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7/29/2019 Module b 1 Session 2
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Part B Module B1 Session 2
When to Start
ARV Therapy in Adults
Part B: Module B1
Session 2
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Part B Module B1 Session 2
Objectives
1. Discuss the rationale and timing for ART initiation,including the pros and cons of the different criteria.
2. Describe the objectives of a clinical patient
evaluation for ART initiation.
3. Discuss the WHO clinical classification system and
its use in deciding when to initiate ART.
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Rationale and Timing of ARV Initiation
A. Typical course of HIV infection and progression of
AIDS to death with and without ART
B. When and how to start ARV therapy:
A patient needs ART only when symptomatic
and/or there is evidence of significant
immune system damage
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Rationale and Timing ofARV initiation, continued
Do not start ART if:
the patient is not motivated without intensive counseling
if treatment cannot be continued
patient has poor renal/hepatic function
patient is asymptomatic and there is no CD4 data
laboratory monitoring is not possible
there is no access to diagnosis and treatment ofOIs
during an acute opportunistic infection (includingTB)
In the presence of terminal incurable disease, e.g.cerebral lymphoma
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How to start:
First-line therapy: The simplest, cheapest,
effective 3-drug combination
Second-line therapy: Select the next one or
two combinations
Rationale and Timing ofARV initiation, continued
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Clinical Evaluation for ART
Elements of ART clinical evaluation
Establish presence of HIV infection through: history and physical exam
voluntary counseling and testing (results frompatients seeking a test while not hospitalized orseeking clinical care)
counseling and testing (for diagnostic purposes)
Establish status of HIV disease, e.g., which OIs arepresent
Discuss the need for ARV therapy
when to start and what to use Discuss adherence and other issues
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Obtain basic laboratory support and establish
baseline laboratory test results
Absolute minimum tests: HIV test; hemoglobin
or hematocrit level
Basic tests: WBC count; Liver function tests(LFTs) and renal function tests (RFTs); blood
sugar; lymphocyte count
Desirable tests: CD4; amylase; bilirubin; lipids
Optional: Viral load
Clinical evaluation for ART, contnued
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Get a baseline medical history
Psychosocial history
Essential demographic characteristics
Family economic status
Family coping
Length of time since diagnosis of HIV infection, currentmedications, and symptoms
Past medical history including major illnesses (e.g.,
tuberculosis), hospitalizations, and surgeries, past
medications and allergies
For women, pregnancy history (gravida)current or plannedpregnancy and access to contraceptive services
Clinical evaluation for ART, continued
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Baseline physical exam:
Vital signs
Weight and detailing of any abnormalities(including fundi if possible)
Oropharynx
Lymph nodes Lungs
Heart
Abdomen
Extremities Nervous system
Genital tract
Clinical evaluation for ART, continued
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Stage I: Asymptomatic, generalized lymphadenopathy
Stage II: Weight loss 10%, chronic diarrhea or fever, oral
candidiasis/HL, pulmonary TB, severe bacterial
infections
Stage IV: AIDS-defining illnesses: e.g HIV wasting syndrome,PCP, brain toxoplasmosis, candida oesophagitis,extra-pulmonary TB, CMV retinitis, Kaposis
sarcoma, non-Hodgkins lymphoma and/orperformance score 4: bedridden >50% of the dayduring the last month
WHO Clinical Classification System
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Adults: When to start ART
WHO stage IV disease (clinical AIDS) irrespectiveof CD4 cell count (CD4 cell count irrelevant)
2003 WHO guidelines: for stage III use
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Children: When to start ART (see Module 2,
Session 3 for more details)
18 months: Stage III or stages I &
II disease + CD4 < 15%. An assessment of viral
load is not considered essential to start therapy
WHO Clinical Classification System, continued
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Table 1. Recommendations for Initiating Antiretroviral Therapy in Adults
and Adolescents with Documented HIV Infection
If CD4 Testing Available: WHO Stage IV disease irrespective of CD4 cell count
WHO Stage I, II, III [3] with CD4 cell counts < 200/mm3 [1]
If CD4 Testing Unavailable:
WHO Stage IV disease irrespective of total lymphocyte count
WHO Stage II or III [3] disease with a total lymphocyte count
< 1000-1200/mm3 [2]
NOTES T bl 1 R d ti f I iti ti
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1]The precise CD4 level above 200/mm3 at which to start ARV
treatment has not been established but the presence of symptomsand the rate of CD4 cell decline (if measurement available) should befactored into decision making2 A total lymphocyte count of
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The WHO Clinical Staging System
A. The WHO staging system includes a clinical
classification system and a laboratoryclassification to categorize theimmunosuppression of adults by theirtotallymphocyte counts
B. This staging system has been proven reliable forpredicting morbidity and mortality in infectedadults
C. The WHO Clinical Staging System is based on
clinical markers believed to have prognosticsignificance resulting in four categories. It ishelpful to incorporate a patient performance scaleinto the system.
