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INNOVATIONS APRIL 2020 Cure Trial Launches amfAR Institute to Test Landmark Combination Also Inside: New Grants, New Dimensions in Cure Research Cost of HIV Treatment Rising Can HIV Drugs Combat Coronavirus? amfAR, The Foundation for AIDS Research amfar.org

APRIL 2020 COVER STORY The biannual newsletter of amfAR, 8-9 The Foundation for AIDS Research Pioneering Clinical Trial Gets Under Way 120 Wall Street, 13th Floor New York, NY 10005-3908 Study will test first-of-its-kind combination cure strategy T: (212) 806-1600 F: (212) 806-1601 POLICY 1100 Vermont Ave. NW 4 Cost of HIV Treatment Rising Suite 600 4 Ending the AIDS Epidemic Among Latinx Washington, DC 20005 5 Context Matters: Ending the HIV Epidemic Among T: (202) 331-8600 F: (202) 331-8606 Black Communities TREAT Asia 6 amfAR’s Greg Millett to Address International Exchange Tower 388 Sukhumvit Road AIDS Conference Suite 2104 Klongtoey, Bangkok 10110 6 Data Transparency Key to Strong HIV/AIDS Response Thailand T: (+66) 2 663-7561 RESEARCH F: (+66) 2 663-7562 7 Can HIV Drugs Combat Coronavirus? www.amfar.org 7 Cure Summit Bridges Science and Community 10 New Grants, New Dimensions in Cure Research Innovations Staff: 12 Illuminating the Reservoir Andrew McInnes, Editor 12 Krim Fellowships Support Promising Young Adam Winters, Senior Staff Writer Raoul Norman-Tenazas, HIV Researchers Creative Director Yolande Hunter-Johnson, GLOBAL Creative Coordinator 13 “Student Who Rocked Public Health” amfAR meets the BBB 14 Addressing Mental Health and HIV in the Asia-Pacific Wise Giving Alliance’s 14 Global Gag Rule May Drastically Impact Global Fund Standards for Charity 15 How the Global Fund Improves PEPFAR Investments Accountability EVENTS 16 Benefit Event Highlights (amfAR Gala Milano, Los Angeles, and New York; amfAR Mexico City; TWO x TWO for AIDS and Art; amfAR Charity Poker Tournament; and generationCURE Holiday Party)

From the CEO Photo: Evan Rummel Breakthrough Potential The clinical trial getting underway at the amfAR Institute datasets is combined with sophisticated analysis methods, for HIV Cure Research is the culmination of a vast powerful new information could help us overcome some of amount of work over the past four years by teams of the key challenges that stand in the way of a cure. dedicated researchers. As you’ll read in our cover story, this groundbreaking trial is unusually complex but has the These are just three examples of the vibrancy of HIV potential to bring us further along the path to a cure. The cure research and of the kind of studies our generous outcome won’t be known for some time, of course, but we supporters—you—make possible. They are also emblematic are optimistic and look forward to keeping you up to date as of the collaborative approach to science that has been our the trial progresses. hallmark for 35 years. While it represents a very different approach to a cure, As always, we deeply appreciate all who stand with us in our the next phase of our gene therapy study (see page 10) is effort to end the global HIV/AIDS epidemic through innova- similarly complex and also has breakthrough potential. Gene tive research. As someone who has worked in this field for therapy is an extremely exciting new field. It has already led the past 30 years, I am gratified to do this rewarding work to extraordinary advances in the treatment of certain types and personally grateful to you for your continued support. of cancer and played a central role in curing Timothy Brown (and possibly the London and Düsseldorf patients) of HIV. A newer and highly innovative amfAR research initiative is also full of promise. We’re recruiting the expertise of data scientists to mine some of the vast amounts of data that HIV researchers have amassed over the past decade or more (see page 10). When information contained in a variety of www.amfar.org 3

Policy Ending the AIDS Epidemic Among Latinx By Zulema Iboa, Rosenfield HIV/AIDS Public Policy Research Fellow at amfAR The theme of the latest National Latinx AIDS While the EHE initiative should be applauded greatly increases risk of transmitting the virus Awareness Day—“Living with HIV or not … for including jurisdictions with large Latinx to others. we’re fighting this together”—exhorts us to populations, the Administration has advanced promote solidarity, expand access to prevention policies and rhetoric that drive Latinx We must fight for policies that protect the and treatment, and address the stigma that populations to the margins, making it harder communities that most need access to HIV weighs heavily on HIV in the Latinx community. to access healthcare and services. This services. This means increasing access to health is especially problematic for people living insurance for Latinx populations for whom rates The Latinx population is disproportionately with chronic conditions like HIV who require of uninsurance are among the highest in the impacted by HIV. Despite comprising only 18% consistent access to medical care to support nation. Lack of health insurance stymies access of the U.S. population, roughly 26% of people medication adherence and viral suppression. to treatment and care, a situation that is further diagnosed with HIV in 2017 were Latinx. The Lack of access to treatment not only leads to compounded by the fact that five of seven disparity is also evident among Latino men who health complications and even death, but also states under the EHE plan have not expanded have sex with men (MSM), who comprised 20% Medicaid. States that have expanded Medicaid of all new HIV diagnoses in 2017. While there have been shown to make much greater were decreases in new HIV infections among progress in reducing HIV diagnoses. most at-risk communities across racial and ethnic groups between 2010 and 2016, HIV Nearly four decades into the HIV epidemic, diagnoses among Latino MSM rose by 18% we’ve learned some fundamental lessons. First overall and by 34% among young (aged 25 to and foremost, providing access to antiretroviral 34) Latino MSM. therapy and keeping people on treatment saves lives and reduces HIV transmission. Similarly, Increased attention has been given to the localities that scale up treatment and expand national HIV response since President Trump access to prevention options such as PrEP announced Ending the HIV Epidemic: A Plan are successful in reducing HIV diagnoses. But for America in his 2019 State of the Union despite these successes, HIV disparities persist address. The initiative (EHE) aims to reduce among marginalized communities, and policies new HIV infections in the U.S. by 75% within that further marginalize these communities the next five years by initially focusing efforts threaten our efforts to meaningfully address and on 50 jurisdictions with the highest HIV burden ultimately end HIV. and seven states with substantial rates of HIV in rural areas. www.amfar.org/ ending-the-aids-epidemic-among-latinx/ Cost of HIV Treatment Rising Increasing cost of treatment may hinder effort to end epidemic A new study reports a 34% increase in the “High ART costs are among many structural infections by 2030. According to the authors, to cost of antiretroviral therapy (ART) in the barriers that lead to poor treatment access and achieve that goal, the U.S. must increase viral United States since 2012, far outpacing the adherence,” the authors report. “Slowing the suppression by 33%—requiring a total of more rate of inflation. trend of rapidly increasing ART costs is essential than $35 billion annually on ART. to expand and sustain access to effective Published in JAMA Internal Medicine, the individualized care and treatment.” The study looks only at overall costs, not out-of- study shows that the average annual cost of pocket costs after insurance and other rebates. recommended ART combinations ranged from Used for HIV prevention and treatment, ART is The authors note that costs absorbed directly about $25,000 to $35,000 in 2012. By 2018, the a major part of efforts to end the epidemic. The by patients may affect their engagement in care cost had increased to between $36,000 and federal government’s “Ending the HIV Epidemic” and adherence to medications like ART. $48,000—even with new generic options. initiative calls for a 90% decrease in new 4 Innovations, April 2020

