Diagnosis of HIV infection in adults

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with tuberculosis 91

6.1 Clinical recognition of HIV infection in TB patients 91

6.2 HIV testing 92

6.2.1 HIV antibody tests 92

6.2.2 Tests to detect the virus itself 93

6.2.3 Objectives of HIV antibody testing in TB patients 94

6.2.4 Strategy for HIV antibody testing in TB patients 94

6.2.5 Diagnosis of HIV infection in individual TB patients 95

6.3 HIV counselling 95

7 Diagnosis of HIV infection in children with tuberculosis 99

7.1 Clinical recognition of HIV infection in children with TB . 99

7.2 HIV testing 100

7.3 Counselling 101

8 Standardized tuberculosis case definitions and treatment categories 105

8.1 Standardized case definitions 105

8.1.1 Introduction 105

8.1.2 Questions and answers about case definitions 105

8.1.3 Case definitions by site and result of sputum smear . . . 106

8.1.4 Category of TB patient for registration on diagnosis . . . 107

8.2 Standardized dignostic categories 108

9 Management of patients with tuberculosis 111

9.1 Introduction 111

9.2 Modes of action of anti-TB drugs 112

9.3 TB treatment regimens 113

9.3.1 New cases 114

9.3.2 Re-treatment cases 114

9.3.3 Standard code for TB treatment regimens 114

9.3.4 Recommended treatment regimens 115

9.3.5 Use of streptomycin in areas of high HIV prevalence. . . 117

9.3.6 Use of TB drugs in children 117

9.4 TB treatment regimens: questions and answers II8

9.5 Use of anti-TB drugs in special situations I20

9.6 The role of adjuvant steroid treatment: questions and answers I2I

9.7 Monitoring of TB patients during treatment I22

9.7.1 Monitoring of patients with sputum smear-positive PTB . 122

9.7.2 Recording treatment outcome I23

9.7.3 Cohort analysis: questions and answers I24

9.8 Response of HIV-positive TB patients to anti-TB treatment I24

10 Side-effects of anti-tuberculosis drugs I29

10.1 Introduction 129

10.2 Prevention of side-effects 129

10.3 Where to manage drug reactions 129

10.4 When to stop anti-TB drugs 129

10.5 Side-effects of anti-TB drugs 130

10.5.1 Side-effects of anti-TB drugs in HIV-positive TB patients 131

10.6 Symptom-based approach to management of drug side-effects I32

10.7 Management of skin itching and rash 132

10.7.1 Treatment regimen includes thioacetazone 133

10.7.2 Treatment regimen does not include thioacetazone. . . . 133

10.8 Desensitization 134

10.9 Management of hepatitis 135

11 Antiretroviral therapy for the treatment of

HIV infection 137

11.1 Introduction 137

11.2 Antiretroviral drugs 138

11.3 Principles of ART 138

11.4 Principles of a public health approach to ART 139

11.5 Initiation of ART 139

11.5.1 Adults and adolescents with documented HIV infection 140

11.5.2 Infants and children 140

11.6 Recommended doses of ARV drugs 141

11.6.1 Adults and adolescents 141

11.6.2 Children 142

11.7 Choice of ART regimen 149

11.7.1 Adults 149

11.7.2 Children 150

11.8 Monitoring the efficacy of ART 151

11.9 Adverse effects 151

11.10 Interactions between ARV drugs and drugs used to prevent or treat opportunistic infections 153

11.11 Antiretroviral drugs and TB treatment 153

11.11.1 Drug interactions 153

11.11.2 Treating TB and HIV together 153

11.11.3 Immune reconstitution syndrome 154

11.11.4 Options for ART in patients with TB 154

12 Treatment and prevention of other HIV-related diseases in TB/HIV patients 157

12.1 Introduction 157

12.2 Clinical spectrum of HIV-related disease 157

12.3 Sexually transmitted infections 158

12.3.1 Syndromic management 158

12.3.2 Treatment regimens for common STIs 159

12.4 Skin and mouth problems 161

12.5 Respiratory problems 165

12.5.1 Respiratory problems in adults 165

12.5.2 Respiratory problems in children 167

12.6 Gastrointestinal problems 167

12.6.1 Dysphagia 167

12.6.2 Diarrhoea in adults 168

12.6.3 Diarrhoea in children 170

12.7 Neurological problems in adults 171

12.7.1 Acute confusion 171

12.7.2 Chronic behaviour change 172

12.7.3 Persistent headache 172

12.7.4 Difficulty in walking 174

12.7.5 Poor vision 175

12.7.6 Burning sensation in the feet 175

12.8 Neurological problems common in children 175

12.9 Fever 176

12.9.1 Approach to management 176

12.9.2 Disseminated infection 176

12.10 Other HIV-related problems 177

12.11 Prevention of HIV-related opportunistic infections 179

12.11.1 General measures 179

12.11.2 Immunizations 179

12.11.3 Primary chemoprophylaxis in adults 180

12.11.4 Primary chemoprophylaxis in children 181

12.11.5 Secondary chemoprophylaxis in adults 181

13 Coordinated care in different settings 185

13.1 Introduction 185

13.2 The expanded scope of a new approach to decrease the burden of TB/HIV 185

13.3 Referral to local HIV/AIDS care services 186

13.4 Benefits of support from local HIV/AIDS care services . 186

