hep c 4,8 and 12 week viral count

I started treatment 1st of May. 2.7 million viral count at start. Went to 16,500 at 4 week test. At 8 week test the viral count was still showing at 861. I am now waiting on the 12 week results. I am type 1 and appears little to no damage. How do they count? And what is considered 0? What would cause my start to be so good and slow down? And when could I try again if it does not go to 0?

[Marc1955]

Cindy – You shouldn't worry. Normally with treatment of type 1, they want you to reach a zero viral load count by week 24. So you have plenty of time to hit that mark. Hopefully you'll hit it at week twelve.

When they say zero, they basically mean that the virus is undetected given the limits of the test. The old tests used to test as low as 50, but the newer tests go down to 10.

Good luck. Sounds like things are going well.

[jmjm530]

"Zero" means undetectible to the sensitivity/limit of the test used. These days many liver specialists (hepatologists) prefer to use very sensitive tests that go down to 5-10 IU/ml.

I disagree with "Marc" above, regarding tx goals for genotype 1's. UND by week 4  (or less) is the brass ring and UND by week 12 (or sooner) still gives you a decent chance of SVR with only 48 week of treatment. If you're still detectible at week 12, then studies suggest you will have to extend tx to 72 weeks for a decent shot at SVR (cure).

In your case you had a two-log drop at week 4 but the virus still hangs on a bit. Hard to say why, but some of us have had success bumping up the riba dose a bit, especially if it appears that our hemoglobin didn't fall very much from pre-treatment baseline. Something to discuss with your liver specialist especially if you do not go UND by week 12.

As to "when to try again", this is a complicated question because first you have to end treatment which often at least partly a subjective judgement call based on projected odds of SVR versus projected risk of the tx drugs. But in a hypothetical where you do decide to stop, personally I'd then wait for the newer drugs (PIs like Telaprevir) to hit the market. As someone with "little or no damage" you certainly have time to wait.

-- Jim

-- Jim

[cindyh113]

Thanks Marc. You have helped. My Dr. said he would take me off at 12 weeks if its not 0. He has been saying he wants 0 since the start. Darn, I hope he gets what he wants and me too! I hate this stuff and want to at least be able to see it to the end of trying to get rid of it.

[cindyh113]

Thank you for more info. This is a blessing!

[jmjm530]

Regarding your doctor's recommendations above, I agree with him given you have little or no liver damage. The alternative would be to extend treatment to at least 72 weeks which in my opinion is much too long an exposure to these drugs (risk versus reward) for someone with little or no liver damage. Pretty sure this is his reasoning but you can always ask. The exception might be if you are currently being underdosed with the riba, but even then you would be flying blind if you attempted only 48 weeks while still detectible at week 12.

[jmjm530]

Probably should add since you're new here that extending treatment -- or even doing treatment -- for someone with little or no liver damage is a controversial topic here.

Some, like myself wouldn't do it for ourselves -- others feel that you should pretty much do whatever you reasonably can to get rid of the virus as early as possible. In the end, it comes down to your personal decision and if it comes to pass -- hopefully it will be based on as much information as you can get from your doctor, places like here, and independent research.

[cindyh113]

After I thought about what you said about the riba dose. I remembered this, when I started the treatment I had it in my head to start with the riba first, on Saturday, for a week then take the interferon the following Saturday evening. Wonder if this had anything to do with the good start. That was May. Then June 2 my Dad had emergency heart surgery, who I live with. I started feeling the treatment then. The stress of dealing with my siblings and being self employed may have had something to do with June. July has been getting better. My white cells got low and I started taking a shot for that the first week of July also.

[cindyh113]

Finding out the numbers of people who have it and don't know it, along with I don't want this, makes me want to try to get rid of it. I want to be successful so someone else will have hope. I stopped drinking at 32. Hardly saw a doctor and took supplements. Was very active. Very fortunate my lifestyle changed long before finding out. Since the Jan. 2006 finding out I have this, I suddenly realized I had not felt good for a long time. How much of this is in my head? Hard to say. I have always had problems with eating and getting tired. And others. I have probably had this since my teens or early 20's.  I am now 50 and have a lot to be grateful for.

