Protocol for surveillance of transmitted HIV drug resistance in Burkina Faso

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Protocol for surveillance of transmitted HIV drug
resistance in Burkina Faso

• Tiendrébéogo JA, Sanou JM, Balima Z, Zampaligré/K
  F, Drabo YJ, Sangaré L, Sawadogo A,
  Beloum/Ouédraogo C, Tiendrébéogo Y, Sanou PT,
  Bigirimana F, Conombo G, Bazié B
• 4th Regional Advisory Panel (RAP) Regional
  Clinical Coordination Sub-Committee (RCCC)
  Meeting.
• Accra, GHANA 18-19 january 2007

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PLAN DE PRÉSENTATION

• Introduction
• Justification
• Objectives
• Study population and methods
• Training
• Interprétation des résultats
• Use of results
• Timing
• Budget
• Conclusion

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INTRODUCTION

• 1986 10 first cases of AIDS in Burkina Faso
• 2001 recommandation for availability of ARV
  drugs in poor setting-countries
• Expanded treatment access programmes in
  ressource-limited settings (3by5)
• Lifelong treatment
• History of drug resistant HIV in developed
  countries
• Emergence and rise of HIV drug-resistant strains
  due to Increase of ARV drugs availability in
  developing countriescountries
• Need to study HIV drug resistance transmission
  to naive persons

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JUSTIFICATIONHIV/AIDS statement in Burkina Faso
2004/2005

• General prevalence (15-49yo) in 2005 2
• General data
• Nomber of PLHIV 150 000
• Adults 15yo 140 000
• Women 15yo 80 000
• Children ?14yo 17 000
• Death/AIDS 12 000
• Tuberculosis 30
• Female Sex workers 20,9

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JUSTIFICATIONHIV sentinel serosurvey in Burkina
Faso 2005
HIV seroprevalence from 2001 to 2005
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JUSTIFICATION Data on ART

• 11 650 ART on December 2006
• PMTCT VIH
• Nevirapine, AZT
• AZT 3TC NVP
• Blood exposure to HIV
• Other use of ARV drugs
• Data available on HIV-drug resistance

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JUSTIFICATION Interest for HIV drug-resistance
surveillance

• Surveillance of HIV drug resistance mutations in
  circulating viruses in the country
• Choice of appropriate ART protocols

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OBJECTIVESGeneral objective

• To study HIV drug resistance in Ouagadougou

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OBJECTIVESSpecific objectives

• To assess primary drug resistance level
• To classify levels of HIV-1 resistance to ARV
  drugs
• To describe the type of mutation

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POPULATION OF STUDY AND METHODSStudy population

• Target group serosurvey target group prenant
  women
• Inclusion criteria
•  Primigest  1rst pregnancy
• 15 -24 yo
• Never tested for syphilis during pregnancy
• HIV-1 seropositive
• Living in Ouagadougou since 3 months, at least
• Sample size
• 8 840 pregnant women
• 60 samples for genotyping (mean47)
• Time
• 6 months

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POPULATION OF STUDY AND METHODSStudy site

• 1 Site Ouagadougou
• 1, 159 083 p in 2006
• 5.4 PLWA among pregnant women with 15-49 yo in
  2005
• 11, 650 ART by 12/2006 (70 of the overall ART in
  Burkina Faso)
• 11 Centres for sample collection

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POPULATION OF STUDY AND METHODS Criteria for
centre selection

• 1000 Primigests/year
• Volontary Acceptation to participate
• In area with 10 of eligibility for ART and with
  expanded availability to ART

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POPULATION OF STUDY AND METHODS Selected centres
for sample collection
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POPULATION OF STUDY AND METHODS Laboratory
methods

• Blood collection and HIV testing
• On EDTA/K3 tube
• Sample identification
• Centrifugation and Storage on site (peripheral
  lab) at 4C for 72h
• Transfert to the NRL-HIV
• Quality assessment of sample at arrival in
  NRL-HIV
• Plasma collection
• Testing for antibodies to HIV
• Storage of selected HIV-1 postive samples at
  80C in NRL-HIV (2 aliquotes)

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POPULATION OF STUDY AND METHODS Laboratory
methods

• Transport of samples to the genotyping laboratory
  (Montpellier, France)
• HIV drug-resistance testing
• Quality Assurance

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POPULATION OF STUDY AND METHODS Data collection
and analyzis

• Data
• Computer analyzis
• Database and data management
• Confidentiality
• National in addition to nationwide serosurvey
  data
• International
• Potential biases and limitations

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INTERPRETATION OF FINDINGS

• Categorizing of prevalence
• Classes
• Low prevalence lt5
• Moderate pre 5 15
• High prevalence gt15

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INTENTED/POTENTIAL USE OF RESULTS

• Alert to HIVDR emergence and the level of its
  transmission in a geographic area.
• Developing and updating guidelines for first-line
  ART regimen within a country
• Clinical group concerned with HIVDR, clinicians
  and Organizations supporting ART scale-up in
  developing countries
• Population health education

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TRANING SUPERVISION

• Staff training
• Laboratory technicians et medical staff
• Protocol surveillance actors
• Supervision
• Quality assurance
• On site visits

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PLANNING
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BUDGET
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CONCLUSION

• ART scale-up reality in Burkina Faso (n11,650)
• Data available on HIVDR
• HIVDR surveillance is necessary
• The study can be done,
• financial ressources must be available
• What can be done by RAP

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MERCI A TOUS