24 vs. 48 weeks controversy

April 18, 2000

Hi Dr Misra and everyone,

I saw my doctor, Dr. Gish, today for my " after-treatment follow-up and

action plan " as I like to call it. To refresh your memories, I am a white,

45 yr. old, type 2B female, with a Stage 3/Grade 2 biopsy and a 5 million

viral load before starting 6 months of combo treatment on 10/18/99 that just

ended 15 days ago, and " non-detectable " at 12 weeks and now at 24 weeks (end

of treatment on 4/3/00).

Dr. Gish said that my viral load, LFT's, etc. are all looking great, and so,

unless I take a turn for the worse, he wants to recheck all my bloodwork,

including viral load, and see me again in 6 months (Sept/October 2000). He

expects I'll be continuing to feel better gradually since I'm still feeling

some of my side effects, although a bit milder than while on treatment. If I

am a " sustained responder " (still non-detectable) 6 months from now then he

said there is a 95% chance of continued success beyond that, and he would

check me again about 2 years after that (again, unless I have problems). We

didn't talk about it today, but last month he had indicated that if I was not

a sustained responder then he would probably try me on the Pegylated

interferon later this year.

I told him I had heard on the Internet hep c sites that a study came out

about a new protocol, where there are 5 factors determining whether a type 2

or 3 should/would go for 24 weeks or 48. He said that he had heard about the

study, but he usually only recommends 48 weeks for a type 2 or 3 when they

have at least borderline cirrhosis. He said that equated to only about 1% of

hep c patients that would fall within those recommendations. He then said

that my treatment plan was appropriate. We did not discuss type 1's at all,

sorry.

This will probably continue to be a controversy, as so much about hep c is,

so let's keep the information flowing so we're all kept current.

Take care everyone,

Sara

(the above message was in response to these emails) :

> Date: Sun, 16 Apr 2000 15:09:10 +0530

> From: " Doc " <gidoc@...>

> Subject: Re:

> Hi all,

> I must add here that Dr Hoofnagle is a pioneer on treatment of Hepatitis

> and we must value his judgment. However, the results of various

> studies are not really applicable to one and all. It has been proven now

> that the longer you take treatment for Hep C the more likely are you to

> remain in remission. Thus irrespective of genotype treatment is

> certainly to be continued for a year unless you are getting serious side

> effects or have minimal damage on liver biopsy which has reversed.

> Remember the virus develops new quasispecies real fast the moment you

> discontinue treatment.

> Dr Sharat C Misra, MD DM

> Consultant Gastroenterologist & Hepatologist

>

> (unknown)

>

> > Hello Everyone,

> > I wanted to share the following with all of you. In a message

> > yesterday (?) someone said their doctor said genotypes 2 & 3 never

> should be on combo more than 6 months, and 1's with viral loads under 2

million

> should only be on 6 months too. I sent a question in to another HCV group

> that is huge, and got an interesting response. This response if from

someone

> who is extremely well educated about HCV and has a medical background, and

I

> have come to respect his opinions and advice. Due to privacy issues and

> list rules I cannot print any of his personal info, but still thought you

> might enjoy hearing what he had to say. The first part is the question I

> sent in.

> >

> > Hi everyone,

> > Could y'all read the following letter and tell me if ANYONE has

> heard anything about this supposed study? (not the French study mentioned,

> the following one on reducing the length of treatment.) I can't believe

> anyone would be saying that genotype 1's with viral loads under 2 million

> should only be treated 6 months, unless maybe the person worked for

Schering.

> I'm sure they would like a bunch of relapsers to buy more drugs.

