BRIDGEWATER, N.J., Jan. 27 /PRNewswire/ -- Tibotec Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has approved a labeling update for PREZISTA® (darunavir) tablets to include 96-week data from the ARTEMIS and TITAN studies. Both ARTEMIS and TITAN evaluated the efficacy and safety of PREZISTA with ritonavir ® vs. lopinavir/r in combination with other antiretrovirals (ARVs) for the treatment of human immunodeficiency virus (HIV-1) in treatment-naive and treatment-experienced adult patients, respectively.
Based on the ARTEMIS results, the United States Department of Health & Human Services (DHHS) Guidelines for HIV recommended once daily PREZISTA/r, in combination with tenofovir/emtricitabine, as one of two preferred protease inhibitors (PIs) for patients starting therapy for the first time, in a December 2009 guidelines update.
"The addition of this information to the PREZISTA label demonstrates our commitment to providing information on the durability and safety profile of our medications over the long-term. In addition, Tibotec continues to invest in its long-standing research and development efforts to bring new options to people living with HIV," said Glenn Mattes, President of Tibotec Therapeutics.
PREZISTA was developed by Tibotec Pharmaceuticals and is marketed in the U.S. by Tibotec Therapeutics, a division of Centocor Ortho Biotech Products, L.P. PREZISTA, co-administered with ritonavir (PREZISTA/r), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adults.
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-naive 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:
ARTEMIS 96-Week Study Results
The ARTEMIS study compared the efficacy and safety of PREZISTA/r 800/100 mg once daily (n=343) versus lopinavir/r 800/200 mg total daily dose (n=346) in treatment-naive adults with HIV-1. All patients received a fixed-dose combination of tenofovir and emtricitabine once daily. At 96 weeks, PREZISTA was shown to be non-inferior to lopinavir/r. The study showed that:
Additional Information About the ARTEMIS Study
ARTEMIS (AntiRetroviral Therapy with TMC114 ExaMined In naive Subjects) is an international, randomized, controlled, open-label, non-inferiority, phase 3 trial that compared the efficacy and safety of PREZISTA/r versus lopinavir/r in treatment-naive HIV-1-infected adult patients with viral load greater than 5,000 copies/mL.
The main objective of the study was to demonstrate non-inferiority of PREZISTA/r versus lopinavir/r in proportion of patients achieving virologic response, defined as confirmed HIV RNA <50 copies/mL. Non-inferiority of PREZISTA/r vs. lopinavir/r was defined as a maximum allowable difference of 12 percent for virologic response, with a one-sided significance level of alpha equals to 0.025.
TITAN 96-Week Study Results
The TITAN study compared the efficacy and safety of PREZISTA/r 600 mg with 100 mg ritonavir ® twice daily versus lopinavir/r 400 mg/100 mg twice daily, each with an optimized background regimen (OBR) of at least two antiretrovirals (NRTIs with or without NNRTIs), in lopinavir/r-naive, treatment-experienced adults with HIV-1 infection. At 96 weeks, PREZISTA/r 600/100mg twice daily (n=298) was shown to be non-inferior to lopinavir/r 400/100mg twice daily (n=297) in achieving viral load <400 copies/mL. The study showed that:
Additional Information About the TITAN Study
TITAN (TMC114/r In Treatment Experienced patients Naive to lopinavir/ritonavir) is a Phase 3, 96-week, randomized, controlled, open-label study. All patients had an HIV viral load greater than or equal to 1,000 copies/mL at screening.
The main objective of the study was to demonstrate non-inferiority of PREZISTA/r versus lopinavir/r in proportion of patients achieving virologic response, defined as confirmed HIV RNA <400 copies/mL. Non-inferiority of PREZISTA/r vs. lopinavir/r was defined as a maximum allowable difference of 12 percent for virologic response, with a one-sided significance level of alpha equals to 0.025.
Important Safety Information
PREZISTA does not cure HIV infection or AIDS, and does not prevent passing HIV to others.
Warnings & Precautions
Post-marketing cases of liver injury, including some fatalities, have been reported. A causal relationship with PREZISTA/r therapy has not been established
Appropriate laboratory testing should be conducted prior to initiating therapy with PREZISTA/r and patients should be monitored during treatment. Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pretreatment elevations of transaminases, especially during the first several months of PREZISTA/r treatment. Evidence of new or worsening liver dysfunction (including clinically significant elevation of liver enzymes and/or symptoms such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly) in patients on PREZISTA/r should prompt consideration of interruption or discontinuation of treatment
Use in Specific Populations
This is not a complete list of all adverse drug reactions reported with the use of PREZISTA/r.
Please see accompanying full Prescribing Information for more details. Full prescribing information is also available at www.PREZISTA.com.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
About Tibotec Therapeutics
Tibotec Therapeutics, a division of Centocor Ortho Biotech Products, L.P., headquartered in Bridgewater, N.J., is dedicated to delivering innovative virology therapeutics that help healthcare professionals address serious unmet needs in people living with HIV.