CROI 2024 Abstract eBook

Abstract eBook

Invited Session

highly effective STI prevention tool while minimizing potential risks will require a multi-pronged, equity-centered implementation strategy. The US Centers for Disease Control and Prevention draft doxy-PEP guidelines give a grade 1A recommendation for doxy-PEP for MSM and TGW with a history of an STI in the past year. Other national, state and local health jurisdictions have released guidance with broader or more limited eligibility for the use of doxy-PEP. Key implementation considerations include: Who should be offered doxy-PEP and in what settings? What counseling should be provided to individuals receiving doxy-PEP? How can doxy-PEP uptake, adherence and persistence be maximized across age and racial/ethnic groups? What training and tools do providers need to integrate doxy-PEP into their practice? What is the risk of antimicrobial resistance in STI and non-STI pathogens with longer-term use of doxy-PEP, and how should this be monitored? How can the effect of doxy-PEP on STI incidence be monitored and how success can be measured? What are the findings to date in terms of the uptake and impact of doxy-PEP in early adopter cities? In this symposium, we will review these key questions, highlight areas of controversy across existing doxy-PEP guidelines, and discuss the available evidence on doxy-PEP implementation outside of the clinical trial setting. Background: Globally, over 110 million people have been forcibly displaced from their homes due to various factors such as conflict, violence, persecution, and human rights abuses. Displaced people, especially women and children face a heightened risk of sexual violence, exploitation, and trafficking exposing them to increased health risks including exposure to HIV infection. Many face discrimination and stigma. Addressing HIV in these contexts is not only a protection and human rights issue but also a public health priority. The End of Oral? How Long-Acting Formulations Are Changing the Management of Infectious Diseases Charles W Flexner The Johns Hopkins University, Baltimore, MD, USA Background: Despite having near-perfect single tablet regimens, adherence to daily oral HIV treatment and prevention is unacceptably low in many settings. Long-acting and extended-release drugs and formulations hold promise for solving this problem and improving outcomes, facilitating the achievement of WHO targets for controlling this epidemic. The first LA/ER formulations for HIV treatment and prevention are now approved and available but are underutilized in LMICs, mainly because of access issues. There is a need for products with less frequent dosing, greater patient convenience, and reduced risk of virologic failure, as well as regimens that also suppress hepatitis B virus infection. Novel products must be accessible in resource-limited settings and for vulnerable populations that include children, adolescents, and pregnant women. Long-acting drug delivery also has the potential to transform the treatment and prevention of other infections including tuberculosis, malaria, and viral hepatitis. This presentation will review recent advances in formulation science that are going to help make available better replacements for daily oral drugs for HIV and many other infectious diseases. Diagnostics 4 0: The Future of Diagnostics for HIV and Related Infections Nitika P Pai McGill University, Montreal, Canada Background: Overview Since the late 1980s, novel HIV screening and diagnostic technologies have led the way in the field of HIV/STBBIs and changed the landscape of diagnostics in Infectious Diseases. Global interest and awareness of timely testing have translated to an enhanced momentum for developing and growing novel testing technologies and related strategies. Multiplexed (nucleic acid amplification) based next-generation sequencing for HIV/STBBI, "omics," and CRISP-R-based technologies are here to stay. Together with connected digital solutions (Apps, machine learning, platforms, wearables), diagnostic technologies have the potential to impact health care through expanded access and precision diagnostics. Home-based testing for HIV, HCV, syphilis, and CT, GC, and HPV self-sampling strategies offer tremendous potential to enhance service delivery in diverse settings, from clinics to communities to homes. In parallel, digital and machine learning technologies are growing exponentially, offering tremendous opportunities for integration and efficiency with data-driven decisions. We will discuss these technologies' role in catalyzing digital health transformation as it Overview of the Global Displacement Crisis Mesfin T Tessema International Rescue Committee, New York, New York

