Hep C Discussion Forum

angelseven · Senior Member

RE: New here. Mavyret n me

Canuck · Guru

Hey moochie,

Let us know how you are feeling now? Last we heard from you, a week ago, you were trying hard to calm down, taking something for your blood pressure, and I was hoping you could have that chat with your doc to seek some clarification and reassurance as to his thinking on your treatment - I guess your EOT VL draw will be coming up right soon (couple days)?

Do keep us posted how you are making out.

My goodness, look at the old "doing-good" Mavies you dredged up here moochie! Hi ya RLS, Angel and D.L.! - long time no hear. So nice to hear from you, to see you here again and to see you meeting moochie. (Moochie, note Angel did not get a UND at 4 weeks, and there were some others on this site as well, who were slower than others to get their UNDs).

Now, only because all of us here on moochies thread have delved further into various aspects of taking Mav, I need to get my 2 cents in - by directing you to a dif recent posting that speaks of Mav firming up their monograph info, as to when a GT1 or a GT 3 can take 16 weeks of Mav ... the article can be found here ... Healio/HCV Updates

(see ... "FDA updates Mavyret label for new safety, efficacy data - August 8, 2018 ") ... it contains this info ...

...The FDA recently approved safety and efficacy revisions to the Mavyret label ...

According to the released revisions, the FDA recommends a 12-week course of glecaprevir/pibrentasvir for liver or kidney transplant recipients. The FDA also recommends a 16-week course for patients with genotype 1 and NS5A inhibitor-experienced without prior treatment with an NS3/4A protease inhibitor, and for patients with genotype 3 who are treatment-experienced with Sovaldi (sofosbuvir, Gilead Sciences) and ribavirin ...

but best to read the whole thing (the article AND the monograph) for changes - I hope they do a decent job of laying it out/clarifying any new bits well in the mongraph! - else we'll have another of these hard to decipher interpretations of who can take it, how and when. C.

-- Edited by Canuck on Thursday 16th of August 2018 04:36:19 PM

Tig · Admin

One other thing, 12 weeks is acceptable for retreatment if a NS5a was not used.

Treatment-Experienced Patients

Patients Previously Treated With a Regimen Containing:

An NS5A inhibitor1 without prior treatment with an NS3/4A protease inhibitor (PI)

16 weeks

An NS3/4A PI2 without prior treatment with an NS5A inhibitor

12 weeks

Tig · Admin

Actually it is entirely possible to have a non quantifiable viral load (<15 IU/ml) and have the test return as <15 Detected. The typical LLOQ (lowest level of quantification) is 15, but the test is still sensitive enough to register viremia, but can’t quantify below 15. Hope that helps.

Quantification Limits

Dandelion22 · Veteran Member

Hello Moochie, Connie and all. It seems there's some confusion? For the 3 plus years I've been following these DAA's, starting with Harvoni, which I relapsed from after 12 wks, <15 has always been understood as UND. If I understand correctly folks have explained this number strictly unique to the labs preferred testing procedure and methods. Presumably there is more than one way to measure HepC.

I do not have a medical background aside form researching HepC for 29yrs, but I'm positive that <15 means non-detected.

I took 16wks of Mavyret this year, and was UND throughout, and even at 12 wks post EOT.

Cheers,
Dandelion

angelseven · Senior Member

I added sofisbuvir to Mavyret as recommended by james freeman for 16 weeks after relapsing following 8 weeks of harvoni in 2015. Going for my SVR test on friday, I was still slightly detected at 4 weeks, clear at 8 weeks On mavyret with sof. I would beg the doctor to at least get you 16 weeks of treatment total..... no clinical trials adding sofosbuvir so he probably wont go for that...

<15 is NON DETECTED.... does your blood test not say non detected.... i thought maybe i was losing my mind because I have been ignoring hep c since i finished my meds but there is always some part of the virus floating around even after you are so called cleared And is why the test reads <15... and the test reads as <15 for non detected. I just reviewed my blood tests with quest and this is what it says: <15 non detected. Am i missing something here?

