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
"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
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
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
SOURCE: DuPont Pharmaceuticals