Brand Name: Sustiva
Active Ingredient: efavirenz
Indication: For use in combination treatment of HIV infection (AIDS)
Company Name: DuPont Pharmaceuticals
Availability: FDA granted accelerated approval in September 1998; FDA granted traditional (full) approval based on long-term efficacy in February 2000
Although several different types of drugs are used by patients with AIDS to treat their human immunodeficiency virus (HIV) infection (usually in combination), until recently no drug has received full approval from the FDA based on long-term results. In February 2000, Sustiva (efavirenz), manufactured by DuPont Pharmaceuticals, became the first anti-HIV drug to receive full FDA approval based on long-term data supporting its effectiveness in fighting HIV infection.
Sustiva had originally received accelerated approval from the FDA in September 1998 to make it available to patients with AIDS. The drug is used to treat AIDS only when taken with other anti-HIV medications that the patient has not received before. Taking Sustiva alone could make the AIDS virus become resistant to the drug. Sustiva is taken as three capsules once a day, and can be used by both adults and children over age 3 who have HIV infection.
Sustiva: Clinical Study Results
When taken with other anti-HIV drugs, Sustiva has been shown to reduce the amount of HIV in the blood (so-called viral load) and increase the number of a type of immune system cell called CD4. Two clinical studies have shown that patients who take Sustiva in combination with two other “antiretroviral” drugs (such as zidovudine, lamivudine, or nelfinavir) experienced a greater reduction in their viral load and that the treatment lasted longer than drug combinations that did not include Sustiva. One study demonstrated this response to treatment for up to 110 weeks so far, and the study is continuing.
“It is not only important for HIV medications to bring the level of virus in the blood down to below detectable levels, but maintain it this way for as long as possible,” said Dr. Cal Cohen, Director, Community Research Initiative of New England. “The long-term data on Sustiva used by the FDA clearly show that this drug, in combination with others, can be successful in achieving this goal.”
What You Should Know
The most common side effects reported by patients taking Sustiva are dizziness, insomnia, impaired concentration, drowsiness, abnormal dreaming, and mild to moderate rash. These symptoms occur early in treatment and generally resolve in two to four weeks. The incidence and frequency of severe rash are higher in children than adults. Patients experiencing drowsiness or similar nervous-system symptoms are advised to avoid driving or operating heavy machinery. Because Sustiva has been associated with birth defects in animal studies, it should not be taken by pregnant women.