FuzeonSupport : Messages : 814-843 of 1195

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#843 From: "harrisontn" <HARRISONTN@...>
Date: Wed Mar 22, 2006 2:52 pm
Subject: Feeling not so alone now harrisontn
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I'm glad to see that I'm not the only one experiencing difficulties
administering T-20. I started T-20 on Dec. 5 after being  heavily
treated on various HAART combos since '96. Just over 2 yrs ago I had
achieved an undetectable VL and maintained that for over 1 yr until
Eckerds misfilled my Zerit with Zetia which I unwittingly took for
almost 30 days until the mistake was discovered. After lab results
showed that I was no longer undetectable and being totally disgusted
with the whole thing in general, I stopped treatment. After two
years of no medications at all and only one major illness...CAB
(community aquired bronchitis), I decided to resume treatment.
Partly because of general fatigue/loss of energy and partly because
of pressure from Dr.s to resume HARRT before a major OI occurred. SO
initial baseline labs showed that, even after over 2 years of no
treatment, my VL had only risen to 51K which I think is a relatively
low number.At any rate, I was really surprised that my Dr.
prescribed such a drastic measure as T-20 when VL was not really
that high. After 2 months of treatment, labs showed a drop in VL
from 51K to 1K which I know is a good thing. Any reduction of VL is
good but at what cost of quality of life? It's russian roulette with
ISRs. Sometimes they happen, sometimes they don't.Believe me I've
tried ALL the tricks..different angle of injection/warming the vial
in my waistband before injection so it's not so cold(which DOES seem
to help)heat before/ice after/cortaid/religiously using a precussion
massager after every injection. BUT when they do, they are bad. I've
limped into the Dr. many times only to be told, "Oh, you gotta
little bee sting there don't you?", as they mash on it.
ANYWAY...going for lab results for the past 2 months on friday. If
they can't dazzle me with some great numbers I think I'll stop T-20.
Although my energy has returned, who could do anything with at least
1/2 a dozen ISRs totally debilitating you not to mention the fact
that now my stomach looks like a lumpy sack of potatoes. LOL Thank
you for letting me vent and for anyone on T-20, you're in my prayers.

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#842 From: "Chuck" <Averageguykc@...>
Date: Wed Mar 22, 2006 2:16 pm
Subject: Have faith nicetostrangers
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Hey guys just thought I would share my experience.  I started Fuzeon
back when it was still in trial phase. So I've been on it about 4
years now I think.  I had all the problems you guys are talking about
and that bio injector I tried for a while but god I can relate to the
guy who just kept putting off his shot.  I'd personally rather see
the needle go in and expect a small prick rather than that painful
gust of snap it was like a rubber band being snapped on my skin.
Anyway the whole reason I'm writting is this:  I do not use the
injection needles that they send with the medicine.  I have my
pharmacy give me insulin needles (1cc 31gage).  It takes a little
longer to draw the medicine up once you reconstitute it but oh my god
it makes such a difference in the stick.  And the reactions are much
less.  I don't know why.  But I also over the past 4 years have
stopped giving shots in my butt, legs and stomach as those were the
worse reactions when they did happen.  I know only do my arms.
Granted I have to use a chip clip or something to grab the skin when
I'm alone on parts of my arm but reduced the reactions by 95%  Hardly
ever have one anymore and when I do have a bad one it only last about
a day or 2.  I have nothing but experience but I think it is because
I use the muscles in my arms all day and thus work out the soreness
quicker than it just sitting in the fat in my belly.
Also for the guy who just posted about failing his regimine.  I had a
glich a while back lasted several months and then worked it's self
out be patient.  I've been poz for 16 year now and this drug is the
first to ever have me undetectable and actually change the direction
of my health back in a different direction.  It did take me almost 6
months in the beginning to get to undetectable so for those not so
lucky as the ones saying it happened in a month have faith also.
Good luck and live big.
Chuck

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#841 From: safford@...
Date: Wed Mar 22, 2006 3:08 pm
Subject: Re: [PozHealth] Re: Fuzeon injection site woes passiondc20009
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hi all--

i was hoping someone might be able to help me. nelson-you have been great. i am planning to move to canada before the summer. my pharmacy tells me they can not mail order my Fuzeon Rx there. Is this the case with all my meds? I may be lucky to carry my employer's insurance until he end of the year. They indicated something about having a freind mail it to me. I will be back and forth to DC, perhaps better to carry my own supply? any advice is appreciated.

--Paul

-----Original Message-----
From: PoWeRTX@...
To: FuzeonSupport@yahoogroups.com
Cc: pozhealth@yahoogroups.com
Sent: Tue, 21 Mar 2006 15:34:54 EST
Subject: [PozHealth] Re: [FuzeonSupport] Fuzeon injection site woes

In a message dated 3/21/2006 2:24:16 P.M. Central Standard Time, allan2947@... writes:

I can only hope that some less painful substitute for Fuzeon will soon be
found.

Allan

Allan:

Good question (and hope)

Fuzeon seems to be here to stay for a while. It seems to provide better efficacy when started with a new active agent. But we may be able to access two active agents sometime in the next year via different ways.

In three months we will most probably have TMC 114 (a new protease for multi drug resistance) approved by the FDA.

In 6 months we will probably have access to Merck's integrase inhibitor MRK 518 via expanded access

In 6- 8 months we will probably have TMC 125 (a non nuke) available via expanded access.

Depending on how things go, in 7-9 months we will probably have Maraviroc (an oral entry inhibitor) available via expanded access ( there are still several questions about the CCR5 entry inhibitor class, so this is not a done deal yet)

A year from now, if things go well with this drug, we may have access to TNX 355, a CD4 monoclonal antibody that is given by IV every two weeks. There are starting a phase III study this summer.

How are we going to combine these drugs? What are the main interactions? What are the main side effects? We still have many questions that may have answers sooner than later (I hope!)

Good news for many of us in salvage. The question for some is "How do we wait and with what?"

Regards,

Nelson Vergel
powerusa dot org

"The great tragedy of life is not that people set their sights too high and fail to achieve their goals but they set their sights too low and do."
Michelangelo

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#840 From: Joe Palmer <glajoe2@...>
Date: Wed Mar 22, 2006 2:51 am
Subject: Re: Fuzeon injection site woes jpalmer567
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Long story made short: I started Fuzeon on Decemeber 2nd after months of stalling my doctor, partly because of th ISRs. I'm no stranger to self-administered injections, having been diagnosed with Type II diabetes nearly four years ago.

During the first week when I went out at night and had forgot to bring the right syringe I discovered using an insulin syringe caused less pain. My little accidental discovery was backed up by another person on this list or the PozHealth list.

After the injection syringe exploded one morning, and the entire dose went on the kitchen table. I asked my doctor to write a scrip for a 1 CC fine gauge insulin syringe with a short needle, and there have been relatively few problems since then. I still have to remember to "rotate" sites, but there is a little more "leeway." I don't like injecting into my thighs and haven't done so in years. And while I think I'm a skinny guy, I do have a bit of a stomach which I'm sure is an assett in this matter.

My advice would be for you to ask you doctor for a scrip or for a few "sample" syringes to try out.

Joe

>I had thought that the Fuzeon biojector was supposed to be a big improvement over the needle injections that I've been doing for over two years. Judging from the messages on this subject, it doesn't really seem to offer much improvement at all. I wonder if there are people who have used both methods who find that the biojector does help minimize injection site reactions.

Even though I don't use the biojector, I really can relate to the pain and the dread that some posters have talked about. For me, it hasn't gotten any easier over time. As a matter of fact, the injections seem to be more painful now than they ever were. And finding new injection sites on my skinny body is a real challenge. Many days I can barely walk due to the injection site reactions on my thighs. The abdomen area isn't any better.

So far, I haven't missed any doses, but

increasingly I think about skipping an injection or two each week just to give my body a little extra time to heal. I hate to do this, since my viral load is currently undetectable.

I can only hope that some less painful substitute for Fuzeon will soon be found.<

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#839 From: "brutur2002" <brutur2002@...>
Date: Tue Mar 21, 2006 10:04 pm
Subject: Biojector or needles ? brutur2002
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Hi,

I was surprised to read all the recent postings about the side
effects experienced by people using the Biojector. And I thought I
was the only one !
I started Fuzeon 12 months ago and originally used the standard
needles to inject the drug. Side effects were annoying (local
swelling, painful nodes, etc) but when my viral load became
undetectable after one month of use, the incentive to continue was
certainly there (poz since 1988, I had never been undetectable no
matter what regimen I was put on).
After a couple of months, I was offered to participate in a study
about quality of life with the use of Biojector instead of needles.
The first few weeks were OK, with somewhat less reactions. And then,
a couple of months ago, things started deteriorating. The local
reactions got more intense, with huge nodules that lasted up to a
week, bruising, pain. Like most people in my situation, I have very
little if any subcutaneous fat except for my belly. So choices of
sites for injections are very limited. I tried the upper anterior
portion of the thigh but got a painful lump the size of an egg ! So I
went back to the standard needles to inject the drug. Although
unconfortable, it seems more manageable than with the Biojector.
And now, for some unknown reason (never missed a dose), I'm failing
this regimen which was my last hope (3TC, Norvir, Aptivus and
Fuzeon). My viral load is back up there. I'm resistant to every drug
available at the moment. Hopefully, some of the new drugs will become
available to me soon.
And I fully understand those of you who often think about skipping a
dose : the thought often crosses my mind too.

