FORTOVASE (tm) Approved: New Saquinavir Formulation

On November 7 the FDA approved FORTOVASE, the new "soft gel" formulation of saquinavir, for treating HIV infection in adults, in combination with other antiretrovirals. The new formulation delivers much more of the drug to the blood than the older version, INVIRASE® (saquinavir mesylate). The main problem with INVIRASE has been that the amount provided by the approved dose is too low.

FORTOVASE, which is taken three times a day with meals (or up to two hours after a meal), should be on pharmacy shelves within a week. The old saquinavir (INVIRASE) will remain in pharmacies for six months; after that, it will still be available on a limited basis to patients who want to continue using it, through a special distribution program.

FORTOVASE has been priced to cost the same as INVIRASE, with a wholesale acquisition cost of approximately $5,700 per year. Developer Hoffmann-La Roche has a patient assistance program, for persons unable to pay for the drug. This program can also help patients who want to convert to FORTOVASE before their health plan approves it for reimbursement.

A safety study with 442 patients who received FORTOVASE in the approved dose, for a median of 52 weeks, found that the main side effects were diarrhea, nausea, and abdominal discomfort. Eight percent of patients had to discontinue the drug due to side effects, mainly gastrointestinal; fewer than one percent discontinued because of laboratory toxicities.

A large U.S. FORTOVASE trial now recruiting is comparing FORTOVASE in a three times a day vs. a twice a day dosing schedule (combined with other antiretrovirals), vs. FORTOVASE plus VIRACEPT plus a new reverse transcriptase inhibitor. This may be an attractive trial since everyone will receive a credible treatment; there is no "loser" arm which must do worse for the study to fulfill its purpose. For more information about this trial, call 800-TRIALS-A.

Hoffmann-La Roche has established the following sources for information about FORTOVASE:

* Healthcare professionals, call 800-526-6367.

* Patients (outside of the Washington D.C. area), call 800-910-4687.

* Patients in the Washington D.C. area, call 202-442-2437.

* For the Roche HIV Therapy Assistance Program, call 800-282-7780.

Or on the Web, see http://www.fortovase.com.