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#1194

From: "Sandra Eniya" <sandraeniya@...>
Date: Mon Jan 12, 2009 4:35 pm
Subject: Re: T20 COMBIVT and ??????

sandraeniya

Offline

--- In FuzeonSupport@yahoogroups.com, "Ed" <edmac@...> wrote:
>
> --- In FuzeonSupport@yahoogroups.com, "Sandra Eniya"
> <sandraeniya@> wrote:
> >
> > Hello guy's I am knew to this group!
> > My name is Sandra and definitly a freak control!
> > I have been under so many differrent therapy for the last ten years
> > that oops
> > at the moment it is T20 and combivir
> > but I think I will not achieve an indetectable viral load after a
> > months
> > so having thanks for the multiples therapy a lovely crown desease
> > I wonder if any one had to use this combo and what if needed had
> they
> > had to take on top
> > trizivir viread truvada atazanavir abaccavir kaletra saquinavir and
> a
> > bit more cannot be used
> > and to make think difficulte I am against all knew drugs cause
> cannot
> > find new data
> > thank you guy's
> > only serious repply please
>
> Hey Sandra
> Has your doc done a resistance test? Are you failing this therapy,
> is your viral load comming down?
> Ed positive Dec 1985
> >
>
I will only know next week on the 20 if my viral load is or not detectable.
Styill ain't really
happy cause back on profilaxe for toxo daraprim and back for cmv with
fameciclovir So an
important quetion to you guy's I want to re use iven with a little resistance
nevirapine
will that benefit
i do not have problemes with the injection and actually since i am back at work
that
working but my live getting a night mare each time i have to change therapy
thank's a million

#1193

From: Okiemo59@...
Date: Tue Dec 16, 2008 4:45 am
Subject: Re: DDI and D4T

Okiemo59@...

Brian, I agree!

I'm a nurse (RN,BSN) who used to work in a Ryan White Clinic and I've taught T-20 injections. I will tell you as a nurse you must call your doctor and discuss with him what his plans are. Don't wait. If he/she ignores you or doesn't give you an answer you can live with get a second opinion soon! In fact it never hurts to have a second opinion anyway. If your doctor is worth his/her salt they won't be bothered by your getting another set of eyes to look at your case.

This is your life!!! Don't let anyone keep you from getting the care you need! You are in charge of your own health care.

All the best!
Okiemo59

-----Original Message-----
From: simon collins <simon.collins@...>
To: FuzeonSupport@yahoogroups.com
Sent: Mon, 15 Dec 2008 6:41 pm
Subject: Re: [FuzeonSupport] DDI and D4T

It has probably been unethical for your doc to prescribe d4T+ddI for at least the last fiver years possibly longer in may peoples views. However if you really had no side effects there are sometimes exceptions - just sounds very out of date. Withdrawing the nukes in my opinion was unethical rather than replacing then with newer drugs.

I'm not aware of any recent law that would have banned this.

If you have been on Kaletra successfully for 5 years (is your viral load undetectable?) then there are plenty of other options other than T-20.

Raltegravir + Kaletra, both twice daily, would have been the easiest to switch too when your viral load was still undetectable, but there are others you could add, included 3TC or newer drugs.

I'd feel more confident if you were to see a new doctor asap, or at least get a second opinions.

Hi,
I really need some advice. I'm nearly resistant to everything and
have been on DDI, D4T and Kaletra for 5 years. My numbers, though not
great (209 T's and 5,700 Viral Load) have remained steady and even
climbed a bit in those 5 years (I also feel/look great and never had a
side effect or opportunistic infection). Suddenly my doctor says it
isn't ethical for him to prescrib DDI and D4T together because of newly
published reports of side effects and my only last option is to start
Fuzeon, which, of course, I'd rather not do or put off longer.
This is very frustrating cause i was coasting along fine before. Is
it true that DDI and D4t can't be prescribed together any longer? Now
they've taken me off it as of a month ago and, not surprisingly, my
viral load has shot up to 60,000.
Thanks,
Brian

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#1192

From: simon collins <simon.collins@...>
Date: Tue Dec 16, 2008 12:41 am
Subject: Re: DDI and D4T

simoninbrixt...

Offline

I'm not aware of any recent law that would have banned this.

If you have been on Kaletra successfully for 5 years (is your viral load undetectable?) then there are plenty of other options other than T-20.

Raltegravir + Kaletra, both twice daily, would have been the easiest to switch too when your viral load was still undetectable, but there are others you could add, included 3TC or newer drugs.

I'd feel more confident if you were to see a new doctor asap, or at least get a second opinions.

Hi,
I really need some advice. I'm nearly resistant to everything and
have been on DDI, D4T and Kaletra for 5 years. My numbers, though not
great (209 T's and 5,700 Viral Load) have remained steady and even
climbed a bit in those 5 years (I also feel/look great and never had a
side effect or opportunistic infection). Suddenly my doctor says it
isn't ethical for him to prescrib DDI and D4T together because of newly
published reports of side effects and my only last option is to start
Fuzeon, which, of course, I'd rather not do or put off longer.
This is very frustrating cause i was coasting along fine before. Is
it true that DDI and D4t can't be prescribed together any longer? Now
they've taken me off it as of a month ago and, not surprisingly, my
viral load has shot up to 60,000.
Thanks,
Brian

#1191

From: "Ed" <edmac@...>
Date: Thu Dec 11, 2008 5:16 pm
Subject: Re: T20 COMBIVT and ??????

edvaardt

Offline

--- In FuzeonSupport@yahoogroups.com, "Sandra Eniya"
<sandraeniya@...> wrote:
>
> Hello guy's I am knew to this group!
> My name is Sandra and definitly a freak control!
> I have been under so many differrent therapy for the last ten years
> that oops
> at the moment it is T20 and combivir
> but I think I will not achieve an indetectable viral load after a
> months
> so having thanks for the multiples therapy a lovely crown desease
> I wonder if any one had to use this combo and what if needed had
they
> had to take on top
> trizivir viread truvada atazanavir abaccavir kaletra saquinavir and
a
> bit more cannot be used
> and to make think difficulte I am against all knew drugs cause
cannot
> find new data
> thank you guy's
> only serious repply please

Hey Sandra
Has your doc done a resistance test? Are you failing this therapy,
is your viral load comming down?
Ed positive Dec 1985
>

#1190

From: "Sandra Eniya" <sandraeniya@...>
Date: Thu Dec 11, 2008 1:04 pm
Subject: T20 COMBIVT and ??????

sandraeniya

Offline

Hello guy's I am knew to this group!
My name is Sandra and definitly a freak control!
I have been under so many differrent therapy for the last ten years
that oops
at the moment it is T20 and combivir
but I think I will not achieve an indetectable viral load after a
months
so having thanks for the multiples therapy a lovely crown desease
I wonder if any one had to use this combo and what if needed had they
had to take on top
trizivir viread truvada atazanavir abaccavir kaletra saquinavir and a
bit more cannot be used
and to make think difficulte I am against all knew drugs cause cannot
find new data
thank you guy's
only serious repply please

#1189

From: PoWeRTX@...
Date: Thu Jan 17, 2008 7:39 pm
Subject: New Drug Soon to Be Approved: TMC125 (etravirine) Intelence �

PoWeRTX@...

http://mundocamp.vox.com/

This is from Rob Camp's blog, a well known treatment activist that sends letters to the FDA before an HIV drug gets approved with his comments and observations about that drug. If you are considering taking this new NNRTI, read this:

Regards,

Nelson Vergel
powerusa dot org

Start the year off right. Easy ways to stay in shape in the new year.

#1188

From: PoWeRTX@...
Date: Tue Jan 22, 2008 8:28 am
Subject: Fwd: [ATAC-DrugDev] Re: Intelence Interactions??

PoWeRTX@...

For those planning to take TMC 125 (etravirine- INTELENCE). This drug has a lot of potential interactions !

It can not be taken with Reyataz, Lexiva, Aptivus

Caution with Kaletra

It can be taken with Prezista, Fuzeon and nucleosides like Viread, Truvada, etc

Regards,

Nelson Vergel
powerusa dot org

From: JuLev@...
To: bobine@..., PoWeRTX@..., atac-drugdev@yahoogroups.com
CC: pozhealth@yahoogroups.com
Sent: 1/22/2008 7:19:37 A.M. Central Standard Time
Subj: [ATAC-DrugDev] Re: Intelence Interactions??

Concomitant use of INTELENCE™ with atazanavir/ritonavir may cause a significant decrease in atazanavir Cmin by about 38% and loss of therapeutic effect of atazanavir. In addition, the mean systemic exposure (AUC) of etravirine after co-administration of INTELENCE™ with atazanavir/ritonavir is anticipated to be about 100% higher than the mean systemic exposure of etravirine observed in the Phase 3 trials. INTELENCE™ and atazanavir/ritonavir should not be co-administered.

INTELENCE™ and fosamprenavir/ritonavir should not be co-administered.

INTELENCE™ and tipranavir/ritonavir should not be coadministered.

The mean systemic exposure (AUC) of etravirine after coadministration of INTELENCE™ with lopinavir/ritonavir is anticipated to be about 85% higher than the mean systemic exposure of etravirine observed in the Phase 3 trials. The amount of safety data at these increased etravirine exposures is limited, therefore, INTELENCE™ and lopinavir/ritonavir should be coadministered with caution.

