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Post Info TOPIC: ION-3 trial


Senior Member

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RE: ION-3 trial
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HI RH...12 weeks will be over before you know it:)  All the best!



__________________

Geno Type A1- VL 16.2m - F1-F2 Moderate Fibrosis - Started treatment 4/16/13 Sofosbuvir/Ledipasvir 6 months -  UND week 4 (5/14/13) - EOT 10/1/13 - 12wk blood draw 12/20/13 UND - 24wk/final blood draw March 2014

HR


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Hello everyone,

 I was assigned to the 12 week arm. I took my first pill this morning and feel fine. I won't get my baseline vl until next week but will update as soon as I do. I asked what my screening vl was and was told 9mil. Thats quite a ways off from the 43mil vl I received back in March from my primary dr. At any rate I feel blessed right now.

Take care

RH



__________________

ION-3 Trial- Sofosbuvir/Ledipasvir 12 weeks.. UND 4 weeks, relapsed 12 week EOT. 

3-4 on Ischank scale

 

Retreat ION-3 Trial- Sofosbuvir /Ledipasvir 24 weeks

GT-1 (1-31-14) Week 1 VL 62 -Week 4,8,12,16,20 UND EOT 7-18-14



Guru

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REG wrote:

Hello all -

I just started on ION-3 last thursday and wanted to share my experience to give everyone here some positive news and hope.  I am on the 12 week arm (no Ribavirin) and have had almost no side effects.  If my SVR comes down as expected I see this as a true miracle pill for anyone who has Hep-C.  I am stage 1, with an initial viral load of about 4M, but have had Hep-c for about 28 years.  

 

I will post again as I know more.


 Hi REG, welcome!  Great to hear you`ve started this trial, we`ll look forward to following your progress.  If you`d like to start a new thread (`start a new topic`) you could post your updates as you go along. 

Best of luck, and keep in touch!  ~ Jill

 



__________________

Jill 

(70 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.

 

 



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RH / REG...Congratulations on getting on this trial.  I am on Sof/Led 24 weeks-4 weeks in... UND!  Very promising.



-- Edited by Karen on Tuesday 28th of May 2013 11:28:24 PM

__________________

Geno Type A1- VL 16.2m - F1-F2 Moderate Fibrosis - Started treatment 4/16/13 Sofosbuvir/Ledipasvir 6 months -  UND week 4 (5/14/13) - EOT 10/1/13 - 12wk blood draw 12/20/13 UND - 24wk/final blood draw March 2014

HR


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Thats great news!!!!! I start tomorrow at 10am and am very glad to hear that you are feeling well. Please keep posting as I want to know how you progress and I will do the same.

RH



__________________

ION-3 Trial- Sofosbuvir/Ledipasvir 12 weeks.. UND 4 weeks, relapsed 12 week EOT. 

3-4 on Ischank scale

 

Retreat ION-3 Trial- Sofosbuvir /Ledipasvir 24 weeks

GT-1 (1-31-14) Week 1 VL 62 -Week 4,8,12,16,20 UND EOT 7-18-14

REG


Newbie

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Hello all -

I just started on ION-3 last thursday and wanted to share my experience to give everyone here some positive news and hope.  I am on the 12 week arm (no Ribavirin) and have had almost no side effects.  If my SVR comes down as expected I see this as a true miracle pill for anyone who has Hep-C.  I am stage 1, with an initial viral load of about 4M, but have had Hep-c for about 28 years.  

 

I will post again as I know more.



__________________
HR


Senior Member

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Thanks Millani



__________________

ION-3 Trial- Sofosbuvir/Ledipasvir 12 weeks.. UND 4 weeks, relapsed 12 week EOT. 

3-4 on Ischank scale

 

Retreat ION-3 Trial- Sofosbuvir /Ledipasvir 24 weeks

GT-1 (1-31-14) Week 1 VL 62 -Week 4,8,12,16,20 UND EOT 7-18-14



Guru

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Hi RH and Matt,

The METAVIR scoring system gives scoring between 0 and 4. This is the most common system in clinical practice.

The Trial is using the ISHAK or revised KNODELL score, where a score of 6 is cirrhosis. ( range 0-6). This is the most common test for research or Clinical Trials.

 

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1856155/



__________________

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

HR


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I didn't mean to post all of that. I was trying to just post the very bottom part.