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#838 From: james tempio <jatem@...>
Date: Tue Mar 21, 2006 8:47 pm
Subject: Re: Fuzeon injection site woes jatem@...
Send Email

I just passed my 2nd year to the day on Fuzeon - I know how you feel
but if you can get through it you'll gain enough weight to have
injection spots.  I've recently heard that there are new formulations
due out before the year's end which may give you more options. Ice,
electric massagers, and cortaid immediately after the injection,
arnica the next day are working for me in varying combinations.

On Mar 21, 2006, at 3:19 PM, Allan wrote:

> I had thought that the Fuzeon biojector was supposed to be a big
> improvement
> over the needle injections that I've been doing for over two years.
> Judging
> from the messages on this subject, it doesn't really seem to offer
> much
> improvement at all. I wonder if there are people who have used both
> methods
> who find that the biojector does help minimize injection site
> reactions.
>
> Even though I don't use the biojector, I really can relate to the
> pain and
> the dread that some posters have talked about. For me, it hasn't
> gotten any
> easier over time. As a matter of fact, the injections seem to be more
> painful now than they ever were. And finding new injection sites on my
> skinny body is a real challenge. Many days I can barely walk due to
> the
> injection site reactions on my thighs. The abdomen area isn't any
> better.
>
> So far, I haven't missed any doses, but increasingly I think about
> skipping
> an injection or two each week just to give my body a little extra
> time to
> heal. I hate to do this, since my viral load is currently
> undetectable.
>
> I can only hope that some less painful substitute for Fuzeon will
> soon be
> found.
>
> Allan
>
>
>
>
>
> If you have been forwarded this email and want to join this group,
> send a blank email to
> FuzeonSupport-subscribe@yahoogroups.com
> Yahoo! Groups Links
>
>
>
>
>

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#837 From: "John Morace" <jmorace@...>
Date: Tue Mar 21, 2006 8:52 pm
Subject: Re: Fuzeon injection site woes jmorace2
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I find that with the bioinjector the injection site reactions are temporary, they either don't really do much, or get sore and form a lump for a couple of days -- about 15 or 20 hours after the shot. But within two or three days the area is ok to inject again. I've never don't the needles, so I have nothing to compare it to.

John

----- Original Message -----

From: Allan

To: FuzeonSupport@yahoogroups.com

Sent: Tuesday, March 21, 2006 12:19 PM

Subject: [FuzeonSupport] Fuzeon injection site woes

I had thought that the Fuzeon biojector was supposed to be a big improvement over the needle injections that I've been doing for over two years. Judging from the messages on this subject, it doesn't really seem to offer much improvement at all. I wonder if there are people who have used both methods who find that the biojector does help minimize injection site reactions. Even though I don't use the biojector, I really can relate to the pain and the dread that some posters have talked about. For me, it hasn't gotten any easier over time. As a matter of fact, the injections seem to be more painful now than they ever were. And finding new injection sites on my skinny body is a real challenge. Many days I can barely walk due to the injection site reactions on my thighs. The abdomen area isn't any better. So far, I haven't missed any doses, but increasingly I think about skipping an injection or two each week just to give my body a little extra time to heal. I hate to do this, since my viral load is currently undetectable. I can only hope that some less painful substitute for Fuzeon will soon be found. Allan

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#836 From: PoWeRTX@...
Date: Tue Mar 21, 2006 3:34 pm
Subject: Re: Fuzeon injection site woes nelsonvergel
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In a message dated 3/21/2006 2:24:16 P.M. Central Standard Time, allan2947@... writes:

I can only hope that some less painful substitute for Fuzeon will soon be
found.

Allan

Allan:

Good question (and hope)

In three months we will most probably have TMC 114 (a new protease for multi drug resistance) approved by the FDA.

In 6 months we will probably have access to Merck's integrase inhibitor MRK 518 via expanded access

In 6- 8 months we will probably have TMC 125 (a non nuke) available via expanded access.

A year from now, if things go well with this drug, we may have access to TNX 355, a CD4 monoclonal antibody that is given by IV every two weeks. There are starting a phase III study this summer.

How are we going to combine these drugs? What are the main interactions? What are the main side effects? We still have many questions that may have answers sooner than later (I hope!)

Good news for many of us in salvage. The question for some is "How do we wait and with what?"

Reply | Forward | Messages in this Topic (6)

#835 From: Allan <allan2947@...>
Date: Tue Mar 21, 2006 8:19 pm
Subject: Fuzeon injection site woes allan2947@...
Send Email

I had thought that the Fuzeon biojector was supposed to be a big improvement
over the needle injections that I've been doing for over two years. Judging
from the messages on this subject, it doesn't really seem to offer much
improvement at all. I wonder if there are people who have used both methods
who find that the biojector does help minimize injection site reactions.

Even though I don't use the biojector, I really can relate to the pain and
the dread that some posters have talked about. For me, it hasn't gotten any
easier over time. As a matter of fact, the injections seem to be more
painful now than they ever were. And finding new injection sites on my
skinny body is a real challenge. Many days I can barely walk due to the
injection site reactions on my thighs. The abdomen area isn't any better.

So far, I haven't missed any doses, but increasingly I think about skipping
an injection or two each week just to give my body a little extra time to
heal. I hate to do this, since my viral load is currently undetectable.

I can only hope that some less painful substitute for Fuzeon will soon be
found.

Allan

Reply | Forward | Messages in this Topic (6)

#834 From: <dalepuri@...>
Date: Tue Mar 21, 2006 4:19 pm
Subject: RE: Digest Number 321 monkeyboyinsf
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I used the biojector almost since it was available with Fuzeon, and I too
started to skip doses.  I never miss meds, or almost never, so this was very
unusual for me.  I dread doing the injections because it hurts so much going
in, and then I can't use that spot for a few days, after a while I run out
of spots.  I finally just took a month off.

Dale Puri.

-----Original Message-----
From: FuzeonSupport@yahoogroups.com [mailto:FuzeonSupport@yahoogroups.com]
Sent: Tuesday, March 21, 2006 1:08 AM
To: FuzeonSupport@yahoogroups.com
Subject: [FuzeonSupport] Digest Number 321

There are 5 messages in this issue.

Topics in this digest:

       1. Biojector Injection Issues
            From: DPB77905@...
       2. Re: Biojector Injection Issues
            From: amuscledaddy@...
       3. Re: Biojector Injection Issues
            From: safford@...
       4. Re: Biojector Injection Issues
            From: RAMB46@...
       5. Re: Biojector Injection Issues
            From: RAMB46@...


________________________________________________________________________
________________________________________________________________________

Message: 1
    Date: Sat, 18 Mar 2006 00:00:12 EST
    From: DPB77905@...
Subject: Biojector Injection Issues

I have been on Fuzeon for 16 months now and have been using the  biojector
needle-free injection system for the past 7 months.  I've notice  I'm
getting
more and more reluctant to give myself the injection; virtually  skipping
all my
meds for half of the day.   I'm finding that my  injections are getting more

and more painful and I am reminded of the pain all  throughout the day and
nite.  I have given injections along my sides of the  chest, and around the
buttucks area.  Another thing  I'm noticing  is  bruises on some injections.

Nothing helps with the pain; my only  remedy is to cease the injection for
12 hours
then I'm good to go  again.  I realize this isn't the thing to do, but felt
I
needed to let the  group know; perhaps others have similar injection issues
with the biojector  system.

Dave
South Texas


[This message contained attachments]



________________________________________________________________________
________________________________________________________________________

Message: 2
    Date: Mon, 20 Mar 2006 12:10:42 EST
    From: amuscledaddy@...
Subject: Re: Biojector Injection Issues

Thanks for the Biojector information. I have been considering using them,
but
until it is FDA approved my HMO will not pay for them. I am curious if the
biojector isnt helpful in process of injections.

John


[This message contained attachments]



________________________________________________________________________
________________________________________________________________________

Message: 3
    Date: Mon, 20 Mar 2006 14:27:37 EST
    From: safford@...
Subject: Re: Biojector Injection Issues

i am not a dr of course, but perhaps some tylenol might  help?