The mean systemic exposure (AUC) of etravirine was reduced by about 37% when INTELENCE™ was co-administered with darunavir/ritonavir. Because all subjects in the Phase 3 trials received darunavir/ritonavir as part of the background regimen and etravirine exposures from these trials were determined to be safe and effective, INTELENCE™ and darunavir/ritonavir can be coadministered without any dose adjustments.

The mean systemic exposure (AUC) of etravirine was reduced by about 33% when INTELENCE™ was co-administered with saquinavir/ritonavir. Because the reduction in the mean systemic exposures of etravirine in the presence of saquinavir/ritonavir is similar to the reduction in mean systemic exposures of etravirine in the presence of darunavir/ritonavir, INTELENCE™ and saquinavir/ritonavir can be co administered without any dose adjustments.

HIV-Antiviral Agents: Protease Inhibitors (PIs)-Unboosted (i.e., without co-administration of low-dose ritonavir)

Table 6: Drug Interactions: Pharmacokinetic Parameters for Etravirine in the Presence of Co-administered Drugs

Table 7: Drug Interactions: Pharmacokinetic Parameters for Co-administered Drugs in the Presence of INTELENCE™

**************
Start the year off right. Easy ways to stay in shape.
http://body.aol.com/fitness/winter-exercise?NCID=aolcmp00300000002489

Start the year off right. Easy ways to stay in shape in the new year.

#1187

From: "pozmilwaukee" <canolli@...>
Date: Fri Dec 7, 2007 2:24 pm
Subject: DDI and D4T

pozmilwaukee

Offline

Hi,
   I really need some advice.  I'm nearly resistant to everything and
have been on DDI, D4T and Kaletra for 5 years.  My numbers, though not
great (209 T's and 5,700 Viral Load) have remained steady and even
climbed a bit in those 5 years (I also feel/look great and never had a
side effect or opportunistic infection).  Suddenly my doctor says it
isn't ethical for him to prescrib DDI and D4T together because of newly
published reports of side effects and my only last option is to start
Fuzeon, which, of course, I'd rather not do or put off longer.
   This is very frustrating cause i was coasting along fine before.  Is
it true that DDI and D4t can't be prescribed together any longer?  Now
they've taken me off it as of a month ago and, not surprisingly, my
viral load has shot up to 60,000.
   Thanks,
Brian

#1186

From: PoWeRTX@...
Date: Thu Nov 29, 2007 11:35 pm
Subject: TMC 125+ Prezista+ Celsentry interactions

PoWeRTX@...

Some of you may be thinking about this combo with or without Isentress

An Open, Randomized, Two-Period, Crossover Study in Two Cohorts to Investigate the Effect of Steady-State TMC125 (etravirine) and the Combination of TMC125/Darunavir/Ritonavir on the Steady-State Pharmacokinetics of Oral Maraviroc in Healthy Subjects

	Reported by Jules Levin 11th European AIDS Conference / EACS Madrid, Spain, 24-27 October 2007 J Davis1, M Sch_ller-Gyyre2, TN Kakuda3, C Ridgway1, S Tweedy1, N Ndongo4, W Petit4 1Pfizer Global Research and Development, Sandwich, UK; 2Tibotec BVBA, Mechelen, Belgium; 3Tibotec, Inc., Yardley, PA, USA; 4Pfizer Clinical Research Unit, Brussels, Belgium BACKGROUND The MOTIVATE 1 and 2 studies showed that combining maraviroc (CELSENTRI¨), a novel CCR5 antagonist, with optimized background therapy significantly enhances virological suppression and the increase in CD4+ cell count in treatment-experienced patients at 48 weeks.1,2 However, co-administration of maraviroc with other drugs carries a risk of drug-drug interactions. ⋅ Preclinical data suggest that maraviroc is a substrate for cytochrome P450 (CYP3A4) and P-glycoproteins (P-gp).3,4 Therefore, modulators of these enzymes/transporters can affect the pharmacokinetics of maraviroc.5,6 ⋅ TMC125 (etravirine; developed by Tibotec), a next generation non-nucleoside reverse transcriptase inhibitor, is an inducer of CYP3A4 and has P-gp inhibitory properties. Therefore, TMC125 may reduce maraviroc exposure. ⋅ The protease inhibitor (PI) darunavir (DRV; developed by Tibotec) is a potent inhibitor of CYP3A4 and is co-prescribed with low-dose ritonavir (/r), itself a potent inhibitor and inducer of several cytochrome P450 enzymes and a P-gp inhibitor. When such combinations of inducers and inhibitors are co-administered in humans, the net effect is CYP3A4 inhibition. As such, a 50% dose reduction of maraviroc (i.e. 150 mg BID) is currently recommended in the presence of boosted PIs and other potent CYP3A4 inhibitors. OBJECTIVES The primary objectives of this study were to investigate the effects of TMC125 at steady-state on the steady-state pharmacokinetics of maraviroc, either alone or in combination with DRV/r at steady-state, in order to provide optimal dose recommendations for maraviroc when these drugs are co-administered in clinical practice. Author Summary of findings ⋅ Analysis of maraviroc pharmacokinetics suggests that TMC125 reduces maraviroc exposure but when co-administered with DRV/r, the exposure of maraviroc is increased. ⋅ The exposures of TMC125, DRV and ritonavir were similar to historical data, suggesting maraviroc has no effect on either TMC125 or DRV/r.7-9 ⋅ There were few treatment-related adverse events, all of which were mild to moderate in severity, and no clinically significant changes in laboratory tests, vital signs or ECGs Author Conclusions ⋅ Short-term co-administration of maraviroc with TMC125 and DRV/r was well tolerated and no safety concerns were raised. ⋅ When maraviroc is co-administered with TMC125 in the absence of potent CYP3A4 inhibitors such as boosted Pls (i.e. DRV/r) exposure is reduced and the recommended maraviroc dose is 600 mg BID. ⋅ Maraviroc exposure is increased when co-administered with TMC125 and DRV/r, and as such, the recommended dose of maraviroc is 150 mg BID, consistent with previous reported data for boosted PIs.7 METHODS ⋅ This study was an open, randomized, two-period, crossover study in two cohorts, each of 14 healthy subjects aged 18-55 years. The protocol and informed consent documentation were reviewed and approved by the Independent Ethics Committee and all subjects gave written informed consent. ⋅ For each cohort, the study consisted of: _ a screening visit up to 28 days before the start of dosing _ two treatment periods (one lasting 20 days, the other lasting 10 days) _ a minimum wash-out period of 14 days between treatment periods _ a follow-up visit 7-10 days after the last dose of study drug. Cohort 1a (n=7) recd TMC125mg bid for 10 days, then TMC125 200mg bid+ MVC 300mg bid for 10 days. There was a 14-day washout, then MVC 300mg bid. Cohort 2a (n=7) recd TMC125 200mg bid+ DRV 600/100 mg bid for 10 days, then TMC125 200mg bid+ DRV 600/100mg bid+ MVC 150mg bid. There was a 14-day washout, then MVC 150mg bid. Cohort 1b (n=7) recd MVC 300mg bid. There was a 14 day washout, then TMC125 200mg bid for 10 days; then, TMC125 200mg bid+ MVC 300mg bid. Cohort 2b (n=7) recd MVC 150mg bid. There was a 14-day washout, then TMC125 200mg bid+ DRV 600/100mg bid for 10 days; then, TMC125 200mg bid+ DRV 600/100mg bid+ MVC 150mg bid. ⋅ All subjects were fasted for at least 2 hours prior to, and 1 hour after, maraviroc dosing. All TMC125, DRV and ritonavir doses were administered 15 minutes after a standard meal and no more than 5 minutes apart. Subjects were not allowed to consume grapefruit-containing products from 7 days prior to the first dose of study drug until collection of the blood sample. ⋅ Serial blood samples were collected for maraviroc pharmacokinetics analysis prior to dosing on Days 11-19 and then from 0-12 hours following maraviroc dosing on Day 20 in the 20-day treatment period; or on Days 1-9 and then from 0-12 hours following maraviroc dosing on Day 10 in the 10-day treatment period. Blood samples for TMC125, DRV and ritonavir pharmacokinetics analysis were collected on Days 6-9 prior to maraviroc dosing and from 0-12 hours post maraviroc dosing on Days 16-19. ⋅ Urine samples were collected just prior to maraviroc dosing on Day 10 or 20, depending on the study period, in order to assess urine maraviroc pharmacokinetic parameters. ⋅ Cmax, Tmax, Cmin and AUC12 (AUC of the dosing interval) were calculated for maraviroc, TMC125, DRV and ritonavir on Day 10 or 20, as appropriate. ⋅ Safety and tolerability data were collected throughout the study. Results ⋅ Co-administration of TMC125 decreased the exposure of maraviroc by 53%, 60% and 39% for AUC12, Cmax and Cmin, respectively, compared with maraviroc alone (Figure 2, Tables 1 & 2). ⋅ Analysis of maraviroc pharmacokinetics suggests that co-administration of TMC125 + DRV/r with maraviroc increased the exposure of maraviroc (Figure 1, Tables 1 & 3); maraviroc AUC12, Cmax and Cmin increased by 210%, 77% and 427%, respectively, compared with maraviroc alone (Figure 2, Table 1). ⋅ Mean Tmax were similar for all treatments (Table 1). ⋅ Maraviroc did not affect TMC125 (Table 4), DRV or ritonavir pharmacokinetics (data not shown). ⋅ The amount of maraviroc in the urine was reduced when co-administered with TMC125 and increased when co-administered with TMC125 + DRV/r (Table 5). ⋅ There were no deaths or serious adverse events. Treatment-related adverse events were most common in subjects receiving maraviroc (150 mg) with TMC125 + DRV/r. All reported adverse events were mild to moderate in severity. ⋅ Four subjects discontinued treatment with maraviroc (150 mg) + TMC125 + DRV/r due to maculopapular rash of moderate severity, which was not seen when maraviroc was given alone or in combination with only TMC125. Discontinuation was permanent in two of these subjects; in the other two cases, the outcome was resolved and discontinuation was therefore only temporary. ⋅ There were no clinically significant changes in laboratory tests, vital signs or ECGs. References 1. Lalezari J, et al. 47th ICAAC, Chicago, USA, 17-20 September 2007. Presentation H-718a. 2. Fatkenheuer G, et al. 11th EACS, Madrid, Spain, 24-27 October 2007. Presentation PS3/5. 3. Abel S, et al. 6th Int Workshop Clin Pharmacol HIV Ther, Quebec, Canada, 28-30 April 2005. Abstract 76. 4. Abel S, et al. 7th Int Workshop Clin Pharmacol HIV Ther, Lisbon, Portugal, 20-22 April 2006. Abstract 77. 5. Jenkins T, et al. 5th Int Workshop Clin Pharmacol HIV Ther, Rome, Italy, 1-3 April 2004. Abstract 5.4. 6. Abel S, et al. 5th Int Workshop Clin Pharmacol HIV Ther, Rome, Italy, 1-3 April 2004. Abstract 5.8. 7. Abel S, et al. 8th Int Workshop Clin Pharmacol HIV Ther, Budapest, Hungary, 16-18 April 2007. Abstract 55. 8. Scholler-Gyure M, et al. 47th ICAAC, Chicago, USA, 17-20 September 2007. Poster A-1427. 9. Scholler-Gyure M, et al. Antiv Ther 2007; 12:789-796.

