Sofosvel (velpatasvir)

This topic has 92 replies, 25 voices, and was last updated 8 years, 1 month ago by vitrus.

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30 August 2016 at 2:24 am #22632
splitdog
- Topics: 5
- Replies: 374
- Total: 379
- Guardian Angel
@splitdog
Yes. I can attest to Beacon’s integrity. Sofosvel just came out like 2 weeks ago, so it is still new. Monkmed and all that is fine also. If you want, you could steer them to Dr. Freeman @ GP2U.com, and let him write the script. He then forwards it directly to beacon, and the process is expedited that way. Sofosvel is Sofosbuvir, and Velpatasvir, and constitutes a complete, accepted fixed-dose combination for the treatment of all genotypes HepC.

splitdog@roadrunner.com

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
30 August 2016 at 2:33 am #22633
cdmazoff
- Topics: 2
- Replies: 17
- Total: 19
- Acolyte
@cdmazoff
This is very interesting. We have found a Dr. in BC who is willing to help out, so that the people will have a script and also follow-up, vl tests, and fibroscan. So, we were thinking that we would steer the patients to enroll in the Redemption Trial and then get their meds at Monkmed. If they do it this way, will it be the same price as Beacon?

I’m running around right now … It’s afternoon in BC, so I’ll check back in a couple of hours..

Thanks muchly splitdog

CD
30 August 2016 at 2:38 am #22634
splitdog
- Topics: 5
- Replies: 374
- Total: 379
- Guardian Angel
@splitdog
I’m not sure how much MonkMed or their prices are. I went through Kingswood Pharmacy the first time, and it was ~$1200 shipped for two drugs Sofosbuvir and Daclatasvir. $840 for Sofosvel seems to be a good deal.

splitdog@roadrunner.com

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
30 August 2016 at 3:15 am #22636
Gaj
- Topics: 29
- Replies: 1,402
- Total: 1,431
- Guardian Angel
@gaj
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
30 August 2016 at 7:13 am #22642
cdmazoff
- Topics: 2
- Replies: 17
- Total: 19
- Acolyte
@cdmazoff
Thanks Gaj.. Okay.. I’m clear on what you say, and I read the info on the trial and see the price of the drugs but need to know how much more people in BC will have to pay for shipment. I have sent an email to Tim at Monkmed and am waiting for an answer. I need to know if shipping is included in the price of the trial (US $1600)..and if not, how much to Vancouver BC.

CD
30 August 2016 at 8:15 am #22646
Gaj
- Topics: 29
- Replies: 1,402
- Total: 1,431
- Guardian Angel
@gaj
Hi CD,

No doubt MonkMed will respond to you but for others reading this in the future the worldwide shipping cost is included in the prices quoted. Please see about 2/3 of the way down the first post in the below link.

https://fixhepc.com/forum/redemption/203-so-what-are-the-redemption-trials.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
30 August 2016 at 8:21 am #22647
cdmazoff
- Topics: 2
- Replies: 17
- Total: 19
- Acolyte
@cdmazoff
Super thanks Gaj.. Man I am so blind.. You should have seen me when I had hep!!!!! OMG.. Brain fog and fibromyalgia so bad. I’ve been clear now about 11 months.. The difference is AMAZING!! Fibro episodes down by 95% and brain fog episodes down by about 80%!!!
30 August 2016 at 10:21 am #22648
Gaj
- Topics: 29
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- Total: 1,431
- Guardian Angel
@gaj
I hear you on that!

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
9 October 2016 at 8:36 pm #23680
vitrus
- Topics: 1
- Replies: 35
- Total: 36
- Treatment Warrior
@vitrus
Splitdog,
you should consider data from this small Phase 2 trial (sof/vel/riba @ 24 weeks for retreatment)
http://www.hcv-trials.com/showStudy.asp?Study=112
http://www.catie.ca/en/treatmentupdate/treatmentupdate-216/anti-hcv-drugs/sofosbuvir-velpatasvir-epclusa-ribavirin-retreatm
http://www.natap.org/2016/EASL/EASL_11.htm
http://www.natap.org/2016/EASL/EASL_56.htm
Another news is Velpatasvir may get available in India ~ March 2017 (or earlier) as the local Indian trials of generic sof/vel end, unless the approval is expedited.
The sof/vel/vox trial for NS5A-experienced people is going to end in Jan 2017 (https://www.smartpatients.com/trials/NCT02607735) => sof/vel/vox may get to be FDA-approved in July 2017. Generic availability – 6+ months from that moment in India, unless local Indian trials requirement is waived there (it might happen because nothing else is better for retreatment) or 0+ months elsewhere (Bangladesh for example).
The main question in your case would be – how effective sof/vel/vox would be for retreatment of a sof/vel/riba & sof/dac combined failure for a fibrosis state. It may get answered in Jan 2017.
However, you should consider sof/vel/riba @ 24wks if your liver got worse. No more trial results for now.

