So what are the REDEMPTION eTrials?

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16 October 2015 at 5:22 pm #2334
Dr James
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- Guardian Angel
@fixhepc
The REDEMPTION clinical trial site is https://clinicaltrials.gov/ct2/show/NCT02657694?term=REDEMPTION&rank=1

REviewing
DAA
Efficacy
Managing
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Treatment
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REDEMPTION-1 is already underway and is closed but REDEMPTION-2, REDEMPTION-3 and REDEMPTION-4 are currently recruiting. The results ~~will be~~ have been presented at EASL and AASLD. ~~We expect to show that generics work but don’t want to pre-empt things.~~ We now know that generics work effectively.

Update2: We were also accepted for AASLD 2016 in Boston and presented.

Update: We were accepted for EASL 2016 in Barcelona and presented. Here’s the results (and they look pretty good)

You can find the full presentation here: http://fixhepc.com/forum/media-news/914-easl-slides-94-4-svr4-overall.html or watch the video.

[video]https://www.youtube.com/watch?v=TVO_lFY7j2U[/video]

REDEMPTION-2 and REDEMPTION-3 will be presented in 2017. They are trials so we don’t know what they will show but expect that giving generic versions of Hep C medications has predictable results.

REDEMPTION-2 is testing the efficacy of generic Sofosbuvir 400 mg / Daclatasvir 60 mg across all genotypes at full phase 3 scale and is open now.

REDEMPTION-3 is testing the efficacy of generic Sofosbuvir 400 mg / Ledipasvir 90 mg in genotypes 1, 4 and 6 only at full phase 3 scale and is open now.

REDEMPTION-4 is testing the efficacy of generic Sofosbuvir 400 mg / Velpatasvir 100 mg across all genotypes at full phase 3 scale and is open now.

The REDEMPTION trials are different:
- First everyone gets active medication at full therapeutic dose, and there is no placebo.
- Next, it is not free. Entry into the Sof/Dac trial -2 arm wil cost $1500 USD and entry into the Sof/Led trial will cost $1600 USD. This is the best price in the market right now and includes shipping.
- Finally there will be no cherry picking of entrants to bias outcome results, so we will find out what the best medications are
The REDEMPTION-2 and -3 and -4 trials will both feature REAL TIME REPORTING of side effect and on treatment viral load for complete transparency.

To get started with REDEMPTION go here: https://fixhepc.com/the-new-hepatitis-c-cure-is-affordable

YMMV
16 October 2015 at 5:59 pm #2338
Sirchinenge
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@sirchinenge
Dr Freeman has said he will update how to subscribe to the trials on Monday.

Good news though.

Sob/Dac from Oct 29 2015
Geno 1b
Fiberscan 9.9 Pre treatment
Fiberscan 7.4 week 10
VL 1.3 million pre treatment
Week 2.5 VL 96
Week 5.5 VL 17
Week 10 VL UD
SVR 3 UD
SVR 16 UD
Cured:
All liver functions in normal ranges.
16 October 2015 at 7:08 pm #2344
Jolie
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@jolie
excellent news!
Many Thanks Dr Freeman,
I hope I’ll be able to do the R2 trial with you,

Geno 3, Fibro 8.7 pKA, tx experinced in 2005 – Peg/Riba, relapsed.
Started tx 1/12/2015 with Indian Sofo & Chinese Dac.
5 weeks result all normal, ALT 18 – down from ALT 73 at the start of tx.
5 weeks HCV PCR RNA – UND. – down from 2 ML
9 weeks HCV PCR RNA – UND.
16 October 2015 at 10:22 pm #2348
LondonGirl
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@londongirl
Sounds amazing .

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
17 October 2015 at 1:04 am #2353
emilio
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@emilio
Dr Freeman, do you ever sleep lol? I have organisational, consultative and strategic planning skills, well I’ve been able to make an accidental career out of these skills. I’d be more than happy to come on board in a voluntary capacity to assist in anyway I can? I’m sure there’s something I could add remotely and will travel occasionally if necessary. My post grad is Public Health Philosophy and Indigenous Health Promotion and fits right here. I’m okay at epi but don’t ask me to do biostats cause I could unravel lol. Happy to assist in any way. Em
17 October 2015 at 1:05 am #2354
emilio
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@emilio
PS: Love the name!
17 October 2015 at 9:22 am #2378
tweakmax
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@tweakmax
Hi doc,

I will be on twinvir soon.