Regards,

Nelson Vergel
powerusa dot org

Check out AOL Money Finance's list of the hottest products and top money wasters of 2007.

#1185

From: PoWeRTX@...
Date: Fri Nov 16, 2007 12:41 pm
Subject: Atlanta HIV Training on Dec 7 and 8

PoWeRTX@...

Please forward to anyone who may be interested. Thanks

FOR IMMEDIATE RELEASE

CONTACT: Edward Rewolinski at negush@... to reserve your space

OPEN TO THE COMMUNITY & COMMUNITY WORKERS:

AIDS TREATMENT ACTIVIST EDUCATIONAL BOOTCAMP TO BE HELD IN ATLANTA ON DEC 7 & 8

November 14 2007- The AIDS Treatment Activists Coalition (ATAC), an
all volunteer non-profit national group that mentors and trains
community activists around the country, will be providing a free one
and a half day session to train Atlanta's community on important
skills to make a difference in HIV treatment research and access. The
training boot camp "Actvism in HIV/AIDS" will be held at the Hyatt
Regency Suites Atlanta NW, 2999 Windy Hill Rd., Marietta, GA on the
evening of Friday Dec 7 and all day Saturday December 8. For more
information contact Ed Rewoliski at email negush@.... Seating
is limited, so please make your reservation today. Dinner will be
served on Friday evening and continental breakfast and lunch on
Saturday.

"This is a great opportunity for anyone who wants to make a
difference in the lives of those living with HIV in Georgia", said
Jeff Taylor, chair of ATAC's Drug Development Committee. "This unique
training will include up-to-date information on new treatments,
microbicide development, and HIV treatment research and access needs.
This opportunity should not be missed by anyone infected or affected
by HIV and those working or volunteering in the HIV/AIDS field", added
Taylor.

"Georgia has very specific needs and issues when it comes to HIV
treatment and access", said Alex Kidaloski, an Atlanta community
activist. "For instance, unlike most of the states in the US, Georgia
has no high risk insurance pool that people who cannot qualify for
AIDS Drug Assistance can get, so many struggle with medication costs
and access to insurance", added Kidaloski.

When asked what one of the main issues in HIV/AIDS in the US is, Cathy
Olufs, a long time activist working at Health Justice in Los Angeles
and President of the Board of Directors of ATAC, said, "People all
over the country think AIDS is over. It is now more important than
ever not to fall asleep and allow complacency to take over our
community. We need to mentor the next
generation of activists to deal with the upcoming issues of research
and access of new treatments".

Who is ATAC?
ATAC, a national coalition of AIDS activists, many living with
HIV/AIDS, has as its mission "working together to end the AIDS
epidemic by advancing research and access in HIV/AIDS. For more
information about ATAC and its work, visit www.ATAC-USA.org

MORE INFORMATION:

You are not alone. Find your allies. Get involved. You can make a difference!

Activism in HIV/AIDS is a chance to learn how to get actively involved in the fight against HIV/AIDS. This informal and interactive training session is designed for anyone interested in HIV research and/or activism—including people living with HIV/AIDS, health educators and advocates.

Using real-life examples and the experiences of veteran community advocates and activists from the AIDS Treatment Activists Coalition (ATAC)—many of whom are living with HIV/AIDS—the goal is to help you get the tools you need to become a skilled advocate for yourself and others

TOPICS:

Training will focus on three areas of critical importance for people living with HIV/AIDS, their advocates and allies. Participants will learn about these three broad landscapes of activism and explore the links to their own backyard.

PREVENTION

Some of the most exciting HIV prevention research today explores the use of antiretroviral drugs and other
chemicals or substances as a microbicide—a substance applied directly to the vagina or anus before sex—
to prevent HIV infection.

Martell Randolph will provide a close look at why there’s a lot of excitement about microbicides, why they will be so important in the fight against HIV/AIDS, and why the role of community activists is key to getting them from research labs to people around the world.

TREATMENT

Antiretroviral drugs to fight HIV don’t just suddenly appear on the pharmacy shelf one day. Many years of clinical trials are conducted, many hurdles are cleared and many questions are answered long before a drug is approved.

Members of the Drug Development Committee of the AIDS Treatment Activists Coalition will provide a detailed look at how drugs get approved in the U.S., the role that activists have played in that process, and where the community’s eyes will be set in the coming years.

ACCESS

If the best drugs to fight HIV are too expensive for the people who need them, what good are they? What happens to people in the United States—a country that does not ensure health care to all its citizens—without the political will to ensure access to care and treatment?

Andrea Weddle will cover a lot of ground—AIDS drug assistance programs, federal Ryan White funding, government health benefits, private insurance programs—to draw a picture of what goes into the process of getting medications to the people who need them. She will illustrate why many believe the system of health care provision in the U.S. is broken, and how critical the voice of the community is in fixing it.

PRESENTERS

Moderator: Rob Camp, ATAC/DDC, Barcelona, Spain

Raffi Babakhanian, ATAC/DDC, New York City NY

Michael Dorosh, ATAC/DDC, Denver, CO

Morris Jackson, Center for Health Justice, Los Angeles CA

Martell Randolph, ATAC/DDC, Los Angeles, CA

Matt Sharp, Test Positive Aware Network, Chicago, IL

Andrea Weddle, HIV Medical Association, Arlington, VA

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#1184

From: "Fiona Pettitt" <fiona.pettitt@...>
Date: Mon Nov 5, 2007 4:53 pm
Subject: Re: ISR's and difficulty injecting

fionapettitt

Offline

Hi Rob and Whit

When I was on T20 in 2005/6 I was provided with a very useful A5 size
booklet by Roche.  On the left page you recorded time and date of injection,
on the right there were drawings of potential injection sites (back,
stomach, arms, legs) on which you could chart your injections.  I've asked
at my pharmacy if they could get hold of any for me, but, on phoning Roche,
it appears they're no longer available.  Which is disappointing as it was
convenient to carry around and helped me keep tabs on things.

On a different but related subject, I'm receiving two injections a week in
difficult to reach places at my clinic, which is helping a lot with rotating
ISs.

Also, for anyone who wants to pre-mix and carry around T20, I've found this
company that sells cool bags for insulin:
http://www.genmedical.com/store/index.html?lang=en-uk&target=d66.html   If
you're interested in buying one, it might be worth calling them and checking
that it's okay to use with T20 - I called and they hadn't heard of T20, and
I didn't have an information leaflet to give them information about what
temperature to store it at....

Very best
Fiona
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Version: 7.5.503 / Virus Database: 269.15.22/1111 - Release Date: 05/11/2007
04:36

#1183

From: Steve DeCorte <theadvocacyproject@...>
Date: Thu Nov 1, 2007 3:20 pm
Subject: Re: ISR's and difficulty injecting

theadvocacyp...

Offline

You should contact Roche's support section for answers at 888-321-2233. This number is for questions just like you have and there are smarter then me about fuzeon

Hope this helps

Steve

whit7807 <whit7807@...> wrote:

New to the group here but have been visiting the site semi-regularly since starting Fuzeon.
Has anyone else had a problem with injecting ( very difficult resistance on the plunger of the
syringe ) when you are like anywhere close to a previous injection site reaction? I try to
reposition the needle or withdraw a bit without sticking myself again, but usually just have to
push like mad to get the drug into the tissue. I've also wondered if injecting into a site that's
so difficult could alter the absorbtion or change the half life or such. I called the Roche
hotline, but they were no help. They didn't have any info on absorbtion and simply advised
to stay away from such areas for injection. Difficult to do after about 3 or 4 mos. of
injecting. Any thoughts, ideas, or info out there?

