Author Topic: About to start Zepatier (Elbasvir/Grazoprevir) (Read 18699 times)

1bit · « **on:** September 03, 2019, 04:24:00 pm »

Hi everyone

Long-time since I was last here, I started my second bout in 2016 (Abbvie3D + Riba) but had to terminate after just 4 days due to severe side effects. before that I was a responder/relapser on Inf+Riba in 2008/09.

Iam now starting Zepatier (Elbasvir/Grazoprevir) on Monday coming and wanted to know if any other members have had this treatment and what I should expect with regards to sides, I found the Abbvie3D+Riba regime way more nasty than Inf+Riba but thats just my personal experience.. I suffer with extreme Anxiety & Depression and my health isnt the best, Im both excited and scared at the same time (sides)

any advice is appreciated

thanks

Lynn K · « **Reply #1 on:** September 03, 2019, 10:29:11 pm »

That ribavirin is tough stuff I took ribavirin during two of my three treatments with interferon. I was a null responder my viral load did not decrease even a tiny bit on those treatments.

I was looking at the prescribing information for Zepatier

https://www.merck.com/product/usa/pi_circulars/z/zepatier/zepatier_pi.pdf

Were you tested for the presence of virus with NS5A resistance-associated polymorphisms?

Several previous scenarios look like they recommend taking Zepatier along with ribavirin. You might want to look the information over.

Wondering why your doctor isn’t going with Mavyret as there is no treatment regimen with ribavirin

https://www.rxabbvie.com/pdf/mavyret_pi.pdf

Or Epclusa which only calls for ribavirin for those with advanced liver disease

https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208341s000lbl.pdf

We have had a couple of people retreat after relapse with one of the new DAA’s they treated with either Mavyret or Epclusa and had great results. I don’t recall anyone retreating with Zepatier. I’m also wondering if with your history maybe you should be taking ribavirin along with Zepatier. I’m thinking ribavirin would be the deal breaker for me.

Anyway just my thoughts as a fellow patient maybe read up and ask your doctor if Epclusa or Mavyret might be better for you.

The PDFs also have clinical trial data and common side effect profiles

Anyway best of luck to you
Lynn

1bit · « **Reply #2 on:** September 04, 2019, 05:37:11 pm »

TBH Im not happy with my specialist because he ALWAYS puts me on cheaper regimens, always 1 or so generations behind what other GP's are giving out, I am dealing with an outreach nurse at the moment and only met her for the first time the other day and she said I would be given either Harvoni or this, I knew straight away that they would give me this because its probably cheaper, and I was right.

She told me that Genotype (1a) doesn't matter anymore? yet I read the same as you on the basic leaflet that it should be given with Ribavirin for G1 or G4?

last time I saw the specialist in April he had a remark "you only get 1 bite of the pie, doesnt matter if you were on treatment 4 days or 4 months".. as he was miffed because I missed an appointment in 2016, I called to cancel due to being too poorly from my 2nd bout on Abbvie3D+Riba to travel and was terminating the treatment due to severe sides, the nurse never told him i called and cancelled so he thinks I DNA'd outright (Did Not Attend), Ive had about 20 appointments with him over 10 years and never missed one but that one, this was in April.. I never heard from him again so I kept trying to call but he was always on leave or on holiday or not available, I had to get my GP to write a letter to see what was going on but I managed to see the outreach nurse, she said he already done the MDT paperwork and had me down as ready to start but failed to inform me to get it started, so she initiated it???
... I think he has an attitude problem, I would get a different specialist but if I do that I worry that the new one will be defensive for his colleague and treat me the same...or I may be refused.

and as far as I know I havent been tested for that thing you say but she did say try not too miss any as you can build up a resistance?

Im not having Ribavirin with this...sorry your post confuses me a little.

1bit · « **Reply #3 on:** September 04, 2019, 05:45:57 pm »

....(continued)

ive just read this on the zepatier PDF:

Hepatitis B virus (HBV) reactivation has been reported, in some cases resulting in fulminant hepatitis, hepatic failure, and death.

I dont have Hep-B but I used to have it? is this a concern? re-activation whats that...causes death??

