Has Hep C ever returned during Incivek?

[Diana66]

If UND at week 4 is it possible to have the virus returning during the remaining 12 weeks?

Also why is the protocol looking for UND at week 4 and week 12? Why not at week 8 as well?

[BoceprevirGal]

  I havent personally, either on here, or at my very large home support group, who had a 4 wk Und with Incivek, and then a breath-through, during the next 8 weeks of Incivek.
   My Doctor said if a personis Und at wks 4 and 12, then it is more to have a relapse, post tx, then to have a break-through, at the end of tx, but again, I have never heard of someone having a breakthrough during Incivek. It is a very powerful Direct Acting Agent, that is targeting the virus, and killing it off. Just make sure to takeit every 8 hrs, so it can do it's timely job.
   I always felt like that, and still feel like that, and will until I have my 24 wk post tx, on Valentines Day. Right now I feel like my virus is back, because I no longer have the beautiful digestion I did during my Tx. But come to think of it, I dont drink water anymore, or eat yogurt, so why would my digestion be good?
   Keep drinking your water, and keep yourself busy, so as not to worry. I was always cooking up something, when I wasn't working, or taking these little walks. And I planted a funny garden in front of my house, I have huge daisy bushes now, in oarnge and yellow, which remind me of my Tx~
   Pamper yourself to the utmost, during this time period~

[rk2761]

It's good to read that other folks are like me - that they are "certain" the virus has returned. I'm 14 weeks post treatment and I have felt all week and last that the virus has returned. Not quite sure why because I can rationalize away all the reasons why I think it has returned.

Fear isn't always rational but it is crazy-making.

While on treatment, just the two drugs - not 3, I would interpret any different sensation I had as a return of the virus. But I was still UND after 36 weeks. Now I'm still doing it.

Diana, these drugs are crazy and the sides change from month to month, week to week and day to day. Heck, I often felt one thing in the am and another at night. And the sides aren't predictable so if you say you feel different, you just might - but it doesn't mean the virus has come back. It could just mean you are experiencing some other weird side - or something that has nothing to do with treatment.

You have my sympathy and my best wishes.

rk

[Diana66]

Thank you Advocate, fingers crossed (and toes :) )

[Diana66]

Thank you for your support, this is encouraging :)

[slideman]

I too just knew I had had a breakthrough because of all the sensations I was feeling all through tx. Then after tx waiting for my post tx test results. I got my SVR last summer, and even now sometimes I have a hard time believing it. I think because I lived with hep for so long that its hard to wrap my mind around having it gone. Your numbers are very encouraging!!

[Advocate1955]

I think the risk for a viral breakthrough during the 12 week period of Incivek is probably low because you were UND at wk 4 and Incivek is such a strong drug and is doing it's job. The risk of viral breakthrough increases more after Incivek, because those who are poor responders to Interferon and/or have the more resistant strains of the virus have their virus rebound without the Incivek to suppress it. Because it's more resistant, it doesn't go away, and when Incivek is stopped, it replicates. That's what happened to my husband. Try not to worry about this. You will be UND next week.

[can-do-man]

Good post Pooh!

Good luck Diana, try not to worry, alot of us think this.

[Diana66]

Thank you Pooh, this is what I thought. I know of breakthrough after the Incivek finished but have not seen any material or cases about breakthrough during the Incivek - you never know though

Concerned as I had that bumpy start stopping the Incivek and restarting at 4 weeks

[Diana66]

Thank you Hector, I am aware of those definitions. I am UND already but right now I started to feel a bit weird so I am afraid that might be a breakthrough.

[Diana66]

I will do a VL at 8 weeks, which is next Wed. But not feeling great lately and have the same sensation in liver area as I had before I started tx. Plus some other little things which make me think that might not be UND this time :(. I hope to find out in the next 10-14 days

[ceanothus]

Some doctors do another PCR at 8 weeks as well - mine did. Well, maybe that was just because I wasn't UND yet at 4 weeks. I was UND at 8 weeks and then stayed there throughout the rest of my 48 week treatment and beyond. I'm not at the 24-week SVR point yet, but I fully expect to make it.

[pooh55811]

"if UND at week 4, is it possible to have the virus showing detectable during the remaining 8 weeks of Incivek "
----------------------------------

Yes, it is possible. If the virus is UND at week 4, it is still possible to have a DET virus at week 8 or 12. This would NOT be because the virus left and then the virus returned. It would be because the virus never left; it was just that it was below the detectable level at week 4.

The way the drugs work is that the wild type virus is wiped out first. However, we all harbor resistant strains and they are not wiped out as fast as the wild type virus. If the resistant strains are very fit (very resistant) they can increase in number. These resistant strains are the virus that replicate and are detected in a viral breakthrough. If a viral breakthrough is going to occur, it is more common to see a viral breakthrough after finishing the Protease Inhibitor (week 16 or 20 or after).


I know you are very concerned but, if I recall correctly, you have had a very good response to the drugs. Try not to worry too much, although I know that is much, much easier said than done. We all get stressed out and worry about our tests.

Best of luck.

[HectorSF]

Oops, I should have said - during the remaining 8 weeks of Incivek
SO if UND at week 4 is it possible to have the virus showing detectable during the remaining 8 weeks of Incivek ...

Viral response determines treatment duration and stopping treatment rules.

Recommended Treatment Duration

Treatment-Naïve and Prior Relapse Patients
Undetectable (Target Not Detected) at Weeks 4 and 12 - treat 24 weeks
Detectable (1000 IU/mL or less) at Weeks 4 and/or 12 - treat 48 weeks
Prior Partial, Null Responder and cirrhotics patients - treat 48 weeks

Discontinuation of Dosing Patients with inadequate viral response are unlikely to achieve SVR, and may develop treatment-emergent resistance substitutions.
Discontinuation of therapy is recommended in all patients with
(1) HCV-RNA levels of greater than or equal to 1000 IU/mL at Treatment Week 4 or 12; or
(2) confirmed detectable HCV-RNA levels at Treatment Week 24

All of this information is on the printed label that comes with your Incivek. Or on the Incivek website or you could ask you doctor.

Hector

[HectorSF]

'If UND at week 4 is it possible to have the virus returning during the remaining 12 weeks?'

Yes. If HCV RNA rebounds and becomes detectable in such a patient before treatment is completed, this is referred to as virological breakthrough. That is way the viral load is tested at week 24 to see if breakthough has occurred and the patient failed treatment.

'Also why is the protocol looking for UND at week 4 and week 12? Why not at week 8 as well?'

Studies have found that rapid virological response (RVR) and early virologic response (EVR) are other important predictors of a successful treatment response.

RVR is defined as becoming HCV negative after 4 weeks of
treatment.

EVR is defined as having a 2 log drop in viral load (example: 1,000,000 IU/mL to 10,000 IU/mL) after 12 weeks of treatment, and cEVR (complete EVR) is defined as undetectable HCV RNA (viral load) after 12
weeks of treatment.

eRVR (extended RVR) is defined as HCV RNA undetectable at treatment week 4 and 12.  In addition to predicting treatment response, becoming HCV RNA  negative at certain time points is used to dictate treatment duration for the HCV medications used to
treat HCV genotype 1.  

Hector

[Diana66]

Oops, I should have said - during the remaining 8 weeks of Incivek

SO if UND at week 4 is it possible to have the virus showing detectable during the remaining 8 weeks of Incivek

I could not really find any reference, so did anyone hear of anything like this?