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HIV Drug Resistance Threshold Surveys and Strategic Planning, Vietnam

The 2nd Global HIV/AIDS Surveillance Meeting Bangkok, Thailand March 2-5, 2009. HIV Drug Resistance Threshold Surveys and Strategic Planning, Vietnam. Vietnam HIVDR Team Nguyen Anh Tuan, PhD National Institute of Hygiene and Epidemiology. Outline. HIV Epidemic in Vietnam

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HIV Drug Resistance Threshold Surveys and Strategic Planning, Vietnam

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  1. The 2nd Global HIV/AIDS Surveillance Meeting Bangkok, Thailand March 2-5, 2009 HIV Drug ResistanceThreshold Surveys and Strategic Planning, Vietnam Vietnam HIVDR Team Nguyen Anh Tuan, PhD National Institute of Hygiene and Epidemiology

  2. Outline • HIV Epidemic in Vietnam • HIV Drug Resistance Threshold Survey • Methods • Results • Challenges and Lessons learned • Next Steps • Plans for future surveys • HIVDR strategic planning in Vietnam

  3. Vietnam Basic Indicators • Population: 84 million • HIV prevalence (15-49 y.o.): 0.54% • Estimated HIV-infected persons*: 280,000 • Estimated IDU: • Estimated number of individuals on ART • Public facilities: 10,200 • Private sector: unknown • Large number of private MDs and pharmacies *Source: Joint HIV/AIDS Estimation and Projection Working Group (Vietnam Ministry of Health, FHI, East-West Center, UNAIDS, WHO, and POLICY Project, 2006)

  4. VietnamHIV Prevalence in Sentinel Groups Source: Vietnam Ministry of Health, Sentinel Surveillance Data, 2006

  5. VietnamImportant ART Issues • ART available in mid-1990s • History of substandard regimens • National Guidelines (2000): Dual therapy • Revised in 2005: training in 2006 • ARV availability in pharmacies • IDU and adherence • 11-38% non-ART naïve at start of national ART program Risk of drug resistance

  6. HIV Drug ResistancePrinciples • Leads to reduced effectiveness of ART • Increases need for second-line regimens • Increases cost of ART program • Important to assess for program monitoring and planning

  7. HIV Drug ResistanceVietnam • Concern about resistance • History of substandard ART • Insufficient treatment adherence monitoring • Large IDU population • MOH desire for national capacity for resistance monitoring • MOH, PEPFAR, WHO collaborating to develop HIVDR monitoring strategy

  8. HIV Drug Resistance Threshold SurveyBackground • 2004 WHO Global Strategy for HIV Drug Resistance Prevention, Surveillance and Monitoring • Protocol for HIV Drug Resistance Threshold Survey (HIVDR-TS) • WHO recommends HIVDR-TS • Geographic settings where ART is already widely available • Starting or scaling up ART • Perform a separate survey in each geographic area • VCT or ANC specimens

  9. HIVDR-TSMethods • Estimate population prevalence of transmitted antiretroviral drug resistance in the newly infected population • Binomial sequential sampling methods • 47 maximum specimens to genotype • Estimate prevalence as low (< 5%), moderate (5-15%) or high (>15%) • Determine if intervention required

  10. HIVDR-TS Vietnam • This survey performed in 2006 • MOH/National Institute of Hygiene and Epidemiology and PEPFAR Vietnam • TA from WHO/WPRO, WHO/Geneva, CDC Thailand, CDC Atlanta • Objective • Assess appropriateness of current ARV drug regimens and to plan future HIVDR surveillance

  11. HIVDR-TS Vietnam Methods Hanoi • Population: 4.4 million • ART available since the mid-1990s • Access to ART through national program/other donors • National referral centers for HIV patients • Sub-optimal regimens and treatment failures • 700 patients on national program ART • unknown private

  12. HIVDR-TS Vietnam Methods • 2 VCT sites in Hanoi • HIV infection prevalence: 17% • Established MOH program with laboratory staff • Eligibility • All VCT clients 18-24 y.o. • Used existing VCT questionnaire • No info on previous ART use • Sample • 70 sequential HIV-positive specimens

  13. HIVDR-TS Vietnam Methods • Genotypic sequencing • Thailand MOPH/CDC Collaboration laboratory • Ethical review • Not human subjects research • Mutation lists • WHO list of recommended mutations for use in HIVDR surveillance • IAS HIVDR list of mutations

