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8. Remdesivir for Treatment of COVID-19 Requiring Oxygen Support: A Cross-Study Comparison From 2 Large, Open-Label Studies.

Author

Fusco, Dahlene, Malenica, Ivana, Günthard, Huldrych F, Gupta, Samir K, Kurbegov, Dax, Balani, Bindu, Olender, Susan, Aberg, Judith A, Telep, Laura E, Tian, Yuan, Blair, Christiana, Wu, George, Haubrich, Richard H, Wang, Chen-Yu, Chokkalingam, Anand P, Osinusi, Anu O, Wendtner, Clemens-Martin, and Gottlieb, Robert L

Subjects
CROSS-sectional method, OXYGEN saturation, MEDICAL quality control, RESEARCH funding, OXYGEN therapy, HOSPITAL care, DISCHARGE planning, RETROSPECTIVE studies, DESCRIPTIVE statistics, ANTIVIRAL agents, COMPARATIVE studies, CONFIDENCE intervals, LENGTH of stay in hospitals, COVID-19 pandemic, COVID-19, ADULTS
Abstract

Background Remdesivir, an RNA-polymerase prodrug inhibitor approved for treatment of coronavirus disease 2019 (COVID-19), shortens recovery time and improves clinical outcomes. This prespecified analysis compared remdesivir plus standard of care (SOC) with SOC alone in adults hospitalized with COVID-19 requiring oxygen support in the early stage of the pandemic. Methods Data for 10-day remdesivir treatment plus SOC from the extension phase of an open-label study (NCT04292899) were compared with real-world, retrospective data on SOC alone (EUPAS34303). Both studies included patients aged ≥18 years hospitalized with severe acute respiratory syndrome coronavirus 2 up to 30 May 2020, with oxygen saturation ≤94% on room air or supplemental oxygen (all forms), and with pulmonary infiltrates. Propensity score weighting was used to balance patient demographics and clinical characteristics across treatment groups. The primary endpoint was time to all-cause mortality or end of study (day 28). Time to discharge, with a 10-day landmark to account for duration of remdesivir treatment, was a secondary endpoint. Results A total of 1974 patients treated with remdesivir plus SOC, and 1426 with SOC alone, were included after weighting. Remdesivir significantly reduced mortality versus SOC (hazard ratio [HR], 0.46; 95% confidence interval,.39–.54). This association was observed at each oxygen support level, with the lowest HR for patients on low-flow oxygen. Remdesivir significantly increased the likelihood of discharge at day 28 versus SOC in the 10-day landmark analysis (HR, 1.64; 95% confidence interval: 1.43–1.87). Conclusions Remdesivir plus early-2020 SOC was associated with a 54% lower mortality risk and shorter hospital stays compared with SOC alone in patients hospitalized with COVID-19 requiring oxygen support. Clinical Trials Registration. ClinicalTrials.gov NCT04292899 and EUPAS34303. [ABSTRACT FROM AUTHOR]

Published
2024
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19. Do Walk Step Reminders Improve Physical Activity in Persons Living With HIV in New York City?--Results From a Randomized Clinical Trial.

Author

Alvarez, Gabriella, Sanabria, Gabriella, Haomiao Jia, Hwayoung Cho, Reynolds, Nancy R., Gradilla, Melissa, Olender, Susan, Mohr, David C., and Schnall, Rebecca

Abstract

Supervised physical activity can increase functional capacity in persons with HIV (PWH); however, aerobic interventions have shown little improvement in overall physical activity in PWH. In response, we sought to assess the effect of wearing a fitness tracker (FitBit) paired with walk step reminders delivered through an mHealth application to improve physical activity and decreasing body mass index among PWH in New York City. There was no significant difference in the frequency of walk steps between participants in the control group and intervention group from baseline to 6-month follow-up. These findings show that walk step reminders alone were inadequate for sustained improvement of physical activity. This study highlights the need to develop and test the comparative efficacy of physical activity interventions that are tailored to the unique needs and capabilities of PWH. Future interventions should incorporate fitness tracking with tailored interventions focused on the promotion of physical activity. [ABSTRACT FROM AUTHOR]

