Harvoni without hospital Help

[untreated]

Hi All,

Amazing to find this forum. I have placed a similar post to this somewhere else on the forum, so apologies if it is your second time reading this.
I'll cut right to the chase. I tested positive for Hep C Genotype 1A November 2016.
All treatment in Ireland has been halted because of budget issues. It is a disaster. So..I stepped up to the plate and managed to secure Generic Harvoni which has cured a friend of a friend. The thing is it is not approved in Ireland so i have to take it without the add of Herpetologists.....I know. I am aware of the risk.
It was a hard decision.  But, it is either continue to let the disease eat away at me, only to be treated with Sofobuvir and ribiviran, a daunting prospect for someone who already has mental health issues or take a perfectly working version of Harvoni by myself and be clear of Hep C by January...
My liver is supposedly healthy (the other post I wrote has the details of my results) so I am just wondering what test i will need to keep taking during the treatment. (I will get a private doctor to do these tests.)
Any advise or guidance would be greatly appreciated.
Good luck to you all.

[lporterrn]

Here is what is recommended by experts in the U.S.: http://www.hcvguidelines.org/evaluate/monitoring

You may also want to contact Greg Jefferys if you have questions re generics. His contact info is on his blog pagehttps://www.hepmag.com/blogger/greg-jefferys

Good luck.

[andrew j]

I received only minimal supervision, for reasons broadly similar to yours.
(I was, however, supervised by a hepatologist).

I live in New Zealand, and straight-forward cases here and in Australia are now supervised by GPs - so you should be fine.

Typically - you get a blood test done just before starting treatment (which includes liver function, and viral RNA (viral load)); another test for liver function 4 weeks into treatment - and the tests for liver function and viral RNA again at 8 or 12 weeks, depending (End of Treatment), and at 12 weeks post-treatment ... at which point you are hopefully declared cured! ...

Best of luck!
You shouldn't need it!

P.S. Try to eat as healthily as you can - and drink plenty of water ...

[untreated]

Andrew,

That's fantastic news, thanks for that. One thing....How do i know if 8 or twelve weeks is the right amount of time?

I was just going to do the 12 as a precaution.

[gnatcatcher]

...How do i know if 8 or twelve weeks is the right amount of time? ...

You've already said your genotype is 1A. The official Harvoni prescribing information:
http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf
has a chart on page 1; this latest version of the prescribing information seems to have discontinued advising anyone with genotype 1 (whether A or B doesn't matter) to take only 8 weeks. Since you are treatment-naive (you haven't been treated for HCV before), the only question is whether you have really bad cirrhosis, which would require ribavirin in addition to the 12 weeks of Harvoni.

On your other thread, you posted this result:
Results Fiber scan: Cap (dB/m)   IQR 20 Median 196/  E[kPa]  IQR 1.0 IQR/med 18%   Median 5.7
"Fiber scan" sounds like what is called FibroScan here. IF the "196/ E[kPa]" corresponds to what would be 19.6 kPa in the US, then that's extremely close to my pre-treatment FibroScan (see below my name). Again, IF I'm guessing correctly on how Ireland reports things, and because you wrote, "My liver is supposedly healthy," that would mean you don't have decompensated cirrhosis, so you wouldn't need the ribavirin but WOULD need 12 weeks of Harvoni.

Gnatty

[dragonslayer]

You've already said your genotype is 1A. The official Harvoni prescribing information:
http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf
has a chart on page 1; this latest version of the prescribing information seems to have discontinued advising anyone with genotype 1 (whether A or B doesn't matter) to take only 8 weeks.

Gnatty

Gnat, just to correct the record, even though this doesnt apply to the op because of his cirrhosis, beneath table 1 on pg 4 is the same conditional recommendation for 8 weeks that its always been:

"HARVONI for 8 weeks can be considered in treatment-naïve genotype 1 patients without cirrhosis who
have pretreatment HCV RNA less than 6 million IU/mL [see Clinical Studies (14.2)]."

[gnatcatcher]

Thanks, dragonslayer. Glad you didn't stop reading after the page 1 chart.

[andrew j]

Hi Untreated,

If in doubt, you're Dr. should be able to advise you on what's best.
Otherwise, you may be able to get advice from one of the Australian Drs through Fix Hep C Buyer's Club, or Greg Jefferys.

If you've already got the meds, I would take the full 12 weeks - it gives you more safety margin.
You may be able to get Riba in Ireland if you need it (Hopefully, you don't).

