抄 録

P l e n a r y L e c t u r e

基 調 講 演

WHO/NCGM/NIH workshop

シ ン ポ ジ ウ ム

ミ ニ レ ク チ ャ ー

ワ ー ク シ ョ ッ プ

ラ ン チ ョ ン セ ミ ナ ー イ ブ ニ ン グ セ ミ ナ ー HIV 感染症薬物療法認定・専門薬剤師講習会

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282 86

Opening Session 1

OP1 Long Acting PrEP Agents in HIV Prevention

David D. Ho

Aaron Diamond AIDS Research Center The Rockefeller University, USA

There is no effective vaccine to protect against HIV infection today, and none will be available for the foreseeable future. The lack of an effective HIV vaccine is in part due to the structural properties of the viral envelope glycoprotein, which possesses highly variable aminoacid sequences along with extensive glycosylation that shield the virus from many antienvelope antibodies. As an alternative strategy, our group is pursuing the use of antibodies as agents for passive administration to prevent HIV infection. We have engineered a number of bispecific monoclonal antibodies that have remarkable potency and breadth against the virus in vitro. We have in hand a number of constructs with 100breadth against a large panel of HIV strains with potency in the nM range. Several of these constructs are now being evaluated as candidates for clinical development. In addition, our group has pursued a slowrelease formulation of the integrase inhibitor cabotegravirformerly known as GSK744LAagainst HIV. The pharmacokinetic profile of cabotegravir in humans suggests that it could be administered as an injectable once every 3 months. In protection experiments against virus challenges in monkeys, this drug has shown high degrees of protection.

We firmly believe that this longacting integrase inhibitor is a promising agent for HIV prevention in high risk populations. We are finishing a Phase2 study at this time, and multiple Phase3 efficacy studies are being planned.

283 87

Opening Session 2

OP2 An Editor�s Insights into Writing a Scientific Paper

Stuart Spencer Lancet, UK

It is important to remember why we write scientific papers. It is notjustto improve our CV and scientific profile. Particularly in medical research, there is an ethical imperative to publish the results of research we have undertaken so that other people are not subjected to unnecessary risk. The scientific paper is therefore about communication. An author�s task in to ensure that the message is clear to the readers. Presentation is important. A visually attractive and wellorganised manuscript helps the reader. Use an easily read fontfor example, Calibri or Arial1112 pointwith double spacing.

The first reader will be the editor of the journal. As a gatekeeper to publication, it is essential that the author communicates the message clearly to the editor. The covering letter1 pageshould explain in simple, nontechnical language the novelty, the importance of the question, the importance of the conclusion, and the reason why the paper is appropriate for the journal.

Because you need to communicate your message, writing style is important. A paper that is poorly structured and difficult to understand will not engage the readers� attention. Crucial aspects are the use of simple language, avoiding abbreviations and using short sentences. One point in each sentenceno more than 30 words.

Pay attention to the Title and the Abstract. A long title suggests thinking is not clear and warns the reader the manuscript might be difficult to follow. The Abstract is very important. Most people only read the Abstract, so the important messages you wish to convey to the reader must be included here. Most journals have a strict specified wordcount for Abstractsdo not exceed this.

The standard structure of a scientific paper helps with writing and reading, but things must be in the correct place. The Introduction should be short. It should usually not exceed 3 paragraphs and should end with the aim of the research, or the hypothesis being tested. Methods should be describedor referenced sufficiently that the work could be repeated by others. Results should be clearly and logically described. Do not repeat data from tables and figures in the text. Discussion should put the results in context. Start with a onesentence summary of the main result. It is much more important to discuss the limitations of your work the strengths. Discuss the implicationsboth clinical and for the next phase of research. End with a strong statement.

Figures should be clear and simple. Do not put too much in any one figure. Figures tell the storytables provide essential detail. Long or complex tables probably provide fine details and might be better placed as an online appendix. Do not overreference the paper. Chose references carefully and make sure they are the most appropriate.