  14. Results • 49 samples sequenced • Reverse Transcriptase (RT) • One specimen with 2 mutations on WHO and IAS lists • L74V (NRTI) and Y181C (NNRTI) • Protease (PR) • No mutations on list • <5% prevalence of transmitted drug resistance

  15. DiscussionFindings • Low prevalence of transmitted resistance • First-line regimen likely to be effective • Mutations found • L74V: abacavir [ABC] and didanosine [ddI] • Unexpected: rarely used/reserved for 2nd line • Y181C: all FDA-approved NNRTIs • Other surveys varying findings

  16. DiscussionSuccesses • Intensive on-site laboratory training and site visits • Institution of barcode labeling system • Database developed: used for sample tracking, identifying specimen quality issues and generating list of specimens eligible to be tested • Regional (Thailand) laboratory technical assistance • Training on sequencing • Assistance with protocol and analysis • Technical assistance on protocol and analysis from WHO Geneva and CDC Atlanta • Paper • Nguyen HT, Nguyen BD, Shrivastava R, Tran TH, Nguyen TA, Thang PH, McNicholl JM, Leelawiwat W, Chonwattana W, Sidibe K, FujitaM, Chau MTL, Kakkar R, Bennett D, Kaplan J, Cosimi L, Wolfe MI. HIV drug resistance threshold survey using specimens from voluntary counseling and testing sites in Hanoi, Vietnam. Journal of Antiviral Therapy. 13 Suppl 2: 115-121.

  17. DiscussionLessons Learned • Target high prevalence sites • Using standard VCT questionnaire limited ability to ascertain prior ART • Excellent national capacity-building exercise • Split samples; all samples will be tested at NIHE and compared with results from Thailand • Cost: 150,000 USD • Need to budget and plan well in advance • Looking at options for reduced test prices

  18. DiscussionSecond survey in HCMC • Repeated threshold survey in Ho Chi Minh City • ARV available longer time period • 20% of HIV cases in Vietnam • Larger IDU population • Release of IDU from government rehabilitation centers • Other surveys found resistance • Likely high risk of transmitted resistance

  19. DiscussionSecond survey in HCMC • Repeated threshold survey in Ho Chi Minh City • CDC IRB approval in September 2007 • Started in October 2007 • Add question on prior ARV exposure • Sites: 6 VCT sites • Participant age criterion: 18-21 • As of March 2008: • 537 clients recruited • 74 (14%) HIV positive

  20. HIVDR Strategic Planning • WHO technical assistance visits • 2 in 2007, 1 in 2008: strategic planning, early warning indicators • National working group, national strategy and 5-year plan are under development • CDC and WHO support HIVDR strategic development, assessment and prevention activities

  21. HIVDR Planned Activities • HIVDR assessment activities: • Early Warning Indicators • 5 indicators (prescribing practice, % lost to follow-up, retention on first line ART, on-time appointment keeping, drug supply continuity) • begin pilot in Dec 2007 at 16 ART sites, and to 50 sites in 2008

  22. HIVDR Planned Activities • HIVDR monitoring at treatment sites • funded by PEPFAR/CDC • 4 sites are selected • protocol in development. Successful NRD in Nigeria, Malawi • HIVDR threshold survey • Possible repeat Hanoi and HCMC

  23. HIVDR Prevention Activities • Prescribing practices • Ongoing QA for drugs • Continuous drug supplies • Standard ART patient records • Adherence support

  24. Additional HIVDR Activities • WHO laboratory accreditation • National referral genotyping laboratory(ies) • Clinical application • Viral load and HIVDR testing for patients with suspected failure of first-line therapy • HCMC • Other provinces through NIHE

  25. Additional HIVDR data • Study in HCMC on 200 treatment naïve individuals: 6.5% with detectable HIVDR mutations (Lan NT et al., AIDS Res Hum Retroviruses. 2003 Oct;19(10):925-8 ) • HIVDR emergence during treatment (NIITD and IMCJ) • Study of HIVDR among HIV+ pregnant women following administration of ARVs for PMTCT (N=163, 0.63% HIVDR, Pasteur Institute HCMC and ANRS) How to incorporate into strategic planning?

  26. CDC/PEPFA in VN Vietnam Ministry of Health Vietnam Administration for HIV/AIDS Control National Institute of Hygiene and Epidemiology Thai Ministry of Public Health- US Centers for Disease Control and Prevention Collaboration, Bangkok, Thailand Department of Health and Human Services/US Centers for Disease Control and Prevention, Atlanta, Georgia World Health Organization, Hanoi, Vietnam World Health Organization, Geneva, Switzerland Acknowledgments

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