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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 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
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
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
The drugs are $840. Shipping for me in the US was $90. 3 days.
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