[This message contained attachments]



________________________________________________________________________
________________________________________________________________________

Message: 4
    Date: Mon, 20 Mar 2006 23:07:19 EST
    From: RAMB46@...
Subject: Re: Biojector Injection Issues

Yes it is easier & less site reations problems

Ron
New  England, Ma.


[This message contained attachments]



________________________________________________________________________
________________________________________________________________________

Message: 5
    Date: Mon, 20 Mar 2006 17:50:05 EST
    From: RAMB46@...
Subject: Re: Biojector Injection Issues

I also use the Bio injector & have MANY site reactions.
I get a lot of hard lumping in areas. I feel pretty soon I may not have
many
sites left.
  Also when doing on my legs, I get pain for a couple of days !
A lot of my problem is I have No body fat, or subcutanios [sp] fat.
  Do you get lumping? Do you have good fatty areas for injecting?
I am also getting to the point I hate having to prepare it let alone doing
it!
  It was nice to hear from someone using the Inj. system & the  problems that

go along with it.

Ron
New  England, Ma.


[This message contained attachments]



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#833 From: PoWeRTX@...
Date: Tue Mar 21, 2006 9:24 am
Subject: Is Enfuvirtide (Fuzeon, T-20) Cost-effective in HIV Therapy for Treatment-Experi nelsonvergel
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http://www.hivandhepatitis.com/recent/2006/ad1/032106_b.html

Is Enfuvirtide (Fuzeon, T-20) Cost-effective in HIV Therapy for Treatment-Experienced Patients in the US?

Enfuvirtide (ENF) [Fuzeon] is the first of a new class of antiretrovirals (ARVs) known as the HIV fusion (entry) inhibitors. It is currently the only FDA-approved drug in this new drug class. Enfuvirtide is arguably expensive compared to most other antiretrovirals. Although it may be costly, is it cost-effective? A study published in the current issue (March 2006) of AIDS Research and Human Retroviruses examines this issue.

Two Phase III studies of ENF, TORO 1 and TORO 2, demonstrated that ENF given in combination with optimized background (OB) therapy significantly improved virological response, increased the time to virological failure, and increased CD4-cell count compared with OB alone among highly treatment-experienced patients.

The present study investigated the long-term clinical outcomes, costs, and cost-effectiveness of ENF. Outcomes, costs, and cost-effectiveness were estimated using a Markov model. Viral suppression and immune reconstitution were determined from the outcomes of the clinical trials. Time to immunological failure, time to AIDS-defining event (ADE), and time to death were estimated based on published mathematical models of disease progression.

Costs were based on published estimates of the use and costs of ARVs, cost of managing ADEs, and cost of laboratory and other outpatient services. Cost-effectiveness was calculated as the incremental cost per year of life gained, adjusted for quality of life.

Results

The combined effects of an increase in CD4 count and delayed time to virological and immunological failure with ENF + OB were predicted to produce a mean life expectancy of 7.4 years from initiation of therapy, which was 1.8 years (1.5 quality-adjusted lifeyears [QALYs]) greater than the life expectancy associated with OB alone.

The incremental cost-effectiveness of ENF + OB was estimated to be $24,604 per QALY.

ENF is projected to increase time to immunological failure, delay onset of new AIDS-defining events, and increase life expectancy by more than 1.5 years among treatment-experienced HIV-infected patients.

The study authors conclude, "The cost-effectiveness of ENF is comparable to many existing treatment and prevention management strategies for HIV."

03/20/06

Reference
John Hornberger and others. Cost-Effectiveness of Enfuvirtide in HIV Therapy for Treatment-Experienced Patients in the United States. AIDS Research and Human Retroviruses 22(3): 240-247. March 2006.

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#832 From: RAMB46@...
Date: Mon Mar 20, 2006 5:50 pm
Subject: Re: Biojector Injection Issues RAMB46@...
Send Email

I also use the Bio injector & have MANY site reactions.

I get a lot of hard lumping in areas. I feel pretty soon I may not have many sites left.

Also when doing on my legs, I get pain for a couple of days !

A lot of my problem is I have No body fat, or subcutanios [sp] fat.

Do you get lumping? Do you have good fatty areas for injecting?

I am also getting to the point I hate having to prepare it let alone doing it!

It was nice to hear from someone using the Inj. system & the problems that go along with it.

Ron
New England, Ma.

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#831 From: RAMB46@...
Date: Mon Mar 20, 2006 11:07 pm
Subject: Re: Biojector Injection Issues RAMB46@...
Send Email

Yes it is easier & less site reations problems

Ron
New England, Ma.

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#830 From: safford@...
Date: Mon Mar 20, 2006 2:27 pm
Subject: Re: Biojector Injection Issues passiondc20009
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i am not a dr of course, but perhaps some tylenol might help?

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#829 From: amuscledaddy@...
Date: Mon Mar 20, 2006 12:10 pm
Subject: Re: Biojector Injection Issues amuscledaddy
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Thanks for the Biojector information. I have been considering using them, but until it is FDA approved my HMO will not pay for them. I am curious if the biojector isnt helpful in process of injections.

John

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#828 From: DPB77905@...
Date: Sat Mar 18, 2006 12:00 am
Subject: Biojector Injection Issues blklthrboots...
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I have been on Fuzeon for 16 months now and have been using the biojector needle-free injection system for the past 7 months. I've notice I'm getting more and more reluctant to give myself the injection; virtually skipping all my meds for half of the day. I'm finding that my injections are getting more and more painful and I am reminded of the pain all throughout the day and nite. I have given injections along my sides of the chest, and around the buttucks area. Another thing I'm noticing is bruises on some injections. Nothing helps with the pain; my only remedy is to cease the injection for 12 hours then I'm good to go again. I realize this isn't the thing to do, but felt I needed to let the group know; perhaps others have similar injection issues with the biojector system.

Dave

South Texas

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#827 From: PoWeRTX@...
Date: Thu Mar 16, 2006 9:51 am
Subject: Give TMC125 to Drug-Resistant HIVers, Activists Urge nelsonvergel
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click here
Give TMC125 to Drug-Resistant HIVers, Activists Urge
A pair of HIV meds in development, TMC114 (darunavir) and TMC125 (etravirine), have generated plenty of excitement lately: Studies suggest they can fight HIV in people who are already resistant to many approved HIV meds, and who may be running out of treatment options. However, both of these drugs are still in clinical trials, which limits the number of people who can receive them. TMC114 is now available through what's called an "expanded access program," which provides the drug to people who may need it most -- but the same isn't true of TMC125. AIDS activists are now publicly pushing for Tibotec Pharmaceuticals, which is developing both TMC114 and TMC125, to make TMC125 more widely available as soon as possible. See how you can help.

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#826 From: PoWeRTX@...
Date: Sun Feb 26, 2006 2:13 pm
Subject: LOOKING FOR TESTIMONIALS nelsonvergel
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Gang

I am adding a new page to salvagetherapies.org with people's testimonials

I would like to hear from people who have failed Fuzeon and/or Aptivus who are waiting for nee drugs to improve their chances of survival.

Please email me directly for more information

This information is very important to put a human face on multiple drug resistance

Many researchers, activists, and clinicians say this is not a big problem since most people in salvage are dead or too sick to save. I am looking to change that perception.

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#825 From: PoWeRTX@...
Date: Tue Mar 7, 2006 4:31 pm
Subject: AIDS Activists Urge Tibotec to be Compassionate towards HIV Salvage Patients nelsonvergel
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For Immediate Release

Contact: Nelson Vergel

Email: nelsonvergel@...

Phone: (713) 539-1978

NEW DRUGS CAN SAVE LIVES; AIDS Activists Urge Tibotec to be Compassionate towards HIV Salvage Patients

HOUSTON, TX (March 8, 2006) – AIDS Activists, seeking to expand access to new drugs for people living with HIV who have run out of treatment options, are urging Tibotec Pharmaceuticals, a subsidiary of Johnson and Johnson, to provide compassionate access to their TMC 125 non nucleoside HIV investigational drug . Compassionate access is often the difference between life and death to help those patients.

Tibotec is the first company in the battle against AIDS to have two promising new drugs simultaneously under development (TMC 114, a protease inhibitor, and TMC 125, a non-nucleoside). This is good news for patients who need access to more than one active drug to improve control of their multiple drug resistant HIV. In separate studies, both drugs have shown to help reduce viral replication in treatment experienced patients. A small pilot study has shown that the combination of the two drugs can suppress the virus to undetectable levels at week 16 in patients who have failed all commercially available drugs. TMC 114 is now available via expanded access and TMC 125 is available through a phase III study. But getting the combination of the two drugs to people in need is still a challenge.