Published
2023
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22. Back2PrEP: Rates of Bacterial Sexually Transmitted Infection Diagnosis Among Individuals Returning to HIV Pre-Exposure Prophylaxis Care: A Retrospective Review of a New York City Comprehensive HIV Prevention Program

Author

McLean, Jacob, primary, Bartram, Logan, additional, Zucker, Jason, additional, LaSota, Elijah, additional, Carnevale, Caroline, additional, Richards, Paul, additional, Perez, Edward, additional, Mori, Kanako, additional, Mgbako, Ofole, additional, Olender, Susan, additional, Cohall, Alwyn, additional, Gordon, Peter, additional, and Sobieszczyk, Magdalena, additional

Published
2022
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25. Get2PrEP: An Electronic Medical Record Laboratory Comment Increased Safe Sex Counseling But Not Preexposure Prophylaxis Services at a Large Urban Academic Medical Center in Northern Manhattan

Author

Spicehandler, Rebecca, primary, Zucker, Jason, additional, Yumori, Caitlin, additional, Adan, Matthew, additional, Carnevale, Caroline, additional, Theodore, Deborah, additional, Castor, Delivette, additional, Meyers, Kathrine, additional, Whittier, Susan, additional, Yin, Michael T., additional, Cohall, Alwyn, additional, Olender, Susan, additional, Gordon, Peter, additional, and Sobieszczyk, Magdalena E., additional

Published
2022
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27. Lost2PrEP: Understanding Reasons for Pre-Exposure Prophylaxis and Sexual Health Care Disengagement Among Men Who Have Sex with Men Attending a Sexual Health Clinic at a Large Urban Academic Medical Center in New York City

Author

Rowe, Kelly, primary, Theodore, Deborah A., additional, Zucker, Jason, additional, Cohensedgh, Omid, additional, LaSota, Elijah, additional, Carnevale, Caroline, additional, Cohall, Alwyn, additional, Olender, Susan, additional, Gordon, Peter, additional, and Sobieszczyk, Magdalena E., additional

Published
2022
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29. Immediate ART and clinical outcomes in New York City among patients newly diagnosed with HIV.

Author

Mgbako, Ofole, Mathu, Rachel, Gonzalez Davila, Mila, Mehta, Monica, Cabrera, Joselyn, Carnevale, Caroline, Zucker, Jason, Gordon, Peter, and Olender, Susan

Subjects
EVALUATION of medical care, RELATIVE medical risk, ANTIRETROVIRAL agents, RETROSPECTIVE studies, FISHER exact test, T-test (Statistics), CONTINUUM of care, RESEARCH funding, HIV, PROPORTIONAL hazards models, SECONDARY analysis
Abstract

Immediate antiretroviral therapy (iART) has been shown to decrease time to viral suppression. Our center underwent significant practice transformation to support iART, including a same-day Open Access (OA) model and enhanced care coordination. We examined whether same-day ART at linkage was associated with favorable proximate and long-term HIV care outcomes. From 2018 to 2019, patients newly diagnosed with HIV, linked to care at our institution, and iART eligible were included. We evaluated the association between iART and time to viral suppression, and between iART and initial/sustained viral suppression and retention in care. We also evaluated the association between use of OA and frequency of care coordination with the same outcomes. Of the 107 patients included, 72 initiated same-day ART at linkage and 35 did not. There was no statistically significant differences in whether patients were ever suppressed, had sustained viral suppression, or were retained in care between those who received same-day ART and those who did not. More care coordination was associated with retention in care (RR 1.21 [1.01–1.5]; p = 0.05). Organizing vital services and ensuring implementation strategies that facilitate iART, while tailoring the approach to the patient's comfort level, is likely optimal for longitudinal HIV care engagement. [ABSTRACT FROM AUTHOR]

Published
2023
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30. Efficacy of an mHealth self-management intervention for persons living with HIV: the WiseApp randomized clinical trial.

