The United States Department of Health and Human Services (HHS) has released an updated version of its “Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.”
The guidelines contain updated recommendations in several areas, including when to start antiretroviral therapy and factors to consider in selecting an antiretroviral regimen. The guidelines also contain new sections on rates and management of various side effects related to the use of antiretrovirals.
The guidelines are intended for use by doctors and other health care professionals when treating HIV-positive children and teens. They were last updated in August 2010.
Key updates to various sections of the guidelines are summarized below.
Start Of Antiretroviral Therapy
Suggestions for when to initiate antiretroviral therapy vary according to age group.
Antiretroviral therapy is now recommended for children five years or older who have CD4 (white blood cell) counts of less than 500 cells per microliter, even if their symptoms are mild or nonexistent. Previous guidelines recommended treatment at a CD4 count threshold of 350 cells per microliter.
The guidelines continue to recommend treatment for children aged one year or older who have normal CD4 counts but HIV viral loads (amount of HIV in the blood) of 100,000 copies per milliliter of blood or higher, regardless of whether or not they have symptoms.
For children under the age of 12 months, the guidelines also continue to recommend starting antiretroviral therapy regardless of CD4 count, viral load, or the presence or absence of symptoms. Several studies have shown that starting therapy early in children of this age significantly reduces the chances a child will progress to AIDS or die.
In children with normal CD4 counts whose HIV viral loads are less than 100,000 copies per milliliter and who have mild or no symptoms initiation of treatment can be either considered or deferred.
Selection Of Antiretroviral Regimens
As with adults, all HIV-positive children should be treated using combination therapy that includes at least three different antiretroviral drugs from two different classes.
For children aged 14 days to three years, the preferred initial treatment regimen is now Kaletra(lopinavir/ritonavir) plus two nucleoside reverse transcriptase inhibitors (NRTIs). Viramune (nevirapine)-based regimens are now considered an alternative regimen in this age group.
However, due to recent information on toxicity of Kaletra in newborn infants, particularly premature infants, Kaletra should not be given to newborns until at least 42 weeks from the date of the mother’s last menstrual period and 14 days after birth (see related AIDS Beacon news).
For children older than six years, Reyataz (atazanavir) boosted with low-dose Norvir (ritonavir) has been added as a second preferred protease inhibitor for initial treatment regimens; Kaletra is already considered a preferred protease inhibitor for this age group.
The preferred dual-NRTI regimen backbones for initial therapy in children are zidovudine (Retrovir) plusEpivir (lamivudine) or Emtriva (emtricitabine) (any age), Ziagen (abacavir) plus Epivir or Emtriva (children three months or older), and Viread (tenofovir) plus Epivir or Emtriva (children 12 years or older who have finished puberty).
Two new alternate dual-NRTI backbones have been added to the guidelines: didanosine (Videx) plus Epivir or Emtriva (any age), and Viread plus Epivir or Emtriva (children 12 years or older in intermediate stages of puberty). Viread plus Epivir or Emtriva is now listed as a possibility under special circumstances for children 12 years or older in the initial stages of puberty.
The guidelines do not recommend use of the new antiretroviral Edurant (rilpivirine) in children for initial antiretroviral regimens due to lack of information on dosages for children and the absence of a child-friendly formulation of the drug.
The guide continues to recommend that patients who have never received antiretroviral therapy complete antiretroviral drug resistance testing before choosing which drugs to use for treatment.
Monitoring Of HIV-Positive Children
The updated guidelines now note that transient viral load increases of up to 1,000 copies per milliliter (“blips”) are normal and should not be considered a sign of treatment failure.
The guide also recommends that urinalysis be conducted in children at their first visit and repeated every six to 12 months. Urinalysis usually measures aspects of a person’s urine such as pH, presence or absence of blood or protein, and signs of a possible bacterial infection.
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