“Patients that have developed HIV drug resistance to all commercially available antiretroviral medications require access to at least two new active drugs to maximize their chances for treatment response and survival,” said Nelson Vergel, a salvage patient who founded SalvageTherapies.org and board member of the ATAC. “Commercial access to Tibotec's drug combination will not become available for over a year, and many patients cannot wait that long,” added Vergel.

The Drug Development Committee of the AIDS Treatment Activists Coalition (ATAC-DDC) and the European Community Advisory Board (ECAB) met with Tibotec a year ago, where they requested early access to both TMC drugs in combination for those who have run out of treatment options so that these patients would not be exposed to the risk of having only one active agent. Unfortunately, Tibotec did not accept this request and, instead decided to open a placebo controlled study (DUET) that provides a 50 % chance of getting TMC 114 as a sole active agent. While ATAC welcomes Tibotec’s decision to combine both of their drugs in a study, it cautions that the placebo arm will fail to help those HIV patients most in need.

Drug resistance and its impact on HIV treatment are major concerns among AIDS activists. More often antiretroviral medications stop working as a result of drug resistance. In fact, national statistics shows that at least 46 percent of people failing HIV medications and 13 percent of newly diagnosed have drug resistance. Some estimate the number of people living with multiple drug resistance at 64,000 in the United States, many of whom have gone through at least four HIV medication regimens already.

“When patients do not have active agents in their optimized background treatment regimen, adding one new active drug to that OBT is considered to be ‘virtual mono-therapy.’ As observed in many previous studies, some of the 600 patients randomized to Tibotec’s placebo arm will obtain a degree of viral suppression in the short term, but benefits may be short-lived and resistance to TMC 114 can emerge in those with no other active agent in their OBT,” summarized Fred Schaich, a long term treatment activist and founder of the International Foundation for Alternative Research in AIDS (IFARA). He added, “This problem will limit the use of TMC 114 in the future as part of a fully suppressive regimen.”

The DUET studies are important clinical trials for Tibotec; they need to be completed successfully so that etravirine (TMC 125) can be approved. They are also placebo-controlled studies. This means that half of the group of patients will receive etravirine (TMC 125) and the other half will receive a placebo of TMC 125. Patients in both groups will receive darunavir (TMC 114) and any approved nucleoside reverse transcriptase inhibitor and/or the entry inhibitor Fuzeon.

To get around Tibotec’s lack of a formal compassionate program, activists are trying to make people aware of a little known process called Emergency IND (EIND) that doctors can use to get access to an investigational drug, provided that the patient meets the criteria and that the manufacturer agrees to provide the drug. This system should help those with little chance of survival and who have no time to wait for drug approval. Unfortunately, EINDs are time consuming and require approval from the manufacturer, the FDA, and local institutional review board. For more information of this procedure and other options soon to be available, go to http://www.salvagetherapies.org/announcements.html.

“With hardly any immune system left and resistance to all approved HIV medications, I have tried desperately to get access to both TMC drugs to help save my life, but my doctor tells me that I have little choice but to join the DUET study and take a 50 % chance that I may get better,” said Gary Bishop, a patient in dire need in Los Angeles who feels time is running out for him.

“We have received and facilitated Emergency IND requests for our compounds and will continue to do so, on an individual patient basis if a physician calls us. But note that patients who are eligible but choose not to participate in the DUET trials would not normally be candidates for an EIND,” said Lew Sibert from Tibotec. “Patient should discuss all of their options carefully with their physician before determining the best course of action.”

“It would be a lot easier for patients and doctors if Tibotec did the right thing and agreed to ATAC’s and ECAB’s original request to have a formal open label compassionate program as soon as possible. This will remove any obstacles due to EIND's extensive paper work, doctors' time and confusion by providing access to several patients at once instead of on a case-by-case basis,” said Nelson Vergel. “It is the most humane and ethical thing to do,” added Vergel.

For additional information, contact Nelson Vergel by phone at 713-539-1978, or email at nelsonvergel@....

####

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#824 From: PoWeRTX@...
Date: Fri Mar 10, 2006 1:57 pm
Subject: Re: New Drug Pipeline Summary Table nelsonvergel
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In a message dated 3/10/2006 12:55:14 P.M. Central Standard Time, mcinlosangeles@... writes:

Nelson, Can you provide some insight into the
ramifications of high leukocytes as a result of taking
CLA as mentioned in the article you posted a couple of
days ago. I posted this question, but no one has
responded to it, so I am asking you directly.

Thanks,
Mike

Mike

Guys, what Mike is referring to is results from a supplement called CLA used for muscle gain and fat loss. The study did not see any benefits on either parameter, but saw an increase in white blood cells. I am not sure what that means. It was not a HIV study.

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#823 From: Michael Carr <mcinlosangeles@...>
Date: Fri Mar 10, 2006 5:41 pm
Subject: Re: New Drug Pipeline Summary Table mcinlosangeles
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Nelson, Can you provide some insight into the
ramifications of high leukocytes as a result of taking
CLA as mentioned in the article you posted a couple of
days ago.  I posted this question, but no one has
responded to it, so I am asking you directly.

Thanks,
Mike

--- PoWeRTX@... wrote:

> New Updated Drug Pipeline Table. You can clock in
> the small boxes next to
> every drug name for more data.
>
>
_http://www.aidsinfonyc.org/tag/tx/pipeline2006b.html_
>
>
(http://www.aidsinfonyc.org/tag/tx/pipeline2006b.html)
>
>
>
> Regards,
>
>
> Nelson Vergel
> powerusa dot  org
>
>
> "The great tragedy of life is not that people set
> their sights  too high and
> fail to achieve their goals but they set their
> sights too low and  do."
> Michelangelo
>

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#822 From: Joe Palmer <glajoe2@...>
Date: Wed Mar 8, 2006 2:18 pm
Subject: Re: NATAP: Fuzeon Biojector Improved ISRs, Ease of Use, PK jpalmer567
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At the beginning of December I started Fuzeon and had a great deal of trouble with ISRs and the needles that are supplied for injection. Someone from this list or the PozHealth one told me to use 1 CC thin gauge, super-fine insulin syringes like those from BD (Walgreens work fine, too). You still need to rotate injection sites but these syringes work much, much easier.

Joe

FuzeonSupport@yahoogroups.com wrote:

There is 1 message in this issue.

Topics in this digest:

1. Fwd: NATAP: Fuzeon Biojector Improved ISRs, Ease of Use, PK Same
From: PoWeRTX@...

________________________________________________________________________
________________________________________________________________________

Message: 1
Date: Tue, 7 Mar 2006 10:24:17 EST
From: PoWeRTX@...
Subject: Fwd: NATAP: Fuzeon Biojector Improved ISRs, Ease of Use, PK Same

Read on...

Regards,

Nelson Vergel
powerusa dot org

"The great tragedy of life is not that people set their sights too high and
fail to achieve their goals but they set their sights too low and do."
Michelangelo

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#821 From: PoWeRTX@...
Date: Tue Mar 7, 2006 10:24 am
Subject: Fwd: NATAP: Fuzeon Biojector Improved ISRs, Ease of Use, PK Same nelsonvergel
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Read on...

NATAP http://natap.org/
_______________________________________________

Biojector Improved Fuzeon ISRs, Ease of Use, with PK The Same

“Enfuvirtide plasma levels and injection site reactions using a needle-free gas-powered injection system (Biojector)”

AIDS: Volume 20(5) 21 March 2006 p 719-723

Harris, Mariannea; Joy, Rutha; Larsen, Gerenea; Valyi, Monicaa; Walker, Ekaterinab; Frick, Lloyd Wc; Palmatier, Robin Mc; Wring, Stephen Ac; Montaner, Julio SGa

>From the aBritish Columbia Centre for Excellence in HIV/AIDS, Vancouver, British Columbia, Canada
bBioject Inc., Portland, Oregon
cDrug Metabolism and Pharmacokinetics, Trimeris Inc., Morrisville, North Carolina, USA.

Abstract
Objectives: To assess the use of the Biojector B2000 needle-free gas-powered injection system for subcutaneous administration of enfuvirtide in HIV-infected patients and to compare this system with standard needles and syringes with respect to ease of use, severity of injection site reactions (ISR), and enfuvirtide plasma levels.

Design: An observational study among 32 treatment-experienced HIV clinic patients receiving enfuvirtide.

Methods: Adult patients were assessed before and after switching from standard needles to the Biojector for enfuvirtide administration. Patients used the Biojector for up to 24 weeks and rated ease of use from 0 (easy) to 3 (difficult). ISR were graded from 0 to 31 for signs and symptoms (erythema, induration, pruritus, nodules/cysts, ecchymosis), duration of individual lesions, and number of lesions. Plasma was collected pre-dose and 1 h post-dose for enfuvirtide measurement. The high-pressure liquid chromatography with tandem mass spectrometry method used was specific for enfuvirtide over its known plasma metabolite. Wilcoxon rank sum tests were used to compare needle-based and Biojector outcomes.

