Dac/Riba 2015/16 relapsed
16wk Tx – 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
SVR7 – 22/06/17 UND
SRV12 – 27/07/17 UND
SVR24 – 26/10/17 UND
And a bit of ‘light’ reading for those who are interested.
http://hepatitiscnewdrugresearch.com/sofosbuvir-velpatasvir-and-gs-9857.html
G3a since ’78 – Dx ’12 – F4 (2xHCC)
24wk Tx – PEG/Riba/Dac 2013 relapsed
24wk Tx – Generic Sof/Dac/Riba 2015/16 relapsed
16wk Tx – 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
SVR7 – 22/06/17 UND
SRV12 – 27/07/17 UND
SVR24 – 26/10/17 UND
vitrus wrote:It has gastrointestinal side effects
Citation please?
Also, Sofosbuvir has a different mechanism of action to both Vel and Vox which themselves have differing mechanisms. As such it is always used in combination with these or other drugs so talk of “sof failures” and “sof relapsers” needs to be qualified by what it was used in combination with (and the genotype and fibrosis status involved) as failure or relapse is far, far more likely to relate to one of those factors than Sofosbuvir.
G3a since ’78 – Dx ’12 – F4 (2xHCC)
24wk Tx – PEG/Riba/Dac 2013 relapsed
24wk Tx – Generic Sof/Dac/Riba 2015/16 relapsed
16wk Tx – 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
SVR7 – 22/06/17 UND
SRV12 – 27/07/17 UND
SVR24 – 26/10/17 UND
Hi PKQ,
A biopsy is the definitive diagnosis for cirrhosis, at least for the area they took the sample from so if the surgeon stated he found it then the only argument is over what is going to happen next and it sounds like he has lost that bet. The good news is that the liver is an amazing organ and in many but not all cases once the cause of the cirrhosis is removed the liver is able to regenerate. The extent of regeneration will vary from person to person depending on any number of factors such as diet, lifestyle, your genetics and how bad and widespread the original scarring. When that occurs it should be possible to live a reasonably normal, healthy lifestyle afterwards.
But you need an answer as to what condition your liver is in now. The surgeon who diagnosed your cirrhosis put you on a liver transplant list so that is your first port of call. The lists are far too long for the number of available livers so if he can safely take you off that list he will be absolutely delighted to do so even if his previous bedside manner seemed like a used car salesman trying to make end of month targets and he shouldn’t need another biopsy to do that.
Failing that, as the others said Fibroscans are available even in some regional centres these days though you will probably need to book ahead by a couple of months. The bush is a big place so if you can give us a better idea of which bit someone here may be able to suggest a suitable option.
G3a since ’78 – Dx ’12 – F4 (2xHCC)
24wk Tx – PEG/Riba/Dac 2013 relapsed
24wk Tx – Generic Sof/Dac/Riba 2015/16 relapsed
16wk Tx – 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
SVR7 – 22/06/17 UND
SRV12 – 27/07/17 UND
SVR24 – 26/10/17 UND
splitdog wrote:Should we start a new thread titled ‘Vox”?
Done, click on link below.
https://fixhepc.com/forum/relapse-corner/1263-voxilaprevir-a-new-protease-inhibitor.html
G3a since ’78 – Dx ’12 – F4 (2xHCC)
24wk Tx – PEG/Riba/Dac 2013 relapsed
24wk Tx – Generic Sof/Dac/Riba 2015/16 relapsed
16wk Tx – 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
SVR7 – 22/06/17 UND
SRV12 – 27/07/17 UND
SVR24 – 26/10/17 UND
Here is some further info on thirteen clinical trials involving Vox that I have been able to track down. I’ve included trial numbers for all phases for completeness but only a shortcut to Phase 3 which are the ones of most interest to us as they determine approvals. The four phase 3 trials are called Polaris 1 – 4.
Phase 1 completed: NCT02402452, NCT02533427, NCT02397707, NCT02185794
Phase 2 completed: NCT02378935, NCT02378961, NCT02202980, NCT02536313
Phase 2 active(recruiting): NCT02745535
Phase 3 active(not recruiting): NCT02607735, NCT02639338, NCT02607800, NCT02639247
G3a since ’78 – Dx ’12 – F4 (2xHCC)
24wk Tx – PEG/Riba/Dac 2013 relapsed
24wk Tx – Generic Sof/Dac/Riba 2015/16 relapsed
16wk Tx – 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
SVR7 – 22/06/17 UND
SRV12 – 27/07/17 UND
SVR24 – 26/10/17 UND
Congratulations Pat1,
I’m so glad to hear that you have received such wonderful news!
But of course such news requires a little (three times) happy dance too.
G3a since ’78 – Dx ’12 – F4 (2xHCC)
24wk Tx – PEG/Riba/Dac 2013 relapsed
24wk Tx – Generic Sof/Dac/Riba 2015/16 relapsed
16wk Tx – 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
SVR7 – 22/06/17 UND
SRV12 – 27/07/17 UND
SVR24 – 26/10/17 UND
Thanks Splitdog, great idea (and article). I think there will be a few GT3s watching this with particular interest.
G3a since ’78 – Dx ’12 – F4 (2xHCC)
24wk Tx – PEG/Riba/Dac 2013 relapsed
24wk Tx – Generic Sof/Dac/Riba 2015/16 relapsed
16wk Tx – 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
SVR7 – 22/06/17 UND
SRV12 – 27/07/17 UND
SVR24 – 26/10/17 UND
Hi Fretboard,
If you were UND at 4 weeks don’t sweat it, you’ll be fine for the rest of treatment. Here’s what Dr James said about it.
“The new DAA medications do not require a lot of monitoring (unless Ribavirin is involved). Once you fall to UND (Undetectable) you will remain undetectable for the duration of treatment so further measurements are a waste of your time and money.”
https://fixhepc.com/forum/viral-load-and-svr/287-viral-load-on-treatment-what-to-expect.html
Maybe try to renegotiate testing frequency with your doctor but you may need to humour them to ensure you get the important SVR tests later.
G3a since ’78 – Dx ’12 – F4 (2xHCC)
24wk Tx – PEG/Riba/Dac 2013 relapsed
24wk Tx – Generic Sof/Dac/Riba 2015/16 relapsed
16wk Tx – 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
SVR7 – 22/06/17 UND
SRV12 – 27/07/17 UND
SVR24 – 26/10/17 UND
25 August 2016 at 12:25 pm in reply to: Spreading the news about HCV generic medication-place for ideas #22513I think Dr James has already made an approach hasn’t he?
G3a since ’78 – Dx ’12 – F4 (2xHCC)
24wk Tx – PEG/Riba/Dac 2013 relapsed
24wk Tx – Generic Sof/Dac/Riba 2015/16 relapsed
16wk Tx – 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
SVR7 – 22/06/17 UND
SRV12 – 27/07/17 UND
SVR24 – 26/10/17 UND
Congratulations Tina!
G3a since ’78 – Dx ’12 – F4 (2xHCC)
24wk Tx – PEG/Riba/Dac 2013 relapsed
24wk Tx – Generic Sof/Dac/Riba 2015/16 relapsed
16wk Tx – 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
SVR7 – 22/06/17 UND
SRV12 – 27/07/17 UND
SVR24 – 26/10/17 UND
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