Policy Context Matters: Ending the HIV Epidemic Among BCloanctkexCtoMmamtteurnsi:tiEensding the HIV Epidemic Among Black Communities The federal government’s Ending the HIV Epidemic (EHE) plan has the goal of reducing new HIV infections by 90% in the next 10 years. This goal will not be met without meaningfully addressing HIV in the black community (13% of US population; 42% of all Americans living with HIV). HIV among black Americans is fueled by persistent inequities that impede access to HIV prevention and care. Demographics What’s Helping? The percent of New HIV Diagnoses among black Americans Medicaid expansion is higher in EHE states than nationally Greater health insurance coverage among black Americans 45% 64% 45% leads to fewer HIV transmissions. Nationally 7 EHE plan in EHE sites Ryan White Programs Epidemiology Ryan White funded clinics have decreased the racial disparity in viral suppression between black and white The lifetime risk of HIV diagnoses is highest among black Americans clients living with HIV. 1 in 30 CDC Expanded HIV Testing Initiative Women Led to more and earlier HIV diagnoses, and greater 1 in 16 1 in 2 opportunities for treatment. Men Transwomen 1 in 3 Increased PrEP access MSM PrEP DAP, Gilead drug assistance programs and Ready, Access Set PrEP can improve access by offering PrEP at low or no cost. Despite a greater lifetime risk for HIV infection among black Americans, PrEP access remains low Community-based Programs Of 500,000 African Americans All people who filled PrEP Trusted sources of care and tailored to the needs of the who could potentially prescriptions in 2016: black community. benefit from PrEP 20% Other What’s Not? only 1% (7000) 69% White filled their prescriptions 11% Black Geography from September 2015 to August 2016 Policies and social determinants in the South complicate HIV prevention and treatment efforts. Uninsurance Without adequate access to health insurance, HIV-positive African Americans will continue to be under-served. Title X and Trump Abortion Rule Restrictions on Title X funding limits the HIV/STD services that health clinics provide to lower income women. HIV Criminalization and Mass Incarceration African Americans are disproportionately targeted by HIV criminalization laws, and mass incarceration disrupts HIV services. Homelessness Unstable housing is associated with medication non-adherence, which can increase HIV transmission. wwTwo.asmefeara.odrgditional data about various policies across EHE locales, go to http://ehe.amfar.org 5

Policy The Power Ending the HIV Epidemic – of Data ehe.amfar.org Data Transparency Key to Strong HIV/AIDS Response The database zeroes in on the “geographic hotspots” of HIV Gaps in data reporting threaten identified in President Trump’s plan— global public health funding Ending the HIV Epidemic—to end new HIV transmissions in the U.S. by 2030. A new report from amfAR, developed as part of the COMPASS Africa collaboration, analyzes data availability from four key funders A leader in data- Opioid and Health Indicators of programs to combat HIV, tuberculosis (TB), and malaria globally. driven advocacy, Database – opioid.amfar.org While systems for collecting data continue to improve, the authors amfAR’s Public argue that costly decisions are being made using incomplete data— Policy Office has Track the opioid epidemic and its jeopardizing critical funds for global public health. developed a series intersection with HIV and Hepatitis of user-friendly free C. Maps from the database have Stressing the importance of data availability for grassroots community online databases been used in congressional briefings advocates, the report looks at the U.S. President’s Emergency Plan for policymakers, and local news broadcasts and were for AIDS Relief (PEPFAR), the President’s Malaria Initiative, USAID featured in the New York Times. bilateral TB funding, and the Global Fund to Fight AIDS, Tuberculosis and Malaria. It outlines the specific data made available by each advocates, journalists, PEPFAR Country/Regional organization and describes their models of engaging civil society. and researchers. Operational Plans (COPs/ROPs) – Data Watch: Data Accessibility from Global Funders of HIV, TB, and Malaria Programming finds that transparent reporting enables The interactive copsdata.amfar.org stakeholders to identify and address problems as they arise, to redeploy resources when necessary, and to ensure that finite databases provide Particularly useful to researchers, civil resources are used to achieve results and improve the quality of service provision. Crucially, the report argues that transparency that a trove of invaluable society organizations, and officials links expenditures to concrete results helps build and sustain political support for global public health assistance. information that is in ministries of health and finance, Read the full report at www.amfar.org/Data-Watch-Accessibility/ helping to guide the database highlights planned For more information on COMPASS Africa, visit www.avac.org/ policymakers and funding by program area, country, and compass advocates in making organization for each year that has informed decisions on been publicly released. domestic and global PEPFAR Monitoring, Evaluation, HIV programming. and Reporting – mer.amfar.org This database charts the crucial impact of PEPFAR and the current state of the HIV/AIDS epidemic. amfAR’s Greg Millett to Address International AIDS Conference amfAR Vice President and Director of Public Policy Greg Millett has AIDS Conference in Washington, DC. Previously, he was a Senior been selected by the 23rd International AIDS Conference to give the Scientist in the CDC’s Division of HIV/AIDS Prevention, where he opening plenary address in San Francisco on July 6, 2020. Millett is expected to explore HIV disparities in published several groundbreaking research papers on various contexts and highlight possible solutions, priority HIV infection disparities that helped shift the scientific topics at this year’s conference. community’s focus on the topic. Prior to amfAR, Millett served as Senior Policy Advisor Greg Millett “It’s a great honor to have been invited to speak at the in the White House Office of National AIDS Policy, where opening plenary of the International AIDS Conference,” said he was a key author of President Obama’s original Millet. “There is no bigger platform from which to shine a National HIV/AIDS Strategy and worked to support light on topics that I believe should be front and center in the Strategy’s implementation across the federal the HIV response.” government. During his tenure at the White House, Millett played a lead role in organizing the federal The International AIDS Conference, which will take place in government’s engagement with the 2012 International San Francisco and Oakland, July 5–10, is the world’s largest conference on HIV and AIDS. 6 Innovations, April 2020

