Question about 4-week post-treatment test

[elias]

I'm setting up future appointments for blood work for after I finish Epclusa on January 13.

After the on-treatment 4-week test came back UNDETECTED last month, my GI said only further test needed was the 12-week post-treatment

I asked if i could have the EOT test as well and he said I can , but of course I'd still need that 12 week test. I did schedule an EOT test for a few days after completion of treatment.

However, I'm thinking a 4 week post-treatment test might give me something in the way of reassurance, more so than the EOT test. That might make the long wait for that 12 week SVR more bearable if its still UNDETECTED then   My reasoning is as follows:

When I looked through the Phase III clinical testing for Epclusa, there were a total of 13 who had a relapse. Of those 13 , 10 relapsed by Week 4 post-treatment. So it would seem odds are strong if there's gonna be a relapse, it'll have occurred by Week 4 post -treatment. Conversely, an UNDETECT at 4 weeks post shows high likelihood for future SVR. So a negative 4-week post tx might provide some measure of reassurance for an SVR 12 eight weeks later

I'm not sure this pattern also holds for Harvoni? Nor if it's true for GT2. None of the GT2 cases the Phase III trials for Epclusa had relapsed at all.

Any feedback on my above reasoning?

Dr's secretary said I can have that 4 week post-treatment test if i want it, but was trying to save me the hassles of going through all that. So I'm trying to decide now on scheduling based on above rationale

[andrew j]

You were clear at 4 weeks - therefore if you are clear at EOT, there is a VERY good chance you are, and will remain, clear.

Either way (and particularly at 4 weeks-post) they won't suddenly begin more Tx.

For my money - the EOT test, and then the 12 weeks-post should be just fine.
At EOT, you will know how you're doing earlier.

A.

[elias]

Thanks, Andrew:

I meant doesn't that 4  week post-tx test give much more assurance for future SVR than the EOT test, given the 10 out of 13 relapse patterns I cited above in those Phase III clinical trials?

[andrew j]

Treatment duration might be a factor in that (8 weeks vs 12 weeks)?

If you aren't clear at EOT (How likely is that?!!) they won't suddenly prescribe more treatment - ditto at 4 weeks-post.
So you may as well find out how you're doing earlier (at EOT)?

I guess you can re-schedule you're EOT test for 4 weeks-post if you want to -
or say, at 3 weeks-post?!
... or get two tests done?!

[KimInTheForest]

Thanks, Andrew:

I meant doesn't that 4  week post-tx test give much more assurance for future SVR than the EOT test, given the 10 out of 13 relapse patterns I cited above in those Phase III clinical trials?

Hi Elias. If reassurance is the sole goal of your future viral load tests prior to 12 weeks post, then I would say: Yes, viral load test at 4 weeks post-tx (assuming undetected) will be even more assurance of achieving SVR12 than the viral load test at EOT. But really, the odds of you not making SVR12 are very tiny however you slice it.

Good luck!
kim

[elias]

Thank you , Kim and Andrew:

I'm on 12 weeks Epclusa

Youre right that the likelihood of success with Epclusa is high. But because of the traumatic circumstances by which I got infected, deep down there's voice telling me ill never be rid of it. So yeah, the goal is some peace of mind... I did get a bit of a lift when i was undetected at 4 weeks into tx. though i know that doesn't mean much.

From my brief conversation with dr's secretary, I think my insurance would cover both an EOT vl test and 4 week vl  if doctor orders those. Of course, I'll need that 12 week post as well

[Lynn K]

As far as post treatment testing for Harvoni if you are not detected at 4 weeks post your odds of remaining not detected are about if I recall 98.5% and at 12 weeks post your odds of staying clear are about 99.8% from the clinical trials for Harvoni.

If you are not detected on treatment you will be not detected at EOT.

[elias]

As far as post treatment testing for Harvoni if you are not detected at 4 weeks post your odds of remaining not detected are about if I recall 98.5% and at 12 weeks post your odds of staying clear are about 99.8% from the clinical trials for Harvoni.

If you are not detected on treatment you will be not detected at EOT.

In that case the EOT-test wont tell me anything new. As I was undetected during tx. But the 4-week post-treatment will narrow it down a lot, if still undetected. That's if Epclusa has similar relapse pattern to Harvoni

[Lynn K]

I expect it will be similar except the 4 week number might be even higher as a guess

But yeah the EOT won't tell you anything you don't already know

[elias]

Update on this:

Completed 12 weeks of Epclusa last Friday

I cancelled the EOT viral load test, as it will tell me little. Scheduled an EOT+4weeks viral load. Just to give me some peace of mind. If it's still undetected then..Will then have the EOT+12 weeks to clinch

I've had pretty bad insomnia throughout all this. I have barely had a single good night's sleep. Though i did feel a bit better at the on-treatment 4 week-undetected- test results.

Insomnia continues  even though I completed Epclusa a few days ago. In part, it's being fueled by flashbacks to traumatic circumstances of original HCV infection. Insomnia began once I learned this.But got significantly worse after beginning Epclusa.  Accompanied by obsessive dread of a relapse . Hope this aspect of it subsides soon

[andrew j]

It will - once you are clear.

We are - or were - all anxious about not clearing - about relapse.

