Hep C Discussion Forum

Tig · Admin

RE: Astral 1 trial

robertsamx · Guru

Good news Mark. eot + 24 is the new gold standard !! You did it . It sounds like all things in your life are looking up. All the mental weight and anxiety ZAPS us before-during-after treatment. Sort things out and go back to work on YOU. Please stop in now and then and let us know how you are doing C-FREE. I want to drop one little tid-bit if I can. My wife RAGDOLL just got the call monday that she is also EOT-24 UND. She did abbvie trial. the V-Pac. Take care Mark RC

Marktq1 · Member

That's it then EOT 24 virus clear just got the official confirmation cannot beleive it

ALT 17 AST 28. ALP 108 Bilurubin 21 didn't check platelects will not get previous viral load results and reason for retest until trial results published which I'm told will be next year had a fibroscan at the unit she had a hard time took her a long time my readings covered a wide range from 12 to 40 plus she tried different probes and several sets of 10 or so readings came up with score of 21

my CAP SCORE Inoticed was 367 if I rember correct and fatty liver can cause a reading up to 10 kpa higher according to new research also Alt over 100 causes a 2kpa increase So not sure how to evaluate result other than I am still clearly cirrhotic

the same week I was passed back to my local hospital to their care they did bloods not got results yet offered me another fibroscan on their machine said I was indeed an awkward bugger to scan wide range again 8.5 to 38 ended up with score of 18.5

So whist my liver is obviously in better shape the cirrhosis seems pretty much the same told in a year to 18 months will be the time to see if improvement has hhappened one worry is my hospital only intends to ultrasound me yearly the research center said to insist on 6 monthly and make a fuss if I have to but was told although the nhs guideline is all cirrhotics must be offered 6 month scans they simply cannot do iit however while booking my ultrasound appointment ( been a year now) they said problem not with them they are happy to do 6 monthly if that is ordered by doctor don't know what to do or how vital it is

Just want to finish off with an overview of my experience of Sov/GS5816

during treatment probably no side effects at all more aches to a degree but I'm nearly 61 doing gardening walking etc and going to the gym so I expect that

gradual improvement in wellbeing accelerating after treatment more so in last couple of months appitite back no nausea depression 10 times better started gym weariness gone stamina improving starting to plan things I want to do /achieve all in all I feel better now than I had even hoped for at beginning of treatment And that is far and away the most important thing fibroscan a little disappointing as is the fact my billuribin is still high and has in fact gone up but maybe in time

Sorry about the long post hopefully the info may be of interest to someone

-- Edited by Marktq1 on Thursday 23rd of July 2015 11:25:37 AM

-- Edited by Marktq1 on Thursday 23rd of July 2015 11:30:31 AM

Tig · Admin

Hi Mark,

Thanks for that update. It certainly appears that the Sovaldi/GS5816 combo is going to be the next big weapon in our war on the Dragon.

For those unaware of this combo, here's a link to a Gilead Press Release From January.

http://www.gilead.com/news/press-releases/2015/1/gilead-expands-hepatitis-c-generic-licensing-agreements-to-include-investigational-pangenotypic-agent

Marktq1 · Member

Just thought I'd post some info about GS5816

the Astral trials are all now just waiting for the SVR12 and SVR24 results to come in

For all 3 trials primary completion is when the SVR12 results are complete and study completion is when the SVR24 results are in

Study completion date for Astral 1 (all genotypes 12 weeks treatment with Sof/GS5816 v placebo) is Feb 2016 Primary completion date is Oct 2015

Study completion for Astral 2 ( genotypes 2 12 weeks Sof /GS5816 v 12 weeks SOS/GS5816+Ribarvarin is ) Aug 2015 Primary completion is June 2015

Study completion for Astral 3( genotype3 12 weeks Sof/GS5816 v 24 weeks sof + Ribarvarin ) is Feb 2016 Primary completion is Dec 2015

If Gilead apply for Aprooval for genotype 2 first it may be available this year?

