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Hep C Discussion Forum -> Clinical Trial Participants -> Started - Gilead Sofosbuvir/Velpatasvir/GS-9857 Clinical Trial
Post Info TOPIC: Started - Gilead Sofosbuvir/Velpatasvir/GS-9857 Clinical Trial
Canuck


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RE: Started - Gilead Sofosbuvir/Velpatasvir/GS-9857 Clinical Trial
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Good one Tig, I borrowed it over to the other sof/vel/vox thread too. smile C.



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)
Tig


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Gilead Sofosbuvir/Velpatasvir/GS-9857 Clinical Trial
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I received this Gilead update regarding some trial results. It's short but sweet!

Gilead's Sov/Vel/Vox Update



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Tig

68yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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angelseven


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RE: Started - Gilead Sofosbuvir/Velpatasvir/GS-9857 Clinical Trial
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I checked with the Baylor girls in Houston and I missed it... they have already finished that trial they told me... but thanks, she now has a sticky note with my name on her monitor!!  for a reminder and I will keep bugging them,,,, LOL



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62 year old female      1a, f1-2, had virus 40 years   STARTED HARVONI for 8 weeks 11/19/14, relapsed one month after tx  ended in 1/15.  Fibrosis level was only .5 after fibroscan 12/15. Began treatment with Mavyret on January 20, 2018 for 16 weeks!  Ending May 12.
Tig


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angelseven wrote:

I understand this combo is for relapsers... what stage is the trial??  thanks

 Hi Star,

Nice to see you again! This is the Polaris trial and is in Phase 3 and recruiting. Here is the clinical trial info:

Polaris Trial



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Tig

68yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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angelseven


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Best of luck... I have no insurance for 3 years... so hopefully I can get on this when I get medicare and supplement... I relapsed after 8 weeks of first treatment with harvoni.... all labs good enzymes good, fibrosis almost not even there so I can wait, I have been waiting over 40years already... LOL



__________________

62 year old female      1a, f1-2, had virus 40 years   STARTED HARVONI for 8 weeks 11/19/14, relapsed one month after tx  ended in 1/15.  Fibrosis level was only .5 after fibroscan 12/15. Began treatment with Mavyret on January 20, 2018 for 16 weeks!  Ending May 12.
angelseven


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I understand this combo is for relapsers... what stage is the trial??  thanks



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62 year old female      1a, f1-2, had virus 40 years   STARTED HARVONI for 8 weeks 11/19/14, relapsed one month after tx  ended in 1/15.  Fibrosis level was only .5 after fibroscan 12/15. Began treatment with Mavyret on January 20, 2018 for 16 weeks!  Ending May 12.
Canuck


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Hey webtomass,

Nice to see your ALT/AST's steadily coming down! Looks very good. Happy you are keeping us updated.

tk36flex (also on similar trial - sof/vel 12 weeks) was able to post his VL at one week and at 4 weeks.

I am wondering why you are not able to post yours? Can you explain why? Are you not allowed to know them or post them? I did not really understand your comment below about "blockers/inlace".

I am still waiting to find out if I am going to be able to get in similar trail (sof/vel/GS-9857 8 weeks, or sof/vel alone 12 weeks).

Glad to hear your sides are manageable.  

Canuck



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)
webtomass


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Hi all,

A quick update from the Golden TGV Bullet Train that arrived at Week 4 gate on February 15. The service in first class has been tremendous so far.

PRIOR TREATMENT:

ALT: 65
AST: 54
Eosinophil 7.5 a little high (range:0.0-6.8)
Platelets 86 (Low)
HCV RNA: 336,000

WEEK 1

ALT: 55
AST: 50
Eosinophil 0.18 (normal range)
Platelets 100 (Low)
HCV RNA: Here's the kicker, study specifics blocker are inlace for subjects results BUT will know more next week.

