Geno 1 24 Weeks Versus 48 Weeks

[nygirl7]

August 2006 Brasilian Study

Just happened upon this today when googling (was basically looking for CIFN info but found this)

http://www.hivandhepatitis.com/2006roberts/hcv/080906_b.html

Results

The end-of-treatment response rates were:
59% for genotype 1 patients treated for 24 weeks;
80% for genotype 1 patients treated for 48 weeks;
92% for genotype non-1 patients treated for 24 weeks.
The SVR rates were:
19% for genotype 1 patients treated for 24 weeks (95% CI 7.2-36.4);
48% for genotype 1 patients treated for 48 weeks (95% CI 30.2-66.9; P = 0.0175).
76% for genotype non-1 patients (95% CI 62.3-86.5).
Safety profiles were acceptable, and there were no unexpected adverse side effects.
Conclusion

The authors concluded that almost half of genotype 1 patients achieved SVR after treatment for 48 weeks with Pegasys plus low-dose ribavirin (although the dose used was not specified in the abstract), confirming that 48-week treatment was superior to 24 weeks for this population.

[jmjm530]

The study posted can be unintentionally misleading because it does not address the discussions we've had here regarding a shortened 24-week treatment period for selected geno 1's.

The key word here is SELECTED, because studies previously posted that advocate treating geno 1's for 24 weeks, all required both a low pre-tx viral loads as well as non-detectible virus at week 4. The study posted by NYGirl does not take into account either pre-tx viral load or the 4-week response.

Again, the short course is only recommended for a selected group of geno 1's who have a low pre-tx viral load and who are non-detectible at week 4. This selected group showed similar SVR rates to those that treated for 48 weeks.

-- Jim

[nygirl7]

I don't think it's as misleading as you constantly suggest - and people who are TRULY UND at week 4 are quite different from people who are TOLD they are UND at week 4.

THAT factor is the definitive piece of information for anyone.

But I truly believe that all this "shorter course" therapy is going to provide huge problems with relapse in the future.

They didn't just decide that geno ones should do a longer course of treatment than 2, 3, and 4 out of nowhere originally.

A TOUGHER strain of the few resistant mutants = relapse.

I was UND for over 50 weeks and it appears may have relapsed myself.

Considering that very recently doctors have been contemplating and extending geno 2 and 3 to 48 weeks..........it goes contrary to all the other information.

It's just something to keep in mind. There is NO EXACT SCIENCE

[jmjm530]

I didn't mean to infer that you were misleading anyone. What I meant is that in all our discussions of the shorter-course treatment, no one has ever suggested that geno 1's should shorten their treatment UNLESS they were non-detectible at week 4 and had a low pre-tx viral load, per study data.

I agree that treating HCV is not a science but just trying to clarify why the study you posted is different from the studies previously posted that suggest similar SVR rates for selected genotype 1's. How one uses this data is a very individual decision.

-- Jim

[jmjm530]

NY: ...people who are TRULY UND at week 4 are quite different from people who are TOLD they are UND at week 4.

THAT factor is the definitive piece of information for anyone.
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I'm a little confused here. Either you're non-detectible at week 4 per a set sensitivity, or you're not. Hopefully people are treating with a hepatologist who knows how to read lab results and order the appropriate tests -- but in any event everyone should double-check their lab results with their own hard copy. I saw an excellent hepatologist, but never considered myself non-detectible until I saw it on the lab form myself. I would also suggest anyone contemplating the shorter course to get hold of the full-text study data and make sure that their 4-week test is equally sensitive to the one used in the study.

-- Jim

[nygirl7]

I'm quite sure that "most" (meaning the non-forum, non-informed and overly educated obsessive MedHelp patient) people in the world don't know to ask for a thorough PCR value such as the TMA.

I think most doctors in "the real world" just order a PCR and the patients, not questioning or reading this that we obsessives do, just say oh GREAT I'M UND!!!!!!!!!! (not realizing that they are UND <615 or such).

THAT is what I am trying to say.

If someone is "truly" (as far as we can see anyway to <5 or <2) of an UND value - that is one thing.

But face it, we know from experience that most doctors don't read up or give us the proper testing (I know from my own doctor experiences and will NEVER again ASSUME that they are - thank God for this forum) - so I think that is going to be VERY misleading to some people.

That is my huge giant elephant in the room concern.  People will hear others are only treating to 24 and are "UND" and they will want to as well feeling that they indeed meet this critera.  And most doctors out there do NOT give TMA without real begging involved and they will say "why sure you are indeedy UND let's try it".  Relapse, relapse, relapse at 30 weeks.

