Jun 4, 2013
I know there are studies involving NanoART which means ways to deliver nanoparticles of HAART drugs to various tissues in the bodies. Actually there are no human trials. Do you know when they should begin? Would they last long? Many ARV's for nanodelivery are approved so I guess they don't need to pass many safety trials. I hope they will start soon since this technique would help to destroy the reservoirs.
| Response from Mr. Vergel
There are several studies being done right now on long acting nano formulations of HIV medications.
During several conferences in the past 2 years, data have been presented on long acting formulations of a monthly intramuscular (IM) injection of rilpivirine and injectable formulations of the integrase inhibitor GSK744 (a second generation integrase inhibitor, both IM and sub-cutaneous) where therapeutic drug levels are sustained for well over a month. Another drug that has been studied for a few years is the monoclonal antibody ibalizumab as a CD4 receptor entry inhibitor to overcome drug resistant HIV is based on intravenous delivery every 2-4 weeks.
At CROI 2013, oral abstract 24LB presented data on a long acting nano-formulation of GSK744. The drug was administered via a single intramuscular injection to HIV- volunteers and found to have a half-life of 21 to 50 days, which may allow a once monthly or even once quarterly dosing schedule. To assess the efficacy of this long acting GSK744 formulation for PrEP, 8 macaques received intramuscular doses of GSK744 at two time points 4 weeks apart. All eight of the control macaques receiving placebo became infected with SHIV. None of the 8 treated macaques had detectable virus 3 weeks after the final viral challenge.
Long acting regimens including one or more injections of three compounds monthly may require oral lead in periods to assess tolerability and easy withdrawal in case of side effects Also, careful guidelines for treatment discontinuation will be important if the three compounds have different half lives.
Dr Puliguji from University of Nebraska presented results on a nanoformulation of atazanavir/ritonavir that in a mouse study which resulted in ten-fold higher concentrations in plasma and tissue and sustained for two weeks following a single intramuscular injection. It will be interesting to see studies on nanoformulations of darunavir and other popular HIV antiretrovirals in the future.
In my opinion, this is one of the most exciting areas of HIV drug development in the present that may change the paradigm with improved adherence, great pre-exposure and post exposure protection, and hopefully side effect profile.
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