Pfizer HIV tablet gets approval

[Markmt]

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.......


http://money.cnn.com/news/newsfeeds/articles/newstex/AFX-0013-18699618.htm

[ronaldinho]

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.

[JamieD]

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"

[JPinLA]

Jamie-

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.

JP

[trellium]

Monogram's HIV Co-Receptor Tropism Assay is used to determine the tropism of the virus.
http://www.trofileassay.com

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)
http://www.aidsmap.com/en/news/4646E7C1-BBAF-4255-BCE8-6E4F6AD8AB2B.asp

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

[RapidRod]

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. 

[powerpuff]

so if your duo tropic you can'tbenifit from this drug. what else are your options??