> > Claudine

> >

> > ****************************

> > ..... I will really be interested to hear what Dr. Gish says about the

> length of treatment next week....I am a 2 b and had resigned myself to 48

weeks

> of treatment because that's what the five factor thingy (from the French

> > study?) seemed to indicate for me....I only had 3 positive factors:

female,

> 1.5 - 2 mil viral load, and non-African....Against me is age (53), disease

30

> years, and stage 2 fibrosis (approaching stage 3?) Well......my hep doc

just

> got back from a symposium on liver disease in Atlanta put on by the

> CDC....He said Dr. Hofnagel (sp?) made an announcement that new studies

indicate that genotype 2's and 3's should never go longer than 6

months....there is

> never an advantage....NOW I'M REALLY CONFUSED.......and I wonder if this

is

> just a different interpretation of the study that proposed the five

positive

> factor gauge......DOES ANYBODY KNOW WHAT MY DOC IS TALKING ABOUT??? Can

anyone tell me if this information from Dr. Hofnagel is really new? ****

> Supposedly, he said that even genotype 1's should quit after 6 months of

treatment if they started with a viral load of 2 mil or less....What's a girl

to believe? I'd appreciate any clarification of this info....I don't know

whether to quit or not......Thanks,

> >

> > ----------------------------------------------------------------------

> > Claudine, This is all hogwash. I have not seen any new Hoofnagel

> info, but these kinds of absolute statements are absolute nonsense. The

> only absolute about Hep C and its treatments are that there are no

absolutes.

> > Since Hoofnagel is the dope that gave us 12 years of mistreatment with

> 3 times weekly dosing I'd have to take anything he says with a LOT of salt.

> > Any genotype 1 that quits treatment after 6 months is begging for

> failure or relapse. I'd consider 6 months of treatment for a genotype 1

as pure

> folly, regardless of beginning viral load. (Although there's no question

> that the lower viral load will fare better... across the board.)

> > And to say genotypes 2 or 3 should NEVER go beyond 6 months is just as

> > stupid, or more so. What should be the measure of the length of

> treatment is to use viral load tests, and to treat genotypes 2 or 3 for at

least

> 5 months after viral clearance (but preferably 9 or 10 months), and

> genotype 1a for 10 or 11 months after viral clearance. Genotype 1b's

should go

> for about 15 months past viral clearance.

> > Using viral clearance as a guidepost to treatment duration is by far

> the best way to determine length of treatment, but even that is no

> assurance of certainty. And the other pretreatment factors also have to

be taken

> into account when trying to approximate treatment durations.

> > Of course these guidelines are for the Schering Combo on standard doses.

> > Daily dosing will at least double the chances of obtaining success for

> any patient.

> > Warm regards,

> > xxxxx

April 18, 2000

Congratulations Sara I am very happy for you I hope

everything stays good for you. It took about 3 months

when I was pulled off meds to feel normal or kind of

normal again so hopefully yours will come quicker and

stay that way.......Connie

--- srw1954@... wrote:

> Hi Dr Misra and everyone,

> I saw my doctor, Dr. Gish, today for my

> " after-treatment follow-up and

> action plan " as I like to call it. To refresh your

> memories, I am a white,

> 45 yr. old, type 2B female, with a Stage 3/Grade 2

> biopsy and a 5 million

> viral load before starting 6 months of combo

> treatment on 10/18/99 that just

> ended 15 days ago, and " non-detectable " at 12 weeks

> and now at 24 weeks (end

> of treatment on 4/3/00).

> Dr. Gish said that my viral load, LFT's, etc. are

> all looking great, and so,

> unless I take a turn for the worse, he wants to

> recheck all my bloodwork,

> including viral load, and see me again in 6 months

> (Sept/October 2000). He

> expects I'll be continuing to feel better gradually

> since I'm still feeling

> some of my side effects, although a bit milder than

> while on treatment. If I

> am a " sustained responder " (still non-detectable) 6

> months from now then he

> said there is a 95% chance of continued success

> beyond that, and he would

> check me again about 2 years after that (again,

> unless I have problems). We

> didn't talk about it today, but last month he had

> indicated that if I was not

> a sustained responder then he would probably try me

> on the Pegylated

> interferon later this year.

> I told him I had heard on the Internet hep c sites

> that a study came out

> about a new protocol, where there are 5 factors

> determining whether a type 2

> or 3 should/would go for 24 weeks or 48. He said

> that he had heard about the

> study, but he usually only recommends 48 weeks for a

> type 2 or 3 when they

> have at least borderline cirrhosis. He said that

> equated to only about 1% of

> hep c patients that would fall within those

> recommendations. He then said

> that my treatment plan was appropriate. We did not

> discuss type 1's at all,

> sorry.

