Strengthening Replication and Reproducibility of NIH-funded Research

This content originally appeared on NIH.gov. View the article here.

NIH is launching a new, agency-wide initiative to elevate replication and reproducibility studies as foundational to the conduct of gold standard science. Driving and sustaining culture change will take ideas from and commitment across the research enterprise, and we will be engaging the scientific community in implementing our strategic vision, which will focus on:

  • Driving Effective NIH Replication and Reproducibility Efforts: NIH has longstanding replication and reproducibility efforts and will continue investing in its flagship policies, resources, and programs. These include sharing and standardizing data to accelerate biomedical research discovery, making NIH research findings freely and quickly available to the public, and supporting independent replication research to generate best practices and lessons learned.
  • Incentivizing Replication and Reproducibility Sciences Across the Research Enterprise: NIH will work with the scientific community to identify innovative approaches that reinforce and incentivize replication and reproducibility across the research enterprise, such as supporting competitions to develop novel reward incentives and recognize champions of rigor. Additionally, NIH will engage researchers in selecting research areas ripe for replication and reproducibility studies.
  • Institutionalizing Replication and Reproducibility as a Scientific Discipline: NIH will invest in building and sustaining critical infrastructure to drive and embed replication and reproducibility throughout biomedical research. By establishing a central locus for cutting edge science, current methods and approaches, and a forum for robust debate, NIH will develop and foster the culture for driving gold standard science.

NIH will continue to update this site, including ways to engage and how to get involved. Learn more about NIH’s ongoing replication and reproducibility efforts:

Bridging the Gap: HIV Prevention and Care in Rural Communities

This content originally appeared on HIV.gov. View the article here.

Summary: Rural communities face unique challenges in accessing HIV services, but support is available. This blog post offers practical tips for getting tested, engaging in care, and using telehealth to overcome distance-related barriers. It also highlights how federal programs are helping to expand HIV prevention and treatment services across rural America.

No matter where you live, you deserve access to the HIV care and prevention tools that support long-term health

HIV touches lives everywhere across the United States, even in small towns and rural areas. Getting tested, finding prevention options, or starting treatment can feel tough in rural communities. The good news? Help is out there, and folks in rural communities are finding creative ways to make sure everyone can get the HIV services they need.

Challenges in Rural HIV Prevention and Care

If you live in a rural area, getting HIV care can feel like an uphill battle. This might mean driving long distances, not having many doctors or clinics to choose from, or struggling to get to appointments. You might also worry about what others will think or say. All of this can make it hard to get tested or to access the HIV prevention or treatment services that you need. But remember, you’re not alone. With the right help and some good resources, you can stay on top of your health and get the care you need, no matter where you live.

Tips for Accessing HIV Services in Rural Areas
  • Get tested: Knowing your HIV status is the first step to protecting your health. You can search for testing options near you using the HIV.gov HIV Services Locator. You can also request a free HIV self-test from Together TakeMeHome, a program supported by the Centers for Disease Control and Prevention (CDC) that mails self-tests to help make HIV testing more accessible across the United States.
  • Explore telehealth options: Telehealth can help bridge the distance between patients and providers. Ask whether your provider or an HIV clinic in your region or state offers virtual appointments for HIV care or PrEP (pre-exposure prophylaxis).
  • Find a provider who meets your needs: The HIV.gov HIV Services Locator can also help you connect with care providers and support services—even in surrounding counties or nearby cities. You can also check with your local health department to see what HIV services they may offer or see whether they know of any clinics or hospitals from nearby communities that may offer HIV services via a mobile clinic that visits your community periodically.
  • Stay engaged in care: Routine visits with your health care provider are important to staying healthy. Consider setting reminders for appointments or enrolling in programs that offer care coordination or navigation services so you have someone you can reach out to with questions between appointments.
Federal Support for HIV Services in Rural Areas

There are federal programs working to make sure that people in rural communities get the HIV services they need:

  • The Indian Health Service (IHS) offers HIV care and prevention for Indigenous communities, including those in rural regions, making sure care fits cultural needs.
  • The Ryan White HIV/AIDS Program helps people living with HIV, including those in rural areas, access medical care, medications, and essential support services by working with clinics, providers, and community programs.
  • The Health Center Program supports local health centers all over the country. Many of these centers are located in rural areas. Health centers offer HIV testing, and many also provide prevention and treatment services.
  • The CDC supports health departments and community-based organizations that provide HIV testing and prevention services, including in rural and high-need communities.

