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Author Topic: Generic News  (Read 16323 times)

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Offline Coach Mike

  • Member
  • Posts: 292
    • Affordable Hepatitis C Treatment
Generic News
« on: March 20, 2016, 07:10:16 am »
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: Generic News
« Reply #1 on: March 20, 2016, 12:25:30 pm »
The REDEMPTION clinical trials are reporting excellent early SVR 4 results approaching 95%.
Below is more detailed info about the medications involved.

MonkMed works with GILEAD licensed medications only. For REDEMPTION-3( Sof+ Led) it is Cipla Hepcvir L and for REDEMPTION-2 it is Mylan MyHep(Sof) and MyDacla(Dac). Because the medications are from reputed pharmaceutical companies( E.g. Cipla is big name in UK and Mylan is a US manufacturer) doctors of respective countries have been more forthcoming to monitor patients as they are more comfortable with brands they prescribe for other ailments.

All REDEMPTION participants avail MonkMed doctor consultation services at no additional cost for duration of treatment of 12-24 weeks and if required any post treatment.

http://fixhepc.com/home/redemption-etrials.html

CM
« Last Edit: March 20, 2016, 12:31:23 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 KimInTheForest

  • Member
  • Posts: 1,972
  • Believe in yourself
Re: Generic News
« Reply #2 on: March 20, 2016, 12:27:56 pm »
Excellent news, Coach Mike! :)

kim
Logged
Kim Goldberg (Nanaimo, BC)
1970s: Contracted HCV (genotype 3a)
2015: Cured with Harvoni + ribavirin (12 weeks)
MY STORY: https://pigsquash.wordpress.com/2016/01/28/undetectable-my-hep-c-story/

Offline Coach Mike

  • Member
  • Posts: 292
    • Affordable Hepatitis C Treatment
Re: Generic News
« Reply #3 on: March 23, 2016, 08:19:55 pm »
WARNING:
The generic situation is very good right now, but could, and probably will, change for the worse after the election or when the TPP is ratified.
12 weeks of Generic harvoni APIs costs $860.
Twinvir, $1000.
The latter requires a script. The former does not.
Both have shown a 4 week SVR rate of 95% in the REDEMPTION trials.
REDEMPTION participation costs $2000. Delivery is guaranteed. I am not aware of any shipments from the above sources that failed to arrive or were not the genuine article.
Insurance maybe loosening coverage restrictions, but the premiums will rise accordingly. The Australians forced Gilead to make a deal because of the availability of generics. Every person who denies Gilead their blood money by using generics is helping to force them to the bargaining table in the U.S.
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 malou

  • Member
  • Posts: 57
Re: Generic News
« Reply #4 on: March 24, 2016, 03:15:44 pm »
I bought Twinvir from Incepta in December and the process worked beautifully.  I've recommended it to several people, two who will order in the next two weeks.  I was undetected at 4 weeks and just took my last pill today.  I feel certain that I am cured now.  Great company, extremely trustworthy and easy to work with.  ML
Logged
HCV 1996- Work Exposure ER nurse
GT 1a
Non-responder to Interferon in 1997
ALT 73 AST 21 F1-2
Applied to Insurance for Harvoni 12-15
Denied 12-3-15  Told I would never qualify for Harvoni because I was not 'ill'.
Started Twinvir (Bengladesh Harvoni) on 1/1/16

After 4 weeks ALT 23, AST 15, HCV-RNA UNDETECTED
After 8 weeks:AST 23, AST 11, HCV RNA UNDETECTED
6 weeks post treatment, undetected.

Offline Coach Mike

  • Member
  • Posts: 292
    • Affordable Hepatitis C Treatment
Re: Generic News
« Reply #5 on: April 12, 2016, 01:18:45 pm »
Dr. James Freeman is presenting the findings of his REDEMTION generic clinical trials April 16 at EASL in Barcelona.  The results are stunning.
Look for big changes in the U.S. similar to what generics forced in Australia.
It is time.  If every person with HCV in the U.S. was approved and covered by their insurer at the present costs, everyone's insurance premium would skyrocket.  Right now, high quality generic sofosbuvir and ledipasvir can be imported from India or Bangladesh for $1000 for a 12 week course.  It can be at your door in a week.
The quality of these medications is about to be proven to the world in Barcelona.
Something has  to give.
This could be it.
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 Luna7

  • Member
  • Posts: 179
Re: Generic News
« Reply #6 on: April 12, 2016, 01:46:36 pm »
I can't express just how happy this makes me feel, Coach Mike. Every time I start to worry about whether my insurance company will deny treatment (I should find out soon) I come here or go to the FixHepC website and start reading about generics...I don't feel trapped anymore.
Logged
Between F2 & F3
Alt & Ast nearly 100
Viral load over 8 million
Gt 3a

Treated 12 weeks with Sovaldi & Daklinza, start date mid-April 2016
Undetected at 4 weeks into treatment
Alt & Ast  normal
Treatment completed July 14
Most likely will be undetected at 12 weeks (mid October 2016) as symptoms are gone

