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PR Newswire
Pennsylvania and Texas State AIDS Drug Assistance Programs Adopt DuPont

March 9, 1999
WILMINGTON, Del., March 9 /PRNewswire/ -- DuPont Pharmaceuticals announced today that Pennsylvania and Texas have added Sustiva(TM) (efavirenz), the first once-daily anti-HIV treatment, to their state assistance program drug formularies, bringing the total to 48 states that have included the drug on such formularies. Sustiva is also on all state Medicaid formularies.

"This acceptance of Sustiva by both Pennsylvania and Texas is good news for the underinsured and uninsured living with HIV and AIDS in those states," said Nicholas L. Teti, President, DuPont Pharmaceuticals. "We applaud these states for expediting their processes and getting the drug on formulary less than six months after its approval by the FDA."

Sustiva was added to the Pennsylvania Special Pharmaceutical Benefits Program (SPBP) formulary and the Texas AIDS Drug Assistance Program (ADAP) formulary, and patients eligible for these programs will have access to the drug immediately.

"There are more than 3,800 people eligible for the SPBP program that are living with HIV and AIDS in Pennsylvania," says John Folby, SPBP Program Administrator. "This gives them access to a new treatment option."

The U.S. Department of Health and Human Services' (DHHS) Panel on Clinical Practices for Treatment of HIV Infection recently recommended that Sustiva be included in the Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents as the first non-protease inhibitor among the preferred antiretroviral agents to be used in first-line treatment of HIV-infected individuals who are naive to antiretroviral treatment. The average wholesale price of Sustiva is 32% less expensive than the average wholesale price of the most commonly dispensed protease inhibitor.

Sustiva was approved in September by the U.S. Food and Drug Administration (FDA) as part of the agency's fast-track program for the treatment of HIV-1 infection in combination with other antiretroviral agents. The accelerated approval of Sustiva was based on analyses of plasma HIV-RNA levels and CD4 cell counts in controlled studies of up to 24 weeks in duration. At present, there are no results from controlled trials evaluating long-term suppression of HIV-RNA with Sustiva.

More than 35,000 patients in the United States have begun taking Sustiva since DuPont Pharmaceuticals launched the drug in September. This includes more than 8,000 patients who had been taking the drug as part of the company's Expanded Access Program, which provided free drug to those who would benefit from it. The company continues to actively enroll patients in the ongoing early access programs outside the U.S.

Sustiva product labeling states that the most significant adverse events associated with Sustiva therapy are nervous system symptoms, which are reported in 52 percent of patients (e.g., dizziness, insomnia, somnolence, impaired concentration, and abnormal dreaming). These symptoms occur early in treatment and generally resolve within two to four weeks. The discontinuation rate for nervous system symptoms was 2.6 percent.

Rarely, patients experience more serious side effects that may affect mood or the ability to think clearly. Patients should be cautioned not to operate hazardous machinery or drive if they experience nervous system symptoms. Skin rash, usually mild-to-moderate, was reported in 27 percent of adults and 40 percent of children. Rash usually occurs in the first two weeks of therapy and resolves with continued treatment within one month. The incidence of severe rash was less than one percent in adults and seven percent in children. The discontinuation rate for any grade rash was 1.7 percent.

Sustiva product labeling also states that resistant virus emerges rapidly when NNRTIs are administered as monotherapy. Therefore, Sustiva must not be used as a single agent to treat HIV or added on as a sole agent to a failing regimen. Sustiva therapy should always be initiated in combination with at least one other antiretroviral agent to which the patient has not been previously exposed. Women should not become pregnant while taking Sustiva because birth defects have been seen in animals given Sustiva.

DuPont Pharmaceuticals, a unit of DuPont's Life Sciences Enterprise, is a worldwide, research-based pharmaceutical company that markets its products under the DuPont Pharma name. The business focuses 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. DuPont Pharmaceuticals is also a leader in medical imaging.

For full prescribing information, please visit the company's website at www.sustiva.com or call 1-800-4PHARMA (1-800-474-2762).

SOURCE: DuPont Pharmaceuticals



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