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HIV PROJECT NEWS

HIV Research in the Era of PrEP: The Implications of TDF/FTC for Biomedical Prevention Trials
September 27, 2017 – A new paper from TAG on the questions surrounding implementation of Truvada pre-exposure prophylaxis (PrEP) in clinical trials of biomedical prevention interventions. 

Advocacy Organizations Celebrate Results as UnitedHealthCare Reverses Discriminatory PrEP Practices; Urge Other Insurers to Follow Suit
August 8, 2017 - TAG along with fourteen health and social justice organizations from across the U.S. celebrate the people-powered effort behind UnitedHealthcare responding so swiftly to demands that they improve access to the HIV drug Truvada for pre-exposure prophylaxis (PrEP), a medical intervention that prevents HIV infection. On Friday, Aug. 4, UnitedHealthcare received a joint letter from this coalition objecting to new prior authorization rules put in place for access to PrEP effective July 1. Read more here.

Community Calls On United Healthcare to End Discriminatory Prior Authorization Practices for PrEP Access
August 4, 2017
 - 14 organizations, along with TAG, sent a community letter to United Healthcare (UHC) calling on the insurer to end discriminatory practices in regards to patient access for Pre-exposure Prophylaxis (PrEP) for HIV prevention. Specifically, UHC has been requiring documentation for prior authorization every three months for Truvada, prescribed for PrEP. Advocates cite such practices as a violation of the Affordable Care Act's non-discrimination policies and a barrier to accessing a vitally important prevention tool for vulnerable communities. Furthermore, denial letters that are being sent contain inappropriate and judgemental language that questions UHC members' sexual orientation, HIV status and/or drug use, which only continues to perpetuate stigma and discrimination. 

TAG’s Annual Pipeline Report: Promising New HIV, TB & HCV Drugs and Diagnostics
July 18, 2017 – Treatment Action Group (TAG) announces the launch of its annual research and development landscape analysis: The Pipeline Report: Drugs, Diagnostics, Vaccines, Preventive Technologies, Research Toward a Cure, and Immune-Based and Gene Therapies in Development.

Sign-on Letter in Response to Critical Shortage of Penicillin for Syphilis Treatment in U.S.
June 22, 2017 – A sign-on letter urging Pfizer to adequately and promptly address the penicillin G benzathine (Bicillin-LA) shortage to ensure normal quantities in the United States. Bicillin-LA remains the preferred treatment for primary and secondary syphilis in adults, infants, and children, and the only approved treatment for syphilis in pregnant women. As the only manufacturer of pencillin G benzathine in the United States, Pfizer’s inability to provide adequate quantities of Bicillin-LA has left the Food and Drug Administration, the Centers for Disease Control and Prevention, and many city and state health departments scrambling to ration existing stockpiles of the drug and develop contingency plans.

TAGline Spring 2017
NEWS ON THE FIGHT TO END HIV/AIDS, VIRAL HEPATITIS, AND TUBERCULOSIS

HIV Activist Learning Modules: Engaging our Community in HIV Prevention Policy Advocacy
March 29, 2017 – To support the efforts of prevention advocates across the United States, TAG's HIV Project has developed a series of modules to help support activists’ capacity needs and to develop advocacy action plans. The slides, handouts, and webinars in each of the four modules focus on how to identify and change the governmental, organizational, and institutional policies that create roadblocks to comprehensive HIV prevention in our communities. The materials are useful for personal education or group discussion on HIV prevention and policy advocacy.

President’s Budget Blueprint Threatens Research Essential to End the Epidemics of HIV/AIDS, TB, and HCV
March 20, 2017 – TAG strongly opposses the President’s 2018 budget blueprint, which threatens research essential to ending the epidemics of HIV/AIDS, tuberculosis (TB), and hepatitis C virus (HCV) in the United States and globally by cutting funding and eliminating programs.

Sign-on Letter to Protect the NIH Fogarty International Center
March 20, 2017 – Sign-on letter urging Congress to reject the elimination of the Fogarty International Center at the NIH in the President’s FY 18 budget proposal and to oppose any funding cuts associated with supporting scientific research.