Follow the guidelines. Guidelines such as CONSORT for randomised trials are there to help you remember what is needed for proper evaluation of your work. Pay special attention to the responsibilities of authorship.

Only the few who meet the International Committee of Medical Journal Editors� guidelines can be authors.

Editors expect you to follow the specific guidelines they have produced for their journal.

282 86

Opening Session 1

OP1 Long Acting PrEP Agents in HIV Prevention

David D. Ho

Aaron Diamond AIDS Research Center The Rockefeller University, USA

There is no effective vaccine to protect against HIV infection today, and none will be available for the foreseeable future. The lack of an effective HIV vaccine is in part due to the structural properties of the viral envelope glycoprotein, which possesses highly variable aminoacid sequences along with extensive glycosylation that shield the virus from many antienvelope antibodies. As an alternative strategy, our group is pursuing the use of antibodies as agents for passive administration to prevent HIV infection. We have engineered a number of bispecific monoclonal antibodies that have remarkable potency and breadth against the virus in vitro. We have in hand a number of constructs with 100breadth against a large panel of HIV strains with potency in the nM range. Several of these constructs are now being evaluated as candidates for clinical development. In addition, our group has pursued a slowrelease formulation of the integrase inhibitor cabotegravirformerly known as GSK744LAagainst HIV. The pharmacokinetic profile of cabotegravir in humans suggests that it could be administered as an injectable once every 3 months. In protection experiments against virus challenges in monkeys, this drug has shown high degrees of protection.

We firmly believe that this longacting integrase inhibitor is a promising agent for HIV prevention in high risk populations. We are finishing a Phase2 study at this time, and multiple Phase3 efficacy studies are being planned.

284 88

Plenary Lecture 1

PL1 Innovations in Nucleoside Nucleotide Research Leading to Advances in Antiviral Therapy

John C. Martin

Gilead Sciences, Inc., USA

Active site directed viral polymerase inhibitors have been the mainstay of antiviral therapy for decades.

For instance, the first major drugs for HIVAIDS patients were the nucleoside analogues AZT, ddI, 3TC, and D4T. In human target cells, these nucleoside analogues are first phosphorylated to a 5�monophosphate and then ultimately to the corresponding triphosphate. The triphosphate serves as a substrate for the viral polymerase and terminates replication of the genome. These early generation nucleoside analogues demonstrated some significant safety and tolerability issues, but nevertheless as drugs prolonged the lives of countless HIV infected individuals around the world including those in lowmiddle income countries.

Over the last 15 years, a new class of drugs called nucleotides has come to predominate. Nucleotide drugs are stable versions of nucleoside 5�monophospates and can more effectively target virus infected cells because of superior pharmacology. During this time, tenofovir DFTDFhas become the predominate backbone agent for chronic therapy of HIV and hepatitis B infection. A measure of the success of TDF is that 801 millionof HIV treated patients in upper income countries are on this medication. An additional 8 million individuals benefit from TDF in lowmiddle income countries. This success is due to the safety and efficacy of TDF and because it has been combined with other agents to provide 3 different daily single tablet regimens. This profile has allowed for an ongoing evolution of treatment guidelines to recommend all patients initiate therapy at the time of diagnosis. Thus, TDF has provided the foundation for treatment as prevention and in the form of Truvada to initiate preexposure prophylaxis in HIV negative high risk individuals, two strategies to lower a community burden of disease. Finally, a new tenofovir prodrug TAF that improves on the safety profile of TDF will begin to become available to HIV patients starting in late 2015.

Over the last three years, the nucleotide analogue sofosbuvir has revolutionized treatment of hepatitis C infection. Historical treatment of this disease with one year of peginterferon, ribavirin plusminus a protease inhibitor was so poorly tolerated that only a small subset of patients could be treated with a moderate cure rate. Now a single tablet regimen containing sofosbuvir can cure the large majority of patients treated for only 12 weeks. As of the end of summer 2015, over half a million individuals have initiated treatment with a sofosbuvir containing regimen.