13.5 A framework for HIV/AIDS care that incorporates interventions to address TB 187

13.5.1 Home and community care 187

13.5.2 Primary care 188

13.5.3 Secondary care 189

13.5.4 Tertiary care 189

13.6 The private sector 191

13.6.1 Private medical practitioners 191

13.6.2 Traditional practitioners 191

13.7 Operational research aimed at improving integrated

TB and HIV/AIDS prevention and care 192

13.7.1 Promoting voluntary counselling and testing (VCT)

for HIV as an entry point to better TB care 192

13.7.2 The Practical Approach to Lung Health (PAL) 192

14 Prevention of tuberculosis in HIV-infected individuals 195

14.1 Introduction 195

14.2 Protection of HIV-positive persons against exposure to TB 195

14.2.1 Environmental control 195

14.2.2 Face-masks 196

14.2.3 Patient education 196

14.2.4 Pulmonary TB suspects 196

14.2.5 Patients with sputum smear-positive pulmonary TB . . . . 197

14.2.6 Patients with multidrug-resistant TB (mDR-TB) 197

14.3 Role of BCG in preventing TB in HIV-infected individuals. 197

14.3.1 Background 197

14.3.2 BCG protection against TB in HIV-infected children. . . . 198

14.3.3 BCG safety in HIV-infected children 198

14.3.4 WHO recommended policy on BCG and HIV 198

14.4 The role of the Expanded Programme on Immunization (EPI) 199

14.5 Preventive treatment 199

14.5.1 Target groups for preventive treatment 200

14.5.2 Role of isoniazid preventive treatment in HIV-positive individuals 201

14.5.3 WHO/UNAIDS recommendations on preventive therapy against TB in HIV-positive persons 201

Index 205

] FOREWORD TO SECOND EDITION

WHO is committed to achieving major progress in global public health. Goals for tuberculosis include a worldwide cure rate of 85% and a case detection rate of 70% by 2005. Goals for human immunodeciciency virus include treating 3 million people with HIV infection in developing countries with antiretroviral drugs by 2005. The Millennium Development Goals include targets for improved child health and survival and for improved control of priority communicable diseases (including TB and HIV) by 2015. Progress in improving TB/HIV clinical care will contribute to achieving these goals. Clinicians have a vital contribution to make, not only to the clinical care of patients, but also to public health.

The public health foundation of TB control is good clinical care, through identification and effective treatment of TB patients. A cornerstone of public health activities for HIV prevention is to increase the proportion of HIV-infected people who choose to know their HIV status. One of the benefits of testing positive for HIV should be access to good clinical care. This is crucial in promoting community confidence in HIV/AIDS care, and therefore encouraging the uptake of HIV testing.This manual provides practical guidance on the clinical care of patients of all ages with HIV infection, including the treatment of HIV infection with antiretroviral drugs and of HIV-related diseases, including TB.

TB and HIV are overlapping epidemics. For clinicians, the patient is at the centre of public health activities to tackle TB/HIV. For example, clinicians are usually in a good position to offer TB patients voluntary counselling and testing for HIV. When patients with TB find out they are HIVpositive, clinicians are well placed to ensure directly or by referral that they receive lifelong care. Lifelong care should comprise the following: treatment of HIV infection; prevention and treatment of HIV-related diseases; support to decrease risk of HIV transmission; and social and psychological support.

This manual provides valuable guidance for clinicians caring for patients with TB/HIV. Their efforts are crucial to the collective achievement of global public health goals.

Dr JW Lee

Director-General,World Health Organization Geneva, Switzerland

] FOREWORD TO FIRST EDITION

Doctors and other health professionals working in sub-Saharan Africa will be only too aware of the many patients they encounter with TB. They will also be all too well aware of the epidemic of HIV infection and the effect this has had on dramatically increasing the TB burden.They will know that in many patients development of clinical TB is the first sign of underlying HIV infection. This excellent book is designed for the busy clinician. It summarizes the characteristics of both diseases and of their interactions. It concentrates particularly on the clinical problems of diagnosis and management, both in adults and children. It summarizes the other HIV-related diseases which the clinician may encounter in TB/HIV patients. It provides a most useful review to those new to the problems and a handy reference for the experienced clinician when faced with some particular difficulty. It is well set out and easy to use.