In addition, seven states with a substantial number of HIV diagnoses in rural areas—Alabama, Arkansas, Kentucky, Mississippi, Missouri, Oklahoma, and South Carolina—are getting extra support and attention through the Ending the HIV Epidemic in the U.S. (EHE) initiative. President Trump launched the EHE in 2019 to substantially reduce new HIV infections in the United States by helping those states, 48 counties, Washington, DC, and San Juan, PR, enhance and expand their HIV testing, treatment, and prevention efforts.

Closing the Distance

Wherever you call home, your health is important. If you live in a rural area and need HIV testing, prevention, or treatment services, there’s help out there—whether it’s through telehealth or special federal programs. Distance doesn’t have to keep you from getting the care you need.

To learn more about HIV testing, prevention, and treatment visit HIV.gov and explore the “HIV Health & Wellness” section for more information and resources.

 

2026 CHIPTS HIV Next Generation Conference Recap

The 2026 CHIPTS HIV Next Generation Conference welcomed over 150 attendees from academic institutions, community-based organizations, health care institutions, and other organizations working to end the HIV epidemic at the California Endowment on Thursday, February 5, 2026. The conference included engaging oral and poster presentations, lively discussions, and networking opportunities to support the next generation of HIV researchers and service providers.

CHIPTS Development Core Director, Jesse Clark, MD, MSc facilitated this year’s conference and provided a warm welcome to participants. CHIPTS Director, Raphael Landovitz, MD, MSc followed with opening remarks setting the tone for an exciting conference. He echoed the conference’s goals with a powerful statement: “Ask bold questions. Show us your unfinished ideas. Let this be a place where curiosity is encouraged and where support is tangible.”

Ashleigh Herrera, PhD, MSW, Assistant Professor, Department of Social Work at California State University Bakersfield offered an engaging and insightful opening plenary on building community, connection, and protection to preserve the HIV continuum of care and research. She emphasized the importance of multilevel social support—strategic guidance from senior mentors and collective care among early-career peers—in navigating challenges and sustaining momentum.

Throughout the day, there were four sets of oral presentations and in-between a fantastic group of poster presentations highlighting innovative research and evaluation projects to support efforts to end the HIV epidemic. Access poster presentations on our webpage.

The first panel was moderated by CHIPTS Development Core Co-Director Marjan Javanbakht, PhD and centered on HIV care and service delivery. The second set of oral presentations moderated by CHIPTS Combination Prevention Core Affiliate Michael Li, PhD, MPH focused on intersectionality (e.g., intimate partner violence, substance use, and stigma). CHIPTS Combination Prevention Core Scientist Ronald Brooks, PhD moderated the third panel on keeping it local: HIV/STIs in Los Angeles. The fourth panel moderated by CHIPTS Development Core Director, Jesse Clark, MD, MSc was a unique conversation on moving research forward that provided tools, perspectives, and examples to foster innovation and long-term career growth.

To close the conference, CHIPTS Co-Director Steve Shoptaw, PhD congratulated this year’s outstanding presenters and encouraged participants to continue their commitment to new ideas and collaborations as we work together to end the HIV epidemic.

Check out our photo gallery on our Facebook page.

Presentation slides, if available, may be provided upon request by emailing chipts@mednet.ucla.edu

Implementing a Unified NIH Funding Strategy to Guide Consistent and Clearer Award Decisions

This content originally appeared on grants.nih.gov. View the article here.

Our funding decisions must balance many competing and dynamic factors when determining the most meritorious research ideas to support. These factors center around peer review, health priorities, scientific opportunities, the workforce, availability of funds, and the wider research portfolio. Thoroughly addressing this balance has implications for the pace of scientific advancements and responsiveness to the often-changing nature of biomedical scientific progress.

With our prior approaches as a foundation, implementing this new framework is based on a set of core tenets for ICO funding policies to ensure NIH mission and health priorities are being achieved.