Community Survey on PrEP and Biomedical Prevention Clinical Trials
March 7, 2017 – TAG is interested in learning more about activist and community leader perspectives on the provision of Truvada for pre-exposure prophylaxis (PrEP) in clinical trials of biomedical prevention interventions (e.g. HIV vaccines, antibody or immune-based prevention interventions, and other forms of antiviral PrEP). Please consider completing our questionnaire by March 20th.

Treatment Action Group Lauds Launch of NYC Sexual Health Clinics as Hubs of Comprehensive HIV Prevention and Care
February 17, 2017
– Amid growing concerns about federal government commitments to the national HIV response, TAG applauds the New York City Department of Health and Mental Hygiene (DOHMH) for its radical expansion of the city’s sexual health clinics as hubs of HIV prevention, care, and treatment. “Now more than ever, activism, community mobilization, and government leadership is required to end HIV as an epidemic in the United States,” said Mark Harrington, TAG’s executive director.

Webinar: Community mobilization – an assessment of mechanisms and barriers at CBOs and ASOs in nine U.S. metropolitan areas
February 8, 2017

Community mobilization: An assessment of mechanisms and barriers at CBOs and ASOs

TAG Expands Its End the Epidemic Campaign to Include Southern States Heavily Impacted by HIV
January 30, 2017 –
New initiative is under way to strengthen community leadership and mobilization toward ambitious HIV prevention and treatment goals against the backdrop of anticipated shifts in federal support and resources for critical programs.

Community Mobilization: An Assessment of Mechanisms and Barriers at Community-Based and AIDS Service Organizations in Nine U.S. Metropolitan Areas
January 9, 2017 – New Report Shines Spotlight on Need for More Investments in Community Leadership and Mobilization to End HIV as an Epidemic

Webinar: How to measure success Improving our national HIV prevention indicators
December 21, 2016

How to measure success Improving our national HIV prevention indicators

The Fair Pricing Coalition Releases New Report Urging Modernization of Existing Laws to Rein in Drug Pricing
December 7, 2016 – The Fair Pricing Coalition announces the release of “Tackling Drug Costs: A 100-Day Roadmap,” an analysis of existing federal statutes and regulations that should be strengthened to dramatically lower the prices of drugs and biologics in the U.S. The report, distributed to the President-elect’s transition team and Congressional leaders, provides a roadmap that can be implemented quickly on the heels of growing bipartisan support for feasible measures to control the skyrocketing costs of prescription medications.

Shortage of Injectable Estrogen a Crisis for Transgender Women
Public health experts call on FDA to better manage drug shortage process.

December 5, 2016―Today, The Fenway Institute of Fenway Health, Callen-Lorde Community Health Center, and Treatment Action Group (TAG) released a policy brief documenting the public health emergency created by a shortage of injectable estrogen, and calling on the U.S. Food and Drug Administration (FDA) to be more proactive in resolving the crisis.

HIV Activists Seek to Accelerate Development of Immune Enhancing Therapies for Immunologic Non-Responders
Dialogues with FDA, scientists and industry encourage consideration of orphan drug designations for therapies to help the immunologic non-responder population and exploration of novel endpoints to reduce the size of efficacy trials.
November 30, 2016 – A coalition of HIV/AIDS activists are calling for renewed attention to HIV-positive people termed immunologic non-responders (INRs), who experience suboptimal immune system reconstitution despite years of viral load suppression by antiretroviral therapy. Studies have shown that INR patients remain at increased risk of illness and death compared to HIV-positive people who have better restoration of immune function on current drug therapies. Risk factors for becoming an INR include older age and a low CD4 count at the time of treatment initiation. To date, efforts to develop immune enhancing interventions for this population have proven challenging, despite some candidates from small companies showing signs of promise.

TAGline Fall 2016
NEWS ON THE FIGHT TO END HIV/AIDS, VIRAL HEPATITIS, AND TUBERCULOSIS

#FairDrugPricesNow
September 28, 2016 – Treatment Action Group, in conjunction with the Human Rights Campaign (HRC) and the Fair Pricing Coalition Launch #FairDrugPricesNow Campaign, a new effort to organize the LGBTQ community around common-sense solutions to drug pricing and price increasing.

