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Prezista non-inferior to lopinavir for HIV


Results presented from a phase III, randomised, open-label, ongoing clinical trial showed that 79% of treatment-naive HIV-1 infected adults taking Prezista 800mg (two 400mg tablets) with 100mg ritonavir once daily reached an undetectable viral load (<50 copies/ml) at week 96, compared with 71% of patients taking lopinavir/ritonavir 800mg/200mg once daily (or 400mg/100mg twice daily), each with a fixed dose of emtricitabine and tenofovir disoproxil fumarate.

Results from the study, known as ARTEMIS, were presented on 28 October 2008 at the 48th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Washington, DC. ARTEMIS is a 192-week study comparing the efficacy and safety of the protease inhibitors Prezista and lopinavir in treatment-naive adults with HIV.

Prezista was developed by Tibotec Pharmaceuticals and is marketed in the US by Tibotec Therapeutics, a division of Ortho Biotech Products, LP.

At 48 weeks, the primary objective of ARTEMIS was reached when Prezista was demonstrated to be non-inferior to lopinavir for virologic response (confirmed HIV RNA <50 copies/ml). The difference between the treatment arms was not significant at week 48. The pre-planned safety and efficacy analysis at 96 weeks was a secondary endpoint. At 96 weeks, the study showed Prezista was non-inferior to lopinavir for virologic response. The estimated difference in virologic response between the treatment groups was 8% and was statistically significant (95% CI 1.8; 14.7). The 96-week results from ARTEMIS will be submitted to the FDA.

“This study offers the healthcare provider community long-term efficacy and safety data for Prezista in treatment-naive adult patients,” said Tony Mills, MD, ARTEMIS clinical investigator.

Prezista, co-administered with 100mg 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 III trials of 48 weeks duration in antiretroviral treatment-naive and treatment-experienced patients and two controlled phase II trials of 96 weeks duration in clinically advanced, treatment-experienced patients.

Tibotec Pharmaceuticals

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