Offline Coach Mike

  • Member
  • Posts: 292
    • Affordable Hepatitis C Treatment
Re: Generic News
« Reply #7 on: April 17, 2016, 08:24:18 am »
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: Generic News
« Reply #8 on: April 19, 2016, 12:33:56 pm »
Thanks so much, Coach Mike, for educating all of us on this valuable aspect of HCV treatment.  Slide 3 on the price of treatment says it all........... 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: Generic News
« Reply #9 on: April 19, 2016, 12:41:30 pm »
Thanks FT,
We the people......
in this great country which has done so much for so many in the world are being held hostage by a company who shelters its tax liability off-shore and forces the citizens of the U.S. to pay more for its products than any other nation on earth.
What a shame.
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 KimInTheForest

  • Member
  • Posts: 1,972
  • Believe in yourself
Re: Generic News
« Reply #10 on: April 21, 2016, 11:49:43 am »
Thanks for sharing the link to Dr. Freeman's slide show on the results of his worldwide generics trials, Coach Mike. Really good to see that data. Pretty impressive results. And thanks for being so vocal about the availability of generics. A lot more people are now aware of that option as a result. I agree with Future Thinker - Slide 3 really says it all about the pricing problem and why so many still aren't being treated.

kim
Logged
Kim Goldberg (Nanaimo, BC)
1970s: Contracted HCV (genotype 3a)
2015: Cured with Harvoni + ribavirin (12 weeks)
MY STORY: https://pigsquash.wordpress.com/2016/01/28/undetectable-my-hep-c-story/

Offline FutureThinker

  • Member
  • Posts: 711
  • Onward and upward!
Re: Generic News
« Reply #11 on: April 21, 2016, 01:10:35 pm »
I'm an optimist at heart (but also definitely a realist) and believe we are well on our way to having everyone have access to treatment for this disease. Look how much new info has been generated just in the past 2 years! The generic option is a huge game changer, for sure. The price WILL come down and needs to, sooner vs. later. Still curious to see what Gilead is going to do re: price if they get their new drug approved in June....... 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: Generic News
« Reply #12 on: April 21, 2016, 02:57:11 pm »
As long as insurance companies are paying them, they will not lower the price.  The only way it will come down is by market or government pressure.
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 malou

  • Member
  • Posts: 57
Re: Generic News
« Reply #13 on: April 21, 2016, 06:25:58 pm »
I agree Mike, and as long as insurance companies can control who receives treatment, based on disease progress, symptoms, and cost, we don't really have universal healthcare.  What we have is market driven healthcare, supported by those in congress who are sucking the life blood from this country in terms of profit and big business.  ML
Logged
HCV 1996- Work Exposure ER nurse
GT 1a
Non-responder to Interferon in 1997
ALT 73 AST 21 F1-2
Applied to Insurance for Harvoni 12-15
Denied 12-3-15  Told I would never qualify for Harvoni because I was not 'ill'.
Started Twinvir (Bengladesh Harvoni) on 1/1/16

After 4 weeks ALT 23, AST 15, HCV-RNA UNDETECTED
After 8 weeks:AST 23, AST 11, HCV RNA UNDETECTED
6 weeks post treatment, undetected.

Offline Tug

  • Member
  • Posts: 19
Re: Generic News
« Reply #14 on: May 10, 2016, 06:11:42 pm »
I am new to this site and would consider Generic Harvoni if my application for Harvoni is denied this month . Does anyone know what company ships Generic Harvoni to Canada.
Logged

Offline Coach Mike

  • Member
  • Posts: 292
    • Affordable Hepatitis C Treatment
Re: Generic News
« Reply #15 on: May 11, 2016, 03:29:22 pm »
Hi TUG,
There is a whole thread on getting generics into Canada at FixHepC.com.  You can also join the REDEMPTION clinical trials by booking an appointment online at GP2U.com.  The total cost: $2000. Guaranteed delivery & quality. The prescription is included. You just need a local doctor to order your blood work at the prescribed intervals.
These trials are run by Dr. James Freeman of Hobart, Tasmania.  I think, with Canadian import restrictions, this is the route most follow up there to access quality generic HCV medications.
Google him.
He's an amazing man.
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 Tug

  • Member
  • Posts: 19
Re: Generic News
« Reply #16 on: May 13, 2016, 06:32:39 pm »
Mike I found the link regarding importing generic drugs into Canada . I will definitely keep this option  open if all else fails  Thanks
Logged

Offline malou

  • Member
  • Posts: 57
Re: Generic News
« Reply #17 on: May 13, 2016, 07:02:46 pm »
So, here is the bad news.  India is caving to Gilead    http://in.reuters.com/article/us-gilead-india-patent-idINKCN0Y12NA
Logged
HCV 1996- Work Exposure ER nurse
GT 1a
Non-responder to Interferon in 1997
ALT 73 AST 21 F1-2
Applied to Insurance for Harvoni 12-15
Denied 12-3-15  Told I would never qualify for Harvoni because I was not 'ill'.
Started Twinvir (Bengladesh Harvoni) on 1/1/16

After 4 weeks ALT 23, AST 15, HCV-RNA UNDETECTED
After 8 weeks:AST 23, AST 11, HCV RNA UNDETECTED
6 weeks post treatment, undetected.

Offline Coach Mike

  • Member
  • Posts: 292
    • Affordable Hepatitis C Treatment
Re: Generic News
« Reply #18 on: May 13, 2016, 07:49:56 pm »
Very sad..
Incentive for future "research", in exchange for people's lives.
Morbid.
Mengele would have approved.
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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