Lynn K · « **Reply #4 on:** September 05, 2019, 12:51:05 am »

Here is an article about hepatitis B reactivation

https://www.hhs.gov/hepatitis/blog/2017/1/17/hbv-reactivation-during-hcv-treatment.html

Lynn K · « **Reply #5 on:** September 05, 2019, 12:54:36 am »

Per the treatment table for Zepatier several scenarios recommend taking ribavirin depending on the patient’s history and if there is liver damage.

They also recommend checking for that specific type of resistance before treating with Zepatier if you have been previously treated with some classes of DAA meds

Lynn K · « **Reply #6 on:** September 05, 2019, 01:05:30 am »

What is your genotype of hep c?

Per the prescribing information for Zepatier

Patient history:
Genotype 1a: Treatment-naïve or PegIFN/RBV- experienced* without baseline NS5A polymorphisms†

Treatment:
ZEPATIER 12 weeks

Patient history:
Genotype 1a: Treatment-naïve or PegIFN/RBV- experienced* with baseline NS5A polymorphisms†

Treatment:
ZEPATIER + ribavirin 16 weeks

Patient history:
Genotype 1b: Treatment-naïve or PegIFN/RBV- experienced*

Treatment:
ZEPATIER 12 weeks

Patient history:
Genotype 1a or 1b: PegIFN/RBV/PI-experienced‡

Treatment:
ZEPATIER + ribavirin 12 weeks

Patient history:
Genotype 4: Treatment-naïve

Treatment:
ZEPATIER 12 weeks

Patient history:
Genotype 4: PegIFN/RBV-experienced*

Treatment
ZEPATIER + ribavirin 16 weeks
*Peginterferon alfa + ribavirin.

Also recommended testing prior to initiating treatment

“Testing Prior to Initiation of Therapy:

Test all patients for HBV infection by measuring HBsAg and anti-
HBc. (2.1)

Genotype 1a: Testing for the presence of virus with NS5A
resistance-associated polymorphisms is recommended. (2.1)”

Lynn K · « **Reply #7 on:** September 05, 2019, 01:11:14 am »

Ok I just saw in your signature you are genotype 1a so if you have the NS5A polymorphism you would need to have Zepatier and ribavirin for 16 weeks to improve your odds of cure. You need to have the test for NS5A polymorphism to ensure you are being treated properly.

Lynn K · « **Reply #8 on:** September 05, 2019, 01:30:37 am »

Per the AASLD (American Association for the study of liver diseases) the treatment recommendation for a patient previously treated with an NS5A Inhibitor DAA Genotype 1

https://www.hcvguidelines.org/treatment-experienced/gt1/ns5a

Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg)/voxilaprevir (100mg)

the trade name of this drug is Vosevi

The 3D combo you previously treated with is several classes of meds including the classification of NS5A so per the AASLD the recommendation is Vosevi.

“VIEKIRA PAK with or without ribavirin is indicated for the treatment of patients with genotype 1 chronic hepatitis C virus (HCV) infection including those with compensated cirrhosis. VIEKIRA PAK includes ombitasvir, a hepatitis C virus NS5A inhibitor, paritaprevir, a hepatitis C virus NS3/4A protease inhibitor, ritonavir, a CYP3A inhibitor and dasabuvir, a hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor. (1)”

Lynn K · « **Reply #9 on:** September 05, 2019, 01:31:32 am »

Here is general information from the AASLD about treatment recommendations for those who failed prior treatment

https://www.hcvguidelines.org/treatment-experienced/gt1

Lynn K · « **Reply #10 on:** September 05, 2019, 01:38:48 am »

Although hepatitis B virus (HBV) reactivation has been reported in hepatitis C patients who received interferon therapy, rare cases of HBV reactivation occur in the context of direct-acting antiviral (DAA) agent therapy for treatment of hepatitis C virus (HCV) infection. Recent studies observed that the reactivations were predominantly in hepatitis B surface antigen (HBsAg) positive patients, but reactivation can rarely occur in patients who are HBsAg negative and hepatitis B core antibody (HBcAb) positive. The severity of an HBV flare varies. In some cases, severe liver injury or fulminant hepatic failure may occur. HBV reactivation may occur regardless of HCV genotype and type of DAA regimens. The onset of HBV reactivation can range from 4 to 48 weeks after initiating DAA therapy.

