Hep C Discussion Forum

Hi Pablo,

Do you still have your Polaris/Gilead trial description hand-out?? Did you read the sides described in there?

While it was still being determined, which arm I was going ultimately end up being placed in, (the 8 week triple sof/vel/gs9857 arm, OR, the 12 week double sof/vel arm), there was a description of sides (one "might" experience), depending on WHICH arm you got. 

The sides were listed for BOTH arms (with and without the gs9857). If you re-read this section of the hand-out, you will see the "possible" sides for the triple was ever so slightly dif, than the sides for the double. Perhaps more G.I. or cold-like symptoms were reported by the gs9857 folks in feedback to Gilead?

I would think "known" sides for these drugs (vel and gs9857) are still being gathered. They could well be non-existent for some people. Known sides for sof should be well documented by now due to it's heavy use/reliance in all regimes now. Sides for vel (perhaps) a little less well documented, and sides for gs9857 perhaps even less so documented (just based on how many subjects have been ingesting vel and gs9857 thus far).

When you read through tkflex36's sof/vel (12 week double) sides - his, he said, were NIL. Webtomass's sof/vel/gs9857 (12 week triple) said "pretty much" the same thing.

For me, my sides, on the 8 week triple, were all in all, very manageable, and were, at times hard for me to really separate from some of my prior long-standing (pre-existing) symptoms. NO nausea (I did wonder on the very first day, if there WAS some nausea happening, as I commenced to have some burgling, gurgling, epigastric "roiling" going on soon after I got my first pill down my gullet, and faintly wondered about whether i was or was not nauseated on day one or two - but ended up deciding NO, that is NOT nausea - I did not feel "sick to my stomach" AT ALL, rather, it was just this weird epigastric burgling, gurgling "roiling" going on for a couple or few hours or so after I took each pill, maybe a small amount of erucitation along with it - but that was all, gastrically, it really didn't bother me (this roiling), I just noted it, every day, after every pill, like clockwork, as as a weird but not bothersome "thing". I took each pill at lunch, and there was always a cessation of this "epigastric roiling" within hours and mostly well before I got around to supper. It was really just a minor oddity, that's all. The gastric roiling persisted up until the last week, but oddly, it did decrease quite a bit, even before I finished the last week. I do think the non-bothersome epigastric "roiling" and erucitation was directly a mild side effect of the treatment/drug(s), I suspect the gs9857?, but I felt like I was "getting used to the drugs" in that last week or so, therefore less roiling? Roiling and erucitation was almost non-existent toward that last week.

I did experience some headaches, especially the first 2/3 weeks, then the headaches also decreased in intensity and frequency. Later half of treatment, they were "ever-decreasing" only a few, small and smaller, infrequent headaches, decreasing proportionately as I neared EOT. Again, I kinda like I was "getting used to the drugs". These were not "severe" headaches AT ALL, they were daily at first, some fairly strong/"moderate" at first, but i never took an analgesic once (I seldom ever have in my life), seriously thought about taking an analgesic once or twice the first week or so, but decided against it, it wasn't that bad, I didn't want to feed my liver any analgesic anyway, nor did i want to mask symptoms that  I was trying to discern as being caused by the drugs. I called my pills my "headache pills" for a while - but, the headaches started to decrease and were quite well tolerated, they got small or tiny and infrequent in the later half of treatment. I do think the headaches were a side effect of treatment/drugs tho.

Headaches (AND, the drugs themselves - I "think") made all my other (pre-exsiting) brain fog, concentration, memory, diplopia and tinnitus more noticeable.

I having been waiting this week (after my EOT) to try to discern how I am NOW feeling, off the drugs - it is still hard to say,! the jury is still out!!, but I will keep you posted when I get it better sorted. While on treatment, the drugs did seem to add an "extra layer" to my normal amount of pre-existing level of fog. This week (after ETO) I am starting to notice that this "extra layer" of fog has been slowly starting to lift. It was like the drug treatment did increase or contribute to how much fog I was having to deal with, it was thicker on the drugs. Additionally, during treatment, I woke feeling like I had an "extra kind" of hangover - like a "drug hangover" - I blamed the drugs. The A.M. hangover got a little less noticeable tho, even before EOT. Post-treatment, I DO think the fog (the "extra" portion for sure) has dissipated greatly, and maybe even some of my "normal" amount of fog is decreasing!! And the "extra" A.M. drug hangover is definitely gone now!!

