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Long-Term Study Evaluates Boosted PREZISTA(R) Vs. Lopinavir/Ritonavir as Part of HIV Combination Therapy in Treatment-Naive Adults
Date:10/26/2008

phase 3 trial that compares the efficacy and safety of PREZISTA/r with lopinavir/r in treatment-naive HIV-1-infected adult patients with viral load greater than 5,000 copies/mL. Patients were randomized to receive PREZISTA/r 800 mg/100 mg once daily or, based on approved dosing in each country, either lopinavir/r 800 mg/200 mg once daily or 400 mg/100 mg twice daily (n=346), plus a fixed-dose background regimen of tenofovir and emtricitabine once daily. Patient randomization was stratified based on viral load and CD4+ cell count.

The main objective of the study was to demonstrate non-inferiority of PREZISTA/r versus lopinavir/r in proportion of patients achieving virologic response, defined as confirmed HIV RNA <50 copies/mL. Non-inferiority of PREZISTA/r vs. lopinavir/r was defined as a maximum allowable difference of 12 percent for virologic response, with a one-sided significance level of alpha equals to 0.025 and 90 percent power.

Important Safety Information

PREZISTA does not cure HIV infection or AIDS, and does not prevent passing HIV to others.

Coadministration of PREZISTA/r is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events (e.g., dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, pimozide, oral midazolam, triazolam, lovastatin, or simvastatin).

Coadministration of PREZISTA/r is also contraindicated with rifampin and products containing St. John's wort (Hypericum perforatum) because this may cause significant decrease in plasma concentration of darunavir, resulting in loss of therapeutic effect and development of resistance.

Coadministration is not recommended with indinavir, lopinavir/ritonavir, saquinavir, and pravastatin.

Caution should be used when prescribing agents such as sildenafil, vardenafil, tadalafil, or other substrates, inhibitors, or inducers o
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SOURCE Tibotec Therapeutics
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