NATIONAL CONSOLIDATED GUIDELINES

1 NATIONAL . CONSOLIDATED . GUIDELINES . FOR THE PREVENTION OF MOTHER-TO-CHILD. TRANSMISSION OF HIV (PMTCT). AND THE MANAGEMENT OF HIV IN CHILDREN, ADOLESCENTS AND ADULTS. NATIONAL DEPARTMENT OF HEALTH. SOUTH AFRICA, APRIL 2015. NATIONAL Department of Health Switchboard: 012 395 8000. Physical address: Civitas Building Cnr Thabo Sehume and Struben Streets Pretoria Postal address: Private Bag X828. Pretoria 0001. Published by the Department of Health, Private Bag X828, Pretoria, 0001, South Africa Copyright: Department of Health, Republic of South Africa December 2014. ii Contents ABBREVIATIONS AND DEFINITION OF KEY LIST OF LIST OF FIGURES:..11. LIST OF LIST OF 1 BACKGROUND AND WHAT IS NEW IN THESE RATIONALE FOR CONSOLIDATED GOALS AND TARGET THE SCOPE AND THE STRUCTURE AND 2 GUIDING INCREASING EFFECTIVENESS AND EFFICIENCY OF MANAGING HIV AS A CHRONIC HEALTH STRENGTHENING INTEGRATION OF PROMOTING HUMAN RIGHTS AND HEALTH PROMOTING A FAMILY APPROACH TO HIV THE HIV CONTINUUM OF CARE 3 HIV COUNSELLING AND OVERARCHING PRINCIPLES OF HIV COUNSELING AND PROCESS FOR HIV COUNSELLING AND MANAGING CLIENTS WHO TEST SUMMARY OF WHEN TO REPEAT HCT IN PREGNANT AND BREASTFEEDING PREGNANT WOMEN WHO TEST HIV COUNSELLING AND TESTING (HCT) IN INFANTS AND HIV tests in infants and children (HIV PCR or Rapid HIV antibody test).

2 24. NATIONAL CONSOLIDATED GUIDELINES FOR THE PREVENTION OF MOTHER-TO-CHILD TRANSMISSION. OF HIV (PMTCT) AND THE MANAGEMENT OF HIV IN CHILDREN, ADOLESCENTS AND ADULTS. iii What HIV tests to do in infants and Repeat HIV testing follow-up for HIV-exposed Using monthly well-baby visits for HIV testing for breastfed HCT IN HCT IN 4 LINKAGES AND RETENTION IN GENERAL PRINCIPLES FOR LINKAGES AND RETENTION IN THE WELLNESS PROGRAMME (PRE-ART)..37. PREPARATION FOR INITIATION ON PREPARATION OF PREGNANT HIV-POSITIVE 5 ADHERENCE, PSYCHOSOCIAL CARE AND PRINCIPLES OF ADHERENCE TO HIV STRATEGIES TO PROMOTE HIV DISCLOSURE IN CHILDREN, ADOLESCENTS AND STEP-UP ADHERENCE IN PATIENTS WITH NON-ADHERENCE OR TREATMENT 6 ANTIRETROVIRAL ART IN PREGNANT AND BREASTFEEDING When to start: eligibility criteria for ART in pregnant and breastfeeding What to start: First-line ART regimens in pregnant and breastfeeding Baseline and routine monitoring for pregnant and breastfeeding Viral load monitoring for first-line regimen in pregnant and breastfeeding Recommended second-line regimen for pregnant/breastfeeding LABOUR, DELIVERY AND POSTNATAL FOLLOW-UP OF MOTHER AND Overview of the PMTCT Immediate post-delivery Care of HIV-exposed infants in the immediate post-delivery Immediate postnatal care for HIV-positive ART PROPHYLAXIS IN HIV-EXPOSED When to start.

3 Eligibility criteria for ART prophylaxis in HIV-exposed When to start: Eligibility criteria for cotrimoxazole prophylaxis in HIV-exposed iv What to start: Dosing guide for NVP, AZT and Cotrimoxazole in ART IN INFANTS, CHILDREN AND EARLY General principles of ART care in infants and When to start: Eligibility criteria for ART in infants, children and early What to start: First-line ART regimens for infants, children and early Baseline and routine clinical and laboratory monitoring for infants, children and early Viral load monitoring and first-line ARV treatment failure for infants and Second-line regimens in infants, children and early Third-line ART General care of HIV-exposed infants and HIV-positive infants and Management of children who are not eligible for ART FOR ADOLESCENTS AGED 10-15 When to start ART in adolescents 10-15 years and < What to start: ART first-line regimen for adolescents 10-15 Second-line regimen for adolescents 10-15 Second-line treatment failure and third-line regimen in adolescents 10-15 ART IN LATE ADOLESCENTS AND Transition from paediatric ART regimens to adolescent/adult General management of adolescents and adults on Immune Reconstitution Inflammatory Syndrome (IRIS).