Sorry



__________________

ION-3 Trial- Sofosbuvir/Ledipasvir 12 weeks.. UND 4 weeks, relapsed 12 week EOT. 

3-4 on Ischank scale

 

Retreat ION-3 Trial- Sofosbuvir /Ledipasvir 24 weeks

GT-1 (1-31-14) Week 1 VL 62 -Week 4,8,12,16,20 UND EOT 7-18-14

HR


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DIAGNOSIS OF FIBROSIS.

The complete evaluation of a patient with diffuse liver diseases requires clinical evaluation, laboratory tests, and pathological examination. The liver biopsy is regarded as the historical gold standard for diagnosis and assessment of prognosis in CLD.[28,29] At least three scoring methods are commonly used to stage liver fibrosis: the Knodell, Ishak, and METAVIR scores.[30,31] The Knodell and METAVIR score fibrosis from stage 04, with stage 4 as cirrhosis, whereas Ishak scores fibrosis from 06 where 5 is incomplete or early cirrhosis and 6 indicates established cirrhosis.[32] These methods are semi-quantitative and the invasiveness of liver biopsies with its associated life-threatening risks and morbidity make it a poor choice when considering assessment of liver fibrosis progression or regression. Furthermore, there is the issue of sampling error, defined as variable levels of fibrosis throughout the liver, with biopsy only examining a small (1/50,000) portion of the liver.[33,34] Liver biopsy has been shown to have significant inter and intraobserver variability among pathologists, with an average 20% error rate in the staging of fibrosis.[35] The minimum suitable length of liver tissue needed for assessing liver fibrosis reliably is 25 mm and the presence of an experienced hepatopatholgist is important.[34



-- Edited by Cinnamon Girl on Wednesday 29th of May 2013 10:46:14 AM

__________________

ION-3 Trial- Sofosbuvir/Ledipasvir 12 weeks.. UND 4 weeks, relapsed 12 week EOT. 

3-4 on Ischank scale

 

Retreat ION-3 Trial- Sofosbuvir /Ledipasvir 24 weeks

GT-1 (1-31-14) Week 1 VL 62 -Week 4,8,12,16,20 UND EOT 7-18-14

HR


Senior Member

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Hey Matt 

I called down there to the trial lady after your post earlier and she confirmed that the scoring model is 0-6.



__________________

ION-3 Trial- Sofosbuvir/Ledipasvir 12 weeks.. UND 4 weeks, relapsed 12 week EOT. 

3-4 on Ischank scale

 

Retreat ION-3 Trial- Sofosbuvir /Ledipasvir 24 weeks

GT-1 (1-31-14) Week 1 VL 62 -Week 4,8,12,16,20 UND EOT 7-18-14



Guru

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Hey RH

Here is a chart based on the normal Z.D. Goodman Journal Of Hepatology

Grading Chart copy.jpg



Attachments
__________________

"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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Thanks Jill!
Cinnamon Girl wrote:
Caryn wrote:

They did have the same study in San Antonio for previous treaters with a protease inhibitor, but when I emailed about it the coordinator said it was closed. I wish I could find results for that study!!


Hi Caryn, yes, the earlier phase 2 `Lonestar` trial included 2 arms for people who had previously been treated with a protease inhibitor. As far as I`m aware Gilead have only released interim results from that trial so far, and that was basis for their decision to proceed with ION-3. You`ll find the summary of the results so far in this article...

http://www.hepctrust.org.uk/News_Resources/news/2013/May/Gilead+announces+3rd+phase+3+trial+of+all+oral+pill

Something will come up for you eventually, keep looking!


 



__________________

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!

HR


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I'm not sure what score system they are going by. I would think they would all be pretty much the same. I was driving down the highway when she was telling me all this. Any thoughts about there not being anything hard in my liver? Of course this information isn't coming from the Dr. I will find out more next Wednesday and clarify.



__________________

ION-3 Trial- Sofosbuvir/Ledipasvir 12 weeks.. UND 4 weeks, relapsed 12 week EOT. 

3-4 on Ischank scale

 

Retreat ION-3 Trial- Sofosbuvir /Ledipasvir 24 weeks

GT-1 (1-31-14) Week 1 VL 62 -Week 4,8,12,16,20 UND EOT 7-18-14



Guru

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Hey RH

Congrats on being accepted into the ION-3 program.

Your biopsy staging report is somewhat baffling because most standard rating for being cirrhotic is stage 4.