#1182

From: "kinder7777" <YouFoundMe@...>
Date: Wed Oct 31, 2007 9:02 pm
Subject: Re: ISR's and difficulty injecting

kinder7777

Offline

I have been on it for years.  Yes You have to move it to new
locations to prevent this.  I have gone all aound my body and some
areas still have scaring.  It is hard to reach some areas but take
Your time, pinching the skin between your fingers to inject.

My doctor reminded me "You are lucky to be alive".






--- In FuzeonSupport@yahoogroups.com, "Rob" <mntwister@...> wrote:
>
> Whit...I am not on Fuzeon anymore, but was for about 5 months. I had
> the same problem you did. The closer it got to the site of a recent
> previous injection, the harder it was to do, and sometimes the
> after-shot swelling acutally connected with the previous swelling.
>
> What I started to do was draw a map of reach-able locations on
paper,
> and charted them out so I could go through all the areas and then by
> the time I had to start over again, most of the ones there
previously
> would be much better or healed. I am sure there are people who have
> been on this longer who will respond, but I hope that helps in some
> way.  Best of health to you. Rob
>

#1181

From: tdelmar@...
Date: Wed Oct 31, 2007 11:05 am
Subject: Re: Re: ISR's and difficulty injecting

tlash43

Offline

I have been on Fuzeon for 1 year (anniv. next week) I started with the the needles that come with the kit; then I changed to the diabetic needle (not sure of the gauge info, but the needle was very short) then, and currently I use the needle-less Biojector. After changing to the Biojector, my ISR's became less severe. I said needle-less not painless!. The pain is similiar to a rubber band snap; but I always don't feel it. I have some favorite areas and I realize that there are some not-so-favorite areas.

One thing I would reccommend is to notice if certain areas are more problematic than others. Then vary your shots based on those findings. Also, contact Fuzeon to get or talk to one of the Nurse Connections nurses to come to your home and help you find other areas on your body.

I've put ice on areas prior to injecting, heat, showered before, massaged the area prior to injecting and tried many other things. Just make of note of what works and what does not. Just try your best not to go too close to where you've injected before. Those ISR's can be reason enough to stop. Your goal is to find enough areas so that you are not going to the same spot too often.

Areas that work for me. I weigh 150 have about 28% body fat and am female. I go in the upper thighs, all around the "love handle" zone; upper buttocks and under my arms (the good-bye grandma flap) I alternate odd days on left, even on right. When I sit down while naked I take note of the areas with a "roll"

Good Luck

Tammi

-------------- Original message --------------
From: "Rob" <mntwister@...>

Whit...I am not on Fuzeon anymore, but was for about 5 months. I had
the same problem you did. The closer it got to the site of a recent
previous injection, the harder it was to do, and sometimes the
after-shot swelling acutally connected with the previous swelling.

What I started to do was draw a map of reach-able locations on paper,
and charted them out so I could go through all the areas and then by
the time I had to start over again, most of the ones there previously
would be much better or healed. I am sure there are people who have
been on this longer who will respond, but I hope that helps in some
way. Best of health to you. Rob

#1180

From: Joe Palmer <glajoe2@...>
Date: Wed Oct 31, 2007 2:11 am
Subject: Re: Digest Number 504

jpalmer567

Offline

Hi, Whit,

If you are using the syringes that are supplied in the kit, then I would suggest you ask your doctor to write you a prescription for 31 gauge 1 ML insulin syringes. The needles are thinner than those in the kit. There are also 2 ML syringes that might make it easier for you to push the plunger down into the barrel of the syringe.

I have tried injecting Fuzeon into my thighs but the ISRs were much too painful and lasted too long for me to try it again, let alone recommend it to someone else.

Joe

FuzeonSupport@yahoogroups.com wrote:

ISR's and difficulty injecting

Posted by: "whit7807" whit7807@... whit7807

Mon Oct 29, 2007 8:18 pm (PST)

New to the group here but have been visiting the site semi-regularly since starting Fuzeon.
Has anyone else had a problem with injecting ( very difficult resistance on the plunger of the
syringe ) when you are like anywhere close to a previous injection site reaction? I try to
reposition the needle or withdraw a bit without sticking myself again, but usually just have to
push like mad to get the drug into the tissue. I've also wondered if injecting into a site that's
so difficult could alter the absorbtion or change the half life or such. I called the Roche
hotline, but they were no help. They didn't have any info on absorbtion and simply advised
to stay away from such areas for injection. Difficult to do after about 3 or 4 mos. of
injecting. Any thoughts, ideas, or info out there?

#1179

From: "Fiona Pettitt" <fiona.pettitt@...>
Date: Sun Oct 28, 2007 5:40 pm
Subject: Re:New Integrase and Entry Inhibitors- HIV Update this Wed. Oct 24 in H

fionapettitt

Offline

Thanks Nelson and Simon for the information on Raltegravir, etc.   Rob - may
your CD4s continue to strengthen and your vl become undetectable.

Best wishes
Fiona

#1178

From: "Rob" <mntwister@...>
Date: Tue Oct 30, 2007 3:34 am
Subject: Re: ISR's and difficulty injecting

mntwister

Offline

Whit...I am not on Fuzeon anymore, but was for about 5 months. I had
the same problem you did. The closer it got to the site of a recent
previous injection, the harder it was to do, and sometimes the
after-shot swelling acutally connected with the previous swelling.

What I started to do was draw a map of reach-able locations on paper,
and charted them out so I could go through all the areas and then by
the time I had to start over again, most of the ones there previously
would be much better or healed. I am sure there are people who have
been on this longer who will respond, but I hope that helps in some
way.  Best of health to you. Rob

#1177

From: "whit7807" <whit7807@...>
Date: Mon Oct 29, 2007 8:04 pm
Subject: ISR's and difficulty injecting

whit7807

Offline

New to the group here but have been visiting the site semi-regularly since
starting Fuzeon.
Has anyone else had a problem with injecting ( very difficult resistance on the
plunger of the
syringe ) when you are like anywhere close to a previous injection site
reaction?  I try to
reposition the needle or withdraw a bit without sticking myself again, but
usually just have to
push like mad to get the drug into the tissue.  I've also wondered if injecting
into a site that's
so difficult could alter the absorbtion or change the half life or such.  I
called the Roche
hotline, but they were no help.  They didn't have any info on absorbtion and
simply advised
to stay away from such areas for injection.  Difficult to do after about 3 or 4
mos. of
injecting.  Any thoughts, ideas, or info out there?

#1176

From: "Rob" <mntwister@...>
Date: Fri Oct 26, 2007 7:26 pm
Subject: New Meds and results

mntwister

Offline

Since alot of people are now getting these meds, I thought I would
report in on my first 2 tests since starting therapy. First, I will
say I have been poz for 19 years and was resistant to everything
including t20. My t count was 0 and my viral load probably in the
millions (wasn't tested after a while to go over 100,000, but always
was). I was without a working combo for 8 years and my results have
been the same during that time.

I started 8 weeks ago on Raltegravir, TMC125, Prezista (all new for
me) along with the boosters for Raltegravir(Rayataz) and Norvir for
Prezista, plus Truvada. After 4 weeks, my t cells climbed to 32 (from
0) and my viral load went to 1500 (from millions). I also take a daily
vitamin, and take biotics for intestinal health.  After the 9th week,
my t-cell count went to 47 and my viral load to 128. That's the lowest
viral load I have ever had, in 19 years. Maybe next time undetectable.

What an exciting thing this is. I've had constant diahrea for the last
year and lost 50 pounds, night and day running to the bathroom, it was
terrible. All tests for pathogens and infections were negative, so
quite possibly it was hiv enteropothy. The last 5 days, with my tcount
reaching around 50 (it's 47 last test) it seems to be gone.

Good luck to everyone, I know there are alot of smiles out there that
are happening or coming soon, including my own.
Rob

#1175

From: simon collins <simon.collins@...>
Date: Fri Oct 26, 2007 1:14 pm
Subject: Re: Re:New Integrase and Entry Inhibitors- HIV Update this Wed. Oct 24 in H

simoninbrixt...

Offline

Hi Fiona

Try raltegravir.com (this is a guess, but as it is liscensed in the US there
should be a Merck site=.

Also, aidsmeds.com is good at following information on all new and pipeline
drugs

Simon


On Friday, October 26, 2007, at 02:08PM, "Fiona Pettitt"
<fiona.pettitt@...> wrote:
>Hi Nelson
>
>I've just started Raltegravir (adding it and T20 into my current combination
>of Prezista, 3TC, TMC125 and Ritonavir), but haven't been given any patient
>information - my clinic pharmacy doesn't have any information and say that
>this is because it is an unlicensed drug and little is known about it.   Can
>you suggest any websites which might provide me with info?
>
>Best wishes
>Fiona
>No virus found in this outgoing message.
>Checked by AVG Free Edition.
>Version: 7.5.503 / Virus Database: 269.15.11/1093 - Release Date: 25/10/2007
>17:38
>

#1174

From: PoWeRTX@...
Date: Fri Oct 26, 2007 9:32 am
Subject: Info on new HIV drugs

PoWeRTX@...

Hi Nelson

I've just started Raltegravir (adding it and T20 into my
current combination of Prezista, 3TC, TMC125 and Ritonavir),
but haven't been given any patient information - my clinic
pharmacy doesn't have any information and say that this is
because it is an unlicensed drug and little is known about
it. Can you suggest any websites which might provide me with
info?

