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Sofosvel (velpatasvir) 7 years 8 months ago #21075
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 The following user(s) said Thank You: beaches | |
Sofosvel (velpatasvir) 7 years 8 months ago #21086
The data is preliminary (from Stage 2 trials), but Gilead announced that sof/vel/vox is 99% effective for previous DAA failures of the studied classes (without naming the classes). Source: GILEAD announcement on EASL Conference in April. It is also widely known that vox causes diarhea and is otherwise bad for your stomach in the short term. (See links below). The data is from Stage 2 trials. So for retreatment of DAA-failures vox is a much much more effective option than say vel+sof for 24 weeks or with ribavirin. Vel is not good for retreament. It is recommended for treatment-naive people. Because it has almost no side effects and although there's no data yet if sof/vel/vox is effective for sof/vel relapsers, it is likely that this data is going to be available in the beginning of 2017. If sof/vel/vox indeed proves effective against vel-resistant viruses, there's more probability to get cured if you do, say, sof+vel and if it doesn't work you do sof/vel/vox. Because sof/vel won't bring in any NS3 mutations and there's no data on retreatment of sof/vel/vox failures yet. That said, if you're treatment-naive, get sof/vel. If DAA-experienced, wait a little. No data on if vox would help and in what situations it would (after which treatment regimens, in which liver conditions), but Stage 2 shows it is effective. regist2.virology-education.com/2016/12co...ion/21_Sulkowski.pdf www.natap.org/2016/EASL/EASL_31.htm The problem is though, vox is not going to be available until mid-2017. It is effective in cirhotic populations. Gen 1b VL pre treatment 29000 ME/ml AST 32 ALT 94, F0 Started treatment 13 January 2017 Generic sofosbuvir/velpatasvir (Incepta) VL 9 days into treatment <300 (undetected) AST 13.8 ALT 22 Side effects: mild dehydration, not a problem at all if I drink water at night, nothing to worry about Diet and gastric ph are very important with velpatasvir. One must think what and when to eat to keep gastric pH low. Side effects disappeared 2 weeks after, unless I ate anything < 4hrs before the pill. SVR60. The following user(s) said Thank You: DrJames | |
Sofosvel (velpatasvir) 7 years 8 months ago #21088
hi vitrus,
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 | |
Sofosvel (velpatasvir) 7 years 8 months ago #21091
I Agree natap.org/2016/EASL/EASL_10.htm www.gilead.com/news/press-releases/2016/...epatitis-c-therapies The last slide Nausea 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. Gen 1b VL pre treatment 29000 ME/ml AST 32 ALT 94, F0 Started treatment 13 January 2017 Generic sofosbuvir/velpatasvir (Incepta) VL 9 days into treatment <300 (undetected) AST 13.8 ALT 22 Side effects: mild dehydration, not a problem at all if I drink water at night, nothing to worry about Diet and gastric ph are very important with velpatasvir. One must think what and when to eat to keep gastric pH low. Side effects disappeared 2 weeks after, unless I ate anything < 4hrs before the pill. SVR60. | |
Sofosvel (velpatasvir) 7 years 8 months ago #21092
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. Gen 1b VL pre treatment 29000 ME/ml AST 32 ALT 94, F0 Started treatment 13 January 2017 Generic sofosbuvir/velpatasvir (Incepta) VL 9 days into treatment <300 (undetected) AST 13.8 ALT 22 Side effects: mild dehydration, not a problem at all if I drink water at night, nothing to worry about Diet and gastric ph are very important with velpatasvir. One must think what and when to eat to keep gastric pH low. Side effects disappeared 2 weeks after, unless I ate anything < 4hrs before the pill. SVR60. | |
Sofosvel (velpatasvir) 7 years 8 months ago #21094
Because I need a permanent record of this statement.
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Sofosvel (velpatasvir) 7 years 8 months ago #21095
What I gleaned from this is Sof/Vel is way better at treating people with RAV's than say Sof/Dac. So it would be better for relapsers. However, I am still going to wait for the silver bullet, Vox. Doesn't it say in there somewhere about SVR12 >90% of DAA failed treatment? This email address is being protected from spambots. You need JavaScript enabled to view it. Genotype 3 VL 4,100,000 ALT 101 AST 71 Treatment Naive Started Sof/Dac Jan 12, 2016 VL= <15 4 weeks in. AST/ALT normal. VL=UNDETECTED 8 weeks in. SVR4= Virus back. 3,300,000 Started generic Epclusa Sep. 23, 2017 4 weeks in <15 *Detected. 12 weeks in <15 *Not Detected. 16 weeks in <15 *Not Detected. Finished 24 weeks treatment 3-17-18 SVR5 <15 Not Detected. SVR 20 <15 Not Detected. SVR 44 <15 Not Detected. Thank you Jesus. Thank you Dr. James | |
Sofosvel (velpatasvir) 7 years 8 months ago #21097
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. www.ema.europa.eu/docs/en_GB/document_li...4210/WC500211152.pdf 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 | |
Sofosvel (velpatasvir) 7 years 8 months ago #21099
And as splitdog notes above the Velpatasvir/Sofosbuvir combination is quite an effective and recommended retreatment course for many relapsers. More info here www.hepatitisc.uw.edu/pdf/treatment-infe...e-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.
