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Gilead Trial with Sofosbuvir & GS-5816
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Gilead Trial with Sofosbuvir & GS-5816

Gilead Sciences:  Twelve week Phase 2 trial of sofosbuvir + GS-5816 (without ribavirin or interferon) for genotypes 1, 2, and 3 treatment-naïve.

The Protocol Number:  GS-US-342-0102
Clinical Trial Number:  NCT01858766

Anyone else in the Gilead 12-week trial with sofosbuvir & GS-5816 (without ribavirin or interferon)?  The initial enrollment was 140 patients and I would like to connect with or hear from anyone else who may be in these trials.  Thanks!
Tags: GS-5816, Sofosbuvir, Gilead Sciences, trials
153 Comments Post a Comment
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1797925_tn?1341099804
http://clinicaltrials.gov/ct2/show/NCT01858766?term=GS-5816+Sofosbuvir&rank=1

The above link is for this trial.
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Avatar_f_tn
I am in this trial but for 24 weeks..just am on week 12 now..plus i have the ribavirin..800 dose.  doing fine..minimum sides. undetected since week 3 or 4.  am going to cut down my RBV dose now.  i have noise in head from this medicine i believe...
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Avatar_f_tn
oops i am in the Sofosbuvir, RBV, and 5885 drug..sorry..
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317787_tn?1373214989
Hi I just did a search and nothing came up,
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317787_tn?1373214989
Hi Margarete here is a person who is starting but that is all I could find

http://www.medhelp.org/posts/Hepatitis-C/Biopsy-Results/show/1959539
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Avatar_m_tn
Hi Dee,

That's me but I did not get into the trial, it is closed. I am now waiting for the FDA decision on sofosbuvir and will most likely be doing the 12 week sofo/riba dual therapy for gen 2s in a few months (hopefully)
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Avatar_m_tn
Hi, I'm at about week 6 in the Sofosbuvir + GS-5816 12-week trial. Liver enzymes normal and HCV undetectable as of week 2. Platelets on the rise. No side effects to speak of. I hope it sticks, obviously. How are you doing? I'm GT-1A, btw.
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131114_tn?1380086790
y'all be sure to keep us informed!
i am 2x tx - and relapser- waiting on breakthru!
no more INF/RIBA

Onward brave warriors!
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163322_tn?1374168641
I am very interested in the results as I am 1A, did an unsuccessful 24 weeks with interferon/RIBA in 2007, and am waiting for this new one to be released. I would have liked to get on a trial, but missed the boat.  I don't think it was offered to people who live in Hawaii.

Wasn't there another all-oral trial going on two years ago or thereabouts?  Can anyone enlighten me about the results of that one?  I rarely come to this website,  so hopefully I'll get email notifications.
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1797925_tn?1341099804
I am genotype 3a and my liver biopsy from Dec 2011 indicated Stage 2, Grade 3.  I started 12 week treatment with sofosbuvir & GS-5816 (no interferon or ribavirin) on May 22nd, in a Phase 2 trial.

My starting levels were VL: 6,500,000, AST 47, ALT 58.
After 1 week treatment:  VL: 567, AST 25, ALT 26
After 2 week treatment:  VL:   42, AST, 22, ALT 17
After 4 week treatment:  VL: <25, AST 20, ALT 13
After 6 week treatment:  VL:  UNDETECTED, AST, 22, ALT 15
After 8 week treatment:  UNDETECTED

The side effects have been absolutely minimal.  The first couple of weeks I had a few fleeting headaches and some nausea, but that has all subsided now.  I now have energy that I didn't expect to ever have again.  My thinking seems to be clearer, the depression has lifted and my spirit is soaring.  Before starting treatment I was constantly and utterly fatigued, bloated, nauseated, and just generally miserable.  My family and friends cannot believe the difference in the way I now look and feel in such a short time and neither can I.  

I have 18 more days of treatment (2 pills each day at 2:30pm), and if I remain UND until November 14th, I will be considered officially cured.  I have only been able to find one other person in this trial (besides you Avandaly) and he is UND as well with no side effects.  Hopefully, there will be others that will find their way here and we will be hearing UND from them all.

My prayer is that GS-5816 is truly Gilead's answer for Bristol's daclatasvir, and that soon all will have access to a cure that is safer, more effective, and with minimal side effects and is effective in ALL genotypes!  If the results from this phase 2 trial are as amazing as the sofosbuvir/daclatasvir trials were, then Gilead plans to initiate a phase 3 trial immediately from what was mentioned in their 2Q investor meeting.  And since both of these drugs are owned by Gilead, we won't experience what we went through in the Gilead/Bristol situation.

Tomorrow is World Hepatitis Day and I pray that by World Hepatitis Day 2014, the whole world will have something to truly celebrate - life without Hep C!

Avandaly- Please keep us posted as to your progress and I will do the same.

Warmest regards to all!
mdudley



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Avatar_f_tn
So happy to read your good news! Thanks for informing us and please keep us updated.

Praying for your SVR.
Love,
Riv
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Avatar_f_tn
  Great news, Margaret, proud of you!~  Katy
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Avatar_f_tn
I'm happy to hear of your good news.  I relapsed after 48 weeks of interferon/ribavirin combo and wanted to do the Gilead trials but it does not appear available for relapsers.  

