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Hep C Discussion Forum -> Clinical Trial Participants -> LoneStar-3
Post Info TOPIC: LoneStar-3
suziq


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RE: LoneStar-3
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Hi Browneyedgirl,

Since the next clinical lab tests are 4 weeks away--I, personally, would go to my local doctor and request a viral load test.  That would stop your worry and confusion for the next four weeks.  My GP did a viral load test for me back when I was trying to get on a trial.  It was part of my required medical records for the study center to get on the waiting list.  My insurance paid for it. My trial center uses Quest Labs.  

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 Browneyedgirl,

I wish Labs would standardize reporting. Log Units are old hat.  In all the reports I've seen using 'Target Not Detected' , this is said immediately after the number.  Log 1.18 is equal to 15 i.u./ml.  Your test has a LLOQ of 15, so my reading is that the Target was detected but could not be quantified. Change your Lab! Cheers.

 



__________________

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
Cinnamon Girl


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Hi Browneyedgirl, thanks for that information, and yes, it is confusing!  I`m not sure I`m qualified to comment on that result and I wouldn`t want to give you the wrong information, so I think it would be best for you speak to you doctor or tx nurse.  I expect mallani (Malcolm) would be able to give you an explanation too. 

All I can really say is that either the virus is undetected or else it`s detected but at levels too low to quantify by the Cobas test.  Either way, it looks very promising, in my opinion! 






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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.

 

 
Browneyedgirl


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Cinnamon Girl, The <1.81 was posted under heading of In Range as HCV log <1.81 HCV 10.2.0. Out of Range heading is where it said <15 Target Detected, and under Reference Range is said Target Not Detected, so you can see why this is confusing. They are using COBAS to measure. 

 



__________________

__________________________________________________

GT 1b, Early stage cirrhotic, Enrolled in the Lonestar-3  8wk study.  Previously treated in 1999'-2000 with interferon & ribavirin.  Bad memories. 
Cinnamon Girl


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Hi Browneyedgirl, it looks like your viral load of <1.18 is being expressed as a log number, which would be the equivalent of <15 IU/ml, which is the `lower limit of detection` if your lab is using the Cobas Taqman test.  The lower limit of detection means that the test isn`t able to measure any lower than that number, even though there could still be a quantity of virus left.

What exactly does it say on your lab report, is it `<1.18 detected`?

All your other numbers are looking great, and your blood counts are bound to be dropping a little.  You`re doing well!

 



__________________

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.

 

 
Browneyedgirl


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Received 4 week results:

VL  <1.18

AST 33

ALT 29

AFP 17.90 (H) - down from last of 77

Everything else looks good.  A little low on RBC, HGB, HCT & Platelets.

Disappointed not totally UND at 4 weeks.  Only 4 more weeks to go on meds and concerned if it will be enough.  Hoping for the best

 

 

 



__________________

__________________________________________________

GT 1b, Early stage cirrhotic, Enrolled in the Lonestar-3  8wk study.  Previously treated in 1999'-2000 with interferon & ribavirin.  Bad memories. 
suziq


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Looking good still.  I wasn't UND until week 4 so don't worry.  Still don't have my week 12 VL results yet.  Think the labs that do VL in Texas just shut down last week??? LOL..  I'm sure we will both do fine.  Great ALT and AST. 



__________________

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
Browneyedgirl


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Didn't get to call for week 2 results yesterday but got them today.

VL 41; AST 39; ALT 36

All still going down and that's good. 

Week 4 draw later this week.   

 



__________________

__________________________________________________

GT 1b, Early stage cirrhotic, Enrolled in the Lonestar-3  8wk study.  Previously treated in 1999'-2000 with interferon & ribavirin.  Bad memories. 
Browneyedgirl


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Thanks to all for the encouraging posts. 

Suziq,

8 week study schedule visits:

1x week for 3 weeks (Day 1 baseline then weeks 1,2)

2 weeks later for week 4  (12/13)

Then 4 weeks for EOT (1/10)

Please, Please let this be long enough on treatment.  I will definitely take <25 at end of week 2.  Hope I can post those results Monday eve.  