Fiona

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

Dear Fiona

What do you need to know? there are no good web sites with a short summary..but here it goes

Raltegravir- trade name: Isentress. FDA approved now in the US. It is an integrase inhibitor taken twice a day with or without food. It does not need Norvir. It does not have any significant interactions with other HIV meds. Probably the most effective HIV drug so far. We do not know how sustainable the response will be after 48 weeks and it will depend on how many active medicines you are taking with it. Side effects do not seem to be bad at all: mostly flatulence and bloating during the first weeks

TMC 125- Etravirine- a second generation non nucleoside ( same family as Sustiva and Viramune)- Not FDA approved yet but available via expanded access if doctors fill out all needed forms. No Novir boosting required. It may lower some HIV medication blood levels so talk to your doctor about it (You should not have any concerns of adjusting dosage if you are taking it with Prezista, Isentress, Truvada). Rash is the main side effect. Tricky drug to know if you have resistance to since the genotype test is not available yet. If you had resistance to Sustiva or Viramune in the past, the drug may not work as well. It seems to work OK with the main non nuke resistance mutation L103, however. It is good that you are starting it with two other active agents.

Fuzeon- enfurvitide- T-20. entry inhibitor that works to attempt to block the virus gp41. Injectable under the skin twice a day. Drug with the most data in multidrug resistance. One side effect: injection side reactions. Almost doubles efficacy of other drugs studied with it. Do not use the needles that come with the product since they are too wide. Get your pharmacist to provide 31 gauge insulin needles since they are very small and do not cause as many problems. A nurse can come to your house for free as many times as you need to show you best injection techniques (you can find out more in fuzeon.com)

Darunavir- Prezista- Second generation protease inhibitor boosted by Novir. Very good results in those with baseline sensitivity to it (around 33% pf patients with Kaletra resistance have resistance to Prezista even if they have not taken it). Side effects are the same as most protease inhibitors. It is a sulfa based drug so it can cause some problems in sulfa sensitive patients.

Regards,

Nelson Vergel
powerusa dot org

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#1173

From: PoWeRTX@...
Date: Thu Oct 25, 2007 2:38 pm
Subject: Raltegravir (Integrase just approved) 24 week Combined Efficacy

PoWeRTX@...

These are definitely the best results we have ever seen in history. It was good for Merck to show a breakdown of efficacy with all drugs used with raltegravir. Most companies in the past have not done so for several marketing reasons.

Read on

Regards,

Nelson Vergel
powerusa dot org

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NATAP http://natap.org/
_______________________________________________

Combined 24-Week Efficacy Data on the Integrase Inhibitor Raltegravir

11th European AIDS Conference
October 24-27, 2007
Madrid

Mark Mascolini

Raltegravir, the integrase inhibitor recently licensed in the US as Isentress, passed a 24-week double-trial efficacy test with flying colors, BENCHMRK-1 and -2 investigators reported at the European AIDS Conference in Madrid [1]. The only bad news for Merck, raltegravir's maker, in this 667-person analysis is that most people with triple-class resistance who can start active enfuvirtide and darunavir can probably save raltegravir for another day. Or they may opt for the twice-daily raltegravir pill right away instead of using the twice-daily enfuvirtide shots.

Because the two BENCHMRK trials follow the same format, researchers could combine 24-week results to afford a more robust look at how to use this muscular new med. These double-blind trials enrolled people with virus resistant to some drugs in the first three antiretroviral classes, a viral load above 1000 copies, and any CD4 count. BENCHMRK 1 took place in Europe, Peru, and the Asia/Pacific region, and BENCHMRK-2 in North and South America. Study participants got randomized to 400 mg of raltegravir twice daily or placebo plus a background regimen tailored for potential potency against each person's resistant virus.

After 24 weeks a noncompleter-equals-failure analysis determined that 75% taking raltegravir had a viral load under 400 copies (versus 40% with placebo) and 63% on raltegravir had fewer than 50 copies (versus 34% with placebo). While the raltegravir group gained an average 84 CD4 cells, the placebo group gained an average 37 (P < 0.001 for all three of these primary endpoint comparisons).

Raltegravir-based salvage regimens outpaced rescue regimens without raltegravir regardless of which other potent drugs a person took (Table). A virologic-failure-carried-forward analysis showed that 4 in 5 people who started the integrase inhibitor with first-time enfuvirtide and first-time darunavir reached a viral load below 50 copies in 24 weeks. That looked slightly better than the 74% sub-50 response rate among people starting enfuvirtide and darunavir for the first time without raltegravir, but the difference probably lacks statistical significance. (Note that numbers of people in some of these subgroups are small, especially for placebo.)

Response to Raltegravir at 24 Weeks With Various Background Drugs

Among people who started only enfuvirtide or only darunavir for the first time in the BENCHMRK trials, raltegravir easily outshone placebo (Table). Study participants with tipranavir-sensitive virus who started that protease inhibitor with raltegravir did just as well as people who started darunavir with raltegravir (and without enfuvirtide), at least through 24 weeks (Table). CD4 gains also proved superior with raltegravir than with placebo, even when placebo takers had a relatively good virologic response at week 24 (Table).

Even among people with a genotypic sensitivity score (GSS) of 0, indicating little or no activity of background drugs, 44% notched a 24-week viral load below 50 copies, compared with 6% for placebo. When the GSS rose to 1, 71% had a sub-50 response to raltegravir versus 37% for placebo. With a GSS of 2 or more, 71% responded to the raltegravir regimen and 56% to the placebo regimen.

This report did not compare side effects in the raltegravir and placebo groups--or between different raltegravir backgrounds such as darunavir versus tipranavir.

Reference
1. Kumar P, Cooper D, Steigbigel R, et al. Efficacy of raltegravir, an HIV integrase inhibitor, in combination with regimens containing enfuvirtide, darunavir, or tipranavir in patients with triple-class resistant virus: combined results from Benchmrk-1 and Benchmrk-2. European AIDS Conference. October 24-27, 2007. Madrid. Abstract P7.2/06.

**************************************
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_______________________________________________

#1172

From: "Fiona Pettitt" <fiona.pettitt@...>
Date: Fri Oct 26, 2007 10:54 am
Subject: Re:New Integrase and Entry Inhibitors- HIV Update this Wed. Oct 24 in H

fionapettitt

Offline

Hi Nelson

I've just started Raltegravir (adding it and T20 into my current combination
of Prezista, 3TC, TMC125 and Ritonavir), but haven't been given any patient
information - my clinic pharmacy doesn't have any information and say that
this is because it is an unlicensed drug and little is known about it.   Can
you suggest any websites which might provide me with info?

Best wishes
Fiona
No virus found in this outgoing message.
Checked by AVG Free Edition.
Version: 7.5.503 / Virus Database: 269.15.11/1093 - Release Date: 25/10/2007
17:38

#1171

From: PoWeRTX@...
Date: Mon Oct 22, 2007 8:15 pm
Subject: New Integrase and Entry Inhibitors- HIV Update this Wed. Oct 24 in Houston

PoWeRTX@...

WHEN: This Wednesday OCT 24, 6:30 PM

WHERE: UNITED WAY AT 50 WAUGH DRIVE

SPEAKER: NELSON VERGEL (POWERUSA.ORG)

LIMITED SEATING. E-mail HIVSeminars@... or call the Houston Buyers Club at 713/520-5288

LIGHT DINNER PROVIDED

TOPICS:

1- Review of data on two new drugs in two new class recently approved- Maraviroc - (Selzentry- CCR5 inhibitor) and raltegravir (Isentress - integrase inhibitor)

2- Review of data on Etravirine (TMC 125), a non nuke now available via expanded access

3- Update on metabolic disorders and lipodystrophy

4- Resources in Houston: programs to help people go back to work or school while keeping social security and Medicare/Medicaid, lipodystrophy study enrolling at Body Positive, and new clinics in Houston for the uninsured.

The New Wave of HIV Drugs Is Here
by Nelson Vergel

For the first time in 10 years, HIV-postive patients will have access to two new HIV drug classes. Patients with ongoing viral replication that have been failing current medicines will have a "second chance" to control their HIV by starting new drugs to which their virus has not mutated and become resistant. It is estimated that 20 percent of the half a million patients taking HIV medications in the United States are not responding to their medication and have ongoing viral replication in their bodies that may shorten their life spans and also make them more infectious to others.

No single HIV medication can control HIV by itself, needing at least two more in combination. But many people have HIV that has developed multidrug resistance (MDR) by mutating around medicines, which allows the virus to aggressively kill the CD4 cells that "direct" the immune system's response against invaders. MDR patients need to start at least two to three "active" drugs that their virus has never seen, but most have not had that luxury in the past few years due to drug approvals that did not happen concurrently.

Fortunately, two new drugs that work in completely new ways are making this possibility a reality for the first time since protease inhibitors were introduced to the market 10 years ago. A new entry inhibitor (Maraviroc, trade name: Selzentry) that works at attempting to block the attachment of HIV to the CD4 T cell, and the first integrase inhibitor (Raltegravir, trade name: Isentress) that works inside the nucleus of the CD4 cell, provide effective new targets to attack the virus. The most critical thing right now is to educate physicians and patients on how to best use these new drugs so that their benefits at lowering viral load to undetectable levels are sustained until a cure is found. Other medications like Fuzeon (an approved fusion inhibitor), Aptivus and Prezista (approved second generation protease inhibitors), and TMC 125 (a second generation non nucleoside analog in expanded access) can be combined with the two novel agents approved this year to hit the virus in different parts of its life cycle outside and inside the CD4 cell.

