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Antiretroviral Therapy for HIV Infection in Infants and Children: Towards Universal Access: Recommendations for a Public Health Approach: 2010 Revision. Geneva: World Health Organization; 2010.

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Antiretroviral Therapy for HIV Infection in Infants and Children: Towards Universal Access: Recommendations for a Public Health Approach: 2010 Revision.

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7CLINICAL AND LABORATORY MONITORING

7.1. Recommendations

7.1.1. CD4 monitoring

  1. CD4 should be measured at the time of diagnosis of HIV infection, and every 6 months thereafter. Monitor with increasing frequency as CD4 count approaches threshold for starting ART.
    (Strong recommendation, very low quality of evidence)
  2. CD4 should be measured prior to initiating ART.
    (Strong recommendation, very low quality of evidence)
  3. CD4 should be measured every 6 months after initiating ART.
    (Conditional recommendation, very low quality of evidence)
  4. Measure CD4 if new clinical staging eventsi develop, including growth faltering and neurodevelopmental delay.
    (Strong recommendation, very low quality of evidence)
  5. Where capacity for CD4 measurement is limited, target the use of CD4 monitoring to assess the significance of clinical events.
    (Conditional recommendation, very low quality of evidence)

7.1.2. Viral load monitoring

6.

VL determination is desirable, but not essential, prior to initiating ART.

(Strong recommendation, moderate quality of evidence)

7.

VL should be assessed to confirm clinical or immunological failure where possible, prior to switching treatment regimen.

(Conditional recommendation, very low quality of evidence)

7.1.3. Routine clinical and laboratory monitoring

8.

Baseline haemoglobin level (and white cell count, if available) should be assessed at initiation of ART.

(Conditional recommendation low quality evidence)

9.

For infants and children, measure haemoglobin at week 8 after initiation of AZT-containing regimens, or more frequently if symptoms indicate.

(Conditional recommendation, very low quality of evidence)

10.

Growth, development and nutrition should be monitored monthly.

(Strong recommendation, low quality of evidence)

11.

Laboratory monitoring for toxicity should be symptom directed.

(Strong recommendation, very low quality of evidence)

7.2. Principle

The inability to perform laboratory monitoring, notably for CD4 or viral load, should not prevent children from receiving ART.

7.3. Background

Clinical and laboratory assessments should be performed at baseline (i.e. at entry into HIV care) for children who have entered care but are not yet eligible for ART, and at initiation of and while on ART.

In resource-limited settings, WHO recommends that clinical parameters be used in conjunction with laboratory assessment, where available, for monitoring of children with HIV who are on ART. The inability to perform laboratory monitoring, notably for CD4 or viral load, should not prevent children from receiving ART. It is highly desirable that each country establish a laboratory monitoring protocol in order to improve the efficacy of therapeutic interventions and to ensure the maximum level of safety when delivering ARV drugs [98-100].

7.4. Baseline clinical and laboratory assessments

The baseline evaluation of HIV-infected infants and children includes clinical assessment and basic laboratory tests, where available. One of the objectives of this initial assessment is evaluation for the presence of active opportunistic infections (OIs). This visit to the clinic also serves as an opportunity to provide counselling and support for children and/or caregivers regarding disclosure of their HIV status to others, nutrition and secondary prevention, as well as for identifying any other specific needs.

Box 8Baseline clinical assessment for children

Following confirmation of HIV infection status, the baseline clinical assessment for children should include:

  • weight, height, head circumference and other measures of growth
  • clinical staging of HIV disease (Annex C)
  • developmental status
  • screening for malaria, TB disease, and exposure to TB
  • identification of concomitant medical conditions (e.g. hepatitis B or C infection, TB, other coinfections or OIs, pregnancy in adolescent girls)
  • details of concomitant medications, including co-trimoxazole and traditional or herbal therapies
  • nutritional status, including assessment of the quality and quantity of intake
  • for those eligible for ART, assessment of the child's and caregiver's preparedness for therapy.