C S
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Clinical Stages
Clinical Stage I
1. Asymptomatic infection
2. Persistent generalized lymphadenopathy
(PGL)
Performance scale 1: asymptomatic, normal
activity
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Clinical Stage II
Clinical Stage II
3. Weight loss,
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Clinical Stage III
Clinical Stage III
7. Weight loss, >10% of body weight
8. Unexplained chronic diarrhea, > 1 month
9. Unexplained prolonged fever (intermittent or
constant) >1 month
10. Oral candidiasis (thrush)
11. Oral hairy leukoplakia
12. Pulmonary tuberculosis within the past year
13. Severe bacterial infections (e.g. pneumonia,
pyomyositis)
** Performance scale 3:
bedridden
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Clinical Stage IV
Clinical Stage IV
14. HIV wasting syndrome, as defined by the Centersfor Disease Control
15. Pnemocystis carinii pneumonia (PCP)
16. Toxoplasma of the brain
17. Cryptosporidiosis with diarrhea >1 month
18. Cryptococcosis, extrapulmonary19. Cytomegaloviral disease of an organ other than the
liver, spleen, or lymph node
20. Herpes simplex virus infection, mucocutaneous (>1
month) or visceral (any duration)21. Progressive multifocal leukoencephalopathy (PML)
22. Any disseminated endemic mycosis (e.g.
histoplasmosis, coccidioidomycosis)
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Clinical Stage IV continued
Clinical Stage IV, continued
23. Candidiasis of the esophagus, trachea, bronchi,and lungs
24. Atypical mycobacteriosis, disseminated
25. Non-typhoid Salmonella septicemia
26. Extrapulmonary tuberculosis27. Lymphoma
28.Kaposis sarcoma (KS)
29.HIV encephalopathy, as defined by the Centers
for Disease Control
** Performance scale 4: bedridden >50% of the day
during lastmonth
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WHO Improved Clinical Staging System
A further refinement of the WHO clinical staging system
includes a laboratory axis
The laboratory axis subdivides each category into 3
strata (A, B, C) depending on the number of CD4 cells
If this is not available, one can use total lymphocytes as
an alternative marker
L b t i Cli i l i
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Lymphocytes* CD4**
Stage 1Asympto-
matic.PGL
Stage 2
Early
HIV
Stage3Inter-
mediate(ARC)***
Stage 4
Late
AIDS
A >2000 >500 1A 2A 3A
B 1000-2000 200-
500
1B 2B 3B
C
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WHO ImprovedClinical Staging System, continued
N.B. The reference values used for lymphocytes and
CD4 count are based on data available from the
developed world. There are indications that Africans
may have a physiologically higher lymphocyte count.Projects with laboratory equipment to conduct
lymphocyte counts in HIV patients should, if possible,
collect data about lymphocyte counts and CD4 counts
and correlate themwith the disease stage.
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P B M d l B1 S i 2
Thank You