Now at 4 weeks i was detected at <18... 3 points to non detected

best of luck, angelseven

angelseven · Senior Member

Hey there, according to the package insert of mavyret, as a relapser, you should be on 16 weeks of treatment?!?!?

best of luck!!! Angelseven

RLS · Member

Moochie, I can relate to the state of anxiety prior to end of treatment. I had relapsed with both peg/rivo and then later with Harvoni. Very frustrating especially since Harvoni has such a high success ratio. Due to the prior relapses I was approved for 16 weeks of Mav which finally worked for me. I'm not sure why they wouldn't add four more weeks of treatment for you but hopefully that won't matter as you will be UND after your treatment.

What kept me going was knowing that the meds were working and that there are other treatments out there. If Mav didn't work I was fully prepared to try a different blocker. My doc explained that certain blockers work for individuals - some don't and it's a matter of finding the right one. Hopefully you won't need to try anything else.

The waiting is the hardest part. I can relate. Wishing you success!

RLS

Canuck · Guru

Oh dear poor moochie,

I felt right there with ya at your regular doc's office. I did one of those once, (melt-down) but it was long before i got treated for the hepc! Had an unexpected melt-down in an unsuspecting gyne's office one day (it was the 7 months or so of constant chasing and working and thinking about HOW I was going to get myself treated etc, that worked my emotions and cry ducts into becoming very inconveniently involuntarily incontinent, my mind and body was tired. I should not have been surprized I could not hold it together long enough to get out of her office before the melt-down started happening. I tried to avoid it ... but then couldn't. I have been told that ugly crying in front of people really doesn't look that bad, as opposed to the weird strenuous facial grimacing one does trying to hold it all back before the melt-down bursts out! That weird almost panicked/confused look the doc got in her eyes just as she realized "OMG, is this person about to melt down, what the hell is going on here?". Same funny look of realization parents get when they hear their wee child fall and the kid should be crying, but he is not yet, but this little one is taking a reeeeeeallly long time to gather a reeeeealllly big breath, so ... everybody watch out eh - huge humongous wailing cry about to begin. That's kinda the almost fearful look of realization I think docs get in their eyes when they are faced with melt-down patients, this "I am hopeful I am wrong", they keep glancing furtively at your face to see if they are reading you wrong, or, to see if your face allows them to muster a glimmer of hopeful feedback (that lucky for them, they may yet be saved from your full monty) if you manage to get control of yourslef and you can hold it together, or if they quickly offer up some conversation toward the direction they think you might be headed they may cut the full-monty melt-down off at the pass ... (that rarely works in the case of a truly justified melt-down BTW!) - in fact it is a curiosity to me that anyone who is seeing another trying very hard to gulp back tears to spare the other from becoming the witness/audience of a full-monty melt-down, that the would-be witness should NE-VER outright ask the gulping person to speak! "What's wrong, is something wrong?, are you upset?" are their favourite questions! Guaranteed to unleash the storm.

So ... you managed to scare your doc during that visit yesterday eh? Well, at least you got his attention - we shouldn't be surprised when we do go all stressed to the point of burst-out, (and hey guess what - I bet you did not scare your doc) - they have seen a few stressed people in their time ... just whether they are any good at witnessing people undergo stress is what counts, and it sounds as though he did not flunk out - he listened, made mention of trying to speak to your hep doc, and thought perhaps he could dole out some med for your BP, so, at least he was trying something he could think of to help you! Not wasted tears or fears - had to be done. But I DO want you to focus (steely-like) on the info we have laid out for you, re: in all likelyhoods, probabilities, plausibilities - focus on the facts, your have completely crashed your ALT/AST and VL, even if your VL is not UND it is infinitesimal, and will soon be undetected (if it is not already). All this will be just end up being wasted stress and worry by the time you get to your EOT+12 week SVR. Look at this way - your hep doc is treating you like a cured person (get it!?).

Please can you not phone your hep docs office and explain you would really appreciate being able to speak to the doc again (that you really need to see him, to be able to talk to him) about your position, that you are not understanding your position and are stressed about it - and please could you come in for an appointment right away. Try it, all they can do is not cooperate in making it easy for you to see him/speak with him. I would give it a try on the phone to get in to see him - what have you got to loose? You may not get to see him, but if you do, he may have a better explanation for you.

