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476246 tn?1418870914

4 weeks VL, NOT RVR

what a bummer..... my 4 week VL came back saying....

Hepatitis C (HCV) PCR: POSITIVE                               HCV PCR:  detectable, less than 80 IU/ml, not quantifiable


My hepa was happy that it had gone down from 1.3 million to that... Needless to say, that I wasn't too thrilled, as I was going for UND.

They don't usually prolong tx, but my hepa is open to it, due to the fact that I am geno 3a and partially Black American and that I'm informed and pushing. We had a great discussion and she will do another PCR at 8 weeks. I have stressed that if UND at 8 weeks I would rather add 8 weeks to treatment, than to risk relapse and do this whole thing again.

(I was referring to Dr. D's advice to add 24 weeks of tx after EVR.)

Now she is going to try and find studies supporting the fact to extend, if not RVR and I will supply her with what I have.

So what I would suggest is to go for 32 weeks of tx, if I EVR at 8 weeks. ( 8 + 24)


If anyone has any studies supporting this, could you please let me know... as the more literature I have on this, the better I can argue my point.

Thanks,

Marcia

180 Responses
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Avatar universal
Marcia, I'm a bit confused at your test results.  What is the sensitivity of this test?  From what I'm reading it seems to say that they detect antibodies but not viral load and that the test has a sensitivity of 80 but that there is undetectable viral load at 80 and so all they can say is detectable but less than 80?   Either you have detectable viral load above the test sensitivity or you don't, I always thought..and it seems that you don't from reading it as written?

Hope you are doing okay with the sides.

Trish
Helpful - 0
498948 tn?1253055841
I'm not going to comment on whether or not you should extend tx because I'm a Geno 1b and I know little about Geno 3s.  But I did want to say, keep your chin up and try not to be too disappointed with your four week results.  I felt the same way when I came back with a reading of 24VL.  I felt so sure that I had cleared by that point it put me into a blue funk for several weeks.  When I got my 12 week results back finally and I had reached UND I was elated.  That time will come for you too.

k
Helpful - 0
Avatar universal
Sorry you didn't make RVR.

If I remember, your genotype is 2 or 3? Are you on weight-based ribavirin or flat dose? (how much do you weigh/height and how much riba are you taking? Do you have fatty liver? Insulin resistance? What was your pre-tx hemoglobin and what was it at various points during treatment? How have your side effects been so far? How much liver damage do you have?
------------------
Study supporting extending tx to 48 weeks and weight based riba for geno 2 and 3 who do not ahieve RVR
http://www.natap.org/2007/EASL/EASL_33.htm
http://www.natap.org/2007/DDW/DDW_11.htm

Importance of Ribavirin concentration (Shorter Course Studies)
http://www.hivandhepatitis.com/2008icr/easl/docs/050608_a.html

---------
The other thing is that you're part Black-American, often listed as a negative predictor although recently I've read some studies (can't find them) modifying this a bit.

Sounds like you probably will want to extend. For how long might depend on your viral response (ideally you would be tested weekly from now on, but at least at weeks 8 and 12); how much fibrosis you have; and to some extent whether geno 2 and 3. Also factoring in might be if you've been properly or underdosed with riba so far.

This would be a good question to ask Dr. Dieterich.

-- Jim
Helpful - 0
Avatar universal
Marcia
I think your VL report is somewhat strange. 80 IU is a weird number not to be able to quantify below. What was the tests name?

I would be surprised if you find any studies supporting 32 weeks improves svr.
The only study I am aware of that recommends anything close to this is the Drusano model.
And that suggests 30-34 weeks after UND. You should be considering 48 weeks.

There isn’t much to go on really. Below is a summary

A 48-Week Duration of Therapy with Pegylated Interferon a2b plus Ribavirin May Be Too Short to Maximize Long-Term Response among Patients Infected with Genotype-1 Hepatitis C Virus
G. L. Drusano
The Journal of Infectious Diseases 2004; 189:964–70

If the hypothesis is that longer durations of therapy will result in a higher probability of a sustained viral response, this will have the greatest effect on patients infected with genotype-1 strains.We would still expect to see an improvement in patients
infected with late-responding non–genotype 1 strains.

