AIDSWEEKLY Plus; Monday, July 13 & 20, 1998
Daniel J. DeNoon, Senior Editor
Protease inhibitors have revolutionized the treatment of HIV infection and are the cornerstone of highly active antiretroviral therapy (HAART). Amprenavir (formerly VX-478 or 141W94), developed by Vertex Pharmaceuticals Inc. and licensed to Glaxo, is the next protease inhibitor in the pipeline - and early results show that it may be a very popular drug indeed.
The drug has demonstrated anti-HIV activity equivalent to that of other protease inhibitors in combination with the Glaxo nucleoside reverse transcriptase inhibitors (NRTIs) zidovudine (AZT) and lamivudine (3TC) in Phase II clinical trials. But that's not all.
New findings, released on the eve of the XII World AIDS Conference, indicate that the drug also penetrates the blood/brain barrier. This highly desirable quality not only means that the drug may prevent the neurologic sequelae of HIV disease but also suggests that the drug can hunt down HIV in one of its most difficult-to-reach refuges.
Moreover, the drug appears to be easier to take than other protease inhibitors: it has twice-daily dosing and does not need to be taken either with food or in a fasting state. It is unclear to what extent amprenavir-associated adverse events - headache and rash - will affect long-term users.
Expect Glaxo to file an expanded access application for amprenavir soon after new trial results are announced at the World AIDS Conference.
Also expect qualified, but rapid approval of abacavir (previously 1592U89), Glaxo's potent new NRTI. Hypersensitivity reactions to the drug must be monitored carefully, but the drug is still expected to capture a significant market share.
Despite Glaxo's strong position, other players are by no means out of the game.
Roche is set to announce new findings showing that the new formulation of its protease inhibitor saquinavir (Fortovase) is as potent as other protease inhibitors and seems to stimulate a better increase in CD4 cells. Saquinavir is particularly effective in a two-protease-inhibitor regimen.
Gilead's adefovir (bis-POM PMEA) remains a strong antiretroviral candidate, and DuPont's efavirenz is the most effective member of the class of non-nucleoside reverse transcriptase inhibitors (NNRTIs) ever tested in clinical trials.
And despite the imminent arrival of abacavir, Bristol Myers Squibb's stavudine (d4T) has recently become the most-prescribed NRTI, surpassing Glaxo's aging AZT. Enhancing the drug's position is its potency in combination with the firm's didanosine (ddI), and with hydroxyurea (also produced by Bristol Myers).
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