Transcript 2-WHOStaging

Stages of Disease and
Initiating Therapy
HIV Care and ART: A Course for
Pharmacists
Introductory Case: Senait
 A 32 year-old Ethiopian woman recently diagnosed
with HIV comes to the clinic for her first evaluation
 She was feeling well until one month ago when she
began losing weight and became too weak to do her
routine chores. She remained in bed 3 days out of
the week for the past month. She has no other HIV
related complications
 At her last visit with her doctor she weighed 62 kg
and today her weight is 53 kg
 CD4 count testing is unavailable. TLC = 1250/mm3
2
Introductory Case: Senait (cont.)

According to the WHO Guidelines criteria for initiating
antiretroviral therapy in adults, which of the following
statements is true?
1. The occurrence of >10% loss of body weight is categorized as
clinical stage I and is not an indication for ART
2. >10% loss of body weight and performance scale 3 (bedridden <
50% of the day for the past month) are both considered clinical stage
III, which indicate that ART would be appropriate
3. ART is not indicated for an individual with a TLC count >1200/mm3
4. WHO stage IV disease is considered clinical AIDS and is the only
indication to begin ART in resource limited settings
3
Unit Learning Objectives
 Define WHO disease staging system
 Identify the goals of HAART
 Identify when it is appropriate to start ART for
individuals and implement ART countrywide
 Recognize the role of the pharmacist in HIV/ART
care
4
HIV Disease Staging
Why Staging?
 To assess disease severity, and to monitor disease
progression
 To get reliable information about prognosis and
criteria to initiate ART
 To avoid unnecessary exposure to adverse effects
 Lower expenses through selecting patients with
critical need
 Compliance may be poor among healthy individuals
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WHO Staging System for
HIV/AIDS: Overview
 Ethiopia uses the WHO Staging System
 Tool used to guide management of HIV patient in
resource limited settings
 Clinically based; CD4 count not required
 Simple, flexible and widely used
 Revised: Interim African version 2005
 Utilizes 5 clinical stages based on the degree of
immunocompromise and prognosis
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WHO Staging of HIV/AIDS
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Primary HIV Infection
Stage I - asymptomatic
Stage II - mild disease
Stage III - moderate disease
Stage IV - advanced immunocompromise
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WHO Clinical Stage I
 Asymptomatic or
 Persistent generalized lymphadenopathy (PGL)
 Swollen lymph nodes will present bilaterally in the cervical
area, under the arm, or groin. Usually not painful.
 Performance scale 1: able to carry on normal activity.
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Persistent Generalized
Lymphadenopathy (PGL)
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Courtesy of Charles Steinberg MD
Introductory Case: Senait (cont.)
1. The occurrence of >10% loss of body weight is
considered clinical stage I and is not an indication
for ART
FALSE
The occurrence of >10 % of body weight is
categorized as clinical stage III, which is an
indication for ART, regardless of CD4 or TLC
11
WHO Clinical Stage II
 Moderate unexplained weight loss (<10% of
presumed or measured body weight)
 Recurrent upper respiratory tract infections
 Herpes zoster
 Angular cheilitis
 Recurrent oral ulcerations
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WHO Clinical Stage II (2)




Papular pruritic eruptions
Seborrheic dermatitis
Fungal fingernail infections
And/or performance scale 2
 Normal activity with effort, but unable to do active work,
requires occasional assistance but is able to care for most
needs.
13
Pruritic Papular Eruption (PPE)
Photograph courtesy of Charles Steinberg MD
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Pruritic Papular Eruption (2)
Photograph courtesy of Charles Steinberg MD
15
Seborrheic Dermatitis (Dandruff)
16
Courtesy of Dr. R. Ojoh, www.thachers.org
Folliculitis
© Slice of Life and Suzanne S. Stensaas
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Apthous Ulcer
18
Source: www.HIVdent.org. Copyright © 1996-2000 David Reznik, D.D.S.
Dermatomal Herpes (Varicella) Zoster
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Image courtesy of Tom Thacher, MD
Dermatomal Herpes (Varicella) Zoster
20
Courtesy of the Public Health Image Library/CDC
WHO Stage III
 Conditions where a presumptive diagnosis can be made on
the basis of clinical signs or simple investigations
• Severe weight loss (>10% of presumed or measured body weight)
• Unexplained chronic diarrhoea for longer than one month
• Unexplained persistent fever (intermittent or constant for longer
than one month)
• Oral candidiasis
• Oral hairy leukoplakia
• Pulmonary tuberculosis (TB) diagnosed in last two years
• Severe presumed bacterial infections (e.g. pneumonia, empyema,
pyomyositis, bone or joint infection, meningitis, bacteraemia)
• Acute necrotizing ulcerative stomatitis, gingivitis or periodontitis
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WHO Stage III (2)
 Conditions where confirmatory diagnostic testing is
necessary:
 Unexplained anaemia (<8 g/dl), and or
 Neutropenia (<500/mm3) and or
 Thrombocytopenia (<50 000/ mm3) for more than one
month
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Introductory Case: Senait (cont.)