Research Cure Summit Bridges Science and Community Recent scientific advances and community their virus after stopping antiretroviral therapy. Can HIV involvement in HIV cure research were the A better understanding of how these individuals Drugs Combat subjects of lively discussion at amfAR’s World are able to do so could help researchers induce Coronavirus? AIDS Day HIV Cure Summit at the University of post-treatment control in other people living California, San Francisco (UCSF), on November with HIV. Physicians in Thailand and Japan have 21. UCSF is home to the amfAR Institute for HIV reported using the antiretroviral drugs Cure Research, established in 2016 with a five- Dr. Rachel Rutishauser of UCSF outlined a lopinavir and ritonavir to fight the novel year $20 million grant. pioneering clinical trial at the Institute that will coronavirus, with apparent success. The test a combination approach to curing HIV (see coronavirus, which causes the respiratory Dr. Paul Volberding, director of the Institute, cover story). disease COVID-19, has infected nearly welcomed about 200 summit participants and 100,000 people and killed more than 3,000, expressed gratitude for amfAR’s partnership Other speakers included: Dr. Keith Jerome of mostly in China. and support. the University of Washington, who gave an overview of gene therapy approaches to a Thai doctors gave the two HIV drugs in Dr. Rowena Johnston, amfAR Vice President cure. Dr. Satish Pillai of UCSF and the Vitalant combination with a large dose of the flu and Director of Research, discussed “societies Research Institute, who outlined cutting-edge drug oseltamivir to a Chinese coronavirus of research,” displaying a visualization tool to technologies that may help produce new insights patient, according to Thailand’s Ministry of show how in recent years HIV researchers are into the latent HIV reservoir; and Matt Chappell Public Health. She tested negative for the collaborating more than ever before. of the amfAR Institute Community Advisory coronavirus within two days. Dr. Rowena Johnston in discussion with Loreen Willenberg In Japan, a patient from Wuhan, China— the epicenter of the epidemic—was treated Speaking with Dr. Johnston, Loreen Willenberg, Board (CAB), who talked about his decades of with just the two HIV drugs. Despite some the “San Francisco patient,” shared her inspiring experience living with HIV and participation in trouble breathing, the patient stabilized after personal story, from her HIV diagnosis in 1992 several clinical studies. treatment, and her fever subsided within five to recognition by her doctors that she was days of being admitted. somehow able to maintain undetectable viral “We need more options for the prevention and levels without ever taking antiretroviral therapy, treatment of HIV, we need a vaccine, and we These results are encouraging, but public to being an invaluable participant in HIV studies need a cure,” said CAB Co-Chair Rob Newells health experts caution that more testing for over a decade. Ms. Willenberg stressed in his closing remarks. “We need a cure for is needed before concluding that the HIV the importance of the relationship between all the people living with HIV who can’t get drugs can effectively treat the coronavirus. researchers and study participants. to undetectable, we need a cure for all the people living with HIV who don’t have access to According to a study published in The Discussing post-treatment control of HIV, regular healthcare.” Lancet, a randomized, controlled clinical Drs. Peter Hunt of UCSF and Marcella Flores trial is underway in China to test the safety of amfAR outlined efforts to study the rare To view videos of the research presentations, go and efficacy of lopinavir and ritonavir in individuals who are able to naturally control to www.amfar.org/summit2019 treating coronavirus. www.amfar.org HIV drugs are not the only treatments researchers are investigating. Pharmaceu- tical company Gilead’s remdesivir drug— designed to treat Ebola, but deemed in- effective—has emerged as a prospective treatment based on encouraging results when tested against other coronaviruses. 7