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 | |
Sofosvel (velpatasvir) 7 years 7 months ago #21119
Has anyone tested sofosvel for solubility and manufacturing process quality? All I could find was www.facebook.com/sofosvel/photos/pcb.157...9006/?type=3&theater Another point is. We might get sof/vel in India in September. There may also be a delay because Indian law requires local trials to be held in India, unless negotiations to waive the requirement succeed. The expected delay is 0 days to 6 months. Gen 1b VL pre treatment 29000 ME/ml AST 32 ALT 94, F0 Started treatment 13 January 2017 Generic sofosbuvir/velpatasvir (Incepta) VL 9 days into treatment <300 (undetected) AST 13.8 ALT 22 Side effects: mild dehydration, not a problem at all if I drink water at night, nothing to worry about Diet and gastric ph are very important with velpatasvir. One must think what and when to eat to keep gastric pH low. Side effects disappeared 2 weeks after, unless I ate anything < 4hrs before the pill. SVR60. | |
Sofosvel (velpatasvir) 7 years 7 months ago #21122
Can anyone give me a ballpark figure for shipping to Vancouver BC? I'm trying to put together information for people who contact HepCBC about getting treated. I'd like to be able to tell them how much 12 weeks of Harvoni equiv will cost them. I see the $1600 US price for the drugs but can't figure out how much the Fedex courier costs. CD | |
Sofosvel (velpatasvir) 7 years 7 months ago #21125
The drugs are $840. Shipping for me in the US was $90. 3 days. This email address is being protected from spambots. You need JavaScript enabled to view it. Genotype 3 VL 4,100,000 ALT 101 AST 71 Treatment Naive Started Sof/Dac Jan 12, 2016 VL= <15 4 weeks in. AST/ALT normal. VL=UNDETECTED 8 weeks in. SVR4= Virus back. 3,300,000 Started generic Epclusa Sep. 23, 2017 4 weeks in <15 *Detected. 12 weeks in <15 *Not Detected. 16 weeks in <15 *Not Detected. Finished 24 weeks treatment 3-17-18 SVR5 <15 Not Detected. SVR 20 <15 Not Detected. SVR 44 <15 Not Detected. Thank you Jesus. Thank you Dr. James The following user(s) said Thank You: cdmazoff | |
Sofosvel (velpatasvir) 7 years 7 months ago #21126
Wow.. that is amazing. And the price you got was from the drugs in the trial and via Monkmed? I need to be sure ..The price listed in the Redemption trial says $1600 US (fixhepc.com/) "Affordable treatment for Hepatitis C is now available for $1600 via parallel importation of Sofosbuvir, Ledipasvir and Daclatasvir. These are active molecules that make up the new age Hepatitis C treatments Sovaldi (400mg sofosbuvir), Harvoni (90mg ledipasvir / 400mg sofosobuvir) and Daklinza (60mg daclatasvir)." or am I reading this wrong? Does this mean $1600 for all 3 drugs? CD | |
Sofosvel (velpatasvir) 7 years 7 months ago #21127
$840 for the Sofosvel. You're in the Sofosvel thread. The other drugs are available through other channels, but I got mine directly from Beacon Pharmaceuticals. A script, a bank transfer, and they're on their way! From what I've been reading, (and I have read a lot ), Sof/Vel is the best option for treating ALL genotypes now. This email address is being protected from spambots. You need JavaScript enabled to view it. Genotype 3 VL 4,100,000 ALT 101 AST 71 Treatment Naive Started Sof/Dac Jan 12, 2016 VL= <15 4 weeks in. AST/ALT normal. VL=UNDETECTED 8 weeks in. SVR4= Virus back. 3,300,000 Started generic Epclusa Sep. 23, 2017 4 weeks in <15 *Detected. 12 weeks in <15 *Not Detected. 16 weeks in <15 *Not Detected. Finished 24 weeks treatment 3-17-18 SVR5 <15 Not Detected. SVR 20 <15 Not Detected. SVR 44 <15 Not Detected. Thank you Jesus. Thank you Dr. James The following user(s) said Thank You: cdmazoff | |
Sofosvel (velpatasvir) 7 years 7 months ago #21128
Okay.. Right, I'm in the right thread. I'm cured now, and just trying to help others who are scared, poor and being denied treatment. Our organization HepCBC is totally for the Redemption trials. We are trying to gather as much info as possible so as to make the journey easier for those who come to us for advice. So please educate me: I thought that the fixhepc club had an arrangement with Monkmed for the trial, or is there also an arrangement with Beacon. I don't know and I'm not trying to cause trouble. We just need to know that if we send someone to the Redemption trial that they will get certified meds with guaranteed delivery. Is this the case for Beacon? CD The following user(s) said Thank You: splitdog | |