4 week Viral Load Results

[veryhopeful428]

Good Morning,
I just received my 4 wk viral load. Please help me to stay hopeful for the treatment.
Jan. 2011 - Before Treatment Resulsts  - Viral Load (760513) - ALT  (182) - AST  (177)
Apr. 2011 - 4WK Results -                         Viral Laod  (720000)  -  ALT (70)  - AST  (54)
Hep C - Genotype 1A - Not overweight - age 48

I need advice. Thank you.

[can-do-man]

Even if you don't get the 12 week results your looking for, you still should remain 'very hopeful'. Sounds like you have no damage, still young and have many years ahead of you as HCV is mostly slow moving as what appears to be your case.

New and promising drugs seem to keep popping up, time is on your side so enjoy life.

cando

[HectorSF]

I am sorry to hear about your non-response to treatment by week 4. Since you are not responding to treatment, perhaps you want to talk to your doctor about the IL28B genotype test before starting retreatment? The results will give you an idea of your chances for SRV.

http://www.hcvadvocate.org/news/reports/AASLD%202010/AASLD%202010%20All%20Abstracts-1.htm

"The IL28B genotype is a major determinant in the induction of a virological response by high-dose peginterferon and ribavirin in null-responders to standard-of-care therapy.

Polymorphisms upstream of the region encoding IL28B have been shown to be associated with both natural and treatment-induced control of HCV infection. With new therapies using direct acting antiviral molecules, a null response to IFN is associated with treatment failure and selection of resistant viruses.

Goal: Our goal was to assess, in null-responders to IFN-ribavirin therapy, whether the IL28B genotype has an influence and predictive value on the ability of high-dose pegylated IFN and ribavirin retreatment to induce a virological response.

Methods: 83 genotype 1 null-responders received peg-IFN alpha-2a, 360 μg/week in one or two injections, plus ribavirin, 1000-1200 or 1200-1600 mg/d. Genotyping of the IL28B SNP rs12979860 was performed from host cell DNA by means of a real-time PCR method using minor groove binding probes.

Results: The IL28B genotype was determined in all 83 patients: 3 (3.6%) had a CC genotype and were removed to allow comparison between CT (n=55) and TT (n=25) patients. The difference between reductions in HCV RNA levels between TT and CT patients was significant at week 2 (<0.5 vs ≥0.5 Log, p=0.02), at week 4 (<1 vs ≥1 Log, p=0.008), and at weeks 12 and 24 (<2 vs ≥2 Log p=0.02). When comparing CT and TT patients, the odds ratio were 3.09 for a more than 0.5 Log drop at week 2; 3.86 for a more than 1 Log drop at week 4; 3.08 for a more than 2 Log drop at week 12; 3.10 for a more than 2 Log drop at week 24; and 3.57 for an undetectable HCV RNA at week 24.

Conclusions: Most patients who fail to respond to pegylated IFN and ribavirin carry either TT or CT rs12979860 genotypes. CT patients are significantly more likely to respond to higher doses of IFN and the difference is significant at week 2. This indicates that the IL28B genotype is a marker of host cell responsiveness to IFN. These findings will have major implications in the treatment of HCV infection with higher peg-IFN doses in combination with ribavirin and direct acting antivirals."

---------------------------------------------------------------------------------------------------------------------------
"IL28B Genomic-Based Treatment Paradigms for Patients With Chronic Hepatitis C Infection: The Future of Personalized HCV Therapies
Am J Gastroenterol 2011; 106:38–47; published online 5 October 2010

http://www.nature.com/ajg/journal/v106/n1/full/ajg2010370a.html

Sustained virological response (SVR) rates by host IL28B genotype for African Americans .
C/C = 53%
C/T = 19%
T/T = 17

Note that these data are from an adherent cohort. For each ethnic group, the proportion of patients with favorable IL28B C/C, and the C/T and T/T less favorable genotypes."

