the role of virological monitoring a clinical perspective eric goemaere msf south africa
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The role of virological monitoring A clinical perspective
Eric GoemaereMSF South Africa
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Treatment simplification?
HIV/TB integration
PHC decentralization
Task shifting
Simplified treatment
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Impact of routine monitoring <> Immuno-clinical monitoring on regimen change
Project/Country
n Median time on ART
on second line
Thyolo,Malawi
18.421 48 M 0.4 %
Buhera , Zimbabwe
13.712 38 M 1.6 %
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VL monitoring in LIC : a love/hate story
HIV Viral Load Monitoring in Resource-Limited Regions:Optional or Necessary?Alexandra Calmy,1,5 Nathan Ford,6 Bernard Hirschel,2 Steven J. Reynolds,7 Lut Lynen,4 Eric Goemaere,8
Felipe Garcia de la Vega,1Luc Perrin,3 and William Rodriguez9,10, CID 2007:44
More accurate assessment of treatment failure will reduce the delay in switching to second-line drugs. Targeted use of VL can limit unnecessary switching and routine use of VL can reduce the risk of resistance. WHO 2010 guidelines
Keiser et al, AIDS 2011
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Female, CHK Kinsahsa N° 040025, DOB 11/10/1972
Exclusive Immuno/clinical monitoring delays clinical reaction
Phase IV Oesophageal candidiasis
VL14.000
VL13.000 -> moved to 2nd line
Cd4 < 30 % Cd4 < 50 %
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Predicting virological failure ( < 30 % of nadir CD4) in adults
M. Pujades, L. Pinoges , Epicentre, not published
Sensitivity = 17.2% (12.3% - 23.0%)
Specificity = 94.5% (93.6% - 95.3%)
PPV = 18.5% (13.3% - 24.8%)
NPV = 94.0% (93.1% - 94.9%)
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Predicting virological failure in children
– Thailand: US IF criteria to identify children with single viral load >1000 copies/ml after 1 year of treatment (n=202)
• Sensitivity: 15%; PPV: 16%(Jittamala et al. 2009)
– Uganda: WHO IF criteria to identify children with confirmed viral load >400 copies/ml for (n=116)
• Sensitivity: 0% (Ruel et al. 2010)
– South Africa : criteria to identify children with VL > 1000 cp/ml( n = 2543 )
• Sensitivity 5 % , PPV= 42 % ( Mary Ann Davies, Durban Aids conference June 2011)
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Impact in early detection of VF
VL6 intervention
VL3 intervention
0.00
0.10
0.20
0.30
0.40
0.50
0.60
0.70
0.80
0.90
1.00
Viro
log
ical
failu
re p
roba
bilit
y
0 1 2 3 4 5Years since start of observation period
Figure 2: Adjusted Kaplan-Meier: Time to virological failure
Viral load at 3 months after initiation of antiretroviral therapy is associated with better virological and treatment outcomes than at 6 months.
B. Kerschberger1, A. M. Boulle2, K. Kranzer3, K. Hilderbrand1,2, M. Schomaker2, D.Coetzee2, E.Goemaere4, N. Ford2,5, G. Van Cutsem1,2
VL3 group : 22% less likely to experience subsequent virological failure, 27% less likely to be later switched to second line regimen
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If no access to VL, priorities for VL ?
Steven Van Den Broucke, Sandra Simons, Katharina Kranzer Dhodho Munyaradzi, Carol Metcalf, Kwenzakwenkosi Ncube, Helen Bygrave Poster : THPE725 Thursday 26th
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Impact of late viraemia detection on horizontal and vertical transmission ?
• Horizontal transmission
• Vertical transmission– PMTCT B + : danger for
subsequent pregnancies
p2 p3 p4
HIV (+):HIV (+): ART:ART:
LTF:LTF:
RIC @ 12 M**
RIC @ 12 M**
Pre-ARTPre-ARTFacility based
HCT :Facility based
HCT :
Enrolled in care:Enrolled in care:
LTF: LTF: LTF: LTF:
Undetect @ 6 M
Undetect @ 6 MOut of facility
HCT :Out of facility
HCT :
LTF:LTF:
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Impact of late viraemia detection on resistance building ( TAM and K65R)
Source : The public health approach to identify antiretroviral therapyfailure: high-level nucleoside reverse transcriptase inhibitor resistance among Malawians failing first-line antiretroviral, Therapy, Mina C. Hosseinipour & all, AIDS 23:1127–1134
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Conclusions
• Immuno/clinical monitoring do not replace virological monitoring
• Key challenges are around technical/ geographical / financial access to virological monitoring
• Unitaid/ Chai/Unicef / MSF concerted efforts will work on all 3 aspects to make virological monitoring a reality in LIC by 2015
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Acknowledgements
• MSF & MOH teams in Zimbabwe , RDC and South Africa
• Helen Bygrave , Teri Roberts ,Nathan Ford
• All the ones fighting to be ‘ viral load undetectable’
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Thank You