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FDA Approves Once-daily Fosamprenavir (Lexiva) Boosted with a Once-daily Lower Dose (100 mg) of Ritonavir

The U.S. Food and Drug Administration (FDA) has approved the use of GlaxoSmithKline's protease inhibitor (PI) fosamprenavir (Lexiva) boosted with a lower dose of ritonavir (100 mg) than previously recommended (200 mg) for treatment-naive patients.

Based on data from a study of fosamprenavir in healthy HIV negative volunteers (published in the February 2007 issue of Antimicrobial Agents and Chemotherapy), the FDA now recommends 1400 mg once-daily fosamprenavir with 100 mg once-daily ritonavir as one of several dosing options for use of the 2 drugs in combination with other antiretrovirals for treatment-naive adult HIV patients. The data from this study also showed that use of the lower 100 mg ritonavir boosting dose was associated with fewer adverse events, according to GlaxoSmithKline.

Following are the current FDA-approved dosing options for use of Lexiva in HIV patients:

In treatment-naive adults:

• Fosamprenavir 1400 mg twice daily (without ritonavir boosting)

• Fosamprenavir 1400 mg once daily plus ritonavir 100 mg once daily [new dosing option recently approved by FDA]

• Fosamprenavir 1400 mg once daily plus ritonavir 200 mg once daily

• Fosamprenavir 700 mg twice daily plus ritonavir 100 mg twice daily

In protease inhibitor-experienced adults:

• Fosamprenavir 700mg twice daily plus 100mg ritonavir twice daily.

"GlaxoSmithKline remains committed to improving patient care by making dosing options more convenient," said Mark Shaefer, PharmD, Director, Clinical Development at GlaxoSmithKline. "We understand that reducing the number of pills taken daily is an important consideration for patients starting HIV treatment."

Fosamprenavir Indication Statement and Background

Fosamprenavir is indicated for the treatment of HIV infection in combination with other antiretroviral medications. The following points should be considered when initiating therapy with ritonavir-boosted fosamprenavir plus ritonavir in PI-experienced patients:

• The PI-experienced patient study was not large enough to reach a definitive conclusion that boosted fosamprenavir and lopinavir/ritonavir (Kaletra) are clinically equivalent.

• Once-daily administration of Lexiva plus ritonavir is not recommended for PI-experienced patients.

Lexiva was initially approved by the FDA in 2003. It is the first PI to offer flexible dosing options for PI-naive patients, with no food or water restrictions.

10/16/07

Source
GlaxoSmithKline. FDA Approves Administration of LEXIVA with Lower Dose of "Boosting" Medication Ritonavir. Press Release. October 12, 2007.