You were clear at 4 weeks, and [as you know] there is a very good chance (like an excellent chance!) you'll still be clear at 4 weeks-post.
95+% odds.
... Those are GOOD odds!!

Many of us had long-term infections like you.
I had Hep C for 40 years - twenty of those years in full-blown symptomatic mode.
That was not a pretty thing, I can tell you.
... So it was all going in the right direction for me, even from pretty-much day one of tx.
(My GI said to me 'You won't relapse!
... You know what Hep C feels like ... You'll know if you have relapsed!).

Hang in there!
You're doing well!
We are rooting for you!

Best wishes (as usual),
A.

P.S. Are you taking anything else that might be fueling the anxiety?

(... Whatever the case - the anxiety starts to dissipate pretty quickly following SVR12).

... I breath in ... I breath out ... I breath in ...

[elias]

Hi Andrew:

I'm not taking anything that might be fueling the anxiety. The diazepam prescribed seems to be helping much less than it usually would. Others (at least one) have noted that with Epclusa the anti-anxiety meds hardly worked

I dont think my HCV has been symptomatic in spite of it being long term and F3. At first i was hoping that my messed up circadian rhythm, which began about same time as infection with HCV, might be a symptom of it. So I was hoping it would get better as tx continued. But it only got worse. Several possible explanations. Might be that it simply takes time  after treatment and not all get immediate relief. Or might be that the same traumas around time of infection also messed me up emotionally. More flashbacks to that recently

[Gaj]

Hi Elias,

HCV itself can cause sleep difficulties and quite a few experience additional difficulties while on the various medications. Sofosbuvir has a half life of 27hrs and Velpatasvir is 15hrs so after 7 days both will be below 1% of the levels they were during treatment and can be considered gone by two weeks if the Epclusa was increasing your insomnia. However, it may take a while longer to redevelop good sleeping habits again after so long but it will happen. Here is a link to some good tips http://www.mayoclinic.org/healthy-lifestyle/adult-health/in-depth/sleep/art-20048379

[Lynn K]

I never really had hep c symptoms. When I relapsed after being not detected at EOT when I treated for 12 weeks with sovaldi and olysio. I had no idea I had relapsed my first indication was my liver function tests were again above normal I got my viral load test back a few days later.

[Johnny_Wayne]

I am seeing with more frequency, medical documentation on the web that refers to SVR 24 as the new benchmark for the newer Hep C drugs (anything besides inter/riba). Does this make sense? Has anyone else noticed the shift to SVR 24?

[Lynn K]

 Haven't seen that myself do you have a link to what you're seeing?

 Everything I have seen says that if you are still not detected at 12 weeks post treatment your odds of staying that way are 99.8%

 And I have not noticed anyone posting that they had relapsed more than 12 weeks after their treatment had concluded

[Gaj]

SVR12 with these DAAs is about as reliable as SVR24 was with Peg/riba which is why it is used. For DAAs the relapse rate between 12 and 24 is about 2 - 3 per thousand including reinfections so very low.The medical profession tests and documents past these points which is why they can provide this data but I haven't seen any general recommendations to make a change to SVR24 as the new "standard" (though I suspect I will want to know when I reach that point )

[Johnny_Wayne]

Thanks for the replies. My Hepatologist at Vanderbilt (transplant center) has also stated that he wants to do the post tx at 24 weeks. Either way, I'm ok, but as a former relapser I have trouble placing much hope in short SVR test durations. Honestly, I'm leaning towards his SVR 24 recommendation. I could make a fuss and insist that he order the bloodwork at 12 weeks, but I am loathe to presume anything.

Thanks for the replies.

[Lynn K]

I know what you mean. I was a nullresponder to 3treatments with interferon based treatment and when the new meds were approved I treated and relapsed with 12 weeks Sovaldi / Olysio so even though I was not detected at 12 weeks post but just for my own peace of mind I asked to be tested again at 6 months when I was doing my regular semi annual blood testing.

One thing that would be a sign of relapse is if your liver function tests start to rise above normal. So even though I am not having HCV RNA testing don my regular blood work still has ALT and AST in normal range so I figure I am still good.

Best of luck to you

[elias]

Either way, I'm ok, but as a former relapser I have trouble placing much hope in short SVR test durations.

Hi Johny_ Wayne:

I see by your signature that you relapsed from Harvoni. I gather you're now retreating?
I'm curious what regimen is being used and for how long?

Thanks

[Johnny_Wayne]

elias,
I retreated with 24 weeks of Sovaldi/Olysio/Ribavirin. I did relapse on 12 weeks Harvoni, due to NS5A resistance. Before retreating they tested me for resistance to Sovaldi (NS5B) and resistance to Olysio (Q80K).

[elias]

That relapse mustve been harrowing!

Glad you got chance to retreat and  for longer 24 month ..Did insurance give you hard time with it?

Waiting must be rough. I guess if the hepatologist wont order vl test earlier that 24 post tx, you can get one on your own or even via a family doctor.

My GI didnt think I needed vl test before the EOT+12 week. But I asked for vl tests at sooner interval (EOT+4week), just to get some peace of mind. Most relapses occur in the early few peaks after completing tx

best wishes