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Date of Report: 09/24/2003
Author: Susa Coffey, MD
Source: AETC National Resource Center
Revised Pediatric Guidelines
The Working Group on Antiretroviral Therapy and Medical Management of HIV-Infected Children has updated its Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.
The new guidelines include significant new information and recommendations in several areas, particularly those concerning initiation of therapy and choice of antiretroviral medications. The Working Group emphasizes the evolving nature of knowledge on treatment of children with HIV infection, as well as the importance of flexibility in designing treatment plans for individual patients.
Indications for Initiation of Therapy (Tables 7 and 8)
The Guidelines acknowledge controversy regarding treatment of asymptomatic infants and children and of children with mild-to-moderately advanced disease. They currently propose the following clinical, immunologic, and virologic criteria for treatment decisions:
Children < 12 months:
| Treat: | Symptomatic (Clinical category A, B, or C)
OR
CD4 <25% (at any viral load) |
| Consider Treatment: | Asymptomatic (Clinical category N)
AND
CD4>=25% (at any viral load) |
Children >= 1 year:
| Treat: | AIDS (Clinical category C)
OR
CD4 <15% (at any viral load) |
| Consider treatment: | Mild-moderate symptoms (Clinical category A or B)
OR
CD4 15-25%
OR
HIV viral load > 100,000 copies/mL |
| Consider deferring therapy: | Asymptomatic (Clinical category N)
AND
CD4>25%
AND
HIV viral load <100,000 copies/mL |
Resistance Testing
The Guidelines recommend consideration of resistance testing:
 | in virologic failure before changing antiretroviral regimen; |
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| before initiation of therapy in infants under age twelve months, especially if the mother has known or suspected drug-resistant HIV virus. |
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Antiretroviral Medications for Initial Therapy (Table 12)
Treatment recommendations for initial therapy have been revised, based on current clinical trial and pharmacokinetic data.
Several complete regimens are "Strongly Recommended" for initial therapy: (Table 12)
| Protease inhibitor-based | Lopinavir/ritonavir + 2 NRTIs*
Nelfinavir + 2 NRTIs*
Ritonavir + 2 NRTIs*
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| Non-nucleoside reverse transcriptase inhibitor-based | Children >3 years: Efavirenz + 2 NRTIs*
Children <=3 years or unable to take capsules: Nevirapine + 2 NRTIs* |
*For NRTI recommendations, see Table 9.
The nucleoside analogue (NRTI) pairs of zidovudine + lamivudine, zidovudine + didanosine, and stavudine + lamivudine are "Strongly Recommended" for use in combination therapy regimens. (Table 9)
Several protease inhibitor (PI) and non-nucleoside reverse transcriptase inhibitor (NNRTI) based regimens are listed as "Alternative Recommendations," as is one triple nucleoside reverse transcriptase inhibitor (NRTI) regimen. The Guidelines also include discussion of regimens and individual drugs that are "Not Recommended" or that have "Insufficient Data to Recommend" (included in the latter category are the newer antiretrovirals tenofovir, emtricitabine, atazanavir, and enfuvirtide).
Other New Material
| Advantages and disadvantages of different classes of antiretroviral medications and of individual drugs (Tables 9-11) |
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| Criteria for changing therapy, including virologic, immunologic, and clinical considerations (Table 13) |
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| Characteristics of antiretroviral drugs (Appendix) |
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| Changing ARV Therapy and Choice of New Regimen (p. 23 - 26) |
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Additional revisions to the Guidelines are expected in October.
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