Author

Schnall, Rebecca, Sanabria, Gabriella, Jia, Haomiao, Cho, Hwayoung, Bushover, Brady, Reynolds, Nancy R, Gradilla, Melissa, Mohr, David C, Ganzhorn, Sarah, and Olender, Susan

Abstract

Importance: Progression of HIV disease, the transmission of the disease, and premature deaths among persons living with HIV (PLWH) have been attributed foremost to poor adherence to HIV medications. mHealth tools can be used to improve antiretroviral therapy (ART) adherence in PLWH and have the potential to improve therapeutic success.Objective: To determine the efficacy of WiseApp, a user-centered design mHealth intervention to improve ART adherence and viral suppression in PLWH.Design, Setting, and Participants: A randomized (1:1) controlled efficacy trial of the WiseApp intervention arm (n = 99) versus an attention control intervention arm (n = 101) among persons living with HIV who reported poor adherence to their treatment regimen and living in New York City.Interventions: The WiseApp intervention includes the following components: testimonials of lived experiences, push-notification reminders, medication trackers, health surveys, chat rooms, and a "To-Do" list outlining tasks for the day. Both study arms also received the CleverCap pill bottle, with only the intervention group linking the pill bottle to WiseApp.Results: We found a significant improvement in ART adherence in the intervention arm compared to the attention control arm from day 1 (69.7% vs 48.3%, OR = 2.5, 95% CI 1.4-3.5, P = .002) to day 59 (51.2% vs 37.2%, OR = 1.77, 95% CI 1.0-1.6, P = .05) of the study period. From day 60 to 120, the intervention arm had higher adherence rates, but the difference was not significant. In the secondary analyses, no difference in change from baseline to 3 or 6 months between the 2 arms was observed for all secondary outcomes.Conclusions: The WiseApp intervention initially improved ART adherence but did not have a sustained effect on outcomes. [ABSTRACT FROM AUTHOR]

Published
2023
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31. Remdesivir Versus Standard-of-Care for Severe Coronavirus Disease 2019 Infection: An Analysis of 28-Day Mortality

Author

Olender, Susan A, primary, Walunas, Theresa L, additional, Martinez, Esteban, additional, Perez, Katherine K, additional, Castagna, Antonella, additional, Wang, Su, additional, Kurbegov, Dax, additional, Goyal, Parag, additional, Ripamonti, Diego, additional, Balani, Bindu, additional, De Rosa, Francesco G, additional, De Wit, Stéphane, additional, Kim, Shin-Woo, additional, Diaz, George, additional, Bruno, Raffaele, additional, Mullane, Kathleen M, additional, Lye, David Chien, additional, Gottlieb, Robert L, additional, Haubrich, Richard H, additional, Chokkalingam, Anand P, additional, Wu, George, additional, Diaz-Cuervo, Helena, additional, Brainard, Diana M, additional, Lee, I-Heng, additional, Hu, Hao, additional, Lin, Lanjia, additional, Osinusi, Anu O, additional, Bernardino, Jose I, additional, and Boffito, Marta, additional

Published
2021
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32. Attitudes and Perceived Barriers to Routine HIV Screening and Provision and Linkage of Postexposure Prophylaxis and Pre-Exposure Prophylaxis Among Graduate Medical Trainees

Author

Zucker, Jason, primary, Carnevale, Caroline, additional, Theodore, Deborah, additional, Castor, Delivette, additional, Meyers, Kathrine, additional, Gold, Jeremy, additional, Winetsky, Daniel, additional, Scherer, Matthew, additional, Cohall, Alwyn, additional, Gordon, Peter, additional, Sobieszczyk, Magdalena, additional, and Olender, Susan, additional

Published
2021
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33. Remdesivir for Severe Coronavirus Disease 2019 (COVID-19) Versus a Cohort Receiving Standard of Care