Best wishes.
A.

[untreated]

Hi all,

Andrew unfortunately my Hep Doc is impossible to get an appointment with. I will do the checks for Liver Function and RNA with my regular doctor as shared here.

Gnatcatcher my E[kPa] is actually a median of 5.7. Which I'm assuming is low right?
It was my Cap[DbM] that was 196.

I think my liver is fairly healthy as I had a test 9 years ago and tested clear for Hep C. So i'm pretty sure i have`had the virus less then 10 years.

I had also slowed down my drinking in the last few years and changed my diet.....it's like I unconsciously knew there was something wrong.

Anyway, thanks for all this help. I will keep you all informed about how it is going. and let you know if there are any drastic changes in the next week or two.
 

[gnatcatcher]

…Gnatcatcher my E[kPa] is actually a median of 5.7. Which I'm assuming is low right? It was my Cap[DbM] that was 196.…

Ah, good! So, you don't have cirrhosis -- a 5.7 kPA fibrosis level is quite low. Therefore, as dragonslayer points out, if your viral load is below 6 million IU/ml, you could get by with eight weeks instead of 12. Page 22 of the prescribing information (both the Genotype 1a line and the paragraph below the Table 6 notes) is relevant.

Best wishes,

Gnatty

[untreated]

Hi all,

Thanks for the advice, i am 8 days into treatment. Very tired, some headaches, but otherwise good. JUst wondering, what i should do test wise, for anemia etc....started a new job and am finding it hard to keep the pace.

otherwise good. haha. I do feel a little high, childish almost, giddy, just with no ebergy. It's confusing. Anyway, my test for the viral load got pushed back. I had them done today, 8 days in, and will see the results next week. i Figure i'll do the 12 weeks to be on the safe side........yup. that's all i got.

[gnatcatcher]

Re: the headaches -- staying well hydrated minimizes them. A rule of thumb is one ounce of fluid for each kg of body weight.

Since you have fatigue, if you are taking the pill in the morning, you might want to gradually adjust the time (perhaps by an hour per day) until you're taking it after your work day is over, so that you'll be the most tired during the night.

I hope someone will be able to answer your question about what to do test wise.

Best wishes,

Gnatty

[Gaj]

Hi untreated,

For blood tests, your private doctor can run Liver Function tests (LFTs) and Full Blood counts (often called FBCs) and a couple of others that will show any issues such as anemia although this one is unlikely to be treatment related as you are not taking ribavirin.

For viral load testing the 'Gold' standard is to test at 4 week intervals on treatment until undetected (there is little point testing on treatment once undetected) then at end of treatment and at 4, 12 & 24 weeks after treatment. This can provide some confidence to the patient and can be useful if determining retreatment for the unfortunate few who relapse. BUT....for the various usual reasons such as costs, policy and access to these tests many are only tested at end of treatment and 12 weeks after which are generally considered the most important ones.

As Andrew J mentions, in Australia patients without complications are now usually treated by GPs. A specialist still needs to sign off the approval but your GP does the diagnosis, recommends treatment and monitors it. To assist international GPs the Fix Hep C website Andrew mentions has a tab in the Forum section called "GP Cheat Sheet" written by doctors for doctors that covers the above in more detail. I recommend you print that out and give it to your private doctor to read.

Best wishes for your successful treatment. 

[andrew j]

Yes.

The essential pattern in the U.S. [for a 12 week treatment] seems to have been to test just prior to commencing Tx, then testing again at 4 weeks, at End of Treatment, and 12 weeks post-Tx.

That's basically what I got, and gives pretty good coverage.

Follow-up testing can be conducted every 6 months, depending ...

It would be good to have a test done at 4 weeks (including Liver Function, and VL) so you can get your bearings.
(You were late with your pre-Tx test, and so won't have a reliable baseline) ...

P.S. I like your description of what it's like to be 'under the influence' of Harvoni!

A.

[untreated]

Hi there,

Thanks for all the replies. I've been so busy with work that i have not been back in a while. Very tired all the time, and bit slow in cognitive function, otherwise, not to bad.

Thanks Gaj, I'll print that as soon as I can. To the rest of you thanks again, had to tell my new job today that I'm ill (I was not sepecific)and on medication. It is a high pressure job and needs a lot of focus, so...well i was struggling, they are giving me time off. which is amazing. So rest is on the way, health comes first, was a risk tbh.

Anyway that's off point, thanks for the advise I'll keep you informed.