2. Recall the principles and aims of VL monitoring
Recall the rationale for VL testing in South Sudan
Review eligibility criteria for Viral Load testing in South
Sudan
Describe the Viral Load Surge approach
Objectives
3. • Mr. John was started on ART (Regimen: TLE) on 23 May
2019. His first VL sample collection date was on 7 June
2020. The VL result was 983 copies/ml. On 11 October
2020 he was transitioned to TLD.
• Is Mr. John eligible for VL sample collection?
• Alice has been on TLD since January 5 2020. Viral load
sample was collected from her on 11 July 2020 and the
VL result showed “LDL”.
• When will she be eligible for a repeat VL sample
collection?
Case scenario
4. Viral load is the concentration of
HIV RNA copies in blood.
This reflects ongoing virus
replication in a person’s body.
Viral load is used as an indicator of:
• Response to ART and risk for clinical disease progression
• Risk of transmission of HIV between sex partners
• Risk of transmission of HIV from mother to child
What is Viral Load?
5. ART prevents HIV replication by inhibiting viral enzymes
causing the viral load to decline
The goal of treatment is a suppressed viral load:
• To achieve better clinical outcomes
• Lower risk of HIV transmission
Persistent viral replication while taking ART can lead to
resistance to one or more antiretrovirals (ARVs)
Virologic Response to ART
6. • Viral load <1000 copies/ml is
considered acceptable
• Risk of transmission and disease
progression <1,000 copies/ml is low
• In most patients taking ART, the
viral load should be <1000
copies/ml after 6 months of
treatment
• Those with high baseline viral
load, such as infants, may take
longer to achieve suppression
Virologic Response to ART
DHHS Guidelines, 2013; Tsibris and Hirsch, PPID 2010; Kaufmann et al., Arch Intern Med 2003
VL target: <1000 copies/ml
• Better
outcome
• Lower risk of
transmission
7. Viral Load Measurement
• Viral load can be
measured using whole
blood, plasma, or dried
blood spots
• Assays quantify HIV viral
load as RNA copies/ml,
also reported on a log10
scale
• Lower limits of detection
vary with assays (e.g.<20,
50, 400 copies/ml)
• Optimal results include
target not detected, or
the lower limits of
detection
8. Viral Load Result Categories
<1,000 copies/ml
• “Suppressed”
• Results below lower
limit of detection
• Results up through
999 (e.g., not
detected, < 20, 367
copies/ml, 934
copies/ml)
>1,000 copies/ml
• Includes all results
greater than or
equal to 1,000
copies/ml (e.g.,
2,000 copies/ml,
30,000 copies/ml,
100,00 copies/ml)
9. • Delayed detection of high viral load leads to:
• Dropping CD4
• Weaker immune system
• Development of new infections and increased morbidity and mortality
• To prevent unnecessary switches to second line ART
• Rutherford et al: Positive predictive value of clinical and immunological
criteria 29%, i.e., wrong 2 out of 3 times
• To reduce transmission (PMTCT and to sexual partners) by identifying those
with a high viral load
• Allow clinicians to focus on patients with high viral load
• Potentially reduce frequency of clinic visits for patients with suppressed viral
load
• To avoid development of drug resistance
Why is Viral Load the Preferred Monitoring
Strategy for Patients on ART?
10. • VL is the preferred approach for monitoring ART
response
• South Sudan started using VL for treatment monitoring
in FY17
• FY19, 32 out of the 41 PEPFAR-supported facilities were
collecting VL from PLHIV on ART, with 13,980 individuals
out of a target of 27,912 having received their VL results
• COP20, South Sudan will aggressively focus efforts to
improve both VL coverage and VL suppression
VL in S Sudan
11. Proposed strategies to improve VL coverage &
suppression:
• Aggressively monitoring of appointment registers for patients due for VL or
repeat VL testing;
• Tracking patients for enhanced adherence counseling (EAC) and repeat VL
monitoring
• Fast tracking children for VL sample collection and non-suppression
management;
• Data utilization for site level quality improvement (QI) activities
• Finalizing TLD transition
• Providing clients with six months of drugs (MMD-6);
• Pediatric ARV optimization;
• Mentorship of clinic staff on EAC and non-suppressed client management;
VL in South Sudan
12. FY 19 ART and VL Coverage by Counties
VLC low and varies across counties (0-75%)
13. Proxy VLC FY 20 Q3 67%
• Blue bar is the FY 20 Q3 testing gap and the top purple portion represents the
number of new patients eligible for VL in FY 20 Q3.
• The sum represents the net number of people who should receive a VL test in FY
20 Q4 and is the VL testing demand (current VL testing gap plus new influx of
patient on ART newly eligible for VL test in a 12 month period)
11,343
14. VLC among pregnant women
• Proxy VLC only 18%!
• FY 20 Q3 VLS pregnant
women 88%
• FY 20 Q3 VLS BF women
87%
15. VLC by Region/ State
• WES VLC: 80%
• CES LC: 65%
• EES VLC:58%
• Lakes VLC: 33%
• WBG VLC: 76%
• Military VLC:58%
16. • All PLHIV receiving ART for 6 months or more at ALL
health facilities offering ART
Who should have routine VL monitoring?