Core Tenets

All ICO funding policies should:

  • Align with the NIH’s mission
  • Prioritize scientific merit; ICOs should consider peer review information in its entirety
  • Integrate a breadth of topics and approaches relevant to the ICO’s priorities
  • Consider investigator career stage and promote sustainability of the biomedical research workforce
  • Promote broad distribution and geographic balance of funding, considering the total amount and type of NIH funding already available to each investigator
  • Align with the availability of ICO funds

More details on the core tenets are shared on NIH’s Funding Decisions webpage. Individual ICO webpages that previously reported similar information will be redirected to this central page.

A new section on the NIH Grants and Funding site is being created to enhance transparency into and accountability for ICO decision-making. Here, ICOs can share their funding policies and financial management plans centrally in a simple, consistent, and streamlined manner.

Peer Review Remains Essential and Vital

Our decision making on applications will still weigh peer review scores and critiques.

Going forward, ICOs will be considering peer review information in its entirety. NIH ICOs will not rely on funding paylines in developing pay plans. Rather, ICOs will consider these scores in context of their and NIH’s priorities, strategic plans, and budgets. ICO Directors will continue to have the delegated authority to decide what is funded by their ICOs.

Moving Away from Paylines 

Around half of ICOs previously set paylines (akin to a cutoff) based on peer review scores or percentiles as part of their funding decision process. When doing so, ICOs would still need to deliberately consider the funds they have available, out-year commitments to existing multi-year awards, anticipated funding for new and established programs, and predicted trends in grant applications. Applications that fell within the payline would be funded, though not in all instances, and applications could still be funded if they fell outside the payline in special cases.

The research community occasionally expressed confusion around the payline process and asked for additional clarity as it related to their applications. Now that ICOs will not rely on funding paylines when developing their pay plans, it should be clearer for applicants to know the award decision was not made only based on overall impact score, without necessarily considering the additional valuable information provided by peer review.

These steps will strengthen accountability for the research NIH continues to support, weighing the actual need, opportunity costs, and good stewardship of taxpayer investments.  It will also make NIH’s research portfolio more robust, moving us towards supporting a breadth of basic, applied, clinical, and translational research.

Annual Reflections: Most Popular CHIPTS Content Of 2025

CHIPTS continues to use our website and social media accounts to disseminate the latest developments in HIV research, enriching learning opportunities, Center news, and more. As we near the end of the year, CHIPTS has taken the opportunity to reflect on the content we shared that sparked the most engagement from our community. We invite you to check out some of our most popular content from 2025 as we prepare to continue our collective work to end the HIV epidemic in 2026.

WEBSITE

In 2025, the CHIPTS website featured nearly 15 blog posts on the latest Center news as well as local, state, and national news from our research and public health partners. Our most popular blog topics included:

  • World AIDS Day 2025 – A Message from Dr. Raphael Landovitz (Read here)
  • 2025 CHIPTS Rapid Project Awardees (Read here)
  • CDC Recommends New Injectable HIV PrEP (Read here)
  • Updates to the NIH Public Access Policy in Effect (Read here)
  • In Case You Missed It: Key Highlights from CROI 2025 (Read here)

The resource library housed on the CHIPTS website includes a wide range of downloadable materials to support HIV researchers and community partners, from assessment tools to research project reports to policy briefs. Check out our most popular downloads of 2025 below:

  • CHIPTS 2026 HIV Next Generation Conference – Call for Abstracts (Download here)
  • Innovative Interventions for Sustainable HIV/AIDS Epidemic Control in Zambia in a Quest to end the Pandemic in Africa by 2030 – Slides (Download here)
  • HIV-Specific Antibody Responses After Early ART Initiation: Obstacles and Opportunities – Slides (Download here)
  • 2026 CHIPTS Mentored Pilot Grant – Call for Applications (Download here)
  • Developing and testing a multilevel intervention to promote viral suppression in the Dominican Republic – Slides (Download here)

SOCIAL MEDIA

CHIPTS continues to have an active presence across our social media platforms. In 2025, we shared relevant content with local, national, and global partners. Here is some of our most popular content posted on TwitterFacebook, and YouTube in 2025:

Twitter:  