Perhaps your trial is using a different standard or number rating system.

Will try to post a regular / standard rating system later.

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! 

HR


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Got a little news today.The biopsy results were stage 3-4 and there wasn't any hard spots. The trial coordinator said 5-6  are cirhhosis. At any rate I will be starting the meds next Wednesday. When I go to my appointment next Wednesday they will punch my name into the computer and it will let us know which arm I'm on.

Thats all I got for today.

Thanks

RH



__________________

ION-3 Trial- Sofosbuvir/Ledipasvir 12 weeks.. UND 4 weeks, relapsed 12 week EOT. 

3-4 on Ischank scale

 

Retreat ION-3 Trial- Sofosbuvir /Ledipasvir 24 weeks

GT-1 (1-31-14) Week 1 VL 62 -Week 4,8,12,16,20 UND EOT 7-18-14



Guru

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Date:
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Caryn wrote:

They did have the same study in San Antonio for previous treaters with a protease inhibitor, but when I emailed about it the coordinator said it was closed. I wish I could find results for that study!!�


�Hi Caryn, yes, the earlier phase 2 `Lonestar` trial included 2 arms for people who had previously been treated with a protease inhibitor. � As far as I`m aware Gilead have only released interim results from that trial so far, and that was basis for their decision to proceed with ION-3.� You`ll find the summary of the results so far in this article...

http://www.hepctrust.org.uk/News_Resources/news/2013/May/Gilead+announces+3rd+phase+3+trial+of+all+oral+pill

Something will come up for you eventually, keep looking!



__________________

Jill 

(70 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.

 

 



Senior Member

Status: Offline
Posts: 305
Date:
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They did have the same study in San Antonio for previous treaters with a protease inhibitor, but when I emailed about it the coordinator said it was closed. I wish I could find results for that study!! 



__________________

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!

HR


Senior Member

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Hello

I want to clarify something. When I said "group", I was referring to the entire ION-3 study. I haven't been assigned to 1 of the 3 groups on this study. My understanding is that the first day of meds you will be assigned to 1 of the 3 groups. Sorry if I confused anyone.

Thx



__________________

ION-3 Trial- Sofosbuvir/Ledipasvir 12 weeks.. UND 4 weeks, relapsed 12 week EOT. 

3-4 on Ischank scale

 

Retreat ION-3 Trial- Sofosbuvir /Ledipasvir 24 weeks

GT-1 (1-31-14) Week 1 VL 62 -Week 4,8,12,16,20 UND EOT 7-18-14



Guru

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Hi RH,

ION-3 is only for treatment-naive non-cirrhotics. There are 600 patients in the Trial. 200 will get Sof. and Led. for 8 weeks, 200 will get Sof.,Led. and Riba for 8 weeks, and 200 will get Sof. and Led. for 12 weeks.

Should be interesting but I'm not impressed that cirrhotics are excluded.  Good luck with the biopsy results.



__________________

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

HR


Senior Member

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Hey Matt The group that I'm in you can't have cirhhosis . That is the only thing in my group that will disqualify a person. Or at least that's what I was told. However when we went through screening it seemed like they took 10 different vials of blood. Maybe they will find something in the blood tests that could disqualify a person. I didn't think of that until now. I may give them a call and ask the question" Am I in if I don't have cirhhosis ?"

__________________

ION-3 Trial- Sofosbuvir/Ledipasvir 12 weeks.. UND 4 weeks, relapsed 12 week EOT. 

3-4 on Ischank scale

 

Retreat ION-3 Trial- Sofosbuvir /Ledipasvir 24 weeks

GT-1 (1-31-14) Week 1 VL 62 -Week 4,8,12,16,20 UND EOT 7-18-14



Guru

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Date:
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Hey RH

Know what its like going through a trial qualification.

In my Abbott study the biopsy was the last hoop we had to jump through,  then if the doctors and the study people like your results your likely will begin. 

Keep on top of the program qualification parameters, the more you understand about your results the better position you can be in controlling your future.

Hoping the best you 

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! 

HR


Senior Member

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Dr said the cure rates were really high on this trial.95 percent is what he said. As far as my vl being high he didn't say anything about that or did I ask him about that. There was another guy that had his biopsy before me and he told me his vl was 56 mil. So if my biopsy comes back with no cirrhosis we will find out how much the vl drops in week 1,2,4,6,8 and maybe 12. I will be sure and update each step. Thanks

__________________

ION-3 Trial- Sofosbuvir/Ledipasvir 12 weeks.. UND 4 weeks, relapsed 12 week EOT. 

