T W O D E C A D E S, O N E M E S S A G E : P R E V E N T I O N M AT T E R S

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1 V 7 YEARS AND COUNTING... VI IV III II AVAC? 4 to an AIDS Vaccine? 3 2 AIDS VACCINE ADVOCACY COALITION MAY 2001 AIDS VACCINE ADVOCACY COALITION MAY HOW DO YOU FIGHT A DISEASE OF MASS DESTRUCTION...? C1 AVA C R E P O RT AND OTHER QUESTIONS ON THE ROAD TO AN AIDS VACCINE. FINLAND RUSSIA UNITED KINGDOM NETHERLANDS BELGIUM GERMANY CANADA FRANCE SWITZERLAND ITALY SCIENCE, URGENCY, AND COURAGE VII CAN A SHIFTING LANDSCAPE ACCELERATE AN AIDS VACCINE 5 How Can We Overcome Obstacles Years & Counting VIII Years and Counting: UNITED STATES CHINA HAITI DOMINICAN REPUBLIC U.S./PUERTO RICO JAMAICA I INDIA TRINIDAD & TOBAGO CAMEROON UGANDA RWANDA PERU THAILAND KENYA TANZANIA BRAZIL MALAWI ZAMBIA AIDS VACCINE ADVOCACY COALITION MAY 2 oo 2 Y E A R S & C O U N T I N G BOTSWANA SOUTH AFRICA AUSTRALIA A I D S VA C C I N E T R I A L S G E T T I N G T H E G L O B A L H O U S E I N O R D E R CIN ES SSR OAD S AC AC S V CRO AV AI AID HE AT T DS VA CC IN D EA VO CAC OA Y C LIT ION R E ss E T T I N G T H E AIDS Vaccines: The Next Frontiers 20 AVA C R e p o r t 06 C L O C K TURNING Piecing Together the HIV Prevention Puzzle AVAC Report 2009 THE PAGE Report 2010 AVA C R E P O R T : Research & Reality THE END PREVENTION on the Line ACHIEVING THE END One Year and Counting AVAC Report 2014/15 December 2015 REPORT 2012 w w w. a v a c. o r g

2 T W O D E C A D E S, O N E M E S S A G E : P R E V E N T I O N M AT T E R S When AVAC was founded in 1995, we were called the AIDS Vaccine Advocacy Coalition. Our singular goal was to advance swift, ethical research for a vaccine that was then and is today essential to bring the epidemic to a conclusive end. Twenty years later, AVAC is still focused on swift and ethical research, but our scope has expanded. Along with vaccines, we advocate for PrEP, microbicides, voluntary medical male circumcision, and more. And we ve evolved with the field. As positive results have delivered new tools, AVAC has led the charge for the rapid, strategic rollout of all options needed to end the epidemic. Through it all, our message has been the same: prevention is the center of the AIDS response. Not just any prevention but smart, evidence-based, community-owned, rights-based strategies. AVAC is the only advocacy group working across the full spectrum of biomedical prevention interventions, from early-stage research to large-scale rollout. We do this work because it s essential. We are able to do it because of our robust partnerships worldwide. We will keep doing it with your help until the epidemic has, finally, come to an end. AIDS VACCINES, HIV PREVENTION AND THE GLOBAL EPIDEMIC: A TIMELINE First US government trial held of preventive vaccine candidate The AIDS Service Organization (TASO) established in Uganda International Community of Women Living with HIV/AIDS founded First phase II AIDS vaccine trial begins, of two gp120 products First major syringe exchange program opens in the US Female condom receives approval from US FDA US Congress requires NIH and other agencies to expand involvement of women and minorities in all research US Public Health Service recommends AZT for pregnant women with HIV to reduce onward transmission

