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Download the File www.iasociety.org 1 PrEP Implementation Policy Forum Developing Country-Level Preparation and Capacity for PrEP Implementation 22 July 2007 Sydney, Australia Prep Implementation Policy Forum www.iasociety.org Participants Co-Chairs Craig McClure, International AIDS Society (IAS) Renee Ridzon, Bill & Melinda Gates Foundation Organisers Rodney Kort and Yasmin Halima, IAS Aaron Brinkworth Gilead Sciences, USA Ward Cates Family Health International (FHI), USA Katchit Choopanya Bangkok Tenofovir Study Group, Thailand Kevin De Cock World Health Organisation (WHO), Switzerland Florindo de la Hoz Gomez Ministry of Health, Botswana Carl Dieffenbach US National Institutes of Health (NIH), USA Mary Fanning NIH, USA Telmo Fernandez PrEP Trial Site, Ecuador Amy Flood Gilead Sciences, USA Pedro Goicochea Impacta, Peru Robert Grant University of California San Francisco (UCSF), USA Catherine Hankins UNAIDS, Switzerland Nick Hellman Bill & Melinda Gates Foundation, USA Mina Hosseinipour Investigator, Malawi Mathias Joshua Ministry of Health, Malawi Somyot Kittimunkong Ministry of Public Health, Thailand Javier Lama Impacta, Peru Michael Martin US Centers for Disease Control and Prevention (CDC), Thailand Veronica Miller Collaborative Forum for HIV Research, USA Biziwick Mwale National AIDS Commission, Malawi Jeffrey Nadler NIH, USA Lynn Paxton US CDC, USA Jim Rooney Gilead Sciences, USA Zeda Rosenberg International Partnership for Microbicides (IPM), USA Dawn Smith CDC, USA Shaleena Theopholus Global Campaign for Microbicides (GCM), Canada Suphak Vanichseni Bangkok Tenofovir Study Group, Thailand Mitchell Warren AIDS Vaccine Advocacy Coalition (AVAC), USA Introduction and Background 2. Discuss possible strategies for implementing PrEP in different country settings including: With the support of the Bill & Melinda Gates • Potential need for bridging studies to ensure Foundation, the International AIDS Society (IAS) findings are relevant to country epidemics convened a meeting engaging researchers, policy • Assess feasibility of implementing a PrEP makers, community members, and representatives programme using tenofovir disoproxil fumarate of normative agencies and the pharmaceutical (TDF) and/or Truvada (co-formulated TDF and industry to discuss implementation of pre-exposure emitricitabine) prophylaxis (PrEP) in light of anticipated clinical trial results from several major PrEP trials over the next Through its Industry Liaison Forum (ILF), IAS has few years. In welcoming participants, IAS Executive been convening dialogue among major stakeholders Director Craig McClure outlined the meeting’s two regarding scientific issues related to PrEP. IAS has primary objectives: also been involved with organising multi-stakeholder consultations in conjunction with the Bill & Melinda 1. Provide guidance on anticipating and translating Gates Foundation to resolve ethical and operational results from PrEP trials to different country challenges as they relate to clinical trials of PrEP. This situations, epidemiology, and local circumstances meeting represents the first attempt to convene Prep Implementation Policy Forum www.iasociety.org 1 stakeholders specifically to address delivery of this • Usage guidelines particular intervention. • Drug procurement and distribution strategies • Plans for initial and ongoing voluntary counselling The meeting began with presentations by Lynn Paxton and testing and Dawn Smith of the US Centers for Disease Control • Communications strategies and Prevention and Cate Hankins of UNIADS. • Clinical monitoring and adverse event follow-up • Behavioral monitoring • For seroconverters, viral resistance testing and access Translating research into policy to second-line therapy, if needed Lynn Paxton and Dawn Smith addressed issues Dr Smith proposed reasons why stakeholders should related to translating research into policy. One safety begin thinking about implementing PrEP now instead trial of TDF PrEP in African women was completed of waiting until trial results are analyzed: last year. Ongoing efficacy trials are evaluating TDF • There is reason to be optimistic that PrEP will in injecting drug users (IDUs) in Thailand, Truvada succeed in young heterosexual male and female adults (18- • It will take time to plan effectively because: 29 years of age)in Botswana, and Truvada in men - new prevention technologies are urgently who have sex with men (MSM) in Peru and Ecuador. needed in order to respond to the needs of A separate safety trial of TDF in US MSM is also countries with high-incidence of HIV under way. Preliminary results of the Thai trial will - many factors must be accounted for in planning be available in 2008. Results of all three efficacy to maximize safety and efficacy trials should be presented