Results:

The Biojector was rated as being significantly easier to use (P < 0.001) and reduced the occurrence of ISR compared with standard needles (P < 0.001). Enfuvirtide plasma levels were not statistically different between the two administration methods at either pre-dose trough (P = 0.41) or 1 h post-dose (P = 0.74).

Of 24 patients with available assessments for ease of use with both needles and the Biojector, 20 found the Biojector easy (score, 0) and only 11 found the needle system easy to use. Approximately half (13/24) found the Biojector easier to use than standard needles and syringes, and 11 found both systems equally easy, scoring both as 0. Overall, the Biojector was assessed by the patients as significantly easier to use than the standard needle and syringe system (P < 0.001). There were no patients who found the Biojector more difficult to use than standard needles and syringes.

ISR scores were available for 23 patients using both the needle-based system and the Biojector (Fig. 2a). The ISR scores were significantly higher (P < 0.001) for enfuvirtide injections using standard needles [median, 11; interquartile range (IQR), 9-12] than for enfuvirtide injections using the Biojector (median, 5; IQR, 1-8).

There were no significant differences between 20 paired observations of pre-dose trough levels of enfuvirtide by needle and Biojector (P = 0.41), where median enfuvirtide plasma concentration was 1.96 É g/ml (IQR, 1.54-3.47) using needles and 2.56 É g/ml (IQR, 1.86-3.20) using the Biojector (Fig. 2b). Likewise, 1 h post-dose drug levels were the same (P = 0.74) after enfuvirtide administration using standard needles (median, 3.30 É g/ml; IQR, 2.12-4.56) and the Biojector (median, 3.80 É g/ml; IQR, 2.08-4.44) (n = 13).

Conclusions: The Biojector needle-free injection system was easy to use for enfuvirtide administration and was associated with a decreased severity of ISR. Plasma enfuvirtide levels pre-dose and 1 h post-dose were comparable when injecting with standard needles or the Biojector.

Fig. 1. The Biojector B2000 gas-powered injection system. (a) The injector; (b) the injection technique.

Discussion
Enfuvirtide, the first approved fusion inhibitor, has provided a useful treatment option for patients harboring HIV resistant to the other available classes of antiretroviral drugs [1-7]. The drug's main side effect is ISR, which may result in pain and cosmetic concerns, thus potentially hindering adherence and affecting treatment outcomes. Enfuvirtide-associated ISR have been shown to be mitigated by use of the Biojector B2000 needle-free gas-powered injection system.

Patients and caregivers found the Biojector as easy or easier to use than standard needles and syringes. Therefore, self-administration of enfuvirtide using the Biojector system is feasible and acceptable to patients and reduces the severity of ISR, without adversely affecting available plasma levels of enfuvirtide. Of note, this evaluation was performed in a selected group of patients having difficulty with the standard needle-based injection system. Based on these results, further clinical evaluation of the Biojector B2000 for administration of enfuvirtide is warranted in the form of a prospective randomized trial including a wider patient population.

Potential drawbacks of the Biojector are cost and availability. Aside from the device itself (current suggested retail list price US$995), there are costs associated with consumable supplies such as carbon dioxide cartridges and syringes (totaling approximately US$66 per month for twice daily injections), while the supplies needed for standard needle-based injection are included in the purchase price of the drug. The Biojector device has been cleared for marketing in the United States and Canada, and is Conformite Europeene Marked for European distribution, but it is not yet commercially available in Australia and other countries. The Biojector may occasionally be associated with temporary pain or numbness when injection occurs close to a nerve, and some patients still prefer to use standard needles. However, the Biojector may make enfuvirtide an option for patients who refuse to use needles and may enable those who are experiencing significant injection-related problems such as ISR to continue taking enfuvirtide for as long as they are experiencing a therapeutic benefit.

Sponsorship: This study was supported by grants from Roche Canada and Bioject Inc.

Introduction
Enfuvirtide (Fuzeon; Roche, Basel, Switzerland), the first approved HIV fusion inhibitor, has been shown to be a highly effective addition to combination antiretroviral therapy for treatment-experienced HIV-infected patients [1-7]. Studies have shown enfuvirtide to be remarkably free of systemic toxicities [1,2,8].

Enfuvirtide is administered by twice-daily subcutaneous injection using a standard needle and syringe. Local injection site reactions (ISR) are the main side effect observed in studies and clinical use, occurring at least once over 48 weeks in 98% of patients in the TORO trials [8]. While seldom resulting in treatment discontinuation in clinical trials [1,2,8], ISR can be bothersome to patients for a number of reasons, including pain and cosmetic concerns, and may limit their willingness to start or continue on enfuvirtide therapy.

Biojector B2000 (Bioject Inc., Portland, Oregon, USA) is a portable needle-free gas-powered system for subcutaneous injection of medication (Fig. 1). The device forces medication through the skin rapidly in a fine stream that is then dispersed throughout the subcutaneous tissue. Potential advantages of the Biojector compared with standard needles and syringes for administration of enfuvirtide include reduced tissue trauma and local injection pain, thus decreasing the number and severity of ISR. The Biojector may also be easier to use and allow access to more sites for self-injection, because injection can be done with one hand. The time needed to teach patients or caregivers to use the Biojector may be less, and the needle-free system may make enfuvirtide an option for patients who refuse to use needles, for example because of needle-related anxiety or phobia. Furthermore, the absence of needles could make enfuvirtide administration safer for caregivers by reducing the risk of accidental exposure to HIV through needle-stick injury.

The bioequivalence of enfuvirtide plasma levels using the Biojector and standard 27-gauge needles has been demonstrated in a single-dose study. Enfuvirtide plasma concentration-time curves for the two systems were superimposable over the 24 h sampling period [9]. The present study assessed the Biojector for enfuvirtide administration in treatment-experienced HIV-infected patients in the clinic and compared this system with standard needles and syringes with regard to ease of administration, severity of ISR, and enfuvirtide plasma levels.

Methods

Participants
Antiretroviral-experienced HIV-infected adults having demonstrated or anticipated problems with needle-based enfuvirtide treatment and who presented in the clinic between 2 November 2004 and 27 January 2005 were offered a switch to the Biojector after appropriate training from clinic nurses. Patients who were new to enfuvirtide were instructed in the use of standard needles and syringes and used this method for at least 1 week before changing to the Biojector. The enfuvirtide dose was the same for both systems, 90 mg subcutaneously twice daily. All patients were assessed at least once while using needles, and weekly for the first 4 weeks then every 4 weeks while using the Biojector. Assessments included patient evaluation of the ease of use of their current administration system, patient and nurse assessment of the current severity of ISR, and pre-dose and post-dose plasma sampling for enfuvirtide levels. Available follow-up data are presented here to 30 June 2005.

Scoring systems
The ease of use of the administration system was rated by the patient on a scale from 0 to 3: 0, easy; 1, somewhat easy; 2, somewhat difficult; and 3, difficult. The most recent ease of use rating for a given system was used in the analysis.

ISR were scored using a cumulative rating scale based on eight measures of patient response to the administration of enfuvirtide, as used in the TORO studies [1,2]. The first parameter was an overall subjective grading by the patient based on pain and discomfort. The remaining seven parameters were objective ratings of the following signs and symptoms: erythema, induration, pruritus, nodules and cysts, ecchymosis, average duration of individual lesions, and number of individual lesions present. Each of the eight parameters was scored from 0 (none) to 4 (most severe) with the exception of pruritus, which was scored from 0 to 3; this gave a maximum total score of 31. The most recent ISR score with a given system was used for the analysis.

Pharmacokinetics of enfuvirtide

Plasma was collected pre-dose (11-13 h after previous dose) and approximately 1 h post-dose (30-90 min) for enfuvirtide measurement. Bioanalysis employed high-pressure liquid chromatography with tandem mass spectrometry in a method that is specific for enfuvirtide over its known plasma metabolite (enfuvirtide deamidated on the C terminus). The method for assaying enfuvirtide in human plasma has been characterized and shown to be accurate and precise, with inter- and intra-assay accuracy and precision better than ±15% and 15%, respectively, over the calibration range 0.025 to 25.0 É g/ml. The laboratory performing the assay was blinded to the patient identity, administration system (needle or Biojector) and timing (pre- or post-dose) of each sample. Paired observations were collected for both systems of enfuvirtide administration (needle or Biojector) as well as matched observations over time of enfuvirtide levels in patients using the Biojector. To assess enfuvirtide levels over time using the Biojector, plasma was collected from baseline to week 12.

