Rescriptor Tablets (delavirdine mesylate tablets)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved April 1997

Specific Treatments:

HIV infection

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General Information

Rescriptor Tablets have been approved for the treatment of HIV-1 infection, the virus that causes AIDS. Rescriptor is indicated for use in combination with appropriate anti-HIV medications to treat patients with HIV infection when treatment is warranted. FDA clearance is being given under the provisions of accelerated approval regulations.

Rescriptor is in a drug class called non-nucleoside reverse transcriptase inhibitor (NNRTI). It can be used to treat HIV-infected patients, including newly infected asymptomatic patients as well as those patients who have AIDS.

The recommended dosage for Rescriptor is 400 mg, taken three times daily. The tablets are 100 mg each and can be dispersed in water to make consumption easier. Rescriptor should always be administered in combination with appropriate anti-HIV medications, because resistant virus appear rapidly when Rescriptor is administered as monotherapy. Rescriptor can be taken with or without food.

Rescriptor will sell at a Wholesale Acquisition Cost of $6.16 per day or $2,250 annually at the recommended dose of 400 mg three times per day.

Clinical Results

Rescriptor was studied in combination with several nucleoside reverse transcriptase inhibitors (anti-HIV medicines) in more than 2,400 patients in clinical trials that began in April of 1994. Patients treated with the combination of Rescriptor plus zidovudine (AZT) showed a significantly greater reduction in the amount of virus in the blood for one year when compared with patients treated with AZT alone. Clinical benefit has not been demonstrated based on survival or incidence of AIDS-related illnesses. In a completed trial comparing the combination of Rescriptor plus didanosine (ddl) versus ddl monotherapy, clinical benefit was not demonstrated for Rescriptor based on survival or incidence of AIDS-defining clinical events.

Side Effects

Rescriptor has also been shown to be well-tolerated. In phase II and III controlled trials, the main side effect attributable to Rescriptor was a skin rash, which was seen in 18 percent of patients given the recommended dose. In most cases, the rash disappeared within 3-14 days without dosage reduction or interruption of treatment. In two pivotal trials, 4.3 percent of patients treated with the recommended dose of Rescriptor discontinued treatment due to skin rash.