otherwise mid to late 2016 for all genotypes if aproved seems ppossible also I noted this from the Vienna 2015 liver congress which may be of interest to any that have failed on Harvoni or other DAA combos

It is the results of a phase 2 study os Sof/GS5816+GS9857 hopefully the ne t blockbuster in Gileads seeming conveyor belt of treatments

Presented as a late-breaker ePoster (ePoster #LP03), a Phase 2 study of triple-combination therapy with a fixed-dose combination of SOF/GS-5816 plus GS-9857 among genotype 1 patients demonstrated sustained virologic response (SVR12) rates following six weeks of treatment of 93 percent (n=14/15) among treatment-naïve, non-cirrhotic patients, 87 percent (n=13/15) among treatment-naïve, cirrhotic patients, and 67 percent (n=20/30) among those who had failed therapy with two or more direct-acting antiviral agents (DAAs). The four-week regimen resulted in a sub-optimal SVR12 rate of 27 percent (n=4/15).

The 67% rate for people who have failed treatment with two or more DAAs looks promising especially considering that it is a 6 week course I wonder if that could be improved over 8 or 12 weeks

The 4 week SVR results are however a bit naff. Can't have everything

Hope this may be of interest to some

robertsamx · Guru

Very good news on you Mark. Way to hang in there! Its good to see the results on Velpatasvir (gs-5816). When this new drug gets FDA aproved it's going to cure a lot of us hard to cure folks, thanks for forging the way with 5816. Keep us informed on your progress and how your feeling. Happy Happy for you. RC

Tig · Admin

Hi Mark,

Congrats!!! That's great news! I know how thrilled you must be right now. You need to control yourself though, doing back flips like that might hurt you, lol!

You are the only one here to do the Sov/GS5816 (trial) combo to my knowledge. I'm glad the sides were minimal. I had heard it was both extremely effective across all genotypes and tolerable. I'm interested to hear more about your journey.

I hope (believe) your stamina will return in time. Nothing happens quickly after treatment, except the joy of SVR! The exercise will help get you moving and increase your strength.

Funny you mention your eyes feeling gritty. My eyes have felt that way ever since I completed treatment. Might just be me getting old and crusty too! The lubricating eye drops have been a blessing, try them if you haven't already. The unmedicated kind btw...

Time to enjoy life! Good luck....

Marktq1 · Member

Just got a call from my hep c nurse after the 12 week EOT test told me Gilead want me back for the 24 week EOT tests which means I was not on the placaebo and am virus clear and that they now consider clear at 12 weeks as cured .... 0.2 % chance of relapse she said

No LFTs this time tho but there will be at week 24 and I can have a fibroscan then if I want myself I am feeling a lot more energy not listless at all but no stamina get tired just as fast but my head is in a much better place GP HAS referred me for 10 weeks gym sessions twice a week so maybe that will help my stamina

hard for me to believe I am virus free especially after the week 6 scare when a retest was asked for maybe at week 24 I will find out what that was all about

To sum up for anyone who is interested in Sovaldi/GS5816 I experienced no side effects or such little ones that I could not tell if they were the drug or hep C

Since treatment brain fog gone enery back depression much better nausea gone

As I said stilll poor stamina do not get tired during the day tho

More back pain but this may well be me trying to do more now and I do have a condition called sacroitis or so a doctor says

Also I seem to get a slightly dry gritty feeling in the eyes at time not a biggie probably not related to treatment

For me this treatment could not have been better hope when results are published they meet up to the expectations that researchers have for it and that it becomes available as soon as possible

-- Edited by Marktq1 on Monday 27th of April 2015 10:07:45 AM

Tig · Admin

Hi Mark,

Your numbers do look good! I agree that your bilirubin at this stage is unimportant. It's common to see bilirubin elevations during treatment.

Regarding your lung function, I don't see mention in your post about your hemoglobin level. It's possible that you're experiencing a lower than normal Hgb and that is directly related to the bloods ability to carry oxygen to the lungs. Less oxygen, means lower than normal strength and stamina. See if you can find out what that is. It may help explain your issue. Search the effects of anemia on strength for more info.