You see the problem I am trying to relate (and have been trying to bring up at least once a month for months so sorry it is rather repetitive but people HAVE to understand for REAL the difference).

I know I'm of the better too much than too little (and I did indeed learn that from you) value in here but - people need to "get this" or it's going to be tragic indeed.

[Myown]

My NP told me at my last visit that a co infected patient had given himself one shot of interferon and deceided he didn't want to continue tx. He didn't come back to the office anymore and then he made an appointment after ONE YEAR.

They tested to see what hisHep C VL was and he was SVR! Talk about surprises. I guess that would shake up a few studies. Who knows why this happened, but I thank God this man received these results. Maybe the ONE SHOT of interferon stimulated his own immune system to kick in (I'm just guessing)

I feel like its all one big guessing game from start to finish for the doctors and patients.

[jmjm530]

I agree that the word "undetectible" is very general/non-specific. As you suggest, there is a big difference between being undetectible to 615 IU/ml and undetectible to 5 IU/ml.

Anyone contemplating a shorter course treatment should make sure that the tests their doctor orders are sensitive to at least the sensitivity of the study data being followed. Even better, simply order one of the very sensitive TMA tests like Quest Diagnostic's "Heptimax" which goes down to 5 IU/ml. In fact, ordering the most sensitive tests is a good idea for anyone, not just those that may choose to treat for a shorter period of time. And always ask for your own hard copy of any labs, just to double check.


-- Jim

[jmjm530]

MO: My NP told me at my last visit that a co infected patient had given himself one shot of interferon and deceided he didn't want to continue tx. He didn't come back to the office anymore and then he made an appointment after ONE YEAR.

They tested to see what hisHep C VL was and he was SVR!
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Now why couldn't that patient have been ME,  without the "co-infected" part, of course :)

But seriously, I'm sure this would happen in a certain per cent of cases although probably not enough to even warrant a trial. That said, I did hear about an approach where you inject until non-detectible and then stop until you're detectible again and then start, repeating the cycle until you are SVR. In theory, using this approach -- it's called "pulse" therapy -- if you became non-detectible after week 1 and remained non-detectible, then like the patient mentioned, you'd only have one peg shot. Last I heard, none of those on pulse therapy -- very small group (under 6) -- remained non-detectible for more than 4 months. Still, an interesting idea to minimimize treatment drug exposure for those that do respond right away. Maybe with the advent of the protease inhibitors this approach may gain some steam.

-- Jim

[zazza]

The full-text study that Jim mentions above would be: "Efficacy of 24 weeks treatment with peginterferon alfa-2b plus ribavirin in patients with chronic hepatitis C infected with genotype 1 and low pretreatment viremia", published in Journal of Hepatology, 44 (2006), page 97-103. The sensitivity of the test used in the study was 29 IU/ml. The ribavirin was weightbased.

47% of the 235 study patients, who all had a screening viral load of < or = to 600,000 IU/ml, achieved RVR at week 4. Of these 110 patients 98 patients achieved SVR after 24 weeks treatment (i e 89% of all patients UND at week 4). The relapse rate was 8%.

MD Thomas Berg has in a recent study suggested that the optimal cut-off point for low baseline viral load should be 400,000 IU/ml.

[Myown]

I think you or another member had posted the 'pulse therapy" approach once before.I would be chicken to try it if I had the opportunity when I started tx. I'm not in one of the best moods as time marches on because I want to stop tx, yet its scary, but you all went thru it and its something I just have to face.

I really believe stress can lower the immune system (IMO) and give the virus a chance to be the muscle man and that has me concerned. There are alot of stressful famiily situations I am surrounded by at this time and I am worried and concerned for some family members and I am afraid that that will weaken my immune system.  Before I was dx I had alot of stress and had my cortisol levels checked and other hormones and everything was out of wack. I think its the waves of 'good days' then followed by days of feeling down that is just hard to deal with. Too much bouncing back and forth mentally. I believe its from how the virus affects the brain and our thought and attitude. Some days I can deal with it and other days I want to curl up into a ball. I should be used to it as a woman cuz its very similiar to what woman feel for years with their menses. Am I whining or what?Ha! I should go sit at the piano, I feel a good blues song in the making. LOL  

This doctor Ren in the above post sounds like someone I would be interested in seeing down the road sometime too. Glad to see he is NY.

