FIGHT Research Publications

HIV Treatment

Changes in Body Mass Index Associated with Antiretroviral Regimen Switch Among Treatment-Experienced, Virologically Suppressed People Living with HIV in the United States

Authors: Karam Mounzer, Laurence Brunet, Ricky Hsu, Jennifer Fusco, Vani Vannappagari, Cassidy Henegar, Jean van Wyk, Melissa Crawford, Janet Lo, Gregory Fusco

Description: With obesity on the rise among people living with HIV (PLWH), there is growing concern that weight gain may result as an undesired effect of antiretroviral therapy (ART). This analysis sought to assess the association between ART regimens and changes in body mass index (BMI) among ART-experienced, virologically suppressed PLWH. ART-experienced, virologically suppressed PLWH ‡18 years of age in the Observational Pharmacoepidemiology Research and Analysis (OPERA) cohort were included for analysis if prescribed a new regimen containing one of the following core agents: dolutegravir (DTG), elvitegravir/cobicistat (EVG/c), raltegravir (RAL), rilpivirine (RPV), or boosted darunavir (bDRV), for the first time between August 1, 2013 and December 31, 2017.

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Preliminary Acceptability of a Home-Based Peripheral Blood Collection Device for Viral Load Testing in the Context of Analytical Treatment Interruptions in HIV Cure Trials: Results from a Nationwide Survey in the United States

Authors: Karine Dubé, Shadi Eskaf, Elizabeth Hastie, Harsh Agarwal, Laney Henley, Christopher Roebuck, William B. Carter, Lynda Dee, Jeff Taylor, Derrick Mapp, Danielle M. Campbell, Thomas J. Villa, Beth Peterson, Kenneth M. Lynn, Linden Lalley-Chareczko, Emily Hiserodt, Sukyung Kim, Daniel Rosenbloom, Brad R. Evans, Melanie Anderson, Daria J. Hazuda, Lisa Shipley, Kevin Bateman, Bonnie J. Howell, Karam Mounzer, Pablo Tebas, Luis J. Montaner

Description: Frequent viral load testing is necessary during analytical treatment interruptions (ATIs) in HIV cure-directed clinical trials, though such may be burdensome and inconvenient to trial participants. We implemented a national, cross-sectional survey in the United States to examine the acceptability of a novel home-based peripheral blood collection device for HIV viral load testing. Between June and August 2021, we distributed an online survey to people with HIV (PWH) and community members, biomedical HIV cure researchers and HIV care providers. We performed descriptive analyses to summarize the results.

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We are looking at the future right now: community acceptability of a home-based viral load test device in the context of HIV cure-related research with analytical treatment interruptions in the United States

Authors: Karine Dubé, John Kanazawa, Christopher Roebuck, Steven Johnson, William B. Carter, Lynda Dee, Beth Peterson, Kenneth M. Lynn, Linden Lalley- Chareczko, Emily Hiserodt, Sukyung Kim, Daniel Rosenbloom, Brad R. Evans, Melanie Anderson, Daria J. Hazuda, Lisa Shipley, Kevin Bateman, Bonnie J. Howell, Karam Mounzer, Pablo Tebas & Luis J. Montaner

Description: People with HIV (PWH) and community members have advocated for the development of a home-based viral load test device that could make analytical treatment interruptions (ATIs) less burdensome. We assessed community acceptability of a novel home-based viral load test device. In 2021, we conducted 15 interviews and 3 virtual focus groups with PWH involved in HIV cure research. We used conventional thematic analysis to analyze the data.

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NK Response Correlates with HIV Decrease in Pegylated IFN-α2a-Treated Antiretroviral Therapy-Suppressed Subjects

Authors: Emmanouli Papasavvas, Livio Azzoni, MD, PhD, AV Kossenkov, N Dawany, KH Morales, M Fair, BN Ross, Kenneth Lynn, A Mackiewicz, Karam Mounzer, MD, Pablo Tebas, MD, JM Jacobson, Jay Kostman, MD, L Showe, Luis J Montaner, DVM, DPhil

Description: We previously reported that pegylated IFN-α2a (Peg-IFN-α2a) added to antiretroviral therapy (ART)-suppressed, HIV-infected subjects resulted in plasma HIV control and integrated HIV DNA decrease. We now evaluated whether innate NK cell activity or PBMC transcriptional profiles were associated with decreases in HIV measures.

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Placebo-controlled randomized clinical trial testing the efficacy and safety of varenicline for smokers with HIV

Authors: RL Ashare, M Thompson, K Serrano, F Leone, David Metzger, Ian Frank, Robert Gross, A Hole, Karam Mounzer, RG Collman , EP Wileyto, R Schnoll

Description: People living with HIV/AIDS (PLWH) smoke tobacco at higher rates and have more difficulty quitting than the general population, which contributes to significant life-years lost. The effectiveness of varenicline, one of the most effective tobacco dependence treatments, is understudied in HIV. We evaluated the safety and efficacy of varenicline for smoking cessation among PLWH.