Cover Story Pioneering Clinical Trial Gets Under Way amfAR-funded study will test combination cure strategy A unique and potentially groundbreaking clinical trial led by “It’s by far the most complex cure trial that anyone has undertaken researchers at the amfAR Institute for HIV Cure Research is about to date and it reflects our expectation that, like the drug cocktails we to open. The study will test a combination of agents in an effort to use to treat HIV, a cure or post-treatment control of the virus is most induce post-treatment control in people living with HIV. likely to result from a combination of agents.” The complex, multi-stage trial is the culmination of four years of work by teams of researchers at the Institute, which amfAR launched in “It’s by far the most complex 2016 with a five-year $20 million grant to the University of California, cure trial that anyone has San Francisco (UCSF). undertaken to date.” “The Institute will leverage three highly complementary strategies that appeared to induce remission in previous studies,” said Dr. Led by veteran HIV researcher Dr. Steven Deeks, the trial will enroll Rowena Johnston, amfAR Vice President and Director of Research. up to 20 people living with HIV who have been on stable, continuous antiretroviral therapy (ART) for at least one year. The investigators plan Dr. Paul Volberding, Director of the amfAR Institute for HIV Cure Research to include 15 participants who started ART during the early stage of infection, and five who started after a longer period of infection, to 8 assess differences in the immune response between the two groups. The centerpiece of the strategy is to boost the immune response, with a focus on CD8 T cells, or killer T cells. “The advantage of CD8 T cells is they can recognize infected cells specifically, and they can actually kill them,” said Dr. Rachel Rutishauser, an immunologist and researcher at UCSF. “The purpose of the first few stages [of the trial] is to elicit that initial CD8 T cell response.” Stages 1-2: Vaccine and Boost In the first two stages of the trial, lasting 24 weeks, participants will receive a therapeutic vaccine with a boost. The DNA plasmid vaccine is effective against almost all subtypes of HIV seen around the world. “The strategy here is to go after regions of the virus that can’t escape from the immune system,” said Dr. Rutishauser. Innovations, April 2020

Graphic from Dr. Warner C. Greene, Gladstone Institutes The boost, along with an additional adjuvant—both commonly used in There will also be a behavioral component to the trial. Members of vaccine trials—will help to enhance the immune response. amfAR’s Community Advisory Board are making active contributions, which include assessing participants’ understanding of the study, their Stage 3: Coax and Activate comfort level with the combination of interventions, and their experience throughout the process. The third stage will involve the administration of two additional agents. “Naturally we hope this trial succeeds in achieving post-treatment The first is a TLR9 agonist, which the researchers hope will coax the control,” said Kevin Robert Frost, amfAR’s Chief Executive Officer. “But virus out of latently infected reservoir cells so that it can be detected by whatever the outcome, the trial will generate invaluable new knowledge the immune system. As an immune adjuvant, it will also further boost that is sure to advance our search for a cure for HIV.” the immune system, and researchers think that it will help natural killer cells of the innate immune response kill infected cells. Dr. Rachel Rutishauser outlines the clinical trial at amfAR’s HIV Cure Summit Participants will also receive broadly neutralizing antibodies that can inactivate diverse types of HIV and reduce the size of the viral reservoir. There is also compelling evidence from animal studies that these specialized antibodies enhance the CD8 T cell response. Stage 4: Interrupt Treatment In the fourth and final stage of the trial, at 34 weeks, participants will undergo an analytic treatment interruption to test the efficacy of the combination approach. At the same time they stop taking ART, participants will be given a second round of broadly neutralizing antibodies. As the initial dose of antibodies wears off, this step is meant to help the immune response outpace the virus as it emerges from latency. Researchers will assess whether post-treatment control has been achieved by measuring the proportion of participants that show sustained viral suppression after treatment interruption. The safety of the combination approach will be gauged by closely monitoring for adverse events. www.amfar.org 9

Research New Grants, New Dimensions in Cure Research amfAR awards more than $2.3 million to support next phase of gene therapy study and bring data to bear in search for a cure In a reflection of the international scope of HIV antibodies. The third is to deliver an enzyme that Big Data cure research, amfAR has awarded new grants would edit the virus out of infected cells. Each totaling more than $2.3 million to research teams of these three tools is now ready to be tested In a new round of innovative Magnet grants, in the U.S., Germany, Australia, and Brazil. The in combination. amfAR is bringing machine learning to bear awards were approved by the Board of Trustees to search for answers within the vast trove of at its meeting in New York City on February 5. amfAR is bringing data HIV researchers have amassed over the machine learning past decade. Already a critical component of “Breakthroughs in a range of technologies are to bear to search for the success of precision medicine, machine helping to deliver new treatments, and even answers within the learning is able to identify patterns in health cures, for a range of previously intractable vast trove of data and disease that we wouldn’t know to look for. diseases,” said Dr. Rowena Johnston, amfAR HIV researchers Through these Magnet grants, which unite data vice president and director of research. “These have amassed over scientists with HIV researchers, amfAR hopes to grants harness those technologies to advance the past decade. use advances in machine learning algorithms to our efforts to bring the global HIV epidemic to find patterns in datasets that may advance our an end.” Dr. Hildegarde Büning of Hannover Medical search for a cure. School in Hannover, Germany, was awarded Gene Therapy $1.65 million for a preclinical study to test their Hillel Haim, M.D., Ph.D. effectiveness. The researchers will start by University of Iowa, Iowa City, IA While gene therapy is emerging as a particularly administering the CAR stem cell treatment in promising area of experimental medicine, the first year of the two-year study. Treatment A natural antibody response against HIV fails including HIV cure, its application is challenged with the other two interventions will follow in to suppress infection because the antibody- by its cost and complexity. These can be partially the second year. At the end of this proof-of- making process lags behind HIV’s mutation addressed by developing methods to administer principle study, researchers will determine the rate. Infusing ready-to-go antibodies into a the gene therapy directly to the patient, known activity of each of the interventions alone and in person has been one way clinicians have tried as in vivo delivery. combination, and their effect on the persistence to stay ahead of HIV’s mutation curve. However, of the virus. This complex gene therapy study infusions in some patients force the virus to For several years, amfAR’s ARCHE-GT will provide vital signposts informing further mutate quickly around those antibodies. What consortium has been designing and fine-tuning curative gene therapy studies. if the evolution of the viral mutations could be three gene therapy approaches to curing HIV predicted before infusion? that could be delivered in vivo. One approach involves the generation of chimeric antigen To answer this question, Dr. Haim, an HIV receptor (CAR) stem cells that are designed scientist at the University of Iowa, has focused specifically to kill virus-infected cells. A second on the viral protein Env, a target of broadly is to spur liver cells to produce HIV-specific neutralizing antibodies. He has found that certain areas of Env mutate in association with other seemingly unrelated areas. Dr. Haim will collaborate with machine learning specialist Dr. Guiping Hu and network systems analyst Dr. Grant Brown to identify those mutation networks in more than 350 patients. If they can predict how HIV will evolve in each patient, they can tailor antibody infusion cocktails to target future HIV strains and thereby improve antibody-based curative interventions. 10 Innovations, April 2020