This second wave of HAART (highly active antiretroviral therapy) has the potential to save many lives. I urge patients not to screw up this last chance to get an effective combination before we go through another dry period of no new drugs in the coming few years. It is imperative to do your homework before jumping into a new regimen with limited data.

Nelson Vergel will be giving the last update for this year on recent conferences that had new data on these and other emerging options for HIV treatment. His lecture will be held on Oct. 24 at 6:30 pm at the United Way on 50 Waugh. Patients and clinicians are welcomed. Free parking and food will be provided. Seating is limited. For reservations or more information, e-mail HIVSeminars@... or call the Houston Buyers Club at 713/520-5288. More information on new HIV medications can be found at Nelson's website SalvageTherapies.org

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#1170

From: PoWeRTX@...
Date: Mon Oct 22, 2007 12:59 pm
Subject: Summary of Fuzeon (enfurvitide) in all studies

PoWeRTX@...

Regards,

Nelson Vergel
powerusa dot org

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#1169

From: Nelson Vergel <nelsonvergel@...>
Date: Wed Oct 17, 2007 3:29 pm
Subject: PoWeR Newsletter Archive

nelsonvergel

Offline

I created an archive of our newsletters (only one is in it now)

http://archive.constantcontact.com/fs020/1101823881298/archive/1101847520288.html

Regards,

Nelson Vergel
powerusa dot org

#1168

From: PoWeRTX@...
Date: Sat Oct 13, 2007 10:23 am
Subject: Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background

PoWeRTX@...

AMICI Study: A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients.. This study is being conducted in:
- North Palm Beach, FL http://www.centerwatch.com/patient/studies/stu118370.html
- Plantation, FL http://www.centerwatch.com/patient/studies/stu118364.html

Regards,

Nelson Vergel
powerusa dot org

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#1167

From: PoWeRTX@...
Date: Fri Oct 12, 2007 6:45 pm
Subject: Fwd: NATAP: Merck's Isentress Approved by FDA Today

PoWeRTX@...

In a message dated 10/12/2007 5:36:06 P.M. Central Daylight Time, nataphcvhiv@... writes:

Merck Gets FDA Approval
For New HIV Treatment

Wall St Jnl
By JENNIFER CORBETT DOOREN
October 12, 2007 5:50 p.m.

WASHINGTON -- A U.S. Food and Drug Administration panel Friday approved a new type of HIV drug from Merck & Co., a company spokeswoman said.

The drug, known by the brand name Isentress, was approved for use in patients who have failed treatment with other HIV drugs.

Isentress was approved as part of the FDA's accelerated-approval mechanism, which is aimed at getting life-saving treatments to market faster by allowing companies to submit less clinical data than usually required. Companies obtaining accelerated approval must keep studying drugs after they are on the market to gain full approval.

Isentress is designed to target one of three enzymes needed by HIV to reproduce. Current drugs on the market attack the other two enzymes, reverse transcriptase and protease. If approved, Isentress would be the only drug to target the third enzyme, known as integrase. Amy Rose, a Merck spokeswoman, said treatment with Isentress would cost about $9,850 a year.

Patients with HIV typically are treated with a "cocktail" of two or three types of drugs. However, over time, most HIV viruses mutate and stop responding to certain drugs, creating the need for new ones. Isentress is meant to be used in combination with other HIV drugs.

Merck's Isentress HIV Medicine Approved by U.S. FDA

By Shannon Pettypiece and Rob Waters

Oct. 12 (Bloomberg) -- Merck & Co.'s HIV drug Isentress was approved by U.S. regulators, offering a new option for the thousands of AIDS patients whose virus has developed resistance to other medicines.

Adding Isentress to drugs already on the market can slow the advance of HIV, the virus that causes AIDS, the Food and Drug Administration said today in a statement announcing the approval.

Isentress, Merck's first HIV therapy since 1999, may generate as much as $1 billion in annual sales worldwide, analysts said. About 150,000 Americans taking HIV medicines have a hard-to-treat form of the virus and may benefit from the new drug, said Robert Rode, Merck's vice president for infectious disease and hospital products.

``This is the first of a class of agents that should show growth for many years,'' said Robert Hazlett, an analyst with BMO Capital Markets in New York, in a telephone interview. ``We expect this drug to be widely considered in conjunction with other therapies for patients where existing therapies are failing.''

Hazlett said he expects sales of $400 million next year, rising to $950 million in 2010.

Merck rose 47 cents to $53.51 at 4 p.m. in New York Stock Exchange composite trading and have risen 23 percent this year.

Analysts had expected the FDA to approve Isentress after a panel of advisers recommended in August that the agency do so.

$27 a Day

Isentress, taken twice daily, will cost $27 a day, or almost $10,000 a year, similar to AIDS drugs developed in recent years, Merck spokeswoman Amy Rose said in a phone interview.

``We're pleased that the FDA recognizes the clinical profile of Isentress and the benefits it will bring to patients and physicians who are struggling to keep this disease under control,'' Rose said.

The new medicine uses a different method from other AIDS drugs to block the HIV virus from inserting its genetic material into human DNA, allowing replication. Isentress targets an enzyme called integrase that HIV uses to accomplish the task. Studies have shown the medicine helps patients with resistant strains of HIV when used in combination with other drugs.

Pfizer's Selzentry

This is the second new form of HIV medicine to come on the market this year. Pfizer Inc., the world's biggest drugmaker, won FDA approval in August for Selzentry, the first drug to block a chemical portal the HIV virus uses to enter cells.

Merck's studies found that Isentress reduced the virus to less than could be detected after four months in 61 to 62 percent of patients who got the medicine in combination with other anti- HIV drugs. That compares with 33 to 36 percent of those who got a placebo along with their most effective therapies.

Side effects included rashes, diarrhea, nausea and headaches. Although more patients taking Isentress developed cancers, the drug didn't appear to pose an increased risk, according to regulatory advisers.

Thirty AIDS treatments are approved in the U.S., according to the FDA. AIDS patients take so-called cocktails of anti-HIV drugs each day, typically three or more medicines. The drugs can't cure HIV, and people with the infections still have the virus in their bodies. Eventually, HIV develops resistance to treatment. Once a drug fails, the combination loses effectiveness.

Further Studies

Merck is also studying the drug in children and patients who haven't been on any other HIV medicines.

All HIV drugs are designed to interfere with a part of the HIV life cycle of infection and replication. HIV attacks and destroys white blood cells, which the immune system uses to fend off invasions from viruses and bacteria.

GlaxoSmithKline Plc's Lexiva and Pfizer's Viracept interfere with the action of the protease enzyme, while drugs such as Gilead Sciences Inc.'s Viread inactivate another viral enzyme, reverse transcriptase.

A third class of medications, called entry inhibitors, works by blocking HIV from entering target white cells. These drugs include Roche Holding AG and Trimeris Inc.'s Fuzeon, which reached the market in 2003.

Merck sold the U.S. rights to its previous AIDS drug, Stocrin, to Bristol-Myers Squibb Co., which markets it under the name Sustiva. Merck continues to market Stocrin outside the U.S. and sells another older AIDS drug, Crixivan.

Regards,

Nelson Vergel
powerusa dot org

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Merck Gets FDA Approval
For New HIV Treatment

Wall St Jnl
By JENNIFER CORBETT DOOREN
October 12, 2007 5:50 p.m.

WASHINGTON -- A U.S. Food and Drug Administration panel Friday approved a new type of HIV drug from Merck & Co., a company spokeswoman said.

The drug, known by the brand name Isentress, was approved for use in patients who have failed treatment with other HIV drugs.

Isentress was approved as part of the FDA's accelerated-approval mechanism, which is aimed at getting life-saving treatments to market faster by allowing companies to submit less clinical data than usually required. Companies obtaining accelerated approval must keep studying drugs after they are on the market to gain full approval.

Isentress is designed to target one of three enzymes needed by HIV to reproduce. Current drugs on the market attack the other two enzymes, reverse transcriptase and protease. If approved, Isentress would be the only drug to target the third enzyme, known as integrase. Amy Rose, a Merck spokeswoman, said treatment with Isentress would cost about $9,850 a year.

Patients with HIV typically are treated with a "cocktail" of two or three types of drugs. However, over time, most HIV viruses mutate and stop responding to certain drugs, creating the need for new ones. Isentress is meant to be used in combination with other HIV drugs.

Merck's Isentress HIV Medicine Approved by U.S. FDA

By Shannon Pettypiece and Rob Waters

Oct. 12 (Bloomberg) -- Merck & Co.'s HIV drug Isentress was approved by U.S. regulators, offering a new option for the thousands of AIDS patients whose virus has developed resistance to other medicines.

Adding Isentress to drugs already on the market can slow the advance of HIV, the virus that causes AIDS, the Food and Drug Administration said today in a statement announcing the approval.

Isentress, Merck's first HIV therapy since 1999, may generate as much as $1 billion in annual sales worldwide, analysts said. About 150,000 Americans taking HIV medicines have a hard-to-treat form of the virus and may benefit from the new drug, said Robert Rode, Merck's vice president for infectious disease and hospital products.

