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Darunavir Now Available for Pediatric Patients as Part of HIV Combination Therapy

BRIDGEWATER, N.J., Feb. 11 /PRNewswire/ -- 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."

In October 2008, PREZISTA received traditional (full) approval for treatment-naive and treatment-experienced adult patients as part of combination therapy.

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 The following points should be considered when initiating therapy with PREZISTA/r in treatment-experienced pediatric patients:

  • 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.

Pediatric Dosing Information
For pediatric patients (6 to Specific pediatric dosing is based on weight as follows:

  • At least 44 lbs to less than 66 lbs: 375 mg PREZISTA/50 mg ritonavir twice daily
  • At least 66 lbs to less than 88 lbs: 450 mg PREZISTA/60 mg ritonavir twice daily
  • 88 lbs or more: 600 mg PREZISTA/100 mg ritonavir twice daily

Source: Tibotec Therapeutics

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