Global HIV Drug Resistance Surveillance Programme
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Transcript of Global HIV Drug Resistance Surveillance Programme
E P I D E M I C A L E R T A N D R E S P O N S EE P I D E M I C A L E R T A N D R E S P O N S E
Global HIV Drug Resistance Surveillance Programme
Dr Stefano LazzariCoordinator Risk Containment, Mapping and Drug Resistance (RMD)Communicable Diseases ClusterWorld Health Organization
EPIDEMIC ALERT AND RESPONSE
AntimicrobialDrugs
Human/AnimalInfection
ConsumerExpectations &Compliance
PrescribersBehaviour
RegulatoryFramework
Distribution/Management
DrugQuality
Procurement
DiseaseBurden
Monitoring DrugSuppliesMonitoring Drug Resistance
MonitoringDrug Use &Selection
ARCS: Antimicrobial ResistanceContainment and Surveillance
Diagnostics
Treatment Regimens
ConsumersHealth Education
DiseasePrevention
Appropriate
Test QualityAssurance
AMR Containment
Rational Drug Use
Drug DeliverySystems
DrugRegulations
EssentialDrug Lists
Drug ApprovalSystems
E P I D E M I C A L E R T A N D R E S P O N S E
First Consultation on Monitoring the Emergence of Antiretroviral Resistance, Rome, October 2000
First Draft workplan of WHO HIV Drug Resistance Surveillance Programme, February 2002
The Global HIV Drug Resistance Surveillance Programme launched, Barcelona, July 2002
Final workplan of WHO HIV Drug Resistance Surveillance Programme, November 2002
Meeting of Task Force Members, Boston, February 2003
Meeting of European Task Force Members, Luxembourg, March 2003
Meeting of Working Group 1 (Surveillance) in Oslo, 25-26 April 2003
Meeting of Steering Committee, Paris, 12 July 2003
E P I D E M I C A L E R T A N D R E S P O N S E
Milestones of the ProgrammeMilestones of the Programme
E P I D E M I C A L E R T A N D R E S P O N S EE P I D E M I C A L E R T A N D R E S P O N S E
Structure of the ProgrammeStructure of the Programme
Steering Committee
ad hoc Technical Committee
WG
WG
WG
WG
WG
HIVResNet
WHO Secretariat
Epidemiology
Data use
Technology transferData Management
Lab
E P I D E M I C A L E R T A N D R E S P O N S E
““Steering Committee”Steering Committee”
Functions– Provide direction to the Programme
– Coordinate activities
– Develop global strategy for monitoring
– Approve operational guidelines, workplans and budgets
– Review progress and suggest new directions
– Set criteria for membership of technical working groups
– Suggest country level priorities
Meet at least twice yearly
Hold regular conference calls between meetings
E P I D E M I C A L E R T A N D R E S P O N S E
Steering CommitteeSteering Committee
Suggested Members– WHO
– IAS
– CDC
– Euro-SPREAD
– ANRS
– Representatives from Asia, Latin America and Africa with operational and scientific expertise (3 total)
– Major donors/foundations (1-3)
– Community representatives (2)
– Representative of Scientific Coordinating Committee
Appointed by WHO
E P I D E M I C A L E R T A N D R E S P O N S E
Ad Hoc Scientific CommitteeAd Hoc Scientific Committee
Role– Coordinate and provide oversight to working groups
– Respond to scientific and operational questions
Functions– Ensure Working Group productivity
– Review guidelines and other documents produced by the working groups
– Ensure development of tools for planning and needs assessments
– Support to the Secretariat in providing expertise and technical support to participating countries
– Assist in developing tools for monitoring of the Programme
E P I D E M I C A L E R T A N D R E S P O N S E
Ad Hoc Scientific CommitteeAd Hoc Scientific Committee
Members– Chairs and Vice Chairs of Working Groups
– Population sampling expert
– Data management specialist
– Biostatistician
– Modeling expert
– Ethics expert
– Others, depending on emerging needs
Selected by WHO in consultation with the Steering Committee
E P I D E M I C A L E R T A N D R E S P O N S E
Working GroupsWorking Groups
Proposed and operative– Surveillance operations and design
– Data management and analysis
– Laboratory, quality control and monitoring
– Capacity building, technology transfer and training
– Policies and data dissemination
Roles/functions outlined in Plan of Action document
New WGs will be established as need arises
E P I D E M I C A L E R T A N D R E S P O N S E
Operational Network (Operational Network (HIVResNetHIVResNet))
Global network of laboratories and surveillance sites
Participation open to all countries interested
Sites may be designated as National HIV Drug Resistance Surveillance Sites – responsibilities:– Assess local needs
– Suggest revisions in the protocols to suit local requirements
– Liaise with Secretariat for operational needs and training
– Facilitate implementation of surveillance studies
– Provide data to the HIVResNet Data Management Centre
E P I D E M I C A L E R T A N D R E S P O N S E
SecretariatSecretariat
Hosted at the WHO
Functions– Provide technical and administrative support to the Programme
– Manage and coordinate the network
– Ensure quality and timeliness of plans and products
– Ensure dissemination of protocols, guidelines and data through website and other mechanisms
– Facilitate needs assessments, regional training and technology transfer
– Coordinate efforts with other WHO departments and regional offices
E P I D E M I C A L E R T A N D R E S P O N S E
Progress to DateProgress to Date
WHO/IAS Endorsement
WHO Secretariat established with 2 Professional staff
Draft Action Plan
Data base support and structure developed.