If phase III comes available, I'm wondering if there will be any arms for relapsers.  

sljl
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Avatar_f_tn
I feel so encouraged from your current results.  I've had HepC 2b since 1995.  I've been blessed that my symptoms have, for the most part, been kept at bay and my ALT/AST within range.  There have been a few times, and most likely now, that my VL has been considerably high.  I'm very excited about this drug and the "minimal" side-effects.  If it weren't for the side-effects of current treatments and the multiple horrific stories I've read from others having gone thru the treatment "hell" I might have been more brave to reconsider but I'm thankful I'm in good health for the most part and that I've gone this long without any health issues from this disease.  Awesome, thank you for being a testament to those of us who are waiting in the wings to make a bold step forward to the treatment for a cure!  MRC
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Avatar_m_tn
I just signed up for the sofosbuvir gs5816 12 wk trial. I completed 48 wks
Interferon/ RIBA combo and relapsed ov a year ago. I'm 62 yr old male
Stage 1, geno3a. I start the treatment on Thursday. Good luck to you.
Your results are encouraging to me
Thanks,
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Avatar_m_tn
@mdudey my experience is Identical!!     september 4th will be my first 30 day test after finishing the pill regimen.. fingers crossed..  
same 3A genotype
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congrats mdudley.  I know you have put a lot of time and effort into getting a better cure out there faster for everyone!  Best wishes to you
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Avatar_m_tn
I started today gileads 12 wk trial. I'm in the sofo and gs 5816 100 dose group
And no RIBA or interferon. Glad to be in this study.
Hope your progressing well.


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Avatar_f_tn
I too am in this trial.  Now at wk 5.    Geno 3a, stage 2-3, Grade 2.   Also relapsed after 24 wks of standard tx in 2011.
Age 69.  I'm in the arm with Sofo + 25 mg of GS-5816.  Wk 1 and 2 viral load were both <25.  I should get the wk 4 viral load in about a week.  Baseline AST 55, wk1 24, wk2 21, wk4 48.   Baseline ALT 52, wk1 25, wk2 16, wk 4 25.
My best wishes that you reach SVR.  Let us know of your progress.  Regards,  zandra666
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Avatar_m_tn
I'll keep posting as my blood work comes back
Good luck to you
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Avatar_m_tn
I just started the 12 week trial yesterday.  I am taking the Sofosbuvir with Ribavirin AND 5816.  I have previously been treated with interferon and ribavirin after 12 weeks as the treatment seemed to be working but the the viral load climbed back up to where it was when i started.  Very discouraging i am hopin this will work.  I am taking 1,000 mg RBV, 400 Sofosbuvir and 100mg 5816.  Anyone else in this same trial?
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Avatar_m_tn
Ion 2 study
Naive stage 2
geno1a
24 weeks with RIBA
Completing week 18
6 weeks to go
UDL at week 4
Hemo went to a low of 12 and has rebounded
enzymes low range of normal
Feel better with more energy than in recent yrs - just finished in gym :)

Skin rashes
Aggressive behavior
Insomnia
Lack of energy in the beginning

There you have it :)
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Avatar_f_tn
I am in this Gilead trial, also.   Previously relapsed after 24 wks of standard tx.   Geno 3a.  I am in the arm with Sofo + 25 mg GS-5816 and no riba.
I am at wk 6 and just got back the viral load for wk 4 -  UNDET.    No sides.  I am hopeful.  You should do well.  Let us know how you are progressing.
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Avatar_f_tn
I did a long post a few hours ago but I don't think it went through.

I, too, am in the 12 week study with only 5 days of pills left.

Dianne
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1797925_tn?1341099804
I just received my 12 week EOT results from August 14th and virus remains  UNDETECTED!  My AST is 19 and ALT is 13.  I feel great and have energy that I have not had in years. Feeling so good that I took a little trip out of town with my husband to celebrate his birthday this past weekend.  I go for my PT Week 4 on Sept. 11th and will post results as soon as I get them.

I am so thrilled to see that you all are doing well and thank you for sharing your status/progress.  I pray this is what we have all been waiting for... safe and effective treatment for all genotypes with minimal or no side effects!

Warmest regards to all,
mdudley
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Avatar_f_tn
  Great news, M!  I am so happy for you, and yes, this is what we need ;)
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131114_tn?1380086790
OMG please Lord- let this be a break-thru.
I so want to feel good again!!!!! Yes.

So happy for you , Margaret! Yay!
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♫.•*´★☆ ¸¸.•*¨*•*♦ Congrats Margaret! ♥.•*´★☆ ¸¸.•*¨*•*♦¸.•*´✡

I know this has been an uphill battle for some time now. I regret it was that way for you however I am truly thankful for your efforts at promoting Hepatitis C Awareness in the process :)

Interferon is a serious beast and I am glad you were able to clear the virus without it. I wish you peace and happiness as you move on to the next chapter of your life.
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Avatar_f_tn
How wonderful!!!  It is great to hear that you are feeling so well.