be a critical component to long-term, off-treatment HBV control. Therefore, immunological adjuvants such as IFN-α, therapeutic vaccines, checkpoint inhibitors, and innate immunomodulators are being/will be combined with novel direct acting antivirals (DAAs) to try and increase the durability of cure. Whether immunomodulation will be a requirement for durable cure, or endogenous immunity will be sufficient, is likely to be patient/cohort specific. This presentation will look at immune correlates of viral control, clinical trials where immunomodulation enhances functional cure rates, and immunological questions that need to be addressed in DAA therapies. How New WHO Guidance Can Transform Hepatitis B in Sub-Saharan Africa Olufunmilayo Lesi World Health Organization, Geneva, Switzerland Background: The presentation will provide the latest epidemiology of HBV in sub-Saharan Africa (including Hepatitis delta) and highlight the unique consideration and status of elimination (and comparison to other regions); recent evidence related to reducing new infection (HB PMTCT); strategies for transforming the HBV public health response; and highlights from the updated 2024 WHO guidelines for hepatitis B treatment and care. Background: New strategies are needed to address persistently increasing rates of bacterial sexually transmitted infections (STI). Recent trials demonstrate that doxycycline post-exposure prophylaxis (doxy-PEP) significantly reduces the risk of chlamydia, syphilis, and gonorrhea in cisgender men and transgender women who have sex with men. One study found doxy-PEP did not reduce risk for STI in cisgender women, potentially due to low adherence to the intervention in the trial. Despite its potential benefits for STI risk reduction in some populations, several potential implications of doxy-PEP in the near and longer term merit consideration. This presentation will review current evidence to frame the knowns and unknowns about doxy-PEP, highlight the range of doxy-PEP guidance and position statements, discuss the basis for concerns about antimicrobial resistance, and introduce future considerations for implementation to maximize benefit and minimize harms related to doxy-PEP use. Background: Increased rates of bacterial sexually transmitted infections (STIs) are reported among men who have sex with men (MSM), particularly among those using HIV pre-exposure prophylaxis (PrEP). Interventions to reduce the incidence of STIs are needed. In the field of STI prevention using doxycycline on-demand post-exposure prophylaxis (PEPdoxy), we are witnessing significant advances. Three large-scale randomized clinical trials (ANRS Ipergay, ANRS Doxyvac trial, DoxyPEP) have demonstrated a reduction of more than two thirds in the incidence of bacterial STIs among MSM, notably for Chlamydiae trachomatis (CT) and Treponema pallidum (TP) infections, thanks to PEPdoxy. However, efficacy against Neisseria gonorrhoeae (GC) varies according to tetracycline resistance rates within populations, with Europe showing higher resistance rates than the US. This approach raises two major concerns: (i) the potential emergence of antimicrobial resistance, mainly to tetracycline, in pathogens responsible for STIs, as already observed for GC, which could worsen, or a new acquisition of resistance for CT and TP which has never been described, and (ii) the impact of doxy-PEP on the composition of the various microbiota and the pathogens present in these flora, in particular for Escherichia coli and Staphylococcus aureus. This presentation will give an overview of the available data on the impact of doxy-PEP strategies on the microbiota and the molecular mechanism conferring resistance. These studies on the microbiome and antimicrobial resistance surveillance for bacterial STIs should be continued over time to fully assess the impact of this strategy. DoxyPEP: Should We Worry About Antimicrobial Resistance? Beatrice Bercot St Louis Hospital, APHP, University Paris City, Paris, France Implementation of DoxyPEP: Challenges and Opportunities Stephanie E Cohen San Francisco Department of Public Health, San Francisco, CA, USA Background: Doxycycline post-exposure prophylaxis (doxy-PEP) is highly effective in reducing bacterial STIs among men who have sex with men (MSM) and transgender women (TGW). Optimizing the public health impact of this Introduction to DoxyPEP: Understanding the Issues Chase Cannon University of Washington, Seattle, WA, USA

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CROI 2024