February 11, 2009
Bridgewater, NJ -- Tibotec Therapeutics, a division of Centocor Ortho Biotech Products, L.P., today announced the availability of a lower-dose (75 mg) formulation of PREZISTA® (darunavir) for pediatric patients with HIV. The announcement follows the FDA approval of PREZISTA, co-administered with ritonavir (PREZISTA/r) and with other antiretroviral agents, for the treatment of HIV infection in pediatric patients six years of age and older, granted December 18, 2008. PREZISTA was developed by Tibotec Pharmaceuticals, Ltd. and is marketed in the U.S. by Tibotec Therapeutics.
According to the most recent reports from the Centers for Disease Control (CDC), there were 2,587 children under 13 years of age living with HIV and 1,116 children under 13 years of age living with AIDS in the U.S. at the end of 2006. The CDC estimates that 56,500 young people between the ages of 13 and 24 years were living with HIV in 2006.
"The HIV epidemic continues to affect thousands of children in the U.S., and these patients have fewer treatment options than adults," said Ram Yogev, M.D., Director of Pediatric, Adolescent and Maternal HIV Infection at Children's Memorial Hospital in Chicago. "The availability of PREZISTA in a formulation designed especially for children over the age of six provides an important new option for these patients."
The pediatric indication for PREZISTA is based on 24-week analyses of pharmacokinetics, safety, tolerability and antiviral activity from DELPHI (TMC114-C212), an open-label Phase 2 trial in which antiretroviral treatment-experienced HIV-1 infected pediatric patients (6 to <18 years of age and weighing at least 44 lbs [20 kg]) received twice-daily PREZISTA/r in combination with other antiretroviral agents.
The following points should be considered when initiating therapy with PREZISTA/r in treatment-experienced pediatric patients:
For pediatric patients (6 to <18 years of age and weighing at least 44 lbs [20 kg]), the dosage of PREZISTA/r is based on body weight and should not exceed the recommended treatment-experienced adult dose. PREZISTA tablets should be taken with ritonavir twice daily and with food.
Specific pediatric dosing is based on weight as follows:
Before prescribing PREZISTA, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow a tablet, the use of PREZISTA tablets may not be appropriate. Do not use PREZISTA once daily dosing in pediatric patients. The safety and efficacy of PREZISTA/r in pediatric patients ages 3 to <6 have not been established. Do not use PREZISTA/r in pediatric patients below 3 years of age.
Tibotec will also be introducing PREZISTA 150 mg tablets for pediatric patients, and expects these tablets to be available in the next several months.
DELPHI (TMC114-C212) is an open-label, Phase 2 trial evaluating the pharmacokinetics, safety, tolerability, and efficacy of PREZISTA/r in combination with other antiretrovirals in 80 antiretroviral treatment-experienced HIV-1-infected pediatric subjects 6 to <18 years of age and weighing at least 44 lbs (20 kg). Virologic response rate was evaluated at week 24.
Virologic response was defined as a decrease in plasma HIV-1 RNA viral load of at least 1 log10 versus baseline. The mean baseline plasma HIV-1 RNA was 4.64 log10 copies/mL, and the median baseline CD4+ cell count was 330 cells/mm3 (range: 6 to 1505 cells/mm3). Most pediatric subjects (79 percent) had previous use of at least one NNRTI and 96 percent of pediatric subjects had previously used at least one protease inhibitor PI.
Pediatric subjects who were at risk of discontinuing therapy due to intolerance of the ritonavir oral solution (e.g., taste aversion) were allowed to switch to the capsule formulation. Of the 44 pediatric subjects taking ritonavir oral solution, 23 subjects switched to the 100 mg capsule formulation and exceeded the weight-based ritonavir dose without changes in observed safety.
At week 24, 74 percent of subjects had at least 1 log10 HIV-1 RNA decrease from baseline. The proportion of pediatric subjects reaching undetectable viral load (<50 HIV-1 RNA copies/mL) was 50 percent, and the proportion of pediatric subjects with <400 HIV-1 RNA copies/mL was 64 percent. The mean change in plasma HIV-1 RNA from baseline was -1.98 log10 copies/mL. The mean CD4+ cell count increase from baseline was 117 cells/mm3.
PREZISTA does not cure HIV infection or AIDS, and does not prevent passing HIV to others.
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.
This is not a complete list of all adverse drug reactions reported with the use of PREZISTA/r.
Please see full Prescribing Information for more details. Full prescribing information is also available at www.PREZISTA.com.
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