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Overview
The guidelines identify the most potent, effective and feasible first-line, second-line and subsequent treatment regimens, applicable to the majority of populations, the optimal timing of ART initiation and improved criteria for ART switching, and introduce the concept of third-line antiretroviral regimens.
The primary audiences are national treatment advisory boards, partners implementing HIV care and treatment, and organizations providing technical and financial support to HIV care and treatment programmes in resource-limited settings.
It is critical that national ART programme and public health leaders consider these recommendations in the context of countries’ HIV epidemics, the strengths and weaknesses of health systems, and the availability of financial, human and other essential resources. In adapting these guidelines, care must be exercised to avoid undermining current treatment programmes, to protect access for the most at-risk populations, to achieve the greatest impact for the greatest number of people and to ensure sustainability. It is similarly important to ensure that the adaptation of these guidelines do not stifle ongoing or planned research, since the new recommendations reflect the current state of knowledge and new information for sustainability and future modifications of existing guidelines will be needed.
Contents
- 1. ACRONYMS AND ABBREVIATIONS
- 2. ACKNOWLEDGEMENTS
- 3. EXECUTIVE SUMMARY
- 4. BACKGROUND
- 5. FUNDING AND DECLARATIONS OF INTEREST
- 6. GUIDING PRINCIPLES
- 7. OBJECTIVES OF THE GUIDELINES AND TARGET AUDIENCE
- 8. METHODOLOGY AND PROCESS
- 9. FROM EVIDENCE TO RECOMMENDATION
- 10. ADAPTING THE GUIDELINES
- 11. SUMMARY OF CHANGES
- Earlier initiation of ART
- Simplified, less toxic antiretroviral drugs for use in first-line and second-line therapy
- Promoting the initiation of ART for all those with HIV/TB coinfection
- Promoting improved HBV diagnosis and more effective treatment of HIV/HBV coinfection
- More strategic monitoring for antiretroviral efficacy and toxicity
- 12. RECOMMENDATIONS AT A GLANCE
- 13. WHEN TO START
- 14. WHAT TO START
- 14.1 Recommendations
- 14.2 Evidence
- 14.3 Summary of main findings
- 14.4 Benefits and risks
- 14.5 Acceptability and feasibility
- 14.6 The choice between NVP and EFV
- 14.7 AZT + 3TC + EFV option
- 14.8 AZT + 3TC + NVP option
- 14.9 TDF + 3TC (or FTC) + EFV option
- 14.10 TDF + 3TC (or FTC) + NVP option
- 14.11 Triple NRTI option
- 14.12 Stavudine (d4T)
- 14.13 NRTIs not to be used together
- 15. SPECIFIC POPULATIONS – WHEN AND WHAT TO START
- 16. WHEN TO SWITCH ART
- 17. SECOND-LINE REGIMENS
- 17.1 Recommendations
- 17.2 Evidence
- 17.3 Summary of findings
- 17.4 Benefits and risks
- 17.5 Acceptability and feasibility
- 17.6 Clinical considerations
- 17.7 Selection of second-line NRTIs
- 17.8 Maintaining 3TC in the second-line regimen
- 17.9 NRTIs for HIV/HBV coinfection
- 17.10 Selection of boosted protease inhibitor
- 18. THIRD-LINE REGIMENS
- 19. PACKAGE OF CARE INTERVENTIONS
- 19.1 Guiding principles
- 19.2 Voluntary counselling and testing and provider-initiated testing and counselling
- 19.3 Preventing further transmission of HIV
- 19.4 The Three I's for HIV/TB
- 19.5 Cotrimoxazole prophylaxis
- 19.6 Sexually transmitted infections
- 19.7 Treatment preparedness
- 19.8 Early initiation of ART
- 19.9 ART as prevention
- 20. LABORATORY MONITORING
- 21. ANNEXES
- 21.1 Special note on coinfection with HIV and hepatitis C
- 21.2 Dosages of recommended antiretrovirals
- 21.3 Toxicities and recommended drug substitutions
- 21.4 ARV-related adverse events and recommendations
- 21.5 Diagnostic criteria for HIV-related clinical events
- 21.6 Grading of selected clinical and laboratory toxicities
- 21.7 Prevention and Assessment of HIV Drug Resistance
- 21.8 Special Note on Antiretroviral Pharmacovigilance
- 21.9 GRADE evidence tables
- 22 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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