U.S. Food and Drug Administration
FDA Consumer magazine
November-December 2001
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By Jeffrey S. Murray, M.D., M.P.H.
Will we ever be able to relax again? Like many other people, my thoughts have been overwhelmed with the tragic events of Sept 11. As I wrote this commentary addressing HIV/AIDS therapy, my mind started drawing parallels between the battle against HIV and the war against terrorism. After all, both of these enemies lived silently among us before unleashing unimagined suffering. Within a short period of time both unalterably changed the world. Furthermore, both will require a long-term commitment of constant vigilance, in a way that impinges upon personal freedom.
Lifelong treatment of an infectious disease is a new reality ushered in by HIV/AIDS. Although HIV drug cocktails suppress the virus very well, eradication in a chronically infected individual seems unlikely with the current drugs. I can think of no other infection that requires continuous, lifelong treatment with nearly perfect adherence. It's difficult to imagine that even the best of pill-takers will perfectly adhere to lifelong treatment regimens, particularly when drugs cause troublesome adverse events or are not well-tolerated. However, for most HIV-infected individuals the alternative to lifelong therapy may be devastating complications, resulting in death.
One might ask how this differs from any other chronic illness such as high blood pressure requiring lifelong therapy. The difference is that for most diseases missed doses of drug don't have the same consequences as when treating an infectious disease like HIV. When treating HIV infection, indiscretions in adherence to the regimen may allow the virus to evolve in a way that it becomes resistant to the current drugs and possibly to future drugs. In addition, because the current drugs aren't perfect, even people who never miss a dose may develop resistance to one or more of them.
Likewise, preventing HIV requires constant vigilance. A vaccine for HIV does not appear to be imminent so it is necessary to rely on more traditional methods of risk reduction. However, decreases in the rates of sexually transmitted diseases realized in past decades have recently rebounded in at- risk populations, particularly in younger gay men and minorities. It is clear that changing behavior and maintaining it over decades is notoriously difficult. The worst news is that some newly infected individuals have acquired drug-resistant strains. For these people, treatment with drugs may not be as effective.
How do we deal with HIV battle fatigue? The first step is realizing that the fight is not over. On the treatment front we need an open pipeline of new HIV drugs. Some may have the notion that the currently approved 15 drugs should be a sufficient arsenal. However, given the need for lifelong therapy there is an urgent search for drugs that are more convenient to take, better tolerated and more forgiving if doses are late or missed. In addition, because drugs of the same class are similar, some individuals harbor virus that is resistant to an entire class of drugs or even several classes of drugs. Drugs that fight the virus in new ways are urgently needed to treat individuals harboring drug-resistant HIV. Otherwise, the rates of AIDS complications and death, reduced in the latter part of the last decade, could once again increase.
There are no easy answers. Sharing our world with a foe requires constant resolve, vigilance, and innovation. Our country is fortunate to have access to drugs that keep HIV under control for many individuals. Hopefully, new scientific breakthroughs will continue so that the battle against HIV/AIDS can be won for the entire world.
Jeffrey S. Murray, M.D., M.P.H., is the acting deputy director of the FDA's division of antiviral drug products and a volunteer physician at the Elizabeth Taylor Medical Center of Whitman-Walker Clinic in Washington, D.C.
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2001-OCT-26.