> This will probably continue to be a controversy, as

> so much about hep c is,

> so let's keep the information flowing so we're all

> kept current.

> Take care everyone,

> Sara

>

> (the above message was in response to these emails)

> :

> > Date: Sun, 16 Apr 2000 15:09:10 +0530

> > From: " Doc " <gidoc@...>

> > Subject: Re:

> > Hi all,

> > I must add here that Dr Hoofnagle is a pioneer on

> treatment of Hepatitis

> > and we must value his judgment. However, the

> results of various

> > studies are not really applicable to one and all.

> It has been proven now

> > that the longer you take treatment for Hep C the

> more likely are you to

> > remain in remission. Thus irrespective of

> genotype treatment is

> > certainly to be continued for a year unless you

> are getting serious side

> > effects or have minimal damage on liver biopsy

> which has reversed.

> > Remember the virus develops new quasispecies real

> fast the moment you

> > discontinue treatment.

> > Dr Sharat C Misra, MD DM

> > Consultant Gastroenterologist & Hepatologist

> >

> > (unknown)

> >

> > > Hello Everyone,

> > > I wanted to share the following with all

> of you. In a message

> > > yesterday (?) someone said their doctor said

> genotypes 2 & 3 never

> > should be on combo more than 6 months, and 1's

> with viral loads under 2

> million

> > should only be on 6 months too. I sent a

> question in to another HCV group

> > that is huge, and got an interesting response.

> This response if from

> someone

> > who is extremely well educated about HCV and has

> a medical background, and

> I

> > have come to respect his opinions and advice.

> Due to privacy issues and

> > list rules I cannot print any of his personal

> info, but still thought you

> > might enjoy hearing what he had to say. The

> first part is the question I

> > sent in.

> > >

> > > Hi everyone,

> > > Could y'all read the following letter and

> tell me if ANYONE has

> > heard anything about this supposed study? (not

> the French study mentioned,

> > the following one on reducing the length of

> treatment.) I can't believe

> > anyone would be saying that genotype 1's with

> viral loads under 2 million

> > should only be treated 6 months, unless maybe the

> person worked for

> Schering.

> > I'm sure they would like a bunch of relapsers to

> buy more drugs.

> > > Claudine

> > >

> > > ****************************

> > > ..... I will really be interested to hear what

> Dr. Gish says about the

> > length of treatment next week....I am a 2 b and

> had resigned myself to 48

> weeks

> > of treatment because that's what the five factor

> thingy (from the French

> > > study?) seemed to indicate for me....I only had

> 3 positive factors:

> female,

> > 1.5 - 2 mil viral load, and

> non-African....Against me is age (53), disease

> 30

> > years, and stage 2 fibrosis (approaching stage

> 3?) Well......my hep doc

> just

> > got back from a symposium on liver disease in

> Atlanta put on by the

> > CDC....He said Dr. Hofnagel (sp?) made an

> announcement that new studies

> indicate that genotype 2's and 3's should never go

> longer than 6

> months....there is

> > never an advantage....NOW I'M REALLY

> CONFUSED.......and I wonder if this

> is

> > just a different interpretation of the study that

> proposed the five

> positive

> > factor gauge......DOES ANYBODY KNOW WHAT MY DOC

> IS TALKING ABOUT??? Can

> anyone tell me if this information from Dr. Hofnagel

> is really new? ****

> > Supposedly, he said that even genotype 1's should

> quit after 6 months of

> treatment if they started with a viral load of 2 mil

> or less....What's a girl

> to believe? I'd appreciate any clarification of

> this info....I don't know

> whether to quit or not......Thanks,

> > >

>

----------------------------------------------------------------------

> > > Claudine, This is all hogwash. I have not seen

> any new Hoofnagel

> > info, but these kinds of absolute statements are

> absolute nonsense. The

> > only absolute about Hep C and its treatments are

> that there are no

> absolutes.

> > > Since Hoofnagel is the dope that gave us 12

> years of mistreatment with

> > 3 times weekly dosing I'd have to take anything

> he says with a LOT of salt.