2016 Pipeline Report
July 15, 2016 – HIV and TB Drugs, Diagnostics, Vaccines, Preventive Technologies, Research Toward a Cure, and Immune-Based and Gene Therapies in Development

Webinar: The stigma of HIV prevention
July 13, 2016

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TAGline Spring 2016 
NEWS ON THE FIGHT TO END HIV/AIDS, VIRAL HEPATITIS, AND TUBERCULOSIS

HIV Community Letter to Hillary for America
March 14, 2016 – Dear Secretary Clinton: We write to you in the sincere hope that we can work together to transform the pain caused by your March 11th mischaracterization of the Reagans’ role in the AIDS crisis into an urgently needed public discussion of a plan to end the United States HIV epidemic by the year 2025.

Pre-CROI Community HIV Cure Research Workshop 2016
On Sunday February 21, 2016 in Boston, the AIDS Treatment Activists Coalition, AVAC, European AIDS Treatment Group, Project Inform and TAG co-sponsored a community workshop on HIV cure research. The workshop has become an annual event that takes place immediately prior to the Conference on Retroviruses and Opportunistic Infections (CROI). Slide presentations are posted below, and there is coverage of workshop on the EATG at CROI 2016 Facebook page.

Treatment Action Group hails Governor Cuomo’s proposed legislation allowing minors to maintain confidentiality when obtaining HIV treatment or preventive therapy
February 11, 2016 – "Governor Cuomo continues to provide globally unprecedented leadership with New York State's plan to end AIDS as an epidemic by the year 2020,” said Treatment Action Group executive director Mark Harrington. “With today's announcement that he will submit legislation allowing minors to consent to receive antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP) to treat or prevent HIV infection, New York State moves closer to achieving an AIDS-free generation in this decade. Treatment Action Group salutes the governor's sustained leadership in these efforts and calls on state legislators to rapidly and unanimously pass this lifesaving, infection-averting legislation to end AIDS and HIV acquisition among our state's youth."

WEBINAR: Countering Threats to AIDS Research at NIH: What happened and what you can do
February 2, 2016

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WEBINAR: HIV Prevention Advocacy in the 2016 Election Year: Priorities and Challenges
January 25, 2016

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2015 Research in Action Awards Honoree Jim Eigo's Acceptance Speech

Webinar: Envisioning comprehensive HIV prevention service delivery in the U.S.
December 18, 2015

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TAG's Response to Senator Cassidy's Statements on AIDS Research Spending
November 19, 2015 – I would like to offer comments to correct the record on statements given by Senator Bill Cassidy (R-LA) at the October 7, 2015, hearing on the National Institutes of Health fiscal year 2016 budget. Several of his comments to the committee and NIH Director Francis Collins were incorrect or misleading. If his erroneous statements about AIDS research funding at the NIH are mistaken for fact, we will set a dangerous course for current and future research being conducted at the agency and undermine the prioritization process under way at the Office of AIDS Research (OAR).

ACT UP\New York and TAG to Host Town Hall Meeting to Discuss Drastic Cuts to Citys HIV Testing and STD Screening Programs
August 31, 2015, New York, New York – In response to disturbing trends in New York City’s response to the ongoing HIV and STD epidemics, ACT UP/New York and Treatment Action Group (TAG) will host a town hall meeting at the New York City LGBT Center on 13th Street in Manhattan at 6:30 PM on September 1, 2015. ACT UP and TAG seek to push the de Blasio administration to mitigate the massive citywide reduction of sexual health services in recent years, including the March 2015 closure of the Chelsea STD Clinic.

2015 Pipeline Report
July 17, 2015 – HIV, HCV, and TB Drugs, Diagnostics, Vaccines, Preventive Technologies, Research Toward a Cure, and Immune-Based and Gene Therapies in Development

Toward Comprehensive HIV Prevention Service Delivery in the United States: An Action Plan
June 24, 2015 – An objective of the National HIV/AIDS Strategy (NHAS), released by the White House in July 2010, is to lower the annual number of new infections in the United States by 25 percent by the end of 2015. Yet it is unclear if we will succeed in meeting this arguably unambitious target: 36,400 estimated new infections in 2015, compared with the 48,600 new infections estimated for the baseline year of 2006.

Governor Releases Blueprint to End AIDS in NYS by 2020
April 29, 2015 – New York, NY– Governor Cuomo formally accepted the long-awaited Blueprint to End AIDS at a public event on Wednesday, marking an important step towards fulfilling his commitment to end AIDS in New York State.

