FDA Approves Videx EC and Trizivir
November 27, 2000
A new formulation of the nucleoside reverse transcriptase inhibitor (NRTI) Videx was recently approved by the U.S. Food and Drug Administration (FDA). Videx EC is a new formulation of the anti-HIV medication ddI, (also known as didanosine and Videx) currently owned by Bristol-Myers Squibb, and originally approved in 1991. The new capsules have the same active ingredient as the old Videx, but the drug is now made in an enteric coated capsule, rather than an antacid buffered tablet. This means that Videx EC can now be taken at the same time as other medications. Like the old formulation of Videx, however, Videx EC capsules must still be taken on an empty stomach (one hour before, or two hours after a meal).
Videx EC was also approved for once-daily dosing based on a study which showed that its anti-HIV effectiveness was comparable to the standard twice-daily dose of Videx tablets. The dosing for Videx EC is one 400-mg capsule taken once-daily (every 24 hours). Smaller doses are available for people under 60 kg (132 lbs) or those with certain kidney problems. Videx EC is in pharmacies now.
Glaxo Wellcome has also received approval to market their new formulation of existing anti-HIV drugs known as Trizivir. Trizivir is a combination of three NRTIs. Each Trizivir capsule contains 150 mg of Epivir, (3TC, lamivudine) 300 mg of Ziagen (abacavir) and 300 mg of Retrovir (AZT). One tablet is taken twice-daily with or without food. Trizivir can be used alone, or with other anti-HIV medications.
It is important to note that Trizivir may be less effective in people with resistance to any of the three NRTI components. The fact that Ziagen is a component of Trizivir is also critical. The risk of the hypersensitivity reaction to Ziagen (which is rare, but serious) exists with Trizivir, and anyone who has previously experienced an abacavir (Ziagen) hypersensitivity reaction should not use Trizivir.
Trizivir is only available at one dose and can therefore, not be taken by people who would require dose adjustment, including those under 40 kg (88 lbs) or with impaired kidney function. Trizivir is expected to be available from pharmacies in early December 2000.
For more information about Videx EC, Trizivir, or the Ziagen hypersensitivity reaction, call the STEP TalkLine at (877) 597-STEP.
This article was provided by Seattle Treatment Education Project. It is a part of the publication STEP Ezine.