I must agree that with the significant drop in your enzymes and simply by the way you're feeling, you are likely on the active protocol. Once treatment is finished and provided you achieve SVR, many things can and most often do improve. But it takes time for that to occur. It won't be overnight but you will see improvements in many areas. Good luck...

Tig

PS: Yes, HCV can affect your strength during the chronic phase of activity. Especially after years of infection. That is one symptom (Hepatic manifestation) that is a signal to many doctors to test for it.

Marktq1 · Member

Just got my LFT results 4 weeks EOT

ALT 24. AST 31. ALP 103. Platelets 113 Billirubin. 19

my nurse says that's all good news. She said not to worry about the platelet count and my billirubin level they wouldn't expect big changers there yet

Of coarse I may be on the placaebo but they tell me that is most unlikely

next test in 8 weeks time get unblinded tthe

Quick question does anyone know if there is a link between lung function and hep c or cirrhosis

I ask as my stamina has been slowly decreasing these last few years walking on the level household tasks are ok but if I walk up a moderate hill I am like a fish out of water

have checked my forced experitary. Reading occasionally. Was 650 2 year ago was 500 last year now is 400

just wondering if this drop is due to liver damage and if it is can I expect it o improve now I?

-- Edited by Marktq1 on Friday 27th of February 2015 03:26:44 PM

Cinnamon Girl · Guru

Hi again Mark, good to hear you`ve finished your trial now. well done!

Those lab results look great! And definitely a very good indication that you`ve been on the real meds and not the placebo arm.

As long as the virus is not longer detectable and stays that way then it`s quite possible that over time your cirrhosis will improve in which case that could eventually be reflected in the ALT/AST ratio as it has a direct correlation to the level of liver damage.

I`d be surprised if your viral load does start to increase now but if that were the case then it would show up quite quickly, and certainly by week 16 when your next viral load test is due. Let`s hope that`s not the case though!

Great to hear that you`re already feeling less tired, and as long as you`ve cleared the virus then I would expect your energy levels to continue to increase over time.

All in all I would say it`s sounding very promising for you, Mark! Thanks for sharing your journey with us and we`ll be looking forward to your next update.

Best of luck! ~ Jill

Marktq1 · Member

treatment finished now just got week 12 LFTs ALT IS 27 AST IS 36 and ALP is 91 all down from week 8 ( my AST at week 8 was 37 not 31 as I had thought These look good to me tho I wonder about the AST/ALT ratio if my cirrhosis were to improve wouldn't that ratio alter?

next test is week 16 I guess that is a big one

I am wondering if viral load starts to increase how soon is that reflected in your LFTs?

Doctor says retest request after week 6 must just have been a blip so that explains everything !

Doctors and my nurse all say they are 100% sure I am on the sof/gs5816 not the placebo

I would say my treatment went pretty much with no side effects at all and no problems since EOT tho it has only been 5 days the nurse says that is what most people are finding

my enery tho not as bad as it once was is still low and I feel very weak when I do anything

can I expect this to improve?

Mark

-- Edited by Marktq1 on Friday 30th of January 2015 09:39:19 AM

Matt Chris · Guru

Hello Mark

Hang in there Mark, things like this always happens with clinical trials. I been in your shoes, so know its nerve racking so you are going to have to tough through it the best you can. Really most of the time the trial sponsors will find a way for its patients to complete its study its in there best interest to have all its trialist complete the 12 weeks.

As longer your LFT (ALT & ASt) remain low its likely you are still UND.

matt

robertsamx · Guru

Good news Mark. Everyone is pulling for you, way to keep your cool !! I know it wasent easy for you to stay focused during the questionable time in the trial. I'm really happy for you. RC

Tig · Admin

Hi Mark,

That's good news (no news) and a relief for you I'm sure! Certainly no reason to feel silly when you're going through the things this treatment has brought to your life. The kids are always going to present their own circumstances, so combined with yours, it's no wonder you were feeling a bit dicey! BP looks good now, keep up the good attitude and all will work out fine! Good luck...