WEEK 2

ALT: 49
AST: 38
Platelets 102
HCV RNA: Unknown

WEEK 4

ALT: 37
AST: 28
Platelets: 104
HCV RNA: UNKNOWN - specifics blockers are in place for subjects results. Week 8 visit on March 14.


Liver panels and everything else is in normal range, woohoo.
No side effects to report at this time other than what I'm already going through. Difficulty falling asleep, brain fog. Minor itching and rash on right legs all but disappeared. Drink lots of water no matter what treatment you are on CRUCIAL. Cheers. M



-- Edited by webtomass on Tuesday 23rd of February 2016 08:42:47 PM

__________________

Contracted 1980's - blood transfusion
F4 FibroScore 28 - Genotype 4 - VL 233,000 at beginning of treatment
Treatment: Sofosbuvir, Velpatasvir, GS-9857
Gilead clinical trial - NCT02607735
Start: 01/19/16
12 weeks treatment
Relapsed - Vieira Pak+Rib 2015
webtomass


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Hi JimmyK,

Jump on board, there's a nice seat beside me here in first class. What regiment are you going on exactly? I recall you talked about getting on the same clinical trial I'm on. 

P.S. Will be getting 1 month results today or tomorrow and will be posting them.

 

Cheers, M



__________________

Contracted 1980's - blood transfusion
F4 FibroScore 28 - Genotype 4 - VL 233,000 at beginning of treatment
Treatment: Sofosbuvir, Velpatasvir, GS-9857
Gilead clinical trial - NCT02607735
Start: 01/19/16
12 weeks treatment
Relapsed - Vieira Pak+Rib 2015
JimmyK


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Just informed I screen Monday.

 

You guys know me by now so do you want to seee something very strange?

 

JimmyK is speechless.



__________________

Harvoni TX 2 12 weeks. UND weeks 4, 12 and now EOT + 4 Weeks. SVR-12 09/29/16. All Glory, Honor and Thanks be to God.

"I go to war with the brothers I trust."
JimmyK


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Greetings and pardon my delay in saying welcome.

If the seat next to you is not taken, I would enjoy the company as I just received the same ticket. My Doctor just called and he is offering me the single trial for this compound here in Houston.

When I thanked him he said.

"No problem, I am willing to do anything to get you out of my office!" He then laughed and said this was by far the best and most promising possible treatment.

I am a bit stunned but very grateful.

Regards

 

JimmyK

 



__________________

Harvoni TX 2 12 weeks. UND weeks 4, 12 and now EOT + 4 Weeks. SVR-12 09/29/16. All Glory, Honor and Thanks be to God.

"I go to war with the brothers I trust."
Shadowfax


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Hey webtomass,

A delayed welcome from me and those numbers seem good as everyone said. All going in the right direction and no side effects. Sounds like a good way to slay this dragon.

Cheers



__________________

65 yo, GT1A, , Cirrhosis, F-Scan F4 33.5, TX Naive Harvoni 12 wks

SOT 2/9/16 / ALT 187 AST 114 VL 2.3M.    POSTS

EOT 5/2/16  ALT 35/ AST/25  platlets 126 C/B VL UND

EOT +12 7/26/16  ALT 25 /AST 22/ ALP 83  platlets 129 C/B VL UND

EOT + 24 10/18/16 ALT 27/ AST 20/ ALP 71 platlets 153 C UND

 * SVR *
Linuxter


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Hi Web2mass,

Those numbers all going in the right direction sure are encouraging, I think you won the lottery getting on this trial ... Nice!!

Best of luck going forward!!!