4 71. When to start: ART eligibility in late adolescents 15 years and adults living with What to start: ART first-line regimen for adolescents 15 years and Viral load monitoring and first-line ARV treatment failure in late adolescents 15 and Second-line regimen for late adolescents and Second-line treatment failure and third-line regimen in late adolescents and Management of patients previously on 7 ARV DRUG INTERACTION, TOXICITY, SUBSTITUTION AND ARV DOSING AND SUBSTITUTION IN INFANTS AND ARV DOSING AND SUBSTITUTION IN ADOLESCENTS AND NATIONAL CONSOLIDATED GUIDELINES FOR THE PREVENTION OF MOTHER-TO-CHILD TRANSMISSION. OF HIV (PMTCT) AND THE MANAGEMENT OF HIV IN CHILDREN, ADOLESCENTS AND ADULTS. v COMMON DRUG TOXICITIES IN PREGNANT WOMEN, ADOLESCENTS AND Lactic acidosis in Abacavir hypersensitivity reaction (HSR)..83. BCG adverse COMMON SIDE-EFFECTS OF DRUG SENSITIVE TB THERAPY AND COMMON DRUG TOXICITIES AND SIDE-EFFECTS OF ARV 8 NUTRITION IN INFANTS AND INFANT FEEDING: BREASTFEEDING AND FORMULA ASSESSING THE NUTRITIONAL STATUS OF MANAGEMENT OF SEVERELY MALNOURISHED CHILDREN WITH 9 HIV AND ANAEMIA IN Prevention of anaemia in Screening for anaemia in Management of anaemia in ANAEMIA IN INFANTS AND Common causes of anaemia in infants and Treatment for iron deficiency Dietary management of iron deficiency ANAEMIA IN ADOLESCENTS AND 10 PREVENTION AND MANAGEMENT OF OPPORTUNISTIC ISONIAZID PREVENTIVE Exclusion of active Eligibility for TB preventive Treatment and dosing guide for INH for children, adolescents and Infants born to mothers with Who is not eligible for TB Isoniazid Preventive Therapy?

5 96. Isoniazid side-effects and COTRIMOXAZOLE PREVENTIVE Cotrimoxazole prophylaxis in infants, children and early Cotrimoxazole prophylaxis in late adolescents and CRYPTOCOCCUS (CRYPTO) SCREENING AND vi Screening for cryptococcal disease in Recommended cryptococcal Cryptococcal screening and Diagnosis of TB treatment in 11 MONITORING AND DATA COLLECTION DATA TRANSMISSION, ANALYSIS, REPORTING AND ROLES AND 12 ANNEXURE 1: WHO CLINICAL STAGING OF HIV/AIDS FOR CHILDREN, ADOLESCENTS AND ANNEXURE 2: TB SCREENING ALGORITHM FOR IPT IN ADOLESCENTS AND ANNEXURE 3: TB SCREENING ALGORITHMS FOR IPT IN ANNEXURE 4: INFANTS BORN TO MOTHERS WITH ANNEXURE 5: PAEDIATRIC ARV DOSING CHART FOR ANNEXURE 6: CREATININE CLEARANCE ANNEXURE7: GRADING OF ADVERSE EVENTS IN ADULTS AND ANNEXURE 8: GUIDELINES FOR ADVERSE DRUG REACTION NATIONAL CONSOLIDATED GUIDELINES FOR THE PREVENTION OF MOTHER-TO-CHILD TRANSMISSION. OF HIV (PMTCT) AND THE MANAGEMENT OF HIV IN CHILDREN, ADOLESCENTS AND ADULTS.

6 Vii viii FOREWORD. I am proud to present the new CONSOLIDATED GUIDELINES for the prevention of mother-to-child transmission of HIV (PMTCT) and management of HIV in children, adolescents and adults. The 10 point plan of the Health Sector is aimed at creating a well-functioning health system capable of producing improved health outcomes. Priority 7 of the 10 point plan alludes to accelerate implementation of the HIV/AIDS plan and the reduction of mortality due to TB and associated diseases. The Department of Health is committed to ensuring universal access to Anti-Retroviral Therapy (ART) in order to improve the quality of lives and country health outcomes. The eligibility criteria for ART initiation have been revised to increase access to treatment. With effect from the 1st January 2015, the following criterion to start patients on lifelong ART applies: all HIV positive pregnant and breastfeeding women, regardless of CD4 count or WHO staging and Children >5 years old, adolescents and adults with CD4 500 cells/mm3.