Ya-Chi Ho, M.D., Ph.D. ones with an intact genetic reach areas of our genome. Using over 600GB of Yale University, New Haven, CT sequence. Dr. Brad Jones cloud computing memory and mining 30 public posits that he has discovered and private datasets, the researchers aim to gain The size of the HIV reservoir changes throughout yet another mechanism the a more complete understanding of what insertion the lifespan of a person living with HIV. The virus uses to protect infected site means for HIV latency—and ultimately cure. reservoir may expand when infected T cells cells. Collaborating with data grow in number to fight invading pathogens. scientists Drs. Doron Betel Simone Gonçalves da Fonseca, Ph.D. Identifying how to limit that expansion in and Friederike Dundar, Dr. Federal University of Goiás, Goiás, Brazil reservoir cells while maintaining normal Jones will try to identify, using expansion in uninfected T cells would be an public and private datasets, Elite controllers (ECs) are able to control their HIV important step toward a cure. Dr. Ya-Chi Ho has differences between reservoir infection without the need for ART. Researchers collected vast amounts of data on the activity cells that survived immune have been studying ECs for decades because of over 133,000 T cells, including rare reservoir attack versus those that it is hoped that by learning how they achieve cells, across seven people living with HIV. With were susceptible. Then they control could point the way to inducing control the help of bioinformatician Dr. David van Dijk, will analyze cancer datasets in the majority of people living with HIV who are the team will build machine-learning tools to to determine whether those not ECs. Dr. Gonçalves aims to combine datasets identify mediators of T cell expansion that affect protective factors identified in HIV are also from those decades of EC research with her own reservoir cells specifically. present in cancer—a disease that may have data on metabolic activity in a cohort of ECs. By FDA-approved drugs to target those factors. forming a collaboration with data scientist Dr. Brad Jones, Ph.D. Luiz Gustavo Gardinassi, Dr. Gonçalves hopes Weill Medical College of Cornell University, Sharon Lewin, F.R.A.C.P, Ph.D. to glean new insights from archived data into New York, NY University of Melbourne, Melbourne, Australia mechanisms of viral control. HIV has an impressive arsenal of defenses HIV inserts itself into our own genome and Dr. Gonçalves da Fonseca’s grant is underwritten against the human immune system’s best efforts causes lifelong infection because it persists in its entirety by the FAIR Foundation to destroy those viruses that matter, namely the under the radar of our immune system. The human genome contains areas that are easily Synergy accessible to researchers, who can quickly map where HIV has inserted itself. However, amfAR has launched a new type of grant as much as 20% of our genome is inaccessible to capitalize on unforeseen opportunities by current mapping tools. By understanding for collaboration. The first of these Synergy exactly where HIV inserts itself, researchers grants—$50,000—was awarded to Jonathan Li, can make inferences about how location may M.D., M.M.Sc., of The Brigham and Women’s predict latency. Hospital in Boston. Dr. Sharon Lewin, a world-renowned HIV cure In 2019, amfAR launched Project PTC, the researcher, has teamed up with Dr. Daniel largest study to date aimed at discovering the Cameron, a former software developer turned underpinnings of post-treatment control (viral academic bioinformatician, to develop a data control in the absence of ART). Led by Dr. Li, science mapping pipeline to chart the hard-to- one of the world’s leading PTC researchers, the team has been using cutting-edge tools to explore immune control and viral dynamics. The new grant recruits the expertise of Dr. Michael Seaman, an expert in HIV antibody responses at Harvard Medical School. This additional expertise could help determine whether antibodies help shape the ability of PTCs to control virus once they stop taking ART. Discovering what leads to post-treatment control in these rare individuals could help in designing methods to achieve durable ART-free control in all people living with HIV. www.amfar.org 11

Research High Illuminating the Reservoir By Rowena Johnston, Ph.D. Sun Tzu told his readers 2,500 years ago that in order to win a war, Low we must know our enemy. But the HIV reservoir—the collection of infected cells that persists even with antiretroviral therapy—has been EXPLORER Imaging: (Left to right) CT scan, PET overlaid on CT, and PET image. Scale at right remarkably coy in revealing its essential nature. Understanding how shows virus signal intensity. much of it persists, and where in the body, are fundamental challenges for researchers hoping to eliminate the reservoir and thereby cure HIV. To answer these questions, Dr. Tim Henrich and colleagues at amfAR’s Institute for HIV Cure Research have turned to high-sensitivity PET The machine produces images imaging. They have forged a collaboration with researchers at the that are approximately 40-fold University of California, Davis, to produce full-body images of people living more sensitive than current with HIV, using the only EXPLORER scanner that is up and running in the technology, and in a fraction United States. The machine produces images that are approximately 40- of the time. fold more sensitive than current technology, and in a fraction of the time. While taking blood samples from people living with HIV is fairly easy, Recently, Dr. Henrich presented these first-in-human results at the the reservoir in the blood is only a tiny fraction of the total, and is Conference on Retroviruses and Opportunistic Infections (CROI). I took probably not representative of reservoir in tissues. Meanwhile, taking the opportunity to interview him at the conference. Watch the interview at tissue samples is far more difficult and does not solve two crucial www.amfar.org/imaging. questions: Have the right pieces of tissue been taken? And does the reservoir behave the same way in a petri dish in the lab as it does in Dr. Johnston is an amfAR vice president and director of research. a person’s body? Krim Fellowships Support Promising Young HIV Researchers In December, amfAR announced the 2019 had used a lab-made version of the HIV envelope 2011 study of a vaccine administered before recipients of the Mathilde Krim Fellowship in protein, Env, to produce broadly neutralizing infection found that more than half of the study Basic Biomedical Research. Named in honor of antibodies that could prevent or treat HIV animals infected with the HIV-like virus SIV amfAR Founding Chairman Dr. Mathilde Krim, infection. Using these imaging techniques, Dr. eventually cleared the virus. However, there the Fellowships support early career scientists Lu was able to show that this version of Env was no protection if the vaccine was given only pursuing innovative solutions to HIV/AIDS. The wasn’t an accurate model after all. after infection. new fellows will each receive $150,000 over two years. Mentored by Dr. Walther Mothes, Dr. Lu will Dr. Abdulhaqq will investigate what prevents build on her study to map the exact sequence vaccine-induced immune cells called CD 8 T “These annual awards enable us to continually of structural changes when Env fuses to a cells from being effective therapeutically once infuse the field with youthful vigor, exceptional target cell. Understanding how these proteins infection has been established. He hypothesizes talent, and new ideas,” said Kevin Robert Frost, on the HIV surface change upon encountering that vaccine-induced T cells for prevention amfAR’s Chief Executive Officer. host cells may advance the development of targeted the gut, whereas they need to target powerful new broadly neutralizing antibodies persistent reservoirs of HIV in other tissues in Maolin Lu, Ph.D., of Yale University, is a and antiretroviral therapies. order to have a therapeutic effect. Using a gene structural biologist and expert in the use therapy approach, he plans to modify CD8 T of imaging techniques that can interrogate Shaheed Abdulhaqq, Ph.D., of Oregon Health cells to make them like vaccine-induced cells single molecules. Dr. Lu recently published a and Science University, working in the lab of and direct them, with the addition of a homing groundbreaking study in Nature that upended mentor Dr. Jonah Sacha, is testing a hypothesis protein, to the HIV reservoirs where infected the HIV vaccine field. Previously, vaccinologists that may have implications for an HIV cure. A cells hide. 12 Innovations, April 2020