Statistical methods
Non-parametric statistics were used to analyze differences between outcomes of the needle-based and Biojector injection systems. Comparison of ease of use scores, ISR, and enfuvirtide levels were all tested using Wilcoxon signed rank tests for paired observations. Ease of use scores and ISR analyses were tested as one-sided hypotheses where the alternate hypothesis stated the Biojector injector system would be easier to use and be associated with less ISR. Two-sided hypotheses were used for all enfuvirtide pharmacokinetic analyses. All analyses used a significance level of 0.05.

RESULTS

Participants
Between November 2004 and January 2005, 32 HIV-infected adults (29 men and 3 women) were instructed in the use of the Biojector and began using it for enfuvirtide administration. Five of these patients were naive to enfuvirtide, four were on a treatment interruption but had used enfuvirtide in the past, and 23 were receiving enfuvirtide at the time of the switch to the Biojector. The last 23 had received enfuvirtide for a median of 8 months (range, 1 to > 36). The median available follow-up after starting the Biojector was 12 weeks (range, < 1 to 24). Patients were followed until 30 June 2005.

Patient disposition
At the end of the follow-up period, 20 of the 32 patients who started using the Biojector for enfuvirtide administration were still using it, including three who alternated use of the Biojector with standard needles and syringes. Two patients were lost to follow-up, and 10 stopped using the Biojector, for the following reasons. Four discontinued all antiretroviral drugs (one because of fatigue, one because of hepatotoxicity, and two because of virological failure with multidrug-resistant virus); four stopped using the Biojector within the first week because of pain, swelling, and ISR after experiencing similar difficulties with standard needles and syringes. Of these, one went back to using needles, and three discontinued enfuvirtide altogether. Two stopped using the Biojector after more than a month for reasons possibly attributable to the device (both of these patients resumed using standard needles and syringes for enfuvirtide administration). These events were local bruising at the site of injection, which may be related to imperfect injection technique [10], and numbness in the thigh after injecting enfuvirtide at the top of the anterior thigh near the inguinal region, which is not an area recommended for subcutaneous injection [10,11].

In summary, 23 of the 32 patients (72%) who started using the Biojector remained on enfuvirtide at the end of the follow-up period, and 20 (63%) were still using the Biojector to administer enfuvirtide. Only two (6%) discontinued using the Biojector because of adverse events possibly attributable to the device itself.

Ease of use

Of 24 patients with available assessments for ease of use with both needles and the Biojector, 20 found the Biojector easy (score, 0) and only 11 found the needle system easy to use. Approximately half (13/24) found the Biojector easier to use than standard needles and syringes, and 11 found both systems equally easy, scoring both as 0. Overall, the Biojector was assessed by the patients as significantly easier to use than the standard needle and syringe system (P < 0.001). There were no patients who found the Biojector more difficult to use than standard needles and syringes.

Injection site reaction scoring

ISR scores were available for 23 patients using both the needle-based system and the Biojector (Fig. 2a). The ISR scores were significantly higher (P < 0.001) for enfuvirtide injections using standard needles [median, 11; interquartile range (IQR), 9-12] than for enfuvirtide injections using the Biojector (median, 5; IQR, 1-8).

Pharmacokinetics of enfuvirtide

There were no changes detected during the course of therapy for enfuvirtide levels using the Biojector (all pairwise tests; P > 0.1), and, therefore, average enfuvirtide levels over time could be used to compare plasma levels with the needle and Biojector administration methods at pre-dose trough and 1 h post-dose times. There were no significant differences between 20 paired observations of pre-dose trough levels of enfuvirtide by needle and Biojector (P = 0.41), where median enfuvirtide plasma concentration was 1.96 É g/ml (IQR, 1.54-3.47) using needles and 2.56 É g/ml (IQR, 1.86-3.20) using the Biojector (Fig. 2b). Likewise, 1 h post-dose drug levels were the same (P = 0.74) after enfuvirtide administration using standard needles (median, 3.30 É g/ml; IQR, 2.12-4.56) and the Biojector (median, 3.80 É g/ml; IQR, 2.08-4.44) (n = 13).

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#820 From: PoWeRTX@...
Date: Mon Mar 6, 2006 8:44 am
Subject: New Drug Pipeline Summary Table nelsonvergel
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New Updated Drug Pipeline Table. You can clock in the small boxes next to every drug name for more data.

http://www.aidsinfonyc.org/tag/tx/pipeline2006b.html

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#819 From: PoWeRTX@...
Date: Fri Mar 3, 2006 6:51 pm
Subject: Fwd: [ATAC-DrugDev] NATAP: Update on CCR5 Vicriviroc Study in Experienced Pat... nelsonvergel
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Let's just hope that this drug, and Maraviroc from Pfizer, have a good role as add-ons in treatment experienced patients. We will know in a few months.

In a message dated 3/3/2006 5:49:06 P.M. Central Standard Time, JuLev@... writes:

SCHERING-PLOUGH PROVIDES UPDATE ON PHASE II STUDY OF VICRIVIROC

Announcement from Schering tonite

Study Continues in HIV Treatment-Experienced Patients

KENILWORTH, N.J., March 3, 2006 - Schering-Plough Corporation (NYSE: SGP) today provided an update on vicriviroc, its investigational CCR5 receptor antagonist, currently being evaluated by the NIH-sponsored Adult AIDS Clinical Trials Group (ACTG) in an ongoing Phase II clinical study of 118 U.S. treatment-experienced HIV patients. Patients who entered this trial were heavily treatment experienced with advanced HIV disease and low CD4 counts. The ACTG Study Monitoring Committee (SMC) for this trial has informed the ACTG and Schering-Plough that five cases of malignancy have been observed in patients treated with vicriviroc. The five cases included four patients with lymphoma and one patient with adenocarcinoma (stomach cancer). The ACTG has concluded that a causal association between vicriviroc and the lymphoma cases could not be established at this time. ACTG further concluded that since vicriviroc, at the two highest doses tested, together with an optimized background antiretroviral regimen, showed evidence of virologic activity and CD4 count increases, the trial will continue.

Patients and investigators in the trial are immediately being informed of these results. ACTG is taking additional measures to assure the safety of patients in the trial. These include introducing long term follow-up (3-5 years) and unblinding the patients in order that they and their physicians may make a more informed decision about their treatment options. Schering-Plough intends to continue to work closely with the ACTG as well as the U.S. Food and Drug Administration and other Health Authorities to fully determine the potential role of vicriviroc in HIV therapy.

Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 32,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.

SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain “forward-looking statements” within the meaning of the Securities Litigation Reform Act of 1995, including statements relating to the timing of clinical trials and the potential market for vicriviroc. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Item 1A. Risk Factors in the Company's 2005 10-K.

SCHERING-PLOUGH PROVIDES UPDATE ON PHASE II STUDY OF VICRIVIROC

Announcement from Schering tonite

Study Continues in HIV Treatment-Experienced Patients

KENILWORTH, N.J., March 3, 2006 - Schering-Plough Corporation (NYSE: SGP) today provided an update on vicriviroc, its investigational CCR5 receptor antagonist, currently being evaluated by the NIH-sponsored Adult AIDS Clinical Trials Group (ACTG) in an ongoing Phase II clinical study of 118 U.S. treatment-experienced HIV patients. Patients who entered this trial were heavily treatment experienced with advanced HIV disease and low CD4 counts. The ACTG Study Monitoring Committee (SMC) for this trial has informed the ACTG and Schering-Plough that five cases of malignancy have been observed in patients treated with vicriviroc. The five cases included four patients with lymphoma and one patient with adenocarcinoma (stomach cancer). The ACTG has concluded that a causal association between vicriviroc and the lymphoma cases could not be established at this time. ACTG further concluded that since vicriviroc, at the two highest doses tested, together with an optimized background antiretroviral regimen, showed evidence of virologic activity and CD4 count increases, the trial will continue.

Patients and investigators in the trial are immediately being informed of these results. ACTG is taking additional measures to assure the safety of patients in the trial. These include introducing long term follow-up (3-5 years) and unblinding the patients in order that they and their physicians may make a more informed decision about their treatment options. Schering-Plough intends to continue to work closely with the ACTG as well as the U.S. Food and Drug Administration and other Health Authorities to fully determine the potential role of vicriviroc in HIV therapy.

Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 32,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.

SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain “forward-looking statements” within the meaning of the Securities Litigation Reform Act of 1995, including statements relating to the timing of clinical trials and the potential market for vicriviroc. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Item 1A. Risk Factors in the Company's 2005 10-K.

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#818 From: "Jef" <jefn@...>
Date: Fri Mar 3, 2006 7:12 am
Subject: Re: Fuzeon access problems in California- Any solutions? jefn01
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It's been on my behalf that these messages have appeared on this
listserv.