[Marc1955]

Cindy – I do want to clarify . . . although Jim sounds very knowledgeable I don't believe his advice is the current standard operating procedure. With genotype 1, you are looking for total clearance by week 24. Granted the chance for clearance at that point are not incredibly high, but that is the standard operating procedure. I'd be really surprised if a doctor would start treatment for genotype I and not let it go 24 weeks.

[cindyh113]

I'll be sure and ask my doctor. He has kept repeating that he wants 0 and says he will take me off. It was my choice to go on and I had started having some nerve issues going on in my feet and hands. That made him want to do the treatment also. I at that point did not know hep c would affect the nerves. Still unclear as to how.

[jmjm530]

Marc: "I'd be really surprised if a doctor would start treatment for genotype I and not let it go 24 weeks."
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But Cindy just reported that is what her doctor is suggesting :) And she is not alone in that regard.

BTW I'm not saying that treatment should be across-the-board stopped at week 12 if not UND. What I am saying is that the chances of SVR in that instance are very low unless treatment is extended to at least 72 weeks per a number of recent studies. Hopefully we're on board in that regard.

The subjective part -- and I hope I've made that clear -- is whether someone with little or no liver damage (like Cindy) should risk exposing herself to these strong drugs for a minimum of 72 weeks.

Personally, I was willing to do so (ended up treating for 52 weeks) but I was Stage 3. Also,alternatives like Telaprevir to fall back on, were not around then. And perhaps Cindy is also willing to do so. All I'm saying is that if in her shoes I wouldn't because the risk/reward equation -- for me -- would not look very good.

The current trend among liver specialists is to individualize treatment as much as possible -- be it to shorter or lengthen SOC, primarily based on viral kinectics and their projected SVR rates. But at the same time it's often up to us as the ones most intimately involved, to make those final decisions as to whether or not -- given such and such odds for so many weeks -- to forge ahead or to cut losses, regroup and fight another day.

-- Jim

[jmjm530]

Here are several studies re extended tx for those still detectible at week 12. Limitations are fixed-dose riba and sample size but newer studies are out there re extended tx and have been posted. Also note that the first study actually mentions using week 4 as a "stop" rule, as opposed to the more used week  12 stop rule that many clinicians still use, at least selectively, including Cindy's. Personally, I favor early stop rules and even newer studies suggest that in the future a stop rule might be developed for the 24 hour (not day) PCR. This would give select patients a chance of very minium exposure to these drugs with a very early look at the odds for tx success or failure.


http://www.ncbi.nlm.nih.gov/pubmed/16618403

http://www.hivandhepatitis.com/2007icr/easl/docs/042407_a.html


http://www.hivandhepatitis.com/hep_c/news/2006/082906_a.html

"...Some clinicians recommend discontinuing therapy to spare patients additional side effects and expense if they have not achieved rapid virological response by Week 4, but a subset of such patients do eventually achieve sustained response..."

[Trinity4]

I've been having night terrors about this 4, 12, 24 wk thing. I sat straight up in the bed last night literally yelling "I told you 12 wks" or so my husband said.  I've not been sleeping well since my last PCR and it's freaking me out.  So many different viewpoints studies, opinions.  We can't change what we won't acknowledge, I understand what detectable at 12 wks means.  If you reach UND at 12 wks =  48 wks tx.  If not but UND by 24 wks = 72 wks.   I don't like it...I don't like it....I don't like it.  But nobody said I had to like it right!!!
Trin

[HectorSF]

Basically the later your HVC RNA is undetectable, the lower your chance of SVR.

The Stats for genotype 1s who respond to treatment: (Dr. Peter Ferenci, J Hepatol Sept 2005, 43(3) 425-433)

UND by week 4 = ~91% SVR
>2 log by week 4 = ~72% SVR
2 log by week 12 = ~48% SVR
<2 log by week 12 = ~43% SVR

Any viral load at week 24 = ~2% SVR

Note: These stats do not include "non-responders" and "partial responders" which make up 35% of genotype 1s.

Hector

[Trinity4]

Are those percentages based on 48 wks of treatment?

[SenorD]

Based on your postings, my response to the tx is NOT doing so well here.  until today, i was quite hopeful, but now, i am completely at lost on what to do next.