Tig

Marktq1 · Member

Just had a call from the trial nurse Gilead have said continue with trial ,I'm in the last 2 weeks now

No reason given for the retest nurse says may have been a false positive but more likely a problem with the sample whatever the reason this a terrific relief for me

I fel a bit silly really was sure I wasn't feeling quite as well as I had been ignoring the fact that all my children and gran kids have been down with winter bbugs also regards the carvadilol my anxious feelings have diminished over the last half hour , seriously though I have just increased to 12mg in morning and 6 mg at night BP AROUND 110 over 80

If I get no side effects and BP stays low think I will stick with carvadilol rather than switch to ace inhibitor

mallani · Guru

Hi Mark,

Great ALT/AST numbers.

Beta-blockers, like propanolol and Carvadilol are often used in cirrhotic patients who have developed varices from portal hypertension. The reasoning is to try to reduce the portal venous pressure, making bleeding less likely.

There is no evidence that taking beta-blockers reduces the chance of a cirrhotic patient developing varices. In your case, cirrhotic but no varices, they are not indicated. If your spleen is enlarged, you undoubtedly have a degree of portal hypertension, and probably need yearly gastroscopies until you achieve SVR.

I would wear a 24 hour BP monitor before I accepted a diagnosis of hypertension, requiring treatment. If you do have hypertension, there are much better drugs than beta-blockers (ACE inhibitors and Calcium channel blockers).

Beta-blockers reduce the heart rate, and a rate of 40-60 bpm is usual.

I'm surprised by your reaction to propanolol. It's often used to reduce stress and anxiety, particularly by performers before live shows. We're all different.

I took propanolol from the age of 20 until I was in my fifties, when I was changed to a selective beta-blocker (tenormin). I still take it, and my resting PR is about 45 bpm. Cheers.

Marktq1 · Member

Spoke to nurse ALT/AST NOW 29 and 31 everything else looking good apparently but she now thinks Gilead will not get back to them before Mon when I will have done 10 weeks

for people who are considering this treatment I would say side effects so mild I cannot be sure if they are from the drugs or not no headaches nausea a tiny bit but no more than before tx and infact that stopped week 4

Finally a question all my life my blood pressure was fine then suddenly it shot up my GP prescribed propanadol because of my high fibroscan (23) and enlarged spleen

blood pressure normalised but I felt terrible stopped taking it and felt much better

When I started the trial the doctor put me on carvadilol and has very slowly increased dose to 6.125 mg twice a day blood pressure down a bit systolic about 135 but dyastolic still about 90

when I saw the professor who is in charge of the trial he was dubious about carvadilol saying as my endoscopy showed no sign of varcies he would not think carvadilol my best treatment as it is not as effective as other drugs for arteries hypertension and he says there is little evidence that it will prevent varcies although it is the best option to reduce them once they appear

I am reluctant to have my carvadilol increased as I am starting to feel as I did on the propanadol more tired listless anxious etc

One other problem is that my normal pulse is fairly low mid fifties and with the propanadol it dropped to mid four ties anyone got any advice how important is it to treat the high blood pressure I am tempted to stop taking the tablets at least til the trial is over

-- Edited by Marktq1 on Tuesday 6th of January 2015 11:18:57 AM

Cinnamon Girl · Guru

That all sounds very promising then, Mark.

Keep us updated, and fingers crossed!

Marktq1 · Member

Just spoke to the nurse ,she was just ringing to say that my LFTs were all good no word from Gilead about the retest if I am still on the trial she feels that if my in increased you would not

Expect my LFTs to continue to improove

I will just have be patient she is ringing later this afternoon to go through my LFT results in more detail

Cinnamon Girl · Guru

Hi again Mark, it is fairly normal for a viral load to fluctuate quite a lot over time and the fact that yours had dropped by such a lot by the time your started the trial is probably in your favour.

