Site Map

Search

Important Safety
Information

Drug Interactions

Prescribing Information

Patient Education

Resources

Home

LEXIVA: Resistance Profile

ART-naive patients

LEXIVA/r, QD — no primary or secondary protease mutations¹ through 48 Weeks

APV30002 (SOLO) a randomized, open-label study of LEXIVA/r (1400/200 mg) QD vs NFV (1250 mg) BID in combination with ABC/3TC BID in 649 ART-naive patients.

Because the potential for HIV cross-resistance among protease inhibitors has not been fully explored, it is unknown what effect therapy with LEXIVA will have on the activity of subsequently administered protease inhibitors.

Clinical relevance of resistance data is currently being evaluated.

* Excludes patients without paired genotypes at baseline and at the time that virologic failure was first detected.

^† Common natural polymorphisms in the absence of other PRO mutations are excluded: NFV n = 3 [M36 m/l, K20k/m, L10l], LEXIVA/r n = 1 [V77v/i].

•

LEXIVA/r provides a high genetic barrier to the development of resistance at 48 weeks

º	No PRO mutations
º	Very low incidence of RT mutations — no K65R mutations

LEXIVA, BID — limited cross-resistance¹ through 48 Weeks

APV30001 (NEAT) a randomized, open-label study of LEXIVA (1400 mg) BID vs NFV (1250 mg) BID in combination with ABC/3TC BID in 249 ART-naive patients.

^‡	Excludes patients without paired genotypes at baseline and at the time that virologic failure was first detected.
^§	Common natural polymorphisms in the absence of other PRO mutations are excluded: LEXIVA n = 1 [A71a/t].

•	No significant difference in incidence of PRO or RT mutations for LEXIVA vs NFV
•	At the time of first treatment failure, PRO mutations I54L/M or V32I + I47V were selected by LEXIVA. These mutations result in limited cross-resistance to other PIs

PI-experienced patients

LEXIVA/r, BID

• The following amprenavir resistance-associated mutations were selected either alone or in combination: V32I, M46I/L, I47V, I50V, I54L/M, and I84V

• Varying degrees of cross-resistance among HIV-1 protease inhibitors have been observed

Resistance

• Because the potential for HIV cross-resistance among protease inhibitors has not been fully explored, it is unknown what effect therapy with LEXIVA will have on the activity of subsequently administered protease inhibitors.

• Clinical relevance of resistance data is unknown.

Reference: 1. Data on file, GlaxoSmithKline.