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Plasma and antibody glycomic biomarkers of time to HIV rebound and viral setpoint

Authors: LB Giron, Emmanouli Papasavvas, Livio Azzoni, MD, PhD, X Yin, A Anzurez, M Damra, Karam Mounzer, Jay Kostman, I Sanne, C Firnhaber, H Tateno, Q Liu, Luis J Montaner, Mohamed Abdel-Mohsen

Description: HIV cure research urgently needs to identify pre-Analytic Treatment Interruption (ATI) biomarkers of time-to-viral-rebound and viral setpoint to mitigate the risk of ATI and accelerate development of a cure. We previously reported that galactosylated IgG glycans, G2, negatively correlate with cell-associated HIV DNA and RNA during antiretroviral therapy (ART). We hypothesized that this and other plasma glycomic traits can predict time-to-viral-rebound and viral setpoint upon ART cessation.

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Real-world efficacy of direct acting antiviral therapies in patients with HIV/HCV

Authors: S Patel, D Jayaweera, K Althoff , JJ Eron, J Radtchenko, Anthony Mills, Graeme Moyle, S Santiago, Paul Sax, J Gillman, Karam Mounzer, Richard Elion, GD Huhn

Description: The advent of direct-acting antiviral (DAA) therapies has dramatically transformed HCV treatment, with most recent trials demonstrating high efficacy rates (>90%) across all genotypes and special populations, including patients with HIV/HCV coinfection. The efficacy rates of HCV treatment are nearly identical between patients with HCV monofection and patients with HIV/HCV coinfection; however, there are limited studies to compare real-world efficacy with efficacy observed in clinical trials.

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Validation of the Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) chronic kidney disease risk score in HIV-infected patients in the USA

Authors: AM Mills, KL Schulman, Jennifer Fusco, Laurence Brunet, R Hsu, A Beyer, G Prajapati, Karam Mounzer, Gregory Fusco

Description: The aim of the study was to assess the validity of an easy-to-calculate chronic kidney disease (CKD) risk score developed by the Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) group in a longitudinal observational study of people living with HIV (PLWH) in the USA.

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HIV Pre-Exposure Prophylaxis (PrEP)

Are We Hitting the Target? HIV Pre-Exposure Prophylaxis from 2012 to 2020 in the OPERA Cohort

Authors: Karam C. Mounzer, MD, Jennifer S. Fusco, BS, Ricky K. Hsu, MD, Laurence Brunet, PhD, Vani Vannappagari, MBBS, MPH, PhD, Kevin R. Frost, Mark S. Shaefer, PharmD, Alex Rinehart, PhD, Keith Rawlings, MD, Gregory P. Fusco, MD, MPH

Description: Preventing HIV transmission is a crucial step in ending the HIV epidemic. Safe and effective pre-exposure prophylaxis (PrEP) has been available in the United States since 2012. We set out to determine if persons at greatest risk for HIV acquisition were receiving HIV PrEP. HIV-negative individuals from the Observational Pharmaco-Epidemiology Research & Analysis (OPERA) cohort who were prescribed daily PrEP were contrasted with newly diagnosed HIV persons without PrEP use between July 16, 2012 and October 31, 2020 to determine if the PrEP prescriptions reached the populations who were seroconverting.

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Urine Assay to Measure Tenofovir Concentrations in Patients Taking Tenofovir Alafenamide

Authors: Linden Lalley-Chareczko, M.A., Emily Hiserodt, M.P.H., Ganesh Moorthy, PhD, Athena Zuppa, MD M.S.C.E., Karam Mounzer, MD, Helen Koenig, MD, M.P.H.

Description: This study describes the ability for an existing tenofovir assay to quantify tenofovir after TAF dosing. 

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Barriers and Facilitators of PrEP Adherence for Young Men and Transgender Women of Color

Authors: Sarah Wood, M.D., M.S.H.P Robert Gross, M.D., M.S.C.E., Judy A. Shea, José A. Bauermeister, M.P.H., Ph.D., Joshua Franklin, Danielle Petsis, M.P.H., Meghan Swyryn, Linden Lalley-Chareczko, M.A., Helen C. Koenig, M.D., M.P.H., Nadia Dowshen, M.D., M.S.H.P.

Description: We aimed to discover barriers and facilitators of HIV pre-exposure prophylaxis (PrEP) adherence in young men and transgender women of color who have sex with men (YMSM/TW). Short-term and sustained adherence were measured by urine tenofovir concentration and pharmacy refills, respectively.

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Challenges to PrEP use and perceptions of urine tenofovir adherence monitoring reported by individuals on PrEP

Authors: Travis Hunt, Linden Lalley-Chareczko, MA, Giffin Daughtridge, Meghan Swyryn & Helen Koenig, MD, MPH

Description: Maximizing the impact of HIV pre-exposure prophylaxis (PrEP) requires optimizing access and adherence for those at risk of contracting HIV. This study examined challenges to the processes of accessing and adhering to PrEP encountered by participants from a large, U.S. urban clinical center and assessed the utility of objectively monitoring PrEP adherence via urine.

