2. Outline
• Objectives
• Background
• 90-90-90 target
• What has changed?
– HIV testing services
– PMTCT
– Criteria for initiation on ART
– Recommended ART regimens
– HIV prevention- Introduction of Pre-exposure prophylaxis
– Service delivery
• Conclusion
3. Objectives
• To understand the process by which new
guidelines were developed
• To learn about the major changes in the
guidelines
• To understand timelines involved with some of
the changes
4. Background
• 2016 ART guidelines are based on
– Review of 2014 South Sudan National ART guidelines
and
– Adaptation from:
1. WHO Early Release Guideline on When to Start Antiretroviral
Therapy and on Pre-exposure Prophylaxis for HIV September
2015
2. WHO Policy Brief: Consolidated Guidelines on the Use of
Antiretroviral Drugs for Treating and Preventing HIV Infection:
What’s New November 2015
5. MOH/UNAIDS/WHO/PEPFAR 90-90-90
Target to be achieved by the year 2020 in RSS
5
90 90
90
90% of HIV-
infected know
their status
90% of those are
initiated on
treatment
90% of those
achieve viral load
suppression
Test Treat Retain
6. Estimate of National HIV burden and Adults ART Coverage
Based on Program Performance Using 90-90-90 by 2020.
193,376
27,072 15,715
XXXX
0
50,000
100,000
150,000
200,000
250,000
300,000
PLHIV PLHIV who know
their HIV status
PLHIV receiving ART PLHIV with
suppressed viral load
Target Coverage
90 90 90
14%
8%
?
7. New guidelines and the 90-90-90 targets
.The new 2016 guidelines have the following changes that will help us
achieve this
• Emphasis on early diagnosis (focus on key populations)
• Innovative testing strategies
• Early ART initiation (ART for all)
• Linkage to care
• Retention support (care packages)
• Treatment optimization (new regimens)
• Early detection of treatment failure (expanded access to VL testing)
• Retention support (adherence/social /community)
• Treatment optimization (maintenance strategies)
8. What’s new in the 2016 guideline?
HIV Testing Services
9. Definition
• HIV testing services (HTS) refers to a full range of
services that should be provided together with HIV
testing, including:
– Counselling (pre-test information and post-test counselling)
– Linkage to appropriate HIV prevention, treatment and care
services and other clinical and support services
– Coordination with laboratory services to support quality
assurance and the delivery of correct results
10. HIV Testing Services
Emphasis on earlier diagnosis of HIV
Routine provision of opt-out provider-initiated HIV
testing services in all health facilities and during all
health care encounters
Community-based testing as an option for HIV
testing
11. HIV Testing Services
Need for risk assessment at every health
service delivery point and every encounter
• All individuals to be routinely assessed for their need
for HIV testing and their risk for recent HIV exposure
at every health service delivery point.
• Risk assessment will guide frequency of HIV testing at
each health service contact
12. HIV Testing Services
Frequency of HIV testing will depend on risk assessment
• Regular HIV testing (3 monthly) recommended for people who are diagnosed
HIV-negative but remain at high risk, such as some people from key
populations.
– Unprotected intercourse with an HIV-positive partner or partner with unknown HIV status
(risk significantly reduced if HIV-positive partner’s viral load is <1000 copies/ml)
– Men who have sex with men and transgender persons
– Commercial sex workers and their clients
– Exchange sex for money or having paid for sex
– Incarcerated individuals
– Injection drug use
– Multiple sexual partners
• All sexually active adolescents and adults in South Sudan should be tested at
least annually depending on risk assessment
13. HIV Testing Services: HIV Self Testing
Self testing refers to individuals who want to
know their HIV status collecting a specimen,
performing an HIV test, and interpreting the test
result themselves
Intended to reduce barriers to HIV testing in
certain populations that have low HTS utilization
rates
Adolescents,
Key populations
Individuals fearful of testing in health facilities due
to stigma or poor treatment by health care
providers
Reactive test does not confirm HIV diagnosis and
patients with positive test must go through the
National HIV testing algorithm
HIV-positive clients already on ART should
be discouraged from performing HIV self
testing as a false negative result can be
obtained due to viral suppression from ART
14. HIV testing services: testing algorithm
Changes to HIV testing Algorithm Adults, Adolescents and children >18
months old
– Introduction of confirmatory rapid retesting for patients who test positive on serial
testing by a second tester
– Retest can be done same day, same facility but should be on a different sample by a
different tester on a different blood sample
– Can be done in a facility or through community testing
– This is done to minimize false positive patients being initiated on treatment.
