New Phase 3 Study Published in The Lancet Evaluates Efficacy and Safety of PREZISTA/ritonavir vs. Kaletra As Part of HIV Combination Therapy in Treatment-Experienced Adults with HIV
Results from the primary analysis of a randomized, controlled, open-label, Phase 3 study showed that 77 percent of treatment experienced HIV-1 infected adults taking PREZISTATM (darunavir) 600 mg tablets with 100 mg ritonavir (PREZISTA/r) twice daily, plus an optimized background regimen (OBR) of antiretroviral agents (ARV), reached a plasma viral load of 400 copies/mL at week 48, compared to 68 percent of patients taking Kaletra®1 (lopinavir/ritonavir) 400 mg/100 mg twice daily, plus OBR in a per-protocol analysis. The mean difference in response was nine percent and was statistically significant (95 percent confidence interval 2-16).
The 48-week efficacy and safety results, published in the July 7, 2007 issue of The Lancet, will also be presented at the 4th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2007) in Sydney, Australia on July 24, 2007.
The Phase 3 study, known as TITAN, (TMC114/r In Treatment-experienced pAtients Naïve to lopinavir/ritonavir), compared the efficacy and safety of PREZISTA/r with the protease inhibitor (PI) lopinavir/r in treatment-experienced adult patients who were lopinavir/r-naïve. The primary endpoint of this study was non-inferiority (95% CI lower limit for the difference in treatment response −12% or greater) for HIV RNA of less than 400 copies per mL in plasma at week 48 (per-protocol analysis).
“This is exciting new information that adds to the body of knowledge on PREZISTA in a much broader group of treatment-experienced patients,” said Daniel Berger, MD, Medical Director of NorthStar Healthcare and Clinical Assistant Professor of Medicine at the University of Illinois, Chicago.
The 48-week primary analysis from the TITAN study provides additional information regarding efficacy and safety of PREZISTA/r in combination with other ARV agents for the treatment of HIV infection in treatment-experienced adult patients. The use of PREZISTA/r therapy in this broader range of treatment-experienced patients has not been approved by the FDA. These results will be submitted to the FDA as part of the post-marketing commitment to support the traditional approval of 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-naïve 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 and 96-week data from POWER 1, 2, and 3 will be required before the FDA can consider traditional approval for PREZISTA.
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