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Scaling up Antiretroviral Therapy in Resource-Limited Settings SCALING UP ANTIRETROVIRAL THERAPY IN RESOURCE-LIMITED SETTINGS GUIDELINES FOR A PUBLIC HEALTH APPROACH Full guidelines available at http://www.who.int For orders, contact: WORLD HEALTH ORGANIZATION – Family and Community Health Cluster – Department of HIV/AIDS World Health Organization 20, avenue Appia – CH-1211 Geneva 27 – SWITZERLAND – E-mail: [email protected] June 2002 GUIDELINES FOR A PUBLIC HEALTH APPROACH SCALING UP ANTIRETROVIRAL THERAPY IN RESOURCE-LIMITED SETTINGS GUIDELINES FOR A PUBLIC HEALTH APPROACH World Health Organization Department of HIV/AIDS Family and Community Health Cluster 1 SCALING UP ANTIRETROVIRAL THERAPY IN RESOURCE-LIMITED SETTINGS WHO Library Cataloguing-in-Publication Data Scaling up antiretroviral therapy in resource-limited settings : guidelines for a public health approach. 1. Anti-HIV agents - therapeutic use 2. Anti-HIV agents - pharmacology 3. HIV infections - drug therapy 4. Treatment outcome 5. Drug interactions 5. Exposed population I.Interim WHO Antiretroviral Treatment Working Group (2001 : Geneva, Switzerland) II. WHO International Consultative Meeting on HIV/AIDS Antiretroviral Therapy (2001 : Geneva, Switzerland (ISBN 92 4 154570 4) (NLM classification: QV 268.5) The World Health Organization welcomes requests for permission to reproduce or translate its publications, in part or in full. Applications and enquiries should be addressed to the Office of Publications, World Health Organization, CH-1211 Geneva 27, Switzerland, which will be glad to provide the latest information on any changes made to the text, plans for new editions, and reprints and translations already available. © World Health Organization 2002 Publications of the World Health Organization enjoy copyright protection in accordance with the provisions of Protocol 2 of the Universal Copyright Convention. All rights reserved. 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 Secretariat 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. 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. 2 Printed in France GUIDELINES FOR A PUBLIC HEALTH APPROACH This document would not have been possible without the input of the numerous national and international experts who have participated in the consultations that led to the formulation of these guidelines. The guidelines on “Scaling up antiretroviral therapy in resource-limited settings, Guidelines for a public health approach” were edited by Scott Hammer, Columbia University, New York City, USA Editor in Chief Diana Gibb, British Medical Research Council, London, U.K. Editor, Pediatric Chapter Diane Havlir, University of California at San Diego, USA, Editor, HIV related Co-infections Chapter Lynne Mofenson, National Institutes of Health, NICHD, Bethesda, USA Editor, Pregnancy Chapter Ingrid Van Beek, Sydney Hospital, Sydney, Australia, Editor, Injection Drug User’s Chapter Stefano Vella, Instituto Superiore de Sanita, Rome, Italy Editor, Clinical and Laboratory Monitoring of ARV use Chapter Overall coordination Basil Vareldzis and Jos Perriëns of the HIV/AIDS Department of WHO, Geneva The World Health Organization would like to express its special thanks to the others members of the Writing Committee including Kenneth Chebet, Mark Dybul, Carlo Giaquinto, Elly Katabira, Christine Katlama, Jean Elie Malkin, James McIntyre, Souleyman M’Boup, Jacques Mokhbat, Joia Mukherjee, Praphan Phanupak, Mauro Schechter, Marco Antonio de Avila Vitoria. The World Health Organization would also like to acknowledge comments from many experts including: Suzanne Crow, Kevin DeCock, Jean Emmanuel, Charles Gilks, J. Gölz, Julian Gold, Gregg Gonsalves, Ian Grubb, Vincent Habiyambere, Hans Hogerzeil, Arata Kochi, Eric van Praag, S. S. Lee, Paul Nunn, Mark Harrington, Robert Soliz, Eve Lakritz, Gaby Vercauteren and Bernhard Schwartländer. WHO acknowledges the generous contribution of NIH in the development of the guidelines. 