  • CHIPTS very own Combination Prevention Core Affiliate, Dr. Dvora Joseph Davey is presenting both oral and poster abstracts at #CROI2025. Dr. Davey is part of the 4,000 HIV researchers and leaders across the globe sharing their impactful work. (View here)
  • #2025HIVNextGen has started! Opening remarks by CHIPTS Director Dr. Steve Shoptaw set the stage for a more meaningful and engaging conference: “Today is to talk about science and solutions that helps our communities, we also have to link and work together.” (View here)
  • A comprehensive list of all featured abstracts from the 13th IAS Conference on #HIV Science (#IAS2025) in Kigali, Rwanda is available in the Journal of the International AIDS Society (jiasociety). Access this helpful resource: onlinelibrary.wiley.com/toc/17582652/2
  • Weeks after #IAS2025, we wanted to share an inspiring reflection that highlights the significance of presenting in a #global stage. Dr. Amanda Miller describes #IAS2025 as a “powerful space focused on the essential role of #mentalhealth in the global #HIV response.” Read more: tinyurl.com/2pu4j36p (View here)
  • Exciting news shared by @GileadSciences about the approval of the Yeztugo (#lenacapavir) twice-yearly injection indicated for pre‑exposure prophylaxis to reduce the risk of sexually acquired HIV-1 in adults and adolescents who are at risk for HIV-1 acquisition. gilead.com/news/news-deta

Facebook:

  • Check out our gallery capturing key moments from the 2025 CHIPTS HIV Next Generation Conference that took place at the California Endowment on January 31, 2025. (View here)
  • Dr. Giang Le from Hanoi Medical University in Vietnam met with CHIPTS colleagues following #CPDD25 to discuss future research collaborations related to #HIV and substance use. (View here)
  • Today is National Women and Girls HIV/AIDS Awareness Day, a day to address the barriers to HIV/AIDS treatment for women and girls. In honor of #NWGHAAD, CAB Co-Chair Natalie Sanchez shares a reflection and highlights the Confessions: HIV+ Women Podcast. Read more: https://tinyurl.com/4up99jyc (View here)
  • The UCLA-CDU CFAR and the UCLA AIDS Institute are accepting applications for their Pilot Projects designed for early-career investigators, Letters of Intent (LOIs) are being evaluated until deadline on Friday, September 12, 2025. Learn more: https://cfar.ucla-cdu.org/pilot-projects/ (View here)
  • Accepting abstracts for #HIVNextGen, the submission deadline is on October 27, 2025, by 5PM PT. Abstracts that examine contextual factors influencing #HIV health outcomes are strongly encouraged. Learn more about submission guidelines and requirements: https://chipts.ucla.edu/hiv-next-generation-conference-4/ (View here)

YouTube:

  • HIV-Specific Antibody Responses After Early ART Initiation: Obstacles and Opportunities (Watch here)
  • Shaping the Future of HIV and HBV Therapeutics: Centering Socio-Behavioral Research (Watch here)
  • Roll-out implementation optimization in Practice: Methodological Considerations and Case Examples (Watch here)
  • The power and pitfalls of social media strategies: Lessons learned from implementation science efforts to end the HIV epidemic (Watch here)
  • An Innovative intervention for Sustainable HIV/AIDS Epidemic control in Zambia (Watch here)

We look forward to bringing more relevant, engaging content to the CHIPTS community in 2026.


World AIDS Day 2025 – A Message from Dr. Raphael Landovitz

In observance of World AIDS Day on December 1, 2025, Center Director Dr. Raphael Landovitz shares a message of resilience and highlights the need for a bold response to help end the HIV epidemic. Read more below.

This World AIDS Day arrives at a moment of profound uncertainty. The global architecture that sustained HIV prevention and care for decades is shifting beneath us. The loss of PEPFAR and USAID funding, coupled with renewed threats to science and research itself, reminds us that progress—no matter how hard-won—is fragile. Yet, while these are unthinkable challenges, they are not unfamiliar ones. The HIV field has always thrived in adversity, forging paths where none were visible, insisting that evidence and empathy must coexist even when the world turns away.