 

Linus



__________________

63yy,HCV,2b,F3-A1, Sof/Riba,12wks Tx   SOT: 1/20/16, HCV-RNA 9,816,581, ALT 56, Hb 14.6

4wk: HCV-RNA <15 Detected, ALT 15, AST 17, Hb 13.6 EOT: 4/12/16, ALT 18 , Hb 12.9176a2f85d05d9c965eafe199f2ba9ba5.jpg SVR Achieved 7/8/16

 
webtomass


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Hi Tig,

 

Thanks and agree with your words of wisdom :)

As for my rash on my right leg, its not even expose to the sun and am applying Gold Bond powder on it and when its really itchy I have a cortisone cream I use lightly. I had that happen on last treatment and resolve itself. I read stories on effect of sun while on these drugs... I do wear sunglasses all the time though. Cheers, M



__________________

Contracted 1980's - blood transfusion
F4 FibroScore 28 - Genotype 4 - VL 233,000 at beginning of treatment
Treatment: Sofosbuvir, Velpatasvir, GS-9857
Gilead clinical trial - NCT02607735
Start: 01/19/16
12 weeks treatment
Relapsed - Vieira Pak+Rib 2015
Tig


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Hey Michael,

Your test results are looking better each time, that's great. No side effects from it is even better! I'm not familiar with your protocol, but if you're developing a rash, you might want to avoid too much sunlight when you're out there blading away. Don't wear yourself out, this is the time to scale it back a little and let your body use all that energy for healing. Staying active is good, but don't overdue it during treatment if you can avoid it. Just an opinion.... Sounds like you're doing well, keep it up. smile



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Tig

68yo 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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webtomass


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Hi Cinnamon Girl,

You are right, these drugs act quickly and am quite happy with liver and platelet results so far. Best, M



__________________

Contracted 1980's - blood transfusion
F4 FibroScore 28 - Genotype 4 - VL 233,000 at beginning of treatment
Treatment: Sofosbuvir, Velpatasvir, GS-9857
Gilead clinical trial - NCT02607735
Start: 01/19/16
12 weeks treatment
Relapsed - Vieira Pak+Rib 2015
webtomass


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Thanks Guru,

Its looking good so far and feeling just fine. Abbie and others will take a beating once Sof. + Velpatasvir hit the market soon.



__________________

Contracted 1980's - blood transfusion
F4 FibroScore 28 - Genotype 4 - VL 233,000 at beginning of treatment
Treatment: Sofosbuvir, Velpatasvir, GS-9857
Gilead clinical trial - NCT02607735
Start: 01/19/16
12 weeks treatment
Relapsed - Vieira Pak+Rib 2015
webtomass


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Posts: 25
Date:
Permalink  
 

Thanks Mike for the support. I would like to know what treatment you will be getting on when it starts up. Cheers. M



__________________

Contracted 1980's - blood transfusion
F4 FibroScore 28 - Genotype 4 - VL 233,000 at beginning of treatment
Treatment: Sofosbuvir, Velpatasvir, GS-9857
Gilead clinical trial - NCT02607735
Start: 01/19/16
12 weeks treatment
Relapsed - Vieira Pak+Rib 2015
webtomass


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Posts: 25
Date:
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Hi,

Just to clarify, I'm in the trial arm referred to Deferred Treatment Subsidy group. About 100 in that arm and we are getting the treatment drugs. No placebo.

__________________

Contracted 1980's - blood transfusion
F4 FibroScore 28 - Genotype 4 - VL 233,000 at beginning of treatment
Treatment: Sofosbuvir, Velpatasvir, GS-9857
Gilead clinical trial - NCT02607735
Start: 01/19/16
12 weeks treatment
Relapsed - Vieira Pak+Rib 2015
webtomass


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Posts: 25
Date:
Permalink  
 

Hi all,

A quick update for now.

PRIOR TREATMENT:

ALT: 65
AST: 54
Eosinophil 7.5 a little high (range:0.0-6.8)
Platelets 86 (Low)
HCV RNA: 336,000

WEEK 1

ALT: 55
AST: 50
Eosinophil 0.18 (normal range)
Platelets 100 (Low)
HCV RNA: Here's the kicker, study specifics blocker are inlace for subjects results BUT will know more next week.