Hey really good job on the sig line BTW - impressed - wondering where you had been going previously to ask questions, to look for info or converse with others, prior to coming here? Had anyone (other than your hep doc) actually been saying to you that you might go from Mav to epclusa?? Where did you get these ideas from (doing epclusa after Mav, and/or doing a Daa with riba)? I believe your doc believes Mav has done it for you, you will get your SVR12 and SVR24 and be hepcfree forever more, so there is no need to discuss what drugs to go to with failure - as you are not failing. But I would have thought with the unfortunate rampant fear that has erupted around you that by now the calming knowledge of the existance of Vosevi would have at least come to the forefront by now.

Give it a try, phone your hep docs offcie and see if he won't/can't just squeeze you in, even if it is just for a short visit, "at the end of the day-like", tell him you will gladly sit in his waiting room late in the afternoon just in the off chance that may find a few minutes to fit you in before he goes home for the day. wink C .

Please do that for me and for yourself, at least try to get in.

And, tell me how high is a high blood pressure and what did the regular doc give you for it. C.

Canuck · Guru

Ok, Ok, now you've done it Tig, you've let the cat out of the bag, and here all this time i thought you were gunna keep my secret, about how I invented sof! along with being independently wealthy and being a spelling geniush! hahahahahah. smile C.

Tig · Admin

Introductions are always welcome... You know, one of our members is actually one of the scientists/pharmacologists that was part of the research team that developed Sofosbuvir! You just never know whom graces our forum...

If you would like to tell us more about yourself, Will, please enlighten us! All are welcome in our Hep C family. Except spammers and trolls, that’s when the ban hammer comes out! wink

Canuck · Guru

Well, Hi again stranger man! Hey, willBB when are you EVER going to properly introduce yourself and share something about yourslef with the rest of us aside from your reading preferences? confuse

The studies you read and post are riveting to me and many of our more nerdy readers. They do not exactly apply "directly" to moochies case though (her situ of being on Mav), other than she is being treated today on a modern DAA.

I think the reassurance she SHOULD HAVE received , that should have already been provided to her, should have been done by her doc (as to what his opinon, thinking and advice to her would have been on this matter).

moochie is right, none of us are docs, and we cannot advise her on such things (unless of course ... you are a doc! - jeesh ya never know eh?!). The studies she has already heard of and refered to via info she has read that Tig posted previously about folk going UND later than sooner - she is already aware of.

But nice of you to scoop in, anonymously, with great seemingly professionalism and try to help make moochie feel better about things - that is of course always our priority around here - that people do not suffer needlessly and that they always have some safe, warm friends here.

Really willBB, when are you going to share something about yourself - I'm seriously beginning to wonder about your mysteries.

My dear moochie, please do try to get speaking time with your doc - that is the least they should be doing for and with you given the circumstances. C.

moochie · Newbie

Thank you to everyone that responded to my post! I truly appreciate it so much!!

Im trying hard to calm down, still fighting the high anxiety but trying take in and find hope that I still have a chance of undetected. Yesterday I also had an appt with my regular dr and no doubt he fully believes im completely unstable as I was in tears and talking in circles the entire visit. I was in full panic attack mode while trying to explain all this to him... he has no experience with hep c or treatments involved. He offered to call my gastro because he was upset too lol. he prescribed blood pressure meds because its very high. Ill leave it at that cuz my complaint list could create a novel.

again, thank you all... Im still reading all I can about ppls experiences.

willbb · Member

I meant to include this data for you also.

Dr. Wyles is known as one of the leading researchers in regards to these new meds.

