The FDA has granted Prezista (darunavir) tablets, a protease inhibitor, approval for an expanded indication for once daily dosing as part of HIV combination therapy in treatment naïve adults (those who have never taken HIV medication before). The FDA also granted traditional (full) approval to Prezista as twice daily for use in treatment experienced adult patients. Prezista was developed by Tibotec Pharmaceuticals and is marketed in the US by Tibotec Therapeutics, a division of Ortho Biotech Products, LP.
In June 2006, Prezista received accelerated approval for use in combination with other antiretrovirals (ARVs) in treatment experienced adult patients, such as those with HIV1 that is resistant to more than one protease inhibitor. Following today's approval, Prezista, co-administered with 100 mg ritonavir (Prezista/r), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV1) 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 treatmentnaïve and treatment experienced patients and two controlled phase-2 trials of 96 weeks duration in clinically advanced, treatment experienced patients.
In treatment experienced patients, the following points should be considered when initiating therapy with Prezista/r: treatment history and, when available, genotypic or 2 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 pediatric patients. No clinical studies have demonstrated the effect of Prezista/r on clinical progression of HIV1. The traditional approval is based on 48week data from the Artemis and Titan phase-3 noninferiority studies and 96week safety and efficacy data from the phase-2b power studies. Both Artemis and Titan studied the efficacy and safety of Prezista/r vs. lopinavir/r in combination with other ARVs.
The Artemis study was conducted in treatment naïve HIV1infected adult patients with an HIV viral load greater than or equal to 5,000 copies/mL. Titan was conducted in lopinavir/rnaïve, treatment experienced adult patients and the power studies were conducted in clinically advanced, treatment experienced adult patients with a high level of protease inhibitor resistance. In the Titan and power studies, patients had evidence of ongoing HIV1 replication despite antiretroviral therapy. "Over the past two years, Prezista has made an important contribution to the care of treatment experienced adults with HIV. The medical community welcomes the news that Prezista is now available as an effective, once daily option as part of combination therapy for adults who have never taken HIV medications before," said Calvin J. Cohen, clinical investigator and Research Director at Community Research Initiative of New England and Harvard Vanguard Medical Associates.
"Tibotec is proud to reach this important milestone that makes Prezista available to those who are just starting HIV treatment for the first time," said Glenn Mattes, President of Tibotec Therapeutics. "We look forward to continuing to provide treatment options that will add to the arsenal of anti HIV therapies."