WEEK 2

ALT: 49
AST: 38
Platelets 102
HCV RNA: Unknown

Ending Week 4 Monday and doc. will have HCV RNA results back from week 2. Everything else is in normal range, Looking good.

I have no side effects whatsoever on this other than what I'm already going through. Difficulty falling asleep, brain fog, drugs do take their toll when I go out and blade around the park. Did over 50K last week and I was down and out. A little itching on legs with a light rash that doesn't seem to be getting worse. Drink lots of water. Cheers.



-- Edited by webtomass on Friday 12th of February 2016 11:41:42 PM



-- Edited by webtomass on Saturday 13th of February 2016 02:08:19 AM

__________________

Contracted 1980's - blood transfusion
F4 FibroScore 28 - Genotype 4 - VL 233,000 at beginning of treatment
Treatment: Sofosbuvir, Velpatasvir, GS-9857
Gilead clinical trial - NCT02607735
Start: 01/19/16
12 weeks treatment
Relapsed - Vieira Pak+Rib 2015
Mike


Veteran Member

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Posts: 95
Date:
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Hi Michael,
I'm not on treatment yet, however in the process of starting it up, it takes a while as you already know. I hope the very best for you while you are fighting the dragon. I've heard so many positive things about the new drugs coming out. Since you've been on this treatment ten days and no side effects, it is reasonable to assume your body is handling this well. Keep on posting info for us so we can discuss and support you at this time. Take care
Mike

__________________

1-18-16 referred to gastroenterologist;  AST 191 ALT 246, Viral Load 1,976,000, Alpha Feto Protein/Negative for Cirrhosis. Genotype 1 a. Tx began 3/9/16 Harvoni, 8-12 weeks

 
Zlikster


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Hi Michael,

thats a great trial to be on! Can't wait for your w2 results. How long with tx last? 6w, 8w or 12w?

With all respect to Abbvie, Viekira pak is a pretty weak response to competition (Gilead foremost). ****tail with Ritonavir as a booster definetly doesn't sounds like that DAA combo (Dasabuvir, Ombitasvir, Paritaprevir) is working enough on it's own. Sofosbuvir is much better NS5B inhibitor than Dasabuvir.

You gonna kick dragon's ass easy man. Sof+Vel on it's own, from previous clinical trials is a great combo, but you even have GS-9857 as NS3/4A inhibitor. I presume Gilead is exploring shorter version of tx with this combo (6-12w). Can't wait for your results! Enjoy the ride! :)


best



__________________

GT 3 dg. 08-2012 / FibroScan: 5 kPa F1 / FibroTest: F0-1 A1 / SoC TX: PegInt 120mcg+Riba 1000mg UND from w8 relapse EOT+4w
01-2016 Sof+Dac+Riba UND from w8, SVR24!
Cinnamon Girl


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Hi again, Michael, thanks for posting those results, they`ll be a good baseline for comparison as you go through your treatment.

The elevation in your liver enzymes, ALT and AST, shows that there`s some inflammation going on, which is what we`d expect to see with an active infection.  You do have low platelets but that`s not unusual with cirrhosis/advanced fibrosis.  You have a low viral load but that tends to fluctuate quite a lot anyway.

I`m sure you`ll see an improvement in those numbers once you get your first set of results, these drugs start working very quickly! 

Keep up updated...  smile



__________________

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.

 

 
webtomass


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Thanks Wendy, Jill, and Dave,

Here's the few blood panel readings I personally will be following carefully. These are from end of December before I started treatment. 

ALT: 65
AST: 54
Eosinophil 7.5 a little high (range:0.0-6.8)
Platelets 86 (Low)
HCV RNA: 336,000

HGB, HCT, RBC, WBC, and everything else in normal ranges. AFP is in normal range also.

Any feedbacks or comments greatly appreciated.

Cheers.

