Viral Load Monitoring of ART:
Feasibility & Affordability of
Scale up
IAS, Kuala Lumpur, 1st July 2013
Presented by: Nalinikanta Rajkumar, CoNE
About CoNE
Community Network for Empowerment (CoNE) is a
state level network of community based organisations
(CBOs) of people who use drugs in Manipur, India
contributing to the state health response related to
drug use including HIV and other blood borne viruses
and also take up the issues and problems faced by
people who use drugs at the state and national level.
Key Strategic focus Areas:
• Watch Dog
• Advocacy
• Crisis Intervention
• Research
Manipur
 A small State in North east region of
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India
Geographically isolated from the rest of
India
Characterised by multiple sources of
conflict including a longstanding civil
insurgent struggle
Poverty & Unemployment
Poor health infrastructure in all the
districts other than Imphal (Capital of
Manipur)
Approximately 2% of the population in
Manipur inject drugs (Total population:
2.8 million)
Highest prevalence of HIV in the
country - 1.13%
Loktak lake: The largest freshwater
lake in North east India)
HIV Scenario in India 2012
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Adult (15-49 years) HIV prevalence = 0.27%
No. of PLHIV = 20,88,642(2.8 million)
No. of Adult new infections = 1,16,456(0.11 million)
No. of annual AIDS related death = 1,47,729(0.14) million)
No. of PLHIVs on first line ART= 486173(0.48 million)
No. of PLHIVs on second line ART= 4000+
Manipur
• No. of PLHIV in Manipur = 42,116 (till oct.2012)
• No. of PLHIV registered in ART centre = 22,750
Why do we need viral load testing
for HIV management?
Viral Load testing for routine monitoring to ensure adherence
to treatment and timely switch to second line or alternate first
line regimens on failure of first line treatment
WHO guideline on use of Viral Load
If resources permit, use viral load in a routine approach,
with the objective of detecting failure earlier than would
be the case if immunological and/or clinical criteria
were used to define failure.
Viral Load in India: National AIDS
Control guidelines
• Decision to switch from first line to alternate first line ART
and second line ART resides with State AIDS Clinical
Expert Panel (SACEP)
• SACEP to meet on weekly basis- to review the case history,
order the viral load testing and approve initiation of second
line ART for treatment failure and use of alternative
regimens.
• Currently, 7 VL testing centres in India
Criteria for second line evaluation
 CD4 cell counts declined to pre-ART levels
 CD4 cell counts had dropped to less than 50% of their highest
on-treatment level
 Failed to reach a CD4 cell count of 100/mm³
 If PLHIV developed a World Health Organization stage 3 or 4
AIDS-defining illness.
Patient’s Experience
Dolly, 18 years started her ART in 2004. In January 2007, her CD4 count was 393
cells/cu.mm (highest CD4 since the initiation of ART.) It dropped to 107 in
January 2011 and she was referred by ART Centre for case review by SACEP for
second line ART.
She had to wait for 2 months for the next SACEP meeting to take place and was
compelled to continue the first line treatment. Unfortunately, she fell very sick at
that time and could not attend the meeting. Meanwhile, she was advised to go for
further clinical investigations to strengthen her case. Due to increase in her CD4
count level, she was advised not to do her viral load test.
December 2011, she was advised by SACEP to start with first line alternative
regimen without doing a viral load testing. Her condition improved a bit after
switching from d4T to TDF for a while. However, during the entire process of
treatment she suffered from numbness of legs, loss of appetite & headache etc.
By September 2012 her CD4 count dropped to 57cells/cu.mm.
She was admitted to hospital where there was no any further discussion for
taking her case in the next SACEP meeting except giving I.V. fluids. She was
discharged in two weeks from the hospital without any sign of improvement
and despite of her grandmother’s repeated requests for further treatment. She
was admitted again after a day due to severe sickness to hospital. The physician
suggested the grandparents to shift her to RIMS as this was case of second line
ART initiation. Program Director, RIMS (SACEP member) who promised to look
into the matter personally and ensured that she will be provided second line
immediately.
With the hope of getting second line ART she was brought from casualty of JNIMS and
admitted again at RIMS casualty on 2nd October 2012. But, regrettably before getting her life
saving drugs she expired on that day.
This is just the one of the many patient’s experience of
accessing second line treatment.
Viral load facilities in India: Problems
 Viral load testing is not routinely used in India
 First line treatment failure testing is based upon clinical and
immunological failure criteria
 Only the expert panel-SACEP- will determine eligibility criteria
for VL confirmatory testing
 Doctor at ART Centre can only refer to SACEP
Challenges faced in accessing second line ART
• Irregular SACEP meetings – held monthly/bi-monthly
• Non availability of viral load machine in many States
• Blood sample for viral load send to Kolkata for testing
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(Take minimum 1 month to get result), conditionminimum no. of samples to be sent – 10
Mandatory physical presence of the patient at SACEP
meeting - even if the person is bed ridden
Non acceptance of viral load testing from private sector
Repetitive clinical investigation
CD4 count result inconsistent.
Our Demands
• Accessibility to viral load testing on routine basis.
• Remove structural barriers viz. SACEP.
• Viral load testing as a treatment monitoring tool in
resource-limited settings.
“Undetectable Viral Load for us means empowerment as
we then can concentrate on other work instead of
worrying about our health.”