https://www.sciencedirect.com/science/article/pii/S2542568418300382

1bit · « **Reply #11 on:** September 06, 2019, 07:52:06 am »

phwoarr! I wished I never asked now lol... I do appreciate the deep research you have done but i think sometimes the less you know the better, I was already scared and now im having palpitations and i haven't even started yet...

it seems to me that HBV reactivation is possible in all or most treatments including the two I had before..

on the Abbvie3D (3 drugs in 2 tablets) + Ribavirin I only managed 4 days before my face turned grey, eyeballs yellow and felt like I was dying, I woke at 2am on the 4th day with 180BPM heart-beat which lasted 7 hours straight.. thus I stopped the treatment, it was 10x worse than Peg-Inf+Rib in my opinion.

Iam in the UK too (just so your aware)

Mugwump · « **Reply #12 on:** September 06, 2019, 04:01:55 pm »

Most importantly IMO if you have extreme fears associated with a DAA treatment is to try to follow a regime that makes some sense during treatment. What I mean by this is if the treatment needs to have a meal consumed to absorb the drug then make certain that you follow the recommendation. For me the opposite was the case with Harvoni treatment. However; carefully staying well hydrated and active during treatment is crucial regardless of which DAA you are taking.

The reason for this is that clearing large amounts of the byproducts of inert HCV, dead liver cells and all the associated substances that are associated with the rapid removal and recreation of liver cells will put stress on your renal system. And this is why you can experience side effects like increased blood pressure, the anxiety that it causes if you stress your system too much during treatment with a DAA. I am also somewhat prone to anxiety and overthinking things at times. What helped me the most during treatment was staying active mentally and physically during treatment and not reading things into every little ache and pain that occurred during treatment.

All DAA treatments will effect your renal and waste systems to an extent so you can expect increased blood pressure for this very reason.

I did experience some rapid heart beat at first with Harvoni treatment and found that getting out and doing relaxed exercises while staying adequately hydrated and properly nourished was the only solution to the side effect of having the sudden renal stress that a DAA treatment creates. All my best and I am certain everyone here is pulling for your success and future free from this God forsaken disease! Eric

Lynn K · « **Reply #13 on:** September 06, 2019, 05:37:19 pm »

Yeah sorry about all that less than happy information. I’m just a lay person fellow patient but your I would suggest you get information from your doctor about the hep b reactivation “black boxed” warning

1bit · « **Reply #14 on:** September 11, 2019, 09:49:47 am »

I started this treatment 3 days ago... the only symptoms so far are extra sensitivity to cold, sound and smell/taste but only a small amount its not serious, in fact, the smell is welcome, being a smoker I usually struggle to smell anything, today I just had to move the ash-tray because of the smell and could smell downstairs cooking!! hehe.

I have been feeling a bit...well..sort of "better" since about 2 hours in, I dunno what or how but I feel a bit 'clearer' and have a sense of well-being, I found others online who had similar experiences with Zepatier and Harvoni, my tinnitus is much less pronounced too (more than 50%) and I recalled that this happened during INF+RIB Tx also but didn't happen within hours like this drug, more of a few months in on INf+Rib that my tinnitus reduced...a most welcome side-effect as you can imagine.

I have been taking the meds with my tea with x1 paracetamol and x1 multivitamin around the 5pm mark as I've read of quite a few people have some acute stomach issues and its of my opinion that its possible these patients took the drugs on an empty stomach. I make sure I drink at least 1-litre of water per day (usually 2-3 x 500ml).

Seems I may be right about the hep-b reactivation in that its a concern on all DAA's, I have assumed this from research, I have not spoken to the nurse about it but I will when I see them next week for a Doppler Ultrasound..bit strange my specialist wants to do this 2 weeks AFTER starting treatment...is this normal?

