CHIPS APPENDICES: VERSION 2.4

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1 CHIPS APPENDICES: VERSION 2.4 Page number Appendix 1 CDC classification of stages N, A and B 1 Appendix 2 CDC classification of stage C (AIDS) 2 Appendix 3 Definition of body fat changes 3 Appendix 4 Reason for starting, stopping or changing therapy 4 Appendix 5 Common adverse events related to ART 5 APPENDIX 1 CDC classification of stages N, A and B (Abbreviated from CDC 1994 classification) Clinical categories for children with human immunodeficiency virus (HIV) infection. CATEGY N: NOT SYMPTOMATIC Children who have no signs or symptoms considered to be the result of HIV infection or who have only one of the conditions listed in Category A. CATEGY A: MILDLY SYMPTOMATIC Children with two or more of the conditions listed below but none of the conditions listed in Categories B and C. Lymphadenopathy (>= 0.5 cm at more than two sites; bilateral = one site) Hepatomegaly Splenomegaly Dermatitis Parotitis Recurrent or persistent upper respiratory infection, sinusitis or otitis media CATEGY B: MODERATELY SYMPTOMATIC Children who have symptomatic conditions other than those listed for Category A or C that are attributed to HIV infection. Examples of conditions in clinical Category B include but are not limited to: Anaemia (<8 gm/dl), neutropaenia (<1,000/mm 3 ), or thrombocytopaenia (<100,000/ mm 3 ) persisting for longer than 30 days Bacterial meningitis, pneumonia or sepsis (single episode) Candidiasis, oropharyngeal (thrush), persisting for longer than 2 months in children > 6 months of age Cardiomyopathy Cytomegalovirus infection, with onset before 1 month of age Diarrhoea, recurrent or chronic Hepatitis Herpes simplex virus (HSV) stomatitis, recurrent (more than 2 episodes within one year) HSV bronchitis, pneumonitis, or oesophagitis with onset before 1 month of age Herpes zoster (shingles) involving at least two distinct episodes or more than one dermatome Leiomyosarcoma Lymphoid Interstitial Pneumonia (LIP) or pulmonary lymphoid hyperplasia complex Nephropathy Nocardiosis Persistent fever (lasting >1 month) Toxoplasmosis, onset before 1 month of age Varicella, disseminated (complicated chickenpox)

2 APPENDIX 2 CDC Classification of stage C (AIDS) (Abbreviated from CDC 1994 classification) Opportunistic Infections Candidiasis Coccidioidomycosis Cryptococcosis Cryptosporidiosis or Isosporiasis Cytomegalovirus disease Herpes simplex virus Histoplasmosis Atypical mycobacterial (M Avium or M Kansasii, other) disease Mycobacterium tuberculosis Toxoplasmosis Pneumocystis carinii pneumonia Progressive multi focal leukoencephalopathy Salmonella (non-typhoid) Septicaemia Severe recurrent documented bacterial infection Wasting Syndrome HIV encephalopathy Kaposi's Sarcoma Lymphoma Immunoblastic Sarcoma Definitions Oesophageal or respiratory tract Disseminated or extrapulmonary Extrapulmonary Chronic intestinal with diarrhoea for > 1 month Disseminated, with onset > 1 month of age Disseminated, with onset > 1 month of age, or chronic ulcer persisting > 1 month Disseminated or extra pulmonary Disseminated at site other than or in addition to lungs, skin, cervical or hilar lymphadenopathy Disseminated or extra pulmonary Of the brain with onset > 1 month of age Pneumonia Recurrent Recurrent Any combination of at least 2 of the following within a 2-year period: septicaemia, pneumonia, meningitis, bone or joint infection, abscess of internal organ or body cavity. Wasting syndrome in the absence of a concurrent illness other than HIV infection that could explain the following findings: a) persistent weight loss >10% of baseline b) downward crossing of at least two of the following percentile lines on the weight-for-age chart (e.g. 95th, 75th, 50th, 25th, 5th) in a child >1 year of age c) <5th percentile on weight-for-height chart on two consecutive measurements, >30 days apart plus a) chronic diarrhoea (i.e. at least two loose stools per day for >30 days) b) documented fever (for >30 days, intermittent or constant) At least one of the following progressive findings for at least two months in the absence of a concurrent illness other than HIV infection that could explain the findings: a) Failure to attain or loss of developmental milestones or loss of intellectual ability, verified by standard developmental scale or neuropsychological tests b) impaired brain growth or acquired microcephaly demonstrated by head circumference measurements or by brain atrophy demonstrated by computerised tomography or magnetic resonance imaging (serial imaging is required for children <2 years of age) c) Acquired symmetric motor deficit manifested by two or more of the following: paresis, pathologic reflexes, ataxia, or gait disturbance CNS or small cell, non cleaved (Burkitt or non-burkitt) Definitive diagnosis: microscopy (histology or cytology); culture; antigen detection Presumptive diagnosis: characteristic clinical presentation, supported by investigations other than microscopy or culture and after exclusion of other causes in the differential diagnosis. 2