FYI, I have gen1, grade2 activity, and stage 1 fibrosis.  I started the tx with a viral count of 3.5M.  the tx had reduced my viral load approx 2logs/mo.  At 13th wk, an ultra-sensitive Heptimax PCR showed a viral count of (7).  Since it was not under 5, my doc did not call it UND and wanted to repeat the test in 4 wks. Given the results being almost there, i was hopeful and happy. untill...I repeated the same ultra-sensitive Heptimax test a month later which is at my 17th wk, and the results showed the viral load going up to (174) while a regular HCV Quant PCR showed <50.

Tomorrow begins my 18th wk, and with my viral load going up and being far from UND, i am quite depressed and need your advices and comments regarding:
- How long should i continue the tx till UND?
- what are the risks?
- Assuming it's UND at 24th wk, odds on SVR?
- Assuming it's NOT UND at 24th wk, should i stop the tx?

Many thanks! SenorD

[SenorD]

Sorry for jumping into your post here.  i should be more careful about posting my message next time.

Hope your 12wk results will be UND.  All the best.  SenorD

[CockSparrow]

...I repeated the same ultra-sensitive Heptimax test a month later which is at my 17th wk, and the results showed the viral load going up to (174) while a regular HCV Quant PCR showed <50.
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My opininion if i have read this right is the the Heptimax test has been cominated.
You cant be <50 on one test and 174 on another. One of them is wrong.

As you were detectable at 12 weeks then 72 weeks would seem to give you the greatest chance of svr.

The odds of svr when detectable at 12 weeks are around 20% which arent that good.
Although yours could well be higher as you VL was quite low.

All the Best
CS

[jmjm530]

Must be very frustrating.  Why dont you ask your doc for Quests "HCV RNA TMA QUALITATIVE"  Anedotally hv heard fewer false positves. Same sensitivity asHeptimax

[cindyh113]

Your alright. You raised good questions for me too! Hang in there and don't give up. Its like they said if this doesn't work there is new drug on the rise. I know a lady who had quite a bit of liver damage. Went through treatment and she feels great. She did clear and is still clear after several years. She was in my yoga class. I think she is about mid to late 60's. She still does not have all liver back but enough to make me look like a whimp.

[virgocharm]

when will telaprevir be available for tx, ?

[virgocharm]

whats the difference between telaprevir and interferon/riba?

[CockSparrow]

Telaprevir is a direct HCV anti Viral. It targets HCV and kills it.
However this just annoys the virus and it develops resistance to it and quite quickly.

If Interferon & riba are also added then these kill off the Telaprevir resistant strains.
When used together this produces quite high svr rates for G1s.

The downside is that if it doesnt work then you may have made yourself even more difficult to treat than you otherwise would have been. Bit of an unknown this.

However anyone with a good IFN response, this will be an excellent combination.

CS

[nygirl7]

If you reach UND at 12 wks =  48 wks tx.  If not but UND by 24 wks = 72

Bingo this is the standard being used today in AGGRESSIVE treatment (for example with little or no liver damage you do have time to wait and many doctors might just stop you at week 24).

I started off with a great big bang. Straight down to 411 at week 4 - if I'd had one of the older tests I would have believed I was undetectible.   At week 12 I still had a count of 419.  Because I had already determined I was going to do everything I had to (and I had stage 3 diagnosis) I continued to week 72.

It's not all that uncommon this strange plateau that some of us hit.  Nobody really knows why so don't beat yourself up over it.

If you are doing ok side effects wise and think you can do the 72 weeks that certainly is a viable option.  For some, they don't really care about living with it and they do have the time to wait and see if and when the new drugs pan out so they wait.

As you can see - a very personal decision that we each have to face based on things like finances (when you treat next will you still have insurance?), support group, side effect severity etc. etc. on and on.

We can tell you what SCIENCE says but only you can decide which way to go.

I don't remember how much riba you said you were on - I can't actually find that - but make sure it is enough. Having a good high serum level (usually means your hemoglobin starts to tank big time, but not always) is crucial to success.  to treat for 72 weeks being undermedicated would be a giant waste of time.

Good luck!