– Enrolled pre-ART patients will need retesting before initiation on ART but only one
rapid test is necessary
– Do not retest ART patients already on ART
• If a pregnant woman has an indeterminate rapid test result, treat her as if she is
HIV positive and initiate and continue her on ART until her true HIV status
can be established
15. HIV testing services
Prevention Testing
Linkage to
care
Treatment
Chronic
care
IMPACT
The continuum of HIV care
• HIV testing is only part of a continuum of HIV prevention, care,
treatment and support services and this is stressed in the new
guidelines
• Linkage to prevention, care, treatment and support services
remains a crucial part of ensuring impact of this continuum
• The 2016 guidelines have shortened the time from HIV testing to
linkage to care and treatment through the test and treat approach
Confi
rmed
HIV
posit
ive
16. HTS & Service Delivery: Retention in Care
• Retention across the continuum of
HIV care is crucial to ensure
impact
• The new guidelines stress need for
the following interventions to
ensure this
– Service integration
– Linkages between facilities
– Linkage within facilities
– Linkage of communities to health
facilities
– Proper accounting for HIV clients,
including tracking defaulters and
those lost from care Need to
provide community support for
people living with HIV
18. PMTCT
Care of HIV exposed infants
• Start infant ARV prophylaxis at birth and continue based
on when the mother initiated ART:
Maternal ART initiation NVP prophylaxis
Mother was on ART for ≥4 weeks prior to
delivery
Give NVP prophylaxis until the infant is 6
weeks old
Mother was not started on ART until <4
weeks before delivery or until the peri-
partum / early postpartum period
Give NVP prophylaxis until the infant is 12
weeks old
Mother refuses to start or has defaulted
ART
Give infant ARV prophylaxis until 12
weeks after their mother has
initiated/restarted ART or 1 week after
breastfeeding stopped
20. ART Initiation: ‘Test and Treat’
Initiation of ART now recommended for all people living
with HIV regardless of CD4 and HIV clinical stage
Otherwise known as the ’Test and treat’ or ‘Test and
Start’ approach
ART should be started as soon as possible after diagnosis
for all HIV positive patients regardless of age, clinical
status or CD4 count.
Based on evidence that earlier initiation of ART results in
better clinical outcomes for people living with HIV and
reduces HIV transmission
21. What is new in the 2016 ART guidelines….
Recommended ART regimens
22. First-line ART regimens
First line ART regimen changes
– NVP scaled down from 1st line regimens to 1st line alternate
due to its
• lower potency than other available options
• High risk of hepatotoxicity when initiated at CD4 ≥250 cells/ml
for women and ≥400 cells/ml for men
– LPV/r or ATV/r to be used as first line therapy for adults,
adolescents and children who cannot take EFV due to serious
adverse effects or contraindication
23. First line ART Regimens
– Fixed-dose combination TDF/3TC/EFV remains the
preferred first-line ART regimen for adults and adolescents
– EFV 400mg to be used instead of 600mg (when FDC
becomes available) to reduce adverse effects
– Currently no evidence available for efficacy and safety for use of EFV
400mg in pregnancy and TB/HIV co-infected patients. Further
guidance will be provided in due course.
24. First line ART regimen
First line ART regimen changes
– Inclusion of Dolutegravir (intergrase inhibitor) in first line therapy
when fixed dose combination TDF-3TC-DTG becomes available
(2018)
– Is an alternative where first choice EFV cannot be used though
further guidance will be provided at time of introduction
– DTG has high potency, excellent tolerability and high genetic
barrier to resistance
25. 2nd line ART regimens for adults, adolescents
and children>3 years
Failure on NNRTI based first line regimen
• To be switched to PI based regimen- LPV/r or ATV/r
Failure on PI based regimen first line regimen
• Resistance testing should be done to determine best 2nd line
regimen
• When genetic tests are not available, the integrase inhibitors
raltegravir(RAL) or dolutegravir(DTG) are the preferred second-
line ARVs in combination with a NRTI backbone
26. 2nd line ART regimens for children < 3 years
2nd line regimen after LPV/r failure
Resistance testing is recommended for all of these
children to determine 2nd line regimen
If no LPV/r resistance identified, failure is likely due to poor
adherence and ART regimen does not likely need changed
In case of lack of resistance testing with clinical status
of child deteriorating:
Review by an expert
An integrase inhibitor-based empiric 2nd line regimen should
be used
27. 3rd line ART regimen
All patients failing 2nd line need resistance testing and review by expert
HIV clinician/committee.