I DO think I noticed slow and subtle improvements in fatigue, even before EOT. I was starting to experience less of those overwhelmingly irresistible crashing daytime naps that used to overcome me, sometimes on a daily basis! I was "crashing" less and less the last couple weeks on treatment, and even less now! I know I am feeling "some" less fatigue, but mental clarity and fatigue levels are taking me a while to truly sense and measure well yet. Like I say, I'll update you as i go along.

I hope your symptoms are short lived, dissipate and are not sides. I did have some night sweats on occasions during treatment, but I did before treatment as well. Perhaps just like Tig's "man"opause. Of course, me being emotionally liable, moods, irritability factors, frustration with concentration etc., abilties/disabilites were noted during treatment, but I did so before treatment too.

I AM pleased thus far!!  C.

Hi Pablito,   I'm hopeing you have the two day flu. If you were on RIBA this would be about the time you would start feeling side-effects-  hang in there your doing great! RC

Aaww syd,

Jeez, now compliments! - my good-ness!!, my head is just a-swimming!! - and is getting bigger and bigger by the moment. Thnaks - keep it up!! - you are my very best morale builder!! I heard a ding dong from my computer, and it was you!, always glad to get a ding dong from you - why is it that we often we seem to cross paths at 3AM my time! Ships in the night? Man, when my partner wakes up in the AM, I gotta show him this one, right away! He won't believe I've got you fooled SO goodl!! HE SEES me counting on my fingers! He will get a special chuckle when he reads the clarity part!! Oh well, feels real good.

No, my friend is very ill, and sadly, will not recover, only 66!

Me too!, fer sure ditto what you said, about being on this journey at the same time as you - perfect storm I'd say! Aren't we all lucky to have each other like this.

Now, I am going to go off to bed, if I can manage to lift my overly-inflated ego and my real puffed up head off this sofa. Thansk syd. C

Hey everybody,

I neglected to thank everyone, for their very kind, and always enjoyable, bouying, funny, weird, ever-so-cute, creative and supportive posts about me eating my last pill and my EOT. Don't know what I'd do without all you guys! What a wonderful motley crew we are! It truly is, very much, a great privilege for me to be able to share my life moments, fears, happiness and celebrations with you all, and I am truly humbled and honoured to be able to share in yours. 

Since my trip down to my ETO appointment on May 5, chaos and busy-ness has fallen upon me. Too much happening around here. I have a friend who is very ill, and time just goes and goes and goes.

I will post more soon, about my appointment, and perhaps both (the balance) of my 4 weeks labs that I only received May 5, and as well, the newest EOT 8 week VL and labs done May 5 as well - hope I can receive the 8 week EOT VL this week! (Anti-climax tho - we ALL know what it is going to be!) Still exciting tho - I can't wait to see those dang zeros again!

Thanks to each one of you, you are good friends.   C.

Hi all

Thanks for the comments.  You are, of course, right.  A VL at week two of 1000 is not much and the one taken today (i.e. week 4) will no doubt be much lower again.

I think this has been posted before but I found this link very useful.  I've pasted the take home message below. The gist of it is that the new DAAs damage the HCV's replication process and, as such, even if one is still detectable at week 4 (or even end of treatment for that matter (as long as the VL is not so high)) one will likely achieve SVR12 as the remaining viral cells can't replicate properly and die over time.

Cheers

Pablo

"Low negative predictive values of HCV RNA at week 4 underscore the importance of continued therapy for patients who fail to achieve undetectable levels of HCV RNA early on during treatment because the likelihood of achieving SVR12 is still high," the researchers concluded. "Contrary to past experience with interferon-containing treatments, the presence of detectable HCV RNA at EOT [end of treatment] is not predictive of relapse in these studies."

Firstly, and most importantly ... your VL drop IS brilliant, it IS a VERY profound drop, it IS a VERY telling drop - everyone is scared that their treatment won't work - more so when you have failed a treatment prior - you will just have to go through and deal with this fear - we all do - you have EVERY SINGLE indication to the contrary of failure, you HAVE EVERY SINGLE indication that you ARE responding EXACTLY like the rest of us (who have been lucky enough to get these sof/vel/and/or gs-9857 drugs, and have also experienced a STUPENDOUS dizzying crashing of their alts/asts and VLs. (I am speaking for myself) when I say, as a "desperate" beggar, I could NOT be a chooser, no matter how much I might have wished for it to be otherwise. None of us "on trials" get much "choice", except for getting in a "good" one, with "good drugs", maybe, if we are lucky enough and try hard enough to get there, and be positioned for it . Lucky "Polaris" stars. We had no choice but to accept the vel trials that were currently offered up and running (what was available), the arm(s) we got, the trial(s) and arms that "happened" to have any of the few seats still open and available for us, the particular trial we happened to "qualify" for, within their "narrow" inclusion profiles, it is for the most part "out of our hands. We have no control of this, no choice (in the end, my actual arm was ultimately decided on, by a computer!, and my synthesized parameter data).

