TOPIC:

Hello, I am about to begin the 12 weeks of treatment using the Sofo/Dac sourced through Mesochem. Though I have found a doctor in Tokyo, Japan willing to take blood tests he is not very supportive and insists that I pay all costs - actually 200/300% of actual costs as I am not covered for treatment by health insurance as I do not have a prescription. Nonetheless, I am grateful that he is willing to do the tests so accept the situation. He has been pushing the Interferon treatment as it is covered by health insurance but I rejected that option. He is also very, very hesitant to discuss anything related to treatment so I am in need of some advice.

First, some basic background info.

I have had my initial blood work done and have had a CT scan showing no cirrhosis/fibrosis/fatty liver. He will not refer me to a hospital for a Fibroscan and I cannot access it without a referral. I did not have the meds tested for purity, etc., as it is not possible to do so in Japan but I believe them to be safe as many people on the forum are using meds from the same company.

As of two weeks ago some of my numbers were: AST = 45, ALT = 66., HCV = 5.6 L.IU/mL. All of my other blood work shows that I am very healthy for a 53 year old.

On to the questions:

The doctor has recommended that I have blood tests done every 2 weeks during treatment. This seems excessive as the norm seems to be after 4 and 12 weeks, then perhaps after an additional 12 or 24 weeks to confirm there has been no relapse.

1. Can anyone confirm how often I should have blood tests? Is there any value in having tests every two weeks other than perhaps after the initial 2 weeks to confirm no negative reaction to the meds?
2. What tests should be done other than the following: Complete blood count (CBC), creatinine level, calculated glomerular filtration rate (GFR), and hepatic function panel are recommended after 4 weeks. Do the same tests need to be done at 12 weeks or just a HCV viral load test?
3. What are alarm bells to consider with the test results in regards to stopping treatment other than if quantitative HCV viral load has increased by greater than 10-fold (>1 log10 IU/mL) on repeat testing at week 6 (or thereafter), then discontinuation of HCV treatment is recommended?

If anyone has detailed feedback regarding the above questions I would be very grateful for any assistance.

Thanks very much. Regards, Gary

I had a liver function test to make sure I was OK. That was at two weeks. I was having some sides that worried me. All is good now and the results showed I was responding well..... My liver showed great improvement immediately.

I will be getting viral load done at one month. Unless there is issues with your health monthly should be fine as far as I know. I am no doctor of course.

Good luck.

Hi Gary,i cant help much with detailed feedback about blood tests but i can tell you about my experience with harvoni.i am 57 was genotype 1a for about 38 years and got on one of the first trials 2 years ago.
I had not previously treated as i didnt want to do interferon.As it was a trial i was tested at 1 week 2 weeks 4,6 8 and 12.it was a 24 week regimen but for the last 12 weeks i was tested monthly.
The thing i wanted to highlight to you is that although i had absolutely no side effects that i could feel, at my first weeks blood test my liver enzymes were very elevated to the point of concern to the doctors.They said i may have to stop the trial but i pleaded with them not to as i was feeling fine.They let me carry on and by the time i had my 2 week test the liver enzymes had dropped back to normal and my viral load had gone from 5 million to 5 hundred.
i wanted to share this with you as i think it is common for the enzymes to be briefly elevated and you should ask your doctor to get informed about this.Good luck,David

Thanks David. I will probably go with the 2 week, 4 week and 12 week tests. Regards, Gary

Thanks Johnboy. Good luck with your treatment. Gary

Thanks Gary for the information!
I'm starting as well, can you info me about your encapsulation experience...

Thanks! Good luck!!

In the absence of Ribavirin and with you feeling well:

Baseline: FBC, Cr&E, LFTs and Viral load are sufficient

4 weeks into treatment: LFTs and Viral load (expecting normal LFTs and zero viral load). This proves you have the right medication and that things are progressing as expected.

If your liver function is better and your viral load zero at 4 weeks into treatment you can stop testing. If not a repeat in 2 weeks would be sensible.

There is very little point in doing further testing once you are VL 0 until after you finish treatment unless you are unwell.

More monitoring won't hurt (other than your pocket) but is not likely to add any actionable information.

Post treatment we wait to see if you VL 0 was a real zero or if you still had some HCV below our limit of detection (which is where recurrence comes from).

• A viral load of zero at 4 weeks (SVR 4) predicts a 97% chance of being SVR24
• A viral load of zero at 12 weeks (SVR 12) predicts a 99.7% chance of being SVR24
• A viral load of zero at 4 weeks (SVR 24) predicts a 100% chance of being SVR24

SVR24 means < 1% chance of ever seeing the virus again.

Thanks very much, Dr. Freeman. I really appreciate the feedback. Regards, Gary

What is Cr&E?

The same procedure for Sofusbuvir+ledipasvir?

Cr&E = UEC

Urea
Electrolytes
Creatinine

Yes, it is the same for all new DAAs

Just wondering if the LFT's are not normal at 4 weeks but have improved, halved would this still be within normal limits for treatment, still awaiting viral load.

Yes, provided the trend is towards better be happy. Trending worse is bad, trending better is good.

When we look at liver function tests what we are looking at is things like AST, ALT, GGT and LDH that should not normally appear in the blood in high levels. These enzymes are present inside liver cells and when a cell is damaged and die they get released. Now if I stop damaging liver cells right now - what are the levels of AST, ALT, GGT and LDH?

Yes that's right they have not changed. They fall only as our bodies break them down, and our bodies break them down at known rates, in fact exactly the same as for drugs they have a 1/2 life - the time they take to fall by 1/2 if no more is added. Here is the detail:

www.ncbi.nlm.nih.gov/pmc/articles/PMC545762/

Enzyme	t 1/2
ALT	47 hours
AST	17 hours
GGT	4 days
LDH	10 hours to 3 days

In my experience we see ALT and AST fall faster and earlier than GGT and LDH which makes sense given the half lives.

Bilibubin and ALP are indicators of poor drainage from the liver and this relates to inflammation and fibrosis so they tend to resolve more slowly.

Maybe a dumb question, and probably answered before, but (Dr. Freeman) as I see your reference in post above to "Zero" levels, and since my tests appear to only go to the undetectable below 15 mark, is there another more specific test that can identify an actual ZERO level as opposed to just not showing an undetected below 15 marker? I've been wondering about this since I got my "undetected" below 15 at 4 weeks.

I would be interested in this too...my test just had HCV undectable.......not sure where to look on the tests for VL0.

I think they can detect lower that 15 ... they just can't quantify accurately below 15 ... undetected means they didn't find any at all ... doesn't mean there is zero, just that they can't detect it.

That's why you keep treating after you hit undetected, to pick off the stragglers.

And that's why you have to test 12-24 weeks after eot ... if there are too many for your immune system to finish off they'll show back up before that time ... if they don't show back up by then you can assume they were all finished off.

Dr. James wrote a post here somewhere that gives probabilities ... I'll have to look in the expert's corner and see if I can find it.