31. • Extract folders of all active clients
a) Using the ART database, the Data Clerk will create a line-list of UANs of “ACTIVE” clients
b) VL focal persons will systematically extract folders of “ACTIVE” clients according to the
developed line-list.
c) The VL focal person(s) will review each “ACTIVE” client’s folder and fill the VL surge
abstraction template
• Filling the VL surge abstraction template
a) The VL focal person(s) will review each “ACTIVE” client’s folder and fill the VL surge
abstraction template
b) As client data is filled into the template, analyze to identify ELIGIBLE or Not-Eligible
clients.
Operationalizing Viral Load Surge at Facility level
32. • Tracking eligible VL clients
a) All identified “ELIGIBLE” clients (UAN and contact details) will be
transferred from the VL abstraction template to the VL appointment log
b) The VL appointment log shall be handed over to tracking team to initiate
tracking activities immediately
c) Contact tracing of clients:
a) Set aside folders of eligible clients (flag)
b) If client’s appointment date is imminent- Flag folder
c) Phone call: Review script for phone call tracing
d) Home visit: Review SOP for home visit tracing
Operationalizing Viral Load Surge at Facility level
33. • VL request form
a) The VL focal person will pre-fill VL request forms and insert in client’s
folders, while awaiting return of client for sample collection.
• Sample collection:
a) As clients return to the facility for VL sample collection, clients are fast-
tracked and escorted to the sample collection point
b) The VL phlebotomist will verify correctness of the VLRF and immediately
collect VL sample
• Record and report weekly VL sample collection updates
a) The VL focal person will review and report weekly achievements: Number
of eligible clients with samples collected / Total number identified for the
week
Operationalizing Viral Load Surge at Facility level
34. The clinical provider should review the pre-filled VL Requisition Form.
Patient demographic information should be reviewed and updated to
ensure if contact tracing is needed in future; telephone number, address
and treatment supporter information are updated in the patient care card.
The clinical provider should document that S/he has ordered a VL test in
the HIV care and ART patient card under the “investigations” column by
writing “VL”.
The clinical provider should send the client for sample collection (or
collect the specimen).
Clients Returning for VL sample collection…
35. The sample collection person should review the VL requisition form, and if any
sections of the form are incomplete, to immediately send the form back to the
ordering provider for completion.
The sample collection focal person should fill out the Daily Sample Log/VL
Register, (kept at the site of sample collection), prepare the sample for dispatch,
and enter the relevant information in the Viral load Dispatch Form.
The VL focal person should review the Daily Sample Log every week to
determine and follow
up on outstanding results (>21days) and progress status of clients yet to return for
VL.
Clients Returning for VL sample collection
36. VL focal person will pre-fill the VL
laboratory request form
Viral Load Request Form
37. • Increase in VL requests as clients return to facility
• Transient increase in sample collection workload for VL Phelobotomist
• Increase in sample assays in the NPHL (ensure adequate supply of
reagents)
• Increase phone calls for tracing and reminding VL eligible clients by VL
focal person and tracking team
• NPHL dashboard to provide analysis of received, rejected samples and
improved result TAT.
Other operational considerations
Now that we have reviewed how VL is measured and what the typical natural history of VL is over the course of infection without treatment I want to describe briefly what the desired and expected VL response is when ART are given.
ART prevents HIV replication by inhibiting viral enzymes causing the viral load to decline. The goal of treatment is to achieve an undetectable viral load:
associated with better clinical outcomes
lower risk of HIV transmission.
While the goal of treatment is an undetectable viral load, VL <1000 copies/ml is considered acceptable given that risk of transmission and disease progress are low at this level.
You can see from the curve here that in most patients on ART, VL will decline to below 1000 copies/ml after 6 months of treatment.
Those with high baseline VL such as infants may take longer to reach viral load <1000 copies/ml.
In addition to content on the slide can say:
Assays quantify HIV VL by means of cycles of amplification then detection with indicator primers that target viral enzymes
WHO defines HIV viral suppression as VL<1000 copied/ml
Viral load result reports may vary in appearance, here we discuss the different categories relevant to patient management
We use the term “suppressed” for VL <1000 because WHO is currently using that cut off. Traditionally this term has been used for when the VL is below the lower limit of detection. Ongoing studies are examining this cut off and we will have an increased understanding of the risk of regimen failure with VL > 50 < 1000 cp/mL, there may be changes In definition of VF, but at this time current WHO guidelines still use > 1000 copies
Viral load has been chosen as the preferred strategy for a number of reasons
As shown previously delayed detection of a high viral load will lead to a drop in CD4 , reduced immunity and eventually new infections with the risk of increased morbidity and mortality for the patient
In addition, by identifying a patient with a high viral load and intervening early if there are adherence problems, it may avoid future development of resistance.
If a high viral load is acted upon with adherence interventions or a switch to second line, transmission both to sexual partners and from mother to child can be reduced
Finally, knowing someone is suppressed and doing fine on their ART provides reassurance and the potential for the patient to receive extended refills of ART or enter into alternative refill strategies such as fast track or community based refill groups
PEPFAR will continue to prioritize interventions in all the supported counties by working closely with stakeholders, including MOH in order to scale-up viral load testing in priority counties and sites for FY20 and FY21
VL also related to other key areas s/a case identification- will hear more about index testing focus on clients with HVL (and newly diagnosed)
BLUF: Retention and VLS paramount goals
IMPORTANT to emphasize-> delaying EAC delays monitoring and leaves viremic patients longer with the risk of developing drug resistance.
Timely, high quality EAC critical and we need to strengthen this.
