Viral Load Monitoring of ART: Feasibility & Affordability of Scale upIAS, Kuala Lumpur, 1st July 2013Presented 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 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• 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 LoadIf 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 levelFailed to reach a CD4 cell count of 100/mm³ If PLHIV developed a World Health

Organization stage 3 or 4 AIDS-defining illness.

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.

Patient’s Experience

She was admitted to hospital where there was no any further discussion fortaking her case in the next SACEP meeting except giving I.V. fluids. She wasdischarged in two weeks from the hospital without any sign of improvementand despite of her grandmother’s repeated requests for further treatment.

Shewas admitted again after a day due to severe sickness to hospital. The

physiciansuggested the grandparents to shift her to RIMS as this was case of second

lineART 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 IndiaFirst line treatment failure testing is based

upon clinical and immunological failure criteriaOnly the expert panel-SACEP- will determine

eligibility criteria for VL confirmatory testingDoctor 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 (Take minimum 1 month to get result), condition-minimum 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 aswe then can concentrate on other work

instead ofworrying about our health.”