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New Phase 3 Study in Treatment-Naive Adults with HIV Evaluates Efficacy and Safety of Once-Daily PREZISTA(TM)/ritonavir vs. KALETRA(R) as Part of HIV Combination Therapy
Date:9/18/2007

ek primary analysis from ARTEMIS will be submitted to the FDA later this year as part of the post-marketing commitment for PREZISTA.

PREZISTA, co-administered with 100 mg ritonavir and with other antiretroviral agents, is currently indicated for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor.

This indication is based on week 24 analyses of plasma HIV RNA levels and CD4+ cell counts from two controlled trials of PREZISTA/r in combination with other antiretroviral drugs. Both studies were conducted in clinically advanced, treatment-experienced (NRTIs, NNRTIs, and PIs) adult patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.

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.

-- The risks and benefits of PREZISTA/r have not been established in

treatment-naive adult patients or pediatric patients.

PREZISTA received accelerated approval in June 2006 based on the 24-week analysis of HIV viral load and CD4+ cell counts from the pooled analysis of the TMC114-C213 (POWER 1) and TMC114-C202 (POWER 2) Phase 2b studies. As part of the post-marketing commitment, 48-week data from ongoing Phase 3 studies, including ARTEMIS, and 96-week data from POWER 1, 2, and 3 will be required before the FDA can consider traditional approval for PREZISTA.

About the ARTEMIS study

ARTEMIS is an international ongoing, randomized, open-label Phase 3 trial in which 689 treatment-naive adult patients were treated. The participants enrolled in the study had not previously received treatment w
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SOURCE Tibotec Therapeutics
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