Several potent antiretrovirals (ARVs) in the past 4 years have enabled many patients with multidrug resistance (MDR) to suppress their HIV viral load.
Due to several factors, there is still a relatively small number of patients that have developed resistance or toxicity to the new ARV’s
To protect them from functional monotherapy, these patients are not allowed in pre- approval studies.
Some HIV ARV’s in phase II studies may potentially help those patients, but combining them after their respective approvals may take at least 3 or 4 years.
Some of these patients may be at risk of clinical decline and death if no viable regimen is available for them before 2012
We do not know how many of these patients there are in the U.S.
I performed a physician survey with the help of some researchers and activists to find out how many patients may be present in the U.S. with HIV multidrug resistance in deep salvage (one or zero active medications to treat their HIV).
These figures summarize our findings (click on figures to enlarge):
These are the HIV medications in current development. The ones with an asterisk are the ones that may work for patients with no options left.
The closest ones to approval are Taimed's ibalizumab ( an IV once every two weeks) which may be two years away from approval, and GSK's integrase inhibitor GSK572 (2-3 years) . Avexa recently stopped the development of Apricitabine and Myriad may follow suit with their maturation inhibitor. A combination of at least two compounds will probably not be feasible until 2013. Efforts towards creating an expanded access program using multiple investigational agents is currently under way but it may not be a possibility until 2011. All companies and the FDA are welcoming the concept in its early stages. I will provide an update during the last quarter of 2010.
I wish we could help patients who need help now.
Nelson Vergel
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