At CHIPTS, we draw strength from that lineage of innovation and resistance. Our mission has never depended on comfort or consensus—it has endured through the conviction that science must be bold, inclusive, and unafraid. As support structures falter, our response cannot be retreat but reinvention: deeper collaboration across disciplines, new models of discovery, and research that continues to center the communities most affected. The times demand not only our intellect, but our imagination—our ability to create, to adapt, and to quietly subvert the forces that would diminish human dignity.

So today, we remember that hope is itself an act of defiance. In the words of Amanda Gorman, from “New Day’s Lyric”:

“For wherever we come together,
We will forever overcome.”

Raphael Landovitz, MD, MSc

CHIPTS Director

2025 CHIPTS Rapid Project Awardees

A spotlight featuring the three projects of our 2025 CHIPTS Rapid Projects awardees that includes project titles and project abstracts. Dr. Wei-Ti Chen tests a compassion-based intervention to reduce stigma and improve mental health. Dr. Huyen Pham uses evidence synthesis and machine learning to improve care for people with HIV and co-occurring mental health or substance use disorders. Beimnet Taye examines how transportation, crime, and neighborhood factors shape care access in Los Angeles. Together, they drive innovative strategies to strengthen engagement and outcomes for people living with HIV.

 

Project Title: The impact of a culturally adapted stigma-reduction intervention on mental health and care engagement

Awardee: Wei-Ti Chen, PhD

Project Abstract: This project evaluates the impact of a spiritually grounded, compassion-based intervention on mental health and HIV care engagement among adults living with HIV. The primary aim is to generate evidence to inform innovative, adaptable strategies for reducing stigma and improving outcomes among people living with HIV (PLWH) in the United States. HIV-related stigma—manifested as negative societal attitudes and internalized shame—remains a major barrier to mental health, social support, and treatment adherence, especially within marginalized communities. The intervention integrates mindfulness, nonattachment, and self-compassion, drawing from cognitive-behavioral frameworks and culturally-informed practices. Participants are randomized to an enhanced treatment group or a standard care group. The enhanced group receives four weekly, facilitator-led sessions focused on coping with stigma and building peer support. Outcomes assessed include depressive symptoms, anxiety, antiretroviral therapy adherence, and viral load. Mediators such as internalized stigma, self-compassion, and perceived social support are measured at multiple time points. Generalized Estimating Equations (GEE) will compare changes over time between groups, controlling for demographics and baseline stigma, and mediation analyses will test whether improvements in these mediators account for better mental health and care engagement.

 

Project Title: Integrating Predictive Modeling and Evidence Synthesis to Improve Care for Individuals with Co-occurring HIV, SUD, and MHD

Awardee: Huyen Pham, PhD

Project Abstract: People with HIV (PWH) often experience co-occurring mental health disorders (MHD) and substance use disorders (SUD), which negatively impact HIV treatment outcomes. Integrated care models are essential but remain poorly understood. This study has two aims: (1) to conduct a scoping review of integrated care models for individuals with HIV and co-occurring SUD/MHD, and (2) to use machine learning (ML) to predict SUD/MHD comorbidity, treatment utilization, and identify key drivers of treatment utilization among PWH, using 2010–2019 National Survey on Drug Use and Health (NSDUH) data. The first aim will follow Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping review (PRISMAScR) framework, drawing from electronic databases and focusing on studies published between 2015 and 2024. Integrated care models will be characterized by setting, provider type, services offered, and evaluation metrics (e.g., accessibility, effectiveness, quality, cost). Additionally, patient characteristics associated with positive outcomes will be identified. For the second aim, the study will analyze data from 409,521 adult respondents from NSDUH data, including 702 individuals who self-reported an HIV diagnosis (representing a weighted estimate of 488,000 annually). Key drivers of SUD/MHD comorbidity and treatment utilization among individuals with HIV and co-occurring SUD and/or MHD will be identified. Findings from this project will improve understanding of integrated care strategies and inform healthcare policy to better address service needs and treatment engagement among individuals with comorbid HIV, SUD, and/or MHD.

