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Redefining Expanded Access for Patients With Multidrug-Resistant HIV

By Nelson Vergel, B.S.Ch.E., M.B.A.

March 21, 2013

In a host of meetings on treatment access and HIV research, we have repeatedly heard the following statements about multidrug-resistant HIV (MDR-HIV) patients:

"These patients no longer exist -- they're either dead or have responded to the latest ARVs."

"Only patients who do not adhere to their HIV regimens have MDR-HIV."

"Our clinic cannot provide expanded access programs (EAPs) due to cost and staff restraints."

However, after surveying physicians around the country, we have found that although these patients are in a minority, they do exist and are anxiously waiting for access to viable regimens that could save their lives.

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 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 EAPs 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). It is time to create a new paradigm to break the vicious cycle of single-drug access that has failed these patients.

More Information: GMHC Treatment Issues, December 2012.




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