PR Newswire; Tuesday June 30, 8:00 am EST

"It is exciting that adding a once-daily dose of Sustiva as a fourth drug can make such an important difference in both viral load suppression and CD4 cell rise after only eight weeks, and that the improvements are maintained at 24 weeks," said W. Jeffrey Fessel, M.D., director, HIV Research Unit, Kaiser Permanente in San Francisco, Calif. "If four drugs rather than three drugs were to become widely used, it is encouraging that this can be achieved by adding just three capsules once daily."

In an analysis of the first 184 patients in this study, treatment with Sustiva, a protease inhibitor and two nucleoside analogues was compared to a combination containing the same protease inhibitor and two nucleoside analogues alone, a current standard-of-care regimen. As early as eight weeks after initiating treatment, inclusion of Sustiva as part of a four-drug combination resulted in HIV-RNA reduction to BQL in a greater percentage of patients than those on the three-drug combination, by three methods of analysis.* The difference in results between two arms of the study from 12 through 24 weeks of treatment achieved statistical significance for last- observation-carried-forward (LOCF). Patients taking the four-drug combination containing Sustiva had statistically superior reduction in HIV-RNA levels less than 50 copies/mL (using an ultrasensitive assay) by multiple methods of data analysis. For example, 74 percent of patients taking the combination containing Sustiva achieved HIV-RNA BQL in the ultrasensitive assay (less than 50 copies/mL) compared to only 45 percent of patients taking a standard three-drug regimen, according to an observed data analysis.

Patients taking both regimens achieved CD4 cell count increases of between 85 and 115 cells/mm3 at 24 weeks, using LOCF analysis, and between 95 and 130 cells/mm3 using observed data analysis.

Data Show Sustiva Performs Well in Two-Drug Combination with Viracept(R) (nelfinavir) Study 024:

DuPont Pharmaceuticals Study 024 showed that Sustiva used in combination with Viracept also significantly reduces HIV-RNA and elevates CD4 cell counts in both the treatment-experienced and treatment-naive patients studied. The report about this ongoing study contained data on 63 patients who had received treatment for 16 weeks.

A two-drug combination of Sustiva and a commonly used protease inhibitor shows early, promising results," said Donna Mildvan, M.D., chief, Infectious Diseases, Beth Israel Medical Center in New York. "It will be important to see how well these findings are sustained over time."

Sustiva Performs Well in Combination with Two Nucleoside Analogues, Study 005: Researchers also presented data at the Conference today from DuPont Pharmaceuticals Study 005. This study showed Sustiva, given once daily in combination with two nucleoside analogues, Retrovir(R) (zidovudine, AZT) and Epivir(R) (lamivudine, 3TC), suppresses HIV-RNA to BQL after 36 weeks and may therefore offer physicians and patients a new initial HIV treatment regimen. In the 137-patient study, all 11 patients randomized to Sustiva (600 mg)/AZT/3TC who had reached the 36-week time point achieved HIV-RNA BQL. Using a more conservative 36-week LOCF analysis, 82 percent of the patients in this arm achieved BQL. The CD4 cell counts of patients in this arm of the study increased an average of more than 100 cells/mm3 at 36 weeks.

Yesterday, similar data were presented at the Conference from DuPont Pharmaceuticals Study 006 in which, when using the most rigorous analysis for reporting data (a method known as non-completer = failure), 19.2% more patients receiving Sustiva/AZT/3TC achieved HIV-RNA BQL compared to patients receiving Crixivan/AZT/3TC, which was statistically significant.*

DuPont Pharmaceuticals reports that Sustiva is generally well tolerated in clinical trials studying Sustiva in combination with protease inhibitors and/or nucleoside analogue reverse transcriptase inhibitors. Commonly reported side effects include rash, nausea, dizziness, diarrhea, headache and insomnia. Severe rashes were reported in fewer than one percent of patients receiving Sustiva. Pregnant women should not take this new medication unless the potential benefit to the mother outweighs the potential risk to the fetus.

During the Conference on Thursday, additional Sustiva interaction studies will be presented. Meanwhile, the company has expanded access programs for Sustiva. For information, physicians and patients may call 800-998-6854 in the U.S. and Canada, or +44-0-1462-488263 in Europe.

DuPont Pharmaceuticals submitted a New Drug Application for Sustiva to the U.S. Food and Drug Administration on June 11, 1998 and intends to submit similar marketing applications with European and Canadian regulatory authorities. DuPont Pharmaceuticals is a worldwide, research-based pharmaceutical company that markets its products under the DuPont Pharma name. DuPont announced on May 18, 1998 that it would acquire Merck's 50 percent interest in the company, which was formed in 1991.

DuPont Pharmaceuticals is focused on research, development and delivery of pharmaceuticals to treat unmet medical needs in the fight against HIV, cardiovascular disease, central nervous system disorders, cancer and arthritis-related disorders. The company is also a leader in radiopharmaceuticals.

Crixivan is a registered trademark of Merck & Co.

Retrovir and Epivir are registered trademarks of Glaxo Wellcome Inc.

Viracept is a registered trademark of Agouron.

Last-observation-carried-forward data analysis is a method of analyzing data in which missing viral load data is assumed to be equivalent to the last recorded data for that patient. Analysis performed at only 16 and 24 weeks. Non-completer = failure data analysis is a method of reporting data in which missing data is reported as equivalent to failure (i.e., above quantifiable viral load). Only if a patient's viral load measurement is missing or unavailable at one time point in the study, the patient's results are not included in the analysis at that point -- if the patient's viral load was BQL both before and after that point.

SOURCE: DuPont Pharmaceuticals

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