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Author Topic: REDEMPTION Clinical Trial Registered  (Read 11717 times)

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Offline Coach Mike

  • Member
  • Posts: 292
    • Affordable Hepatitis C Treatment
REDEMPTION Clinical Trial Registered
« on: January 21, 2016, 03:31:43 pm »
Here is the link to the clinical trial listing:

https://www.clinicaltrials.gov/ct2/show/NCT02657694?term=redemption&rank=1

REDEMPTION (Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods) is observing and collating the treatment course, safety profile, and outcomes of patients around the world who are choosing to self import generic versions of the Direct Acting Antivirals Sofosbuvir, Ledipasvir and Daclatasvir from countries like China, India and Bangladesh.

Information on participation can be found at fixhepc.com

Coach Mike
« Last Edit: January 21, 2016, 03:49:03 pm by Coach Mike »
Logged
Genotype 1a, Biopsy:11/2014: F-1, Tx Naive
Fibrosure, 7/20/15: F-1-2
Pre tx v/l: 1,600,000, ALT: 75, AST: 48
Started generic sofosbuvir & ledipasvir: 10/23/15
4 wk labs: 11/19/15, ALT: 21, AST: 16, V/L:  UND
Started 8 week Harvoni tx: 11/20/15
8 wk labs, 12/15/15, ALT: 15, AST: 13, V/L: UND
4/11/16 12 week EOT-Undetected
7/5/16 SVR 24

Offline Westy

  • Member
  • Posts: 17
Re: REDEMPTION Clinical Trial Registered
« Reply #1 on: January 21, 2016, 05:15:56 pm »

So that means Redemption has approval from the U.S. National Institutes of Health ?
Logged
Gen 3a Started Sof Dac 16/10/15
Ribavirin Started 18/11/2015

V/L 19 Mill +
Hep C pos approx. 27 yrs
2 Week Bloods = Normal Ast Alt, V/L 16 :)
10/Dec/15    UND  Probably was at week 4

Non responder 2011 BMS (dac) Peg Rib

Offline lporterrn

  • Member
  • Posts: 1,969
  • LucindaPorterRN
    • LucindaPorterRN
Re: REDEMPTION Clinical Trial Registered
« Reply #2 on: January 21, 2016, 09:55:54 pm »
Interesting...
Logged
Lucinda Porter, RN
1988 Contracted HCV
1997 Interferon nonresponder
2003 PEG + ribavirin responder-relapser
2013 Cured (Harvoni + ribavirin clinical trial)
https://www.hepmag.com/blogger/lucindakporter

Offline Coach Mike

  • Member
  • Posts: 292
    • Affordable Hepatitis C Treatment
Re: REDEMPTION Clinical Trial Registered
« Reply #3 on: January 22, 2016, 07:23:44 am »
Yes,
It appears REDEMPTION has met the National Institute of Health's criteria and is considered a worthwhile study of generic HCV treatments. The goal is 10,000 participants. That should be an adequate sample to produce valid data.
Coach Mike
Logged
Genotype 1a, Biopsy:11/2014: F-1, Tx Naive
Fibrosure, 7/20/15: F-1-2
Pre tx v/l: 1,600,000, ALT: 75, AST: 48
Started generic sofosbuvir & ledipasvir: 10/23/15
4 wk labs: 11/19/15, ALT: 21, AST: 16, V/L:  UND
Started 8 week Harvoni tx: 11/20/15
8 wk labs, 12/15/15, ALT: 15, AST: 13, V/L: UND
4/11/16 12 week EOT-Undetected
7/5/16 SVR 24

Offline HazelAustralia

  • Member
  • Posts: 178
Re: REDEMPTION Clinical Trial Registered
« Reply #4 on: January 22, 2016, 09:59:56 am »
Hasn't it just been approved by the Australian dept of Health? Great study.
Logged
Female age 53
Australia
Contracted in the 1980's
Genotype 1A
VL 314k

Started treatment with Veikira Pak and Ribaviron on Thursday 17th December 2015
NOT DETECTED, End of Treatment, 16th March 2016

Offline Coach Mike

  • Member
  • Posts: 292
    • Affordable Hepatitis C Treatment
Re: REDEMPTION Clinical Trial Registered
« Reply #5 on: February 01, 2016, 07:20:47 am »
February 2016 Generic Update

(Insurance: Restrictions are easing, but time and effort is still required to negotiate the process. In all likelihood, you could be "cured" by generics before ever being approved for coverage by your insurer. HCV is a dangerous, infectious, debilitating and potentially deadly disease. Your insurer should pay for treatment. Fight them and get it to the external review. Most find tx a "medical necessity".)


The situation continues to be favorable for importation of quality, affordable HCV medications into the United States. Hundreds of people are now reporting UND or <15 four week test results on fixhepc, the generic HCV tx "hub".

Several options are available. All require a prescription. If your PCP or specialist won't prescribe generic tx, you can get one from GP2U.com. Get your lab results scanned and ready to send before your appointment. (Genotype, viral load, CMP, CBC)
Your PCP can order those and give you a copy. Scan them and your U.S. prescription if you have one.

Option 1: Join the REDEMPTION clinical trials. GP2U can assist you in that regard.

Option 2: Contact a legitimate supplier directly. Incepta seems to be the simplest as far as paperwork is concerned. Go to fixhepc for specific contact information.

Option 3: Become a "medical tourist" This is the next most expensive option both in time and money, but still pennies on the dollar compared to the cost of branded U.S. Treatments. India appears to be the destination of choice.

Don't forget the many patient assistance programs available to those who meet the income requirements.