Also note that the data is based on today's standard treatment of SOC meds, NOT with the addition of a DAA.

Hang in there.
Good luck!
Hectorsf

[GSDgirl]

Hi Billm, grand poobaa.....haven't seen you around in a while

[nygirl7]

Yes, Jan 2011 before treatment my viral load was 760,513 (low range)
Mar. 11th - Started treament
Apr 4th - 4 week results - viral load 720,000 "

Techincally if your viral load went up greatly right before you started treatment and then you were not tested right before you started........it could skew the results greatly.

I would definitely ask the doctor (nicely insist) on an 8 week test. Insurance shouldn't care and since the docs already botched up your test schedule (great call on that one Robert totally went over my head) although I know I had a test two months before I started too - just like this person, my doctor didn't know that much really I never had a right before treatment baseline either.....(but in my case it didnt' matter).

I mean it's a far outside shot because at week 4 nobody should have a 700,000+ count on a 4 week PCR, not even if they started with 70million.....but it could show that there was some reaction to the IFN.

Good catch.
I guess in this case it's a wait and see what happens but I certainly would insist on the 8 week test to see if I had any improvement!

[Fnzol]

"My doctor was so hpeful and sure that my viral load would come back negative"

Your doctor, if he/she actually said that, was doing you a disservice.  

[RobertBeWell]

You should have had your viral load done on Day 1, March 11th, immediately before you took your first shot and pills. And by immediately, I mean you should have had a blood draw, then taken the meds ASAP afterwards.

There isn't any way to make sense of the result otherwise. Viral load can and does fluctuate all the time. This, coupled with the fact that your liver enzymes have dropped significantly seems to indicate you are providing the wrong information.

Since you don't know your starting viral load, I'm not sure what you can do except continue on to week 12.

Also might ask your doctor how they could have made such an omission.

Best of luck

RBW

[Fnzol]

"Anyway, I believe that I am negative and the results have not come through yet. On my 12 weeks, I will be negative."

Not according to your viral load numbers.  You're not responding.  African Americans are known to respond less well to standard treatment.  

"I just don't understand why the ALT & AST would go down and not the viral load."

They can cycle above and below the cutoffs.  

[Bali05]

I would check for insulin resistance HOMA2-IR

[veryhopeful428]

Yes, Jan 2011 before treatment my viral load was 760,513 (low range)
Mar. 11th - Started treament
Apr 4th - 4 week results - viral load 720,000

Maybe the meds haven't kicked in yet?:) 12 weeks will be the negative I am looking for!:)

[nygirl7]

Dear Hopeful

I too had a low starting VL and as I said above I had a heck of a time getting to UND at all myself. Sometimes it seems that perhaps our immune systems are doing such a bang up job at trying to kill the virus the interferon can't help ramp up the immune system cause it's already going gangbusters. That is what some of us surmised so there really isn't too much science behind it except to say - sometimes the low VL works negatively against us.

Fortunately for you you dont have much liver damage so you do have time to see what happens. And you are lucky because the new drugs will hopefully be out soon regardless. It's looking much more positive for people treating now than it was way back when I treated.

What ever you do dont give up.....your attitude will keep you strong for sure and we will be here hoping all the best for you.

[willbb]

  Thanks..that was a cut and paste...looks like a typo  on their part ..if i refer to that again I will change it..thanks again

WILL

[FlGuy]

Just a minor thing in your post.  It could be part of something you cut and pasted..

"Null response means that hepatitis C viral load drops by "less" than one log (10%) after four weeks of treatment, and drops by less than two logs (99%) drop after 12 weeks of treatment."


I think that a one log drop is 90%, not 10%.  For example the log of a million is 6, the log of 100,000 is 5.

[willbb]

Did you get a viral load test done right before you started treatment?

[can-do-man]

Like was said please check your viral load numbers, your starting viral load is really pretty low.... Best to you.

