2. Steps to Successful ART
• ART is not an emergency however, there is
need to initiate ART as soon as possible
• Try to diagnose and treat before the immune
system is severely suppressed (when the CD4
count is very low)
– If ART is started too late, the patient will be at high risk for
clinical complications of AIDS
3. Steps to Successful ART
• The first shot is the best shot at sustained
viral suppression and long term clinical
success
• Use it wisely !
– ART is almost never an emergency. Take your time and do it right
– Check patient readiness, address psychosocial issues, provide
psychosocial support
– Conduct patient education at a digestible pace
– Make detailed, patient-specific, and realistic adherence plans
4. Steps to Successful ART
• The first regimen is critically important.
Choose your triple therapy with care.
– Highly active
– Minimal pill burden
– Durable effects
– Acceptable side effects/ toxicity
– Logical sequencing
– Consistent with national guidelines
5. When to Start ART
ART is rarely an emergency:
• Be sure the HIV diagnosis is confirmed
• Conduct a careful clinical and laboratory baseline assessment
• Stage the patient’s illness using the WHO staging system
• Review the results of the patient’s CD4 cell count and other
lab results (where available)
• Start OI prophylaxis (if indicated) and manage side effects
• Provide patient teaching – side effects and their
management, how to stop if necessary, how to contact clinic
• Plan for adherence
6. Starting ART: Four Simple Questions
1. Does the patient have a medical
indication for ART?
2. Does the patient have a medical
contraindication to the first-line regimen?
3. Is the patient pregnant?
4. Does the patient have a non-medical
contraindication to ART?
7. Question #1:
Medical indication for ART?
• As we have noted, not all individuals with
HIV need to take ART at the time of
diagnosis / presentation
• There are specific and standardized
eligibility criteria that tell us who will
benefit the most from ART
– Consistent with WHO guidelines
– Consistent with RSS guidelines
8. ART Eligibility (Adults)
If CD4 available:
• All patients regardless of WHO Clinical stage and/or
• All patients regardless of CD4 cell count
If no CD4 available:
• All patients regardless of CD4 or WHO clinical
9. • As a priority, ART should be initiated in all
Adults & Adolescents:
• WHO clinical stage 3 or 4
• CD4 count ≤350 cells/mm³
ART eligibility (Adult)
10. • ART should be initiated in all children ≤5 years with
confirmed HIV +ve result, regardless of WHO
clinical stage or at any CD4 cell count
ART eligibility (children)
11. • As a priority, ART should be initiated in all children ≤2
years of age or children <5 years of age with
• WHO clinical stage 3 or 4 or
• CD4 count ≤750 cells/mm³ or CD4 percentage <25%,
– Children 5 years of age and older
• WHO HIV clinical stage 3 or 4 disease or
• CD4 count ≤500 cells/mm³
– All infants under 18 months of age with a
presumptive diagnosis of HIV
ART eligibility (children)
12. Eligibility Adult: Summary
Recommendation
Initiate ART regardless of CD4 or Clinical
stage
Initiate ART regardless of CD4 or Clinical
stage
Initiate ART regardless of CD4 or Clinical
stage
Initiate ART regardless of CD4 or Clinical
stage
Initiate ART regardless of CD4 or Clinical
stage
Initiate ART in all clients regardless of
WHO Clinical stage
Target Population
HIV Infection (WHO clinical Stage 1 or 2
or 3 or 4)
Severe/ Advanced HIV infection
(WHO Clinical stage 3 or 4)
TB co-infection
Hepatitis B co-infection
HIV Sero-discordant couples
CD4 ≤500 cells/mm³
13. Eligibility Children: Summary
Recommendation
Initiate ART in all clients regardless of CD4
cell count or WHO Clinical Stage
Initiate ART in all clients regardless of CD4
cell count or WHO Clinical Stage
Initiate ART in all clients regardless of CD4
cell count or WHO Clinical Stage
Initiate ART in all clients regardless of CD4
cell count or WHO Clinical Stage
Initiate ART in all clients¹
Target Population
≤ 5years with confirmed HIV +ve result
*Severe/ Advanced HIV infection
(WHO Clinical stage 3 or 4)
*HIV Infection (WHO clinical Stage 1 or 2)
[≤ 5years ]
*CD4 ≤500 cells/mm³
[>5years]
*All infants < 18 months of age with a
presumptive diagnosis of HIV
*Priority
14. When to Start ART in Adults and Adolescents
TARGET
POPULATION
(ARV NAIVE)
Previous ART
GUIDELINES
South Sudan
Consolidated
National
Guideline 2014
2016 ART
GUIDELINES
HIV+ (ADULTS
AND
ADOLESCENTS
)
CD4 ≤500 or clinical
stage 3 or 4
CD4 ≤500 or clinical
stage 3 or 4
Start ART regardless
of CD4 count or
clinical stage
PREGNANT
AND
BREASTFEEDI
NG WOMEN
WITH HIV
Regardless of CD4 cell
count or WHO clinical
stage
Regardless of CD4 cell
count or WHO clinical
stage
No change
HIV/TB CO-
INFECTION
Initiate ART for all TB
co-infected
Initiate ART for all TB
co-infected
No change
HIV/HBV CO-
INFECTION
Evidence of severe
chronic HBV liver
disease, regardless of
CD4 cell count
Evidence of severe
chronic HBV liver
disease, regardless of
CD4 cell count
No change
HIV+
PARTNERS IN
Regardless of CD4
cell count or WHO
Regardless of CD4
cell count or WHO No change
TEST AND
TREAT!!!