This presentation will provide an overview of the scientific accomplishments leading to these therapeutic advances with nucleotide analogues.

285 89

Plenary Lecture 2

PL2 Prevention of HIV Infection in 2016 and Beyond

Myron S. Cohen

University of North Carolina, USA

HIV prevention research has contributed to a falling incidence of HIV in many countries, and in some key populations. HIV prevention strategies can be broadly divided into vaccine and nonvaccine related. Vaccine strategies have reached a milestone with focus on improving on one successful trialRV144, and increasing knowledge of broad neutralizing antibodiesbnABs. The most advanced bnAB trial is HVTN 703HPTN 081, a Phase 2b study designed to determine if VRC01 given every 8 weeksfor passive immunityreduces acquisition of HIV in men who have sex with menMSMand transgender participants in the Americasn 2400and women in sub Saharan African1500. Nonvaccine HIV prevention has recently focused on optimal use of antiviral treatment. Successful ARTthat limits HIV replicationgreatly reduces sexual transmission of HIV. The HPTN 052 trial was completed in May, 2015. HIV serodiscordant couples were followed for 8494 person years. By intention to treat analysis ARTcombined with counseling and condoms reduced a virologically linked HIV transmission eventfrom infected person to partnerby 93. Linked transmission eventsn8 totalwere only observed early in treatment before antiretroviral agents could prove effective, or when treatment failed. Unlinked transmission event occurred in 1300 person years of follow up.Treatment as preventionis a credible strategy if enough people, and the people most likely involved in ongoing transmission can be successfully treated. However, this strategy has yet to be proven at the population level and community based randomized controlled trials exploring this idea are underway.

Alternatively, ART can be used as preexposure prophylaxisPrEP. Tenofovir emtricitabine can prevent HIV acquisition, but the magnitude of benefit depends on adherence, and men may benefit more than women. Potent newer drugsrilpivirine, cabotegravirdelivered as nanosuspensions provided every 8 12 weeks are being explored for PrEP. HPTN 083 is a Phase 2b trial designed to determine whether cabotegravir can prevent HIV acquisition in MSM in the Americasn4500 subjects. ART can also be provided as a topical agent. In early 2016, the results of two large trials examining the ability of dapivirine impregnated rings used intravaginallymonthlyto prevent HIV will be reported. The most immediate and available HIV prevention lies in inspiring reduced risk taking procedure. Strategies that reduce risk are in constant development, and the use of behavioral economic tools such as cash transfershave had mixed results, but great potential. In the absence of a highly effective vaccine, HIV prevention will continue to depend on implementation of a combination of tools that have proven effective.

284 88

Plenary Lecture 1

PL1 Innovations in Nucleoside Nucleotide Research Leading to Advances in Antiviral Therapy

John C. Martin

Gilead Sciences, Inc., USA

Active site directed viral polymerase inhibitors have been the mainstay of antiviral therapy for decades.

For instance, the first major drugs for HIVAIDS patients were the nucleoside analogues AZT, ddI, 3TC, and D4T. In human target cells, these nucleoside analogues are first phosphorylated to a 5�monophosphate and then ultimately to the corresponding triphosphate. The triphosphate serves as a substrate for the viral polymerase and terminates replication of the genome. These early generation nucleoside analogues demonstrated some significant safety and tolerability issues, but nevertheless as drugs prolonged the lives of countless HIV infected individuals around the world including those in lowmiddle income countries.