For patients infected with HCV non–genotype 1, the 80% and 90% probabilities of a long-term antiviral response would require that virus loads be undetectable for 30 and 34 continuous weeks, respectively.


Increased SVR Rate with 48 Wks' Treatment and Higher RBV Dose in HCV Genotype 2/3 Pts Without a Rapid Virologic Response (RVR) Treated with Peginterferon Alfa-2a (40KD) (PEGASYS) Plus RBV (COPEGUS)
http://www.natap.org/2007/DDW/DDW_01.htm


Peginterferon alfa-2b plus ribavirin for treatment of chronic hepatitis C in previously untreated patients infected with HCV genotypes 2 or 3.
Journal of Hepatology 40 (2004) 993–999

Stefan Zeuzem


HCV-RNA was undetectable in serum after 4 weeks of therapy in 33 of 42 HCV-2 and 137 of 182 HCV-3 infected patients. This initial viral response was independent from baseline HCV-RNA levels in HCV-2 infected patients. The week 4 virologic response in HCV-3 infected patients, however, was higher for patients with a low baseline HCVRNA level (90 vs. 79% for patients with baseline HCVRNA #600,000 and .600,000 IU/ml, respectively).

The present study confirmed that an early virologic response predicts SVR [13,15]. The SVR rate in HCV-2 and HCV-3 infected patients who had undectable serum HCVRNA already after 4 weeks of combination therapy was 94% (31 of 33 patients) and 85% (117 of 137 patients), respectively.
Thirty-five additional HCV-3 infected patients cleared HCV-RNA from serum by treatment week 12. The SVR rate in these 35 patients according to baseline HCVRNA (600,000 IU/ml) was 85% (11/13) and 59% (13/22), respectively.

In the present study, the SVR rate was higher in patients infected with HCV-2 than in those infected with HCV-3, suggesting that virologic response rates should be presented according to single genotypes rather than to any arbitrary combination of genotypes. Within the group of chronically HCV-3 infected patients, a higher virologic relapse rate was observed in patients with a baseline HCV-RNA concentration of more than 600,000 IU/ml.

Additional prospective studies are required to address the question whether patients infected with HCV-3 and a high baseline viremia should be treated for longer than 24 weeks.


Peginterferon Alfa-2a and Ribavirin for 16 or 24 Weeks in HCV Genotype 2 or 3
The New England Journal of Medicine

Mitchell L. Shiffman, M.D.,


Accelerate Stats
Genotype 3 Rapid virologic response
Yes…..187/219 (85)
No……57/145 (39)

Patients who do not have a rapid virologic response should not be considered easy to cure and should not be offered abbreviated treatment.

Understanding HCV Nonresponse and Identifying Candidates for Retreatment
Mitchell L. Shiffman, MD

For patients with genotypes 2 or 3 who relapsed after their initial course of treatment, retreatment for a longer duration, from 24-48 weeks, is also a logical approach and supported by a retrospective analysis.[21]
However, no prospective data are available to support this approach.

CS
Helpful - 0
451988 tn?1209911825
you are on the money; that's what they do here in NYC; UND+24w;  you will be undetectable at 8w, for sure; remember most studies look at GT2/3 together; practically  all GT2's are UND at 4w; that often is overlooked; so considering you are GT3, you are not doing that bad, just looking at your log drop; i think 32w is a good idea; good luck to you...
C.
Helpful - 0
476246 tn?1418870914
Trish... thank you... Hope you are doing better yourself.  The sides are a bummer, too. I thought I was seriously anemic, but my Hb from last week was still 12.4. They took it again this morning and the doc will call me tomorrow with the results. Everything else still looks great, except the ferritin has gone a bit above normal range and whites are at 2.2 now.

As to my results, I believe you have misread the results.

It is not a HCV Antibody test, it is a HCV PCR test. If I would have been UND the result would have read

Hepatitis C (HCV) PCR: NEGATIVE  

On the next line it explains that there was DETECTABLE virus below 80, but that it was not quantifiable. It does not say undetectable anywhere.

How I understand it is that they do there testing in stages. They went down to the sensitivity of 80 IU/ml and there was detectable virus.... so they did not go further down to their most sensitive test, which is 20 IU/ml.