We did VERY well to position ourselves to get in the way of this magic velpa comet and grab the tail of it before it sped by us. I hear through the unofficial grapevine, and "depending" on one's country, sof/vel "might" soon be available on the "open" market .... (vaguely "in general" it seems these are the promising announcements), but who really knows (depending on the country, and many other factors), really, how "soon" sof/vel (and especially the triple sof/vel/gs-9857) will be truly be readily available and easily accessible to people everywhere.

Ignore your stellar alt and ast, for just a moment (if you can, for pete's sake!). Look at your CRASH AGAIN!! From 2.1 million!! decimated down to 3000!!! in LESS THAN one week!!! Good-ness me!  Breathless!!Then steady as she goes, still crashing down to only 1000 at week 4!! You have ONLY a mere, minor load of 1000 (already injured, dying) stragglers left to be easily wiped off the face of this earth and you still have half your ammo left!! No brainer. DO YOU REALLY THINK, AT THIS STUPENDOUS RATE ... that another 4 weeks of this MAGICALLY lethal drug combo,  is NOT going to fry up the last few mere bits of maimed virus into oblivion!! They are exploding, imploding, committing suicide, jumping ship, being starved out, poisoned, tortured, torn apart, beheaded, gutted, de-limbed and eaten alive, all the while, and at this very and every second we speak!! WE ALL decimate at our own rates, "personal" warfare style is allowed and condoned, whether you be a Harvonian or a Ribalander. To each their own way.  I can't say if prior load really plays too much into the speed of decimation, with vel or not, maybe, don't matter, you got lots of ammo left. Slam dunk. I had less than half your load, tkflex36 less than me (if I recall correctly). Can't recall webtomass's load at the moment. Maybe it does have a "small" bearing - what is important is that this magic stuff is OBVIOUSLY very effectively lethal ammo and you are following suit, just like the rest of us, you have crashed your ALT/AST/VL SPECTACULARLY! Do the math (if you need to, insist or want to)  but your annihilation/ "kill rate" is as good as mine!! You and I are doing very well indeed, to say the least - we will soon be out of the trenches. Had I actually started my trial when I was at my 10 million load a short time ago, then yes, I guess (knowing me) I would have probably wasted time luxuriating in more worry, more than I did - but I do think, with this potent new regime, that load is very much less a factor.  

Currently, in Canada (this IS my understanding - so correct me please, anyone, if I AM wrong!) I would STILL be waiting (since Jul 2015), if I had wished for my provincial govt. to "allow" me to have even sof/dacla. This is REMAINS the current provincial situ to date, as far as I know, I STILL cannot even get sof/dacla where I am located, even though it was "approved" for use (generally in Canada) "long" ago. International/national/federal/provincial things, such as "approvals" can differ and tend to move slowly and get impeded "in practice" to the reality of wonderful news announcements of the fast-tracking approvals (in theory) that people are truly, desperately wishing and waiting for. Insurance (for some), govts. (for others), "best practices", and the almighty "dollar"gets in the way of what people really need today. Things move slowly, country to country. Here, I was only offered the Provincial govt's  first in line favourite", what's on the "books" (the govt's recommended preference) namely, 24 weeks of sof/riba, AND, I would have had to fail that, before i would even possibly "qualify" for sof/dacla. In my province even sof/dacla is not yet truly "approved" as an easily obtained "first choice"!! Debating, deliberating, deciding was short and mostly mute for me, as far as comparing cure "rates", sides, RAV's to ANY of the drugs that were available to me in my Province. I readily chased the tail of this velpa comet with both hands as my best choice, and feel lucky indeed to have grabbed it, to get myself into this 8 week sof/vel triple trial opportunity. As a 3a, hands down, it was my best choice, had I been a 2 or 4, better yet!

 C.

Don't sell yourself short my friend, that is impressive for short period of time!

Pablo you are doing great. Outside of trials you would not even get a 1 week or 2 weel VL Count. It is for data gathering right now is all.

The 4 week also is nothing to sweat. It is good to see the UND sure for a moral boost, but fact is EOT + 12 is the true show your hand test.

You are doing great no worries.

JimmyK

LOL!

Hi C

        Let me deal with these goose bumps first!  I can't believe your done!!  You have been on an incredible beautiful journey, you did it like a pro.  I"m so very happy for you. As your post treatment results come back, it will just keep getting better for you. congratulations!! RC

Such great news Canuck. I hope you are taking some photos of that beautiful countryside in late spring, either before or after your chauffeur makes a quick and, ah so deserved deviation, into the drive through of the pearly M golden gates. And yes, a choc sundae seems like the perfect way to go. 

