HIV & AIDS Drug Discovery
New FDA Approved Drugs
The U.S. Food and Drug Administration (FDA) November 5, 2015, approved Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.
Genvoya contains a new form of tenofovir that has not been previously approved. This new form of tenofovir provides lower levels of the drug in the bloodstream, but higher levels within the cells where HIV-1 replicates. It was developed to help reduce some drug side effects. Genvoya appears to be associated with less kidney toxicity and decreases in bone density than previously approved tenofovir containing regimens based on laboratory measures. Patients receiving Genvoya experienced greater increases in serum lipids (total cholesterol and low-density lipoprotein) than patients receiving other treatment regimens in the studies.
On March 1, 2016, FDA has approved Gilead’s Second TAF-Based Single Tablet Regimen Odefsey (emtricitabine/rilpivirine/tenofovir alafenamide), which includes a new, safer version of tenofovir.
This tablet is an updated version of Complera (rilpivirine/tenofovir disoproxil fumarate/emtricitabine), swapping tenofovir alafenamide, or TAF, for tenofovir disoproxil fumarate, or TDF.Research has shown that TAF is safer to the bones and kidneys than TDF and suppresses HIV just as well.
TAF more efficiently enters cells, requiring a dose one tenth that of TDF, and leads to 90 percent less drug in the bloodstream where it may cause toxicities.
Genvoya -FDA approval November 2015
Odefsey -FDA approval March 2016
Long Acting Injectable Drugs
Although advancements in treatment have made HIV much easier to manage, the daily dosage of medication can often feel like a burden. Researchers have been working hard to develop new ways treatment can be delivered to those living with HIV to improve adherence and increase viral suppression.
Now, ViiV Healthcare and Janssen are one step closer to making life with HIV a lot easier. Findings from the LATTE 2 trial were presented at the Conference on Retroviruses and Opportunistic Infections, Bostom in February 2016.
If approved, ViiV and Janssen’s injectable treatment of cabotegravir (CAB LA) and rilpivirine (RPV LA)would allow for people with HIV to achieve higher viral suppression rates; improving the lives of people on treatment and driving down infection rates.
If successful, this regimen would offer people living with HIV who have achieved viral suppression an alternative option to the standard oral daily, three-drug therapy.
Today, the two drug companies announced that Phase III trials will begin in mid-2016 for their bi-monthly two-drug long-term injectable treatment.
Vaccine Development
New research published in the February 2016 Journal of Leukocyte Biology shows that it may be possible to repurpose the drug for use in an HIV vaccine. A drug Adenosine deaminase, or ADA, already approved by the U.S. Food and Drug Administration may prove useful in an HIV vaccine to help the immune system “remember” the virus to prevent or quickly eliminate future infection, according to a news release published Feb. 2 by Federation of American Societies for Experimental Biology.