2. >10% loss of body weight and performance scale 3
(bedridden <50% of the day for the past month) are
both considered clinical stage III, which indicate that
ART would be appropriate
TRUE
23
Oral Candidiasis
24
Source: http://members.xoom.virgilio.it/Aidsimaging
Oral Hairy Leukoplakia
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Courtesy of Dr. R. Ojoh, www.thachers.org
WHO Stage IV
 Conditions where a presumptive diagnosis can be made on
the basis of clinical signs or simple investigations:
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HIV wasting syndrome
Pneumocystis pneumonia
Recurrent severe or radiological bacterial pneumonia
Chronic herpes simplex infection (orolabial, genital or anorectal of
more than one month’s duration)
Oesophageal candidiasis
Extrapulmonary TB
Kaposi’s sarcoma
Central nervous system (CNS) toxoplasmosis
HIV encephalopathy
Performance Scale 4: bedridden > 50% of the day during the last
month
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WHO Stage IV (2)
 Conditions where confirmatory diagnostic testing is
necessary:
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Extrapulmonary cryptococcosis including meningitis
Disseminated non-tuberculous mycobacteria infection
Progressive multifocal leukoencephalopathy (PML)
Candida of trachea, bronchi or lungs
Cryptosporidiosis
Isosporiasis
Visceral herpes simplex infection
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WHO Stage IV (3)
 Conditions where confirmatory diagnostic testing is
necessary:
 Cytomegalovirus (CMV) infection (retinitis or of an organ
other than liver, spleen or lymph nodes)
 Any disseminated mycosis (e.g. histoplasmosis,
coccidiomycosis, penicilliosis)
 Recurrent non-typhoidal salmonella septicaemia
 Lymphoma (cerebral or B cell non-Hodgkin)
 Invasive cervical carcinoma
 Visceral leishmaniasis
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Cytomegalovirus Retinitis
 Afebrile patient
 Reduced vision in
one or both eyes
 Painless
 External eye
exam normal
 Retinal exudate
and hemorrhage
follow retinal
vessels
From Ahmed I et al. Ophthalmic Manifestations of HIV.
HIV Insite 2005. http://hivinsite.ucsf.edu
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Wasting Syndrome
30
© ITECH India, 2005
Kaposi’s Sarcoma (KS)
 Usually, multiple dark
raised lesions
 Lesions themselves
are not itchy and
are rarely painful
Courtesy of Tom Thacher, MD
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Kaposi’s Sarcoma
Courtesy of Toby A. Maurer, MD, Timothy G. Berger, MD,
From HIV InSite Knowledge Base
Courtesy of CDC, Dr. Steve Kraus
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Oral Kaposi’s Sarcoma
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Courtesy of Tom Thacher, MD
Severe Chronic Herpes Simplex Ulcers
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© Slice of Life and Suzanne S. Stensaas
Molluscum Contagiosum and Cryptococcus
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Esophageal Candidiasis
 HIV infected patient
with oral candidiasis
and chest (sub-sternal)
pain with swallowing
has presumed Candida
esophagitis
 Endoscopy would
prove the diagnosis
but is unnecessary if the patient responds to antifungal therapy
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Esophageal Candidiasis
 Linear ulcerations of the
esophagus as seen on
barium x-ray
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Source:http://members.xoom.virgilio.it/Aidsimaging
When to Start Anti-Retroviral
Therapy (ART)
Starting ART is NOT an Emergency!!
Time is needed to educate patient about ART
and to identify potential adherence barriers
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Convincing Patients
 Give patients reasons ART is not an emergency
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Early ART is expensive
ART has side effects
There is potential for resistance development
Early treatment limits future treatment options when
immunity gets weaker
 HIV does not progress overnight to AIDS or from AIDS to
death
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WHO Guidelines: Criteria for Initiating ART in
Adults, Adolescents, and Pregnant Women
If CD4 Cell Testing Is Available
Clinical Category
Stage IV
(Symptomatic)
Stage III*
Stage I or II
CD4 Cell Count
Recommendation
Any Value
Treat
CD4 cells < 350/mm3 to
assist in decision making
Treat
CD4 cells < 200/mm3
Treat
Source: Guideline for Use of Antiretroviral Drugs in Ethiopia. MOH, January 2005. p. 4
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WHO Guidelines: Criteria for Initiating ART in
Adults, Adolescents, and Pregnant Women
If CD4 Testing is NOT Available
Clinical Category
Total Lymphocyte
Recommendation
Count (TLC)
WHO Stage IV
Any Value
WHO Stage III
(Symptomatic)
Any Value
WHO Stage II
<1200/mm3
Treat
Treat
Treat
Source: Guideline for Use of Antiretroviral Drugs in Ethiopia. MOH, January 2005. p. 4
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Introductory Case: Senait (cont.)
