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A Network of Multidisciplinary Research on ARV- based Prevention

A Network of Multidisciplinary Research on ARV- based Prevention. Carlos F. Cáceres, MD, PhD Cayetano Heredia University Lima. Key Messages. More than 7,000 people continue to become infected around the world every day (approximately 2.7 million per year, UNAIDS).

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A Network of Multidisciplinary Research on ARV- based Prevention

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  1. A Network of MultidisciplinaryResearchon ARV-basedPrevention Carlos F. Cáceres, MD, PhD Cayetano Heredia University Lima

  2. Key Messages • More than 7,000 people continue to become infected around the world every day (approximately 2.7 million per year, UNAIDS). • ARV-basedprevention (mainlyPrEP and ETfP) isnow a technicalreality and representsanimportantadditiontopreventionoptions. • However, itisstillnot a programmaticreality • Barriers of variouskinds, including: • Limitedawareness • politicalbuy-in (governments, communities), • healthsystemsissues, • cost and cost-effectivenessconsiderations, • resolvingethicaldilemmas, • transformation of technologies (and meanings) bycommunities • A mechanismtoexchangeinformationamonginterestedpartiesaroundtheworldishighlyrelevant

  3. HIV Prevention Options Timeline *** Last updated June 2013 Bangkok Tenofovir Study/CDC 4370 2005 Oral TDF TIMELINE LEGEND Oral TDF Partners PrEP Partners PrEP (no placebo) 2008 Oral TDF/FTC Positive efficacy result VOICE/MTN 003 TFV gel 2009 No effect Rectal TFV gel Oral TDF/FTC Regulatory submission/filing TDF2/CDC 4940 2007 TDF2 Open-Label Extension DPV ring TMC278 LA Injectable 2007 iPrEx iPrEx Open-Label Extension (OLE) Planned FEM-PrEP DNA/Ad5 2009 Final results pending Additional demonstration projects & intermittent PrEP studies Pox-Protein US FDA approval CAPRISA 004 2007 TFV gel CAPRISA 008 VOICE/MTN 003 Earliest regulatory submission 2009 FACTS 001 Rectal TFV gel FACTS 002 and other adolescent studies DPV Ring MTN 017 Earliest regulatory submission ASPIRE/MTN 020 TMC 278 LA Inject. The Ring Study/IPM 027 Various Phases of Long-Acting Injectables (SSAT 040 & MWRI-01) Possible TMC278 LA Injectable DNA/Ad5 HVTN 505 2009 South Africa Licensure RV 144 Pox-Protein 2004 South Africa Research Various Phase I/II preliminary and bridging studies Thai Licensure * Trial end-dates are estimates; due to the nature of clinical trials the actual dates may change. For full trial details, see www.avac.org/pxrd. ** Not all trials included are effectiveness trials. Trials included on this list are mainly phase II/IIb, III/IIIb and IV trials. AVAC Report 2012: Achieving the End – One year and counting. www.avac.org/report2012

  4. Pre-Exposure Prophylaxis • Several trials have explored the efficacy of Oral and Topical HIV Pre-Exposure Prophylaxis in various populations, using TDF or TDF/FTC. • The US FDA, in mid-2012, approved TDF/FTC oral pills for use in HIV prevention, based on results from clinical trials testing oral PrEP among MSM (Grant et al 2010), and sero-discordant couples (Baeten 2012). • Further supported by the results of the TDF2 study in Botswana (Thigpen 2012). • PrEP has the potential to address the need for a female-initiated prevention method for women worldwide who may be unable to negotiate condom use, or find themselves in situations in which condoms are not available or their use is not feasible or desired.

  5. WHO Guidelines: PrEP Demo Projects In July 2012 WHO released recommendations for Demonstration Projects focused on PrEP. • “In countries where HIV transmission occurs in serodiscordant couples and additional HIV prevention choices for them are needed, daily oral PrEP (TDF or TDF-FTC) may be considered“ • “In countries where HIV transmission occurs among men and transgender women who have sex with men and additional HIV prevention choices for them are needed, daily oral PrEP (specifically TDF-FTC) may be considered.” It is currently not possible to provide definitive guidance on how best to deliver daily oral PrEP, for which demonstration project research is needed.

  6. EarlyTreatmentforPrevention • Early Treatment for Prevention(TasP), has already been recommended for administration to HIV+ individuals with CD4 counts over 350/mm3 in serodiscordant couples (WHO 2012). • In 2011, the HPTN 052 trial showed that, among HIV-serodiscordant couples, ART given to the HIV-positive partner with a CD4+ count <550 cells/mm3 decreased HIV transmission by 96% when compared with those who started ART at CD4+ counts <350 cells/mm3 (Cohen et al 2011). • Complementary programmatic changes needed at the individual level include scaling-up HIV testing and counseling through strategies such as provider-initiated, and couples, HIV testing and counseling (WHO 2012) and their integration with care, treatment and prevention.

  7. New ConsolidatedGuidelines Forthe use of Antiretroviral DrugsforTreating and Preventing HIV Infection TobeLaunched TODAY at 14.45 here in IAS 2013

  8. WHO Guidelines – ETfP • As a priority, ART should be initiated in all individuals with severe or advanced HIV clinical disease (WHO clinical stage 3 or 4) and individuals with CD4 count ≤350 cells/mm3 (strongrecommendation, moderate-qualityevidence). • ART should be initiated in all individuals with HIV with CD4 count >350 cells/mm³ and ≤ 500 cells/mm3 regardless of WHO clinical stage (strong recommendation, moderate-quality evidence). • ART should be initiated in all individuals with HIV regardless of WHO clinical stage or CD4 count in thefollowingsituations: • Individuals with HIV and active TB disease (strong recommendation, low-quality evidence). • Individuals coinfected with HIV and HBV with evidence of severe chronic liver disease (strongrecommendation, low-qualityevidence). • Partners with HIV in serodiscordant couples should be offered ART to reduce HIV transmission to uninfected partners (strong recomm., high-quality evid.).