EDIT: Please, note that people on this trial had been treated with suboptimal doses of velpatasvir before relapsing (25 and 50mg vs 100 mg). The natap publication includes more details, but there is a typo there – it is 50 mg that the dose of velpatasvir that 59% of prior relapsers had been treated with was, not 100 mg. The results may differ for those previously treated with the optimal 100 mg dose of velpatasvir or patients with an advanced liver disease.
Also, the problem is dac gives y93h resistance in 90% of variants after a relapse. http://aac.asm.org/content/58/9/5155.full
Velpatasvir is generally weak against Y93H in gen 3 viruses. However, 14 of 15 people with Y93H mutation were cured with sof+vel+vox, 9 of 11 (13 people with NS5A RAVs in total) people with gen 3 and y93h were cured with sof+vel+riba @ 24wks.
Both were phase 2 trials, so they do not provide statistically significant information. You may or may not get cured with sof + vel + ribavirin (for 6 months) now, if treated. More reliable statistical data on retreatment comes in 2017.

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.
10 October 2016 at 1:03 am #23691
splitdog
- Topics: 5
- Replies: 374
- Total: 379
- Guardian Angel
@splitdog
Thank you. I am hoping for the earliest release of Vox. I am ready. I already have the Sof/Vel.

splitdog@roadrunner.com

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
10 October 2016 at 1:47 am #23695
mgalbrai
- Topics: 28
- Replies: 1,298
- Total: 1,326
- Guardian Angel
@mgalbrai
You’re in my thoughts Split…
Come on vox!!!
m

Curehcvnow@gmail.com
http://forums.delphiforums.com/generichcvtx

G 1a F-1
Started tx 10/23/15 (Meso sof & led) ALT 48 AST 28 v/l 1.6 mil
11/17/15 4 wk lab ALT 17 AST 16 <15
11/18/15 Started Harvoni
12/16/15 8 wk lab ALT: 15 AST: 13 V/l UND
1/14/16 Fin. Tx
7/07/16 UND SVR 24
10 October 2016 at 1:48 am #23697
vitrus
- Topics: 1
- Replies: 35
- Total: 36
- Treatment Warrior
@vitrus
Another good option for you could be to enroll into a phase 3 US trial of some other company. Abbvie for example has some meds that are effective for retreatment, but has not tested them on gen 3 people yet. A trial of some other company could get you cured earlier.

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.
10 October 2016 at 1:57 am #23699
coral
- Topics: 8
- Replies: 598
- Total: 606
- Guardian Angel
@coral
Hi Splitdog,

Good to see you are holding steady at the start line waiting for that Vox. We’re here waiting for you.
10 October 2016 at 2:02 am #23700
LondonGirl
- Topics: 16
- Replies: 1,348
- Total: 1,364
- Guardian Angel
@londongirl
Here for you Splitdog – Come on you Vox

GT1a Dec14 F2/8.7 VL 900000-2.5M
Jan16 Hepcivir-L MonkMed/Redemption
Baseline: VL 913575 Alt 76 Platelets low
Wk2 VL1157 Alt 23
DET Wk 8 VL 32 Alt19 ‘In the slow lane’
June16 Fibro 5.7 F0/1 LIF 1.5
Wk 11 VL<12 Alt 13 Det/Unq
Extending tx 12 wks Mylan Sofo/Dac MonkMed
Wk 14 VL <12 Det/Unq
Wk 16 VL UNDETECTED
Wk 22 + 4 Wks Sunprevir FixHepC
Wk 24 UNDETECTED Alt 13
Wk 12 post tx SVR12 Wk 26 SVR24
Thank-you Tim, Dr Debasis @ MonkMed & Dr Freeman @ Fix HepC
10 October 2016 at 5:23 pm #23718
fitz
- Topics: 9
- Replies: 490
- Total: 499
- Guardian Angel
@fitz
You’re locked and loaded now, Splitdog! Hope you know how inspirational your story is. You had a temporary setback, brushed yourself off, and got right back into the game with a brand new set of high tech brass knuckles.

Looking forward to the news you’ve started the new treatments! You WILL beat this.
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