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Hep C Discussion Forum -> Hep C News -> Gilead Files for U.S. Approval of Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Genotype 1 Hepatitis C
Post Info TOPIC: Gilead Files for U.S. Approval of Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Genotype 1 Hepatitis C
Cinnamon Girl


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RE: Gilead Files for U.S. Approval of Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Genotype 1 Hepatitis C
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Hi again Mohammed,

Yes, that makes good sense. Your results look fine and indicate that you have time to wait for better all oral treatment options to become available.  Keep in touch with us and you`ll see how the new Hep C treatments are progressing.  There may be something more suitable for you as early as later this year.

Wishing you all the best, Jill



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Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 
Mohammed


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Hi Cinnamon

Thank you for your valuable information. As I have indicated before that my fibroscan test last July was F0-F1 and  I had fibrotest recently ( please see the result below ) my doctor in Saudi Arabia told me that I can wait for the new treatment all oral

 Test                                               result                                   range

Alpha 2 macroglobulin                   2.98                                     1.3 3

 

Total  Bilirubin                                 15.9                                     < 18

ALT / GPT                                       38                                        <  41

Gamma GT                                      33                                      11 49

APO  A1                                          1.17                                     1.2 2

Haptoglobin                                     1.24                                      03 - 2

 

 



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TazKat


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well, my doc appt. has been move to monday. he clinic has grown by a vast amount in a short time. i asked about these meds & the girl that i talked to that changed my appt. said this was really a gooodddd drug.. BUT that BcBs has not approved yet. My daughter works for a docgtor & she said everytime a new drug came out, it takes a small amt of time for them to ok it. just the way it is. so heres to hoping that doc will EVEN put me on it & here's to ME getting on it.. :)  my meld score has been an 8 the last 1 1/2 yrs. some kind of calculation they come up with blood numbers to see how close u would be to transplant. they 14 & u need new liver NOW.  so hopefully i can undpressed about this & get active somewhat to lose some more weight. the weight i lost i have gained back. so here is to being happy bout something!!! :)



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TazKat Genotype 1A null responder x 3 riba & iterferon twice, relapsed from Incivek 2012 with only 12 weeks left to do. stage 4 mild cirrhosis 4/25/2014/ started sovaldi riba & interferon.. finished treatment 7/17/14  results 7/25  cleared..

 

 
suziq


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Hi Tig,

Thanks. How are your Post treatment labs??  UND, I'm sure. 

The discount could only be allowed in countries that have approved the drugs I would think.  Not sure what the cost of treatment without insurance in US would be, but it might just be the cost of doctor visits and any lab tests with the drug company discount.  The cost of medical treatment to those who are not rich--in any country--can be daunting.  And in many countries the new drugs are not yet approved.  The internet and forums like this are a real eye opener in how medical treatment is "rationed out" worldwide.

SuziQ 



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Geno 1A  Age 82 Treatment naive Cirrhotic Told I had liver disease in 1966. Diagnosed as Hep C 1999.Started Merck clinical trial with Riba on 9/9/2013 Week 1 and 2 <25  Weeks 4, 8, 12,16,18 UND.  EOT Jan 14,2014  EOT +12 UND   JULY 1 2014 EOT+24= SVR
Tig


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Hey Susan, that's great news on your +4 week tests, yah!!! Congrats! I also believe that anyone, regardless of citizenship or location for that matter, should be eligible for discounted treatment (drug) costs. The impact on the individual shows no favoritism based on nationality or citizenship, that we know is fact...

Tig



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Tig

67yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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suziq


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Hi Jill,

That is an interesting question--if the drug companies will give the discounted rates to anyone coming to the US for treatment.  I would think/hope that anyone using a US doctor and pharmacy and doing treatment in the US would be eligible for the discount regardless of citizenship.

Just got my 4 week post treatment labs.  Still UND.  Do my 8 week labs in 2 more weeks. 

The new meds rock!!!