Coach Mike
« Last Edit: February 01, 2016, 12:40:34 pm by Coach Mike »
Logged
Genotype 1a, Biopsy:11/2014: F-1, Tx Naive
Fibrosure, 7/20/15: F-1-2
Pre tx v/l: 1,600,000, ALT: 75, AST: 48
Started generic sofosbuvir & ledipasvir: 10/23/15
4 wk labs: 11/19/15, ALT: 21, AST: 16, V/L:  UND
Started 8 week Harvoni tx: 11/20/15
8 wk labs, 12/15/15, ALT: 15, AST: 13, V/L: UND
4/11/16 12 week EOT-Undetected
7/5/16 SVR 24

Offline FutureThinker

  • Member
  • Posts: 711
  • Onward and upward!
Re: REDEMPTION Clinical Trial Registered
« Reply #6 on: February 01, 2016, 11:27:43 am »
Hey Coach Mike, thanks for such complete info which I have flagged. 

Another note: Merck's new drug, Zepatier, was FDA approved last week and will be priced at $54,600, a substantial decrease from Gilead's Harvoni.  They obviously heard all the backlash on the Harvoni price, altho it's still expensive.  However, I am very hopeful that stupid insurance companies like mine (BS) will be willing to cover it at that price, and likely lower w/negotiations.

I am also very curious to see what Gilead will do when/if their new pangenotypic drug is approved in June w/ price. At any rate, there WILL be better priced drugs this year that open the door to more of us getting the treatment we deserve. FT
Logged
Treatment naive
Likely contracted mid-70s
Diagnosed 1a, 2011
F1-2
Harvoni X 12 weeks, completed 5/17/16
Pre-treatment: VL 3 mil, AST 64, ALT 84
4 week labs: VL 30, AST 21, ALT 14
8 week labs: VL UD!!!, AST 22, ALT 16
12 week labs: VL UD, AST 23, ALT 14
2 wk EOT: VL UD
12 wk EOT: VL UD, AST 22, ALT 13 =  SVR 12! Yay! 
Last hep appointment: VL UD, AST 19, ALT 12 = SVR 39! I AM DONE!

Offline Coach Mike

  • Member
  • Posts: 292
    • Affordable Hepatitis C Treatment
Re: REDEMPTION Clinical Trial Registered
« Reply #7 on: February 01, 2016, 07:23:42 pm »
Good Points FT,
$54,000 is still outrageous. The insurance industry, the government and market pressure. Those elements can force the prices down.
At least there are options now for people who refuse to wait.
Or can't....
Coach Mike
Logged
Genotype 1a, Biopsy:11/2014: F-1, Tx Naive
Fibrosure, 7/20/15: F-1-2
Pre tx v/l: 1,600,000, ALT: 75, AST: 48
Started generic sofosbuvir & ledipasvir: 10/23/15
4 wk labs: 11/19/15, ALT: 21, AST: 16, V/L:  UND
Started 8 week Harvoni tx: 11/20/15
8 wk labs, 12/15/15, ALT: 15, AST: 13, V/L: UND
4/11/16 12 week EOT-Undetected
7/5/16 SVR 24

Offline FutureThinker

  • Member
  • Posts: 711
  • Onward and upward!
Re: REDEMPTION Clinical Trial Registered
« Reply #8 on: February 02, 2016, 10:26:27 am »
Yes, all these options are fantastic news -- we've waited a very long time for this! FT
Logged
Treatment naive
Likely contracted mid-70s
Diagnosed 1a, 2011
F1-2
Harvoni X 12 weeks, completed 5/17/16
Pre-treatment: VL 3 mil, AST 64, ALT 84
4 week labs: VL 30, AST 21, ALT 14
8 week labs: VL UD!!!, AST 22, ALT 16
12 week labs: VL UD, AST 23, ALT 14
2 wk EOT: VL UD
12 wk EOT: VL UD, AST 22, ALT 13 =  SVR 12! Yay! 
Last hep appointment: VL UD, AST 19, ALT 12 = SVR 39! I AM DONE!

Offline Coach Mike

  • Member
  • Posts: 292
    • Affordable Hepatitis C Treatment
Re: REDEMPTION Clinical Trial Registered
« Reply #9 on: February 14, 2016, 07:19:03 am »
Hi All,
Preliminary REDEMPTION results show 104 early participants are SVR 4!
CM
Logged
Genotype 1a, Biopsy:11/2014: F-1, Tx Naive
Fibrosure, 7/20/15: F-1-2
Pre tx v/l: 1,600,000, ALT: 75, AST: 48
Started generic sofosbuvir & ledipasvir: 10/23/15
4 wk labs: 11/19/15, ALT: 21, AST: 16, V/L:  UND
Started 8 week Harvoni tx: 11/20/15
8 wk labs, 12/15/15, ALT: 15, AST: 13, V/L: UND
4/11/16 12 week EOT-Undetected
7/5/16 SVR 24

Offline Coach Mike

  • Member
  • Posts: 292
    • Affordable Hepatitis C Treatment
Re: REDEMPTION Clinical Trial Registered
« Reply #10 on: March 09, 2016, 03:33:52 pm »
Up to 400 now.
95.2% initial SVR across the board average.
« Last Edit: March 09, 2016, 03:35:44 pm by Coach Mike »
Logged
Genotype 1a, Biopsy:11/2014: F-1, Tx Naive
Fibrosure, 7/20/15: F-1-2
Pre tx v/l: 1,600,000, ALT: 75, AST: 48
Started generic sofosbuvir & ledipasvir: 10/23/15
4 wk labs: 11/19/15, ALT: 21, AST: 16, V/L:  UND
Started 8 week Harvoni tx: 11/20/15
8 wk labs, 12/15/15, ALT: 15, AST: 13, V/L: UND
4/11/16 12 week EOT-Undetected
7/5/16 SVR 24
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