Author

Olender, Susan Aileen, Perez, Katherine K.K., Go, Alan A.S., Balani, Bindu, Price-Haywood, Eboni E.G., Shah, Nirav N.S., Wang, Su, Walunas, Theresa T.L., Swaminathan, Shobha, Slim, Jihad, Chin, Bum Sik, De Wit, Stéphane, Ali, Shamim S.M., Soriano Viladomiu, Alex, Robinson, Philip, Gottlieb, Robert R.L., Tsang, Tak Yin Owen, Lee, Heng I.H., Hu, Hao, Haubrich, Richard, Chokkalingam, Anand A.P., Lin, Lanjia, Zhong, Lijie, Bekele, Benjamin Nebiyou, Mera-Giler, Robertino, Phulpin, Chloé, Edgar, Holly, Gallant, Joel J.E., Diaz-Cuervo, Helena, Smith, Lindsey L.E., Osinusi, Anu A.O., Brainard, Diana D.M., Bernardino, José Ignacio, Olender, Susan Aileen, Perez, Katherine K.K., Go, Alan A.S., Balani, Bindu, Price-Haywood, Eboni E.G., Shah, Nirav N.S., Wang, Su, Walunas, Theresa T.L., Swaminathan, Shobha, Slim, Jihad, Chin, Bum Sik, De Wit, Stéphane, Ali, Shamim S.M., Soriano Viladomiu, Alex, Robinson, Philip, Gottlieb, Robert R.L., Tsang, Tak Yin Owen, Lee, Heng I.H., Hu, Hao, Haubrich, Richard, Chokkalingam, Anand A.P., Lin, Lanjia, Zhong, Lijie, Bekele, Benjamin Nebiyou, Mera-Giler, Robertino, Phulpin, Chloé, Edgar, Holly, Gallant, Joel J.E., Diaz-Cuervo, Helena, Smith, Lindsey L.E., Osinusi, Anu A.O., Brainard, Diana D.M., and Bernardino, José Ignacio

Abstract

BACKGROUND: We compared the efficacy of the antiviral agent, remdesivir, versus standard-of-care treatment in adults with severe coronavirus disease 2019 (COVID-19) using data from a phase 3 remdesivir trial and a retrospective cohort of patients with severe COVID-19 treated with standard of care. METHODS: GS-US-540-5773 is an ongoing phase 3, randomized, open-label trial comparing two courses of remdesivir (remdesivir-cohort). GS-US-540-5807 is an ongoing real-world, retrospective cohort study of clinical outcomes in patients receiving standard-of-care treatment (non-remdesivir-cohort). Inclusion criteria were similar between studies: patients had confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, were hospitalized, had oxygen saturation ≤94% on room air or required supplemental oxygen, and had pulmonary infiltrates. Stabilized inverse probability of treatment weighted multivariable logistic regression was used to estimate the treatment effect of remdesivir versus standard of care. The primary endpoint was the proportion of patients with recovery on day 14, dichotomized from a 7-point clinical status ordinal scale. A key secondary endpoint was mortality. RESULTS: After the inverse probability of treatment weighting procedure, 312 and 818 patients were counted in the remdesivir- and non-remdesivir-cohorts, respectively. At day 14, 74.4% of patients in the remdesivir-cohort had recovered versus 59.0% in the non-remdesivir-cohort (adjusted odds ratio [aOR] 2.03: 95% confidence interval [CI]: 1.34-3.08, P < .001). At day 14, 7.6% of patients in the remdesivir-cohort had died versus 12.5% in the non-remdesivir-cohort (aOR 0.38, 95% CI: 22-.68, P = .001). CONCLUSIONS: In this comparative analysis, by day 14, remdesivir was associated with significantly greater recovery and 62% reduced odds of death versus standard-of-care treatment in patients with severe COVID-19. CLINICAL TRIALS REGISTRATION: NCT04292899 and EUPAS34303., SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2021

