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Data From Landmark Study Evaluating Gender Differences in Response to an HIV Therapy Published in Annals of Internal Medicine
Date:9/20/2010

ere nausea (5.2 percent for women and 2.8 percent for men), diarrhea (4.5 percent for women and 4.9 percent for men) and rash (2.1 percent for women and 2.8 percent for men).

Additional analyses were conducted as part of the GRACE study, including a sub-study examining efficacy and safety differences in response to race, as well as an immunology sub-study.

PREZISTA Indication: AdultsPREZISTA, co-administered with ritonavir (PREZISTA/r), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection.

This indication is based on analyses of plasma HIV RNA levels and CD4+ cell counts from two controlled Phase 3 trials of 48 weeks duration in antiretroviral treatment-naïve and treatment-experienced patients, and two controlled Phase 2 trials of 96 weeks duration in clinically advanced, treatment-experienced adult patients.

In treatment-experienced adult patients, the following points should be considered when initiating therapy with PREZISTA/r:

  • Treatment history and, when available, genotypic or phenotypic testing should guide the use of PREZISTA/r.
  • The use of other active agents with PREZISTA/r is associated with a greater likelihood of treatment response.

  • Important Safety Information PREZISTA does not cure HIV infection or AIDS, and does not prevent passing HIV to others.

    Drug Interactions

  • 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 (eg, alfuzosin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, pimozide, oral midazolam, triazolam, lovastatin, simvastatin, or sildenafil for the treatment of pulmonary arterial hypertension)
  • Coadministration of PREZISTA/r is also contraindicated with rifampin and products containing St. Joh
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  • SOURCE Tibotec Therapeutics
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