An SVR is a SUSTAINED Viral Response

[willy]

(I'm going to "sticky" this up at the top of this forum.  Enjoy!!- Willy)

Sustained Response to Anti-Hepatitis C Virus Drugs Results in Cure in Virtually All Cases: Presented at EASL
By Jill Stein

BARCELONA, SPAIN -- April 16, 2007 -- More than 99% of patients infected with hepatitis C virus (HCV) who achieve a sustained virological response (SVR) have an outcome that may be considered a cure, according to data presented here at the 42nd Annual Meeting of the European Association for the Study of the Liver (EASL).

Lead investigator Mark G. Swain, MD, professor of medicine, University of Calgary, Calgary, Canada, said that only 8 of 997 patients who achieved an SVR later developed re-infection.

Dr. Swain and colleagues reviewed the long-term outcomes from nine studies and identified patients who had achieved a SVR after treatment with alpha peginterferon alfa-2a (40 KD) (Pegasys(R)) as monotherapy or in combination with ribavirin (Copegus(R)).

"I tell my patients who have had a sustained virological response that they can go home and get on with their lives," Dr. Swain said in a presentation on April 12th. "I tell them that there is less than a 0.5% chance that the disease will ever return."

The study included three trials in which patients were treated with monotherapy and six trials in which the combination treatment was used. The combination therapy is now considered the treatment standard, and as many as 66% of HCV patients who take their antiviral medication as prescribed -- usually for 48 weeks -- are able to achieve the SVR.

A SVR was defined as an undetectable viral load in the blood six months following cessation of treatment.

Dr. Swain noted that statistical analyses on this study were not performed. "We were looking for an absolute number," he said. "There was no comparator group."
   
Of patients who achieved a SVR, 163 patients who had HCV monoinfection were treated with peginterferon alfa-2a alone; 741 patients with HCV monoinfection were treated with peginterferon alfa-2a plus ribavirin in combination; 93 patients co-infected with HIV and HCV were treated with either monotherapy or combination therapy.

"We found that a sustained virological response is a sustained virological response whether it occurs in an immunosuppressed patient due to disease such as HIV or in a patient who has undergone transplantation and requires immunosuppressive drugs," Dr. Swain said. "There was no falloff in response."

Because of the study's methodology, it will be impossible to determine if patients indeed relapsed or were re-infected, he added.

The study was supported by Roche.


[Presentation title: Durable Sustained Virological Response After Treatment With Peginterferon a-2a (PEGYSUS) or in Combination With Ribavarin (COPEGUS): 5-Year Follow-Up and the Criteria of a Cure. Abstract Number 1]
   

[robin]

Good article Willy...thanks for posting...keep your spirits high...robin

[missy]

thanks a bunch willy - you're a plethora of information!
w.c. missy

[jan]

I am going to be rececked this week, i hope i am with the lucky ones.
Jan

[19Dragon52]

Acheived 6 month SVR but want a 1 year check which I will get in October 2007...after I return from vacation.  Genotype 1a...Stage 2...Grade 2.  Physically feeling like a $$$$$million bucks$$$$$

Oh Yeah!  Update:  Jan has her 1 year SVR!  Couldn't have happened  for a better Gal!

Love To Us All.....

[KatNyerHAT]

Man, it's so great to hear you're feeling like a million, Joyce!!!   

When in October and where are you going for your vacation?

Congrats to Jan for her 1 year SVR!!!!!!!!!!!!!!!!


Way to go, Jan!!!

Big hugs, 
Kat

[Kristi]

So clear me up please. EVR at 12 weeks. Doing full tx for 48 weeks. Then check (6 months) 24 weeks after treatment  is over.  So am I SVR at 1 year after my clear EVR or 1 year after my 48 weeks (if I am still EVR thoughout)  Kristi

[willy]

RVR is clear 4 weeks and remains clear
EVR is clear at 12 weeks

A SVR requires a sustained viral response following treatment's end.  It might be better called an anti-viral response.   So....you don't get to start counting until treatment and dosing ends.

best,
willy

[hanklive39]

"We found that a sustained virological response is a sustained virological response whether it occurs in an immunosuppressed patient due to disease such as HIV or in a patient who has undergone transplantation and requires immunosuppressive drugs," Dr. Swain said. "There was no falloff in response."

Interesting to say the least but unfortunately for me, that has not been the case so I guess I fall under the five tenths of a percent of folks that does not continue to have SVR after certain periods of treatment... Still, I am able to maitain a suppressed viral load through the low dose maintenance therapy that I'm currently on so, All is not lost!!! I still have hope with the new types of treatments that eventually will become available foe "Enigma's" like myself!!!

Thanks for the story Willy!!! May you and everyone out there have a happy & safe new year.

Respectfully,
Henry


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[Kristi]

Loved to have all the personal info  and Svr info simple enough for us Riba fog brains to understand.  Whole Bunches Ya'll Kristi

[Pancho and Lefty]

I'm looking at the developing accuracy of what defines UND. I got this from another forum and seems to be the most recent.

