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The CONTEXT Study

CONTEXT enrolled 315 PI-experienced patients with prior virologic failure. The study compared Lexiva with ritonavir to the PI lopinavir/ritonavir (LPV/r). The PIs were given in combination with two NRTIs. The following points should be considered when initiating therapy with 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.

• 58 percent of patients receiving Lexiva/r BID achieved undetectable viral load (<400 copies/mL) compared to 61 percent of patients taking LPV/r BID.
• 46 percent of patients taking Lexiva/r BID achieved viral loads below 50 copies/mL compared to 50 percent taking LPV/r BID.
• The overall incidence of drug-related adverse events of at least moderate severity was comparable between patients receiving Lexiva/r BID and LPV/r BID.
• The most common adverse events were diarrhea, nausea, vomiting, headache and rash.

Lexiva is contraindicated in patients with previously demonstrated clinically significant hypersensitivity to any of the components of this product or to amprenavir. New onset or exacerbations of diabetes mellitus and hyperglycemia, and spontaneous bleeding in hemophiliacs have been reported with protease inhibitors. Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have been observed in patients receiving antiretroviral therapy. The causal relationship, mechanism, and long-term consequences of these events are currently unknown. Lexiva is contraindicated with ergot d
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