Once
diagnosed with
HIV, patients
should be
enrolled into
chronic care
and initiated
on ART after
proper
adherence
counselling and
preparation
15. When to Start Art in Children
TARGET
POPULATI
ON
(ARV-
NAIVE)
Previous ART
GUIDELINES
South Sudan
Consolidated
National
Guideline 2014
2016 ART
GUIDELINES
HIV POSITIVE
<5 years
Start ART regardless
of CD4 count
Start ART regardless
of CD4 count
No change
HIV POSITIVE
≥ 5 TO 9
YEARS OF
AGE
CD4 ≤ 500cells/ml or
clinical stage 3 or 4
CD4 ≤ 500cells/ml or
clinical stage 3 or 4
Start ART
regardless of CD4
count / clinical
stage
TEST AND
TREAT!!!
Once diagnosed
with HIV,
patients should
be enrolled into
chronic care and
initiated on ART
after proper
adherence
counselling and
preparation
16. Question #2:
Medical contraindication?
• Some conditions will prevent the use of any ART
medications
– For example, in someone with severe renal dysfunction (renal
failure), the risks of ART outweigh the benefits unless the patient
has access to dialysis
• Some conditions will prevent the use of one
specific ARV, requiring an adjustment in the first-
line regimen
– For example, patients with severe anemia at baseline should not
start zidovudine (ZDV, AZT) because one of its side effects is anemia
17. Medical Contraindications to ART
Contraindications to any ART include:
liver function tests > 5x upper limits of normal
creatinine > 3x upper limit of normal
Patients with these conditions should not be started
on ART, even if they meet eligibility criteria because
the risks outweighs the benefits.
Next step is evaluation to see if condition is
treatable/ reversible.
18. Medical Contraindications to ART
Contraindications to specific first-line ARVs include:
Severe anemia (Hb < 8.0 g/dl)
and/or severe neutropenia (ANC <
750)
Use Tenofovir (TDF) instead of
Zidovudine (AZT)
Concurrent use of rifampicin for
TB treatment Use Efavirenz (EFV) instead of
Nevirapine
The patient has liver dysfunction
(LFTs > 2x normal but not > 5x
normal)
The patient has taken ART before Consult clinical advisor / local expert
19. Question #3:
Is the patient pregnant?
• Pregnancy is NOT a contraindication to ART
• Indications for ART (triple-therapy) are the
same for pregnant & non-pregnant patients
20. Is the patient pregnant?
• Cont’d…
• However, there are specific issues that need to be taken
into account during pregnancy:
Need to expedite ART initiation for maximum benefit to
mother and infant
Need to select appropriate first-line regimen
Need for additional lab monitoring for toxicity
21. Question #4:
Non-medical contraindication to ART?
• If ART is not taken correctly and consistently, it
does not work
– Patients who take ART irregularly have all the risks
(side effects, viral resistance) and none of the benefits
• Although health care workers do not always know
who will and will not take ART correctly, there are
some situations in which it is highly unlikely that
adherence will occur
22. Non-medical contraindications
• Recent history of program or medication non-
adherence
• Unstable social situation that will prevent adherence
• Severe psychiatric illness
• Ongoing substance abuse (e.g., alcoholism)
• Lack of interest in or ambivalence about starting ART
23. Non-medical contraindications
• For children:
• Identification of a primary & secondary caregivers who
understand the disease and implications of ART
• The status of disclosure to the child and family
• Access to nutrition and other OVC services.
• Child specific adherence strategy.
24. Non-medical contraindications
• These decisions are complex ones, and are best made by the MDT,
rather than a single provider
– Be very careful not to make assumptions based on group characteristics
(religion, tribe, sex, age)
– Focus on the individual patient
• Non-medical contraindications do not mean that the patient should
never be prescribed ART, just that at this moment, the risks outweigh
the benefits.
– Additional social services, counseling, referrals, and other interventions may be
needed
– The situation should be reassessed regularly and systematically.
25. Four “Simple” Questions
1. Does the patient have a medical indication
for ART?
2. Does the patient have a medical
contraindication to the first-line regimen?
3. Is the patient pregnant?
4. Does the patient have a non-medical
contraindication to ART?
26. 8 Steps to HAART success
1. Identify patient for whom benefits outweigh risks (and
local guidelines permit therapy)
2. Assess prior adherence, all potential adherence barriers
3. Implement solutions to adherence barriers
4. Educate patient about HIV & HAART
5. Select treatment that is potent, durable, convenient, non-
toxic, well-tolerated, and sustainable
6. Train patient on dosing and schedule
7. Monitor response and adherence
8. Respond promptly to problems
27. Case Vignettes
Do these HIV+ people qualify for starting
therapy?
• 32 year old male, asymptomatic, CD4 count
of 180
• 22 year old female, pulmonary TB, CD4 count
of 500
• 41 year old female, oral candidiasis, CD4 300
• 33 year old male, TB meningitis, CD4 250
• 4 year old female, asymptomatic, CD count of
750