  I screened for that trial BUT they found cirrhosis during the biopsy and I was rejected.  I was so so disappointed.  I screened Tuesday  Aug 27 for a Merck trial that will accept cirrhosis.  I do have a slot but won't know if I am accepted until Merck reviews the bloodwork  I'm 79 so really don't want to wait for FDA approval.  I had no idea that I had cirrhosis as I feel pretty good for my age most of the time.
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Avatar_m_tn
Started my sofosbuvir and 100 mg 5816 on aug 22
Baseline viral load was 1,700,000
After 1 week viral load was 39
After 2 weeks viral load undetectable.
And no side effects at all
Hope this brings hope to all
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1797925_tn?1341099804
That is excellent news & it definitely brings hope.  What genotype are you?  I am 3a and I go in for my 4-week post-treatment labs on 09/11 & will post those as soon as I receive them.  Thank you for sharing this with us all!
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Avatar_m_tn
I'm a 62 yr old male geno 3a. Stage 1 grade1. Probably have been walking around with hep c for 35 yrs or so.
Correction on my earlier post I started sofo and 5816 on aug 17. Got my undetected news today (week delay for bloodwk to come back).
My research team was very excited for me. I relapsed from 48 wks of interferon and RIBA about a year ago.
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Avatar_m_tn
Does anyone know anything about this trial going to phase 3? I would love to get into it. I am keeping an eye on clinical trials.gov but so far nothing. I have found that site is often outdated in it's information. How does one find out about new trials? Should I contact a hospital where the phase 2 was held and ask about phase 3? I am a genotype 2 treatment naive, stage 2-3. I am waiting for the sofo/riba treatment to come along but if this trial became available I might consider it to avoid the riba sides. I don't want to wait very long tho....
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Avatar_m_tn
In gileads second quarter conference call, they said the preliminary data for the two phase 2 study's that are currently ongoing for sofosbuvir and 5816 combo will have preliminary data to analyze later in the year and then they will decide on a possible 3rd phase fixed dose study of that combination. The ongoing 2 nd phase study is currently testing the proper dosage of the 5816 as well as the efficacy of the combo. I would suggest you go to the clinical.gov website and click on study locations for the 2 nd phase thats underway
And pick the hospital in your area, call the hepatology research dept
And get to know someone over there. Maybe the research coordinator. They might be asked to do the phase 3 when it opens up. Tell them your story. Maybe they'll be nice enough to call you if they get to do the study.
Best of luck,
Eduardian
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Avatar_m_tn
Thanks that's very helpful. I may give the hospital in Providence RI a call. However I suspect the time frame for the phase 3 opening is longer than I would be comfortable with. I am doing fine now with no HCV related problems but don't want to push my luck waiting too long.
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Margaret, so happy for you. You have come so far since your diagnosis, you must be so proud!!
Dee
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Avatar_m_tn
Hi 5 years ago I was stage 0 grade 2 geno3..now stage 3 fibrosis grade 3...am on 100mg gs5816 400mg sofo 12 week trial been und since  week 2. pt 4 labs 9-25..not going to wait a month to find out..have app with gp on 9-26 for labs figure labcorp NGI QuantaSure test would be the best one? supplements im taking pt are life extension super r-lipoic acid 300mg twice a day 200 mcg selenium twice day..750 mg milk thistle twice day super bio curcumin 400mg one aday..one pure encapsulations nutrient 950 without copper iron and iodine multi vit.what do you take? looking for suggestions..was thinking about adding low dose naltrexone...I hope you get independent labs as well..i don't have that kind of patience .a month and then they might not have them #%$& that lol if were und @ pt4 might be time to buy gilead stock...cheers
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1797925_tn?1341099804
Quick update:  Received 4 week post treatment results:  UNDETECTED!  All other lab results in normal range as well.  

Hope and pray that all in this trial reach SVR and that a Phase 3 will start soon!

1Krieger - I am only taking NAC, Vitamin D3, and B12 supplements.
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Avatar_f_tn
Congratulations Margaret!   You are well on your way to clearing for good.
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4806014_tn?1384584937
Where (City/State?) was this study?  So nice to read your post. Inspiring!  

Thanks   ツ
(='.'=)
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Avatar_f_tn
Great News!
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Avatar_m_tn
Fantastic news. I started my treatment last week. Geno 3b stage 2. Hope it works for me too.
Rodgon65
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Avatar_m_tn
Congratulations to you! That news gives us all great hope. I started my treatment last week. I am geno 3b and stage 2. I've got 1200mg Riba, 400 Sofo and 5816 25mg for 12 weeks.
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6277868_tn?1379995782
Were you treatment naive or an IFN failure?

I  fit your description except I am an IFN/RBN non-responder. I am on week 1 of Sofosbuvir + GS5816 only. - 12 wk. trial . (in Melbourne, Aust.)

I have experienced some nausea but nothing compared with how ill I felt on IFN Tx.

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Apologies I can see now that this particular trial is for tx - naive only. Not me! I will try to find the right trial to comment on !
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4806014_tn?1384584937
I saw your post that you were looking to get in to a study.  Did you know that NIH is starting studies in a few months and they are now screening? They are accepting those with cirrhosis geno 1s and gt 4s only.  

Previous Study | Return to List | Next Study
Combination Therapy for Chronic Hepatitis C Infection
This study is currently recruiting participants.
Verified December 2012 by National Institutes of Health Clinical Center (CC)
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier:
NCT01805882
First received: March 5, 2013
Last updated: August 22, 2013
Last verified: December 2012
History of Changes
Full Text View Tabular ViewNo Study Results PostedDisclaimerHow to Read a Study Record
  Purpose
Background:
- GS-7977, GS-5885, GS-9669, and GS-9451 are new drugs for treating hepatitis C virus (HCV) infection. GS-7977 may help treat the infection when used with other treatments like interferon therapy. GS-5885, and GS-9669, and GS-9451 also lower the amount of HCV in the body. Researchers want to see whether GS-7977 can be combined with any of the other three drugs to treat HCV infection. Some participants will take GS-7977 and GS-5885. Others will take GS-7977, GS-5885 and GS-9669 or GS-7977, GS-5885 and GS-9451.
Objectives:
- To see whether GS-7977 with GS-5885 alone or in combination with either GS-9669 or 9451 can be used to treat HCV infection.
Eligibility:
Individuals at least 18 years of age who have chronic HCV infection and have never been treated for it.
Individuals at least 18 years of age who have chronic HCV infection and have not responded to interferon therapy.
Individuals at least 18 years of age who have chronic HCV infection with advanced liver disease and have never been treated for HCV
Design:
Participants will be screened with a physical exam and medical history. Blood samples will be collected. A liver biopsy may also be performed.
Some participants will take the two study drugs and some will take three study drugs. Those who take GS-7977 and GS-5885 will have one daily tablet named fixed dose combination or FDC. Those who take GS-7977 and CS-9669 will have three daily tablets taken once daily. Those who take GS-7977 and GS-5885 and GS-9451 will take 2 pills once a day. GS-7977 and GS-5885 will be combined in one pill and GS-9451 will be in another pill.
Treatment will be monitored with frequent blood tests. These tests will check liver function and the level of HCV infection. Participants may have other blood tests as needed for treatment.
Participants will have 6, 8, or 12 weeks of treatment depending on which study drugs are scheduled to take. After they complete their schedule, they will stop treatment with the study drugs. They may also have another liver biopsy.
Participants will have regular follow-up visits over the next 48 weeks. They will have physical exams and provide blood samples....