3. ART is not indicated for an individual with a TLC
count >1200/mm3
DEPENDS
If CD4 counts are unavailable, it is recommended
that individuals receive ART when TLC is <
1200/mm3 in clinical stage 2 disease only. If an
individual has clinical stage III or IV disease,
therapy is indicated regardless of TLC
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Introductory Case: Senait (cont.)
4. WHO stage IV disease is considered clinical AIDS and is the
only indication to begin ART in resource limited settings
FALSE

Indications for starting ART include:
•
If CD4 testing is available:
•
•
•
•
Stage IV regardless of CD4 count
Stage III with consideration of CD4 counts < 350/ mm3
Stage I or II if CD4 < 200/ mm3
If CD4 testing is unavailable:
•
•
Stage III or IV disease regardless of TLC
Stage II if TLC < 1200/mm3
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Initiating HAART Treatment
What is HAART (ART)?
 HAART = Highly Active Antiretroviral Therapy
 The HAART and ART acronyms may be used interchangeably
 ART is not a cure. ART cannot eliminate HIV completely
 ART includes at least three compatible antiretroviral agents
 Treatment:
 Controls HIV
 Allows the body to rebuild its immune system (its ability to fight
infections)
 Reduces the chance that a mother will pass HIV to her baby during
pregnancy, birth or breastfeeding
 If treatment is stopped, the virus will increase
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Goals of ART
 Prolong and improve quality of life
 Reduce viral load
 HIV RNA < 400 copies/mL or “undetectable” within 4-6
months of ART initiation is good achievement
 Ultrasensitive assay goal is < 50 copies/mL
 Immune reconstitution
 Maintain treatment options
 Reduce HIV transmission
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How Long Will Treatment
Keep People Alive?
 We don’t know
 ART is still very new in Africa and Asia
 BUT:
 Where enough drugs are available to take several
combinations, people are still doing well after 10 years with
good adherence to treatment
 We are all working together in a great effort to make the
best use of limited resources
 Everyone has a part to play
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Factors to Consider When
Starting Therapy
 Ethiopia ARV guidelines
(Jan 2005)
 Potential side effects
 Concurrent health
conditions
 Including abnormal laboratory
values
 Drug interactions
 Potential for pregnancy
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Prior antiretroviral use
Antiretroviral resistance
Future treatment options
Conditions for storing
medications
 Patient ability to follow-up in
clinic and laboratory
monitoring requirements
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Factors to Consider When
Starting Therapy (2)
 Potential barriers to adherence
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Recent HIV diagnosis (limited time to process information)
Patient life-style and preferences
Limited ability to follow-up in clinic
Live far from clinic
Compromised food access
Limited support from family / friends
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Conditions for Implementing
HAART Country-wide
 Easy access to VCT for early diagnosis of HIV
 Long-term sustainable national free ARV program
 Counseling for the patient, their supporters, and
caregivers on HAART, treatment compliance, timing
of drug intake and possible side effects
 Follow-up counseling to ensure continued
psychosocial support and to enhance adherence to
treatment
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Conditions for Implementing
HAART Country-wide (2)
 Healthcare capacity to recognise and appropriately
manage common HIV related illnesses, opportunistic
infections and adverse reactions to ARVs
 Reliable laboratory monitoring services for the
detection of drug toxicity and response to therapy
 Assurance of an adequate supply of quality drugs
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Conditions for Implementing
HAART Country-wide (3)
 Availability of trained interdisciplinary health teams,
including doctors, nurses, pharmacists, counselors,
social workers. These teams should work closely
with support groups of PLWHA and their caregivers
 Availability of a system for training, continuous
education, monitoring and feedback on management
of HIV disease and HAART
 Availability of appropriate care, support services and
referral mechanisms in case of treatment failure
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Role of the Pharmacist in HIV
Care and HAART
Role of the Pharmacist
 Discuss the treatment regimen properties and
selection with health care professionals, considering
efficacy, safety, cost, convenience and availability
 Define monitoring parameters (TLC, CD4, LFT, etc)
 Review medication side effects, short and long term
and their management
 Discuss potential drug-drug, drug-food, or drugalternative medicines interactions to avoid with ART
 Explain medication dosing and how to handle missed
doses
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Role of the Pharmacist (2)
 Discuss importance of regular follow-up to assess
clinical efficacy/failure of therapy and to detect drug
related toxicity
 Give the patient contact information in case of
questions
 Discuss importance of adherence and how that
impacts resistance development