 



-- Edited by webtomass on Saturday 30th of January 2016 11:21:27 PM

__________________

Contracted 1980's - blood transfusion
F4 FibroScore 28 - Genotype 4 - VL 233,000 at beginning of treatment
Treatment: Sofosbuvir, Velpatasvir, GS-9857
Gilead clinical trial - NCT02607735
Start: 01/19/16
12 weeks treatment
Relapsed - Vieira Pak+Rib 2015
Cinnamon Girl


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Posts: 5629
Date:
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Hi Michael, welcome!  Good to see you here and congrats on getting on this trial, you should expect to do very well, this is a very powerful drug combo.

Thanks for introducing yourself to us in the New Members Area and for starting this thread for your updates, we`ll be very interested in following your progress.

Great to hear you`re having no side effects so far and I hope you have an easy ride to SVR. 

Wishing you all the best of luck this time around!  Please keep in touch! 

 



__________________

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.

 

 
wendyo


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Best of luck on the new TX and here's to continued no side effects. Keep us posted. 



__________________

Wendy 53 y/o, DX 1994, geno 1A F1

1999 TX 1 - Inter -non responder 2001 TX 2 - Peg + Riba - viral load tripled and taken off

T3:  Harvoni 12 weeks Sept. 19, 2015 ALT 41 AST 30 VL 541800 UND at EOT and SVR 24 ALT 18 AST 26 platelets 223

 
webtomass


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Thanks Dave,

I'll call it the Nuke Option Train :). After exhaustive reading of these 3 compounds, I believe it will do the trick and exterminate any vermin roaches roaming around. The good news is that so far I'm feeling absolutely no side effects from this combo. I might add that I'm in excellent physical condition and do endurance running/inline skating. Helps lots. 



__________________

Contracted 1980's - blood transfusion
F4 FibroScore 28 - Genotype 4 - VL 233,000 at beginning of treatment
Treatment: Sofosbuvir, Velpatasvir, GS-9857
Gilead clinical trial - NCT02607735
Start: 01/19/16
12 weeks treatment
Relapsed - Vieira Pak+Rib 2015
Linuxter


Guru

Status: Offline
Posts: 1515
Date:
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Hi Web2mass,

Welcome to the forum!

That's a wicked (in a good way) combination you're taking.

I'm sure you'll be hearing from TK, he's moving through Tx right now via the Silver Bullet Train (at least that's what I'm callin' it).

Best of luck and welcome aboard!

 

Dave



-- Edited by Linuxter on Saturday 30th of January 2016 03:13:27 AM

__________________

63yy,HCV,2b,F3-A1, Sof/Riba,12wks Tx   SOT: 1/20/16, HCV-RNA 9,816,581, ALT 56, Hb 14.6

4wk: HCV-RNA <15 Detected, ALT 15, AST 17, Hb 13.6 EOT: 4/12/16, ALT 18 , Hb 12.9176a2f85d05d9c965eafe199f2ba9ba5.jpg SVR Achieved 7/8/16

 
webtomass


Member

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Posts: 25
Date:
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Hi Everyone,

New treatment - 2nd. round: Sofosbuvir, Velpatasvir, GS-9857. 1 pill a day with food. I'm in the Deferred Treatment Substudy. This will be the one for all genotypes that will hit the market later this year or early next year I assume.

Its been 10 days and no side effects whatsoever. Vieira Pak + Ribavirin treatment relapsed @ 12 weeks EOT this past fall. Hopefully this one does its magic. I'm doing all I can on my own but need this. Anybody else failed to cure on Viekira Pak? Feedback or insight from anyone would be gratefully appreciated.

 



__________________

Contracted 1980's - blood transfusion
F4 FibroScore 28 - Genotype 4 - VL 233,000 at beginning of treatment
Treatment: Sofosbuvir, Velpatasvir, GS-9857
Gilead clinical trial - NCT02607735
Start: 01/19/16
12 weeks treatment
Relapsed - Vieira Pak+Rib 2015
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