Best of luck with speaking to your nurse tomorrow, let`s hope it`ll be good news for you!

Marktq1 · Member

seen I had a missed call from the research center New Year's Eve which would have been too soon for my VL results will ring them tomorrow doubt my nurse would ring with bad news New Year's Eve. She waited til after Christmas to tell me about the retest request so that gives me more hope

also was wondering my VL WAS OVER A MILLION A YEAR AGO BUT AT START OF TRIAL WAS ONLY 105000 is that usual would the lower level increase my chance of SVR

Marktq1 · Member

Thanks for that gives me some hhope they delayed telling me til after Christmas so it was 14 days between tests which is ok they say

also my alt and ast had gone down again to 30 and 32 after they had stabalized at 40 the test before from an initial 200 they have been up above 250 earlier this year

I will just have to wait but your post makes me feel more hopeful thank you

robertsamx · Guru

Mark, Dont throw in the towel just yet I was on a gilead trial early this year and at week 8 blood draw i was not und, and was also told i may be pulled off trial if retest showed any hcv. So i asked my trial nurse what the re-test window was and it seems to me it was 7 days so we agreed to do the re-draw on the last day and i got one more week of solv/riba and my test came back UND. So dont hurry back for the re-test and try to put it off as long as you can. Also something to note is blood glucose 10 or higher will get you pulled off trial. There are several blood test results that will get you pulled off, Hang in there. RC

suziq · Senior Member

Thanks Jill for posting the link. This trial is being conducted outside the US as well. Great for those who have been unable to participate in US trials.

It is wonderful to see the options for future treatment grow.

Marktq1, I am hopeful that the retest was just a lab blunder. Wishing you luck!!! Let us know more about you by filling in the info and signature in your profile.

SuziQ

Marktq1 · Member

I hope you are right , my doctor was surprised looking at my LFT results said that from them it seemed I was responding well as you say I may be on the placebo but my doctor says that he is 99 % sure I am on the real drugs it would be a bit strange for all my liver tests to suddenly normalise

She warned me that tho she does not know the reason a retest has been asked for her previous experience is that it will mean I am to be withdrawn from the trial if that happens she will go through my options with me

I would add that my billurubin was outside acceptable limits when I was screened but the hep c nurse had me retested saying that result was an aberration and I was allowed on the trial

billurubin now in normal range

They will ring next week so fingers crossed

Cinnamon Girl · Guru

Hi Marktq1, welcome to the forum and thanks for posting.

Your ALT and AST levels have dropped by an impressive amount in the 8 weeks of the trial you`ve done so far which is a very good sign that the treatment certainly has been working well. I can understand how downhearted you must feel at the prospect of being taken off the trial but try not to assume the worst at this point, just hang in there until after the results of the VL retest and take it from there.

Wishing you all the best of luck and do let us know how it goes! ~ Jill

PS - I`m posting the details of the Astral 1 trial here for general info...

https://clinicaltrials.gov/ct2/show/NCT02201940

-- Edited by Cinnamon Girl on Tuesday 30th of December 2014 11:39:42 AM

mallani · Guru

Hi Mark,

With ALT and AST levels like that, I'd be surprised if you had breakthrough.

You may be in the placebo arm, and Sovaldi won't work by itself. Best of luck and let us know how it turns out. GS-5816 seems to be a great drug. Cheers.

Marktq1 · Member

Hi I am on the gilead astral 1 trial sof plus gs5816 or placeabo alt and ast have dropped from over 200 to 30 and 40

All was going great until I went on week 8 gilead have requested a retest dr says this usually means my viral load has gone back up and it is likely I will be removed from trial

She was surprised that my liver function are continuing to improove alt and ast still dropping

I feel in limbo now and worry about my options as I am cirrhotic with a fibroscan of 23 and an enlarged sspleen it's frustrating as I was starting to get my energy back and feel more motivated less listless

I try to be positive and say at least my liver has had a rest for a couple of months but to be honest I do feel down about my future prospects

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