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Overview
These treatment guidelines serve as a framework for selecting the most potent and feasible first-line and second-line ART regimens for the care of HIV-infected infants and children.
These guidelines address the diagnosis of HIV infection and consider ART in different situations, e.g. where infants and children are coinfected with HIV and TB, or have been exposed to ARVs, either for PMTCT or because of breastfeeding from an HIV-infected mother on ART. In addition, these guidelines address the importance of nutrition in the HIV-infected child and of recognizing the severity of malnutrition, especially in relation to the provision of ART. Adherence to therapy and resistance to ARVs are discussed. A section on ART in adolescents briefly outlines key issues related to treatment and care for this age group.
WHO recognizes the need to strengthen health systems with a view to maximizing the quality and long-term benefits of ART. Improved access to HIV diagnostic testing for infants and children is necessary to save lives. The inability to diagnose HIV infection as early as possible in infants and children severely limits access to ART and its timely initiation. Reliable access to immunological assays for assessing CD4 levels in children is crucial for guiding the initiation of treatment and for optimizing the maintenance of ART.
These guidelines are intended primarily for use by treatment advisory boards, national AIDS programme managers and other senior policy-makers who are involved in the planning of national and international HIV care strategies for infants and children in resource-limited countries. Elements of the guidelines such as the simplified dosing guidance (Annex E) are also designed for clinical implementation in the field.
Contents
- ACRONYMS AND ABBREVIATIONS
- EXECUTIVE SUMMARY
- 1. INTRODUCTION
- 2. OBJECTIVES OF THESE GUIDELINES
- 3. DEVELOPMENT OF THESE GUIDELINES
- 4. ESTABLISHING A DIAGNOSIS OF HIV INFECTION IN INFANTS AND CHILDREN
- 4.1 Recommendations
- 4.2 Background
- 4.3 The determination of HIV infection in infants and children
- 4.4 Diagnosing HIV infection in breastfeeding infants and children
- 4.5 Diagnosing HIV infection where mother or infant has received ARV drugs for PMTCT
- 4.6 Presumptive diagnosis of severe HIV disease in HIV-exposed infants and children less than 18 months of age
- 5. WHEN TO START ANTIRETROVIRAL THERAPY IN INFANTS AND CHILDREN
- 5.1 Recommendations
- 5.2 When to initiate ART in HIV-infected infants
- 5.3 When to initiate ART in HIV-infected children 12 months of age and older
- 5.4 Clinical criteria to start ART
- 5.5 Immunological criteria to start ART
- 5.6 Criteria for starting ART in infants and children less than 18 months with a presumptive diagnosis of severe HIV disease
- 6. WHAT TO START – RECOMMENDED FIRST-LINE ARV REGIMENS FOR INFANTS AND CHILDREN
- 6.1 Recommendations
- 6.2 Antiretroviral treatment using a public health approach
- 6.3 Considerations for drug formulations and doses for infants and children
- 6.4 Choice of a first-line regimen
- 6.5 Choice of NRTIs
- 6.6 Choice of NNRTIs
- 6.7 Use of PIs in initial therapy
- 6.8 Summary of Chapter 6 – First Line ARV Regimens
- 7. CLINICAL AND LABORATORY MONITORING
- 8. WHAT TO EXPECT IN THE FIRST SIX MONTHS OF THERAPY
- 9. ARV DRUG TOXICITY
- 10. SUBSTITUTING DRUGS BECAUSE OF TOXICITY IN INFANTS AND CHILDREN
- 11. FIRST-LINE REGIMEN TREATMENT FAILURE; WHEN TO SWITCH REGIMENS