"There are several test out there, the Heptamax, Quantative viral load, TMA, and Qualitative.  These are are a little different the the range they detect.  If you remember that the viral load is the amount of virus in your system at one point of time, this is a little easier.

All of the tests count the number of viral particles, but the big difference is how few it will detect.  For example, the Quantative viral load range is 400 International Units per mL (IU/ml) as a lower level and 850,000 IU/ml.

If the report says below assay range, it means that the viral count is less than 399IU/ml.  It does not say negative!

The Qualitive test goes as low as 50 IU/ml and the report will read detected or not detected.

The Heptamax goes as low as 5 IU/ML and the report may gear <5 IU/ml.  I have seen viral loads as low as 30 IU/ml.  Most people agree that <5 is a negative result."

So, which of the above do YOU call UNDIE. It seems to have evolved over time. My first test was detectable to <50 iu, latest was detectable to <5.

It's a guess, but I'm thinking UND by older standards may have been the reason for recurrence of the virus. (relapse is not in my vocabulary regarding hcv. It implies I did or did not do something that made the dam stuff come back)

  My 18 iu/ml was und for a long time.

I'm sure this seems very nit picky. But, right now, it's seems significant to me.

Peace,

Max

[willy]

I'm not aware that there is a standard.  the most common usaage that I see now is merely quantifying the undetectable with both the week and the sensitivity of the test.  If one were trying to differentiate a less than 10 versus a less than 25 ml/IU I think that it's pretty much slicing hairs.  Some insurance companies will only pay for less expensive PCRs (the more accurate the more expensive they are) and so this debate could also not only be driven by science, but perhaps even moreso by economics.

My feeling is that (for genotype 1's) a check at week 4 is important and that a sensitive one at least at week 12 is also important.  An RVR could qualify the patient for a shorter treatment time.  That could save the insurance company some money and save the patient a longer and perhaps unneeded TX.

Willy

[joycemc]

Thanks for addressing this issue.  My question is: how does a person sufficiently prove the absence of HepC when a blood test reveals the HC virus antibody?

Here is my story:  Before a recent elective cosmetic surgery procedure, I disclosed that I had been cured of hepatitis C.  I provided the surgeon's office with a note of clearance from the doctor who had treated me, and a copy of the sensitive PCR results from blood work done seven months following the completion of my treatment.

(I had been a genotype B, with EVR).

A few days after the surgery, while removing my stitches, the nurse asked: "So what are your thoughts on the status of your blood?"
Me: "I'm sorry. I don't quite know what you mean...."
Her: "You know, the Hep C.  I got a needle prick during your surgery, so I just wanted hear what you think...."

I tried to reassure her that I was virus free, but I was mortified that she had concerns that I might have infected her, and I was upset that the clearance and verification that I had provided must have been insufficient.  Moreover, I worried that maybe my HCV had come back since I had the PCR at the end of last summer.  Maybe I did, indeed, infect her!

Should the doctor who treated my hepC be ordering a PCR every few years?  Should excellent liver enzymes help to verify the absence of the virus? How could that very uncomfortable conversation have been avoided?

Thanks for your response(s)

[negative1]

Wow JMC,

I guess it is possible to have the virus become completely undetectable, but normally, undetectable means that the virus is still there in a small amount but not enough to worry about and that it is not replicating. I have not heard of a zero reading myself. Do your PCR results show a zero or do they give a number such as <9, or <600, depending on the test used?

I reached svr about 3 years ago but I get tested for it every year now to make sure it is still *sitting quietly*. Eventhough I have reached this great milestone, I still take precautions with respect to infecting others, IE not sharing razors, tooth brushes, etc.

I have not ever had anyone, professional or not, tell me that I do not need to worry about it anymore or the trasmission to others.

That is my experience and about as far as I want to go on this topic as I do  not want to sound like I know it all or give unsound advice.

Just give it a little time and I am sure that others here  that are more educated than I am will chime in here. Maybe some of our nurses in here.....

Nice to see you here as I noticed this is your first post.

Earl

[jb]

I have often wondered where does this very smart virus hide when at the 12 week stage in my Tx I am undetectable yet I relapse just 8-12 weeks post Tx...... Before my last Tx I used to get some terrible head aches so bad my GP would get an ambulance and have me sent to hospital... nothing seemed to be found as to the cause and it was put down to HCV....
I went to a Medicine and Me conference at the Royal Society of Medicine last month and there was a very interesting talk on the virus crossing the blood/brain barrier.... it was stressed that it was only found in SOME patients... it appears that it lives in the brain tissue and replicates using the white blood cells.....the replication is a lot slower than if it lives in its normal environment ..... research is still ongoing although expensive.... still the above report doe look good statiscally


http://www.hepctrust.org.uk/NR/rdonlyres/42FA94F9-8C1A-41AA-84A9-FD0735D3B9BC/0/SimonTaylorRobinsonPresentation.pdf