Over the last 15 years, a new class of drugs called nucleotides has come to predominate. Nucleotide drugs are stable versions of nucleoside 5�monophospates and can more effectively target virus infected cells because of superior pharmacology. During this time, tenofovir DFTDFhas become the predominate backbone agent for chronic therapy of HIV and hepatitis B infection. A measure of the success of TDF is that 801 millionof HIV treated patients in upper income countries are on this medication. An additional 8 million individuals benefit from TDF in lowmiddle income countries. This success is due to the safety and efficacy of TDF and because it has been combined with other agents to provide 3 different daily single tablet regimens. This profile has allowed for an ongoing evolution of treatment guidelines to recommend all patients initiate therapy at the time of diagnosis. Thus, TDF has provided the foundation for treatment as prevention and in the form of Truvada to initiate preexposure prophylaxis in HIV negative high risk individuals, two strategies to lower a community burden of disease. Finally, a new tenofovir prodrug TAF that improves on the safety profile of TDF will begin to become available to HIV patients starting in late 2015.

Over the last three years, the nucleotide analogue sofosbuvir has revolutionized treatment of hepatitis C infection. Historical treatment of this disease with one year of peginterferon, ribavirin plusminus a protease inhibitor was so poorly tolerated that only a small subset of patients could be treated with a moderate cure rate. Now a single tablet regimen containing sofosbuvir can cure the large majority of patients treated for only 12 weeks. As of the end of summer 2015, over half a million individuals have initiated treatment with a sofosbuvir containing regimen.

This presentation will provide an overview of the scientific accomplishments leading to these therapeutic advances with nucleotide analogues.

286 90

Role of World Health Organization Towards Ending AIDS Endemics

Hiroki Nakatani Keio University

The first 15 years of the 21th century have seen great progress in the fight against three major infections HIVAIDS, tuberculosis and malaria, under the framework of the MDGs. In many low income countries, the massive inflow of external fundings achieved decline of both mortality and morbidity, breaking the vicious cycle of poverty and ill health. However, many affected persons are still waiting for health services.

Furthermore, HIV communities have reasons to worry about the consequence of the end of the MDGs by the end of 2015 and the emerging new paradigm of SDGs, in fear of diluting the legendary efforts so far.

In recent years, global health discussions have shifted from communicable to noncommunicable diseases and health systems, until the Ebola crisis in West Africa gave a hard lesson for every party including WHO.

In this keynote lecture, the following points will be discussed 1 Progress of HIVAIDS control and its architecture

The remarkable progress will be reviewed and partnerships such as UNAIDS, GF, UNITAID and BMGF will be mentioned.

2 SDGs and emerging global health architecture

Triggered by both SDGs and Ebola response, discussion on the global health architecture is activated.

3 Lessons learned and way forwardimplication for the work of WHO

Ongoing work of WHO will be reviewed and placed within a wider context of global health.

WHO has been a strong team player in the complicated and competitive environment of global health, and HIVAIDS can offer a good case study in terms of its contribution, potentials and limitations.1569 characters including spaces

The views expressed in this summary are those of the author and do not necessarily reflect the official position of WHO.

WHONCGMNIHworkshop

287 91

WHONCGMNIH workshop

Advancing implementation research on HIVAIDS in Asia

Organizer YingRu LoWHO Regional Office for the Western Pacific

Session 1Key populations

Chair Wafaa ElSadrColumbia University

Presentations

1Translating research to implementationThe role of WHO in Asia YingRu LoWHO Regional Office for the Western Pacific

2The treatment cascadeWhat does it take to monitor and evaluate impact of test and treat David CooperKirby Institute, Australia

3Moving towards communitybased test and treat and PrEP service delivery Thailand perspective

Praphan PhanuphakThai Red Cross, AIDS Research Center and Inform Asia, Thailand 4Test, treat, and prevent HIV implementation science study among MSM and transgender

women

Michael MartinU.S. CDC Thailand

5Integrated treatment and prevention for people who inject drugs A vanguard study in Indonesia, Ukraine and Viet NamHPTN 074 William MillerUniversity of North Carolina, USA

6Interventions in prison for people living with HIV in Malaysia Adeeba KamarulzunamUniversity of Malaya, Malaysia

286 90

Role of World Health Organization Towards Ending AIDS Endemics

Hiroki Nakatani Keio University

The first 15 years of the 21th century have seen great progress in the fight against three major infections HIVAIDS, tuberculosis and malaria, under the framework of the MDGs. In many low income countries, the massive inflow of external fundings achieved decline of both mortality and morbidity, breaking the vicious cycle of poverty and ill health. However, many affected persons are still waiting for health services.