Condition Intervention Phase
Hepatitis C, Chronic
Drug: Fixed Dose GS-7977/GS-5885
Drug: FDC with GS-9451
Drug: FDC with GS-9669

Contacts
Contact: Amy K Nelson, R.N. (301) 451-1426 ***@****
Contact: Shyamasundaran Kottilil, M.D. (301) 435-0936 ***@****

Locations
United States, District of Columbia
Family Medical and Conseling Services Recruiting
Washington, DC, District of Columbia, United States, 20020
Unity Health Care, Inc./DC General Recruiting
Washington, DC, District of Columbia, United States, 20002
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)     800-411-1222 ext TTY8664111010     ***@****    
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Shyamasundaran Kottilil, M.D. National Institute of Allergy and Infectious Diseases (NIAID)

THEY ARE ACCEPTING NULL RESPONDERS WITH COMPENSATED. CIRRHOSIS if liver condition is within their inclusion/exclusion guidelines.
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1797925_tn?1341099804
I was treatment-naïve.  But please keep posting your results here so that we all can see how you are doing with these drugs.  Many previous treaters are hoping for new treatment w/o ribavirin or interferon.  So your progress is very important to us all.  Wish you SVR all the way.  And thank you for keeping us posted.
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Avatar_m_tn
Genotype 1A. Four weeks post Sofosbuvir/GS-5816-100 treatment: HCV undetectable, ALT=20, AST=40. Still have 8, 12, and 24 weeks to go. Good luck to all of us!
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Avatar_f_tn
Several of us are tx experienced with Interferon/riba on a Gilead trial with Sofosbuvir and GS-5816 w or w/o riba.   I just ended 12 wk of tx with Sofo + 25 mg 5816 no riba on 10/3/13.    Geno 3a.  UNDET at wk4 and still UNDET at wk12.   4wk after EOT is 10/29.   Please keep reporting and best of luck to you.
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Avatar_m_tn
Anybody asked to do trial of 8 weeks, not 12  of Sofo & GS-5816 w/ or/wout riba (geno type 1)?
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142526_tn?1397094272
I'd be interested in looking into a trial like this one.

Is it for geno 1a or 1b, tx experienced or tx naive?

Can you please give us a link to this trial?

Are you thinking about joining an 8 wk trial if you're eligible to do this one?

Thanks!
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Avatar_m_tn
Any news about your 8 week post treatment? Thanks.
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Avatar_m_tn
I too am in this study just got my EOT test results back today still UND go back November 13th for my 4 week post treatment test. Mdudley what was your GS5816 dose 25 or 100?
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Avatar_m_tn
New trial now recruiting. If you're interested Go to clinicaltrials.gov
Identifier nct01826981
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Avatar_m_tn
Genotype 1A. Eight weeks post Sofosbuvir/GS-5816-100 treatment: HCV undetectable. Still have 12, and 24 weeks to go.
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1797925_tn?1341099804
My dose was 100mg.  Recently received my SVR8 and will be going in on Nov. 6 for SVR12 testing.  Praying that we all continue to be UND and reach SVR12 and then SVR24!
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Avatar_m_tn
I was in the Sofosbuvir + 25mg  of the GS5816...I hope it was enough....
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Avatar_m_tn
Finished up my meds on Wednesday. While at the hospital in Chicago (northwestern)I was told that gilead is going to open up this study again of sofosbuvir and gs5816 to new recruits of different geno types.
Best,
Eduardian

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Avatar_f_tn
I finished the sofosbuvir and 25 mg GS-5816 on 10/3.  Undet.  I was still UNDET at 4 wks post tx on 10/29.  Best of luck to all of you.  Geno 3a tx experienced.
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Avatar_m_tn
Great news, you're ahead and in the home stretch.
Gives me hope!
You must be on cloud 9!
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Avatar_m_tn
I too had am in that same arm...I took my 4 week post tx blood test yesterday. I should have the results next week.
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Avatar_f_tn
I am going in for my 12 week post treatment work on Tuesday.  I am genotype 1a and was on Sofosbuvir and 5816 once a day for 12 weeks in the stage 2 clinical trial at SouthWest Care Center in Santa Fe, NM.  Went viral release after week 2 and am SVR after 8 weeks post treatment.  Next one is the really big test...
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Avatar_f_tn
How exciting for you (and the rest of us).! You're almost there...hang in there.
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1797925_tn?1341099804
November 16, 2013:  CURED!  I received my SVR12 results this past Thursday and the virus is still UNDETECTED 12 weeks after end of treatment.  I am told the chances of the virus returning are less than 2%.  I continue to pray that GS-5816 combined with sofosbuvir will eventually prove that most cases of HCV (regardless of genotype) can be eradicated without toxic interferon or ribavirin.  This disease is tough enough as it is and God knows we need a treatment that is kinder and more gentle if we are to overcome this epidemic.  There are other treatment combinations on the horizon for genotype 1s that will not require interferon or ribavirin, but there are no others that I know of that are currently being tested for genotype 3 that do not require ribavirin or interferon.

I look forward to hearing from all of you who were in this same trial.  I am in touch with a few others on other forums and they still remain UND but are still waiting for their SVR12 results.

If it wasn't for forums like this, we would not have such great opportunities to share such momentous information such as this.  Thank you all for sharing, and thank you Medhelp.org for giving us this wonderful forum to CHANGE lives!

Warmest regards (always)

mdudley
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Congradulations, great news.
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1815939_tn?1377995399
Congratulations on being UND at 12 weeks post EOT. Please let us know how your 24 week post EOT VL comes out. Hoping and wishing for UND at 24 weeks post EOT also.
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Avatar_f_tn
Wonderful news! Congratulations on your SVR12.

Every positive outcome,  no matter which genotype, gives hope to all that the complete eradication of this HCV virus is not that far off in the future.