Third-line ARVs drugs include:
– Boosted darunavir (DRV)
– Raltegravir (RAL)
– Dolutegravir (DTG)
– Etravirine (ETV)
– Recycled NRTIs based on a patient’s genotypic resistance test
results and complete ARV treatment history
28. What is new in the 2016 National ART
Guidelines…
ART Monitoring
29. Viral load monitoring
• Viral load monitoring remains the preferred method
for assessing the success of antiretroviral therapy
and diagnosing treatment failure
• Viral load should be checked 6 and 12 months after
starting ART and annually thereafter if suppressed
– Pregnant and breastfeeding women and children under 5
should have viral load checked every 6 months
30. ART monitoring: Role of CD4
• CD4 monitoring still has an important role though its
unavailability should not delay ART initiation
• CD4 count can be used for
– Assessing degree of immune suppression from HIV
– Assessing risk of developing opportunistic infection
– Determining need for co-trimoxazole prophylaxis
31. CD4 monitoring frequency
ART Clinical status CD4 Viral load
Frequency of
CD4 testing
NO ANY ANY Not applicable 6 monthly
≥12 months Stage 1 or 2 ≥350 <1000 12 monthly
≥12 months Stage 1 or 2 <350 <1000 6 monthly
≥12 months ANY ANY ≥1000 6 monthly
≥6 months Stage 3 or 4 -- --
Do Viral load
and CD4 count
immediately
32. What is new in the 2016 National ART
Guidelines…
HIV Prevention
–Treatment as Prevention
–Positive Health, Dignity and
Prevention
–Pre-exposure Prophylaxis (PrEP)
33. HIV prevention: Treatment as Prevention
• From a public health perspective PLHIV constitute
the most important group in terms of HIV
prevention
• HIV treatment for PLHIV is the most effective way
of preventing HIV transmission (Treatment as
prevention)
• Treatment as prevention should be done in
combination with general prevention strategies
34. Positive Health, Dignity and Prevention (PDHP)
The entire package of services aimed at prevention of HIV
transmission for people living with HIV is often referred to as
Positive Health, Dignity and Prevention (PHDP)
interventions (formerly called Prevention with Positives
[PwP]) and includes:
– Improving consistent condom use
– Disclosure of HIV status to partners
– Encouraging partner testing
– Reduction in unprotected sex
– Reduction in number of sexual partners
– STI screening and treatment
– Contraception
– Routine adherence support for PLHIV on ART
35.
36. HIV Prevention: Pre-exposure Prophylaxis
(PrEP)
Definition: The use of anti-retrovirals by HIV-negative
individuals to prevent acquisition of HIV
• PrEP is a new preventive strategy in the 2016 National
ART guidelines
Eligibility: High risk populations defined as persons with risk
of HIV incidence ≥3% per year in the absence of PrEP
– High incidence of HIV has been found in the following groups
and offering PrEP should be focused on individuals in these
groups
• Men who have Sex with Men (MSM)
• Commercial Sex Workers (CSW)
• Exchanged/paid for sex for cash in past 6 months
• Person whose primary partner is known to be HIV-positive and is not on
ART or has been on ART for less than 12 months
37. What is new in the 2016 National ART
guidelines
Service Delivery
38. Service Delivery (1)
• The following are recommended for good ART service delivery
in the 2016 National ART guidelines
– Stable patients should be given ARV refills lasting 3-6 months
– Community adherence groups should be established for
stable patients to decongest health facilities
– ART initiation and refills should be decentralized as close to
the community as possible, including health outreaches and
health posts
39. Service Delivery (2)
• Appropriately trained lower-level cadres of health workers can initiate and re-prescribe
ART
• The following cadres can initiate ART
– No change: Physicians and nurses, nurse midwives, nurse clinicians
– NEW cadre: Trained nurse assistants
• The following cadres can re-prescribe ART
– No change: Physicians, nurses
– NEW
• Trained nursing assistants (health extension workers; require further training)
• Pharmacists & pharmacy technicians (re-prescribe for stable patients only)
• Trained expert patients (re-prescribe for stable patients only)
• New cadres permitted to initiate and re-prescribe ART will requiring
appropriate training and certification before they can provide these services
40. Conclusions
• Changes have been introduced in the 2016 ART
guidelines which help Lesotho achieve 90-90-90 goals
by 2020
• The changes are adopted from WHO guidelines and
are based on scientific evidence
• The anticipated increase in patients has necessitated the
need for changes to be made in HIV service delivery