Furthermore, HIV communities have reasons to worry about the consequence of the end of the MDGs by the end of 2015 and the emerging new paradigm of SDGs, in fear of diluting the legendary efforts so far.

In recent years, global health discussions have shifted from communicable to noncommunicable diseases and health systems, until the Ebola crisis in West Africa gave a hard lesson for every party including WHO.

In this keynote lecture, the following points will be discussed 1 Progress of HIVAIDS control and its architecture

The remarkable progress will be reviewed and partnerships such as UNAIDS, GF, UNITAID and BMGF will be mentioned.

2 SDGs and emerging global health architecture

Triggered by both SDGs and Ebola response, discussion on the global health architecture is activated.

3 Lessons learned and way forwardimplication for the work of WHO

Ongoing work of WHO will be reviewed and placed within a wider context of global health.

WHO has been a strong team player in the complicated and competitive environment of global health, and HIVAIDS can offer a good case study in terms of its contribution, potentials and limitations.1569 characters including spaces

The views expressed in this summary are those of the author and do not necessarily reflect the official position of WHO.

WHONCGMNIHworkshop

288 92

Session 2Using implementation science

Chair YingRu LoWHO Regional Office for the Western Pacific

Presentations

1Enhanced test, link to care, plus treat approach for HIV prevention in the United States HPTN 065

Wafaa ElSadrColumbia University, USA

2A community randomized trial of universal test and treat in Zambia and South Africa HPTN 071

Christophe FraserImperial College, United Kingdom

3Using molecular phylogenetics to assess HIV transmission and prevention Thomas QuinnJohns Hopkins University, USA

4Using implementation science research for scaling up HIV services in India Raman GangakhedkarNational AIDS Research Institute, India

Description

Access to antiretroviral therapyARThas significantly expanded in the past decade in Asia and the Pacific. To harness the benefits of antiretroviral drugs towards eliminating new HIV infections and deaths, the World Health Organization is updating its guidelines for HIV treatment and prevention, and most countries in the region are moving towards earlier treatment. Yet major challenges remain in the wider implementation of recommendations from previous guidelines, including early diagnosis and linkages to care, the use of pre exposure prophylaxisPrEP, reaching and engaging key populations, developing robust monitoring and evaluation systems, and identifying efficient service delivery models in the face of challenging funding scenarios. Implementation research helps address such challenges by identifying innovative interventions and approaches to improve service delivery, improve efficiency and reduce cost.

This consultation will update and expand the research agenda towards eliminating new HIV infections and deaths in Asia. The consultation process among selected programme managers, researchers and civil society representatives would help ensure that they are better connected and able to share and access knowledge, expertise and funding resources to engage in appropriate and necessary implementation research towards elimination of new HIV infections.

289 93

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WHONCGMNIHworkshop

288 92

Session 2Using implementation science

Chair YingRu LoWHO Regional Office for the Western Pacific

Presentations

1Enhanced test, link to care, plus treat approach for HIV prevention in the United States HPTN 065

Wafaa ElSadrColumbia University, USA

2A community randomized trial of universal test and treat in Zambia and South Africa HPTN 071

Christophe FraserImperial College, United Kingdom

3Using molecular phylogenetics to assess HIV transmission and prevention Thomas QuinnJohns Hopkins University, USA

4Using implementation science research for scaling up HIV services in India Raman GangakhedkarNational AIDS Research Institute, India

Description

Access to antiretroviral therapyARThas significantly expanded in the past decade in Asia and the Pacific. To harness the benefits of antiretroviral drugs towards eliminating new HIV infections and deaths, the World Health Organization is updating its guidelines for HIV treatment and prevention, and most countries in the region are moving towards earlier treatment. Yet major challenges remain in the wider implementation of recommendations from previous guidelines, including early diagnosis and linkages to care, the use of pre exposure prophylaxisPrEP, reaching and engaging key populations, developing robust monitoring and evaluation systems, and identifying efficient service delivery models in the face of challenging funding scenarios. Implementation research helps address such challenges by identifying innovative interventions and approaches to improve service delivery, improve efficiency and reduce cost.