1bit · « **Reply #15 on:** September 12, 2019, 08:33:52 am »

I woke up at 3am just like last time going into the 4th day with rapid heart rate which set my anxiety off and made it even worse, i also started shivering badly but managed to stop it with extra blankets and breathing exercises and paracetamol and water... if I didnt have anxiety it would have been nothing.

woke up feeling fine just a bad gut, I slept in much longer than normally too

fingers crossed that was just it saying "hi, im here", I feel fine now

Mugwump · « **Reply #16 on:** September 16, 2019, 01:08:46 am »

Quote from: 1bit on September 12, 2019, 08:33:52 am

I woke up at 3am just like last time going into the 4th day with rapid heart rate which set my anxiety off and made it even worse, i also started shivering badly but managed to stop it with extra blankets and breathing exercises and paracetamol and water... if I didnt have anxiety it would have been nothing.

woke up feeling fine just a bad gut, I slept in much longer than normally too

fingers crossed that was just it saying "hi, im here", I feel fine now

For me I was scared to hell because my liver was on the way down and the HCV was starting to weaken me physically. In 2014-15 It was a catch 22 for me with treatment at first, too weak to get effective exercise, overweight with a distended liver and rapid heart beats, dry mouth all the time. Not so much the fear of dying but more the feeling before treatment that my life had just about run its course at the age of 62-63.

Curing HCV turned my life around and focusing on doing things that I put off because I never thought that I would get the chance in this lifetime gave me the strength to overcome all the terror that is having long term HCV.

I truly hope that your fears abate as have mine. It took about 2 weeks into the treatment before I started to hope that my liver would really start to turn around and heal itself. At which point all of a sudden I found a boost in my energy and spirit that comes from having normal liver enzymes and functions for the first time in a great many years.

Your liver should begin to heal very soon and when it does you will begin to feel the benefits of ridding yourself of HCV. I am pulling for you and so is everyone who has gone through this horror.

Eric

1bit · « **Reply #17 on:** September 20, 2019, 06:02:48 am »

ok so im on day 11 and the past 2 nights around 4 hours after taking the Zepatier with my tea I have been having terrible sides similar to previous ones but way more intense, again only lasting about 20-40 minutes.

It gives me an early warning of dull-head and my tinnitus become so loud I can hear it over a loud TV (increased blood pressure) and then the heart starts racing about 160bpm, I also start to feel cold and shivering.. last night was way more intense than the night before and I was actually praying to god cos I felt like I was going to die, I drank a load of water, took a paracetamol and done some slow breathing and I managed to stall it and fall asleep... Iam really worried about this as it was worse then the previous times

anyone else had these symptoms?

Mugwump · « **Reply #18 on:** September 20, 2019, 02:53:55 pm »

Quote from: 1bit on September 20, 2019, 06:02:48 am

ok so im on day 11 and the past 2 nights around 4 hours after taking the Zepatier with my tea I have been having terrible sides similar to previous ones but way more intense, again only lasting about 20-40 minutes.

It gives me an early warning of dull-head and my tinnitus become so loud I can hear it over a loud TV (increased blood pressure) and then the heart starts racing about 160bpm, I also start to feel cold and shivering.. last night was way more intense than the night before and I was actually praying to god cos I felt like I was going to die, I drank a load of water, took a paracetamol and done some slow breathing and I managed to stall it and fall asleep... Iam really worried about this as it was worse then the previous times

anyone else had these symptoms?

I wound up doing a stress test after a visit to er concluded that my blood pressure was up but not to the point where I could not relax. No damage to heart on the monitors or in the blood work on the visit so a stress test. My conclusion after the stress test was that being overweight and a light smoker was most likely the cause of most of my issues with blood pressure and the anxiety that having high blood pressure can create.
Like you I can relax to the point where my heart will stop thumping. So I have been very fortunate in being able to deal with the same issues you are experiencing.

By all means if you feel that the stress of taking the DAA is doing damage or is becoming dangerous, what I suggest is that you write down the specifics of what is happening, the drug(s) that you are on and the timing of their taking. Then call for help if necessary to deal with the drug regime necessary to get rid of HCV.

I was fortunate in that I had a wonderful clinic that kept track of my treatment and my personal day to day state of health. The specialist nurse was fantastic and made certain that my treatment was one hell of a lot easier than Peg and Riba!

