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Introduction
This 3rd edition is an inclusive update of the latest data for five HIV protease inhibitors presented at the 11th International Conference on AIDS held in Vancouver, B.C. in July and at the 36th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held in New Orleans in September. As well, the 20 week data update is included for the first protease-protease study, of ritonavir+saquinavir, presented at the 3rd Int'l. Congress in Birmingham, England.
As you know, Invirase (saquinavir), Norvir (ritonavir), and Crixivan (indinavir) have received marketing approval from the FDA and are available; Viracept (nelfinavir) is in phase III pivotal clinical trials and 141W94 is in phase I/II clinical trials.
Despite the fact that a larger body of research now exists with regards to protease inhibitors, we are really at the beginning of research efforts in a broader attempt to understand how to best use this new class of antiretrovirals in the treatment of HIV disease. Many new and diverse studies are being planned:
· pediatric;
· vertical transmission (mother-to-fetus transmission);
· when to start therapy, when to switch and with which drugs;
· cross-resistance—ACTG 333 is the first study of protease inhibitor cross-resistance; an early look at data from ACTG 333 should be available in 1st quarter 1997; ACTG 359 is expected to explore treatment options for protease failures; additional studies of both type are urgently needed;
· combination therapy of two protease inhibitors; in 1997, a number of double protease inhibitor studies are expected to begin;
· potent four- and five-drug combinations; one 4-drug study has already began, and another is about to begin;
· the concept of induction and maintenance therapy—individuals will start therapy with a potent regimen, after a prolonged period of time, if viral load has been rendered "undetectable," a group of study subjects will stop some of the drugs they're taking.
We are truly entering a more hopeful time for the treatment of HIV. However, there are also problems that need to be addressed. Some individuals have not been as responsive to protease inhibitor therapy as others, while others have begun to rebound after initial decreases in their viral load possibly due to resistance developing. This could be caused by pre-existing mutations to protease inhibitors prior to any exposure to therapy; lack of compliance as a cause of therapy failure is also a great concern. The NIH, the federal government and the pharmaceutical industry have neglected the compliance problem. We need new and more powerful antivirals; and, we must continue to fully support research into finding immune-based therapies that may be used as adjunct to antivirals. Such efforts by academic researchers, the NIH and the OAR (Office of AIDS Research) need our support.
Many individuals cannot access protease inhibitors at all. Our ADAP (AIDS Drug Assistance Program) system which provides drugs to about 70,000 individuals nationwide is under siege. In financial difficulty before the approval of protease inhibitors, many of these state-run (mostly federally funded programs) are NOT offering availability of protease inhibitors to their clients. We are trying to force the Clinton Administration to supply the needed funding. Although increases in funding for this need are being provided, it is nowhere near the funding we need nor what we requested. It is not good public health policy, unfair and extremely shortsighted because good treatment is cost-effective.
With regards to compliance, NATAP recently published a compliance manual which details the guidelines for taking each of the three approved protease inhibitors— Protease Inhibitors User's Guide: How to Maximize Benefit of Protease Inhibitors. Contact us for copies. Finally, our treatment web site on the Internet has an extensive array of "real-time" data and other HIV treatment related information; it can be accessed at: http://www.aidsnyc.org/natap
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