``This is the first of a class of agents that should show growth for many years,'' said Robert Hazlett, an analyst with BMO Capital Markets in New York, in a telephone interview. ``We expect this drug to be widely considered in conjunction with other therapies for patients where existing therapies are failing.''

Hazlett said he expects sales of $400 million next year, rising to $950 million in 2010.

Merck rose 47 cents to $53.51 at 4 p.m. in New York Stock Exchange composite trading and have risen 23 percent this year.

Analysts had expected the FDA to approve Isentress after a panel of advisers recommended in August that the agency do so.

$27 a Day

Isentress, taken twice daily, will cost $27 a day, or almost $10,000 a year, similar to AIDS drugs developed in recent years, Merck spokeswoman Amy Rose said in a phone interview.

``We're pleased that the FDA recognizes the clinical profile of Isentress and the benefits it will bring to patients and physicians who are struggling to keep this disease under control,'' Rose said.

The new medicine uses a different method from other AIDS drugs to block the HIV virus from inserting its genetic material into human DNA, allowing replication. Isentress targets an enzyme called integrase that HIV uses to accomplish the task. Studies have shown the medicine helps patients with resistant strains of HIV when used in combination with other drugs.

Pfizer's Selzentry

This is the second new form of HIV medicine to come on the market this year. Pfizer Inc., the world's biggest drugmaker, won FDA approval in August for Selzentry, the first drug to block a chemical portal the HIV virus uses to enter cells.

Merck's studies found that Isentress reduced the virus to less than could be detected after four months in 61 to 62 percent of patients who got the medicine in combination with other anti- HIV drugs. That compares with 33 to 36 percent of those who got a placebo along with their most effective therapies.

Side effects included rashes, diarrhea, nausea and headaches. Although more patients taking Isentress developed cancers, the drug didn't appear to pose an increased risk, according to regulatory advisers.

Thirty AIDS treatments are approved in the U.S., according to the FDA. AIDS patients take so-called cocktails of anti-HIV drugs each day, typically three or more medicines. The drugs can't cure HIV, and people with the infections still have the virus in their bodies. Eventually, HIV develops resistance to treatment. Once a drug fails, the combination loses effectiveness.

Further Studies

Merck is also studying the drug in children and patients who haven't been on any other HIV medicines.

All HIV drugs are designed to interfere with a part of the HIV life cycle of infection and replication. HIV attacks and destroys white blood cells, which the immune system uses to fend off invasions from viruses and bacteria.

GlaxoSmithKline Plc's Lexiva and Pfizer's Viracept interfere with the action of the protease enzyme, while drugs such as Gilead Sciences Inc.'s Viread inactivate another viral enzyme, reverse transcriptase.

A third class of medications, called entry inhibitors, works by blocking HIV from entering target white cells. These drugs include Roche Holding AG and Trimeris Inc.'s Fuzeon, which reached the market in 2003.

Merck sold the U.S. rights to its previous AIDS drug, Stocrin, to Bristol-Myers Squibb Co., which markets it under the name Sustiva. Merck continues to market Stocrin outside the U.S. and sells another older AIDS drug, Crixivan.

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#1166

From: PoWeRTX@...
Date: Fri Oct 12, 2007 3:15 pm
Subject: Fwd: NATAP: Merck Integrase 'Approval Expected Today'

PoWeRTX@...

In a message dated 10/12/2007 8:26:15 A.M. Central Daylight Time, nataphcvhiv@... writes:

NATAP http://natap.org/
_______________________________________________

Merck HIV drug 'Approval Expected Friday'

WASHINGTON
http://www.businessweek.com

Merck & Co. is expected to receive approval to market a first-of-kind HIV drug as early as Friday.

The Food and Drug Administration is scheduled to make a decision on the company's drug Isentress to treat HIV patients who have developed a resistance to other medications. Physicians often prescribe a "cocktail" of several HIV drugs to fight the virus because it changes very rapidly.

A panel of outside advisers unanimously recommended FDA rapidly approve the drug at a meeting last month.

The Merck drug targets integrase, one of three enzymes used by the virus to reproduce and infect cells. The FDA previously has approved drugs that target the two other enzymes.

Despite Isentress' innovative HIV-fighting mechanism, the drug could have trouble reaching blockbuster sales. Like most HIV therapies approved in recent years, Isentress will serve as a second-line therapy for patients who have stopped responding to older, more established drugs.

BMO Capital Markets Robert Hazlett predicts sales of $400 million next year and peaking $950 million by 2010. By comparison, Gilead Science's market-leading drug Truvada posted sales of $1.1 billion last year. Gilead is also expected to have a drug similar to Isentress on the market by the end of the decade.

Merck's New AIDS Drug Has Promise -- if It Isn't Too Pricey

Wall St Jnl
By SARAH RUBENSTEIN
October 11, 2007; Page B1

Merck & Co. could break new ground on the AIDS-fighting front this week with the Food and Drug Administration's expected approval of Isentress, a new type of drug that could be especially useful for patients who no longer respond to many existing treatments. Yet despite the continuing need and market for HIV treatments, and doctors' enthusiasm about the drug's prospects, it's no sure thing that Isentress will pay off for Merck.

A major factor is pricing, yet to be determined and especially important because of the recent arrival of several other drugs to fight HIV, the virus that causes AIDS. Pfizer Inc.'s Selzentry, which won regulatory approval this summer, costs about $10,600 a year wholesale. Roche Holding AG's Fuzeon, which came out in 2003, costs about $24,500 a year wholesale, much higher than many other AIDS drugs. And Johnson & Johnson came out with Prezista last year and may win approval of another HIV drug in early 2008.

Merck declines to discuss pricing ahead of an FDA decision. But if the company were to price Isentress at the high end of the range, "there's no way the system could handle that," says Lanny Cross, a former director of the New York AIDS Drug Assistance Program and a consultant for the National Alliance of State and Territorial AIDS Directors.

Martin Delaney, a longtime AIDS activist, who has participated in price negotiations with Merck on behalf of a group called the Fair Pricing Coalition, says the company has shown sensitivity to patients' financial needs in the past. But he says Merck officials have been "arguing they need to get profitability." He says Merck has indicated it wants to price Isentress in the range of relatively new AIDS drugs such as Prezista and Bristol-Myers Squibb Co.'s Reyataz, both of which cost around $9,500 a year wholesale, according to their makers. He also says Merck has told him it has spent close to $2 billion on HIV research.

Isentress arrives at a time when Merck has just one other HIV drug in clinical trials, at the earliest stage of such testing. And it is just weeks after Merck's leading experimental AIDS vaccine collapsed in a clinical trial. Isentress represents a chance for Merck to show it is still a major player in this arena despite a years-long gap since it last brought a new drug to counter HIV to the market. Some doctors are excited by Isentress's potential, in particular because the pill represents a new way to attack a virus that has managed to develop resistance to many other drugs.

An advisory panel of outside medical experts last month said the data support FDA approval of Isentress for patients who have failed treatment with other HIV drugs. The agency isn't required to follow such panels' advice, but usually does.

Merck may find it difficult to sell Isentress at the highest price possible when many public-assistance programs that help pay for HIV treatments are experiencing fiscal strain. In the 2006 fiscal year, 20 out of nearly 60 AIDS Drug Assistance Programs saw their budgets decrease, according to the Kaiser Family Foundation, a nonprofit health-policy research group in Menlo Park, Calif. Such programs bought drugs for nearly 100,000 HIV patients in 2006 and provided insurance coverage for thousands more, according to Kaiser.

Merck declines to specify how much it spent to develop Isentress or to research other HIV drugs, beyond saying it has spent "hundreds of millions of dollars" on such work. "We believe [HIV research] is the right thing to do," says Robin Isaacs, the Whitehouse Station, N.J., company's executive director of infectious-disease clinical research. "We are hopeful that will translate into return on investment for our shareholders."

While Merck is viewed by many in the AIDS community as one of the major drug makers most committed to HIV research, revenue from such products currently represents a modicum of Merck's total revenue, which amounted to $22.64 billion last year. The company drew a combined $327 million from sales of Crixivan, an HIV drug from the mid-1990s that is no longer used widely, and Stocrin, which Merck sells overseas.

Isentress could provide a bottom-line boost, though it doesn't carry the potential of some major Merck products such as asthma-drug Singulair, which had $3.58 billion of sales last year. Credit Suisse drug analyst Catherine Arnold estimates Merck's annual sales of Isentress could be $500 million world-wide by 2012, and likely more if used in a broad swath of patients. Merck is an investment-banking client of Credit Suisse.

Another factor influencing Isentress's prospects is whether doctors will prescribe it for patients in early stages of HIV treatment. The FDA advisory panel debated how early in a patient's treatment to approve Isentress use, given that most patients in Merck's trials had used a number of drugs already. It will be up to the FDA to make that determination -- though doctors would be permitted to prescribe Isentress "off label" at any point in treatment.

About two-dozen HIV drugs are now available, most of which block two enzymes that HIV uses to replicate in the body: protease and reverse transcriptase. Isentress, known generically as raltegravir, would be the first drug on the market to target a third enzyme -- integrase -- that helps the virus insert its DNA into that of human cells.

Because HIV mutates quickly to outwit drugs, cocktails of three medications are typically used to simultaneously attack the virus in different spots. Patients tend to change drugs as their virus adapts. Isentress would be taken along with other drugs.