I just joined the group.

I'm having problems identifying who the Consumer rep members are on
California's ADAP board.

Any ideas?

Jef

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#817 From: SUSTIVADreams@...
Date: Thu Mar 2, 2006 9:15 pm
Subject: ADAP Alert gr8bns
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FYI - Please Share and Call your Senator in your Area.

Note: forwarded message attached.

Kory R. B. Montoya

HIV/AIDS Educator and Advocate

2940 E. Colfax Ave. # 335

Denver, Colorado 80206-1605

Yahoo! Mail
Bring photos to life! New PhotoMail makes sharing a breeze.

Please forgive duplicate posting and please share widely: ACTION ALERT Urge Your Members of Congress To Ask For Full ADAP Funding In Their Appropriations Request Letters Earlier this month, President Bush started the Fiscal Year 2007 appropriations process with the release of his proposed budget. He is proposing a $70 million increase for the AIDS Drug Assistance Program (ADAP), to assist states in addressing waiting lists for lifesaving drugs. The identified need is $196.6 million to ensure that all ADAPs around the country are able to provide a basic level of service to everyone who needs it. Years of insufficient funding have created a crisis in the program, with many states having to restrict access to treatment through waiting lists and other measures. In the next few weeks, all Senators and Representatives will write their "programmatic appropriations request letters", which asks members of the Appropriations Subcommittees to support funding for their priorities. These letters play a crucial role in educating key decisionmakers about the importance of programs like ADAP. The first thing you can do this year to fight for ADAP funding is to contact your elected representatives and ask them to include ADAP in their programmatic appropriations request letter. Please take a few minutes to make these important phone calls! How you can help: By March 9th, call your U.S. Representative and by March 31st call your two U.S. Senators in their Washington, DC offices. Ask to speak to the staff person who handles HIV/AIDS and healthcare issues. Whether you speak to this person live or leave a message, tell them: "My name is ____________ and I live in City/State. I am calling to urge Representative/Senator________________ to include funding for the AIDS Drug Assistance Program in his/her Fiscal Year 2007 appropriations request letter. This program provides access to lifesaving treatment for people with HIV and AIDS who otherwise wouldn't be able to afford it." Below is sample language that your representatives can use when writing their request letters. Offer to email or fax it to the staff person. ------------------------------------------------------------------------ --------------------- FY07 Appropriations Request for Ryan White AIDS Drug Assistance Program (ADAP) Mr. Chairman, as your Subcommittee begins work on the Fiscal Year 2007 appropriations bill for Labor/HHS/Education, I wanted to call your attention to the very real needs of Americans living with HIV/AIDS. As you know, the Ryan White CARE Act's AIDS Drug Assistance Program (ADAP) makes it possible for low-income Americans to access and afford the drugs to treat HIV/AIDS. Today, over 135,000 Americans depend on ADAP to preserve and extend their lives. Unfortunately, dozens of states are finding themselves unable to keep up with the demand for patients in need of coverage under ADAP and many states have been forced to take drastic action to offset funding shortfalls, including closing their programs to new patients, putting patients on waiting lists, reducing drug coverage, denying access to new and innovative treatments, and restricting eligibility to lower and lower income thresholds. In my state of (x), (as relevant, add line or 2 on specific state ADAP program) While I am appreciative of the President's budget request of a $70 million increase over the Fiscal Year 2006 ADAP program, it is simply too little to keep pace with those in need of these life-saving treatments. According to the National ADAP Working Group, an increase of $196.6 million above the current FY06 ADAP funding level is what is needed to care for current and new patients in the coming fiscal year. This "need" number objectively represents the amount that would allow each state to promptly enroll clients under their original eligibility rules-before the introduction of caps and other cost-containment strategies. The restrictions currently in place, including waiting lists, lead to dangerous treatment interruptions, which increase morbidity, encourage drug resistance, and discourage patient retention in care, all of which have profound effects on public health. Therefore, I urge your support for a $196.6 million increase for ADAP in the Fiscal Year 2007 Labor, Health and Human Services, and Education Appropriations bill. Thank you, on behalf of my state and those living with HIV/AIDS, for your careful consideration of this request. Murray C. Penner, Deputy Executive Director of Domestic Programs National Alliance of State & Territorial AIDS Directors 444 N. Capitol Street, NW, Suite 339, Washington, DC 20001 Phone: (202) 434-8090 Fax: (202) 434-8092 mpenner@... www.NASTAD.org "Bridging Science, Policy, and Public Health" Notice: This email message, together with any attachments, contains information of the National Alliance of State and Territorial AIDS Directors (NASTAD) that may be confidential, proprietary, copyrighted and/or legally privileged, and is intended solely for the use of the individual or entity named in this message. If you believe you are not the intended recipient and that you have received this message in error, please immediately return this by email and then delete it. Thank you.

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#816 From: SUSTIVADreams@...
Date: Thu Mar 2, 2006 9:13 pm
Subject: Re: Fuzeon access problems in California- Any solutions? gr8bns
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RE FUZEON:

As a Board Member on a STATE ADAP and a PLWHA and a Medical Provider ..this issue has come up on another listserver ..folks are cashing in retirement plans to get themselves outta the donut hole to get to the point that Medicare D will end up paying the 90-95 % cost and the balance going over say to ADAP...

1) Recomend finding out who your Consumer Reps are on the CA ADAP and setting up a meeting with them and changing this rediculous criteria...

2) ADVOCACY ITS TIME TO STAND UP AND ACT UP AGAIN ! looking at the ratio of Consumers on the Board ...should be at least 3-5 depending on the Board size ...Contact state ADAP Director find out who the consumer reps are and get your self appointed to the board ...so you can have a say in what is going on

Kathleen Russell
ADAP Section Chief, Office of AIDS
California Department of Health Services
1616 Capitol Ave. Suite 616
Sacramento, CA 95814
Tel: (916) 449-5942
Fax: (916) 449-5959
e-mail: krussel2@...
Public Contact Number: (916) 449-5900

Contact

3) Generally our state ADAP reviews drugs when we receive a request in writing to add a new drug or when a new drug comes out that is directly related to HIV .If we turn down a drug which has been requested then it cannot ( at this point) be brought back up for review for one year ...This drug is due for a review ..last done 2 yrs ago ...we have had many changes in 2 yrs in our current healthcare system ..if thats what yu call it

4) I would say that there are always exceptions and in view on the critical importance of this drug for many folks in particular those who dont get any extra assistance but that were on it prior to this Medicare Part D ( D= Disaster) introduction and those who maybe on say SSDI thats doesnt qualify them for help ..folks need to apply the pressure ...

5) do an organized targeted write in campaign ....everyone on these list in CA write them ASAP ( our ADAP meets 1/4 we would accept a urgent request even at this late date for a review) and request that the drug be reviewed and that the criteria be changed in view of the Medicare disaster...in particular for those who fall into the donut hole and have to come up with the cash to get outta it..

6) Its says that they cover donut hole coverage ..is it that T20 is an acception to the general coverage???

ENGLISH | SPANISH | TAGALOG | CHINESE

Medicare Part D

Medicare is the national health insurance program for:

People age 65 or older
Under age 65, disabled and receiving Social Security Disability Insurance (SSDI) for 24 months
People with End-Stage Renal Disease (ESRD), which is permanent kidney failure requiring dialysis or a kidney transplant

Effective January 1, 2006 the Medicare drug benefit, Medicare Part D will be available for all eligible Medicare beneficiaries. The Medicare Part D benefit is provided through private prescription drug plans (PDPs) and Medicare Advantaged managed care health plans with prescription drug coverage (MA PDs). To access the Medicare Part D benefit, eligible beneficiaries must be enrolled in one of the PDPs or MA PDs.

California ADAP:How ADAP and Medicare Will Work, ADAP Client Information and Frequently Asked Questions (FAQs), ADAP Pharmacy Provider Information, and ADAP Enrollment Worker Information and Frequently Asked Questions, and Links To Other Medicare Websites

How ADAP and Medicare Will Work

California ADAP clients who are Medicare beneficiaries are required to enroll into a Medicare Part D drug plan. ADAP will provide the following levels of coverage for eligible ADAP clients:

Part D Premiums
- ADAP will not cover the cost of a Medicare beneficiary's monthly Part D premium.
Part D Deductibles, Copayments and Coinsurance
- ADAP will cover the costs associated with Part D deductibles, copayments and coinsurance.
"Donut Hole" Coverage
- ADAP will cover ADAP formulary prescription costs when the Medicare beneficiary reaches this gap in coverage.

To receive this coverage, clients must use an ADAP participating pharmacy.