3 APPENDIX 3 Definition of body fat changes Mild: (grade 1) Moderate: (grade 2) Severe: (grade 3) Noticeable only if specifically looked for. No change in clothes fitting (other than expected by normal increase in height due to normal growth). Easily noted by patient or clinician. Clothing has become tight or loose (other than expected by normal increase in height due to normal growth). Obvious to the casual observer. Has required a change in clothing, due to change in body shape not due to increase in height. APPENDIX 4 Reasons for starting, stopping or changing therapy Please give as many reasons as applicable for starting, stopping or changing therapy. Reasons have been separated into stop/start/change for clarity. See page 4 for summary of abbreviations. STOPPING TREATMENT/ STARTING SBSEQENT THERAPY) A Treatment failure (e.g. virological, immunological, and/or clinical failure) J Hyperlactataemia/lactic acidosis A1 Virological failure K Toxicity, not mentioned above / unspecified A2 Immunological failure - CD4 drop L Death A3 Clinical progression M Comorbidity A4 Resistance test result N B Abnormal fat redistribution O B1 Fat accumulation O1 Changing from a FDC to individual drugs (e.g. arrival from abroad, TDM results require change to individual drugs) Availability of more effective treatment (not specifically failure or side effect related) Simplified treatment available (e.g. BD to OD, individual drugs to FDC) B2 Lipoatrophy O2 Treatment too complex B3 Gynecomastia O3 Drug interaction C Concern of cardiovascular disease P Structured Treatment Interruption (STI) D Hypersensitivity reaction P1 nstructured treatment interruption D1 Rash Q D2 E F Hypersensitivity with fever and constitutional symptoms (include ABC hypersensitivity) Toxicity, predominantly from abdomen/g-i tract (incl. jaundice (e.g. from ATV)). Toxicity, predominantly from nervous system (e.g. anxiety, drowsiness, sleep disturbance) Q1 R S Patient's or parent s wish/decision, not specified above Non-compliance Physician's decision, not specified above (where reason not coded for, please specify) Pregnancy G Toxicity, predominantly kidneys ( upcr) T Study treatment (part of clinical trial) H I Toxicity, predominantly from endocrine system (e.g. insulin resistance) Toxicity, haematological (e.g. anaemia, neutropenia) V nknown (reason not known) 3

4 STARTING TREATMENT F 1 ST TIME CHANGING DOSE/FMLATION W Child taking MTC prophylaxis (at birth) Z X Y Asymptomatic HIV+ infant (HIV+ child <1yrs starting therapy as stated in clinical guidelines) Clinical guidelines (includes because symptomatic, CD4 decline etc) Z1 Z2 Body/size recalculation (dose change due to child growth) Change to adult dose Change in formulation T Study treatment (start of clinical trial) Z3 Change due to TDM results V nknown S Pregnancy N V Changing from a FDC to individual drugs nknown Abbreviations: ABC: Abacavir; ATV: Atazanavir; BD: twice daily; FDC: fixed dose combination; G-I: gastrointestinal; OD: once daily; TDM: therapeutic drug monitoring; upcr; urinary Protein Creatinine Ratio. APPENDIX 5 Common adverse events related to ART (These include but are not limited to the following list) (Adapted from NIH/DAIDS toxicity tables for grading severity of paediatric adverse events, November 2014; see for further information/ other events.) Event Grade 2 Moderate Grade 3 Severe Grade 4 Life-threatening Abacavir hyper-sensitivity reaction One or more of the following: fever, gastro-intestinal symptoms (nausea, vomiting, diarrhoea), rash (erythema that may be macular, maculopapular, urticarial or pruritic), and malaise and/or constitutional flu-like symptoms including myalgia. Grade as Symptoms. Alkaline phosphatase 2.5 <5.0 x LN 5.0 <10.0 x LN 10.0 x LN ALT 2.5 <5.0 x LN 5.0 <10.0 x LN 10.0 x LN Amylase (Pancreatic) or Amylase (Total), High 1.5 <3.0 x LN 3.0 <5.0 x LN 5.0 x LN AST 2.5 <5.0 x LN 5.0 <10.0 x LN 10.0 x LN Bilirubin <2.6 x LN 2.6 <5.0 x LN 5.0 x LN Calcium (low) (mg/dl (mmol/l)) 7 days old <7 days old Cholesterol (fasting, high) Creatinine (high) Glucose High, fasting High, non-fasting Low <7.8 ( <1.95) <7.0 (1.53 to < 1.75) <6.5 ( <1.63) <6.0 (1.38 to < 1.50) 5.15 <7.77 mmol/l 7.77 mmol/l > x LN increase of >0.3mg/dL (26.5µmol/L) above baseline <13.89 mmol/l <13.89 mmol/l <3.05 mmol/l >1.8 <3.5 x LN increase of 1.5 to < 2.0 x above baseline <27.75 mmol/l <27.75 mmol/l <2.22 mmol/l <6.1 (< 1.53) <5.50 (< 1.38) 3.5 x LN increase of 2.0 x above baseline mmol/l mmol/l <1.67 mmol/l 4

