Rescriptor Tablets (delavirdine mesylate tablets)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
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.