Thank you.

Nan
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Avatar_f_tn
BIG Congratulations!!!! What a journey it's been eh? I did the sofosbuvir/5885. Did 14 weeks and also heard I'd been cured. I'm very, very happy for you.
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Avatar_m_tn
How wonderful for you and your family!
I hope to have same to report in some weeks.
Good work!
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Avatar_m_tn
Genotype 1A. Eight weeks post Sofosbuvir/GS-5816-100 treatment: HCV undetectable 12 weeks post treatment. The combination of Sofosbuvir and GS-8516 looks like it's clearing almost everybody-- all genotypes.
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Avatar_m_tn
Sorry, not eight weeks, twelve weeks post treatment. SVR12.

-Art
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1840891_tn?1383280315
Thanks to all who are keeping us posted on this, and congratulations to all who are looking likely to achieve SVR!
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Avatar_m_tn
I'm in a very small arm added to this trial that is treating for 8 weeks. Genotype 1a, grade 2, stage 3, high viral load &liver  enzymes. I'm on 400mg sofosbuvir and 100 mg 5816. I'm hoping it's enough time - these are great drugs-no side effects for me. Dr. said if I relapse I can do the 12 week sofo + interferon + riba next year. Will keep you posted..
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Congratulations, Margaret!    I am so happy for you and your family.  Thanks for keeping us posted on your results.  For all genotypes, but especially for those of us with Geno 3, Gilead's Sofosbuvir and 5816 may be the non-interferon DAA combination we have all been waiting for as the news has all been so positive so far.
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Avatar_f_tn
HI
First, congratulations on being selected for participation in this arm of the trial.
Would you mind sharing your VL and enzyme numbers?
My husband is  post transplant genotype 1a and doctors have said the plan is to address his HCV in 2014. Liver biopsy will be done  in January.

Thanks for participating  as it gives those at 1a hope for a cure in the near future.
Nan
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That is amazing news!  Congratulations.  As my husband is post transplant with some bilary tree and other complications, finding a treatment that is short with few side effects is so important for him.  I wish you the very best in your quest to eradicate this virus. Thank you for sharing,

Nan
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My viral load was 13.5 million and my enzymes have been around 200 for the last year. Five years ago I was stage 1 with normal enzymes, due to my husband being ill I ignored my health and last march finally got checked, biopsy showed stage 3 in July . Have felt like was in a decline since then but was waiting for the 12 week sofosbuvir  plus soc . I have just finished first week and feel great. I will keep you posted. Sorry for all the typos.

Congrats to all who are SVR!
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I am so happy to hear you are feeling great on treatment.  When my husband did the triple treatment with Incivik, interferon and ribaviran pre-transplant, he had decompensated cirrhosis. He felt really terrible for the 5 weeks he lasted on treatment.  It was then that I saw what an amazing will to live he had. I honestly don't think I could have done it.

But I don't think there is any way he would agree to use anything that requires either interferon or ribaviran ever again. That is why we are greatly these new treatments are in the pipeline and grateful that people like you are willing to try them out.

All the best for a a great outcome.
Nan
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12 week post treatment results just in.  Solvadi ( sofosbuvir) and 5816 ( 25 mg).  Treatment naive, geno 1a, no cirrohsis or other complications.  Research at Southwest Cares in Santa Fe.

CURED!
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I am so happy to hear your great news. I have completed the same dosage of the same meds and I am anxiously waiting to hear my 4 week post treatment results. I took them 2 weeks ago today and I am still waiting, the research nurse says the lab is backed up do to the holiday so I have to wait until next week for her to check again....

Mike
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I keep hearing successful cures for those in sofosbuvir and gs 5816 studies.
I was wondering if anyone has had a relapse, or a failure in this study?
I finished these meds a couple weeks ago and I am hoping this regimented is
the answer we've all been waiting for.

Eduardian
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Macrojane, Congratulations!  Wonderful news!!!  Thank you for sharing with us.  I hope we will be hearing more and more of the same.... SVRs for all genotypes!
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Well my 4 week post treatment test results finally made it back and I am still undetectable!!! I go back a week from Wednesday for my 8 week blood work. I will keep you all updated. While I was on the phone I asked her if she had heard of any relapse's with this study and she said none to date, great news.

Mike
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Anyone interested in the new gilead study now recruiting for geno type 1 and 4. Go to clinical trials.gov.     Search box type nct01805883
I think this is a winner!
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Sorry I had the wrong search number on the previous post.
Search  nct01885882

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I tried the corrected search number and got "no study found".

Can you check it again and repost.
Thanks
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try NCT01938430 this may be a good one for your husband
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Sorry about the confusion on the number. I must be getting a learning disability in my old age! Go to.     Clinicaltrials.gov.                                      The correct number to type in the search box is Nct01805882
Or you can type in gs9451 instead.

Hope this clears up the confusion that I caused you.


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It only gives locations is the DC area, too bad won't help my friend. What I find most interesting from the "Exclusion Criteria" on this trial  Nct01805882 1.Current or prior history of the following, and they list: Lactose allergy, patients with lactose intolerance will be evaluated on a case-by-case basis.

To my knowledge I'm not lactose intolerant, but I had to stop eating cheese during my GS7977/GS5885 trial.  The first few weeks I had stomach upset with one day of gripping pains.  A friend advised me to give up dairy so I did just as a fluke, and bingo, my headaches and digestive problems went away and I had no other side effects.  UKGirl55 had to stop at week 14 due to extreme nausea and stomach upset.  

They did not have this exclusion listed on my trial.  When I'm at home this evening I'm going to check my paper work just to make sure, but I do not recall seeing that. Very interesting.  I was in ION2.
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As I posted elsewhere, my husband is in the hospital due to a UTI and HE.
They moved up the liver biopsy planned for January and have  found he now has cirrhosis in the new liver. Pathologist says this was caused by both the bile duct damage as well as the Hep C recurrence after his transplant a year and a half ago.
They plan to start him on Solvaldi and Ribavirin for 24 weeks (no interferon)
in January.  I asked if they considered putting him in a clinical trial that doesn't include Ribavirin and was told that as he is post transplant he is not a candidate.
This combo of Solvaldi and Ribavirin has been used on transplant patients.
(Apparently, they have not published the results on these patients yet.)