3 KEEPING THE FIELD ON TRACK N O M AT T E R W H AT. We ve experienced 20 years of breakthroughs and disappointments in prevention research. A vaccine that many had given up on was the first to provide modest protection. One microbicide everyone hoped for didn t pan out. Male circumcision and PrEP studies overcame skepticism and, together with antiretroviral therapy, paved the way for a prevention revolution. Through it all, AVAC has worked with partners to maintain the field s focus and press for continued research into an AIDS vaccine, a cure and more. Vaccine PrEP Combination Prevention Microbicides On Treatment Virally Suppressed Diagnosed Dx U Ending the AIDS epidemic takes comprehensive targets and action. Voluntary Medical Male Circumcision Contraceptive Methods Safe, Effective Harm Reduction Syringe Exchange Human Rights Cure UNAIDS formed Levine Committee calls for overhaul of NIH AIDS research International AIDS Vaccine Initiative (IAVI) formed First efficacy trials of VaxGen s AIDSVAX candidate start South Africa s Treatment Action Campaign founded The first protease inhibitor approved; effective HIV treatment now exists. AVAC co-founder Bill Snow publishes, Why We Need AIDS Vaccine Activism; AVAC founded the next month US President Bill Clinton announces goal of effective AIDS vaccine in 10 years UNAIDS estimates 16,000 new HIV transmissions each day South African AIDS Vaccine Initiative (SAAVI) established First African AIDS vaccine trial begins in Uganda

4 D E F I N I N G T H E P AT H FROM RESEARCH TO ROLLOUT. When AVAC was founded, the only biomedical HIV prevention options for adults were male and female condoms. The pathway for introducing any new strategy was largely unmapped. No one knew where the gaps would be between trial result and country action, between guidance and financial support. Now we do. Over two decades, AVAC has not only identified the gaps; we ve worked to bridge them, so that products reach people in programs that work without delay. Research to Rollout: A schematic road map Phase I Phase II/IIb Phase III Open-Label Extension / Post-Trial Access Demonstration Projects Product Introduction Scale Up Clinical Trial Safety and Efficacy Real-World Effectiveness For the first decade of AVAC s existence, most prevention advocacy focused on actions to the left of the red arrow above. But with results, come new challenges. We now work on research and on ensuring products cross the gap between efficacy and real-world use. Dale and Betty Bumpers Vaccine Research Center (VRC) opened at NIH Thousands march for global treatment access in Durban, South Africa IAVI, VRC and other leading laboratories and collaborators form Neutralizing Antibody Consortium first entity of its kind dedicated to solving this key scientific challenge facing field Eastern Europe and former Soviet Union reported to have highest rising rates of new infections in the world UN General Assembly convenes first ever special session on AIDS George W. Bush announces PEPFAR initiative Rationale for Global HIV Vaccine Enterprise laid out in Science

5 C R E AT I N G A G L O B A L N E T W O R K OF PREVENTION ADVOCATES. Twenty years ago, advocacy for HIV prevention hardly existed. So AVAC helped build a global network of advocates equipped with effective advocacy strategies and the latest evidence. With our support, they are putting prevention on the agenda in countries and communities around the globe. Partnering for a Prevention Revolution Through Advocacy Fellows, PxROAR members, coalition-building, strategic convening, training and other support, AVAC partners with stakeholders throughout the world to increase awareness and understanding of the current state of HIV prevention research and implementation. Together, we hold decision-makers accountable and press for smart investments and sound policies in all aspects of HIV prevention. Protests at Bangkok AIDS Conference target PrEP trials VaxGen Thai trial shows no efficacy Malawian government halts PrEP trial citing concerns about using ARVs for prevention Bill and Melinda Gates Foundation announces $287 million to support the Collaboration for AIDS Vaccine Discovery (CAVD) Kenyan and Ugandan trials confirm South African data showing voluntary medical male circumcision reduces HIV risk for HIV-negative men US FDA announces approval of Gardasil, which protects against strains of HPV that cause cervical cancer NIH convenes summit on HIV vaccine research with renewed emphasis on basic research Merck and HIV Vaccine Trials Network launch test of concept study of adenovirus-based vaccine Global HIV Vaccine Enterprise Scientific Strategic Plan published in PLoS Medicine Step and Phambili trials halted Merck s MRK-Ad5 vaccine shows no benefit and increased susceptibilty among some volunteers WHO recommends voluntary medical male circumcision for HIV prevention