34. Remdesivir Versus Standard-of-Care for Severe Coronavirus Disease 2019 Infection: An Analysis of 28-Day Mortality

Author

Olender, Susan Aileen, Walunas, Theresa T.L., Martinez, Esteban, Perez, Katherine K.K., Castagna, Antonella, Wang, Su, Kurbegov, Dax, Goyal, Parag, Ripamonti, Diego, Balani, Bindu, De Rosa, Francesco Giuseppe, De Wit, Stéphane, Kim, Shin Woo, Diaz, George, Bruno, Raffaele, Mullane, Kathleen K.M., Lye, David Chien, Gottlieb, Robert R.L., Haubrich, Richard, Chokkalingam, Anand A.P., Wu, George, Diaz-Cuervo, Helena, Brainard, Diana D.M., Lee, Heng I.H., Hu, Hao, Lin, Lanjia, Osinusi, Anu A.O., Bernardino, José Ignacio, Boffito, Marta, Olender, Susan Aileen, Walunas, Theresa T.L., Martinez, Esteban, Perez, Katherine K.K., Castagna, Antonella, Wang, Su, Kurbegov, Dax, Goyal, Parag, Ripamonti, Diego, Balani, Bindu, De Rosa, Francesco Giuseppe, De Wit, Stéphane, Kim, Shin Woo, Diaz, George, Bruno, Raffaele, Mullane, Kathleen K.M., Lye, David Chien, Gottlieb, Robert R.L., Haubrich, Richard, Chokkalingam, Anand A.P., Wu, George, Diaz-Cuervo, Helena, Brainard, Diana D.M., Lee, Heng I.H., Hu, Hao, Lin, Lanjia, Osinusi, Anu A.O., Bernardino, José Ignacio, and Boffito, Marta

Abstract

Background: Remdesivir is approved by the US Food and Drug Administration for the treatment of patients hospitalized with coronavirus disease 2019 (COVID-19) and has been shown to shorten time to recovery and improve clinical outcomes in randomized trials. Methods: This was the final day 28 comparative analysis of data from a phase 3, randomized, open-label study comparing 2 remdesivir regimens (5 vs 10 days, combined for this analysis [remdesivir cohort]) and a real-world retrospective longitudinal cohort study of patients receiving standard-of-care treatment (nonremdesivir cohort). Eligible patients, aged ≥18 years, had confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), oxygen saturation ≤94% on room air or required supplemental oxygen, with pulmonary infiltrates. Propensity score matching (up to 1:10 ratio) was used to ensure comparable populations. We assessed day 14 clinical recovery (determined using a 7-point ordinal scale) and day 28 all-cause mortality (coprimary endpoints). Results: A total of 368 (remdesivir) and 1399 (nonremdesivir) patients were included in the matched analysis. The day 14 clinical recovery rate was significantly higher among the remdesivir versus the nonremdesivir cohort (65.2% vs 57.1%; odds ratio [OR], 1.49; 95% confidence interval [CI], 1.16-1.90; P=0.002). The day 28 mortality rate was significantly lower in the remdesivir cohort versus the nonremdesivir cohort (12.0% vs 16.2%; OR, 0.67; 95% CI, 0.47-.95; P=.03). Conclusions: Remdesivir was associated with significantly higher rates of day 14 clinical recovery, and lower day 28 mortality, compared with standard-of-care treatment in hospitalized patients with COVID-19. These data, taken together, support the use of remdesivir to improve clinical recovery and decrease mortality from SARS-CoV-2 infection., SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2021

35. Attitudes and Perceived Barriers to Sexually Transmitted Infection Screening Among Graduate Medical Trainees

Author

Zucker, Jason, primary, Carnevale, Caroline, additional, Theodore, Deborah A., additional, Castor, Delivette, additional, Meyers, Kathrine, additional, Gold, Jeremy A. W., additional, Winetsky, Daniel, additional, Scherer, Matt, additional, Cohall, Alwyn, additional, Gordon, Peter, additional, Sobieszczyk, Magdalena E., additional, and Olender, Susan, additional