Global “Student Who Rocked Public Health” Former TREAT Asia student researcher honored Christina Chandra is a Master of Public Health What were your findings from these mental health service integration, while societal (M.P.H.) in Global Epidemiology student at surveys and interviews? Did you garner any stigma seemed to be a barrier. the Rollins School of Public Health at Emory surprising or new insights? University. As part of her graduate studies, she How do you envision building on this conducted research with amfAR’s TREAT Asia We found that the integration of diagnosis and research? program in 2019, surveying and interviewing treatment of mental health problems lagged HIV care providers on mental health service behind mental health screening. This meant I think this research could be expanded by integration for adults living with HIV in Bangkok, that screening for mental health problems— evaluating the feasibility and effectiveness of Thailand. She previously interned with amfAR including depression, anxiety, and substance two different methods of mental health service through the Allan Rosenfield HIV/AIDS Public use—was being done by HIV care providers. integration in Bangkok: 1) having an “in-house” Policy Internship and Fellowship Program. For Then patients who screened positive for severe specialist available within HIV care settings, or her work with TREAT Asia, Christina was honored mental health problems were often referred 2) training various providers in screening for by the Journal of Public Health Management to a specialist for diagnosis and treatment. mental health problems as well as diagnosing and Practice as one of the “students who rocked Providers noted that referrals may be a concern and treating common mental health problems. public health” in 2019. if mental health problems worsened before the Additionally, this project centered on provider individual’s appointment or if they did not go to perspectives, so I think it would be helpful to How did you become interested in the their scheduled appointment. hear the perspectives of people living with HIV relationship between HIV and mental health? who are seeking mental health care at these Many providers suggested that having a clinics and understand their preferences. I became interested while conceptualizing specialist within the HIV clinic would be this project with TREAT Asia and learned that preferable. We also found that task-shifting What do you plan to do after you finish your mental health can impact clinical outcomes of screening was already occurring among graduate studies? of people living with HIV. I believe that mental counselors and nurses (i.e., the burden of mental health is an important aspect of any person’s health care was not solely on physicians) and I have applied to Ph.D. programs in epidemiol- overall health, but this project brought to my that providers we surveyed were receptive to ogy, and I hope to hear positive news over the attention the multiple stigmas that people in training. Having established clinic protocols and next couple months about where I will continue the Asia-Pacific region may face as a result of care guidelines were identified as facilitators to my studies. their HIV status, gender identity, drug use, or sex work that can further impact their mental health (which is also stigmatized). Once I was in Bangkok conducting interviews and meeting with physicians who treated patients of all ages living with HIV, I realized that providers were very much concerned about mental health and were motivated to address it. Can you describe your research project with TREAT Asia? Our project aimed to assess the extent of (Left to right) amfAR Vice President and Director of TREAT Asia Dr. Annette Sohn, Christina Chandra, Project Manager Tor integration of mental health services—including Petersen, and TREAT Asia Director of Research Dr. Jeremy Ross screening, diagnosis, and treatment—for common mental health problems in adult HIV care settings in Bangkok. We were also interested in facilitators and barriers to integrating these services. To answer our questions, I conducted key informant interviews and surveyed HIV care providers, which included community health workers, counselors, nurses, peer educators, and physicians. www.amfar.org 13

