Access to new AIDS drug grows

DuPont Merck plans to submit a new drug application to the U.S. Food and Drug Administration this spring for its investigational drug Sustiva. The drug maker also has agreed to expand access to the drug.

In the non-nucleoside reverse transcriptase inhibitor class of drugs, Sustiva (efavirenz) is being used in combination therapy with the existing retrovirals on the market. Previously, the drug was available to AIDS patients who were either failing or intolerant of existing combination regimes and had CD4 counts of 50 or less. Based on positive trials and requests from health care officials, however, now patients who have CD4 counts of 400 or below can gain access to the drug. Trials have included Sustiva in positive-result combinations with Crixivan, Retrovir, and Epivir.

The expanded access program can be reached at (800) 998-6854.