I am grateful that there is a new drug combination he can use with fewer side effects and I am praying it will cure him.

Nan
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The info on the trials listed at clinicaltrials is often very old or incomplete.
I don't think nct01805882 is only in washDC. Gilead has a phone number for the inquiring public. Call 1800GILEAD5  leave a message.

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Just received the 4 week post treatment results of my most recent viral load test. undetectable! Thanks to 12 weeks of sofosbuvir (sovaldi), and gs5816 100 mg. no sides to speak of during treatment(slight headache occasionally)
Genotype 3a, treatment experianced going in to study after relapsing after 48 wks of peg interferon and RIBA about 2 years ago.
My family and I are elated.
Eduardian
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Congratulations hardly seems the right word. "Undetectable" is such a wonderful word that has such an amazing meaning to those who have struggled with this insidious virus for so long.  

Here's to all those who read your post (including my husband) and know that it gives us all hope that one day we, too, will read that amazing word knowing that the battle is finally over.

CONGRATULATIONS!
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Happy to hear that great news!! I just took my 8 week post treatment test yesterday and am hoping to hear good news as well...

Mike
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Wonderful news.  I was SVR @ 12 weeks....you will be too!
My next test is at 24 weeks......mid-February

To everyone, eat very healthy, exercise and maintain your health to the best of your ability.....this treatment , once approved , is going to be a game changer.
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...Is Ribavirin necessary with Sofosbuvir 400 Mg and 5816 25Mg..?
Seems like you may not need the RBV to Cure Hep C?
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They did have arms in the study that added Ribavirin but so far from all of the results I have seen here it has not made a difference for those of us that did not get in the study arms that included Ribavirin.
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I am in the study with Sofosbuvir 400 and GS-5816 25 mg + or - riba for tx experienced Geno 3.   There were 4 arms of the study, 2 w/riba and 2 w/o it.  My arm of the study did not have ribavirin.    

As of 11/26/13 at 8 wks post tx I am still UNDET.    12 wk post tx blood draw is 12/30/13.   I will keep the group posted.
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I just checked gileads pipeline on their website and it now lists sofosbuvir (sovaldi) and gs5816 as a fixed dose combo. Over a week ago they were listed separately. Must be good news for this combo. I wonder what dose they fixed the gs5816 at (100mg or 25 mg.)
I haven't heard of any failures in this study at either dose.
From my early unscientific poll were batting 1,000
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So you don't think you need RBV with Sof and 25 mg 5816?
RBV has too many side effects..Can make you sick and tired.
Any side effects with the Sof or 5816 ?
TIA
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To summarize my experience on the sof and gs5816 you should read
the post from mdudley on July 27, 2013, which describes my experience exactly. Good luck!
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not one side effect for me!
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Do you need the Ribavirin with Sofosbuvir 400mg and the GS 5816 25 Mg to cure Geno 1A???
Is the RBV necessary to Clear the virus
TIA
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Well I am not a Dr. But I can share my experience as a subject. I was give a combination of Sovaldi and 5816 /25 mg. I was on the meds for 12 weeks. I went UND in week 2.  At 12 weeks post treatment I was still SVR.

I did not take Ribavirin, so my treatment has been successful ytd without Ribavirin.

I understand that some of the new trials do include Ribavirin. I am inclined to believe, without further knowledge, that Gilead is proving efficacy with and without Ribavirin.    The first trial that I did not make, because of use of Chinese herbs, included Ribavirin. I was very unsure, but the outstanding Dr. At SW Cares in Santa Fe NM, said that effects of Ribavirin would be very minimal or non-existent in a 12 week trial. I was good with that, but as I said, did not get accepted into that trial of Solvadi/ Ribavirin.
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Thanks MJ..
Ribavirin is a Nasty Drug!
I believe Sof and 5816 can Kill the virus for Good..
Hope that is true.. and Congratulations!
RBV has too many side effects
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Just got my phone call for the 8 week post treatment blood test results...
Still undetectable, I am just amazed with these new meds, very hopeful that this is the real deal for us all....

Mike
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Thanks mike, for blazing the way for the rest of us!
One more month and you're officially "cured".
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Hi, this is Albert46. I am in  a similar trial (400mg of SOF +25 mg GS 5816), but for 8 weeks. I am 1b naive. Similar situation before treatment.  I was very depressed and could not accept myself living with the virus. Thank G-D , I was accepted to the trial, and immediately felt a big difference in the way I feel and the energy I started to have.
I have a similar table of decreasing of the viral load. Please, take a look:
Start          2,200,000
1st week   165
2nd week   30
4th week   <25
I have to go for more testing at week 6 and 8.
We will see what the results will show, but I pray every day to G-D that the virus will be gone forever.
I have to tell you this: Gilead has bravely made a revolutionary difference for millions of sick people!  
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Have a healthier, happier and more prosperous new year!
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and to the Group:      Just rec'd my 12 wk PT viral load:   still UNDET.   Best X mas present I could receive.    I have high hopes for everyone else on this clinical trial of Sofo + GS-5816 + or - riba.  My study coordinator has known of no failures or relapses on this combination to date.

Genotype:  3a
TX experienced  (relapsed after 24 wks of standard TX in 2011)
1L 28B:    TT
Age:  69
Stage:   2-3
Grade:  2
Starting viral load:   approx 274,000
Clinical trial:   Sofosbuvir 400 mg + 25 mg GS-5816 no riba
for 12 wks for tx experienced.

Happy New Year and best wishes to all.
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Great news!!! I go for my 12 week post treatment lab work Wednesday, same study, same arm.