Global Global Gag Rule May Drastically Impact Global Fund amfAR issue brief analyzes far-reaching impacts on global AIDS funding In January 2017, President Trump signed a presidential memorandum to reinstate and expand the so-called Global Gag Rule—the Expanded Mexico City Policy (EMCP)—to apply to all U.S. global health assistance. The policy prohibits the provision of U.S. global health funding to non-U.S.-based or foreign nongovernmental organizations that provide, advocate, counsel, or refer patients for abortions, even if using the organization’s own funds for these activities. U.S.-based organizations and multilateral institutions such as the Global Fund to Fight AIDS, Tuberculosis and Malaria are formally exempt from the policy. However, the policy’s restrictions apply to the entirety of an organization’s activities, potentially impacting private and multilateral investments when partner networks overlap. Given how common it is for the Global Fund and U.S. government to fund the same NGO, this policy now has implications for that prime recipient and its sub-recipients. A new amfAR issue brief, The Expanded Addressing Mental Health and HIV Mexico City Policy: Implications for the Global in the Asia-Pacific Fund, examines the effects of the policy on the Global Fund, quantifying the proportion of Global Fund investments that are subject to the policy. Key findings include: In 2019, amfAR’s TREAT Asia program launched a five-year HIV, mental health, and implementation science research training program funded by the Fogarty International Center and the U.S. • More than $1 billion of Global Fund allo- National Institute of Mental Health. Capacity development in HIV and MEntal health Research in cations could be subject to the Expanded Asia (CHIMERA) aims to address the critical need to build capacity among Asia-Pacific clinicians Mexico City Policy. and researchers to study the intersection between HIV and mental health. • Five countries have greater than 60% of Co-led by Principal Investigators Dr. Annette Sohn, amfAR Vice President and Director of TREAT their Global Fund funding restricted by Asia, and Dr. Milton Wainberg, Professor of Clinical Psychiatry at Columbia University and the EMCP: Botswana (61.7%), Kosovo (100%), New York State Psychiatric Institute, the program plans to build a team within the Asia-Pacific Nepal (64.1%), Philippines (87.2%), and Ukraine (78.5%). with the capacity to lead regional HIV-mental health-implementation science research that • Global Fund investments in key population will inform public health policy and improve disease prevention are most likely to be the quality of clinical care for people living restricted by the EMCP. with HIV. The authors recommend that “the Global CHIMERA Fellows (left to right): Wipaporn Natalie Song- The program is nested within the IeDEA Fund and other donors should assess taweesin (Thailand), Rena Janamnuaysook (Thailand), Pui Li (International epidemiology Databases to their grant portfolios to be cognizant of Wong (Malaysia), Meng Li Chong (Malaysia), Maureen Dungca Evaluate AIDS) Asia-Pacific regional research when and how the EMCP is impinging on (Philippines), Nguav Bora (Cambodia), Timothy Dizon (Philip- network that TREAT Asia directs. CHIMERA their investments and take steps to track pines), and Meng Somanythd Chhay (Cambodia). will create the opportunity to bring together and mitigate the effects in cases where stellar training faculty from academic centers quality sub-recipients would be excluded and public health and development agencies from participating.” within the region and across the world, and will build on existing NIH-funded mental Read the issue brief at www.amfar.org/EMCP health research being conducted through IeDEA Asia-Pacific. 14 Innovations, April 2020

GloHbaol w the Global Fund Improves HoPwEtPheFGAloRbaInl FvuensdtImmpernovtses PEPFAR Investments The President’s Emergency Plan for AIDS Relief $886 million (PEPFAR) and the Global Fund to Fight AIDS, Tuberculosis and Malaria (GF) work together in the Global Fund contributed 49.6% ($886 million) of world’s most highly burdened countries to provide the total invested in ARVs in 2017. life-saving antiretroviral drugs (ARVs) for HIV. In 2017, the GF spent $886 million on ARVs in PEPFAR countries, and it is frequently the primary purchaser of ARVs for an entire country. In these areas, such as Malawi where HIV prevalence is 10% and the GF purchases nearly 100% of the ARVs, PEPFAR relies heavily on GF investments to reach its goals. Global Fund Cameroon 65% purchased >50% $27,479,873 72% of the ARVs for 100% several major DR Congo 60% PEPFAR $25,819,581 50% countries 66% Ethiopia 100% Population Living With HIV $72,313,353 59% 0 – 499,999 75% 500,000 – 999,999 Uganda 77% 1,000,000 – 1,499,999 $73,757,867 1,500,000 – 1,999,999 2,000,000 – 2,100,000 Kenya $79,864,861 % of Total ARV Commodities Purchased by the GF in 2017* Tanzania $117,373,206 Malawi $141,247,465 Mozambique $57,710,675 Zimbabwe $97,180,050 Botswana $21,035,558 www.amfa*rP.oErgPFAR Country Operational Plans 15

Events amfAR Gala Milano amfAR joined the Italian fashion community in Milan on September 21 to sensation Rita Ora. Attended by fashion industry luminaries such as honor Federico Marchetti, chief executive of the YOOX Net-a-Porter Group Joan Smalls, Candice Swanepoel, Maria Borges, Jasmine Sanders, and a generous amfAR supporter, and to raise funds for the Foundation’s Carine Roitfeld, and Toni Garrn, the gala raised over $1.3 million. innovative AIDS research programs. The eleventh annual amfAR Gala Milano was held at the Palazzo Mezzanotte in conjunction with Milan Special thanks: Signature Sponsors Champagne Perrier-Jouët and Fashion Week and featured an exhilarating performance by British pop Absolut Elyx; Wines courtesy of Boroli 1 23 1. Carine Roitfeld and Honoree Federico Marchetti 2. Ellen von Unwerth 3. Rita Ora performs (Photos: Getty Images, Ryan Emberley) 12 TWO x TWO for AIDS and Art 34 On October 26, the 21st installment of TWO x TWO for AIDS and Art raised $8 million to benefit amfAR and the Dallas Museum of Art (DMA). Five hundred people attended the sold-out black-tie event co-hosted by Cindy and Howard Rachofsky at their home, The Rachofsky House, along with Lisa and John Runyon. amfAR CEO Kevin Robert Frost presented artist Alex Katz with amfAR’s 2019 Award of Excellence for Artistic Contributions to the Fight Against AIDS. The evening featured both silent and live auctions of major works of contemporary art and unique luxury items and experiences, and concluded with a soulful performance by Aloe Blacc. Special thanks: Nancy C. Rogers, Sotheby’s, 5 Congratulations to @rachofskycindy Headington Companies, Neiman Marcus, Ruinart, and @rachofskyhoward on another Casa Dragones, Belvedere, TODD Events successful year supporting @amfar 1. Aloe Blacc performs 2. amfAR CEO Kevin Robert Frost and @dallasmuseumart! - @Naseebs honors artist Alex Katz 3. Auctioneer Oliver Barker 4. (L-R) John and Lisa Runyon, Howard Rachofsky, Ada and Alex Katz, Cindy Rachofsky, and Melissa Ireland 5. Nancy Rogers and Hamish Bowles (Photos: Ryan Emberley) 16