Governor Cuomo’s Plan to End AIDS Will Save Lives and Money
April 21, 2015 – TAG & Housing Works Report Shows Plan to End AIDS by 2020 Will Translate into $4.5 Billion in Net Medicaid Savings for NY State.

150 HIV Organizations Urge Continuation of D:A:D Study
February 20, 2015 – HIV drugs are used in combinations, so it is right that the companies who make and sell these drugs collaborate on this study on long-term safety.

Governor Cuomo’s Ending the Epidemic Task Force Completes Plan to End AIDS in NY State by 2020
– Activists, service providers, public health professionals hail governor’s leadership, call on legislators and local governments to join forces to end the epidemic –
January 13, 2015, Albany, New York – Today the Ending the Epidemic Task Force, convened by the New York State Department of Health (DOH) at the behest of Governor Andrew M. Cuomo, completed its comprehensive, rigorous, and unprecedented Plan to End AIDS in New York State by 2020.

Advocates Urge Governor Cuomo to Withdraw Mandatory Quarantine Order
October 26, 2014 – We write as professionals, activists, and public health researchers who have worked to combat AIDS and other infectious diseases in New York and around the world for over three decades.  We have not forgotten how HIV/AIDS was at first largely ignored while it appeared to affect only marginalized communities or the stigma generated once fear of the virus took hold in the larger population.  We have watched with growing concern as Ebola virus disease (EVD) was ignored far too long while confined to some of the poorest countries in the world, and how it has now led to hysteria here in the United States, based on only a very small number of cases. As you know, stigma remains our biggest enemy in fighting AIDS and could quickly become the biggest barrier in combatting EVD.  Therefore, we implore you to withdraw the mandatory quarantine requirement for all people entering the United States through Newark Liberty International Airport and John F. Kennedy International Airport who have had direct contact with individuals with EVD in Guinea, Liberia, and Sierra Leone.

NYS Ending Epidemic Task Force
October 14, 2014, New York, New York – Treatment Action Group (TAG) welcomes today’s announcement by the New York State Department of Health (DOH) of the Ending the Epidemic Task Force to more fully develop Governor Andrew Cuomo’s Plan to End AIDS as an epidemic in New York State by the year 2020.

Letters to Menigitis Vaccine Makers Urging Efficacy Studies in People with HIV
September 17, 2014 – Significant gaps in our knowledge base on the effectiveness of meningococcal vaccination with respect to preventing disease in people living with HIV make it more difficult to mount a strategic public health response to the outbreaks, both in New York City and other settings.

2014 Pipeline Report
July 20, 2014 – HIV, HCV, and TB Drugs, Diagnostics, Vaccines, Preventive Technologies, Research Toward a Cure, and Immune-Based and Gene Therapies in Development.
Read the HIV chapters online:


Treatment Action Group Commends Governor Cuomo for Launching Historic New York State Plan to End AIDS
TAG Calls on Governor to Expeditiously Appoint a High-Level Task Force to Develop Blueprint to End AIDS Deaths and Halt New HIV Infections

June 29, 2014, New York, New York – Treatment Action Group (TAG) applauds Governor Andrew M. Cuomo for his full support of a historic community-developed plan to end the AIDS epidemic in New York State by 2020, as announced this morning by the Governor’s office and reported in today’s edition of the New York Times (“Cuomo Plan Seeks to End New York’s AIDS Epidemic,” Anemona Hartocollis, page A18). With this bold initiative, New York State—long the epicenter of the nation’s HIV epidemic—becomes the first jurisdiction anywhere in the world to publicly declare a goal of ending AIDS as an epidemic with the launch of a comprehensive effort to end AIDS deaths and halt new infections by employing state-of-the-art testing, preventive technologies, treatment, and supportive services.

ACT UP to Tom Frieden: You’re MIA on HIV
New Infections on the Rise in Key Subpopulations, Despite Options for Prevention
June 9, 2014 – Members of ACT UP NY, along with Treatment Action Group (TAG) and Atlanta allies, will meet with the Centers for Disease Control & Prevention (CDC)’s HIV prevention personnel in Atlanta, GA. ACT UP will call upon the CDC to meet its commitment of keeping all Americans healthy and to act now upon the promise of TasP, PrEP, and PEP, address social and structural barriers to lifesaving prevention options, and reduce the transmission of HIV in those groups where the incidence is rising.