Mike
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I did the interferon & ribavirin 2 yrs ago and relapsed  8 weeks after stopping meds, now I just finished trial with GS5816 and Sofo and once again relapsed 8 weeks after I stopped meds. It's really heart breaking if you know what I mean.
I am 53 with a 2 1/2 year old girl and a 5 1/2 year old boy and I would do anything to beat this virus so I can watch them grow up.
I have type 3 hep and already cirrhosis. after last relapse really thinking how long I am going to be around and those thoughts tear me apart.
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I am very sorry that you relapsed. I know it must be devastating. Hopefully there will be another treatment you can do soon.

Do you know what dose you were on of the drugs? Were you on 25mg of GS 5816 or 100 mg?

Also, are you under the care of a Hepatologist? If you have Cirrhosis, you should be under the care of a Hepatologist at a large university affiliated medical facility. Most regular GI doctors do not have the expertise to manage the care of someone with Cirrhosis.

Best of luck.
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it was 25 mg
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You don't really have a choice what group they put you in, I only hope they let me try different doses and  different combination of drugs. I asked if I could just keep taking the treatment because I was clear all those weeks that means liver not being damaged by the virus during that time of treatment
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So sorry you relapsed. I read your post last night because I am in the same study and I took my 8 week post treatment labs last week and I was waiting for that phone call dictating my viral load today.
I completed 12 weeks of  sofosbuvir and 5816 100 mg and was undetectable at week 2 and believe me I was sweating the phone call today. You are the first relapse I've heard of in this study. I'm also treatment exp. did 48 wk program standard treatment and relapsed at 4 wks almost 2 years ago.
Stage 1 grade 1 but my doc thinks I'm really worse than that. The biopsy is unreliable he says. He also says don't drink because I don't want to have to do a transplant on you down the road. Great guy and I appreciate the scare.
Got the call today and I'm still undetectable after 8 weeks post treatment.
Big relief as you all might imagine.
A couple weeks ago I read on gileads website that they were listing sofosbuvir (sovaldi) and gs5816 as a single dose meaning combined in 1 pill as they do with ledipasvir. I wonder what dose they're planning in the single dose 25 mg or 100 mg of the 5816 combined with the 400 mg sovalid?
Gilead also lists another newer drug they're developing to be used in trials for hep c which are starting up.
Bristol Myers has a great combo and abbvie has a great combo in testing too.
There are going to be a lot of alternatives for you but it's really important you don't drink with hep c. My doc is always stressing that.
There are going to be lots of alternatives for a young guy like you!

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Believe me drinking is the furthest thing from my mind, which I haven't done in 8 years, I wouldn't do anything that would damage my liver more than the hep c is doing every minute of everyday already.
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And congrades on your 8 week results that must feel super wonderful
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I received my 12 week post treatment results today and I am still undetectable. It is all so surreal I still can't believe it, the treatment was so easy and the sides so minimal, like night and day compared to the ribavirin and interferon. I go back for 24 week post treatment test in early April and that will conclude this trial. The study nurse said that there is a long term follow up study they encourage us to do where they test you every 6 months ( I think)  for several years. I will participate in that study as well. Good luck to all of you with your upcoming test. Jonybgood...keep your head up and keep looking for another trial I am sure they will find a drug combination that will cure everybody, they are getting very close.

Mike
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Great news general!!
Thanks for posting.
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Just got the phone call from my study nurse that I'm still "undetectable"
after 12 weeks post sofosbuvir (sovaldi) and 100 mg gs5816 treatment in this study. So grateful!
Just to recap,
I'm a 62 year old male, gt 3a, treatment experienced.
Went undetectable at week 2. No sides to speak of except slight headache once in a while during treatment. Thanks to everyone who has gone before me.
Edward
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Great news, congratulations!!
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Yay, you did it, that's considered a SVR status in most trials these days.....
Woooohooo!
Enjoy your hep c free life :)
Mag
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Congratulations and thank you for sharing this news!
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I cleared 1a without RBV on Solvaldi and 5816/25 mg.  20 week post treatment test tomorrow.
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Good news! 24-week post treatment, Sovaldi + GS-5816 100 mg, Genotype 1A still undetectable. Best to all.
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Received 24-week post treatment results with Sovaldi + GS-5816 (100mg), Genotype 3a - Virus Undetectable!  The NP said I should be receiving a letter in the mail either Friday or Monday stating that I am now cured of Hepatitis C.  Have any of you that are SVR24 been told you would receive such a letter?

Congrats to all and hope some day soon this disease will be completely eradicated.



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Hi and a BIG congrats, you made it to officially be SVR!!!  :))))))))

My trial PA has told us that we will receive the same cure letter once we get to your ending point of SVR24. I'm in a BMS trial.

Great news! Enjoy your hep c free life :)
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I came across a great website that highlights all the new drugs being studied to cure all geno types of hep c


hepatitiscnewdrugresearch.com

Best wishes,
Edward
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The data from this study (the treatment naive part) will be rolled out at the EASL conference in London on April 8 to 13th.


Eduardian
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Have you received your SVR24 yet?  Wishing you all the best!

I received my "cured" letter but could not figure out how to post it here.  I will see if I can post it on my profile.  I have read it so many times that I almost have it memorized.  


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I feel your pain.  I was infected in 1976 and diagnosed in 1992, and thought my life was over.  My kids were 7, 9 and 12 and treatment was not recommended.  After a decade-long divorce, the virus suddenly took off.  My first clinical trial was Interferon only, failed at the fourth month.  It never occurred to me the treatment wouldn't work.  I was so upset I almost had a car accident.  I went through a second round of treatment in 1997, Pegylated Interferon and Ribavirin, stopped after fourth month because treatment wasn't working.  2005 went through a third round of treatment with daily Infergen and Ribavirin.  I felt pretty good, but my 9-week retinal checkup showed retinal hemorrhaging, had to stop immediately.  I tried to get into a VX-950 trial and was excluded when one test showed I had an irregular heartbeat, excluding me from all future trials.