- 11.1 Recommendations
- 11.2 Principles
- 11.3 Background
- 11.4 Clinical definition of treatment failure
- 11.5 Immunological definition of treatment failure
- 11.6 Virological definition of treatment failure
- 11.7 Use of clinical and immunological findings for decision-making on switching ARV regimen
- 11.8 Decision-making on switching ART in the absence of CD4 measurement
- 11.9 Decision-making on switching ART using viral load measurement
- 11.10 Use of other laboratory parameters for decision-making regarding switching ART
- 12. CHOICE OF SECOND-LINE REGIMENS IN THE EVENT OF TREATMENT FAILURE
- 12.1 Recommendations
- 12.2 Principles
- 12.3 Background
- 12.4 Choice of second-line regimen following a preferred first-line regimen of two NRTIs plus one NNRTI
- 12.5 Choice of NRTIs
- 12.6 Choice of PIs
- 12.7 Choice of a second-line regimen following an alternative first-line regimen with triple nucleosides
- 12.8 Choice of a second-line regimen following a PI-based initial regimen
- 13. CONSIDERATIONS FOR INFANTS AND CHILDREN WITH TUBERCULOSIS AND HIV
- 13.1 Recommendations
- 13.2 Background
- 13.3 TB screening and prevention for HIV-infected infants and children
- 13.4 Diagnosis of TB
- 13.5 Treatment of TB in HIV-infected infants and children
- 13.6 Choice of first-line ARV regimens in children receiving rifampicin-containing TB treatment
- 13.7 When to start ART following initiation of rifampicin-containing TB treatment
- 13.8 Considerations for children diagnosed with drug-resistant TB
- 13.9 Considerations for children diagnosed with TB while on first-line ARV regimens
- 13.10 Considerations for children diagnosed with TB while on RTV-boosted PI ARV regimens
- 13.11 IRIS in the context of co-therapy for TB/HIV
- 14. NUTRITION FOR HIV-INFECTED INFANTS AND CHILDREN
- 15. CONSIDERATIONS FOR ART IN ADOLESCENTS
- 16. ADHERENCE TO ART
- 17. STRATEGIES IN THE EVENT OF FAILURE OF SECOND-LINE REGIMENS
- 18. DRUG RESISTANCE
- 18.1 Principles
- 18.2 HIV drug resistance in infants and children
- 18.3 Minimizing the emergence of HIV drug resistance
- 18.4 Monitoring HIVDR early warning indicators
- 18.5 Monitoring emergence of HIVDR transmission in infants and children on ART
- 18.6 Surveillance for HIVDR in newly infected treatment-naive infants
- ANNEX A MEMBERS OF THE TECHNICAL REFERENCE GROUP ON PAEDIATRIC HIV CARE AND TREATMENT
- ANNEX B GRADING OF RECOMMENDATIONS AND LEVELS OF EVIDENCE
- ANNEX C WHO CLINICAL STAGING OF HIV FOR INFANTS AND CHILDREN WITH ESTABLISHED HIV INFECTION
- ANNEX D PRESUMPTIVE AND DEFINITIVE CRITERIA FOR RECOGNIZING HIV-RELATED CLINICAL EVENTS IN INFANTS AND CHILDREN WITH ESTABLISHED HIV INFECTION
- ANNEX E PRESCRIBING INFORMATION AND WEIGHT-BASED DOSING OF AVAILABLE ARV FORMULATIONS FOR INFANTS AND CHILDREN
- ANNEX F SERIOUS, ACUTE AND CHRONIC TOXICITIES CAUSED BY ARV DRUGS
- ANNEX G SEVERITY GRADING OF SELECTED CLINICAL AND LABORATORY TOXICITIES MOST COMMONLY SEEN WITH RECOMMENDED ANTIRETROVIRAL DRUGS FOR CHILDREN
- ANNEX H SEXUAL MATURITY RATING (TANNER STAGING) IN ADOLESCENTS
- ANNEX I SUMMARY OF WHO RECOMMENDATIONS ON LABORATORY INVESTIGATIONS FOR CLINICAL CARE BY LEVEL OF HEALTH CARE FACILITY
- ANNEX J FIGURES
- ANNEX K REFERENCES
The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement.
The mention of specific companies or of certain manufacturers' products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.
All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use.
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