I agree with WMLJ1960 think that sweet smell is your body thanking you because the virus has turned its toes up.

And yes, I did get your message - it was lovely - you have been a firm hand pulling me along and have handed me many cyber tissues (and belly laughs). 

I still haven't got my latest bloods back but suppose what will be will be whether I'm in the know how or not. My specialist wanted me to have an ultra sound to check on ascites, because I had developed that such a short time before treatment that she's hoping I may have slipped back into compensated mode - I had it today, but of course no results yet. I am also booked in for a laparoscopy to check for  varises and they are doing a colonoscopy at the same time - there will be no stone unturned.

Anyway I'm really looking forward to one of your lyrical accounts of the journey, the appointment and of course, the chocolate sundae.

Syd

Heh Canuck

Congrats of finishing treatment.  It's a biggie.  And, yes, time flies...I'm almost at the half way stage in no time.

Am I right in thinking from your previous post that your VL test was undetectable at some point during the trial?  (Sorry - I'm still orientating myself to the website and find I get a bit confused with the cross referencing of posts and user names).  If so, that's great news...obviously our presentations are similar and we're on the same trial, and you get the 8 weeks vs. 12 weeks worry, so I'm watching your progress with interest.

Not sure about the Micky Ds...surely you have some tastier bites in Canada?  In fact, I know you do, as I've been there.

I continue to essentially be side effects free.  One day in seven I wake up feeling exhausted, but that could well be from working silly hours 'til late at night (occupational hazard, work in dance music). 

P

Congratulations

We finished 2 days apart. I cannot wait to hear your results.

I am so happy for you.

WOOOHOOO!!! I'm so happy that your day to end treatment is upon you. You did it my friend and look at that Dragon after your 8 second ride, they're dragging it out of the Hep C corral now. LOOK>>>> it still has your Velpa spurs dug into it's side!! 

Congratulations and thanks for showing us how it's done! On to SVR....

Well done, Canuck, May 4th has arrived!  Congrats on last pill day!!    

Onwards to SVR!! 

Hey Canuk, happy last day of tx ;) on to the SVR!

Hi Canuck,

May 4!!!! Finally understand that we are in front of you by world clock standards, if nothing else, so you've probably got two more days to go. 

So pleased for you.

Syd 

Hi all

Thanks for your support and tips...I do switch between mental states of optimism and pessimism, but actually my body feels so much better 3 weeks into the trail that something good must be going on.

But I have a very important question to ask; actually one raised by my mother...do I need to dump my toothbrush and get a new one?  The doctors on the trial didn't mention anything about doing so and I don't know if one has already developed antibodies to the strain of HCV that one has already and therefore can't be re-infected by same said strain; but it's such a small thing to do i am going to do it anyway...but does anyone know the science around this?

Pablo 

Hey Pablo,

While the results of the 8 week regimen aren't in, there are a number of reports regarding the efficacy of the 12 week program. Incredibly high SVR rates are reported. "High sustained virologic response achieved with sofosbuvir/velpatasvir and GS-9857, even in patients unsuccessfully treated with direct-acting antivirals The study showed that 99% of patients with HCV genotype 1, 2, 3, 4 and 6 who had previously received treatment, achieved SVR 12 weeks after treatment using this triple combination". That's the deal with these trials, consider yourself a pioneer and be honored (I would be) to have the opportunity to prove that the shorter course of treatment is viable. Your success and from what I read, there is no reason to doubt otherwise, will mean a lower cost and patient impact across these genotypes. Your willingness to step up and do this is important for everyone affected by this. The 12 week protocol results indicate rapid declines in viral load, I mean in a matter of days after starting. Since you are non cirrhotic, 8 weeks of this magic bullet provide a very good chance of achieving SVR. Stay positive and do your part. I think you've got an excellent chance of defeating this disease right now, you should too. It's an anxiety ridden time right now, just wondering if things are working. Do your best to throw those doubts and concerns aside and fix your thoughts on success. You'll get there!

Welcome Pablo,

You will get all the right answers here!

Canuck!  How many more days for you? I have lost track!

It seems you are still doing great on it. That is wonderful!

SF

Pablo,

I try to NEVER vary the time the time I take my sof/vel/GS-9857. I started taking it at lunch (with food, as instructed) and will continue to do so no matter what. Being that you and I are on such a "SHORT" treatment arm anyway (8 weeks), AND, you are already WELL into your course now (for over one week?), AND did not (?) really express any debilitating sides?, then I would not be going to all the trouble to radically shift the dosing time from night to day.

