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Effect of temporary treatment cessation on SVR
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Effect of temporary treatment cessation on SVR

I achieved my "negative" status at week 12 of treatment (Pegasys as that is the SOC where I am), however at about week 14 developed a cellulitus infection in the lower leg that required intravenous antibiotic treatment. The infection turned out to be rather resistant and I went through a a few levels of antibiotics and ended up having a PICC line put in as I ran out of veins for peripheral IV's. After 3 weeks of IV outpatient therapy I was admitted to the hospital with a 40.3 degree fever. I ended up with 2 strains of bacteria infection and a fungal infection in my blood stream, likely from the PICC line and due to low white cells and neutrophils (WBC's had been ranging between 2-2.8 and neutrophils between .7-1.4)
Nonetheless, until the infection was brought under control, treatment was paused. 3 weeks with no interferon or ribavirin. We just restarted, at the full dose, but I am wondering what that pause may have done to my viral count. How much will it affect my chance at SVR?
9 Comments Post a Comment
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Avatar_m_tn
Sorry to hear about all the problems you were having aside from going through the rigors of treatment and glad to hear they finally got the infection under control.

To answer your question about how this has affected your tx. possibly you could answer a few questions..

Would I understand correctly that you are only taking Peg/Riba because you are either Geno type 2 or 3 ?  .

Did they do another viral load test just prior to you starting again and do you know the result of that? Also,at what week did you first get undetected?

Best..
Will
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Avatar_f_tn
Thank you for the response Will :)
I am genotype 1B. I had done tx with Rebetron in 2000 and was a null responder. I live in Canada and the province I am in has not approved coverage for the triple therapies yet-and is unlikely to do so for null responders. We decided to proceed with the tx with Peg Inf and Ribavirin as I was showing an increase in Fibrosis, and with the hopes that even if I only managed a partial response, then I could qualify for coverage when Boceprevir or telaprevir coverage is approved.

Unfortunately, they didn't do another viral load test after the time off. Our medical system only covers PCR prior to treatment, a qualitative PCR at week 4, a qualitative at week 12 (which if comes back as positive is followed by a quantitative to see if a 2 log drop was acheived) and the PCRs at the end and 6 and 12 months post tx.

I didn't respond at week 4, but was neg. at the 12 week PCR. I'm hoping 3 weeks off wasn't enough to allow the virus to rear it's ugly head. Especially since between being on 2 antibiotics, an antifungal, and Riba the nausea is crazy and I don't keep alot down :( even with the help of metaclopramide.

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Avatar_m_tn

Hi..,
Interestingly I am also from Canada ,in Ont. actually. You must be from another province ,as when I treated our health system allowed for an unrestricted amount of PCR's  (while in treatment)  They do limit them here when not in treatment however.

I am very surprised that Vic and Incivek are not approved where you are . They have been available for prescription in Ont. since last July and it was actually "Health Canada " that approved them.

About your situation. I am obviously not a doctor and hopfully yours can guide you properly,however I will give you my layman's opinion .

If you were a true "null" (<2 log drop by week 12 ) previously then doing the same treatment again (just Peg/ Riba) this really did not have good results in the past re-treating with the same regime.

Some would make some changes (ie. doing pegasys vs. pegintron or vice versa ,adding more Riba, trying peg every 5 days instead of 7 in the beggining,,adding  sameE,) and sometimes with a better outcome.

The good thing is that you were Und. this time  @wK.12 so at least you responded this time.

The fact thought that you were off all meds for three weeks and being a prev. null  however I don;t think would bode well  and the chances you had a breathrough within this timeframe would be likely IMO.

I would somehow try to get a PCR as soon as possible ,,your doctor could submit I imagine for one given the extenuating circumstances (having stopped) and your health system may approve this.

If you are still UND then I would carry on ,however if Virus has returned then at best I would imagine when you started again would be considered a new treatment start date and the PCR's need to be altered again anyway..

Hope this helps some, welcome to the group and good luck..

Will
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446474_tn?1404424777
I agree with Will's assessment totally.

Repeating the same treatment, usually produces the same results. Plus having stopped treatment for 3 weeks does not bode well for treatment success.
The statistics for treatment success in previous null-responders are low to begin with (only 5%) even following the proper treatment protocol. Cure rates (SVR) with the addition of telaprevir/INCIVEK is about 30 percent among previous null-responders. (Data from the ADVANCE and REALIZE phase III trials).

It would be cruel to have to wait until week 24, only to find out that the virus has returned.


Best of luck to you!

Hector
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Avatar_f_tn
Thank you both!
My first go round with treatment was with Rebetron-the old 3xweek shot and ribavirin. I lived in BC then so the protocal was to do 6 months then do the PCR which came back positive. I didn't bode well with side effects, thus it took a long time to get the nerve up to try again with Pegasys/copegus.

I live in Alberta and you can get the triple cocktails here, however they aren't covered and I couldn't afford it. They are have been under review since march. It's funny, here we have the most minimal requirements to get treatment covered (either abnormal biopsy or a minimum of 2 sets of labs showing elevated enzymes) but we are slow to approve the cost of the new drugs.

They did the PCR at week 4 (RVR) and I was positive, but week 12 was negative. I hate to say it but I would think three weeks off breakthrough is likely (of course secretly I want someone to tell me otherwise).

Which brings about another question-even if there was viral breakthrough, because there was a response, I could theoretically carry on and be negative by the end-but because we stopped at week 18, then started again that would mean only 30 weeks continuous treatment. I don't know if that would be enough for a genotype 1 to have an SVR. I guess it's just a matter of wait and see. If nothing else, at least I responded and if it means trying once more when the newer meds are covered, at least I'll qualify.


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148588_tn?1405690829
Since you did a non-PEG IFN the first time I don't think you are a "null responder" or that null responder stats apply. If you think you have a handle on the infectons, I would push to have your restart counted as the start of tx and do 48 weeks starting from there. I don't know much about the prophylactic use of Cipro (though I did a course of it during my tx due to cellitis). I think Hector has mentioned this before and might have some input.
Good luck.
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Avatar_f_tn
Cipro is actually one of the antibiotics they have me on, along with ampicillin and an antifungal called fluconazole. After all the IV ones, they sent me home with a few weeks of oral to ensure everything was wiped out. Between those, my Ribavirin and some anti-nausea meds and the occasional sleeping pills for the mass insomnia I get-it's over 20 pills a day :( Yuck.

I had wondered about restarting and doing a full 48 weeks. I don't think my infectious disease doctor would object, it's just a matter of drug coverage. We get 48 weeks for genotype 1 and thats it. But maybe there are ways around that :) Good idea and if I start fighting for it now, then maybe I'll find a way to make it happen :)
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446474_tn?1404424777
You make a good point about the interferon. I looked at the REALIZE trial document and found this...

'This is a randomized, double-blind, placebo-controlled Phase III trial with telaprevir in subjects with chronic hepatitis C virus (HCV) genotype 1 infection who failed prior treatment with pegylated interferon (Peg-IFN; Peg-IFN alfa-2a or Peg-IFN alfa-2b) plus ribavirin (RBV).'

'failed prior treatment with pegylated interferon'
So it is hard to say what type of previous responder he would be. He is not treatment naive but beyond that I don't know.

Hector
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Avatar_f_tn
Well....saw the good doctor today. 2 shots into it again (week 19 and 20). And yes, due to the pause he is arranging a PCR at week 24. He told me that one week missed, not too bad, but 2 or more and the chance of breakthrough goes up.

So....I now have 3 1/2 weeks to go till we see. I'm dreading the wait already.
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