National Antiretroviral Treatment and Care Guidelines for Adults, Adolescents, and Children
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National Antiretroviral Treatment and Care Guidelines for Adults, Adolescents, and Children Ministry of Health Edited by: Elly T. Katabira, FRCP Moses R. Kamya, M. Med, MPH Israel Kalyesubula, M. Med Alice Namale, M. Med, DPH 2nd Edition – January 2008 Errors and omissions excepted. Every effort has been made to ensure that drug dosages and treatment schedules are correct and in accordance with current medical practice. However, medical knowledge is constantly and rapidly changing, particularly in relation to HIV/AIDS. Thus, when using an unfamiliar drug, clinicians are urged to confirm that information (especially with regards to drug usage) complies with the latest standards of practice. Hence these guidelines will need regular updating based on new knowledge, experiences and practices. We would welcome feedback and comments from the users and experts addressed to: The Director General Health Services Attn: Programme Manager STD/AIDS Control Programme Ministry of Health P.O. Box 7272 Kampala, Uganda ii Table of Contents TABLE OF CONTENTS...........................................................................................................................III ACRONYMS AND ABBREVIATIONS: ...................................................................................................V FOREWORD............................................................................................................................................ VII ACKNOWLEDGEMENTS ....................................................................................................................VIII 1.0 INTRODUCTION.......................................................................................................................... 1 2.0 DIAGNOSING HIV INFECTION AND DISEASE.................................................................... 2 2.1 HIV COUNSELING AND TESTING (HCT)........................................................................................ 2 2.1.1 HIV counseling for ART in adults and adolescents ................................................................ 3 2.1.2 Counseling for ART in children.............................................................................................. 4 2.2 LABORATORY DIAGNOSIS AND ASSESSMENT OF HIV INFECTION IN ADULTS ................................ 5 2.2.1 Tests to detect the virus itself.................................................................................................. 6 2.2.2 Measuring immune suppression ............................................................................................. 6 2.2.3 Clinical evaluation for HIV in adults ..................................................................................... 6 2.3 DIAGNOSING HIV INFECTION IN INFANTS AND CHILDREN ............................................................ 6 2.3.1 Laboratory diagnosis of HIV infection in children using antibody tests ................................ 6 2.3.2 Laboratory diagnosis of HIV infection in children using virologic tests -.............................. 9 2.3.3 Clinical evaluation in infants and children ............................................................................ 9 3.0 ANTIRETROVIRAL THERAPY (ART) .................................................................................. 10 3.1 GOALS OF ART.......................................................................................................................... 10 3.2 PRINCIPLES OF ART................................................................................................................... 10 3.3 LIMITATIONS OF ART ................................................................................................................ 11 4.0 AVAILABLE AGENTS FOR ART............................................................................................ 12 5.0 WHEN AND HOW TO START ART........................................................................................ 15 5.1 INSTITUTIONAL REQUIREMENTS FOR STARTING ART................................................................. 15 5.2 IN ADULTS AND ADOLESCENTS................................................................................................... 15 5.2.1 Baseline clinical assessment................................................................................................. 17 5.3 IN CHILDREN AND INFANTS ........................................................................................................ 20 6.0 RECOMMENDED REGIMENS OF ART ................................................................................ 21 6.1 RECOMMENDED STARTING (FIRST LINE) REGIMENS IN ADULTS AND ADOLESCENTS ................... 21 6.2 RECOMMENDED SECOND LINE OF ART REGIMENS IN ADULTS AND ADOLESCENTS..................... 25 6.3 RECOMMENDED FIRST LINE ART REGIMENS FOR INFANTS AND CHILDREN ................................ 26 6.4 RECOMMENDED SECOND LINE ART REGIMENS FOR INFANTS AND CHILDREN ............................ 27 6.5 ART RECOMMENDATIONS FOR SPECIAL GROUPS ....................................................................... 28 6.5.1. Women of childbearing potential or who are pregnant ......................................................... 28 6.5.2 People co-infected with tuberculosis and HIV infections........................................................ 32 6.5.3 People coinfected with Hepatitis and HIV ................................. Error! Bookmark not defined. 8.3 IN INFANTS AND OLDER CHILDREN.................................................ERROR! BOOKMARK NOT DEFINED. 8.4 WHAT TO DO AFTER 2ND LINE TREATMENT FAILURE .............ERROR! BOOKMARK NOT DEFINED. 7.0 FOLLOW-UP AND MONITORING PATIENTS ON ART.................................................... 37 7.1 CLINICAL GUIDELINES FOR MONITORING ART........................................................................... 37 7.2 LABORATORY GUIDELINES FOR MONITORING ART.................................................................... 38 7.2.1 Basic laboratory tests for monitoring toxicity & treatment response of antiretroviral therapy 38 iii 7.2.2 CD4 lymphocyte counts ........................................................................................................ 40 7.2.3 Plasma HIV-RNA levels (Viral Load) .................................................................................... 40 7.3 MONITORING OF ART IN INFANTS AND CHILDREN ..................................................................... 40 7.4 FOLLOW-UP AT HOSPITAL LEVEL................................................................................................ 40 7.5 FOLLOW-UP AT LOWER LEVEL FACILITIES .................................................................................. 41 7.6 FOLLOW-UP IN A PRIVATE CLINIC SETTING ................................................................................. 42 7.7 FOLLOW-UP AT COMMUNITY LEVEL ........................................................................................... 42 7.8 ART DATA COLLECTION AND MANAGEMENT ............................................................................. 42 8.0. WHEN TO CHANGE THERAPY ............................................................................................. 44 8.1 INTRODUCTION........................................................................................................................... 44 8.2 INDICATIONS FOR CHANGING REGIMENS .................................................................................... 44 8.2.1 Changing for treatment failure............................................................................................. 44 8.2.2 Changing for toxicity ............................................................................................................ 46 8.2.3 Occurrence of active tuberculosis and/or pregnancy........................................................... 48 8.2.4 Inconvenient regimens ............................................................................................................ 48 8.2.5 Economic constraints.............................................................................................................. 49 9.0 CHALLENGES OF ART .................................................................................................................... 50 9.1 IMMUNE RECONSTITUTION SYNDROME....................................................................................... 50 9.2 PATIENT ADHERENCE ................................................................................................................. 51 9.3 ART IN THE ADOLESCENTS ........................................................................................................ 52 9.4 ART IN CHILDREN...................................................................................................................... 53 9.5 SUSTAINABLE ARV DRUG SUPPLIES AND DELIVERY SYSTEMS ................................................... 53 10.0 ART AND PRIMARY OR SECONDARY PROPHYLAXIS......................................................... 55 11.0 POST-EXPOSURE PROPHYLAXIS............................................................................................... 56 11.1 PREVENTION OF OCCUPATIONAL EXPOSURE IN HEALTH FACILITIES ........................................... 56 11.2 PROCEDURE TO BE FOLLOWED IN THE EVENT OF INJURY WITH A SHARP OBJECT ........................ 57 11.3 ANTIRETROVIRAL DRUGS TO BE USED IN POST-EXPOSURE PROPHYLAXIS................................... 57 11.4 POST-SEXUAL EXPOSURE PROPHYLAXIS .......................................................................................