 

Project Title: Transportation Vulnerability & HIV Care Engagement in Los Angeles County

Awardee: Beimnet Taye, MPH

Project Abstract: Although effective treatment and testing options exist for HIV care, people still face issues in fully utilizing these care options. External neighborhood level factors such as crime prevalence, public transportation access, and traffic congestion could all affect a person living with HIV’s ability and willingness to seek HIV care by impacting their ability to commute to and from HIV clinics and pharmacies. In Los Angeles County these factors vary significantly between neighborhoods. Thus, this project provides an opportunity to explore how these factors at the census tract level are associated with individual HIV care engagement and how these factors affecting residential mobility modify the association between individual behaviors such as frequency of substance use and care engagement among a cohort of men who are living with HIV (The mSTUDY). By linking publicly available crime and arrest data from the Los Angeles Sheriff and Police departments, Public transport stops density data, and daily average traffic data to the individual level cohort data by census tract of residence we can leverage hierarchal mixed models to quantify cross level associations and interactions with HIV related appointment adherence and viral suppression (≤ 200 copies/mL) among those living with HIV. Quantifying these relationships will not only identify important residential based issues facing this population in Los Angeles, but can also inform future specifically tailored interventions for this population that can attempt to ameliorate these issues and better HIV care engagement for all.

CDC Recommends New Injectable HIV PrEP

This content originally appeared on CDC.gov. View the article here.

Dear Colleague,

Today, CDC published new Clinical Recommendations for twice-a-year injectable lenacapavir as an additional option for HIV prevention in the United States. The U.S. Food and Drug Administration approved injectable lenacapavir, a prescribed medication, for HIV pre-exposure prophylaxis (PrEP) in June 2025. This is a significant step forward in expanding prevention options and reflects decades of research, partnership, and commitment to ending the HIV epidemic.

CDC has reviewed and graded the evidence on lenacapavir as PrEP from two clinical trials, which demonstrated strong efficacy in preventing HIV infection among both females and males and found no serious safety concerns. On the basis of a high certainty of evidence for its efficacy and safety derived from the agency’s analysis, CDC strongly recommends lenacapavir, administered every six months as a subcutaneous injection, for HIV PrEP in all people weighing at least 35 kg who would benefit.

The Clinical Recommendations for lenacapavir are an addition to CDC’s current Clinical Guidance for PrEP which also recommends daily oral pills or injectable cabotegravir, which is administered every two months. All FDA-approved PrEP options are highly effective in preventing HIV when taken as prescribed.

CDC recommends health care providers inform all sexually active adults and adolescents about proven options for PrEP and prescribe PrEP to anyone who requests it. The addition of lenacapavir provides another powerful option in HIV prevention. Because lenacapavir only needs to be administered every six months, it may help some people overcome challenges with adherence or more regular health care visits associated with other existing PrEP options.

This milestone would not have been possible without the tireless efforts of our partners — federal, academic, community-based, and clinical — who lead and help generate the evidence-based research and programs.

According to the most recent CDC estimates, more than 31,000 people acquire HIV in the United States each year. The FDA approved the first HIV PrEP in 2012, and PrEP has become a vital part of U.S. HIV prevention efforts. Combined with HIV testing and effective treatment, PrEP has contributed to significant reductions in new HIV infections. Reaching people with more options for PrEP, including lenacapavir, will further strengthen national efforts and accelerate progress toward ending the HIV epidemic.

CDC estimates 2.2 million Americans could benefit from PrEP and is currently working to update estimates of current PrEP coverage in the United States. Thank you for helping us raise the visibility of this new prevention option as we continue to work together to maximize the impact of all available strategies for preventing HIV.

Sincerely,
/Robyn Fanfair/
Robyn Neblett Fanfair, MD, MPH
Captain, USPHS
Director
Division of HIV Prevention
National Center for HIV, Viral Hepatitis, STD, and TB Prevention
Centers for Disease Control and Prevention

UNAIDS welcomes US announcement to expand access to medicine to prevent HIV and urges greater global ambition to reach all in need

This content originally appeared on UNAIDS.org. View the press release here.

GENEVA, 5 September 2025 – UNAIDS welcomes the announcement by the US State Department that the President’s Emergency Plan for AIDS Relief (PEPFAR) will be supporting an initiative by the Global Fund to Fight AIDS, TB and Malaria to provide lenacapavir to up to 2 million people in countries with high burdens of HIV.

