Well now, this is something that I can get behind, a WHOLE NEW approach to HIV, eradicating it! And Gilead Sciences is proposing to do just that. In a press real yesterday from Gilead Sciences, it said in part:
FOSTER CITY, Calif.--Jun. 27, 2012-- Gilead Sciences, Inc. (Nasdaq:GILD) announced today it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of elvitegravir, an integrase inhibitor for the treatment of HIV-1 infection in treatment-experienced adults. Elvitegravir is also a component of Gilead's once-daily Quad single tablet regimen, which is currently under U.S. and European regulatory review for treatment-naïve adult patients.
The Science behind the New Eradication program was given in a slide show at Ishield, here is a link to the presentation: < http://www.natap.org/... & from Ishield here: http://www.isheid.com/... >
SOME ISSUES THAT I FORESEE:
THE WHO:
The proposal before the FDA is currently only for NEW patients, and does not cover the 10's of thousands of people currently taking HAARTs. I have found no references about any plans to provide an eradication program for people currently on HAARTs.
COST:
There is no number yet on what this Eradication Program will cost, or if it will be covered by insurance companies. From past experience I have seen insurance companies NOT cover new therapeutic approaches by calling them "experimental", one can assume that they will play the "experimental" card here, ad the COST of this regiment becomes a REAL issue. A 96 week Eradication Treatment for $2,000 a week is probably out of reach for most newly diagnosed patients!
TOXICITY:
Most of the current studies that are referenced are In Vito studies, and say nothing about how these drugs will do in the complex environment of the human body. We have seen many drugs that do well in the lab and test tubes, but fizzle dramatically i the body, or even are found to be too lethal to the patient to make them useful!
TIME OF TREATMENT:
I read one paper that said time of treatment would be 96 weeks. But I don't think this is set in stone. One issue with PEP, and one reason so few people decide to take it is its side effects and toxicity, and the length of time that one has to take the PEP, and be 100% compliant in order to work.
DEFINITION OF NEW
Does NEW mean as close to sero-conversion date as possible, or does it mean not having been exposed to any HAART medications? A person might live a 10-15 year asymptomatic life with out any drug intervention and without having to deal with the side effects of the very potent HIV drugs, and many do choose this approach. In the 90's the belief was not to begin HAART therapies till one reach the 250 T-cell line. The current guideline is to begin treatment at 350 T-cells and I have found studies < http://www.sciencedaily.com/... > that are suggesting that 500 t-cells might be a better place.
So what is a new patient, and at what time should this treatment e started.
SOME BACKGROUND
I am providing some of the background information that I looked at before I wrote this. I have been taken to task in the past for "not doing my home work" and due to my dementia I do extra work to get my facts straight. So here is some of the background I have uncovered on this subject.
HIV anti Latency Agents Pipeline - http://www.hiv-reservoir.net/...
Gilead Quad Performance Comparable to Atripla in First-Time Treatment Takers -
http://www.aidsmeds.com/...
New Approach in HBV & HCV: Gilead's TLR 7 Agonist GS-9620 at EASL - New Approach in HBV & HCV: Gilead's TLR 7 Agonist GS-9620 at EASL
Therapeutic Efficacy of a TLR7 Agonist for HBV Chronic Infection in Chimpanzees - http://natap.org/...
Anti-Viral Efficacy and Induction of an Antibody Response Against Surface Antigen with the TLR7 Agonist GS-9620 in the Woodchuck Model of Chronic HBV Infection - http://natap.org/...
Preclinical Characterization of GS-9620, A Potent and Selective Oral TLR7 Agonist - http://natap.org/...
A Phase-I, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Escalating Oral Doses of GS-9620 In Healthy Subjects - http://natap.org/...
Some information from Gilead on Drug Costs and HIV < http://www.gilead.com/... >
Want further information, Let me Google that For You! http://bit.ly/...