Research Toward a Cure
March 27, 2014 – A listing of clinical trials and observational studies related to the research effort to cure HIV infection, mainly derived from the clinicaltrials.gov online registry. Click the identifier numbers for a link to the full clinicaltrials.gov entry containing detailed information on the trial design, enrollment criteria, principal investigators and location(s). It's important to appreciate that at the current time, none of these studies is expected to produce a cure for HIV infection—they represent research working toward that goal. Table 3 contains completed studies, with links to published or presented results where available.

Filling the Gaps in the U.S. HIV Treatment Cascade: Developing a Community-Driven Research Agenda
December 1, 2013 – TAG and amfAR sponsored a workshop in Washington, D.C., on June 18–19, 2013, to develop a community-based agenda to improve implementation of effective service-delivery approaches and identify research priorities for improved management of HIV treatment and prevention, with a particular focus on filling the gaps in the United States HIV continuum of care (or treatment cascade). This document represents the outcomes from that meeting, attended by representatives from government, academia, and health care systems, along with community-based advocates and service providers.

167 Organizations and 513 Individuals Signed on to Letter to Secretary Sebelius on the Allowance of Co-pay Assistance in the ACA Health Plans
December 2, 2013 – We, the undersigned organizations and individuals, are writing to urge that the HHS issue clear guidance on the allowance of drug industry–provided co-payment, co-insurance, or other out-of-pocket discount cards and coupons in the Affordable Care Act’s (ACA) Health Insurance Marketplaces. As people living with, and organizations serving people with, HIV, HCV, and other life-threatening and chronic health conditions, we are alarmed by the possibility of the prohibition of these critical financial lifelines in the ACA, just as affordable health insurance for people with preexisting conditions is finally becoming a reality in the United States, thanks to the ACA.

amfAR/TAG Issue Brief: The Cost of Flat Funding for Biomedical Research
August 12, 2013 – “The Costs of Flat Funding for Biomedical Research,” prepared by the Foundation for AIDS Research (amfAR) in collaboration with TAG, examines the declining purchasing value of public funding for health research at the National Institutes of Health (NIH) and the impact this has on public health, scientific progress, US productivity, and US science leadership.

2013 Pipeline Report
June 30, 2013 – HIV, HCV, and TB Drugs, Diagnostics, Vaccines, Preventive Technologies, Research Toward a Cure, and Immune-Based and Gene Therapies in Development

Preexposure Prophylaxis (PrEP) Trial among Thai Injection Drug Users Marred by Lack of Response to Community Concerns
June 26, 2013 – On June 12, results from an efficacy trial of tenofovir as pre-exposure prophylaxis (PrEP) against HIV infection in individuals with a self-reported history of injection drug use were published in the Lancet. The trial was sponsored by the U.S. Centers for Disease Control and Prevention (CDC) and took place in Bangkok, Thailand (named the Bangkok Tenofovir Study). The publication was accompanied by a flurry of press releases and drew considerable news coverage due to the documentation of a statistically significant reduction in risk of HIV acquisition of 48.9%.

Letter to Gilead - Tenefovir Alafenamide Fumarate (TAF) (Final with 293 signatories)
June 24, 2013 – With a phase II clinical trial of tenofovir alafenamide fumarate (TAF) yielding encouraging preliminary results and regulatory planning for TAF-inclusive fixed-dose combinations (FDCs) under way, we are compelled to reach out to you regarding the need for a stand-alone formulation of the drug.

The Immune System, HIV, and Aging
June 3, 2013 – Little more than a decade ago, it was almost inconceivable that the issue of aging with HIV infection would emerge as an important concern. But it has now become clear that combination antiretroviral therapy (ART) can suppress virus replication for many years—likely for life—in most people who can access the drugs, and the opportunistic infections that were once the primary causes of illness have largely evanesced everywhere treatment is available. Morbidity and mortality from HIV infection has plummeted, and the survival of HIV-positive individuals is edging ever closer to that of comparable HIV-negative people. With the specter of AIDS having finally been chased from the near horizon, attention has turned to health problems that may lie further down the road.