Box 9Baseline laboratory assessment for children

  • confirmation of HIV infection using virological or antibody testing
  • measurement of %CD4+ (preferable for children <5 years) or absolute CD4 cell count where available
  • haemoglobin measurement where AZT-containing first-line regimens are being used
  • white blood cell count (WBC), if available
  • pregnancy test, if indicated from the history, for sexually active adolescent girls
  • hepatitis B and C status, where available
  • VL, where available

7.5. Routine monitoring of children who are not yet eligible for ART

Because of the rapid rate of disease progression in infants and young children, more frequent clinical and laboratory monitoring is indicated for them than for adults. The clinical evaluation of HIV-infected children who are not yet eligible for ART should be performed every three to six months, at a minimum, and should include the same parameters as are used in the baseline evaluation. CD4 monitoring should be performed every six months; the results of CD4 measurement are useful in determining whether the child has become eligible for treatment and/or co-trimoxazole prophylaxis. Clinical evaluation and CD4 measurements should be obtained more frequently as the clinical or immunological threshold for initiating ART approaches, and at initiation of ART (see Table 12). Routine monitoring of viral load is not essential where capacity and resources are constrained and WHO does not recommend specific virological thresholds for initiating treatment.

Table 12. Laboratory parameters for monitoring infants and children at baseline, before and during ART.

Table 12

Laboratory parameters for monitoring infants and children at baseline, before and during ART.

Percent CD4 is preferred for children less than 5 years of age rather than absolute CD4 count. However, the inability to perform laboratory monitoring, notably for CD4 or viral load, should not prevent children from receiving ART.

7.6. Routine monitoring of children on ART

Once an infant or child is on ART, the frequency of clinical monitoring will depend on their response to ART. At a minimum, after starting ART, follow-up visits should occur:

  • for infants, at weeks 2, 4, 8, and then every 4 weeks for the first year
  • for children, at weeks 2, 4, 8, 12, and then every 2 to 3 months once the child has stabilized on therapy.

See Annex J Figure 7 for a description of the routine follow-up visits for infants and children on ART.

Routine clinical assessment should include addressing the child's and/or caregiver's understanding of and adherence to therapy, along with their need for additional support. Key signs of an infant's and child's response to ART include:

  • improvement in growth in infants and children who have been failing to grow
  • improvement in neurological symptoms and development in children with encephalopathy or those who have demonstrated delay in the achievement of developmental milestones
  • decreased frequency of infections (bacterial infections, oral thrush and/or other OIs).

Observation of the child's responses to therapy should include vigilance for symptoms of potential drug toxicities or treatment failure (i.e. reassessment of WHO clinical stage).

Laboratory assessment of CD4 values is desirable at a minimum of six months after the initiation of ART, and every six months thereafter. More frequent CD4 monitoring is indicated in cases of new or recurrent clinical staging events, growth faltering or neurodevelopmental delay. Where capacity for measuring CD4 is limited, monitoring should be targeted to the assessment of clinical events. Routine monitoring for viral load is not essential where capacity and resources are constrained; however, viral load should be used whenever possible to confirm suspected clinical or immunological failure. Where available, viral load should be assessed at six months after initiation of ART for infants on NNRTI-based regimens who are known to have been exposed to NNRTIs intrapartum or through breastfeeding. Failure to suppress the viral load to below 5 000 copies/ml in an adherent child at this time warrants switching to a PI-based regimen (see Chapter 11).

Laboratory assessment of the child's response to treatment and monitoring of adverse reactions should be directed by clinical symptoms (see Annexes F and G), though. some routine monitoring tests are advisable in accordance with the use of specific drugs. In infants and children initiated on AZT-containing regimens, haemoglobin should be measured 8 weeks after starting ART or more frequently if symptoms indicate. Liver function tests (LFT i.e. liver enzymes) are recommended during the first few months of treatment in infants and children receiving NVP who have any signs of hepatitis or hepatotoxicity, who are coinfected with hepatitis viruses, or who are on hepatotoxic medications. Based on data in adults on ART, routine monitoring of LFTs is unlikely to be cost-effective [101].

7.7. Laboratory capacity for routine monitoring

Laboratory protocols for monitoring the safety and efficacy of ART are important. However, WHO recognizes that the same laboratory infrastructures may not be available at all levels of the health-care system. Therefore, WHO has tiered its laboratory monitoring recommendations to primary health-care centres (level 1), district hospitals (level 2) and regional referral centres (level 3) in order to facilitate HIV care and treatment in a variety of settings. Standard quality assessment of laboratories at all levels is important for ensuring reliability. Existing tools for addressing laboratory capacity and quality include the following:

Footnotes

i

Staging events are changes in health status that result in a change in the child's stage of HIV, as per WHO guidelines. See Annexes C and D.

Image annexjf7
Copyright © 2010, World Health Organization.

All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: tni.ohw@sredrokoob). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: tni.ohw@snoissimrep).

Bookshelf ID: NBK138582

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