This consultation will update and expand the research agenda towards eliminating new HIV infections and deaths in Asia. The consultation process among selected programme managers, researchers and civil society representatives would help ensure that they are better connected and able to share and access knowledge, expertise and funding resources to engage in appropriate and necessary implementation research towards elimination of new HIV infections.

290 94

S1-1 Impact of genetic and functional changes in HIV 1 and SIVcpz transmission

Kei SatoYoshio Koyanagi

Institute for Virus Research, Kyoto University

Although genetic changes of individual viruses including HIV1 and SIV have been found, specific assessments are required to know the implication of the changes. Phylogenetic analysis of SIV and HIV genetic data indicated that HIV1 group M has been emerged by transmission of SIVcpz from chimpanzees to humans. To accomplish the crossspecies transmission, two transmission modes are knowntailor madeadaptation andofftheshelfemergence. The former requires genetic alternations to adapt the new host species, while the latter includes the existence of preadapted pathogens in the old host species. It is unclear how SIVcpz changed to be pandemic HIV1. To address this question, we inoculated several genetically distinct SIVcpz strains, HIV1 M strains, and HIV1 N strains into humanized mice and found that the viral pathogenicitydecrease of human CD4T cellssignificantly correlated to the level of peak viral load during the initial phase of infection. Interestingly, the peak viral load of one SIVcpz strain, genetically closest to HIV1 M, was comparable to that of HIV1 M and was clearly higher than those of HIV1 N and the other SIVcpz viruses, suggesting that the emergence of HIV1 M is partly attributed to the offtheshelfadaptation. Furthermore, from viral RNA sequence analysis in the plasma of infected mice, we found a substitution mutation augmenting viral replication capacity. These findings suggest thatioff theshelfemergence of SIVcpz virusandiisubsequenttailormadeadaptation resulted in the emergence of pandemic HIV1.

291 95

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290 94

S1-1 Impact of genetic and functional changes in HIV 1 and SIVcpz transmission

Kei SatoYoshio Koyanagi

Institute for Virus Research, Kyoto University

Although genetic changes of individual viruses including HIV1 and SIV have been found, specific assessments are required to know the implication of the changes. Phylogenetic analysis of SIV and HIV genetic data indicated that HIV1 group M has been emerged by transmission of SIVcpz from chimpanzees to humans. To accomplish the crossspecies transmission, two transmission modes are knowntailor madeadaptation andofftheshelfemergence. The former requires genetic alternations to adapt the new host species, while the latter includes the existence of preadapted pathogens in the old host species. It is unclear how SIVcpz changed to be pandemic HIV1. To address this question, we inoculated several genetically distinct SIVcpz strains, HIV1 M strains, and HIV1 N strains into humanized mice and found that the viral pathogenicitydecrease of human CD4T cellssignificantly correlated to the level of peak viral load during the initial phase of infection. Interestingly, the peak viral load of one SIVcpz strain, genetically closest to HIV1 M, was comparable to that of HIV1 M and was clearly higher than those of HIV1 N and the other SIVcpz viruses, suggesting that the emergence of HIV1 M is partly attributed to the offtheshelfadaptation. Furthermore, from viral RNA sequence analysis in the plasma of infected mice, we found a substitution mutation augmenting viral replication capacity. These findings suggest thatioff theshelfemergence of SIVcpz virusandiisubsequenttailormadeadaptation resulted in the emergence of pandemic HIV1.

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292 96

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