3 GUIDELINES FOR A PUBLIC HEALTH APPROACH Abbreviations ________________________________________ 7 Preface ______________________________________________ 8 Summary ___________________________________________ 10 I. Introduction ___________________________________ 19 II. Objectives of the document ______________________ 21 III. Background and purpose ________________________ 22 IV. Approach to antiretroviral therapy _________________ 24 V. When to start antiretroviral therapy in adults and adolescents ___________________________ 25 VI. Recommended first-line regimens for adults and adolescents ___________________________ 27 VII. When to change therapy in adults and adolescents ___ 34 VIII. Recommended second-line regimens in adults and adolescents ___________________________ 36 IX. Drug resistance_________________________________ 39 X. Antiretroviral therapy in women, with specific reference to pregnancy _______________ 41 XI. Infants and children _____________________________ 58 XII. Tuberculosis and other HIV-related conditions ______ 71 XIII. Injecting drug users _____________________________ 76 XIV. Drug adherence ________________________________ 80 XV. Monitoring antiretroviral therapy __________________ 81 Annex 1. WHO staging system for HIV infection and disease in adults and adolescents ____________ 98 Annex 2. WHO staging system for HIV infection and disease in children _______________________ 100 5 SCALING UP ANTIRETROVIRAL THERAPY IN RESOURCE-LIMITED SETTINGS Annex 3. Characteristics of NNRTI-based regimens ___ 101 Annex 4. Characteristics of triple NsRTI-based regimens _______________________________ 102 Annex 5. Characteristics of PI-based regimens _______ 104 Annex 6. Characteristics of NNRTI-, triple NsRTI- and PI-based regimens in special populations ____ 106 Annex 7. Antiretroviral dosage regimens for adults and adolescents ___________________ 108 Annex 8A. Antiretroviral drug interactions ____________ 109 Annex 8B. Drug interactions between non-nucleoside reverse transcriptase inhibitors and protease inhibitors _______________________ 112 Annex 8C. Drug interactions involving non-nucleoside reverse transcriptase inhibitors and protease inhibitors of relevance to poor countries ____ 114 Annex 9. Choice of antiretroviral drugs in HIV-infected pregnant women _____________ 120 Annex 10. Summary of paediatric drug formulations and doses ______________________________ 122 Annex 11A. Antiretroviral drug toxicity ________________ 128 Annex 11B. Monitoring and management of antiretroviral drug toxicity ________________ 136 References _________________________________________ 142 Interim WHO Antiretroviral Treatment Working Group, Geneva, 19-20 November 2001 _______________________ 159 WHO International Consultative Meeting on HIV/AIDS Antiretroviral Therapy, 22-23 May 2001, Geneva ________ 162 6 GUIDELINES FOR A PUBLIC HEALTH APPROACH ABBREVIATIONS 3TC lamivudine ABC abacavir AIDS acquired immunodeficiency syndrome APV amprenavir ART antiretroviral therapy ARV antiretroviral AUC area under the curve AZT zidovudine CNS central nervous system d4T stavudine ddC zalcitabine ddI didanosine DLV delavirdine DOTS directly observed therapy, short course EFZ efavirenz also known as EFV ELISA enzyme-linked immunosorbent assay FDA Food and Drug Administration (USA) HAART highly active antiretroviral therapy HIV human immunodeficiency virus ICD immune-complex-dissociated IDU injecting drug user IDV indinavir LPV lopinavir MSF Médecins Sans Frontières MTCT mother-to-child transmission NAM nucleoside analogue mutation NFV nelfinavir NGO nongovernmental organization NIH National Institutes of Health (USA) NNRTI non-nucleoside reverse transcriptase inhibitor NsRTI nucleoside analogue reverse transcriptase inhibitor NtRTI nucleotide analogue reverse transcriptase inhibitor NVP nevirapine OI HIV-related opportunistic infection PCP Pneumocystis carinii pneumonia PCR polymerase chain reaction PGL persistent generalized lymphadenopathy PI protease inhibitor PPD purified protein derivative skin test for TB QA quality assurance r low-dose ritonavir boost RT reverse transcriptase RTV ritonavir STI sexually transmitted infection SQV saquinavir TAB treatment advisory board TB tuberculosis TDF tenofovir disoproxil fumarate TLC total lymphocyte count UN United Nations UNAIDS United Nations Joint Co-sponsored. Programme on HIV/AIDS UNGASS United Nations General Assembly Special Session on HIV/AIDS VCT HIV voluntary counselling and testing WHO World Health Organization ZDV zidovudine 7 SCALING UP ANTIRETROVIRAL THERAPY IN RESOURCE-LIMITED SETTINGS PREFACE ess than a decade ago, someone living with HIV/AIDS had little L hope.HIV infection brought a steady inexorable decline towards the complete destruction of the immune system and death. The introduction of ARVs in 1996 was a turning point for hundreds of thousands of people with access to sophisticated health care systems. Although they cannot cure HIV/AIDS, antiretrovirals (ARVs) have dramatically reduced mortality and morbidity, prolonged lives, and improved the quality of life of many people living with HIV/AIDS. Today we are once
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