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Medical Forum / Diseases and Disorders / Hepatitis / June 2005

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more good news for genotypes 2 &3

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ghibelno - 23 Jun 2005 09:17 GMT
Morning glory!

I was listening to the radio while driving to my work place this
morning and heard about this study about the standard treatment.

It has already been published on the "New England Journal of Medicine".

If you want you can check the source out:

 http://content.nejm.org/cgi/content/short/352/25/2609.

Hope that something good will come along for the others genotypes, too.

Have a nice day you all,
jeeb.
Waterspider - 23 Jun 2005 23:14 GMT
> Morning glory!
> I was listening to the radio while driving to my work place this
[quoted text clipped - 5 lines]
> Have a nice day you all,
> jeeb.

Thanks for the excellent news, Heebie Jeebie, and the link!

Waterspider

p.s. Damb, wish I'd known this before I finished the 24 weeks <g>
greyhackles - 24 Jun 2005 02:33 GMT
>Morning glory!
>
[quoted text clipped - 11 lines]
>Have a nice day you all,
>jeeb.

"The rate of relapse (defined as HCV not detectable at the end of treatment
but detectable at the end of follow-up) was 3.6 percent in the
standard-duration group and 8.9 percent in the variable-duration group
(P=0.16)."
[...]
"Conclusions A shorter course of therapy over 12 weeks with peginterferon
alfa-2b [ie: Peg-Intron] and ribavirin is as effective as a 24-week course for
patients with HCV genotype 2 or 3 who have a response to treatment at 4
weeks."

Well....Respectfully, that conclusion is not supported by the data. It's
better than a sharp poke in the eye, but more than double the relapse rate for
the 12 week course is clearly NOT "as effective" as 24.

Who would want to sign up for 12 weeks if they knew there was a 248% higher
relapse rate than going the full 24?

I'd go the 24 whether or not I had an undetectable qualitative RNA PCR at 4
weeks, or not, and not be one of those 5 extra relapsers per 100 patients.

In for a penny, in for a pound.

Cheers - and never forget to read the fine print...

/greyhackles
ghibelno - 24 Jun 2005 08:59 GMT
> [...]
>
[quoted text clipped - 23 lines]
>
> /greyhackles

Hi greyhackles,

 first of all, the study demonstrates that the SVR rate is (almost)
the same betweeen the two groups, showing that the presence of a
shorter treatment duration subset of people *does not* influence the
SVR rate.

"... Fifty-three patients (76 percent) in the standard-duration group
and 164 patients (77 percent) in the variable-duration group had a
sustained virologic response (difference, -1 percent; 95 percent
confidence interval, -13 to 10 percent).
..."

This leads to the conclusion that, as far as SVR rate is concerned
(this is the only criteria they've been basing their study conclusions
upon), 12 weeks of treatment are as effective as 24 for genotypes 2 & 3
(with differences between genotypes, though), treated as said.

That said, of course, this is what _this_ study demonstrates, these are
_this_ study conclusions and not statitical or medical assumptions.

Statistical or medical assumptions usually take place in steps and need
time to become guidelines or rules.
It is not so easy as doing simple maths like the one you've being doing
;-)

 3.6 : 8.9 = 100 : x => x = (8.9*100)/3.6 => x = 248 (~)

showing a big number that _still_ represents what scientists consider a
trascurable difference in this case (tip, look at the "P" variable in
the following sentence):

"...
The rate of relapse (defined as HCV not detectable at the end of
treatment but detectable at the end of follow-up) was 3.6 percent in
the standard-duration group and 8.9 percent in the variable-duration
group (P=0.16).
..."

Anyhow, this study conclusions won't be used as guidelines.

Probably current treatment standard guidelines will be changed in the
future (as they've been in the recent past) as new drugs will come
along and as more studies will help better understand how to use them,
for how long etc., to help obtaining always better rates of SVRs.

IMO.

Cheers,
jeeb.
greyhackles - 24 Jun 2005 19:19 GMT
>> [...]
>>
[quoted text clipped - 30 lines]
>shorter treatment duration subset of people *does not* influence the
>SVR rate.
[snipped]

I think you are overanalyzing the wrong data, or perhaps haven't really come
to grips with what "effective" means in the context of the post-tx HCV
patient. Or have a different definition of SVR in mind than I.

Note that the quoted conclusion doesn't use (or even misuse) the acronym
"SVR". It claims 12 weeks was "as effective" as 24, without qualification.
Clearly, that "conclusion" is an over-statement at best.

Second, their use of the term SVR is bogus from the jump. Their usage appears
to mean "did not experience viral break-through while under therapy".

In *my* world, SVR means "post-therapy Sustained Viral Response" as
demonstrated by an undetectable PCR taken post-tx +6 months minimum.

Hopefully, we can agree that is the only meaningful benchmark when it comes to
defining "effective".

Finally, consider what happens to those unlucky, extra 5 relapsers.

Not only are they faced with repeating therapy - and for the full 24 weeks, no
doubt, for a total of 36 months of "Dancing With Drugs That Can Seriously Mess
You Up" - you have to wonder if they are saddled with a higher probability of
second-round tx-failure due to tx-induced viral mutation during the first
course of treatment.  Like what can happen when patients prematurely stop
taken antibiotics and unleash a mutant bacterial "superbug".

"Are you feeling lucky?"

/greyhackles
ghibelno - 27 Jun 2005 08:33 GMT
> [...]
>
[quoted text clipped - 3 lines]
> Hopefully, we can agree that is the only meaningful benchmark when it comes to
> defining "effective".

Oh yes we do agree on this :-)
Anyway, I'm too miserable now to go and look for the source article but
seems to me that they were evaluating the effectiveness of treatment by
checking for undetectable viral load 24 weeks after the end of
treatment.
They have the same idea of us about a SVR, haven't they?

> Finally, consider what happens to those unlucky, extra 5 relapsers.
>
[quoted text clipped - 5 lines]
> taken antibiotics and unleash a mutant bacterial "superbug".
> "Are you feeling lucky?"

Oh I can only agree on this.
Don't know whether Science uses to do the same.

Anyway, how are you?
We're at the same week in treatment, I had my 36th injection on
saturday night and it was no fun at all. I don't know if it is the
summer and the heat that is hitting me hard now, or my body getting
more and more weak but side effects seem heavier.
Are you experiencing the same?

Cheers,
jeeb.
greyhackles - 28 Jun 2005 02:02 GMT
[snipped]

>Anyway, how are you?
>We're at the same week in treatment, I had my 36th injection on
[quoted text clipped - 5 lines]
>Cheers,
>jeeb.

Shot 36 coming up Friday, I can almost make out the horizon...

I've lost 35 pounds, a good chunk of it is muscle mass - plainly put, I look
atrophied. I'm *far* weaker than pre-therapy, I can't lift but maybe half what
I could before. So dragging my now 198 pounds around isn't any easier than
dragging 235 pre-tx. And I'm swimming in my clothes, to boot ;-)

Coupled with the low hgb I get wicked lightheaded if I push myself too hard or
long, so it's all kind of self-regulating, until I actually grey-out and crash
to the floor or something worse ;-)

But, wtf, this is still a *lot* better than I was over the winter, and as long
as things don't get much worse than this, I can deal.

I haven't really had to confront the current heat wave head-on, I certainly am
in no shape to do much more than schlep from ac in the house to the ac in the
car to the ac at work. I can't imagine doing any kind of physical work when
the temps are in the 90's and the dew point is in the 70's...

Anyway....I'm on your six.
We'll get through this and celebrate OctoberFest for real :-)

Cheers

/greyhackles
 
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