Lenacapavir, an American-based innovation, is one of the most promising new HIV prevention tools that has emerged in the HIV response, offering protection against HIV with just twice-yearly injections. The breakthrough medicine will save thousands of lives if made widely available for all people and populations at risk of HIV including young women and adolescent girls as well as sex workers, people who inject drugs, and men who have sex with men in high burden countries and geographies.

“This deal offers hope that many more people around the world who are at risk of HIV will have access to this revolutionary HIV medicine. More global work will be needed to increase scale and rapidly make lenacapavir available, affordable and accessible in all low and middle-income countries. But at this critical moment, the United States’ backing of this breakthrough medicine is an important signal to the world that by investing in the HIV response we can stop new infections,” said Winnie Byanyima, Executive Director of UNAIDS.

An initial roll-out of 2 million is an important start toward a broader ambition and i t is important that lenacapavir be available to all people in need, not only to some. UNAIDS estimates that 20 million people will need to be reached with antiretroviral-based prevention such as lenacapavir as part of efforts to achieve the 2030 global HIV prevention targets. UNAIDS also estimates that for every US$ 1 invested in HIV prevention, US$ 7 will be saved in treatment and care costs later.

The price for lenacapavir in France, Norway, Spain and the United States in late 2024 exceeded US$ 28 000 per person per year. For this initiative, manufacturer Gilead has pledged to supply the medicine at no profit. Research published earlier this year showed that lenacapavir can be made and sold for just US$ 40 per person per year, falling to US$ 25 with sufficient scale.

To successfully expand access to lenacapavir, community engagement will be essential. To advance progress in the roll-out, populations most impacted by HIV must play a central role in its delivery and people most at risk of HIV must have access.

UNAIDS will continue to support countries and partners in driving the response to HIV forward to ensure that everyone, everywhere has access to the HIV services they need and that AIDS is ended as a public health threat by 2030.

Yeztugo is Now the First and Only FDA-Approved HIV Prevention Option Offering 6 Months of Protection

This content originally appeared on Gilead.com. View the full article here.

Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Yeztugo (lenacapavir)—the company’s injectable HIV-1 capsid inhibitor—as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg, making it the first and only twice-yearly option available in the United States for people who need or want PrEP. Data show that ≥99.9% of participants who received Yeztugo in the Phase 3 PURPOSE 1 and PURPOSE 2 trials remained HIV negative.

“This is a historic day in the decades-long fight against HIV. Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences. “This is a medicine that only needs to be given twice a year and has shown remarkable outcomes in clinical studies, which means it could transform HIV prevention. Gilead scientists have made it their life’s work to end HIV and now, with the FDA approval of Yeztugo and in collaboration with our many partners, we can help to make that goal a reality.”

The first PrEP medication, which was also developed by Gilead, was approved in the U.S. in 2012. However, data from the Centers for Disease Control and Prevention (CDC) show that, in 2022 (the most recent year with available data), only about 1 in 3 (36%) people in the U.S. who met the CDC’s eligibility criteria for PrEP were prescribed a form of PrEP. CDC data show that all populations in the U.S. are not yet using PrEP at rates that could end transmission of the virus at the population level, with particular gaps for women, Black/African American and Hispanic/Latino people, and people in the U.S. South. Data also show that barriers including adherence challenges, stigma and low awareness of existing PrEP options—by both healthcare providers and consumers—contribute to this low uptake of PrEP across multiple populations. The potential impact of this limited uptake, adherence and access is underscored by the fact that, in 2023, more than 100 people were diagnosed with HIV every day in the U.S.

“Yeztugo could be the transformative PrEP option we’ve been waiting for—offering the potential to boost PrEP uptake and persistence and adding a powerful new tool in our mission to end the HIV epidemic,” said Carlos del Rio, MD, Distinguished Professor of Medicine in the Division of Infectious Diseases at Emory University School of Medicine and Co-Director of the Emory Center for AIDS Research in Atlanta. “A twice-yearly injection could greatly address key barriers like adherence and stigma, which individuals on more frequent PrEP dosing regimens, especially daily oral PrEP, can face. We also know that, in research, many people who need or want PrEP preferred less frequent dosing.”

Access the full article on the Gilead Sciences, Inc website: Yeztugo Lenacapavir Is Now the First and Only FDA Approved HIV Prevention Option Offering 6 Months of Protection

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