Is 4 million considered pretty high?

[moopertan]

So I'm in week 12 of a 24-week drug study that combines the polymerase inhibitor PSI 7977 (Pharmasset) w/pegasys and ribavirin.  I was at the clinic on Tuesday and realized i hadn't even asked what my viral count was at the start of the study.  So the nurse looked at my chart and on the day the study started (Nov 9th), my viral load was 4 million.  I know about 5 years ago, i had a viral count done, and it was 800,000.

So really, i guess my question is, what is 4 million considered?  High?  Really high?  Not so bad?

The study seems to be going well so far, i should know in about 2 weeks what my viral load is (fingers crossed it will be undetected, but i'm trying not to get my hopes up, i just don't want to be disappointed on the off-chance i'm actually getting the placebo of the study drug.)  Side effects haven't been too bad, my hemoglobin and white blood cell counts are low, but not so much that i need to take medication for it or anything.  About the most annoying things are the itching, headaches, and general fatigue feeling.  But it's really not so bad.  (Heck, i even went skiing last week, i just made sure to take it real slow and easy and i only did a half-day.)

So i was just wondering what other people thought about having 4 million as a viral count.  I just wasn't sure what that was considered.  I'll be really curious to find out what my count is in a couple of weeks.

thanks in advance for any feedback

cheers,

-Chris

[philbert58]

As you know I'm also in same study and we basically had same wk-12 results.. I just read where your VL was 284 at wk 4. Didn't you mean wk-12? From my understanding the only VL results we got were wk-12 and after. . I was told we wouldn't know what our wk-4 results were until week 24. Being under at or before wk 4 determines if you need to continue past wk 24. Early pre wk-4 results could possibly cause some to drop out of study that could possibly eventually become SVR. If you know something I don't, please let me in on it.  Later..

[Cory255]

Additionally, This chart indicates the Viral load of 4 million as medium.  
Also, it could be reported as high too.  
Hepatitis C New Drug Research And Liver Health:

Viral Load Chart
Expressed as copies/mL:
Below 200.000 very low
200,000-1,000,000 low
1,000,000-5,000,000 medium
Average viral load at 3,200,000
5,000,000-25,000,000 high
Above 25,000,000 very high

Interpreting Viral Load Test Results
HCV viral load is often reported as low or high.
Expressed as copies/mL:
·Low: less than 2 million copies
·High: more than 2 million copies

Expressed as International Units (IU/mL):
·Low:less than 800,000 IU/mL
·High:more than 800,000 IU/mL

http://hepatitiscnewdrugresearch.com/hcv-viral-load-test.html

[spectda]

I agree completely Will. Those last remaining virons can make all the difference in whether treatment is successful or not. It's wonderful that the odds with the new DAAs have improved so drastically, but 70-75% is not 100% success.

Hitting this virus with all the tools and fire power you can, especially if a person previously relapsed or did not respond still seems like the best approach to treatment even with telaprevir or boceprevir added to soc.

I would want to take as high a dose of riba as I could tolerate safely and treat for 48 weeks rather then 24-28 weeks if I had not been successful previously. All the data still shows that getting to und as quickly as possible on tx and staying that way for the duration is the goal.  

Interferon is still part of tx and I assume a person's response to it is still relevant although obviously diminished by adding a PI. Ribavirin still appears to be perhaps the most important factor in preventing relapse.

[spectda]

Hi chris-

Your viral load was a bit high but nothing particularly unusual for many of us.
I suppose at this point 12 weeks into treatment what your viral load was at the beginning treatment is kind of moot. Many people have treated with higher viral load then you started with and were successful even with riba and interferon alone, also there is a good chance you are getting the trial drug that will of course improve your odds.

Good luck with your results from your trial and hopefully we will hear that you are und very soon.
- Dave

[willbb]

I am in a BMS study and  for sure I had a phenomenal quick drop. However  my point was if that  fast drop was because of the P.I ,it still didn"t manage to clean up them all,so I believe we have to just relax a bit and see how all of these P.I. "s work out, before we can make too many predictions.I am still DET.at wk12 so  we shall see. Also it would seem to me that non responders and relapsers  may not get away with doing just 6 mo. Just throwing that out there.

Yes ..hope so on the SVR and  Thx. for that

WILL

[copyman]

I meant what study you are in, etc.