The modern treatment ofTB in HIV-infected patients is highly successful. This not only benefits the patient but reduces the spread of TB to families and the community. Other treatments can help to improve or control many HIV-related diseases.This book well summarizes the range of treatments available. It also provides useful guides on counselling and on interagency cooperation, both essential components of TB/HIV management.

The enormous problems of HIV and TB in sub-Saharan Africa are now also increasing in Asia and South America, where the book should prove equally useful.

I congratulate WHO on deciding to produce this valuable book and the authors on the imaginative and practical way they have presented the problems and their management.

Sir John Crofton

Professor Emeritus of Respiratory Diseases and Tuberculosis University of Edinburgh, Scotland

I I PREFACE TO SECOND EDITION

Recognition of the impact of HIV on the clinical management of TB prompted WHO to publish the first edition of this manual in 1996. In response to popular demand, the manual was adapted for different regions and translated into many languages.The total number of copies distributed has run to well over 100000. Recognition of the strengths and weaknesses of the first edition and developments in the TB/HIV field have now prompted a second edition.

There is increasing attention to the need to ensure high quality care of children with TB within National TB Programmes.Therefore this second edition provides improved guidance on dealing with TB in children.

HIV fuels the TB epidemic in populations where there is overlap between those infected with HIV and those infected with Mycobacterium tuberculosis. Intense transmission of M. tuberculosis increases the pool of HIV-infected people exposed to, and subsequently infected with, M. tuberculosis. In populations with high HIV prevalence, many people infected with HIV develop TB, and many TB patients are coinfected with HIV. Unfortunately, at present a very small proportion of all people infected with HIV have access to antiretroviral treatment. However, this proportion is sure to increase and clinicians involved in managing TB patients need to know about antiretroviral treatment. For these reasons this edition includes a new chapter on antiretroviral drugs in the treatment of HIV infection.

The new expanded framework for TB control and the strategic framework to control TB/HIV reflect the development of TB control policies since 1996. Chapter 2 incorporates these new policies.

With the above changes, the manual provides up-to-date guidance on clinical management of patients with TB and HIV.

This manual is mainly for doctors and other health professionals working in district hospitals and health centres in high HIV and TB prevalence countries. It deals mainly with sub-Saharan Africa, since this is the region most badly affected by HIV and HIV-related TB. However, we hope it will also be helpful in other parts of the world facing similar problems.

Facilities vary from hospital to hospital and from health centre to health centre. In this manual we assume your hospital has a small laboratory and X-ray service. Even if you do not have these facilities, the manual should still be useful. Health professionals who care for TB patients now need to know how to diagnose and treat TB, the principles of diagnosis and treatment of HIV and other HIV-related diseases. This manual will help you in this task.

The manual fits into a white coat pocket so you can use it on the ward, in the clinic and at home.There is not enough room in a pocket manual for all the possible information you may want to know about TB among HIV-infected people. So, at the end of each chapter there are suggestions for further reading. These suggestions include relevant books, background material, reviews and recent articles in journals.

Since English is not the first language of many of the people using this manual, the writing style is deliberately simple.You are welcome to send any comments on the manual to WHO.We will use your comments to help improve future editions. Many of the references in the manual are to WHO publications.To order copies of WHO publications, you should contact Marketing and Dissemination,World Health Organization, 1211 Geneva 27, Switzerland.

2 GLOSSARY AND ABBREVIATIONS

This glossary explains the abbreviations and acronyms and some of the terms used in this book.

ambulatory acquired resistance adherence to treatment adjuvant treatment AFB

agranulocytosis

AIDS

anorexia

atypical mycobacteria bactericidal bacteriostatic BCG

bronchiectasis bubo caseation chemotherapy

CD4 cells

coinfection contacts cotrimoxazole counselling able to walk resistance of Mycobacterium tuberculosis to anti-TB drugs in a TB patient who has previously received anti-TB treatment the patient taking the medicines as directed an addition to other treatment Acid-Fast Bacilli absence of polymorph white blood cells Acquired ImmunoDeficiency Syndrome loss of appetite for food AIDS-Related Complex AntiRetroviral Therapy AntiRetroViral (drug) nontuberculous mycobacteria kills bacteria stops bacteria from growing Bacille Calmette-Guerin irreversibly dilated bronchi with persistently infected sputum swollen, pus-containing lymph node tissue breakdown by TB bacilli, forming yellow-

white, cheese-like material treatment with drugs, e.g. anti-TB chemotherapy means treatment with anti-TB drugs

