Children

In 2008, the US, the Food and Drug Administration (FDA) issued revised dosing recommendations for the use of the atazanavir (Reyataz) in children, to allow its use in children 6 years of age and older.

Atazanavir (ATV) dosing in children up to age 18 is based upon body weight, but should never exceed the adult recommended dose. ATV with ritonavir-boosting (ATV/r) can be used in all children 6 to 18 years, regardless of ARV experience.
 
Atazanavir should always be taken with food. Weight-based dosing can be found at the Bristol-Myers Squibb website online at http://packageinserts.bms.com/pi/pi_reyataz.pdf or at the website of the National Institutes of Health (NIH), aidsinfo.nih.gov, accessed 28 october 2008.
 
In the US, if a treatment-naive patient aged 13 years and older and weighing at least 39 kilos cannot tolerated ritonavir, the recommended dose is ATV 400mg once daily with food.
 
The use of atazanavir is not recommended in children younger than 6 years; without ritonavir in children from 6 to 12 years, or for any child whose weight is less than 25 kilos.
 
Additionally, based on results from the ACTG 5175, unboosted atazanavir should not be used in a regimen for treatment-naive patients with enteric-coated didanosine (ddI) and emtricitabine (FTC).[1]
 
In clinical trial P1020A discovered that to achieve pharmacokinetic targets in children between the ages of 6 and 13 years when using unboosted atazanavir required dosing at 520mg/per meter2 of body surface, never to exceed 400mg.[2]
 
Atazanavir cannot be used in infants because of the risk of kernicterus, a type of brain damage caused by excess levels of bilirubin. 
 
The safety profile of atazanavir in children is similar to adults. The most commonly observed moderate to severe side effects are cough (21%), fever (19%), jaundice (13%), diarrhoea (8%), vomiting (8%), headache (7%), and runny nose (6%). Increased levels of bilirubin were found in the blood of 49% of patients. In the P1020A study, 8.5% of patients had a bilirubin level more than 5 times the upper limit of normal.[3] 
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