SuziQ  



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Geno 1A  Age 82 Treatment naive Cirrhotic Told I had liver disease in 1966. Diagnosed as Hep C 1999.Started Merck clinical trial with Riba on 9/9/2013 Week 1 and 2 <25  Weeks 4, 8, 12,16,18 UND.  EOT Jan 14,2014  EOT +12 UND   JULY 1 2014 EOT+24= SVR
Tig


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Hello Mohammed,

I found this information on the topic as well. The release of Sovaldi has shown great promise in treating GT 4 as well. Here's a link to that information. http://hepatitiscnewdrugresearch.com/hepatitis-c-genotype-4.html

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Tig

67yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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Cinnamon Girl


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Hello again Mohammed, good to hear from you.

You mentioned in a previous post that you`d be prepared to travel to the USA rather than wait for new drugs to become available in Saudi Arabia, would this still be the case? 

The latest recommendations from the AASLD (American Association for the Study of Liver Diseases) suggest that the best new drug treatment options for your genotype would be either a 12 week course of Sofosbuvir (Sovaldi) + Ribavirin + Peg Inf, or Simeprevir (Olysio)  for 12 weeks + Ribavirin + Peg Inf for 24 weeks. There`s also the possibility that you could do a course of treatment with just Sofosbuvir (Sovaldi) + Ribvirin which would probably be of more interest to you as an `all oral` treatment.

Here`s the link to that information, scroll through the `Table of Contents` and click on section 18 `Initial Treatment of HCV Infection in Patients Starting Treatment`, then scroll down to section `1V. Genotype 4`.

http://www.hcvguidelines.org/sites/default/files/full_report.pdf

I think the best thing would be to talk to a knowledgeable hepatologist who could advise you.  As you`re a Saudi Arabian national I don`t know what the situation would be concerning payment for the drugs if you were to travel to the USA for treatment.  There are other treatment drugs in the pipeline if you are prepared to wait.



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Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 
Mohammed


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Are any of the new medicine suitable to cure G4

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tonib


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Sovaldi & Olysio !!!!  I have been waiting for you!!!  

I'm making an appointment next week with my hepa!!

 

biggrinbiggrinbiggrin    



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 geno 1, started peg and riba 7/5/13, now 29th day is vicrellis ***tonib VL started 6 million, after 5 weeks 374,000, after 8 weeks 150,000....the big test for VL is 9/27 at 12 weeks  TAKEN OFF THERAPY JUST NOT WORKING FOR ME...12 WEEKS STILL HAVE 9000 VL
Matt Chris


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Hey Baddog

Congrats on your SVR the Gilead combo work very well for you, get you tell how the treatment went?

matt 



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 
52baddog


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That is the medication I was on for three months, and just got my 6 months test result...........undetected.

Thank you Gilead:)))))



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Geno type 1b, F1 vl 640,000 enrolled in Gilead's sofosbuvir/ledipasvir -week 1 66, week 2 <25
Caryn


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I hope I am making the right decision treating now! Scheduled to start soon with sovaldi, olysio and riba. 



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1a, CT. Incivek triple 1/2013, vl 810 @ 2 weeks, 610 @ 4 weeks, 3000 @ 8 weeks, tx stopped. 

4/2014 - tx with Sovaldi/Olysio/Riba. VL 39 mil. - VL 230 @ 1 week, VL 40 @ 3 weeks, 5 weeks UND, EOT - UND, EOT @ 4 weeks UND, EOT @ 12 weeks UND!
TazKat


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Thank you !! Mallani!!!! i pray hard. depression has been a factor for me. got ot get over that crap!! lol



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TazKat Genotype 1A null responder x 3 riba & iterferon twice, relapsed from Incivek 2012 with only 12 weeks left to do. stage 4 mild cirrhosis 4/25/2014/ started sovaldi riba & interferon.. finished treatment 7/17/14  results 7/25  cleared..

 

 
mallani


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Hi TazKat,

Yep, this is the one. These are Ns-5A and NS-5B blockers respectively. Hope you're keeping well. Cheers.



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Geno 1b, IL28B CT,  x3 prior relapser,  ex-cirrhotic, 75 yo, did 48 weeks with Victrelis/Peg./Riba.  VL 1.28m at start, UNDET. at 8 ,12 ,16 ,24 ,30  and 48 weeks.  EOT 15 Feb 2013 , UNDET. at EOT + 28 weeks. SVR!  Still Undet. at EOT +5 years

Malcolm
TazKat


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is this the one that is not a protease inhibitor? i get so confused since there are so many things in the works. i relapsed on the incevik. 2 yrs ago. in a cirrohsis stage. go for 6 months checkup march 7th. hoping for some news on a med for me.. peace out.. TazKat



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TazKat Genotype 1A null responder x 3 riba & iterferon twice, relapsed from Incivek 2012 with only 12 weeks left to do. stage 4 mild cirrhosis 4/25/2014/ started sovaldi riba & interferon.. finished treatment 7/17/14  results 7/25  cleared..

 

 
Tornado


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I am taking Sovaldi & Olysio and I think the cost is $150,000 for 12 weeks treatment. Breaks down to $64,000 for Olysio and $88,000 for the Sovaldi. So, when the insurance company denied care the first try, I kind of understood it's a lot of money, but thankfully they approved it the second try. So, If I had to guess, They say the Ledipasvir & Sovaldi has a little better cure rate like 98%-100%, compared with 93% for Sovaldi and Olysio, and the fact that is just one pill a day easier to maintain compliance. I am guessing $175,000, we will see. 



-- Edited by Tornado on Thursday 20th of February 2014 07:34:30 PM

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Tim Geno 1A, null responder x 4, mild cirrhosis, contracted 1974 blood transfusion currently on Sovaldi/Olysio
Tornado


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I am on Sovaldi & Olysio. The reason the insurance company approved me the second try was that my doctor said the interferon and ribavirin caused depression and that is why I needed the new meds. So, thats an angle your doctor could approach. I hope you get approved and get well soon.



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Tim Geno 1A, null responder x 4, mild cirrhosis, contracted 1974 blood transfusion currently on Sovaldi/Olysio
LC


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This is the one I'm waiting for!  biggrin  I don't want interferon or ribavirin treatments.  I just hope my crappy insurance will cover it with the usual out of pocket expenses.  no



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Genotype 1a, VL 1,151,923.  51 years old.  Started treatment on AbbVie TOPAZ II clinical trial Oct 10, 2014!  Undetected at weeks 2 and 4! 
suziq


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Thanks Matt

The new drug combos are moving right along.  There will be choices in the near future.  And no ribavirin or interferon.  Really an exciting time for those who have been delaying treatment waiting for drug combos with less side effects or have failed the old SOC.  Hopefully everyone will be SVR in the foreseeable future.

Note aside:  My 4 week EOT labs delayed until Thursday due to possible ice storm.  My trial sponsor Merck needs to speed it up--they have not even started Phase 3 trials yet.

SuziQ 



__________________

Geno 1A  Age 82 Treatment naive Cirrhotic Told I had liver disease in 1966. Diagnosed as Hep C 1999.Started Merck clinical trial with Riba on 9/9/2013 Week 1 and 2 <25  Weeks 4, 8, 12,16,18 UND.  EOT Jan 14,2014  EOT +12 UND   JULY 1 2014 EOT+24= SVR
mallani


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Hi Matt,

Thanks for that. This is the ONE. It'll be interesting to see the price of the combo pill. Cheers.



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Geno 1b, IL28B CT,  x3 prior relapser,  ex-cirrhotic, 75 yo, did 48 weeks with Victrelis/Peg./Riba.  VL 1.28m at start, UNDET. at 8 ,12 ,16 ,24 ,30  and 48 weeks.  EOT 15 Feb 2013 , UNDET. at EOT + 28 weeks. SVR!  Still Undet. at EOT +5 years

Malcolm
Matt Chris


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Great News for the future Demise of HCV

Gilead Files for U.S. Approval of Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Genotype 1 Hepatitis C

Follow this link

http://hepatitiscnewdrugs.blogspot.com/2014/02/gilead-files-for-us-approvalledipasvirs.html

What this would likely mean is that in 6-7 months Gilead will be Selling and treating GT1 patients with an all oral combo. Yahoo!

matt 



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 
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