HIV Treatment
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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.
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.
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.
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.
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.
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.
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.
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.
HIV Pre-Exposure Prophylaxis (PrEP)
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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.
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.
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.
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.
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.
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.
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).
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.
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:
- HIV-positive subjects with undetectable viral loads on a TDF/FTC-based regimen,
- healthy HIV-negative subjects who received a single dose of TDF/FTC, and
- HIV-negative subjects receiving daily TDF/FTC as PrEP for 24 weeks
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.
Mental Health
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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.
Authors: Michael Grandner, PhD, Subhajit Chakravorty, MD, Michael Perlis, PhD, Linden Lalley-Chareczko, MA, Indira Gurubhagavatula, M.D., MPH
Description: Self-reported short or long sleep duration has been associated with adverse cardiometabolic health outcomes in laboratory and epidemiologic studies, but interpretation of such data has been limited by methodologic issues.
Authors: Linden Lalley-Chareczko, MA, Andrea Segal, MS, Michael Perlis, PhD, Sara Nowakowski, PhD, Joshua Z. Tai, MS, Michael Grandner, PhD
Description: Intimate partner violence (IPV) is a worldwide health concern and an important risk factor for poor mental/physical health in both women and men. Little is known about whether IPV leads to sleep disturbance. However, sleep problems may be common in the context of IPV and may mediate relationships with mental/physical health. Data from the 2006 Behavioral Risk Factor Surveillance System (BRFSS) were used (N = 34,975).
Authors: Subhajit Chakravorty, MD, H.Y. Siu, Linden Lalley-Chareczko, MA, Gregory Brown, PhD, James Findley, PhD, DBSM, FAASM, Michael Perlis, PhD, Michael Grandner, PhD
Description: The present study used a nationally representative sample to examine the association of suicidal ideation with extreme sleep durations and insomnia symptoms. Cross-sectional data from adult respondents (≥ 18 years of age, N = 6,228) were extracted from the 2007-2008 wave of the National Health and Nutritional Examination Survey.