PR Newswire; Wednesday December 17, 12:52 pm EST

"As promised, we have now made Sustiva available to a wider population, in response to requests from physicians, patients and advocacy organizations," said Paul Howes, president and CEO of DuPont Merck.

Early access to Sustiva began in Europe in October, 1997 concurrent with the U.S. and Canadian Expanded Access programs. The programs in Europe will be similarly broadened during the first quarter of 1998 to provide comparable access to that of patients in the U.S.

In the U.S. Expanded Access program, Sustiva, a non-nucleoside reverse transcriptase inhibitor (NNRTI) in Phase III clinical trials, must be used in combination with and initiated at the same time as at least one other marketed or investigational antiretroviral which the patient has not previously taken. Sustiva is not recommended as monotherapy. Patients are now eligible for this program if at any time they have had a CD4 cell count of less than 400 cells/mm3, they are failing or intolerant to their current treatment regimen, and their physician is unable to assemble a treatment combination without Sustiva that is likely to produce a sustained reduction of virus in the blood.

DuPont Merck believes that patients who have failed non-nucleoside reverse transcriptase inhibitors are less likely to benefit from Sustiva because of a common mutation (K103N).

Physicians and patients may call 1-800-998-6854 for more information on inclusion criteria and materials for investigator and patient enrollment in the Sustiva Expanded Access Program.

With input from representatives of national HIV/AIDS patient advocacy organizations, DuPont Merck designed this more broadened expanded access program to ensure Sustiva would be readily available to patients with limited therapeutic options. Initially, DuPont Merck had promised to expand the program in January 1998. The original program, launched October 1, 1997 was open to patients who had advanced disease with CD4 cell counts of 50 cells/mm3 or less and who were failing therapy or were intolerant to their current treatment regimen.

As part of the company's clinical development program, to date, more than 1,400 patients have taken Sustiva in combination with other antiretrovirals.

Preliminary data indicate that Sustiva can significantly reduce viral load and increase CD4 cell count in combination therapy. In preliminary data reported at 48 weeks, 88 percent of patients receiving combination therapy with Sustiva (increased to 600 mg once-daily at 36 weeks from a 200 mg initial dose) and Crixivan(R) (indinavir) (1,000 mg, every eight hours) achieved HIV- RNA levels below the level of quantification (400 copies/mL) using the Amplicor assay.

Additionally, in a 137-patient Phase II study of once-daily Sustiva at one of three doses (200, 400 or 600 mg per day) in combination with Retrovir(R) (zidovudine, AZT) (300 mg, twice daily) and Epivir(R) (lamivudine, 3TC) (150 mg, twice daily) in treatment naive patients, significant reductions in plasma HIV-RNA were observed. After 16 weeks of treatment, 88 percent of the patients who completed the study at the recommended 600 mg dose of Sustiva in combination with AZT and 3TC achieved HIV-RNA levels below the level of quantification (400 copies/mL).

"These data are very encouraging for HIV-positive patients as they suggest that a combination of Sustiva, and two nucleosides -- without a protease inhibitor -- may prove to be a good initial regimen," said Paul Friedman, M.D., President, DuPont Merck Research Laboratories. "Importantly, data have also shown that Sustiva significantly reduces HIV-RNA in combination with a protease inhibitor."

In clinical studies, Sustiva is generally well tolerated. There have been few discontinuations due to side effects. In one controlled study, the most commonly reported side effects from the Sustiva and Crixivan combination included rash, headache, diarrhea, dizziness, sinusitis, influenza-like symptoms and nausea. There was no apparent increase in serious side effects for treatments containing Sustiva plus Crixivan over treatments not containing Sustiva. Severe rashes have been reported in fewer than one percent of cases.

DuPont Merck plans to submit the NDA for Sustiva to the FDA in the second quarter of 1998.

The DuPont Merck Pharmaceutical Company is a worldwide, research-based pharmaceutical company, which markets its products under the DuPont Pharma name. Formed in 1991 as a partnership between DuPont and Merck & Co., Inc., DuPont Merck 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., Inc.; Retrovir and Epivir are registered trademarks of Glaxo Wellcome Inc.; Amplicor is a registered trademark of Roche Laboratories./

SOURCE: DuPont Merck Pharmaceutical Company

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