in 2009. Other trials are - multiple viewpoints and needs must be planned in serodiscordant couples and heterosexual considered women. Lynn Paxton noted that results of these trials will Dr Smith suggested it is reasonable to prepare for the shed light on four issues: possible efficacy of TDF and Truvada because of: • Efficacy of PrEP In IDUs, heterosexuals and MSM • Biological plausibility • Safety and required frequency of clinical • Concentrations achieved by these drugs in the monitoring genital tract • Emergence of viral resistance among seroconverters • Effectiveness in animal studies • Communication strategies that help researchers • Safety data reported in the Family Health promote understanding to trial participants of PrEP, International trial in Ghana e.g. how it should be taken (in the context of a trial), possible side effects, risk of drug resistance as Finally, despite imperfect adherence, antimicrobial PrEP well as determining community acceptability. has proved effective for prevention of mother-to-child transmission (PMTCT) of HIV, malaria, opportunistic However trial results will not demonstrate (1) infections, and other conditions. how PrEP with TDF or Truvada will work in “real- life” conditions where risk compensation and rare In the event that trials do not demonstrate the efficacy side effects become apparent, (2) safety of PrEP in of TDF and Truvada for PrEP, planning now will yield important unstudied populations such as adolescents strategies that will help with implementation of other and pregnant women, (3) efficacy of alternative biomedical interventions, such as microbicides or an dosing strategies. Perhaps most importantly, results HIV vaccine. from a trial in a specific sub-population may not be directly relevant to the epidemic characteristics of Dr Smith argued that implementation of PrEP with TDF affecting another country. or Truvada may have certain advantages compared to vaccine or microbicide implementation because, unlike Dr Paxton stressed that each country will need those other two strategies, TDF and Truvada: to address the appropriate use of PrEP given the • Are already approved for treatment of HIV characteristics of its epidemic and its prevention and infection treatment infrastructure. Still, any PrEP program • Require no new regulatory procedures should include certain core elements: • Require no new manufacturing processes Prep Implementation Policy Forum 2 www.iasociety.org • Are available at reduced cost for the public sector With a view toward facilitating potential PrEP in the US implementation, Dr Smith noted that the CDC • Are being licensed to generic manufacturers has (1) initiated conversations with a wide range of stakeholders, (2) assembled a multidisciplinary However, Dr Smith stressed that PrEP will bring its own study group to work on implementation planning challenges such as the need for periodic follow-up for and evaluation questions, (3) surveys of national incident HIV and adverse effects. stakeholders, program managers, and potential participants to consult on implementing PrEP, and (4) Because pharmaceuticals can be prescribed for off-label planned focus groups with potential users. indications in the United States, Dr Smith observed that guidance on use of TDF and Truvada for PrEP will have Dr Smith listed the following country-specific factors in to be in place if ongoing trials demonstrate efficacy. planning for PrEP implementation: • Priority groups to maximize reduction of HIV If PrEP proves successful, funding will clearly be a incidence paramount issue. Countries that implement PrEP will • Provider types and sites need to tap new funding sources or will have to divert • Barriers and implementation designs to overcome some funds from other programs, perhaps including them antiretroviral efforts. Countries that do decide to back • Lessons learned from scale-up of PMTCT and PrEP will have to plan for rapid introduction of this antiretroviral therapy strategy to achieve sufficient coverage, intensity and • Reproductive health and pregnancy issues duration to have an optimal effect. Dr Smith proposed • Funding and implementation partners that rollout programs should be built to take advantage of several advantages of PrEP vis-à-vis other preventive strategies: Lessons learned from implementation • More gender neutral planning for male circumcision • Covert use feasible • Coitally independent Cate Hankins described ongoing planning for country- • May work for more than one type of exposure wide implementation of male circumcision to prevent (for example, for an injecting drug user who has HIV infection and highlighted issues that may apply to unprotected sex) a PrEP rollout. • Can discontinue PrEP during periods where individuals are not engaging
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