  9. BarriersforImplementation • Barriers for PrEP • Health systems limitations: • High expenditure implied and potential competition with treatment costs • Insufficient capacity to increase testing and to manage/monitor the use of new technologies); • Acceptability issues • Among potential beneficiaries, potential difficulties in access to information and explaining the use of ARVs for prevention; regular inconsistency in uptake; • Among providers and decision makers, concerns about ‘unethical’ distribution of ARVs and a potential emergence of a PrEP drug black market • Epidemiological consequences • Errors in PrEP prescription to HIV+ individuals; low adherence and risk compensation leading to high infection rates

  10. BarriersforImplementation • Barriers for ETfP • ARVT coverage levels have to be adequate • Health systems have to be prepared • Levels of partner notification have to be higher • Structural components neglected given limited understanding of their operation • Effectiveness of measures already in place is not guaranteed unless targeting, quality and coverage are adequate

  11. A Network forMultidisciplinaryStudies in ARV-BasedPrevention (NEMUS) A network allows for the convergence of a number of groups around the world interested in policy, social science, cost/cost-effectiveness, modeling and/or demonstration projects around combination prevention including ARV-based prevention. 1.   Discuss opportunities and challenges for implementation of ARV-based prevention, based on existing as well as new evidence generated by individual projects. 2.   Foster collaboration in ongoing studies, with a focus on potential: (a) potential comparison of the results of similar studies across countries; (b) diversification of studies to cover various dimensions/models of ARV-based prevention implementation and various target populations.

  12. A Network forMultidisciplinaryStudies in ARV-BasedPrevention (NEMUS) 3.  Develop concepts and resources for collaboration in the design and implementation of potentially useful studies around ARV-based prevention scale-up, including, for example: • policy studies focused on the inclusion of PrEP and ARV-based prevention in combination HIV prevention programs; • social impact of ARV-based prevention scale-up; • modeling effectiveness and cost-effectiveness studies of its implementation in CP programmes; • analysis from the perspective of bioethics (WHO/UNAIDS meeting on ethical issues); • demonstration projects.4.  Communicate findings and lessons learned to global stakeholders.

  13. PotentialResearchQuestions • Policy Who are thestakeholders? Are theyaware? What are theperspectives of each? Whatisthebasisfordisagreement? Isitfeasibletoseekconsensus? (whatkind of consensus: e.g.toconduct a more thoroughassessment of options) • HealthSystems and Cost/Cost-Effectiveness Are servicespreparedtooffer ARV-Basedprevention? Whatneedstobeimplemented and whatisthecost? Istheproposedprogrammeanticipatedtobecost-effective and sustainable? Can thenecessarylevels of coverage and adherencebereached? Whoshouldbeprioritised? • Social Science Howwillpeoplereacttointroduction of new strategies? Isitlikelythattheywillberesignified? Whatwillhappentoother sexual practices? Isthere a possibility of stigmatization of users? Will new strategieshaveanoverall positive impactoncommunities

  14. Example: A StudytoStart in Lima • “Developing a State-of-the-Art” HIV CP Programmefor MSM/TW in Lima withStakeholderInvolvement” • MultidisciplinaryStudytostartlaterthisyear • Phase I: StakeholderAnalysis (Policy) • Phase II: HealthSystemsAssessment • Cost of Current and ProposedPreventionOptions • Cost of ImprovingClinicLaboratoryInfrastructure • Phase III: ModellingScenarios of CP in terms of Effectiveness and Cost-Effectiveness • Phase IV: StakeholderConsensusBuildingWorkshop • Involvement of Gladstone, Imperial College, MoH, INS

  15. Estimated Impact of PrEP Implementation among MSM/TW according to levels of coverage, adherence, and prioritization of sub-populations (Gomez et al., 2012) A. Low coverage (5%) High coverage (20%) B. Less adherence iPrEX adherence profile More adherence

  16. NEMUS: InitialSteps • Exploratory Participation in CROI (March 2013) and PrEP communication meeting (April 2013) to assess interest among researchers and implementers • Informal sessions about this project with other researchers in IAS Conference (Kuala Lumpur) in June 2013, and ASSHH Conference (Paris) in July 2013 • In the KL and Paris meetings, the agenda will include initial work on priorities and research questions in multidisciplinary research on ARV-based prevention. • Given that audiences of those meetings are different (i.e. the IAS KL conference will gather mainly basic researchers, programmatic implementers, modelers and epidemiologists; the ASSHH Paris meeting will gather mainly social scientists), there will likely be no overlap in the discussion. • Next Phase: Establish a Communications Base and carry out initial agenda

  17. This Meeting in Kuala Lumpur • Summarise the state of the art concerning ARV-based prevention (evidence, challenges) • Present the Network of Multidisciplinary Studies on ARV-Based Prevention (goals, communication channels) • Start a discussion about trans-disciplinary research questions on ARV-based prevention that are relevant now • In ASSHH focus will be on social science reesearch 4. Contribute to exchanges among actors interested in this field.

  18. Acknowledgments • Kevin O’Reilly and Florence Koecklin WHO • Tim Hallett, Imperial College London • Peter Godfrey-Faussett and Barbara de Zalduondo, UNAIDS • Papa-SalifSow, The Gates Foundation • ManojKurjan and Helen von Dadelzsen, IAS • Mitchell Warren, AVAC • Robert Grant and Pedro Goicochea, Gladstone

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