Revitalizing the U.S. National HIV/AIDS Strategy
Meeting Report and Action Plan
April 15, 2013 – On December 11–12, 2012, in Washington, D.C., Treatment Action Group (TAG) hosted a meeting of HIV advocates, service providers, and researchers from across the United States (U.S.) to review the current state of the national HIV response and discuss how to revitalize the National HIV/AIDS Strategy (NHAS). Meeting participants reviewed the latest data, discussed the changing landscape of the HIV response, and developed recommendations for continued and expedited progress. The Meeting Report summarizes the presentations and discussions, and outlines the key recommendations from participants. The Action Plan incorporates the recommendations from the meeting report.
 

Funding Scientific Innovation: Global Investments in HIV Treatment Research and Development in 2010 and 2011

March 6, 2013 – Advances in HIV treatment research in 2010 and 2011 saw improvement in treatment regimens and strategies, and reinvigorated optimism for finding a cure. In 2012, TAG and AVAC, with financial support from UNAIDS, put forth a collaborative effort to analyze investment trends in HIV treatment research and development (R&D) in 2010 and 2011.


Micardis Sign-On Letter to Boehringer Ingelheim
November 30, 2012 – Dear Dr. Piliero: We, the undersigned organizations and individuals, urge Boehringer Ingelheim Pharmaceuticals to reconsider its negative decision to provide free telmisartan (Micardis) and matching placebo to the AIDS Clinical Trials Group so that it may move forward with Study A5317, a multicenter trial evaluating the effects of telmisartan on fibrotic and inflammatory contributors to end-organ disease in HIV-infected patients well controlled on antiretroviral therapy.

2012 Pipeline Report

HIV, Hepatitis C Virus (HCV), and Tuberculosis (TB) Drugs, Diagnostics, Vaccines, and Preventive Technologies in Development

July 22, 2012 – Visit our new website www.PipelineReport.org to:

  • Read the report online
  • Download individual chapters as PDFs
  • Browse for specific information by agent


Letter Opposing a Proposed Low-Dose Stavudine Trial
December 14, 2011
Dear Mr. and Mrs. Gates, We write as people with HIV and community activists with serious and unresolved concerns about the proposed clinical trial comparing stavudine at 20 mg to tenofovir. Although we are broadly very supportive of dose optimisation strategies, we do not support this trial; we do not think that the Bill and Melinda Gates Foundation should support it; nor do we think it should proceed. Several of us have discussed this with your representatives both formally and informally over the past months. Those of us who met with your representatives on 19 July 2011 at the International AIDS Society conference in Rome received no response to the concerns we raised. We summarise our objections as follows:

HIV Cure-Related Research Workshop Report 

October 2011 – The meeting, sponsored by the AIDS Policy Project, amfAR, Project Inform, and TAG, featured an overview of HIV latency, persistence, and eradication research; lessons from past clinical trials; a review of current or impending trials; and a full discussion of issues including trial design, appropriate markers and endpoints, and development of better assays. Participants heard a presentation on the ethics of clinical trials and discussed the federal regulatory process and how best to engage the several branches of the U.S. Food and Drug Administration (FDA) in a coordinated and collaborative way to work together to ensure that cure-related clinical trials proceed expeditiously, ethically, and safely.

2011 Pipeline Report – Second Edition

HIV, Hepatitis C Virus (HCV), and Tuberculosis Drugs, Diagnostics, Vaccines, and Preventive Technologies in Development

September 2011 – As this i-Base and TAG 2011 Pipeline Report, Second Edition, makes clear, medically, the prospect for people with HIV, hepatitis C virus (HCV), and tuberculosis (TB) to live long and healthy lives—and in the cases of HCV and TB, to be cured rapidly with safe, effective, oral combination therapy—has never been better.

An Exploratory Analysis of HIV Treatment Research and Development Investments in 2009

July 2011 – The HIV treatment research landscape is changing. Thanks to recent treatment scale-up and prevention science breakthroughs and the new global treatment target of 15 million by 2015, there is real momentum to bring the epidemic under control and ultimately end it. To capitalize on these scientific gains, continued investment and innovation are necessary to prevent new infections, to ensure people currently on treatment are able to continue, and to scale up treatment to reach all those who will benefit from earlier initiation of antiretroviral therapy. This report from TAG, UNAIDS, and the AIDS Vaccine Advocacy Coalition documents $2.46 billion in HIV-related research investments.