Would love to be part of the project (will give patients more confidence in generics and shut skeptics up)

Let me know if you want my data for r-3. I will be on 24 weeks.
17 October 2015 at 8:44 pm #2389
Jolie
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@jolie
Dear Dr James,

REDEMPTION 4 – SOF + Velpatasvir – ???

is this possible to arrange ? it could be very interesting.
I’m not sure where one can get the API’s for Velpatasvir, I checked Mesochem & they don’t advertise it, but maybe they can make it for your trials specially ???
The only API’s I found are sold via Alibaba.com – not the most trustworthy place to buy, still all adds are from Chinese manufactures, so someone there must be making the real thing.

More info for Velpatasvir trials, it’s such a great pan-genotypic combination , SVR rates for Geno 3 – 95%, highest I come across from all the new DAA’s :

http://www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=6370

Geno 3, Fibro 8.7 pKA, tx experinced in 2005 – Peg/Riba, relapsed.
Started tx 1/12/2015 with Indian Sofo & Chinese Dac.
5 weeks result all normal, ALT 18 – down from ALT 73 at the start of tx.
5 weeks HCV PCR RNA – UND. – down from 2 ML
9 weeks HCV PCR RNA – UND.
17 October 2015 at 9:34 pm #2396
2b
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@2b
Hi Dr. Freeman, if you would like a treatment naive genotype 2B in there and if I get my meds, I would participate. Wonderful idea, let me know if you would like me in.

GT 2b; since 80’s, no prior tx, sofosbuvir and daclatasvir compounded from API’s at Kingswood Pharmacy in Sydney, started tx nov 6,2015, undetected at 4 wks, UND at 8 weeks, UND at 1 week after EOT, UND at 4 weeks after EOT and UND at 8 weeks after EOT. I feel GOOD!! I knew that I WOULD!””
18 October 2015 at 2:42 am #2409
emilio
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- Guardian Angel
@emilio
And this will add legitimacy and weight to what fixhepc is trying to achieve and hopefully provide better access internationally. Em
18 October 2015 at 11:37 am #2430
Enkel
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- Guardian Angel
@enkel
Any news?

Male, Fibro F1. Geno 1b. ALT 67 before treatment Viral load 5 million. My huge viral load replicates in my nervous system as I suffer anxiety.
Started Twinvir 12/12/15.
Two weeks
ALT 17 at 2 weeks
Viral Load UND at 2 weeks
ALT 13.5 at 7 weeks EOT
ALT 10.5 at 15 weeks EOT
ALT 13 at 27 weeks EOT, VL UND, Cured
18 October 2015 at 12:19 pm #2434
poodle
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- Guardian Angel
@poodle
Hi Dr Freeman Firstly a thousand thankyous
my sov/led is here and I will start tomorrow evening after dinner. tomorrow morning I will have a blood test done to get the viral load before treatment. If you would like to add my results to your trial I would be happy to add my name to the list. I have type 1a/ F2 treating with 12 weeks of sol/led starting 19/10 exact viral load to be determined after tomorrows test. Thank You Poodle

Geno1a 35years fibrosis 2 or 3 different results from different hospitals ??
24weeks mesochem sof/led as unsure of fibrosis status.
currently UND. No bad side effects
Have svr12 … waiting for svr 24
I now have SVR 36 weeks.
18 October 2015 at 12:25 pm #2436
LondonGirl
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- Guardian Angel
@londongirl
Hi Poodle,

Thanks for that, I will be following your progress closely as 1a F2 too.
May I ask what format the Sofo/Led came in? IWas it Twinvir or API?

Wishing you all the very best for success and good health.

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
18 October 2015 at 2:51 pm #2449
poodle
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- Guardian Angel
@poodle
Hi LG Thanks for asking. I am a bit in the dark and just ordered these meds as soon as the club started. Now as I read the forums I am learning as I go. Could you please tell me what an API is … I hope its good.! And is twinvir better. Iam feeling a bit freaked out maybe i should have waited for more info before i made a purchase. But ive always had my heart set on Harvoni and have lusted after it for years now. Ive known about it for years and knew it as an infant serial number. So when it came to purchasing from the buyers club i just thought.. get some sov and led. Its all the same I hope, just in 2 capsules instead of one. Thanks Poodle

Geno1a 35years fibrosis 2 or 3 different results from different hospitals ??
24weeks mesochem sof/led as unsure of fibrosis status.
currently UND. No bad side effects
Have svr12 … waiting for svr 24
I now have SVR 36 weeks.
18 October 2015 at 3:39 pm #2450
LondonGirl
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- Guardian Angel
@londongirl
I have also been waiting for Harvoni – I hear you!
As far as I can make out, API is the powder ‘format’ (for want of a better word)
Then there is now Twinvir, which is capsule format.
Dr F has tested the medicines, so I’m not suggesting anything for you to worry about, just curious as to whether you have Twinvir or a capsulated combination.
Excited for you – and looking forward to seeing how you get along with treatment as we are same GT and liver damage.

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
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