9 8 7 YEARS 7 Years and Counting: 6 AND CAN A SHIFTING LANDSCAPE ACCELERATE AN AIDS ? 5 5 COUNTI NG. . . How Can We Overcome Obstacles 4 4 to an AIDS Vaccine? 3 3

2 2 AIDS VACCINE ADVOCACY COALITION — MAY 2001

AIDS VACCINE ADVOCACY COALITION MAY 2000

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HOW DO YOU FIGHT A DISEASE AVAC REPORT 2004 OF MASS DESTRUCTION? . . . AND OTHER QUESTIONS ON THE ROAD TO AN AIDS VACCINE.

FINLAND

UNITED KINGDOM RUSSIA NETHERLANDS BELGIUM GERMANY CANADA Years & Counting FRANCE SWITZERLAND ITALY

SCIENCE, URGENCY, AND COURAGE UNITED STATES

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HAITI DOMINICAN REPUBLIC JAMAICA U.S./PUERTO RICO VIII VII VI IV III II I INDIA THAILAND TRINIDAD & TOBAGO

CAMEROON UGANDA KENYA RWANDA BRAZIL TANZANIA PERU MALAWI AVAC AIDS VACCINE ADVOCACY COALITION ‒ MAY 2oo2 ZAMBIA V YEARS & COUNTING BOTSWANA AUSTRALIA SOUTH AFRICA

AIDS VACCINE TRIALS—GETTING THE GLOBAL HOUSE IN ORDER

S OAD SSR CRO THE AT NES CCI A A V V S A ID C A A I D S V A C C I N E A D V O C A C Y

C O A L I T I O N

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REs SETTING THE CLOCK

AIDS : The Next Frontiers 20 AVAC Report 06

TURNING

Piecing Together the HIV Prevention Puzzle AVAC Report 2009 THE PAGE

Report 2010

AVAC REPORT 2013: Research & Reality

THE END

PREVENTION on the Line

ACHIEVING THE END One Year and Counting

AVAC Report 2014/15

December 2015

REPORT 2012 www.avac.org TWO DECADES, ONE MESSAGE: PREVENTION MATTERS

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 International Community of Women preventive vaccine candidate Living with HIV/AIDS founded The AIDS Service Organization (TASO) First phase II AIDS established in Uganda begins, of two gp120 products

1987 1988 1992 1993 1994

First major syringe Female condom receives US Public Health exchange program approval from US FDA Service recommends opens in the US US Congress requires NIH AZT for pregnant women and other agencies to expand with HIV to reduce involvement of women and onward transmission minorities in all research KEEPING THE FIELD ON TRACK— NO MATTER WHAT.

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.

Combination PrEP Prevention

Microbicides Vaccine

Medical Male Circumcision Voluntary

Diagnosed Dx Ending the AIDS epidemic takes comprehensive

On Treatment On targets and action. Suppressed Virally U Methods Safe, Effective Contraceptive

Cure ReductionHarm

Syringe Humanhts Exchange Rig

UNAIDS formed Levine Committee calls for overhaul of First efficacy trials of VaxGen’s NIH AIDS research AIDSVAX candidate start International AIDS Vaccine South Africa’s Treatment Action Initiative (IAVI) formed Campaign founded

1995 1996 1997 1998 1999

The first protease inhibitor US President Bill Clinton South African AIDS approved; effective HIV announces goal of effective Vaccine Initiative treatment now exists. AIDS vaccine in 10 years (SAAVI) established AVAC co-founder Bill Snow UNAIDS estimates 16,000 new First African AIDS publishes, Why We Need HIV transmissions each day vaccine trial begins AIDS Vaccine Activism; in Uganda AVAC founded the next month DEFINING THE PATH 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 Phase Phase Open-Label Demonstration Product Scale I II/IIb III Extension / Projects Introduction Up Post-Trial Access

Clinical Trial Safety Real-World Effectiveness and Efficacy

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.