3-4 on Ischank scale

 

Retreat ION-3 Trial- Sofosbuvir /Ledipasvir 24 weeks

GT-1 (1-31-14) Week 1 VL 62 -Week 4,8,12,16,20 UND EOT 7-18-14

HR


Senior Member

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The biopsy was a breeze. Dr Lawitz did a great job. I'm going to call next week to see if my results are in. Dr said

__________________

ION-3 Trial- Sofosbuvir/Ledipasvir 12 weeks.. UND 4 weeks, relapsed 12 week EOT. 

3-4 on Ischank scale

 

Retreat ION-3 Trial- Sofosbuvir /Ledipasvir 24 weeks

GT-1 (1-31-14) Week 1 VL 62 -Week 4,8,12,16,20 UND EOT 7-18-14



Guru

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Hi Rh,

Wishing you all the best in this trial, I really hope it goes well. I think a lot of us are very interested in how this goes, especially on such a high VL. I hope the biopsy went well.

L



__________________

Genotype: 3b

VL.�over 15, 000 000

Failed TX 2014: Interferon/Riba.

Cured using Sof/Dak combination.

I can eat cake again! <3 



Guru

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Hi RH, how did the biopsy go for you yesterday?  Hope all went smoothly.



__________________

Jill 

(70 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.

 

 

HR


Senior Member

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Just got done with the initial screening. If you haven't had a biopsy in the last 3 years you must get one. I'm scheduled for next Wednesday. If all goes well there I will start the meds on the 29th. I wil update as this goes along.

Thanks



__________________

ION-3 Trial- Sofosbuvir/Ledipasvir 12 weeks.. UND 4 weeks, relapsed 12 week EOT. 

3-4 on Ischank scale

 

Retreat ION-3 Trial- Sofosbuvir /Ledipasvir 24 weeks

GT-1 (1-31-14) Week 1 VL 62 -Week 4,8,12,16,20 UND EOT 7-18-14



Guru

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Hi and welcome, Tanita!  I haven`t found it listed yet either, although it`s only been announced very recently.   Are you having your hep c monitored regularly by a GI or hepatologist?  If so, they should be up to date with available trials in your area.  Best of luck, let us know how you get on.  ~ Jill



__________________

Jill 

(70 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.

 

 



Newbie

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Posts: 1
Date:
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Hi all. I just went to clinicaltrial.gov but I guess this trial is not posted yet. Any idea if there is another site to check if they are recruiting? I've never done a trial before. I was waiting for something like this for a while.

__________________


Guru

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Good luck RH,



__________________

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~



Senior Member

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You are very lucky to be on this trial! They had this trial in San Antonio Texas, but the coodinator emailed me back and said it was closed, plus it was only a week after stopping all of my triple therapy. Good luck!!!!



__________________

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!



Senior Member

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You're the first I've heard from on this specific trial. Good for you! The Sof is a miraculous drug. Thanks for posting. I'll be watching for updates! Karen:)



__________________
Diag 8-10. 1st VL 600,000. Gen 1a. Grade 4 Stage 4 cirrhosis w/ Esophogeal varices level 2. Viral load 1,750,000 7/12/10. Triple Therapy w/ Telaprevir began 7-15-11


Guru

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Hi and welcome, RH.

That's a great Trial to get on and you should do well. Keep us posted. 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

HR


Senior Member

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Hello everyone,

I have been reading these forums for a while now and decided to join and share my experiences as I hopefully pass the screening on Thursday for the ION-3 trial.

ION-3  3 arm- open label

8 weeks of Sof/Led

8 weeks of Sof/Led + Rib

12 week of Sof/Led

Hopefully all goes well as they've had my medical records for over a month.

The last time I had my VL tested I was at 43mil.

I will update as I get more news.

Thanks



__________________

ION-3 Trial- Sofosbuvir/Ledipasvir 12 weeks.. UND 4 weeks, relapsed 12 week EOT. 

3-4 on Ischank scale

 

Retreat ION-3 Trial- Sofosbuvir /Ledipasvir 24 weeks

GT-1 (1-31-14) Week 1 VL 62 -Week 4,8,12,16,20 UND EOT 7-18-14

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