The result means that there is detectable VL below 80 IU/ml

Marcia



Helpful - 0
476246 tn?1418870914
Thank you, kitkat! I won't let that one get me down. I just need to work out a good strategy!

Marcia
Helpful - 0
548668 tn?1394187222
I haven't any info to share here, but do you have a written printout of your PCR so that you can quote the type of test here?  

The log drop is still a huge drop, which is certainly showing your system is responding well to the meds.   I guess some more research is on the cards for your decisions;  maybe we should all boycott Dr D's site until you manage to post him?  

Thinking of you heaps Marcia;  I hope some others with similar historical results will come to the aid of the thread with their experiences...
Helpful - 0
475300 tn?1312423126
My GI did not even check my VL until 12 weeks (GT 2B) and I was UND then.   I did reach SVR at 6 months post TX.  Hang in there, you are on top of your TX much more than I ever was.  Good Luck to you!!!!!

Denise
Helpful - 0
476246 tn?1418870914
Thanks Jim.

Geno 3a
Baseline VL 1.300.000
no biopsy due to slow clotting factor (swimming in the dark reg. stage, steatosis, etc.etc.)
2 ultrasound scans confirming no irregularities anywhere
45 years old, other wise healthy
56 kg, weight based Riba 800mg (14,3 mg / kg)
180mcg Pegasys

So I have been receiving SOC, no underdosing or anything.

I had asked Dr. D all these questions before and he suggested that he would probably try to give me a bit more Riba, but my doc wasn't up to that.

His answer as to extending was that if EVR, he would add 24 weeks to tx after reaching UND.

I am already happy I got my doc to do the 8 weeks PCR, as they usually do 4 and 12. I was trying to get a 6 week PCR, but we compromised on 8 weeks. I have stressed to her that if I UND at 8 weeks, I would like to add 24 weeks to that.... bringing me up to 32 weeks.

Marcia

Helpful - 0
Avatar universal
Firstly, sorry you didn't UND at 4 but you are almost there.  Extending 24 past UND sounds reasonable to me.  Hindsight, how I wish I would have have had regular PCR's past 12 weeks so I would know when I cleared -  could have knocked a couple months off of my extention.  Hang tough, I'll bet money you've cleared already -  Good Luck
Trin
Helpful - 0
Avatar universal
Do you have your pre-tx hemoglobin and hgb values during tx? As per studies, including posted above, serum riba values can be very important in terms of SVR. While crude, hgb drop is one reasonable barometer how well the riba is being absorbed. I agree with Dr. D. that you should probably raise your riba depending on both your hgb curve and how you're handling side effects. Maybe arm yourself with his post and some studies and press harder with your medical team. The fact that you did not RVR should give you more ammunition.

-- Jim
Helpful - 0
220090 tn?1379167187
Some tests are quantitative to 80 and qualitative to 10.  The test Vertex uses in the trial is quantitative to 50 and qualitative to 10.  So it is possible to get a result as Marsha did that detects the virus, but can't quantify it.

Eric
Helpful - 0
388154 tn?1306361691
Yea a little bummer, maybe we geno 3 if not RVR shall be treated as a geno 1. The 48 weeks strategi has something to do with the  time it takes for liver cells to be replaised ( at least my doc talked about that), that could vary but 300days could do the trick for some.

If I were you i should start to advocate for 48 weeks.

I also thought  about Dr Ds aproach about extending 24 weeks
after UND.
But i dont think there is any studies backing that up.

ca

PS if you write in to dr D ask him what hes backing that up with.
Helpful - 0
412873 tn?1329174455
I am so sorry to hear you didn't make RVR.  But the huge drop in vl shows you are responding to the meds.  This is just a bump in the road that you will get past..  You are fortunate that your docs will work with you on possibly extending tx.

You and I both put alot of thought and planning into our tx. But as we are learning, the path tx take cannot be predicted.  Ah, the thing we can't control...blood levels!  The one thing I know I didn't factor in, LOL!

Thank goodness for the forum.  Keep researching, keep advocating and you will win this in the end.  The big picture is SVR and you can still get there. :-)

Love ya, sis!!