Computerized Axial Tomography subgroup of T-lymphocytes carrying CD4 antigens

Centers for Disease Control and Prevention (USA)

CytoMegaloVirus

Central Nervous System infection with different pathogens at the same time, e.g. Mycobacterium tuberculosis and HIV

people (often family members) close to a TB

patient and at risk of infection trimethoprim/sulfamethoxazole (TMP/SMX)

face-to-face communication in which one person

CSF CXR dactylitis default desensitization disseminated dormant DOT

dyspnoea DTO EDL EIA

erythema nodosum empirical treatment

EPTB

exudate false-negative test result false-positive test result FBC FDC

fluorochrome stain

gibbus

HAART

haemoptysis

HEPA

hilar hilum

(counsellor) helps another (patient/client) to make decisions and act on them CerebroSpinal Fluid chest X-ray inflammation of the fingers patient stopping treatment before completion way of overcoming hypersensitivity to a drug in a patient by gradual re-exposure to the drug spread throughout the body to many different organs sleeping or inactive

Directly Observed Treatment (supporter watches patient to ensure the patient takes the tablets)

shortness of breath

District TB Officer

Essential Drugs List

Enzyme ImmunoAssay painful, tender, red nodules over the front of the legs treatment for a certain condition without exact diagnostic confirmation by tests Expanded Programme on Immunization extrapulmonary TB;TB outside the lungs fluid with a high protein content and inflammatory cells in an area of disease a negative test result, when the true result is in fact positive a positive test result, when the true result is in fact negative Full Blood Count Fixed-Dose Combination stain shines brightly under ultraviolet light Global Drug Facility an acute angle in the spine due to vertebral collapse from TB

Highly Active AntiRetroviral Therapy coughing up of blood-stained sputum High Efficiency Particulate Air (filter mask) at the root of the lung the root of the lung Human Immunodeficiency Virus

HIV-negative HIV-positive HIV-related TB HIV status HIV test home care hypersensitivity reaction IEC IMCI

i.m. injection immunosuppressant drugs incidence induration infant initial resistance IPT

IUATLD

JVP KS

latent lesion LIP LFTs MAC

MDR-TB

meningism monotherapy mutant bacilli absence of (antibodies against) HIV presence of (antibodies against) HIV TB occurring in somebody infected with HIV presence or absence of HIV blood test for antibodies against HIV care for a patient at home rather than in hospital immunological reaction to even a small amount of a drug or other antigen, e.g. tuberculin Information, Education and Communication Integrated Management of Childhood Illness intramuscular injection drugs that suppress normal immunity the number of new cases of a disease in a population in a given time (usually one year)

thickening, e.g. of the skin in a tuberculin test child less than 12 months of age resistance of Mycobacterium tuberculosis to anti-TB

drugs in a TB patient who has never before received anti-TB drugs

Isoniazid Preventive Treatment

International Union Against Tuberculosis and Lung

Disease

Jugular Venous Pressure Kaposi Sarcoma something that is there but not obvious (it can become obvious later)

an area of damage or injury to a tissue or organ Lymphocytic (lymphoid) Interstitial Pneumonitis Liver Function Tests

Mycobacterium Avium intraCellulare (one of the atypical mycobacteria) Mean Corpuscular Volume Multidrug-resistant TB

presence of clinical features suggestive of meningitis, e.g. headache, neck-stiffness, positive Kernig's sign treatment with one drug bacilli that suddenly change genetically and become different from the rest of the population mutation

NNRTI

NsRTI

NtRTI

NSAID

opportunistic infection PAL

passive case-finding pathogenesis PCP

pericardial effusion phlyctenular conjunctivitis

PGL PHC PI

pleural effusion

PLWH

pneumothorax PPD

preventive treatment PTB

PTB suspect regimen relapse a sudden genetic change, e.g. a bacillus becoming drug-resistant

NonGovernmental Organization non-nucleoside reverse transcriptase inhibitor nucleoside reverse transcriptase inhibitor nucleotide reverse transcriptase inhibitor Non-Steroidal Anti-Inflammatory Drug National TB Programme an infection that "takes the opportunity" to cause disease when a person's immune defence is weak

Practical Approach to Lung Health detection of TB cases by active testing (sputum smear) of TB suspects how a disease arises

