Two New HIV Studies Give Access to Research Medications to People with Multi-Drug Resistance

By Nelson Vergel.
No one can deny that many patients can now suppress their HIV with effective antiretrovirals (ARVs) that cause fewer side effects. However, a vulnerable and often forgotten minority of people are still struggling with multi-drug resistant HIV (MDR-HIV) while they anxiously wait for access to lifesaving ARVs that would finally control their viral replication. Although some of these patients may have developed resistant HIV due to lack of adherence or other issues, many of them have been strictly following their doctors’ orders for years.
They’re often veterans of drug development research who have accumulated HIV resistance as they repeatedly joined ARV studies or traditional expanded access programs of a single new drug out of desperation to control their HIV viral load. As they signed up for studies that helped companies get their drugs approved by the FDA (U.S. Food and Drug Administration), many of these patients were exposed to suboptimal HIV regimens (namely, functional monotherapy or the addition of a single new active ARV to a failing HIV regimen). 
Currently, the U.S. Department of Health and Human Services (DHHS) adult HIV treatment guidelines recommend three antiretrovirals ( ARVs) be given in combination to suppress HIV. But many patients have HIV that has mutated rendering their virus multi-drug resistant (MDR-HIV). Those with MDR-HIV cannot construct a viable HIV suppressive regimen with current FDA-approved and commercially available ARVs. 
Fortunately, two companies are currently enrolling their phase 3 trials for two new drugs that provide a complete new mode of action in controlling HIV:  an attachment inhibitor (BMS-663068 from Brystol Meyers Squibb) and ibalizumab (a monoclonal antibody from Taimed Bilogics). With the encouragement from the HIV activist community, these two companies are providing access to their respective drugs for use in each one of their studies in combination to control the virus of people who have ran out of treatment options.
BMS-663068 is an oral prodrug of the molecule BMS-626529 and first-in-class HIV-1 attachment inhibitor. The attachment inhibitor is designed to work differently than entry inhibitors, a current class of drugs that targets co-receptors’ activity or fusion after HIV attaches to the CD4+ host cell. BMS-663068 is thought to work at an earlier point in the replication process to prevent the virus’ initial interaction with immune cells entirely, and thus blocks its entry into the cell.
Ibalizumab has a completely new mode of action, so most patients should respond to it when using it with at least one other active agent. It is different from the entry inhibitor maraviroc (Selzentry, Celsentri) in that it blocks the CD4 receptor on T cells rather than blocking the CCR5 co-receptor. This means it could be effective against virus that uses either the CCR5 or CXCR4 co-receptor. It is a genetically engineered monoclonal antibody administered once every two weeks intravenously. 
The studies currently enrolling share many of the same research centers across the country, so doctors can refer their MDR-HIV patients to these centers for access to both drugs at the same time. Please click on each one of these links to get more details about these studies:
Patients interested in joining these studies should talk to their physicians to have them contact the primary study coordinators listed in the two links provided.
Please feel free to contact me via email at for any more information on drug access for patients with MDR-HIV.

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