JoAnne - yes, no interferon - I would never do that again - so far this treatment has been great.  I do feel like my hair may be thinning a little but thankfully I have a lot.  It may just be in my head-but it does feel thinner and there seems to be more in the brush/floor/shower than usual; I lost a lot of hair when on interferon and the memory is still there. 

 

 

 



__________________

__________________________________________________

GT 1b, Early stage cirrhotic, Enrolled in the Lonestar-3  8wk study.  Previously treated in 1999'-2000 with interferon & ribavirin.  Bad memories. 
Cinnamon Girl


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Hi Browneyedgirl, that`s a great result after one week, nothing to worry about there!  And your liver enzyme levels are coming down nicely too.  Very encouraging indeed, best of luck with your week 2 results!  smile



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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.

 

 
newmex


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Congrats suziq, sounds great! Best wishes!!
And also congratulations and best wishes to you also, browneyed girl.!!!

-- Edited by newmex on Saturday 7th of December 2013 01:21:42 PM

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John
suziq


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Your results are fine.  I was still <25 at end of week 2.  Been UND since. So don't be upset if you are not UND yet. Many on the new drugs don't reach UND until week 4. Won't have my latest VL result (week 12) until next week.  Study center and probably the labs were closed Friday due to the "ice storm" here in Texas.

 How often do you do blood work on an 8 week trial?  We both have 6 more weeks. I go in on Dec 30 and then my EOT is Jan 14.  The waiting can be difficult. But, the new meds are getting great results and I expect the same for both of us.



-- Edited by suziq on Saturday 7th of December 2013 01:36:54 PM



-- Edited by suziq on Saturday 7th of December 2013 01:38:53 PM

__________________

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
JoAnneh


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Best wishes to You!
Did I read correctly 8 week with
No interferon! This could be answered
Prayer! Look forward to updates

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JoAnne

Genotype 1a, Triple therapy w/Invicek started May 19, 2012

DET 4 wk. UND 2,6,12,24 48 treatment. Achieved SVR 2013!
Tig


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All of your results are looking very good! I would be very hopeful as well that your next VL will be UND! It sure looks like you're headed in the right direction! Good luck and keep fighting!! smile



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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!

Hep C FAQ   Lab Ref. Ranges  HCV Resistance

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Browneyedgirl


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Went on Monday for week 2 visit and received week 1 results,  VL 266,  ALT 40,  AST 41 woohoo! 

Called to get week 2 results today but they didn't call me back disbelief.

Couple of months prior to study was VL 1.8M.

Baseline they said VL was  750,000  ALT 63, AST 76. AFP 77 (AFP had been higher but coming down)  Big fluctuations in VL throughout testing??

Hoping week 2 will be UND.  Will post when I find out.  They hardest part of this is the waiting for results.  Been doing great on meds.  Had a mild rash for a few days but that is it. 



__________________

__________________________________________________

GT 1b, Early stage cirrhotic, Enrolled in the Lonestar-3  8wk study.  Previously treated in 1999'-2000 with interferon & ribavirin.  Bad memories. 
suziq


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Hi Browneyedgirl,

I went to the Arlington study center.  They did my screening for Gilead and then found the Merck trial for me.  I live a little northwest of Waco so the Dallas/Ft Worth area was closer for me. Gilead has been having great results so I am optimistic that your trial will go well.  Today is the beginning of week 11 for me.  Won't go for labs again until Dec 3rd.  There were no results available in August from Merck, but my coordinator assured me that it was a good trial. 

I will be following you to see how you are doing.

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
Browneyedgirl


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Thanks to everyone for the well wishes and for the signature tip. 

Matt,  I have the same concern; I do hope 8 weeks are enough. I guess time will tell. Fingers crossed.  

Suzig, I was referred by my Hepatologist to a place in San Antonio. (I believe that maybe the place you went for the Gilead pretesting?)  I started going with the hopes and intent of getting in one of their studies and it paid off.  I was still trying for one closer to home and possibly could have gotten in a BMS study but not until Feb or March of next year.  I decide to go with the bird in the hand and will hopefully be UND by that time.  I've been following your adventure since day one and thrilled you are doing so well.

I guess I won't know anything for a few weeks but will post when I do.