5 Event Grade 2 Moderate Haemoglobin (low) Female, age 13yrs 85 - < 95 g/l Male, age 13yrs 90 - < 100 g/l age 57 days to <13 yrs 85 - < 95 g/l (for infants <57 days old refer to DAIDS tables) LDL (fasting, high) age >2yrs to 18yrs Grade 3 Severe 65 to < 85 g/l 70 to < 90 g/l 65 to < 85 g/l <4.9 mmol/l 4.9 mmol/l < 65 g/l < 70 g/l < 65 g/l Lipase (high) <3.0 x LN <5.0 x LN 5.0 x LN Lipodystrophy See Appendix 3 Neuropathy/ Lower Motor Neuronopathy Neutrophil Count (low) (for infants <8 days old refer to DAIDS tables) Phosphate (low) (mg/dl (mmol/l)) >14 yrs 1-14 yrs <1yr Platelets, Decreased (cells/mm 3 ; cells/l) Rash Mild transient Paraesthesia only. Persistent or progressive paraesthesias, burning sensation in feet, or mild dysaesthesia; no weakness; mild to moderate deep tendon reflex changes; no sensory loss. Grade 4 Life-threatening Onset of significant weakness, decrease or loss of DTRs, sensory loss in "stocking glove" distribution, radicular sensory loss, multiple cranial nerve involvement; bladder or bowel dysfunction, fasciculations, respiratory embarrassment from chest wall weakness. Grade 3 symptoms which do not resolve with dose reduction x x10 9 /L 0.400x x10 9 /L <0.400x10 9 /L <2 ( <0.81) <3 ( <0.97) <3.5 ( <1.13) <1.4 (0.32 to < 0.65) <2.5 (0.48 to < 0.81) <2.5 (0.48 to < 0.81) < 1.0 (< 0.32) < 1.5 (< 0.48) < 1.5 (< 0.48) 50,000 - <100,000 25,000 - <50,000 < 25, x x x <50.000x10 9 < x10 9 Diffuse rash Target lesions Diffuse rash AND Vesicles or limited number of bullae or superficial ulcerations of mucous membrane limited to one site Extensive or generalized bullous lesions lceration of mucous membrane involving two or more distinct mucosal sites Stevens-Johnson syndrome Toxic epidermal necrolysis Triglycerides (fasting, high) > mmol/l > mmol/l >11.4 mmol/l Other clinical symptoms (not specified above) Other laboratory values (not specified above) Note: LN = pper limit of normal range May require minimal intervention and monitoring. Sufficiently abnormal to require evaluation as to casualty and perhaps mild therapeutic intervention. Not of sufficient severity to warrant immediate changes in drugs. Requires medical care and possible hospitalisation. Sufficiently severe to require evaluation and treatment, including at least temporary suspension of drugs. Requires active medical intervention, hospitalisation, or hospice care. Life-threatening severity. Requires immediate evaluation, treatment, and usually hospitalisation. Questions and queries: Please contact Donna Dobson (CHIPS Data Manager) on The CHIPS team can be contacted on mrcctu.chips@ucl.ac.uk For further details of the CHIPS study, go to 5

Measure #161: HIV/AIDS: Adolescent and Adult Patients with HIV/AIDS Who Are Prescribed Potent Antiretroviral Therapy

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