Was a couple of years before Mavyret,however the same principles would seem to apply.

http://www.aidsmap.com/HCV-viral-load-levels-during-treatment-and-speed-of-decline-do-not-predict-cure-with-interferon-free-therapy/page/2962856/

(Using the more sensitive Abbott assay with a quantification limit of 12 IU/ml, the majority of participants with HCV RNA >LLOQ, or below the LLOQ but still detectable, at week 4 went on to achieve SVR12. There were five people in SYNERGY and seven in ERADICATE who still had detectable HCV RNA at the end of treatment, and all achieved SVR12. The negative predictive value of week 4 viral load was less than 13%. Looking at people with HCV RNA >LL)

willbb · Member

Hello moochie,

Here is some data for your perusal that may quell some of your anxiety. Your chance of success is still very good,given this research.

http://livertree.easl.eu/easl/2017/international.liver.congress/168237/ubaldo.visco.comandini.virological.and.clinical.significance.of.detectable.html?f=m3t4035

337 patients enrolled in the study.
16 patients relapsed.
18 patients were detected, not quantifiable (DNQ) at end of treatment (EOT).
All patients DNQ at EOT or 4 weeks post were reanalyzed using an ultrasensitive HCV RNA test (US).
Out of 18 with detectable HCV-RNA with both tests at EOT or PTW4, only 1 experienced relapse.
Out of 16 relapsers, only 2 showed DNQ at EOT (12.5%)

Good luck on your future labs.

SeeTheLight · Senior Member

Hi Moochie,

Lovely to see you. smile You will get loads of great advice here. I am in Australia and have recently finished 12 weeks Epclusa. I have not been VL Tested at all. They will only check that at SVR12. They do not find the need to know just how many of the little blighters were/are running about in me prior to that. They check only the Liver Function and yours sounds just great. It seemed weird when I found the forum as everyone is so big on VL and I have no idea as I have not been tested. I have been told it is totally irrelevant. The things that dictate my treatment are my genotype (3a) and state of my liver. Anyway I now wait about 10 weeks to learn the result. I have come around to their thinking now. My nurse said there is no point checking sooner as they do not wish to give false results. The drop in ALT and AST lets them know things are looking very positive, and for now they feel confident I am cured. That is enough for me.

I can understand your worry particularly after failing a horrid previous treatment but try not to worry unduly. By what I understand from that reading your number was so low - less than 15 (so next to none) Your Viral Load was in the millions so under 15 in a few weeks sounds great to me.

We all have fears the treatment may not succeed but

- Don't worry about the next step until you have to.

All the Best.

Canuck · Guru

Hi moochie,

Very good concise and thorough historian you are BTW - helps a lot.

So, I love your clarity and honesty, and you are NOT rambling, you organized all the right pertinent info into this post quite well - are you upset?, yep (we can tell), but - who wouldn't be, given the circumstances.

The whole situ you find yourself in does NOTHING for your anxiety. Wipe the tear drops (if there are any) off your screen, and listen to the plausible and likelihood here.

First of all, I just want to say (to get it out of the way) that you should NOT have been dissapointed with your "super-crashed" ALT/AST and VL at 4 weeks - they crashed wonderfully just as the drugs designed, so what! that it was <15 (versus UND) at 4 weeks. You should have been celebrating then, with a good (telling) crash like that. That early 4 week crash is what we all want to see happen on these new DAA's and you did it just like everyone else has done - the early 4 week crash is very telling and it heralds that you will be cured up just like everyone else.

The problem is the now - this early 10 week VL that still showed you being <15 (versus an UND). Despite still having "super-crashed" everything (your ALT/AST even a tad lower), and your VL still sustaining it's <15 crash at 10 weeks - it's the VL not being UND at 10 weeks right now that is what has you unnerved and off the scale of worry, and failure anticipation.

I am with your doc - (I AM SURE) ... "second guessing" what his thinking may be on the matter, that (1) you will be UND right shortly, AND that you will sustain this UND right it through EOT+12 weeks and on. (2) You will NOT need futher Mav, nor will you need re-treatment with any other DAA+riba ... I'm not going there, because i don't think (and i don't think your doc thinks) YOU are going there! Where your ALT and AST has gone, so will the VL follow - it's just timing - you should have been nicely (conveniently), more tidily, UND by now, BUT "Murphies Law", we just had to cruelly test your anxiety levels and patience.

I think your doc knows you will be successful, because you have shown every sign in the correct direction. Had you been showing VL's in the thousands early and that continued, then i too would have been shattin bricks, but go and read all the Mavers we have on the site - quite a few of them were kinda "slow" here and there, I think this is a little bit of "a thing" with Mav (this bit of slowness in going UND), and, with us oldie/goldie stubbornly chronic hepc'ers going UND. IT WILL happen - it probably has already happened! You could be sitting here right now perfectly UND, and will remain so for the rest of your life.