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A case study of chewed Truvada® for PrEP maintaining protective drug levels as measured by a novel urine tenofovir assay

Authors: Linden Lalley-Chareczko, MA, Devon Clark, Athena Zuppa, MD, MSCE, Ganesh Moorthy, PhD, Caitlin Conyngham, Karam Mounzer, MD, Helen Koenig, MD, MPH

Description: A 22-year-old male reported difficulty swallowing FTC/TDF for PrEP and subsequently began chewing the FTC/TDF tablets. Monthly urine samples assessed using liquid chromatography-tandem mass spectrometry (LC-MS/MS) indicated tenofovir levels >1,000 ng/ml, indicative of protection from HIV acquisition, over a 48-week period.

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Delivery of TDF/FTC for pre-exposure prophylaxis to prevent HIV-1 acquisition in young adult men who have sex with men and transgender women of color using a urine adherence assay

Authors: Linden Lalley-Chareczko, MA, Devon Clark, Caitlin Conyngham, Athena Zuppa, MD, MSCE, Ganesh Moorthy, PhD, Karam Mounzer, MD, Helen Koenig, MD, MPH

Description: PrEP was administered to 50 young men who have sex with men and transgender women of color using weekly, biweekly, and/or monthly dispensation schedules. Primary objectives were retention at 48 weeks (in care at week 48 and completing ≥50% of medication pickups) and adherence assessed by urine tenofovir levels. Risk behaviors and sexually transmitted infection diagnoses were also collected.

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Social Support Networks among Young Men and Transgender Women of Color Receiving HIV Pre-Exposure Prophylaxis

Authors: Sarah Wood, M.D., M.S.H.P., Nadia Dowshen, M.D., M.S.H.P., José A. Bauermeister, M.P.H., Ph.D., Linden Lalley-Chareczko, M.A., Joshua Franklin, Danielle Petsis, M.P.H., Meghan Swyryn, Kezia Barnett, M.P.H., Gary E. Weissman, M.D., M.S.H.P., Helen C. Koenig, M.D., M.P.H., Robert Gross, M.D., M.S.C.E.

Description: The aim of the study was to characterize perceived social support for young men and transgender women who have sex with men (YM/TWSM) taking HIV pre-exposure prophylaxis (PrEP).

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Tenofovir urine assay to monitor adherence to HIV pre-exposure prophylaxis (PrEP)

Authors: Ganesh Moorthy, PhD, Linden Lalley-Chareczko, MA, Helen Koenig, MD, MPH, Athena Zuppa, MD, MSCE

Description: Tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF) are prodrugs of tenofovir and have excellent long-term efficacy and tolerability for the treatment of HIV. An objective marker of adherence to tenofovir-based therapy could be clinically useful in supporting adherence to TDF-based HIV pre-exposure prophylaxis (PrEP) in populations in whom self-report has been shown to be unreliable, and could play a role in resource-limited settings to support HIV and hepatitis B treatment adherence.

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Urine assay for tenofovir to monitor adherence in real time to tenofovir disoproxil fumarate/emtricitabine as pre-exposure prophylaxis

Authors: Helen Koenig, MD, MPH, Karam Mounzer, MD, Giffin Daughtridge, Caroline Sloan, Linden Lalley-Chareczko, MA, Ganesh Moorthy, PhD, Caitlin Conyngham, Athena Zuppa, MD, Luis Montaner, DVM, DPhil, Pablo Tebas, MD

Description: We developed a urine assay using high-performance liquid chromatography coupled to tandem mass spectrometry with high sensitivity/specificity for TFV that allowed us to determine TFV concentrations in log10 categories between 0 and 10 000 ng/mL. We validated the assay in three cohorts:

  1. HIV-positive subjects with undetectable viral loads on a TDF/FTC-based regimen,
  2. healthy HIV-negative subjects who received a single dose of TDF/FTC, and
  3. HIV-negative subjects receiving daily TDF/FTC as PrEP for 24 weeks

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Why do HIV PrEP Patients Become Lost-to-Care and How Can We Improve PrEP Retention?

Authors: Sahana Jayaraman, Linden Lalley-Chareczko, MA, Sarah Williams, Devon Clark, Caitlin Conyngham, and Helen C. Koenig, MD, MPH

Description: Objectives: to assess reasons for patients being lost-to-care (LTC) at an urban health center (Philadelphia, PA, USA) that provides access to oral tenofovir/emtricitabine(TDF/FTC) as pre-exposure prophylaxis(PrEP) to patients ages 13-30 years through a drop-in model of care.

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Mental Health

Correlation of PrEP Adherence to a Mental Health Diagnosis or Experience of Childhood Trauma in High-Risk Young Adults

Authors: Lindsay Young, Linden Lalley-Chareczko, MA, Devon Clark, Michael Ramos, Rachel Nahan, Gregory Troutman, Rose Cantor, Lane DiFlavis, Helen Koenig, MD, MPH

Description: This is a cross-sectional analysis assessing prevalence and experience of mental health disorders and ACEs among YMSMc receiving PrEP. Additionally, this study sought to explore associations between mental health symptoms and ACE history and adherence as measured by urine tenofovir (TFV) testing.

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