module b 1 session 2

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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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



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



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



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



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



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



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



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



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



Clinical Stages

Clinical Stage I

1. Asymptomatic infection

2. Persistent generalized lymphadenopathy

(PGL)

Performance scale 1: asymptomatic, normal

activity



Clinical Stage II

Clinical Stage II

3. Weight loss,



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



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)



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



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



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

module b 1 session 2

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