7) DOnt forget the other option which needs to be tackled at the same time ... is to also lobby the drug company ROCHE under their compasionate care program for the exceptional individuals ....They need to heae what is happeneing to folks who have been on their drug and they need to step up to the plate and help out as well....

8) Perhaps you also need to contact NASTAD ..

National Alliance of State and Territorial AIDS Directors
444 N. Capitol Street, NW
Suite 339
Washington, DC 20001
(202) 434-8090 phone
(202) 434-8092 fax
nastad@...

Your medical providers need to be included in the write in campaing request and the ADAP meetings are open to the public ...ask to testify in advance ....many times the Drug companys Reps are in attendance at these meetings as well and they take info back based on the discussions we the Board have ...Sometimes we say specific things to have it only travel back .....

9) And most certainly folks you need to let the director of HHS & CMS file grievances, your Reps and Senators, the President ect know what is going on ...and the Governator !

Dont forget NAPWA and AIDS ACTION .Project Inform and the other agencies that fight for PLWHAs etc ...Id hit up the PACHA tribe to they meet this month ...

I think you need to hit everyone up ....

This is too serious to be waiting around for one agency's denial after another ....

>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>

Does anyone have any ideas on how to help with these issues? Now with TMC 114 EAP and future approval and the Merck integrase study starting now, patients need access to another active agent.

States like NY and Fl have no such restrictions. Texas just lifted its waiting list restriction also.

*******************

Current Requirements to get Fuzeon through ADAP in CA:

Patient is rolling over from enfuvirtide (Fuzeon) clinical trials/expanded access protocol.

Patient has CD4+ count </=200 AND recent resistance test shows sensitivity to 2 or more ARV agents.

For patients with CD4+ count </=100 AND recent resistance test shows sensitivity to 1 or less ARV agents.

Supporting documentation requires: The ARV history form MUST denote the patient’s CD4+ count prior to starting enfuvirtide (Fuzeon) as well as more current CD4+/viral load values(</= 3 months old).

Current problems that patients and doctors face:

Any patient who is currently on Fuzeon and needs to switch insurance to CA ADAP must meet the original starting criteria. If a patient had private insurance with a starting CD4 of over 200, got Fuzeon and was on drug and doing well and then needed to go on ADAP, he would be denied access and have to stop taking Fuzeon. This also applies for patients who move to CA from another state’s ADAP plan that allowed for Fuzeon access. These criteria are also being applied to patients seeking help with co-pays under Medicare Part D. There is no continuity of care.

In addition to complete ARV history, doctors must also provide a current resistance test showing sensitivity to active agents. Some clinics will limit the number of tests that are paid for. The duplication of having to write out the complete history and provide a resistance test is too time consuming for doctors. Patients who need a regimen change and are trying to get drug through an EAP or study have a hard time getting the review committee to recognize these agents as active since they do not appear on a resistance assay yet.

Patients who have a higher CD4 count but a rapidly increasing viral load are forced to let their CD4 counts drop below 200 before they can get access to Fuzeon if they have two active agents to use with Fuzeon and those with only one active agent need to let their CD4 drop under 100 before they can get Fuzeon. People with HIV are doing better on meds, have higher CD4 counts, and are not waiting until they at risk for an OI before they change their regimens to include new active agents.

Changes that need to happen:

Allow any patient who is eligible for ADAP and is currently taking Fuzeon to continue on drug, regardless of their starting baseline CD4. Apply the same standards to Fuzeon as the other medications in one’s current regimen.

Reduce the number of active agents required to one and leave the CD4 count decision to the treating physician. Patients do not need to be at risk for OIs and should not be forced to lose T cells to become eligible for a drug that they need to take.

Recognize drugs that are in EAP status and clinical trials as active drugs for a patient’s Fuzeon regimen.

Allow doctors and patients to provide either a complete ARV history or recent resistance assay.

Provide doctors the opportunity for a fair clinical appeal process based on medical necessity.

Who to contact:

California Department of Health Services
Office of AIDS
MS 7700
P.O. Box 997426
Sacramento, CA 95899-7426

(916) 449-5900
(916) 449-5909 (Fax)

ooa-web@...

It has been nearly two years since the CA ADAP committee has reviewed the criteria for Fuzeon. Another meeting can not come and go without changes being made to allow those who need and want to take Fuzeon to have access to this drug. The CA ADAP committee will be meeting on March 16, 2006 in Oakland, CA and needs to hear from the people.

Regards,

Nelson Vergel
powerusa dot org

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#815 From: SUSTIVADreams@...
Date: Thu Mar 2, 2006 10:39 pm
Subject: Re CA Medicare D/ADAP re Fuzeon... gr8bns
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FYI...

Read bottom to top ...

Names omited for confidentiality ...time to mass email these sites with your concerns if you live in CA ..

Date: Mar 2, 2006 11:57 AM
Subject: Re: Problems with Medicare Part D / California ADAP

Regarding the message I posted yesterday containing the article from The
Body's newsletter: I posted to all three email addresses listed.

One of the recipients forwarded my message to several other people at the
Center for Medicare and Medicaid Services (CMA) just over an hour after I
sent it. I'm amazed by this .. because it was just after 9:30 p.m.

I received a message from Elizabeth R. Kegler at CMA this morning,
requesting my phone number for contact by the Regional CMA office in San
Francisco. Minutes after I sent my full contact information, she replied
that she had forwarded the information to San Francisco.

At least I'm stirring up some interest.

>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>

Today's email message from TheBody had the following:

Having Trouble With Medicare Part D?

Since the Medicare Part D prescription drug benefit took effect on January
1, there have been an overwhelming number of reported problems with the
benefit. These problems have been prominently covered by many media sources,
and news of the difficulties beneficiaries are having has also reached
Congress. According to these reports, a high concentration of dual eligible
beneficiaries -- those receiving both Medicare and Medicaid benefits -- are
among those experiencing problems with the new prescription drug benefit.
Most of the people living with HIV who are receiving drugs through Part D --
approximately 60,000 people -- are dual eligibles.

If you or your clients have had trouble filling a prescription(s) under the
new Medicare Part D drug program, let the Centers for Medicare and Medicaid
Services (CMS) know so that the agency is aware of the problem and can work
to fix it.

Send an e-mail describing your problem to: lorraine.zicha@...,
Ekegler@... and hivma@....

Suggested information to include in the e-mail (just include what you can):

. A description of what happened
. The names your medication(s), especially if it is an HIV drug
. Pharmacy name and general location (city and state, at a minimum)
. Name of your prescription drug plan
. What you think caused the problem
. Any additional information you wish to provide
. You do NOT Need to Include Any Personal Information

The HIV Medicare and Medicaid Working Group -- of which AIDS Action is a
member -- will be sharing Medicare Part D stories with Administration
officials, Congressional staff, and the media. We will remove all personal
information before sharing stories. If you prefer to have your e-mail sent
anonymously to CMS, e-mail hivma@... directly, and the HIV
Medicine Association staff will remove personal identifying information and
forward the information to CMS.

TAKE AIDS ACTION!
If you or your clients have had trouble filling a prescription(s) under the
new Medicare drug program, let the Centers for Medicare and Medicaid
Services (CMS) know so that the agency is aware of the problem and can work
to fix it.

Our thanks to AIDS Action Council, which provided this article to The Body.

From: http://www.thebody.com/aac/medicare_d.html

.....

Needless to say, I've posted a narrative regarding my troubles to the three
above email addresses.

I'm so beyond personal information. I posted contact information .. I'm
more than happy to talk!

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#814 From: PoWeRTX@...
Date: Thu Mar 2, 2006 6:11 pm
Subject: Fuzeon access problems in California- Any solutions? nelsonvergel
Offline
Send Email

Does anyone have any ideas on how to help with these issues? Now with TMC 114 EAP and future approval and the Merck integrase study starting now, patients need access to another active agent.

States like NY and Fl have no such restrictions. Texas just lifted its waiting list restriction also.

*******************

Current Requirements to get Fuzeon through ADAP in CA:

Patient is rolling over from enfuvirtide (Fuzeon) clinical trials/expanded access protocol.

Patient has CD4+ count </=200 AND recent resistance test shows sensitivity to 2 or more ARV agents.

For patients with CD4+ count </=100 AND recent resistance test shows sensitivity to 1 or less ARV agents.

Current problems that patients and doctors face:

Changes that need to happen:

Recognize drugs that are in EAP status and clinical trials as active drugs for a patient’s Fuzeon regimen.

Allow doctors and patients to provide either a complete ARV history or recent resistance assay.

Provide doctors the opportunity for a fair clinical appeal process based on medical necessity.

Who to contact:

California Department of Health Services
Office of AIDS
MS 7700
P.O. Box 997426
Sacramento, CA 95899-7426

(916) 449-5900
(916) 449-5909 (Fax)

ooa-web@...

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