As the 2004 World AIDS Conference ground on in mid-July in Bangkok, there was not a lot of truly exciting news. But then, most real-life science is accomplished step by unexciting step. Back home, however, several positive moves forward have been enthusiastically received.
The federal Department of Health and Human Services has proposed an “expedited drug-review process” for generic medications, to be used in poor developing countries. Typically, the meds will be fixed-dose combination pills containing several anti-HIV medications that are already approved by the FDA. The lack of an approval process not utilizing lengthy trials has been the latest roadblock to getting drugs to the poor nations of the world.
Heaven knows that some expedited process is necessary if help is to ever come to suffering Africa: Glaxo is just now getting full approval for their “nuke,” Ziagen, six years after it received conditional approval – and has become a widely used drug.
There is also continued improvement in the number of pills that an HIV-infected person must take each day (“pill burden”). Glaxo is about to get approval for their once-daily, single pill containing Epivir and Ziagen. Gilead Sciences is also moving toward the single pill concept by combining their Viread and Emtriva, each of which is separately FDA-approved.
Pfizer is making their protease inhibitor Viracept in a 625-milligram form, necessitating only two pills twice a day, instead of the present five pills twice a day. Bristol-Myers Squibb, Gilead, and Merck are collaborating on a once-daily, three-drug pill combining Viread, Emtriva, and Sustiva. When ready, this will probably become the first treatment regimen for most HIV patients.
All of this is good news with far more immediate applications for the average HIV-infected person than the conference. Let’s keep ’em coming!
This article appears in August 6 • 2004.