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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 is taken three times a day with meals (or up to two hours after a meal). 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. Call 800-282-7780 for details.
A large US 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.
On the Web, see www.fortovase.com
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