I wish you all the best and hope that you can find quick answers as to why you are experiencing extreme reactions almost immediately upon the taking of the drug. Because the drugs should not effect your blood pressure immediately or all be metabolized within a very short period of time. The drugs slowly increase in effectiveness because (their half lives) how long it takes for the drugs to be in lower concentrations in your body and then finally absent is not that fast. There should be no immediate short term increase in renal stress, it should happen slowly over many days not a short time after taking a dose of the medication. So if you are having a reaction as bad as that then please report it to the FDA and your health care providers. [size=78%]https://www.fda.gov/safety/reporting-serious-problems-[/size]

Eric
PS the size78 silliness is happening in the forum software not my typing

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Lynn K · « **Reply #19 on:** September 20, 2019, 03:06:56 pm »

It really sounds more like stress related and les so a result of the meds. Have you asked your personal physician for any meds to help you with stress during this time or possibly looking into yoga or other stress reduction exercises? Have you tried meditation relaxation techniques?

I really hope you can make it through treatment but I really think a lot of this could be self induced worrying so much about side effects you are causing them to manifest.

Maybe see your doctor or a counselor to learn better how to deal with the emotional stress of treatment.

Best of luck

1bit · « **Reply #20 on:** September 21, 2019, 06:33:07 am »

its certainly not anxiety.... but anxiety makes it worse, im kinda pissed off cos i have anxiety and tell everyone cos everyone including the nurse is saying it's just anxiety and it isn't, I've dealt with anxiety for 13 years and I know when its anxiety, it was the drugs but my anxiety worsens it.

last time on Abvvie 3D my face and eyes were yellow after just 4 days and i felt like i was dying then, i stopped immediately and it took another 4 days to start to feel better...according to the stuff ive read thats a sign of hep-b reactivation happening? Im sure ive been tested since then and still negative (but positive for antibodies) but im not 100% sure

Im also pissed off about this BLACK BOX warning and the nurse or doctor not telling me about it, they should be telling patients so they can factor it into a decision, so ive told everyone about it just in case something happens.

Im pretty sure the nurse isn't clued in, she told me no matter what happens DO NOT call 999.. call 101... so these drugs can cause death in patients with Hep-B or had Hep-B and she told me not to ring an ambulance...??

I think my symptoms maybe lack of water, cos thinking back I think I didnt keep it up as much on those days, I drank loads yesterday and last night and I had my pill before bed (with food) so I would sleep through and I was ok, felt irritable and it affected my sleep so think i will go back to tea-time consumption...so hopefully (fingers crossed) it was lack of water.

I am going to start writing daily in my book, thanks for the advice on that I think its a great idea, then I can show them im not just making it all up cos thats how it feels... even in 2016 it did, my specialist is funny with me too for stopping that treatment, its like he doesn't want to treat me after I went to see him in April I had issues with him being funny with me, said "DOESNT MATTER IF YOU WERE ON TREATMENT 4 DAYS OR 4 MONTHS...YOU ONLY GET 1 BITE OF THE PIE" (on about 2016 abvvie3D)...then I waited and waited for months for treatment start and I never heard anything, I would call the hospital and he was always on holiday, on leave or unavailabe...I ended up having to chase it myself through the outreach team, I ended up catching the specialist on the 'back-foot' as i got started before he knew and sent a letter dated 3 months old to my GP saying I am to be started...so its been backdated and sent out to make it look like they weren't making me wait or refusing to treat....cos I also got my GP to write and asks whats going on and why the "1 bit of the pie" comment...

thanks for the advice anyway I really appreciate any support

Mugwump · « **Reply #21 on:** September 21, 2019, 12:32:20 pm »

Just to help clarify why you were asked to have an ultrasound exam. Although the indications on your fibroscan are that your level of cirrhosis has not progressed to a higher level as yet and your liver enzyme test indicate that rapid damage is not happening:
It is still very prudent to rule out any other complications that can happen with areas of the liver and connected vessels, especially the vein going to the spleen and the bile duct. In the case of the liver damage slowly done by HCV it is rare to have severe problems if there is no obvious progression to F4 or cirrhosis.
If you did progress to full blown cirrhosis then ultrasounds would have been called for at least every 6 months to watch for trouble long ago. Your doctors and nurses are doing their job properly and I am sure they have your best interests in mind.

