www.hivandhepatitis.com

Updated Guidelines for Antiretroviral Treatment of Children with HIV

The Department of Health and Human Services this week updated its Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. Changes to the children's guidelines include specific drug recommendations and information about a possible cure of an HIV-infected infant following very early treatment.

The new document, available online, includes a What's New in the Guidelinessection outlining the most important changes. These include:

• The panel now recommends that CD4 T-cell count or percentage can be monitored less frequently (every 6 to 12 months) in children and youth who are adherent to therapy, have CD4 levels well above the threshold for opportunistic infection risk, and have sustained viral suppression and stable clinical status for more than 2 to 3 years. 
• The guidelines provide information related to the recent report of "functional cure" in an HIV-infected child in Mississippi, discusses the lack of pharmacokinetic and safety data for most drugs in infants younger than 2 weeks, recommends that providers considering treatment for infants consult a pediatric HIV expert, and notes that if early treatment is started and the child is found to be infected, the panel does not recommend treatment interruption unless the durability of the findings in the Mississippi case can be replicated.
• The panel added a recommendation indicating that outside of the context of a clinical trial, structured interruptions of combination antiretroviral therapy (ART) are not recommended for HIV-infected children of any age. 
• The panel recommends initiation of combination ART for children of all ages with HIV RNA >100,000 copies/mL.
• A new table has been added summarizing the rationale for not recommending specific antiretroviral regimens or components for initial therapy for children. 
• New guidance and a new table are provided about modifying antiretroviral regimens for children in an effort to improve pill burden, palatability, tolerability, and use of once-daily dosing in children with sustained virologic suppression on their current regimen. Changing to a new regimen should be considered in children who have sustained virological suppression on their current regimen, in order to facilitate continued adherence and increase safety. 
• Clinically stable children with undetectable viral load and stable CD4 counts for more than 6 months can switch from twice-daily to once-daily abacavir (Ziagen) as a component of a once-daily regimen.
• Although the FDA has approved efavirenz (Sustiva) for infants and children aged >3 months and weighing >3.5 kg, the Panel recommends that efavirenz generally not be used in children aged 3 months to 3 years because of insufficient data.
• Modifications were made to the dosing table for atazanavir (Reyataz) because 100 mg capsules have been discontinued and the 250 mg dose is no longer possible with currently available capsule strengths.
• Once-daily darunavir (Prezista) with ritonavir should be used only in treatment-naive and treatment-experienced adolescents age >12 years without darunavir resistance-associated mutations. Twice-daily dosing of darunavir with ritonavir should continue to be used in children aged >3 years and <12 years.
• Raltegravir (Isentress)is now considered as an agent for Use in Special Circumstances for initial therapy in a combination ART regimen for treatment-naive pediatric patients despite limited data in children, because of its favorable safety profile, lack of significant drug interactions, and palatability.
• Information has been added about the recently approved integrase inhibitor dolutegravir (Tivicay), which is now FDA-approved for use in adults and children aged >12 years and weight >40 kg who are treatment-naive or treatment-experienced and integrase inhibitor-naive.

Feedback on the latest revisions will be accepted until February 26. Send comments to JLIB_HTML_CLOAKING with the subject line "Comments on Pediatric Antiretroviral Treatment Guidelines."

2/14/14

Reference

DHHS. Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. February 12, 2014.

Other Source

AIDSinfo. Updated HHS Pediatric Antiretroviral Treatment Guidelines Released. February 12, 2014.