In any course of ongoing daily "systemic" treatment, the idea is to keep supplying a CONSISTENT/EVEN dosing - you have already established this time, for a week now, your daily peak and wane of "saturation time" (as JimmyK mentioned), AND, are already "used to" taking your dose everyday at a particular time ... so ... although it is not impossible to change the time of day (only on advice of your doc, like Gracie said), why bother if you have had no major troubles?

I was repeatedly reminded (just before I got my meds, and on day one) to "strive" to take my med at the same time everyday, so I will, and they ask me, at each appointment about my timing ... they usually ask me "what time did you take your pill yesterday?", and, "what time do you usually take your pill?" - I have a feeling consistent dosing time is important for them to know (when they are looking at your fasting blood draw values/concentrations in relation to your last dose), timing (specifically and or in general) may be of note to Gileads data collection. So, just easier/better all round I figure to maintain a consistent, predictable pattern for them and for you.

If timing is problematic for you, then I would only change it as they advise.

Just curious, did you have any older labs to share with us, ie old ALT's, AST's?

I am glad you are starting to feel more confident in your choice. And I lament your bad experiences. Speaking of conditioning and emotionally driven thinking - I think it is a self-protective necessary thing we all seem to juggle/struggle with - I found being driven by my outright panic/fear was helpful to me in the beginning as it only helped to propel me at hurtling hysterical warp speed to land me as quickly as possible to the right place and drugs. I feel the the waves of fear falling away from me in great sheets of relief, as I go along, like the glee of the happy babes Syd so aptly describes whilst unwinding them from their pig's in a blankey cocoons.

I fondly recall one person's "mantra"  here - she posted something to the effect of ... "but what if I fall? ... oh, but what if you fly my dear!". Loved that one! (Mine tends to go more base I am afraid ... "Kill, kill, kill!" - you might have to go to the warped poetry section to figure that one out).

Dare to dream! Your ALT and VL may have already started to crash, and you just don't know it yet.  C.

Hiya Pablo! Welcome.

It is best not to switch up. If you have been taking it at a particular time stick to that time throughout treatment. Your saturation will be more consistent.

Regards

The 5:55a Guy!

Welcome Pablo! You're on a fantastic trial and all indications are very positive that this is another block buster treatment. You've got a great group of supporters here on the forum and we'll be here to cheer you on. Good luck!!

Hey Pablo,

Welcome to the club! Congrats on getting yourself to and into this trial.

Very glad you showed up here. Glad to have a fellow trial mate to compare notes with. So ... now we have (the count to date, including you), at least 4 of us here, "testing" out sof/vel +- GS-9857, and, maybe a 5th coming to start soon. (I hope you have found the other threads for tkflex36 and webtomass as well).

Lucky you! to get in on this opportunity, especially knowing you are starting with little or no cirrhosis! I am fully expecting you will follow suit, just like, tkflex and WTM and me, and have your VL decimated in short order. I think you have made good moves, a wise choice, and good you kicked the "to enter or not to enter" decision around with an experienced hep guy. I agree with your thinking on the "gamble", but it is ALL in your favour. It is only natural you needed to feel firmly comfortable in your choice and in having a plan c (for after vel) given your disappointment with interferon/riba - and anyone asking for a 3rd treament after 2 failures would get priorty anyway - but please try to concentrate on what is happening now ... tkflex and I are 3's (historically "typified" as "harder to treat" G's, me, packing a higher F status than tkflex), and WTM (like you) is a 4 (but with cirrhosis, and a prior failure under his belt), AND WE ARE ALL responding perfectly. The response to these new drugs is very exciting!

It is hard to quell worry tho, we all vacillate in and out of it, but it IS kind of useless worry, it does serve a self-protective purpose, but like all of us in trials we have no choice in length - 8 weeks/12 weeks/with or without - we are just fortunate (indeed) to be getting these powerful drugs, period, and at short lengths (another really nice bonus) that they have already been successfully testing out and are proving work fast and effectively. I believe the very design of this sof/vel/GS9857 IS to be short.

Really nice to hear you have already discerned a "dif." in how you feel after only one week (with the lessening or absence of the hangover you have been packing), and in feeling no sides! (good to know). I am not much a of a "betting person", (but boy do I ever enjoy winning) and I feel strongly all of us velpa people are going to trump this spectacularly.

I bet you "might" knuckle and ask for a VL. If not, then you should be able to continue judging, by how you feel, and just based on what is happening here to the rest of us on this magic star dust.

Glad you joined.  C.