MEDICAL UPDATE: Update on Protease Inhibitors


MEDICAL UPDATE: Update on Protease Inhibitors

Being Alive Newsletter, Being Alive/Los Angeles - June 1993
Mark Katz, MD and reported by Jim Stoecker

We have been reporting on protease inhibitors for over two years now. This drug holds great promise because it targets a specific step in the HIV life cycle and is able to work in chronically infected T-cells, i.e. cells where HIV has already copied itself into the nucleus.

A number of large drug manufacturers are developing a commercially marketable form of this antiviral. The involvement of so many "big guns" in the pharmaceutical industry is itself encouraging news.

Studies in humans have already started under two manufacturers. Abbott Laboratories studied an intravenous form of the drug in Amsterdam and has reported some spectacular results. The protease inhibitor appeared to completely abolish any evidence of the virus. No other drug yet studied in humans has been able to make such a claim.

The problem with this antiviral is that it is poorly absorbed by the body. The Amsterdam study required continuous IV infusion over long periods in order to get the results noted above. Clearly, eight hours a day hooked up to an IV is going to impact a person's quality of life. An oral form of the drug is needed.

Abbott has developed an oral form and has moved into a Phase I dose escalation study. Although the drug appears to be tolerated, it is still being poorly absorbed. The problem with the current formulation is that it has what we term a "narrow therapeutic window." If you give too much of the drug, serious liver problems develop. If you give too little, you lose the ability to effectively fight HIV. So it appears we still have a good deal to learn about appropriate dosage.

Studies, however, are moving forward. Roche, manufacturers of ddC, have also developed an oral form of protease inhibitor. This is being studied under the auspices of the ACTG. The study compares various combinations of AZT and ddC and the Roche protease inhibitor.

So, after two years of talk, we now are seeing some action in getting protease inhibitors into a form useful to people with HIV. As always, things are not moving fast enough, but they are moving. The promise is there.
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