Approval Date: 10/20/03

Indications And Usage: Lexiva is a prodrug of Agenerase (generic name, amprenavir - see HIV ReSource Review Issue 21) used to treat HIV infection. It is a member of the protease inhibitor (PI) class of anti-HIV drugs. Lexiva was co-discovered by GSK and Vertex Pharmaceuticals.

Agenerase wasn't particularly popular mainly because it meant taking eight large pills twice a day. The new version comes in a two-pill-a-day form. To get the full effect, each 700 mg Lexiva tablet may be taken with a 100 mg Norvir (generic name, ritonavir) capsule. Aside from the Norvir, which lets Lexiva stay in the body longer, Lexiva is meant to be part of a multidrug anti-HIV regimen. In clinical trials, the drug was given in combination with two other HIV drugs, Ziagen and Epivir.

The following points should be considered when initiating therapy with Lexiva/ritonavir (Lexiva/r) in PI-experienced patients: the PI-experienced patient study was not large enough to reach a definitive conclusion that Lexiva/r and lopinavir/ ritonavir are clinically equivalent. Once-daily administration of Lexiva plus ritonavir is not recommended for PI-experienced patients.

Dosage And Administration: Lexiva is a PI that can be taken once or twice daily without food or water restrictions and has been evaluated in clinical trials with both PI-experienced and antiretroviral therapy (ART)-naïve HIV patients.

Lexiva offers the three dosing options below. 

• Two 700 mg Lexiva tablets twice daily (BID)

• Two 700 mg Lexiva tablets once daily (QD) in combination with two 100 mg capsules of ritonavir QD (Lexiva/r QD)

• One 700 mg Lexiva tablet BID in combination with one 100 mg capsule of ritonavir BID (Lexiva/r BID)