> > > Any genotype 1 that quits treatment after 6

> months is begging for

> > failure or relapse. I'd consider 6 months of

> treatment for a genotype 1

> as pure

> > folly, regardless of beginning viral load.

> (Although there's no question

> > that the lower viral load will fare better...

> across the board.)

> > > And to say genotypes 2 or 3 should NEVER go

> beyond 6 months is just as

> > > stupid, or more so. What should be the measure

> of the length of

> > treatment is to use viral load tests, and to

> treat genotypes 2 or 3 for at

> least

> > 5 months after viral clearance (but preferably 9

> or 10 months), and

>

=== message truncated ===

__________________________________________________

April 18, 2000

Hi Sara,

I would agree with his plan but keep a 3 monthly watch on ALT/AST.

April 19, 2000

Hi Connie,

Thanks so much for your reply. I'm feeling pretty hopeful about staying

non-detectable for a long, long time...6 months from now and beyond...but I

still have a little fear deep down because so much is riding on that next

viral load test in 6 months. Maybe when I feel " normal " again I'll be able

to keep that fear on the very back-burner and out of my mind until at least I

get closer to the test date.

Please forgive me, Connie, if I've got this wrong (brain fog?), but weren't

you on combo for 5 months and had bad sides so you were pulled off treatment?

Your story sounds rough. I had some rocky sides, but only had a reduction

of my Ribaviran from 1200 a day to 1000 a day for the last 4 weeks because my

hemoglobin was so low. Connie, you probably had the 3 months of recovery

back-to-normal time because the treatment kicked your butt while on it, and

your body had a lot of adjustment to do to get it out of your system. I

hoping for about half that time, if I continue to feel better at the pace

it's going now for me.

So take care of yourself Connie...my thoughts and best wishes are with you.

............Sara

Date: Tue, 18 Apr 2000 20:53:15 -0700 (PDT)

From: Constance Dickson <constance_clearwater_florida@...>

Subject: Re: 24 vs. 48 weeks controversy

Congratulations Sara I am very happy for you I hope everything stays

good for you. It took about 3 months when I was pulled off meds to

feel normal or kind of normal again so hopefully yours will come quicker

and stay that way.......Connie

--- srw1954@... wrote:

> Hi Dr Misra and everyone,

> I saw my doctor, Dr. Gish, today for my " after-treatment follow-up

and

> action plan " as I like to call it. To refresh your memories, I am a white,

> 45 yr. old, type 2B female, with a Stage 3/Grade 2 biopsy and a 5 million

> viral load before starting 6 months of combo treatment on 10/18/99 that

just

> ended 15 days ago, and " non-detectable " at 12 weeks and now at 24 weeks

(end

> of treatment on 4/3/00).

> Dr. Gish said that my viral load, LFT's, etc. are all looking great, and

so,

> unless I take a turn for the worse, he wants to recheck all my bloodwork,

> including viral load, and see me again in 6 months (Sept/October 2000). He

> expects I'll be continuing to feel better gradually since I'm still feeling

> some of my side effects, although a bit milder than while on treatment. If

I

> am a " sustained responder " (still non-detectable) 6 months from now then he

> said there is a 95% chance of continued success beyond that, and he would

> check me again about 2 years after that (again, unless I have problems).

We

> didn't talk about it today, but last month he had indicated that if I was

not

> a sustained responder then he would probably try me on the Pegylated

> interferon later this year.

> I told him I had heard on the Internet hep c sites that a study came out

> about a new protocol, where there are 5 factors determining whether a type

2

> or 3 should/would go for 24 weeks or 48. He said that he had heard about

the

> study, but he usually only recommends 48 weeks for a type 2 or 3 when they

> have at least borderline cirrhosis. He said that equated to only about 1%

of

> hep c patients that would fall within those recommendations. He then said

> that my treatment plan was appropriate. We did not discuss type 1's at

all,

> sorry.

> This will probably continue to be a controversy, as so much about hep c is,

> so let's keep the information flowing so we're all kept current.

> Take care everyone,

> Sara

April 19, 2000