I think your doc knows that this will be the scenario, it's just hard on you - BIG BOO on him from me - for not spending a good bit of time with you discussing his thinking to you and with you! He should have spent more time explaining this to you.

We won't go here - because there will be NO need - but Vosevi would be a choice for you (or anyone) who failed Mav - we have not seen ANYONE fail Mav! You won't either. You would just feel a whole lot better if you had shown your UND at 10 weeks, that's all.

Go back and see the doc, insist he discuss it with you, completely, to your satisfaction - explain to him that you are beside yourself with worrry and that you need his explanation and thinking on the whole of the matter.

Sorry for your worry. C.

5-1-18 · Guru

moochie, i'm so glad you are here. we got peeps that know stuff here so please do chk back in. i'm cheering for you

Hoodietree · Senior Member

Hey moochie,

Others will have more technical knowledge to help you.

I am pretty new here so I cant do much to help except offer my total and complete sympathy. You are going through sooo much right now. I hope you can take it easy and get some good rest. Ill be praying for you every day starting right now. Take good care and please check back in tomorrow.

hoodie

moochie · Newbie

Whoa what did I do... the font so large! Omg sorry *embarresed*

moochie · Newbie

Hi all, Im new to a forum but not new to hep c. Dunno if I can make sense but heres whats up with my journey:

Im a boomer so not a young one and in poor health... very high anxiety type & majorly neurotic.

Diagnosed in 2000, GT 1a, VL 12mil.

Tried & failed treatment in 2012/2013 (nightmare), peg-riba-inc: had 3 transfusions by end of 3rd month & horrid rash & taken off tx.

Via past tests, biopsies, fibrotest, platelets, etc Im diagnosed f4. I do have ultrasounds every 6 months and regular endoscopy & blood-work.

May 25th 2018 was my start date for 12weeks of mavyret.

Just prior to mavyret VL was 6.2mil, alt & ast in the 60/70 range, platelets 19.

My 4wk mavyret blood work alt/ast 12/13, VL was detected <15 which was disappointing but still quite hopeful. BUT I just got results of a 10 week pcr and feel devastated & confused atm because its the same as the 4 wk test, detected <15. Alt/Ast 9/11.

Doctor did a 10 wk test instead of 12 wk just In case I was still detected... said that might give time with decisions & insurance to approve either longer mavyret or switch straight to epclusa. So, low & behold here I am at 10wk still detected. Now my dr has changed his mind and said we wont continue with longer mavyret and wont do epclusa. No idea why he changed his mind. Im only told he will order another VL test at eot which is in 9 days then the 12 wk post test.

Ive read a few of you know someone that was detected but cleared by 12 wk post but it sounds like that was with harvoni and is rare it seems. I havent read that about mav. Dare I risk waiting to 12 week post on a hope & VL spirals upwards?

9 days to finish up this 12 wk treatment. Anxiety is extreme.

My understanding is if one fails on these newer treatments the next meds they use are not only longer than 12 weeks but they also add ribavarin to the next tx. My doctor told me he wouldnt put me on riba again because of what it did in 2013. And epclusa... is that a good choice without ribavarin for someone that is 1a that didnt clear with mavyret? I may be wrong but it seems like many on epclusa are gt3 n gt2. Which med is the best choice I ask myself this cuz I dont have full trust in my dr. Hes a very nice gastro but not fully up on hep c tx imo. Not many choices in the area I live in and no hepatologist anywhere near. Maybe I should wait a few months then try another treatment?

I realize you cant give medical advice but am still interested in your thoughts/opinions.

Apologies for rambling incoherently, Im ALWAYS spacey but right now my fogged brain is werkin overtime, super confused, worried, n majorly disappointed. Thanks for listening to my ramble & thanks for allowing my post.

I fixed it, no probs...

-- Edited by Tig on Wednesday 8th of August 2018 06:10:06 PM

Hep C Discussion Forum

Legal Disclaimer: