NEW YORK -- June 24, 2008 -- The US Food and Drug Administration (FDA) has approved tipranavir capsules/oral solution (Aptivus) with dosing information for treatment-experienced paediatric patients aged 2 to 18 years infected with HIV-1.
The oral solution formulation, which is a new dosage form of tipranavir, was also approved for treatment-experienced adults. The oral solution formulation will be available in the United States beginning in mid-September.
"An unmet need remains for paediatric indications and new formulations of antiretroviral therapies. This approval is an important development for treatment-experienced children and teenagers who may have limited therapeutic options," said Juan Salazar, MD, Department of Pediatrics, Division of Pediatric Infectious Diseases, University of Connecticut, Farmington, Connecticut; Pediatric and Youth HIV Program, Connecticut Children's Medical Center, Hartford, Connecticut.
This indication is based on the results of a controlled study that included a total of 135 HIV-1 infected, treatment-experienced (with the exception of 3 treatment-naïve patients) paediatric patients aged 2 to 18 years, with baseline HIV-1 RNA of at least 1,500 copies/mL, receiving combination therapy. Of the 135 patients, 110 were enrolled in a randomised, open-label, 48-week clinical trial. The remaining 25 patients were enrolled in other clinical studies.
All patients initially received the tipranavir oral solution. Patients aged 12 or older who received the maximum dose of 500/200 mg BID could subsequently change to capsules at day 28. At 48 weeks, 40% of patients had a viral load of less than 400 copies/mL. The proportion of patients with viral load less than 400 copies/mL tended to be greater (70%) in the youngest group of patients, who had less viral resistance at baseline.
The most frequent adverse reactions in paediatric patients were fever, vomiting, cough, rash, nausea, and diarrhoea. Rash was reported more frequently in paediatric patients than in adults. The most frequent treatment-emergent laboratory abnormalities were increases in creatine kinase (CPK), alanine aminotransferase (ALT), and amylase.
Patients taking tipranavir oral solution should be advised not to take supplemental vitamin E greater than a standard multivitamin as the oral solution contains 116 IU/mL of vitamin E which is higher than the Reference Daily Intake (adults 30 IU, paediatrics approximately 10 IU).
Based on the results, the recommended paediatric dose for both capsules and oral solution is 14 mg/kg with 6 mg/kg ritonavir, or 375 mg/m2 co-administered with ritonavir 150 mg/m2 BID. Prescribers should calculate the appropriate dose for each individual child based on body weight (kg) or body surface area (BSA, m2) and should not exceed the recommended adult dose of 500 mg co-administered with ritonavir 200 mg BID.
SOURCE: Boehringer-Ingelheim
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