1 2 3 amfAR Gala Los Angeles Alan Cumming, Jennifer Jason Leigh, Lea Michele, Paris Jackson, and Eva Longoria were among those who gathered at MILK for the tenth annual amfAR Gala Los Angeles, October 10. The event paid tribute to world-renowned art dealer and philanthropist Larry Gagosian and Academy Award winner and entrepreneur Gwyneth Paltrow, who were presented with amfAR’s Award of Courage in recognition of their commitment to charitable causes including the fight against AIDS. 4 5 The black-tie dinner and auction culminated in a special performance by music sensation Christina Aguilera and raised more than $1.6 million for amfAR’s lifesaving HIV/AIDS research programs. Special thanks: Signature Sponsors Champagne Perrier-Jouët and Absolut Elyx; Wines courtesy of Boroli 6 78 Ming Lee Simmons and Serayah (Photo: Getty Images) generationCURE Holiday Party About 200 young professionals joined amfAR CEO Kevin Robert Frost at the generationCURE Holiday Party on December 10 at Gitano Jungle Room in New York City. The lively event was DJed by Elle Dee and Timo Weiland. Special thanks: Signature Sponsor Moët Hennessy USA; Associate Sponsor Heineken 1. amfAR Trustee Aileen Getty and CEO Kevin Robert Frost 2. Honoree Gwyneth Paltrow 3. Parson James performs 4. Auctioneer Simon de Pury 5. Nina Senicar and amfAR Trustee Jay Ellis 6. Christina Aguilera 7. Former amfAR Trustee Dr. Mervyn F. Silverman and his wife Debbie 8. amfAR Trustees Phill Wilson and Donald Dye (Photos: Getty Images, Ryan Emberley) 17

Events 12 Inaugural amfAR Charity Poker 34 Tournament 1. Gwyneth Paltrow and Jon Hamm 2. Gordon Getty, amfAR Trustee Aileen Getty, and Ivy Getty 3. Victoria Justice, amfAR’s second Charity Poker Tournament was Castellani, and Madison Guest 4. Greg Louganis (Photos: Drew Altizer) held on November 15 at the private residence of Event Chairs Ann and Gordon Getty in San amfAR Mexico City 1 Francisco. Gwyneth Paltrow, Vanessa and Billy 3 Getty, Greg Louganis, and Jon Hamm were On February 4, amfAR hosted its second annual among the notables in attendance. Guests were amfAR Mexico City Dinner. The event featured invited to buy-in to the tournament for a chance a live auction of contemporary artwork curated to play with professional poker players while by Esthella Provas, including works by Chris raising funds for amfAR. The black-tie event Levine, Gabriel Rico, Mario García Torres, Jill included a live auction and non-player activities Magid, Peppi Bottrop, and Octavio Abúndez. such as blackjack, roulette, fashion illustrations Grammy-winning artist Gloria Gaynor concluded by Mokshini, portrait sittings by Drew Altizer, the evening with an unforgettable performance, and music by DJ Dojah. featuring disco favorites “I Am What I Am” and “Never Can Say Goodbye,” and her classic hit “I Special thanks: Signature Sponsors Absolut Will Survive.” Elyx and Champagne Perrier-Jouët; and Associate Sponsors goop and Heineken. Hotel Special thanks: Jose Cuervo, Four Seasons accommodations generously provided by Four Mexico City, Moët & Chandon, Terrazas Seasons San Francisco 1. Eugenio López, Esthella Provas, and Alejandra Fontanet 2 2. Darío Yazbek Bernal and Karla Garza 3. Artist Chris Levine 4. Gloria Gaynor (Photos: Getty Images, Kennedy 4 Pollard) 18

12 amfAR Gala New York 34 5 Longtime amfAR supporter Padma Lakshmi welcomed guests to the 22nd annual amfAR Gala New York at Cipriani Wall Street on Wednesday, February 5. Legendary model and businesswoman Iman, renowned CEO and president of Pace Gallery Marc Glimcher, and award-winning playwright Matthew Lopez were honored for their longstanding commitment to the fight against AIDS. Award presenters were Edward Enninful, Yvonne Force Villareal, and Anna Wintour, respectively. The event, which featured outstanding performances by Charlie Puth and Sofi Tukker, raised over $1.4 million for amfAR’s lifesaving research programs. Special thanks: Signature Sponsors Merry Belle and Mandarin Oriental; Wines courtesy of Boroli 1. Heidi Klum and Honoree Iman 2. Sofi Tukker performs 3. Padma Lakshmi 4. Honoree Marc Glimcher 5. Edward Enninful and Anna Wintour 6. Charlie Puth performs 7. Honoree Matthew Lopez 8. amfAR Chairman Bill Roedy (Photos: Getty Images, Ryan Emberley) 67 HELP US #CURE AIDS 8 amfAR, The Foundation for AIDS Research, you HOLD A BIRTHDAY ❤are a force for good in FUNDRAISER this world. Thanks for getting everyone together Learn how on facebook to continue the fight to @amfarthefoundationforaidsresearch #CureAIDS. - @HeidiKlum 19

Mandarin Oriental, New York has been a dedicated supporter of amfAR for over ten years. Contributing sponsorship and hotel accommodations for talent and guests, Mandarin Oriental, New York has been a pillar of support for marquee events such as amfAR Gala New York. Upcoming Events May 21 amfAR Gala Cannes Cap d’Antibes, France September amfAR Gala Hong Kong Hong Kong September 26 amfAR Gala Milano Milan, Italy October amfAR Gala Los Angeles Los Angeles, California October 24 TWO x TWO for AIDS and Art Dallas, Texas amfAR, The Foundation for AIDS Research 120 Wall Street, 13th Floor, New York, NY 10005-3908 www.amfar.org