Merck's late-stage studies of Isentress involved patients who had been receiving HIV treatment for a median of 10 years, had virus resistant to at least one drug in each of three major classes of HIV drugs and showed evidence the virus was continuing to replicate in their bodies. In other words, they were already sick or in danger of becoming sick soon.

"Since this drug seems to be very effective and pretty well tolerated, I think [there is] potential for it to move in and take territory" from some older drugs, says Judith Feinberg, a leader of the AIDS clinical-trials unit at the University of Cincinnati College of Medicine who served on the advisory panel.

However, she said some doctors may be uncomfortable prescribing Isentress more broadly until further studies are complete. Merck is currently conducting late-stage Isentress studies in patients who are new to HIV treatment. The company expects to have the results toward the end of 2008. Dr. Feinberg says she had no ties to Merck at the time of the panel hearing but has since agreed to give talks sponsored by the company.

Isentress will be used principally in "patients who have tried a whole raft of drugs," says Daniel Kuritzkes, director of AIDS research at Brigham and Women's Hospital in Boston, who consults for Merck and other HIV-drug makers. However, "for patients who have earlier stages of disease, there will be some tendency to hold off because it's so useful in patients with extensive treatment experience."

Another potential complication is that Isentress is taken twice a day, while some new patients take a once-a-day pill called Atripla that combines three drugs. That could make it tougher to get patients to take Isentress from the beginning.

While Merck has little else for HIV in clinical trials, research-and-development chief Peter Kim says the company is committed to pursuing HIV treatments, and continues to do research related to the integrase enzyme.

"We really do think that this drug-resistance issue is going to continue to be a significant unmet medical need," Dr. Kim says.

Regards,

Nelson Vergel
powerusa dot org

See what's new at AOL.com and Make AOL Your Homepage.

NATAP http://natap.org/
_______________________________________________

Merck HIV drug 'Approval Expected Friday'

WASHINGTON
http://www.businessweek.com

Merck & Co. is expected to receive approval to market a first-of-kind HIV drug as early as Friday.

The Food and Drug Administration is scheduled to make a decision on the company's drug Isentress to treat HIV patients who have developed a resistance to other medications. Physicians often prescribe a "cocktail" of several HIV drugs to fight the virus because it changes very rapidly.

A panel of outside advisers unanimously recommended FDA rapidly approve the drug at a meeting last month.

The Merck drug targets integrase, one of three enzymes used by the virus to reproduce and infect cells. The FDA previously has approved drugs that target the two other enzymes.

Despite Isentress' innovative HIV-fighting mechanism, the drug could have trouble reaching blockbuster sales. Like most HIV therapies approved in recent years, Isentress will serve as a second-line therapy for patients who have stopped responding to older, more established drugs.

BMO Capital Markets Robert Hazlett predicts sales of $400 million next year and peaking $950 million by 2010. By comparison, Gilead Science's market-leading drug Truvada posted sales of $1.1 billion last year. Gilead is also expected to have a drug similar to Isentress on the market by the end of the decade.

Merck's New AIDS Drug Has Promise -- if It Isn't Too Pricey

Wall St Jnl
By SARAH RUBENSTEIN
October 11, 2007; Page B1

Merck & Co. could break new ground on the AIDS-fighting front this week with the Food and Drug Administration's expected approval of Isentress, a new type of drug that could be especially useful for patients who no longer respond to many existing treatments. Yet despite the continuing need and market for HIV treatments, and doctors' enthusiasm about the drug's prospects, it's no sure thing that Isentress will pay off for Merck.

A major factor is pricing, yet to be determined and especially important because of the recent arrival of several other drugs to fight HIV, the virus that causes AIDS. Pfizer Inc.'s Selzentry, which won regulatory approval this summer, costs about $10,600 a year wholesale. Roche Holding AG's Fuzeon, which came out in 2003, costs about $24,500 a year wholesale, much higher than many other AIDS drugs. And Johnson & Johnson came out with Prezista last year and may win approval of another HIV drug in early 2008.

Merck declines to discuss pricing ahead of an FDA decision. But if the company were to price Isentress at the high end of the range, "there's no way the system could handle that," says Lanny Cross, a former director of the New York AIDS Drug Assistance Program and a consultant for the National Alliance of State and Territorial AIDS Directors.

Martin Delaney, a longtime AIDS activist, who has participated in price negotiations with Merck on behalf of a group called the Fair Pricing Coalition, says the company has shown sensitivity to patients' financial needs in the past. But he says Merck officials have been "arguing they need to get profitability." He says Merck has indicated it wants to price Isentress in the range of relatively new AIDS drugs such as Prezista and Bristol-Myers Squibb Co.'s Reyataz, both of which cost around $9,500 a year wholesale, according to their makers. He also says Merck has told him it has spent close to $2 billion on HIV research.

Isentress arrives at a time when Merck has just one other HIV drug in clinical trials, at the earliest stage of such testing. And it is just weeks after Merck's leading experimental AIDS vaccine collapsed in a clinical trial. Isentress represents a chance for Merck to show it is still a major player in this arena despite a years-long gap since it last brought a new drug to counter HIV to the market. Some doctors are excited by Isentress's potential, in particular because the pill represents a new way to attack a virus that has managed to develop resistance to many other drugs.

An advisory panel of outside medical experts last month said the data support FDA approval of Isentress for patients who have failed treatment with other HIV drugs. The agency isn't required to follow such panels' advice, but usually does.

Merck may find it difficult to sell Isentress at the highest price possible when many public-assistance programs that help pay for HIV treatments are experiencing fiscal strain. In the 2006 fiscal year, 20 out of nearly 60 AIDS Drug Assistance Programs saw their budgets decrease, according to the Kaiser Family Foundation, a nonprofit health-policy research group in Menlo Park, Calif. Such programs bought drugs for nearly 100,000 HIV patients in 2006 and provided insurance coverage for thousands more, according to Kaiser.

Merck declines to specify how much it spent to develop Isentress or to research other HIV drugs, beyond saying it has spent "hundreds of millions of dollars" on such work. "We believe [HIV research] is the right thing to do," says Robin Isaacs, the Whitehouse Station, N.J., company's executive director of infectious-disease clinical research. "We are hopeful that will translate into return on investment for our shareholders."

While Merck is viewed by many in the AIDS community as one of the major drug makers most committed to HIV research, revenue from such products currently represents a modicum of Merck's total revenue, which amounted to $22.64 billion last year. The company drew a combined $327 million from sales of Crixivan, an HIV drug from the mid-1990s that is no longer used widely, and Stocrin, which Merck sells overseas.

Isentress could provide a bottom-line boost, though it doesn't carry the potential of some major Merck products such as asthma-drug Singulair, which had $3.58 billion of sales last year. Credit Suisse drug analyst Catherine Arnold estimates Merck's annual sales of Isentress could be $500 million world-wide by 2012, and likely more if used in a broad swath of patients. Merck is an investment-banking client of Credit Suisse.

Another factor influencing Isentress's prospects is whether doctors will prescribe it for patients in early stages of HIV treatment. The FDA advisory panel debated how early in a patient's treatment to approve Isentress use, given that most patients in Merck's trials had used a number of drugs already. It will be up to the FDA to make that determination -- though doctors would be permitted to prescribe Isentress "off label" at any point in treatment.

About two-dozen HIV drugs are now available, most of which block two enzymes that HIV uses to replicate in the body: protease and reverse transcriptase. Isentress, known generically as raltegravir, would be the first drug on the market to target a third enzyme -- integrase -- that helps the virus insert its DNA into that of human cells.

Because HIV mutates quickly to outwit drugs, cocktails of three medications are typically used to simultaneously attack the virus in different spots. Patients tend to change drugs as their virus adapts. Isentress would be taken along with other drugs.

Merck's late-stage studies of Isentress involved patients who had been receiving HIV treatment for a median of 10 years, had virus resistant to at least one drug in each of three major classes of HIV drugs and showed evidence the virus was continuing to replicate in their bodies. In other words, they were already sick or in danger of becoming sick soon.

"Since this drug seems to be very effective and pretty well tolerated, I think [there is] potential for it to move in and take territory" from some older drugs, says Judith Feinberg, a leader of the AIDS clinical-trials unit at the University of Cincinnati College of Medicine who served on the advisory panel.

However, she said some doctors may be uncomfortable prescribing Isentress more broadly until further studies are complete. Merck is currently conducting late-stage Isentress studies in patients who are new to HIV treatment. The company expects to have the results toward the end of 2008. Dr. Feinberg says she had no ties to Merck at the time of the panel hearing but has since agreed to give talks sponsored by the company.

Isentress will be used principally in "patients who have tried a whole raft of drugs," says Daniel Kuritzkes, director of AIDS research at Brigham and Women's Hospital in Boston, who consults for Merck and other HIV-drug makers. However, "for patients who have earlier stages of disease, there will be some tendency to hold off because it's so useful in patients with extensive treatment experience."

Another potential complication is that Isentress is taken twice a day, while some new patients take a once-a-day pill called Atripla that combines three drugs. That could make it tougher to get patients to take Isentress from the beginning.

While Merck has little else for HIV in clinical trials, research-and-development chief Peter Kim says the company is committed to pursuing HIV treatments, and continues to do research related to the integrase enzyme.

"We really do think that this drug-resistance issue is going to continue to be a significant unmet medical need," Dr. Kim says.

**************************************
See what's new at http://www.aol.com

_______________________________________________
NATAP nataphcvhiv mailing list -- nataphcvhiv@...

This is an annoucement-only mailing list.  Do not reply.

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