Children

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

Atazanavir dosing in children up to age 18 is based upon body weight, but should never exceed the adult recommended dose. Atazanavir with ritonavir-boosting 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), http://aidsinfo.nih.gov.

In the US, if a treatment-naive patient aged 13 years and older and weighing at least 39 kilos cannot tolerate ritonavir, the recommended dose is atazanavir 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 it was 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 metre2 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 

References

  1. National Institute of Allergy and Infectious Disease Monitoring Board recommends stopping experimental treatment regimen in international study of patients new to HIV treatment. NIAID Bulletin, available online at www3.niaid.nih.gov/news/newsreleases/2008/ACTG_5175 [accessed 28 October 2008], 2008
  2. Panel on antiretroviral therapy and medical management of HIV-infected children Guidelines for the use of antiretroviral agents in pediatric HIV infection. August 16, 2010; pp1-219. Available at http://aidsinfo.nih.gov/ContentFiles/PediatricGuidelines.pdf (accessed November 13, 2010)., 2010
  3. Rutstein R et al. Effect of atazanavir on serum cholesterol and triglyceride levels in HIV-infected infants, children and adolescents: PACTG 1020A. Twelfth Conference on Retroviruses and Opportunistic Infections, Boston, abstract 774, 2005
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