6 D E M A N D I N G A C T I O N ON AN AGENDA TO END AIDS. When the world lacked a plan for ending AIDS, we helped create one. Now we re holding global leaders accountable for results demanding the resources, policies and evidencebased plans needed to deliver all of today s prevention options to the people who need them, and to plan for the rapid rollout of new options as they emerge. A Three-Part Agenda for Ending AIDS DELIVER proven tools for immediate impact DEMONSTRATE and roll out new HIV prevention options C O M B I N E GOAL: A sustained decline in HIV infections DEVELOP long-term solutions needed to end the epidemic Years to impact Zero to 5 5 to to End CAPRISA 004 trial of Tenofovir gel shows modest efficacy in South African women a first for microbicides iprex trial shows efficacy of dail oral PrEP in gay men and transgender women Pox Protein Public-Private Partnership (P5) established to build on results of RV144 US FDA approves daily Truvada as oral PrEP Analysis of RV144 results reveals two correlates of risk in participants Hundreds of broadly neutralizing antibodies IDed as possible targets for vaccine development RV144 trial of ALVAC/AIDSVAX shows modest 31.2% efficacy in preventing HIV acquisition first evidence of efficacy in any AIDS vaccine clinical trial HVTN 505 trial of DNA prime/ad5-boost vaccine begins South Africa begins massive expansion of ART program HPTN 052 trial shows treatment can reduce risk of transmission by up to 96% Partners PrEP trial shows high efficacy of daily oral PrEP in HIV-negative men and women in serodiscordant couples

7 MANAGING THROUGH CONTROVERSY. Communities support for prevention research can never be taken for granted it has to be earned. For 20 years, we ve helped build trust between researchers, funders and communities to speed the ethical development and rollout of new prevention options. And when controversy threatened to derail those efforts, AVAC provided leadership and resources to help get them back on track. The Good Participatory Practice (GPP) Guidelines provide trial funders, sponsors and implementers with systematic guidance on how to effectively engage with all stakeholders in the design and conduct of biomedical HIV prevention trials. Annual AIDS Vaccine Conference and biennial Microbicide Conference merge to become the HIV Research for Prevention Conference (HIV R4P), the first biomedical HIV prevention conference UNAIDS announces new goal for testing, treating and viral suppression; prevention and non-discrimination goals developed but not launched START trial stopped early, confirms individual health benefits of starting those living with HIV on antiretroviral therapy ART at CD4 cell counts above 350 WHO releases new recommendations: 1) Initiation of ART in all people living with HIV, regardless of CD4 cell count, and 2) Offer of PrEP as a prevention option to all people at substantial risk of acquiring HIV P5 outlines two proposed vaccine licensure trials one in Thailand and the other in South Africa and an additional research trial in Southern Africa HVTN 505 stops immunizations after DSMB finds trial cannot show efficacy ECHO trial to explore possible link between hormonal contraception and HIV acquisition FACTS 001 trial does not demonstrate efficacy of 1% tenofovir microbicide gel Two phase II trials of different longacting injectable ARVs launched

8 SUPPORTING OUR WORK Achieving the End of AIDS The world is talking about ending AIDS. AVAC s advocacy is dedicated to realizing that vision. To get there we must: Deliver proven tools for immediate impact. Demonstrate and roll out new HIV prevention tools. Develop long-term solutions to end the epidemic. Your gift to AVAC will support our efforts to accelerate the development and delivery of HIV prevention options to men and women worldwide. With your help, we can continue to convene, collaborate and communicate a strong, clear and cohesive vision for HIV prevention today, tomorrow and to end the epidemic. It will take all of us working together to end AIDS. Please join us. To learn more about AVAC, including our history, our focus and our team, please visit And to support this work, please go to West 127th Street 4th floor New York, NY USA T F E avac@avac.org W FOLLOW US ONLINE