Both Lynn and I have progressed to cirrhosis prior to treatment and cure. So we are very familiar with the tests and why they are done.
Please speak to your physician about why stopping treatment unless absolutely necessary is not a good thing. The over treatment of diseases and incorrect or truncated treatment of bacterial infection with penicillin based drugs is part of the reason why the drugs become ineffective. The very same thing seems to be happening with viruses like HCV that can develop NS5A resistance to treatments.

Just a few more weeks and you will know whether or not the treatment is working for certain. Your doctor should be calling for the mid treatment test very soon if you have not already received the requisition. My bet is that at four weeks of treatment your viral load level will be undetectable!

Chin up and keep your stick on the ice eh; as us Canucks say!
Eric

Lynn K · « **Reply #22 on:** September 21, 2019, 02:47:25 pm »

Hi I don’t mean to imply you are making anything up. Anxiety is a very real condition. What you experienced with developing jaundice on you previous treatment was also a very real symptom. If I were to guess I think it could have been the ribavirin that caused it as that can be a side effect of that medicine. The three times I was on riba I developed anemia another common side effect of Riba.

Your right upping your liquid consumption to the normal recommended amount we all should be drinking every day is what many of us have found to be helpful in warding off side effects especially the mild headaches associated with hep c treatment with the new DAA meds. So the old about two liters of fluid daily should do it. Too much can also be a problem so don’t over do. Also it doesn’t all have to be just water. Fruits that are high in liquid content especially watermelon count toward your fluid intake. Even coffee and tea even though the caffeine is a mild diuretic also contribute to your daily fluid as the intake is greater than the effect of the caffeine. And of course juices, milk and water.

The hep b reactivation black box warning while a concern thankfully doesn’t happen to a large percentage of patients but it can be very serious so something one would want to be aware of. Are you clear of the hep b virus or is it dormant I think if you were cured previously of hep b it’s not a concern only if the virus is sleeping so to speak.

Best of luck hang in there it gets better

1bit · « **Reply #23 on:** September 25, 2019, 09:25:47 am »

I had ribavirin in 2008 and never got jaundice from that then>? this leads me to believe it was the Abvvie3D or combination that caused it.

since making sure i drink at least 2 litres of water per day i have been fine, I've gone back to tea-time consumption too, so it would seem it was very likely lack of water in my system when the pill took effect, also smoking seemed to worsen it too.

I dunno if ive come down with something but i have rough feeling tongue thats very sensitive. its like my taste buds have gone funny, feels like ive been rubbing sandpaper on my tongue lol...

im now into my 3rd week (day 17)... quite chuffed with myself for getting this far considering my history not only with hep-c drugs but any drugs in general...they either work too much or not much at all..

I have been filling in a diary as suggested

my nurses outreach is on the end of my 3rd week dot on and she wants to do my 4th week blood test then??? I told her I dont want to skew results by taking it a week early..her response was "it wont make any difference"....whats your thoughts on that? I think its wrong, I have had treatment "timing" problems in the past with the specialist, where i was still positive at week 12 on Rib+Inf and he wouldnt extend treatment to 72 weeks, I begged and begged and when I ended at 48 weeks he said "oh we were gunna let you go to 60 weeks"... i wanted 72 or nothing...cos if 60 didnt ork then another regimen with 72 weeks would probably be off the table.... it should all be done proper and not piss fart about.

Lynn K · « **Reply #24 on:** September 25, 2019, 10:10:41 am »

All they are looking for on the test is to see if your viral count has significantly decreased assuming they perform a viral load test and how your liver enzymes are doing. The viral load test at this point only confirms patient compliance and has no real diagnostic value. All patients will see a huge reduction in viral load with many achieving non detectable levels of the virus. For most patients liver enzymes will be in or near normal range.

There is no difference in therapeutic meaning if the four week blood testing is performed at 3 weeks or not performed at all. There will be no change in your treatments or the outcome of your treatment.

The only test that has meaning as far as the success of your treatment is the viral load test performed 12 weeks after you have taken your last medicine to see if you have achieved SVR a sustained viral response to treatment.

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Author Topic: About to start Zepatier (Elbasvir/Grazoprevir) (Read 18699 times)