I now have cirrhosis and an umbilical hernia.  My only hope is these new drugs.  I have an incredible doctor who is head of the Liver Center at Beth Israel Deaconess in Boston.  He expresses complete confidence that I'm going to get well, but I now have high blood pressure, had a mild stroke, benign tremor, low potassium that landed me in the ER, arthritis and history of psychiatric problems.

My doctor said we have to wait for these drugs to get FDA approval because he then can prescribe a treatment plan just for me and taking into account my particular health problems.  Most of the time I try not to think about it, but the woman who posted about feeling so much better and clarity in thinking I could really identify with.  I've also been put on Lactulose, a laxative that also does some of the liver's work and gets rid of those toxins.

Anyway, I wish you all the best.  I just want you to know you're not alone.  I posted earlier about my 19-month-old grandson I'm afraid I won't get to see grow up.  I don't know if you feel the skepticism and disbelief that I do, but when your ultrasounds have the label "Screen for liver cancer" instead of judging the progression of the disease, it's pretty discouraging.

I feared I would not live to see my daughters grow up, and I have.  They're now 37, 29 and 25.  What inspires me is when I see little children with cancer and how frightened they must be, and how unfair life can be.  Compared to those little children, I'm pretty lucky.  Take care and keep us posted.  After my April visit, I'll post what my doctor's plan is.
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Just got 24week post treatment results using Sovaldi and 25 mg 5816. Undetectable!  Agreed to multiple year follow up for Gilead as a small way to offer thanks.  Genus 1a.
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Great news, I go back April the 2nd for my 24 week post treatment test. I was in the same dosage trial as you. I will post results when I have them.

Mike
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I know you will have great results!  Let us know as soon as you can.
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Congratulations that is great news indeed!  So happy for you!
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Thank you for your post and good luck to you and all of us. I hope I can redo this treatment with the 100 mg of gs5816 that seems to be the winning combo we are all in need of
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Gilead announced preliminary data from the treatment naive part of this study.
SVR (sustained viral response 4 weeks after finishing 12 weeks of sofosbuvir and gs5816), was achieved in 86 to 100 percent of patients. Across 6 different geno types.
More complete data will be rolled out in London at the EASL convention
In second week of April.

Best wishes, eduardian
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Just rec'd my 24 wk PT viral load:   still UNDET.   Best birthday present  I could receive.    I have high hopes for everyone else on this clinical trial of Sofo + GS-5816 + or - riba.

Arm:   Sovaldi 100 mg + 25 MS GS-5816   No riba

Genotype:  3a
TX experienced  (relapsed after 24 wks of standard TX in 2011)
1L 28B:    TT
Age:  69
Stage:   2-3
Grade:  2
Starting viral load:   approx 274,000
Clinical trial:   Sofosbuvir 400 mg + 25 mg GS-5816 no riba
for 12 wks for tx experienced.
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Where did you get this info,  I searched  and couldn't find it.
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Congrats zandra,
Your free, cured, and onward with your hep c free life!
So happy for you and your family.

The latest statements from gilead on our study can be found at
biocentury.com and you'll find it under biotech and pharma news

I hope to report the same results as you in a few weeks!

Best to you,
Eduardian
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Thanks, Eduardian     I located the info.   Best luck to you on a getting that final UNDET.   These drugs are so good, I don't have much doubt you will be cured.  Regards,   Alex
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Hello I am new to this forum and I just got back from seeing my Doc today.  He is very optimistic that we will have a new drug for us Hep C 1a previous non-responders.  I know in my heart now that we all have a chance now!  I actually found out I have no cirrhosis at this point so I am going to wait one year and hopefully get the newest meds available.   He suggested I save some money this year just for the meds. I here it is at a 90% cure rate.
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Mauilady  have no fear.  I just talked with my Hep C doctor today and help is on the way for us Hep 1a previous non-responders.  Pill form no more interferon and the best of all a 90% cure rate.  
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This is awesome news!  Peace & Love! Rock on !
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Really to everyone...insurance companies are giving serious pushback to Sovaldi because of price.  This is so short sighted, as medically treating the effects of Hep C is far, far more expensive.  At this point Insurance companies are allegedly refusing to pay except for the most seriously ill.
Personally, in a stage to clinicAl trial, Sovaldi. + GS 5816 Inwent SVR in week 2 and remain so 24 weeks post.
I urge all of us to write our senators, congress people, local newspapers and the Presidents of the insurance companies to re-evaluate this very short sighted perspective.
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My 24 week post treatment results are in ....still undetectable!
400mg Sofosbuvir & 25mg GG-5816

Mike
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Congratulations and thank you for sharing your news!
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Today I received my cure letter after completing 12 wks treatment of sovaldi and 100 mg gs5816.
Treatment experienced, relapsed after 48 wks peg interferon and RIBA 2 yrs ago
63 year old male
Gt 3A
Thanks to all those, cured and relapsed, who blazed the trails for me.

Edward

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I am happy for you and that's nice getting your letter. It does make me wonder if I will receive a cured letter. I received my 24 week test results several weeks ago and never received a cured letter after my 12 week results either.....

Mike
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I don't think everyone gets a letter. Some weeks ago I asked my study nurse if I might get one. I don't know if it's standard procedure at all hospitals. My doc wrote the letter on his hospital letterhead and it was short and to the point. During the process they were always kind enough to copy me with all the test results.

It's been a long journey for both of us and congratulations to you Mike.

Edward

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Oh I see, I was under the impression that it came from Gilead.

Mike
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Congratulations, Mike, on your 24 week clearance and cure of HCV.  Re the "cure letter", I asked my study coordinator in March if I would be getting one.  She advised that they do not issue such letters.  To get the cure on the record, I had my regular liver specialist order a viral load blood test that came back UNDET.
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