 



__________________

__________________________________________________

GT 1b, Early stage cirrhotic, Enrolled in the Lonestar-3  8wk study.  Previously treated in 1999'-2000 with interferon & ribavirin.  Bad memories. 
suziq


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Welcome!

This is a great forum.

I am starting week 11 of a phase 2 Merck trial without interferon that posted great results at the ASSLD conference as well.  It is either 12 or 18 weeks.  I won't know until my week 12 appointment.  I am on 1200mg of ribavirin with my two study meds. This is the first study of these meds by Merck with cirrhosis. I read the results from the Lonestar trial while browsing the ASSLD info and probably considered it last Spring since I live in Texas--but think it had an upper age limit.  Didn't know I had cirrhosis until I was screened and given biopsy by Gilead last April. Rejected for that trial, but Merck has come to the rescue and accepted me.

I have few side effects--just lethargy and some itching--probably from ribavirin.  My Hbg has dropped, but not dramatically--just enough to lower my energy levels. I also have dry mouth--more annoying than worrisome.

I find a lot of good information here on the ION-3 thread.  That was a no interferon trial. 

Hoe did you get on a trial that was not posted??  I don't think my trial was posted either. I think it was a follow-up to the original trial and only the study centers/doctors were informed.  My coordinator called to tell me and ask if I was interested.  She already had all my medical records and biopsy results from my attempt to get in the Gilead trial.  I feel so fortunate !!

Keep us posted on how it goes.  My results are posted and updated in my signature.

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
Biggyb


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Welcome from me also, this is a awesome forum with lots of info, got me through 48 weeks of TX. Keep us posted on your journey. ~Bob



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58 yo..Relapsed in 99 and again in 2004. Started triple therapy with Victrelis July 22,2012.  genotype 1a. week 8,12,16,24 VL Undetectable..E.O.T -- 6-22-2013,,,EOT + 24., UND. 

SVR !!!

 

~Bob~
mallani


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Hi B-e-girl,

Just add to your 'Signature' in your profile. Cheers.



__________________

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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Hello Browneyedgirl

Welcome to the forum as well, you have found a great place for your jouney.

We look forward with great interest at following your progress with the Gilead triply combo Meds . That combo has had very good results with cirrhotic participants so you have found a very good trial I hope eight weeks will be long enough.

We would be happy to help in any way possible.

matt

 



__________________

"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! 
Browneyedgirl


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Thanks for the welcome, When I get some lab numbers I will post.
How do I add the reoccurring notes at the bottom of each post?


__________________

__________________________________________________

GT 1b, Early stage cirrhotic, Enrolled in the Lonestar-3  8wk study.  Previously treated in 1999'-2000 with interferon & ribavirin.  Bad memories. 
mallani


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Hi Browneyedgirl,

Welcome to the Forum. That's a good combination, and participants reported few side effects. You're correct, I hadn't seen an 8 week Phase 3 trial with this combo. Although the numbers were small, the Lonestar cirrhotics did well, so best of luck. Please keep us informed of your progress. Cheers.



__________________

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
Browneyedgirl


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New member and my first post. 

Gilead - LoneStar-3  Open Label Study of Sofosbuvir/Ledipasvir Combination with Ribavirin or GS-9669 250 mg or GS-9669 500 mg in Treatment Naïve or Treatment-Experienced Cirrhotic Subjects with Genotype 1 HCV.  (Not posted on clinical trials.)

Just started this study, my Day 1 visit on Friday and received meds.  I am genotype 1b, treatment experienced w/ mild cirrhosis.  I got on the arm with ribavirin (1000mg daily) for 8 weeks.  So far so good with meds just dry mouth and feel a little hyped - drinking lots of water. .    

Been reading post on this forum for a few months and am so glad that I found it.  You guys provide a wealth of information and really encouraged me to continue to try to get in a study with one of the new treatments now available.  I do have to travel 3 hours each way but willing to do so.  From results presented at the recent Liver Meeting in DC and post on this forum I am very optimistic. 

 



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__________________________________________________

GT 1b, Early stage cirrhotic, Enrolled in the Lonestar-3  8wk study.  Previously treated in 1999'-2000 with interferon & ribavirin.  Bad memories. 
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