IAVI, VRC and other leading laboratories Dale and Betty Bumpers Vaccine and collaborators form Neutralizing Research Center (VRC) opened at NIH Consortium—first entity of Thousands march for global treatment its kind dedicated to solving this key access in Durban, South Africa scientific challenge facing field

2000 2001 2002 2003

Eastern Europe and former George W. Bush announces Soviet Union reported to have PEPFAR initiative highest rising rates of new Rationale for Global HIV in the world Vaccine Enterprise laid out in UN General Assembly convenes Science first ever special session on AIDS CREATING A GLOBAL NETWORK OF PREVENTION ADVOCATES.

Twenty years ago, advocacy for HIV prevention hardly existed. So AVAC helped build a global network of advocates equipped with efective 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.

Bill and Melinda Gates Foundation announces $287 million to support the Collaboration for Protests at Bangkok AIDS AIDS Vaccine Discovery (CAVD) Conference target PrEP trials Kenyan and Ugandan trials confirm South African VaxGen Thai trial shows data showing voluntary medical male circumcision no efficacy reduces HIV risk for HIV-negative men NIH convenes summit Malawian government halts US FDA announces approval of ™, on HIV vaccine research PrEP trial citing concerns about which protects against strains of HPV that with renewed emphasis using ARVs for prevention cause cervical cancer on basic research

2004 2005 2006 2007 2008

Merck and HIV Vaccine Trials Network Step and Phambili trials halted— launch “test of concept” study of Merck’s MRK-Ad5 vaccine shows no adenovirus-based vaccine benefit and increased susceptibilty Global HIV Vaccine Enterprise Scientific among some volunteers Strategic Plan published in PLoS Medicine WHO recommends voluntary medical male circumcision for HIV prevention DEMANDING ACTION 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 evidence- based 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 GOAL: A sustained decline in HIV infections DEMONSTRATE and roll out new HIV prevention options COMBINE

DEVELOP long-term solutions needed to end the epidemic

Years to impact Zero to 5 5 to 10 10 to End

CAPRISA 004 trial of Tenofovir gel shows US FDA approves daily Truvada modest efficacy in South African women— as oral PrEP a first for microbicides Analysis of RV144 results reveals iPrEx trial shows efficacy of dail oral PrEP two correlates of risk in participants in gay men and transgender women Hundreds of broadly neutralizing Pox Protein Public-Private Partnership (P5) IDed as possible targets established to build on results of RV144 for vaccine development

2008 2009 2010 2011 2012

RV144 trial of ALVAC/AIDSVAX shows modest 31.2% HPTN 052 trial shows treatment efficacy in preventing HIV acquisition—first evidence can reduce risk of transmission of efficacy in any AIDS vaccine by up to 96% HVTN 505 trial of DNA prime/Ad5-boost vaccine begins Partners PrEP trial shows high South Africa begins massive expansion of ART program efficacy of daily oral PrEP in HIV-negative men and women in serodiscordant couples 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 eforts, 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.

START trial stopped early, confirms Annual AIDS Vaccine Conference and biennial individual health benefits of starting those Microbicide Conference merge to become the HIV living with HIV on antiretroviral therapy Research for Prevention Conference (HIV R4P), ART at CD4 cell counts above 350 the first biomedical HIV prevention conference WHO releases new recommendations: UNAIDS announces new 90-90-90 goal for 1) Initiation of ART in all people living with testing, treating and viral suppression; HIV, regardless of CD4 cell count, and prevention and non-discrimination goals 2) Offer of PrEP as a prevention option to all developed but not launched people at substantial risk of acquiring HIV

2013 2014 2015

P5 outlines two proposed vaccine ECHO trial to explore possible link licensure trials—one in Thailand and the between hormonal contraception other in South Africa—and an additional and HIV acquisition research trial in Southern Africa FACTS 001 trial does not demonstrate HVTN 505 stops after efficacy of 1% tenofovir microbicide gel DSMB finds trial cannot show efficacy Two phase II trials of different long- acting injectable ARVs launched 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 eforts 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 www.avac.org. And to support this work, please go to www.avac.org/donate.

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