Either way that is a great drop and you are probably Und now. Even if you didn't get the real study drug your results are still great from just reg combo drugs.

It does look like you are on your way to SVR.

[willbb]

copyman: told you my stats  9.7 mill   4wk  284     Hope things work out to . thx

[copyman]

willbb, not sure what your stats are , still treating etc. But hopefully things work out.
I also had 9+ million vl when I started the Telaprevir study. I was Und sometime before 3 weeks.

Trin, you can hold me to it. I will give you my personal guarantee that you will beat it with the new PI's. And I bet with only 6 months tx!  
And I don't throw my guarantee around that much :)

[willbb]

Copyman:  If I got the P.I it knocked down 9.7 mill in 4 weeks  but for some reason left 284  so lets all relax. :)

[Trinity4]

Actually, my last viral load a few months ago was only 400,000 so I'm holding you to it when I treat again this summer.  (hopefully)

Wouldn't it be grand to see a UND at 4 weeks or better yet 2 weeks.  

[copyman]

With the new PI's it really don't matter what the VL is. PI's  knock out 20 million virons the same as 400,000, in just a few days.  Viral load will play even less of a part of treatment strategy in the near future. You heard it here first :)

[orleans]

Low vl < 400,000 is also important if one is considering shortening tx from 48 wk to 24 wk if coupled with evr ie. und at 4 wks. Europe changed it,s soc along these lines a couple of years ago.

[Bill1954]

Adding to that from the EASL ’07:

400,000 IU/mL Is New Cut-Off for Low vs High Viral Load in HCV

AUTHOR CONCLUSION
"The current GAM analysis demonstrates that an HCV RNA level >400 000 IU/mL is the most clinically relevant definition for HVL. This threshold, based on using the COBAS AMPLICOR HCV Test, best differentiates the probabilities of achieving an SVR with peginterferon alfa-2a (40KD) plus ribavirin. A 400 000 IU/mL HCV RNA cut-off resulted in the greatest difference in SVR rate between patients with a LVL and a HVL. While HVL remains a poor prognostic factor, it must be remembered that HCV genotype 1 patients with a LVL have a high chance of SVR, which increases as baseline HCV RNA decreases. Others have also demonstrated that a baseline HCV RNA cut-off of 400 000 IU/mL best discriminates between LVL and HVL in HCV genotype 1 patients based on the probability of achieving an SVR.[8,9] This validated cut-off can now be incorporated into the design of prospective studies that are examining alternative treatment strategies in this 'difficult-to-cure' population.”

http://www.natap.org/2007EASL/EASL_41.htm

--Bill

[Trinity4]

I guess it just depends where you look.  Pearlman in Atlanta told me anything over 800,000 is considered high so I think it varies with documentation and specialists.

Hepcadvocate:

Interpreting Viral Load Test Results
HCV viral load is often reported as low or high.
Expressed as copies/mL:
• Low: less than 2 million copies
• High: more than 2 million copies
Expressed as International Units (IU/mL):
• Low: less than 800,000 IU/mL
• High: more than 800,000 IU/mL

US Department of Veteran Affairs:

viral loads >800,000 IU/ml or >2x106 copies/ml are considered "high."(1,2) Some laboratories will give values merely as a range (eg >800,000 IU/ml). Since a "2-log reduction" after 12 weeks of interferon therapy often requires precise knowledge of pretreatment viral load, practitioners may ask their referral laboratory to further "dilute" samples to yield an estimate of the height of viral loads outside their usual dynamic range.
"High" viral loads are associated with lower viral clearance rates in all published studies of interferon and ribavirin therapies.

Hepatitis Central

200,000 to 1,000,000 low

1,000,000 to 5,000,000 medium

5,000,000 to 25,000,000 high

above 25,000,000 very high

[copyman]

Not really that high. It is about average. 1 million is really no different then 5 million.  

It may have been that on the day blood was drawn your immune system lost the constant battle going on with the virus. On a different day the immune system may have had the upper hand and viral load could have been only 1 million.  Hope my explanation makes sense.

Anyway good luck being UND on the next test.

[Trinity4]

4 mill is considered a high but viral load is really only relevant when determining how we are responding to treatment.  Low viral load <400,000 has been indicated as a positive factor for treatment response but there are those who had a low viral load and still responded slowly to treatment or ultimately relapsed.

Good luck with the study,
Trinity