[veryhopeful428]

The lab results I posted in Jan. were before treatment. Mar 11, 2011 started treatment Apr. 4, 2011 4 week lab results. I received the ALT & AST results before the viral load from Apr 4th. My doctor was so hpeful and sure that my viral load would come back negative and when it did not - all the other. I just don't understand why the ALT & AST would go down and not the viral load.

[willbb]

It would be helpful if you could type in your  results with dates

[spectda]

Were the results of the labs you posted from the first day of treatment or were they from january which was 3 months before your 4 week labs?
-Dave

[Bali05]

sure you don`t have one of zeros wrong ?

[willbb]

.
I agree with nygirl....unfortunately your lack of response at the 4 week mark is very predictive of a null -response according to the article below. However if you are in a trial they may want you to continue till week 12  as Dave says above to be  able to apply the study drug. If however you are not in a trial it may be best to talk to your doc about  the future meds that are showing great promise for Geno type 1  Again like everyone has said ,,there is much reason for optimism with what is on the horizon.

WILL




Presented at the AASLD meeting was this abstract on SOC therapy; "High Correlation Between Week 4 and Week 12 as the Definition for Null Response to Peginterferon alfa (PEG) Plus Ribavirin (R) Therapy: Results From the IDEAL Trial"
,
Predictive SVR In Viral Load Testing At 4 and 12 weeks
.,
This was powerful information with results showing a "less" then 1 log drop in viral load at week 4, equates to a "less" then 2 log drop in viral load at week 12. Both are an earlier predictor of "null response".
..
Fact; 97% to 100% of genotype 1 patients in the study who failed to attain an early virologic response (less then a 2-log drop at week 12 of treatment) failed to attain a sustained virologic response (SVR)
..
What is null response ?
"Null response means that hepatitis C viral load drops by "less" than one log (10%) after four weeks of treatment, and drops by less than two logs (99%) drop after 12 weeks of treatment."
..

[spectda]

It's interesting that her LFTs have dropped although her viral load has not. Is it common for this to happen in non-responders?

- Dave

[veryhopeful428]

I'm sorry. When I was diagnosed in Jan. 2011, I started treatment On Mar. 11, 2011, my biopsy was very good. No chirrosis, cancer, or liver damage. My doctor recommended that I go on the standard treatment. Then at 12 weeks if my results were not negative, then we would get the extra drug (I fogot the name of it) but you get it in addition to the standard Ribavirin (200mg- 2ea morning & 3ea evening everyday) + Pegasyus shot once per week (180 mcg)
I am African American, genotype 1a etc.. Dr. said because the trail is ending and the FDA may approve the drug before my 12 weeks are up, then approval - get new drug - no approval wait 12 weeks then get additional drug through the trail.
Anyway, I believe that I am negative and the results have not come through yet. On my 12 weeks, I will be negative.
I am just very very hopeful and positive. I am to young for all of this!:)
Thanks -

[nygirl7]

A null response at week 4 carries different ramifications than a one log drop for example.

This person has had no response to the interferon at all.  I would bail and wait for the new meds. According to Berg we all know that the closer you are to UND at week 4 the better your chance of success. With a zero response the odds are very much against it.

I had a 3 log drop by week 4 but then did not clear until week 24 and had to extend to 72 = but at the time there were no new meds on the horizon......if there had been I would have stopped, even with such a great initial response it was tough.

Just my opinion but I'd ask their take on Berg.

[spectda]

There is every reason to be hopeful. New drugs are being developed very rapidly for hcv currently. The pharmaceutical companies are very inspired by the financial gain associated with winning the race to offer more effective drugs. It's never been better for those of us with genotype 1.

Were you saying that you are participating in a trial or just referring to meds in trial? Did you have a biopsy and what was the result? It makes sense that the doctor would continue to treat you even if you are not responding well to insure that you are approved to add boceprevir or telaprevir.

Good luck and stay positive,
Dave

[Bill1954]

Oops, missed the trial info too…