[jmjm530]

Thanks for posting, had a hard time finding it myself. Short synopsis here:
http://www.hivandhepatitis.com/hep_c/news/2005/ad/121605_b.html

"..In conclusion, the authors write, ?HCV-1 infected patients with a low baseline HCV-RNA concentration who become HCV-RNA negative at week 4 may be treated for 24 weeks without compromising sustained virologic response rates.?"

As Zazza says, the sensitivity of test was 29 IU/ml, so you would want a vl test a t week 4 at least as senstive. Also, anyone considering a short course treatment would probably be well off to order the full-text article online and present it to their doctor.

-- Jim

[jmjm530]

Yes, I've posted it before, but as mentioned, to best of my knowledge it hasn't worked yet. As to "Ren", as long as you check out the herbs he uses -- and monitor your liver enzymes -- I see no harm, except you might consider waiting until you're SVR or even 12 months post treatment. Of course run the formulation by Dr. D. I think what you'll find with some of these alternative practioners is that they have a mix of useful and useless information -- sort of like their conventional MD counterparts. Trick is figuring out which is which.

-- Jim

[Myown]

I think what you'll find with some of these alternative practioners is that they have a mix of useful and useless information -- sort of like their conventional MD counterparts. Trick is figuring out which is which.
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I agree.

I like the fact that this Ren is a 'hepatologist' and alternative doc tho. That's a biggie in my book.

Thanks alot.

[copyman]

i agree with jim here. the study posted by NYG is an old study that did not have the info about 4 weeks or the latest study about 8 weeks. what jim tries to do here is educate people and especially newbies to get a 4 week pcr with the most sensitive test available. many docs are starting to get better with the latest tx and within the next year or so they will automatically do the 4 week pcr. the 12 week standard pcr is on its way out as the "predictor" and will be replaced with the 4 week or perhaps an 8 week test. something has to be done to stop people from tx'ing for NO reason for 48 or 72 weeks when they do not stand a decent chance of svr. if the pcr test show 4 or 8 weeks still DETECTABLE and especially 12 weeks then maybe they should stop and not do more damage to their body with a long tx. only time will tell.............

[GoofyDad]

I agree. It seems to me the early viral decline slope tells the tale. l'd guess that if the current tx we know continues, one day docs will wonder about this crude testing we do.

Testing only at  4-8-12 makes it difficult to plot much of a slope. Weekly tests until UND would make more sense i you ask me - but we would need to gather data to understand how to iterpret those results.

Waiting for 12 weeks to take a reality check seems too long. I think patiernts and docs should have checkpoints along the way and have set their decision matrix in place before the first shot. I believe FLguy did an excellent job of executing this strategy. Maybe he'll jump in at talk about that......    

[painterlady13]

Well that answers my questions about shortened treatments....  Have been reading about so many here doing just 16 weeks and feeling a little jealous.  Tired here of the sides and wish I could feel comfortable in stopping now at 39 weeks.  Guess I won't no matter what.  As long as it ups my chances to remain UND then I'll press on.  

Thanks for posting that though

[sunspot]

Quote snip
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I was UND for over 50 weeks and it appears may have relapsed myself.
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Whats with this statment? You better not  have relapsed.

[jmjm530]

Goof: Weekly tests until UND would make more sense i you ask me - but we would need to gather data to understand how to iterpret those results.
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A number of doctors are already do so. Mine did, I believe "MyOwn's" does, and I think weekly testing was mentioned in one of the modules over at the Clinical Options site. In addition to weekly testing until non-detectible, monthly viral load testing throughout treatment makes sure that the virus stays down. As far as interpretation, the more info the better, not just for trial results already completed, but also for trial results that might report in during the course of one's treatment -- or, trial results even after treatment is completed that might be useful for a future attempt if necessary.

-- Jim

[ladybug52]

My PA told me a similar story about a patient she was treating. He couldn't tolerate more than 7 weeks and quit, inspite of everything he was told and her attempting to get him to tx longer. He came back a yr later for check up and was svr.  She wasn't gung-ho about me quitting unless I confirmed that I accepted full responsibility for my decision. Once I told her I  felt informed of the possible consequences, she told me about him.
Tx is not an exact science and is growing and evolving as we learn more thru communication and research. Since I've been on here, I've learned the factors such as early pcr, stage of the disease, and weight based medications make a big difference in the end result. Longer is better is great IF your liver is getting a rest, but as we all know, the tx drugs attack other bodily parts and systems also.
Bug

[wyntre9]

"there is a big difference between being undetectible to 615 IU/ml and undetectible to 5 IU/ml."

I've been meaning to ask about that.  Since my last reading was VL 510 (after shot 14) and that's less than 615, is that significant?