Izzy
Helpful - 0
476246 tn?1418870914
Thanks everyone. I am so beat up, I will reply everyone later. Love you all
Helpful - 0
476246 tn?1418870914
Baseline hb  13.2
4 weeks        12.4
5 weeks        will get result tomorrow, but I'm sure it's much lower, as I have deteriorated since last week.

VL from 1.3 million to below 80.... I would say the Riba is working and I don't think I should up the dose, as I am feeling mighty bad already
Helpful - 0
476246 tn?1418870914
Thanks for links and info
Helpful - 0
179856 tn?1333547362
Marcia

I don't believe there are any studies out there that would support just adding a random 8 weeks to treatment - it would be do the 24 or do 48 unfortunately.  I had wanted to do 60 weeks and the doctor(s) told me (including Jacobson) that if they didn't have hard evidence that something was beneficial it was not worth just adding extra time helter skelter.......so i did the 72.  The good thing was it worked and was worth it.

Anyway, 80 is practically nothing and most likely you will be UND at 8 so technically you really are still well under the 12 week window.  It just matters how very aggressively you personally want to treat or not.  I can't imagine that the 80 count will still be there at 8 so I wouldn't sweat it much.

Believe me I know how you feel - I know it doesn't make it any easier but...there are a lot of us SVRs out here who did not get an RVR (I did have an EVR at week 4 but never cleared until between 12 - 24 so yup I get the pain at wanting to write that I"M UND email, I sure do!).

deb
Helpful - 0
476246 tn?1418870914
I'm not a geno 1... so not clearing by week 12 would mean STOP.  The 12 week window does not apply in the same way for us as for geno 1.

Dr. D. doesn't suggest adding 8 weeks to tx. He suggests that genotype 3 should add 24 weeks to the time of UND IF EVR.

This is tx he suggested to me:

UND at 4 weeks or before   24 weeks tx (SVR)

UND at 6 weeks would mean 30 weeks tx (EVR)
UND at 8 weeks would mean 32 weeks tx (EVR)

But

UND at 12 weeks would then again mean 48 weeks tx

If not UND at 12 weeks STOP treatment.
Helpful - 0
476246 tn?1418870914
I will present the matter to Dr. D and ask him, if he has any studies backing this up. Or maybe a paper he wrote himself, or something... He must have something to back up his theory, I could show my doc.

I am not in a great hurry, and hope that there will maybe come some more literature on this in the next few months. I mean, I have almost five months to work this out. And she is willing... She suggested herself that she will look for studies on this subject. She really takes her time and we always have long discussions when I'm there. She's actually really cool about stuff and she loves her work very much. I know that we will be able to figure out something. She just doesn't want to do something random with no evidence of it working. Fair enough.

Marcia
Helpful - 0
476246 tn?1418870914
all the others, Isobella, Kristina, nygirl, lolitriqui, GDSgirl, Trinity, thanks for all the input and kind words.

Marcia
Helpful - 0
443006 tn?1229201842
Hi Marcia,

My four week VL, which was HCV RNA PCR, came back less than 75 IU/ML, and I was told by my doctor that that was undetectable because that's as far as the test will go.  You're not much over that at 80, right?  Did you have that same test?  

Keep plugging away.  It sounds like you're SOOO close.  And you're right about on the same schedule as me as far as your HGB and RBC drops.  As soon as I went on Procrit, those levels came right back up to normal and I've been able to reduce that Procrit and I'm still stable and have been able to maintain my 1,000 mg Riba dose.

Hang in there, Marcia.  You're going to make it.

Nancy
Helpful - 0
Avatar universal
Marcia, Sorry to see the news, and I'm praying for a good outcome for you. I will be watching this closely, because I was already having issues with my tx plan.  I'm geno 2, and my NP kept saying that if I was UND at 4 weeks, they would stop tx at 16, rather than 24. (over my dead body).

I'm still meditating for Unnnndddd, unnnnddddd, unnndddd, lol, but realistically,is it even possible to go from 30.3 million to und in 4 weeks?  Has anyone done that??  I was getting ready to ask y'all for clarification on how and what to fight for if I DON'T make it.  Pretty frustrating to think that I'm dam'd if I do, (to 16 weeks) and dam'd if I don't. I'm starting to think that for my situation, your numbers might be better.

Getting nervous here,
cathy
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