7 This new criteria will increase access to ART for more people as well as reducing new infections through viral suppression. The new CONSOLIDATED GUIDELINES provide standardized, simplified and less toxic drug combinations harmonized for the management of Prevention of Mother to Child Transmission (PMTCT), children, adolescents and adults with HIV/AIDS, TB and other common opportunistic infections. It will provide guidance for clinicians, managers and trainers on the use of available regimens within the context of continuum of HIV. comprehensive care for prevention, treatment and support for all age groups in private and public sector to realize our vision of A LONG AND. HEALTHY LIFE FOR ALL CITIZENS. This approach will also ensure that people living with HIV are started on the right regimen at the right time. I am grateful to all the internal and external stakeholders who actively contributed to the development of these GUIDELINES despite their demanding schedules.

8 It is our sincere wish that all clinicians at PHC clinics, community health centers and hospitals across the board will use these CONSOLIDATED GUIDELINES to offer quality, comprehensive services to the public. DR AARON MOTSOALEDI. MINISTER OF HEALTH. DATE: 11/01/2015. NATIONAL CONSOLIDATED GUIDELINES FOR THE PREVENTION OF MOTHER-TO-CHILD TRANSMISSION. OF HIV (PMTCT) AND THE MANAGEMENT OF HIV IN CHILDREN, ADOLESCENTS AND ADULTS. 1. ACKNOWLEDGEMENTS. The Department of Health would like to thank all individuals, organisations and experts who contributed towards the development of these GUIDELINES . We would like to also acknowledge the three clusters namely Child and School Health; HIV/AIDS and STIs; Maternal, Neonatal and Women's Health for providing leadership in the development process. ADULTS ART TWG/CONTRIBUTORS. 1. Dr Zukiswa Pinini 7. Prof Francois Venter 2. Dr Busisiwe Msimang 8. Dr Michelle Moorehouse 3. Ms Lillian Diseko 9.

9 Dr Amanda Kgomotso Vilakazi-Nhlapo 4. Ms Letta Seshoka 10. Dr Tshepo Molapo (M&E). 5. Dr Augustin Ntilivamunda 11. Mr Mukesh Dheda (Pharmacovigilence). 6. Prof Henry Fomundam PEADS ART TWG/CONTRIBUTORS. 1. Dr Nonhlanhla Dlamini 5. Dr Leon Levine 2. Ms Ntombi Mazibuko 6. Dr Lesley Bamford 3. Ms Lebo Madisha 7. Ms Khadija Jamaloodien 4. Dr Moherndran Archary 8. Mr Gilbert Tshitaudzi PMTCT TWG/CONTRIBUTORS. 1. Dr Pearl Holele 9. Dr Mary Magashoa 2. Dr Landon Myer 10. Ms Lerato Lesole 3. Dr Natasha Davies 11. Ms Melanie Pleaner 4. Ms Precious Robinson 12. Prof Ashraf Covadia 5. Ms Theresa Mabale 13. Prof Gayle Sherman 6. Dr Sanjana Bhardwaj 14. Dr Ameena Goga 7. Dr Kondwani Ng'oma 15. Dr Ashraf Grimwood 8. Dr Vivian Black 16. Dr Jennifer Reddy 2. STRATEGIC LEADERSHIP. Dr Yogan Pillay - Deputy Director General: HIV/AIDS, TB and MCWH clusters WHO TECHNICAL SUPPORT. 1. WHO SA - Dr Busisiwe Msimang and Dr Augustin Ntilivamunda for their Technical Assistance, and special thanks to Dr Msimang for the development and pulling together of the CONSOLIDATED ART GUIDELINES 2.

10 WHO headquarters team - Dr Meg Doherty, Dr Nathan Shaffer, Dr Martina Penazzato and Dr Nathan Ford for their contributions SPONSORS: 1. WHO. a. Funding for a 3-day meeting for consolidation of the GUIDELINES at Emperor's Palace b. Printing of 5,000 copies of GUIDELINES for distribution to all public health facilities 2. UNICEF. a. Printing 200 copies of draft GUIDELINES used during training on the CONSOLIDATED ART GUIDELINES b. Funding the editing of the GUIDELINES for first printing 3. FPD and ITECH. a. Funding the 3-day training of master trainers from all provinces 4. AURUM Institute a. Desk aids Managing HIV A Clinician's Tool' and design and formatting of GUIDELINES 5. Right to Care a. Printing of 2000 copies of the GUIDELINES NATIONAL CONSOLIDATED GUIDELINES FOR THE PREVENTION OF MOTHER-TO-CHILD TRANSMISSION. OF HIV (PMTCT) AND THE MANAGEMENT OF HIV IN CHILDREN, ADOLESCENTS AND ADULTS. 3. ABBREVIATIONS AND ACRONYMS. 3TC Lamivudine AIDS Acquired immune deficiency syndrome ALT Alanine transaminase ANC Antenatal care ART Antiretroviral therapy ARV Antiretroviral ATV Atazanavir AZT Zidovudine BCG Bacille Calmette Guerin (TB vaccine).