Pneumocystis Carinii Pneumonia (now known as Pneumocystis jiroveci)

accumulation of fluid in the pericardial cavity painful hypersensitivity reaction of the conjunctiva to primary TB infection, with inflammation and small red spots where the cornea meets the sclera

Persistent Generalized Lymphadenopathy Primary Health Care Protease inhibitor accumulation of fluid in the pleural space People Living With HIV Progressive multifocal lenkoencephalopathy accumulation of air in the pleural space Purified Protein Derivative (tuberculin) treatment aimed at preventing disease, e.g. isoniazid for the prevention of TB in certain circumstances Pulmonary TuBerculosis patient presenting with features that make the health worker think the patient may have PTB, most importantly cough of more than 3 weeks' duration a drug, or several drugs, given in certain doses for a stated duration disease starting again after a patient was declared cured

RNA

Ribonucleic acid

RTI

Reverse transcriptase inhibitor

SCC

Short-Course Chemotherapy

scrofula

tuberculous lymph nodes in the neck

sensitivity test

test of TB bacilli for sensitivity or resistance to

anti-TB drugs

seroconversion

the first appearance of HIV antobodies in the

blood, usually about 3 months after HIV infection

seroprevalence

the proportion of people testing seropositive (e.g.

for HIV) in a population at any one time

slim disease

HIV-related chronic diarrhoea and weight loss

spinal block

obstruction to normal flow of CSF around the

spinal cord

sputum smear

absence of AFBs on sputum microscopy

negative

sputum smear

presence of AFBs on sputum microscopy

positive

STI

Sexually Transmitted Infection

Stevens-Johnson

a characteristic rash with "target lesions" and

syndrome

inflammation of the mucous membranes

syndrome

a group of symptoms and signs

TB

TuBerculosis

TB suspect

patient with symptoms suggestive of TB

TB/HIV

TB and HIV coinfection

TB/HIV patient

HIV-infected TB patient

TEN

Toxic Epidermal Necrolysis

thrombocytopenia

low platelet count

T-lymphocytes

type of lymphocyte providing cellular immunity

TMP-SMX

TriMethoPrim-SulfaMethoXazole

tubercles

small rounded areas of TB disease

tuberculin

protein extracted from TB bacilli (PPD)

tuberculoma

rounded area of TB disease, usually 1cm or more

wide

UNICEF

United Nations Children's Fund

VCT

Voluntary Counselling and Testing (for HIV)

WHO

World Health Organization

window period

the gap of about 3 months between the time

when a person becomes infected with HIV and

the time when antibodies first appear in the blood

ZN stain

Ziehl-Neelsen stain

I I INTRODUCTION

Untreated HIV infection leads to progressive immunodeficiency and increased susceptibility to infections, including TB. HIV is driving the TB epidemic in many countries, especially in sub-Saharan Africa and, increasingly, in Asia and South America.TB in populations with high HIV prevalence is a leading cause of morbidity and mortality.TB programmes and HIV/AIDS programmes therefore share mutual concerns. Prevention of HIV should be a priority for TB control; TB care and prevention should be priority concerns of HIV/AIDS programmes. TB and HIV programmes provide support to general health service providers. Previously TB programmes and HIV/AIDS programmes have largely pursued separate courses. However, a new approach to TB control in populations with high HIV prevalence requires collaboration between these programmes.

HIV infection increases the demands on TB programmes, which are struggling to cope with the increased TB case load. The impact of HIV exposes any weaknesses in TB control programmes. The rise in TB suspects is putting a strain on diagnostic services. Extrapulmonary and smear-negative pulmonary TB cases, which are more difficult to diagnose, account for an increased proportion of total cases.There are more adverse drug reactions.There is a higher morbidity and mortality, partly due to other, curable, HIV-related infections. The risk of TB recurrence is higher. The diagnosis of TB in young children has always been difficult and is even more so with HIV.

The objectives of a TB control programme are to decrease morbidity, mortality and transmission of TB, while avoiding the emergence of drug resistance. Up to now, the efforts to tackle TB among HIV-infected people have mainly focused on implementing the DOTS strategy for TB control. At the heart of this strategy is the identification and cure of infectious TB cases (among patients presenting to general health services). This targets the final step in the sequence of events by which HIV fuels TB, namely the transmission of Mycobacterium tuberculosis infection by infectious TB cases. The expanded scope of the new approach to TB control in populations with high HIV prevalence comprises interventions against TB and interventions against HIV (and therefore indirectly against TB). Implementing this approach depends on TB and HIV programmes continuing their core activities and, in addition, collaborating in joint activities. These activities address areas of mutual interest, e.g. staff training, public education, drug supply, case detection and management, and surveillance.

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