Phase I Pilot Study Completed, Phase II ongoing
Global Fund resolution
Draft surveillance guidelines being developed.
E P I D E M I C A L E R T A N D R E S P O N S E
E P I D E M I C A L E R T A N D R E S P O N S E
Outline of Guidelines on ARV Drug Outline of Guidelines on ARV Drug Resistance SurveillanceResistance Surveillance
1. Introduction2. Objectives and Intended Uses for Guidelines3. Indicators and Definitions4. Overview of Technical Issues
4.1. Epidemiology4.2. Data Management4.3. Quality Control4.4. Laboratory Management including Quality Control4.5. Implementation4.6. Policy Development and Data Disseminatio
5. Annexes5.1. Glossary of Terminology
6. References
E P I D E M I C A L E R T A N D R E S P O N S E
What is the level of resistance to ARV in circulating HIV strains?
How is HIV drug resistance changing over time?
Does the level of HIV drug resistance justify/require changes in preventive or treatment approaches?
Which containment measures and/or treatment regimens reduce/limit/slow down the emergence of HIV drug resistance?
Are current access to treatment programmes causing a rapid increase in HIV resistance?
Key Public Health QuestionsKey Public Health Questions
E P I D E M I C A L E R T A N D R E S P O N S E
Objectives of HIV drug resistance Objectives of HIV drug resistance surveillancesurveillance
Assessing geographical and temporal HIV drug resistance prevalence
Better understanding determinants of resistance
Identifying ways to minimize its appearance, evolution and spread
E P I D E M I C A L E R T A N D R E S P O N S E
Populations of interestPopulations of interest
Persons newly diagnosed with HIV and not previously exposed to antiretroviral drugs
– Newly diagnosed and recently infected with HIV
– Newly diagnosed with established HIV infections
Persons about to begin their first antiretroviral drug regimen (not yet exposed)
Persons receiving antiretroviral drugs for treatment of HIV infection
– First antiretroviral drug regimen (tested after 6 or 12 months)
– Second antiretroviral drug regimen or a subsequent regimen.
• Persons whose previous treatment has not failed, but whose treatment has been switched for other reasons
• Persons whose previous regimen(s) was/were changed because of treatment failure
E P I D E M I C A L E R T A N D R E S P O N S E
Proposed Target PopulationsProposed Target Populations
Persons newly diagnosed with HIV who never received antiretroviral drugs
Where possible, recently infected persons– Detuned ELISA
– first pregnancy or age less 20/25 in ANC (?)
– Previous negative HIV test
Treated population will not be targeted for surveillance though specific studies may be required (e.g. proportion of failures due to resistance)
E P I D E M I C A L E R T A N D R E S P O N S E
Potential Sites for Concentrated EpidemicPotential Sites for Concentrated Epidemic
VCT clinics
– access to ARV programmes
– preventive services for IDU, MSM, etc
Centralized laboratories for confirmation of HIV test, if available.
Blood donors (if regular voluntary donations)
Military recruit, STI patients, occupational clinics
E P I D E M I C A L E R T A N D R E S P O N S E
Potential Sites for Generalized EpidemicPotential Sites for Generalized Epidemic
High-volume VCT clinics
– access to ARV
– preventive services including PMTCT sites (<21 or first pregnancy if possible)
Centralized laboratories for confirmation of HIV test, if available
Blood donors (if regular voluntary donations)
Military recruit, STI patients, occupational clinics
E P I D E M I C A L E R T A N D R E S P O N S E
Patient SelectionPatient Selection
Sample size: around 400-500 sequences (sufficient to determine if resistance prevalence is less that 5% or to detect difference/change from 5% to 10%)
Consecutive newly diagnosed persons meeting inclusion criteria
Periodicity: 2-3 years
Start in urban areas with high ART access
E P I D E M I C A L E R T A N D R E S P O N S E
Sample collectionSample collection
At the same time of HIV diagnostic test – limited epi/clin information, ethical issues regarding consent
– need to store all samples. test only when HIV-positive results come back
when giving back HIV test results to patients– epi/clinical information usually available– need to collect extra sample– informed consent is usually required (difficult time for asking consent)
at time of treatment (pregnant women only)– possibility to draw sample– difficult moment for collecting epi/clinical info
E P I D E M I C A L E R T A N D R E S P O N S E
Additional InformationAdditional Information
Unique subject and site identifier
ART history (if yes--exclude)
Previous HIV test (+/-)
Age group
Date of blood draw for resistance testing
No consensus on: Age/date of birth, gender, area of residence, date of previous negative HIV test, evidence of recent infection, clinical stage, CD4, risk factors
E P I D E M I C A L E R T A N D R E S P O N S E
Suggested options for the initiation Suggested options for the initiation of HIV resistance surveillance of HIV resistance surveillance
well-established public ART programme (more than 3-5 years)
at least 1% of estimated HIV infected individuals on ART
at least 10% of people diagnosed with HIV have been prescribed antiretroviral drugs
a well-designed pilot study or subsequent sentinel site surveillance has detected a prevalence of drug resistance of > 5% among newly diagnosed individuals with HIV in one or more sites
E P I D E M I C A L E R T A N D R E S P O N S E
E P I D E M I C A L E R T A N D R E S P O N S E
E P I D E M I C A L E R T A N D R E S P O N S E
Unresolved issuesUnresolved issues
Cost of sequencing (currently around 200-300 US$)
Type of specimens (currently plasma at -80° but DBS are being validated)
Identifying recent HIV infections
Sequencing at national or supranational level
Site selection and (representative?) sampling strategy
Pilot studies? LQA?