 Reassure the patient that you will keep all
information related to him/her and their health care
confidential
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Role of the Pharmacist (3)
 Explain to the patient that drugs have more than one
name and strength, therefore they must take only
what they’ve been given
 Schedule follow-up appointment for refills and check
to see how the patient is doing
 Provide written drug information, if possible
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Case Studies
Case Study: Desta
 A 37 year-old Ethiopian woman presents with a one year
history of recurrent and persistent vaginal candidiasis, which
has not responded to over the counter antifungal therapy
 HIV ELISA test was negative 1 yr ago. Repeat ELISA was
positive and the patient was referred to your clinic
 Past Medical History (PMH): negative per her history
 Social History (SH): lives alone, earns 500 birr/mo, no alcohol
(ETOH), has one current sex partner but does not use
condom or birth control, poor literacy
 Review of Systems (ROS): non-contributory
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Case Study: Desta (2)
 Emotionally distraught and tearful
 Temp 37, Wt 55kg, Ht 5’5”
 Head, eyes, ears, nose, and throat (HEENT): all
normal
 Cardiovascular system (CVS), Lungs, Abdomen: all
normal
 Skin: seborrheic dermatitis of face
 Pelvic: thick, white discharge, KOH+ (Potassium
hydroxide solution)
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Case Study: Desta (3)
1. What is her current WHO stage?
2. Is she a candidate for ART?
3. What are the immediate health care issues to be
addressed at this visit?
4. What other issues need to be addressed before
ART is considered?
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Case Study: Desta Follow-up (4)
 Other issues that should be addressed
 Refer her to counselor to discuss HIV prevention efforts
 Assess potential for pregnancy
 Perform physical exam
• Sexual history
• Social history
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Case 2
Case Study: Mengistu
 Mengistu is a 28 year-old man from a rural area who has
been HIV+ for 3 or more years. He recently moved into the
city and is establishing care at the local hospital. He is
antiretroviral (ARV) naïve and wishes to consider starting
medications as he has heard about the new HIV medications
that are helping people with HIV live longer and thinks this
would be good for him
 His TLC is 1350; he feels fatigued; has lost about 4 kg over
the last 3 months and has noticed that his neck feels swollen
and tender on one side; he does not report ever having a
serious infection or illness
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Case Study: Mengistu (2)
 What stage of disease is he?
 Should Mengistu be started on ART?
 What factors should be considered in deciding
whether to start medications or not?
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Case 3
Case Study: Tamarat
 Tamarat, a 25 year-old male, presents to your clinic
following hospitalization 1 week ago for severe
headaches (presumed toxoplasmosis), where he
learned he is HIV positive. He brings documentation
confirming his HIV status. Also currently being
treated for pulmonary TB x4 months, responding well
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Case Study: Tamarat (2)
 Physical exam
 Significant lower leg numbness and weakness.
 Current weight = 47kg (down from 54kg).
 PMH
 Hx of Pulmonary TB 2 years ago (treated x8 months)
 Labs
 TLC – 350
 Hgb – 14.1
 AST - 32
CD4 – 56 (5%)
HCT – 40%
ALT - 28
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Case Study: Tamarat (3)
 Social History
 Single male with girlfriend (not present).
 Currently working, earning 800 birr/mo.
 Moderate alcohol use with sporadic binging.
 Current Medications
 Isoniazid and Ethambutol x 4 months
 Fansidar x 7 days
 B-Complex daily
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Case Study: Tamarat (4)
1. Is he a good candidate for ARVs at this time?
2. What is his WHO HIV disease stage?
3. Will you start ART now?
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Case 4
Case Study: Melke
 Melke is a 30 year-old woman who was just
diagnosed with HIV at a VCT center. She comes to
Zewditu Hospital for her first appointment with a
physician specializing in HIV. Her laboratory values
indicate that it is appropriate for her to begin ART
 TLC = 900/mm3 (not able to get CD4 cell count)
 LFTs = normal
 Hgb/Hct = normal
 PMH includes: 8 kg weight loss over the previous 4
months. Her current weight now is 52kg
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Case Study: Melke (2)
 What factors should be considered in deciding which
medications would be best for an antiretroviral-naïve
individual?
 If Melke were to start on ART, what type of ARTrelated information should the pharmacist counsel
her about?
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Key Points
 ART is an important piece of the clinical care of the
HIV patient but is not the entire care spectrum and is
NOT an emergency
 Initiate ART at appropriate WHO staging and when
adherence can be maximized
 Numerous factors must be considered before
starting ART
 A multidisciplinary team approach is essential to
patient adherence and favorable patient outcomes
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