Atazanavir for children approved in European Union

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The protease inhibitor atazanavir (Reyataz) has been approved for use in children and adolescents aged 6 to 18 in the European Union, manufacturer Bristol Myers-Squibb announced this week.

Atazanavir was approved for paediatric use on the basis of data from the Pediatric AIDS Clinical Trial Group (PACTG) 1020A study, which tested the safety, efficacy and pharmacokinetics of atazanavir in children and adolescents.

Atazanavir is already approved for adult use, and has been approved for paediatric use in the United States since March 2008.

Glossary

paediatric

Of or relating to children.

pharmacokinetics (PK)

How drugs are processed and used in the body, including how they are absorbed, metabolised, distributed and eliminated.

European Medicines Agency (EMA)

Regulatory agency that evaluates medicines for safety and efficacy in Europe, performing a similar role to the Food and Drug Administration (FDA) in the United States. The EMA recommends to the European Commission that a medicine can be marketed in the European Union and European Economic Area.

bilirubin

A substance produced during the normal breakdown of red blood cells. Bilirubin passes through the liver and is excreted in faeces. Elevated levels of bilirubin (jaundice) may indicate liver damage or disease.

jaundice

A yellowing of the skin and whites of the eyes associated with liver or gall bladder problems.

European approval will offer another option for treatment of children and adolescents, said Dr Gareth Tudor-Williams of St Mary’s Hospital, London, one of the leading HIV treatment centres for children in Europe.

“The vast majority of children infected around the time of birth are surviving into adulthood,” he said. Newer drugs are needed for children who may have experienced the failure of earlier treatment regimens.

However, no benefit is expected in patients with strains resistant to multiple protease inhibitors (≥ 4 protease resistance mutations). The European Medicines Agency, which approved the drug, also notes that available data do suggest that atazanavir in combination with ritonavir may not be effective in treatment-experienced children with very few (<3) PI mutations.

The most common laboratory abnormality was elevation of total bilirubin (defined as ≥ 2.6 times ULN, Grade 3-4) which occurred in 45% of patients. Elevated bilirubin can lead to jaundice, but has no serious effect.

Atazanavir capsules are taken once a day with a small boosting dose of ritonavir, and should be taken with other antiretroviral drugs. Recommended dosing in children is:

  • 15kg to less than 20kg: Reyataz 150mg + 100mg ritonavir
  • 20kg to less than 40kg: Reyataz 200mg + 100mg ritonavir
  • 40kg and over: Reyataz 300mg + 100mg ritonavir