Or is the important number the < 10 that's on my labs?

And if <615 is a meaningless number, why is it quoted so often?

i really am confused about this.

(And yes, i know if i don't reach UND by week 24 i should consider stopping).

wyn

[Proactive]

The simple answer, different VL test have different ranges of accuracy. For instance reading one of my old tests, HCV Quantification test range 615 IU/ML to 7,700,000 IU/ML, Essentailly with this test, you would be considered undectable, even though you still have a VL of 510 IU/ML...
Now one of my later test, Hep C RNA Qualitative RT-PCR, it has a dynamic range of 10 IU/ML to 50,000,000 IU/ML..with this test your 510 VL would not indicate being undectable...hope that helps, I almost confused myself ( I'm in that riba fog window, the foggiest for me is 3 hours after taking meds (G))

[wyntre9]

Thanks for that.

So the <615 test is not as accurate as the <10 test?  And if that's the case, why is the <615 test still used?

isn't it essentially obsolete?

or does it measure the virons in a different way that's not reciprocal - in other words, might <615 on one test equal let's say a <1500 count on another test?

or is the unit of measurement the same?

OK, what I mean, <10 is much better than <615, right?  So, if I had the other test, the 510 Vl would put me in the UND group but using the same VL for the <10 test would NOT indicate UND?

still confused but thanks for the old college try.


(Can you tell i have no scientific background!)

wyn

[ladybug52]

There are many types of pcr testing. The pcr that tests to 615 or greater is outdated, and doesn't hold any significance, other than it used to give people a false feeling of being UND. The pcr's like the tx continue to get more sophisticated, and they have more jobs than just testing viral load. When I was first told I had Hep c it was because I had hep c antibodies present when I gave blood. Since my liver enzymes were normal and I had no signs or symptoms of liver disease (and probably lack of knowledge from the dr.s I consulted) I was told it was possible that I had cleared the virus on my own. Everything I read said that 15% spontaneously clear the virus on their own. I was thankful I was one of them! Last year when I wanted to determine if I was a possible candidate for kidney donation for my father, my dr ordered the HCV PCR Qualititive test to rule out Hep C once and for all. The qualitative pcr detects whether or not the virus is present. It came back positive of course. So much for my "lucky" spontaneous healing! At the same time he ordered a pcr to find out genotype and pcr to determine viral load. He used the real time quantitative pcr by Quest labs. It's detects the HCV present <50 IU/mL. My viral load was 11 million. Yikes! My luck turned bad quickly!
Since it flucuates, I don't understand why people talk about low viral load being an indicator of better success with tx. I digress. Since coming here, I found out that #1 the most reliable way to determine und is with the most reliable test.Some dr's were still using the <615 which is not sensitive enough to determine if a person is und. Even my quantitatve test that detected <50 is not as sensitive as the Heptimax which can detect to <5. The good news is that since you weren't given false hope that you were und by a test that is outdated, you know what numbers to look for and what the stats are for continuing. Maybe soon we'll have tests that show real UND viral loads by being sensitive to zero. BTW, you know I'm not a fan of stats, especially since I found out I'm not in the 15% bracket!
Hope this PCR101 Readers Digest condensed course helped.
Bug

[wyntre9]

sooooooo my test shows UND from below <10 to the millions.  

Current VL is 510.  Guess I should just keep repeating that test?

thanks for the explanation, wyn

[ladybug52]

If your pcr was  the  test that measured <615, yes you would be UND. But since we now have more sensitive tests, that test would have given you a false sense of und since you still have a viral load of 510.
You're killing the virus, you just haven't achieved und yet.
Some people have tested greater than 5 but less than 50 with the Heptimax, I remember someone who's viral load was 29! Frustrating  isn't it?
Bug

[wyntre9]

Well, i certainly don't want to have a false sense of UND!  

i'd alway rather know the truth, no matter how much it conflicts with
the often preferable fantasy.

you sound goooood.

wyn

[sunspot]

When I first started tx, I knew very little about it. I sure wish I had found this board before I went on tx.
I had a GI treating me with outdated information. I had a total of 4 PCR’s on my 48 weeks. The first was at 12 weeks with a test down to <615 as was the 24 week test. The last 2 were at <10. I celebrated my UND not knowing that I may have had some nasty virons still left in me. Also the fact that I did not know if I was an early responder that could of predicted better odds of being SVR at EOT.
Oh well, I DID become SVR and that’s what counts in the end.

[ladybug52]

Sunspot you're exactly right. They're only numbers till we finish and then it's only one number that counts. You'll get that number Wyn!
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