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Author Topic: Pfizer HIV tablet gets approval  (Read 2815 times)

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Offline Markmt

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  • Posts: 180
Pfizer HIV tablet gets approval
« on: August 07, 2007, 04:46:04 AM »
NEW YORK (AP) - Pfizer (NYSE:PFE) Inc. said Monday the Food and Drug Administration granted accelerated approval to the company's oral HIV medicine Selzentry.

Accelerated approval is given to medications that provide a meaningful advantage over existing treatment for life-threatening diseases. Pfizer said more long-term data will be required for 'traditional' approval of the drug.......

"Live to love and love to live."

Leo Buscaglia

Offline ronaldinho

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  • Posts: 79
Re: Pfizer HIV tablet gets approval
« Reply #1 on: August 07, 2007, 10:41:24 AM »
So, this makes Selzentry the first entry inhibitor to be approved since Fuzeon, a long time ago. Next in line for approval are the integrase inhibitors. Maturation inhibitors will take a little longer. New medicines, new classes of medicines. Le us see  what kind of therapies will be possible with this arsenal of ARVs.

Offline JamieD

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  • Posts: 259
Re: Pfizer HIV tablet gets approval
« Reply #2 on: August 07, 2007, 12:20:31 PM »
How do you know if you will benefit from a CCR5 receptor antagonist (Is that what they are?)? Which people are most likely to benefit from them? Those recently infected? Treatment experienced? I thought it was going to be called "Celestri"

Offline JPinLA

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  • Cheers!
Re: Pfizer HIV tablet gets approval
« Reply #3 on: August 07, 2007, 03:07:38 PM »

My understanding is that this drug is currently approved for treatment experienced HIVers (or at least those with multiple drug resistance, which is predominantly those who are treatment experienced)..although I think that it's use in treatment naive subjects is being explore.  I might be off on this, but I'm pretty sure. 

If you are a candidate, you can have a tropism test done to see if your virus is CCR5 tropic, CXCR4 tropic or dual tropic.  You can find more info on the drug here:     http://www.aidsmeds.com/archive/maraviroc_1629.shtml.

Over all, it's a great new therapeutic, with it's own sets of limitations, but anothe rto add to the arsenal.

11/06 - Diagnosed - VL/5784 & CD4 326
2/07 - VL/6000 & CD4 290 2/07
3//07 -Began Truvada/Viramune 
4/07 VL/undetectable and CD4 320 22%
7/07 VL/undetectable and CD4 286 22%
11/07 VL/undetectable and CD4 302 26%

Offline trellium

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  • stArk raving Borg
Re: Pfizer HIV tablet gets approval
« Reply #4 on: August 07, 2007, 03:13:18 PM »
Monogram's HIV Co-Receptor Tropism Assay is used to determine the tropism of the virus.

Maraviroc will only work as long as your virus is CCR5-tropic.  It is not yet approved as a starting first-line therapy for treatment-naive patients but that might change 'cos studies have shown that 80-85 percent of people newly diagnosed with HIV and previously untreated with HIV therapy have dominant CCR5-tropic virus.  This drops to 50-60 percent in patients who have been treated before with HAART. 

IAS: Maraviroc slightly less effective but more tolerable in treatment-naive patients (compared to Sustiva)

Brand name is Celsentri in Europe, and Selzentry in the US

Offline RapidRod

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  • Posts: 15,288
Re: Pfizer HIV tablet gets approval
« Reply #5 on: August 07, 2007, 10:01:33 PM »
I didn't like where it said, Pfizer also warned that studies counted more cardiovascular problems, including heart attacks. But if you are at the end of your treatment options I believe I would take the risk. 

Offline powerpuff

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  • Posts: 138
Re: Pfizer HIV tablet gets approval
« Reply #6 on: August 23, 2007, 02:34:04 PM »
so if your duo tropic you can'tbenifit from this drug. what else are your options??


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