Published
2021
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37. Effect of Vitamin D3 and calcium carbonate supplementation on muscle strength in postmenopausal women living with HIV

Author

Yin, Michael T, primary, Bucovsky, Mariana, additional, Williams, John, additional, Brunjes, Danielle, additional, Choudhury, Arindam R, additional, Colon, Ivelisse, additional, Ferris, David C, additional, Olender, Susan, additional, Schulze, P Christian, additional, Sharma, Anjali, additional, Zeana, Cosmina, additional, Zingman, Barry, additional, and Shane, Elizabeth, additional

Published
2021
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39. Reply to Pandita et al

Author

Olender, Susan A, primary, Perez, Katherine K, additional, Chokkalingam, Anand P, additional, and Haubrich, Richard H, additional

Published
2020
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40. Women Are Less Likely to Be Tested for HIV or Offered Preexposure Prophylaxis at the Time of Sexually Transmitted Infection Diagnosis

Author

Yumori, Caitlin, primary, Zucker, Jason, additional, Theodore, Deborah, additional, Chang, Michelle, additional, Carnevale, Caroline, additional, Slowikowski, Jacek, additional, LaSota, Elijah, additional, Olender, Susan, additional, Gordon, Peter, additional, Cohall, Alwyn, additional, and Sobieszczyk, Magdalena E., additional

Published
2020
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42. The Major Genetic Determinants of HIV-1 Control Affect HLA Class I Peptide Presentation

Author

Pereyra, Florencia, Jia, Xiaoming, McLaren, Paul J., Telenti, Amalio, de Bakker, Paul I.W., Walker, Bruce D., Ripke, Stephan, Brumme, Chanson J., Pulit, Sara L, Carrington, Mary, Kadie, Carl M., Carlson, Jonathan M., Heckerman, David, Graham, Robert R., Plenge, Robert M., Deeks, Steven G., Gianniny, Lauren, Crawford, Gabriel, Sullivan, Jordan, Gonzalez, Elena, Davies, Leela, Camargo, Amy, Moore, Jamie M., Beattie, Nicole, Gupta, Supriya, Crenshaw, Andrew, Burtt, Noël P., Guiducci, Candace, Gupta, Namrata, Gao, Xiaojiang, Qi, Ying, Yuki, Yuko, Piechocka-Trocha, Alicja, Cutrell, Emily, Rosenberg, Rachel, Moss, Kristin L., Lemay, Paul, OʼLeary, Jessica, Schaefer, Todd, Verma, Pranshu, Toth, Ildiko, Block, Brian, Baker, Brett, Rothchild, Alissa, Lian, Jeffrey, Proudfoot, Jacqueline, Alvino, Marie L, Vine, Seanna, Addo, Marylyn M., Allen, Todd M., Altfeld, Marcus, Henn, Matthew R., Gall, Sylvie Le, Streeck, Hendrik, Haas, David W., Kuritzkes, Daniel R., Shafer, Robert W., Gulick, Roy M., Shikuma, Cecilia M., Haubrich, Richard, Riddler, Sharon, Sax, Paul E., Daar, Eric S., Ribaudo, Heather J., Agan, Brian, Agarwal, Shanu, Ahem, Richard L, Allen, Brady L., Altidor, Sherly, Altschuler, Eric L, Ambardar, Sujata, Anastos, Kathryn, Anderson, Ben, Anderson, Val, Andrady, Ushan, Antoniskis, Diana, Bangsberg, David, Barbaro, Daniel, Barrie, William, Bartzak, J., Barton, Simon, Basden, Patricia, Basgoz, Nesli, Bazner, Suzane, Bellos, Nicholaos C., Benson, Anne M., Berger, Judith, Bernard, Nicole F., Bemard, Annette M., Birch, Christopher, Bodner, Stanley J., Bolan, Robert K., Boudreaux, Emilie T., Bradley, Meg, Braun, James F., Brndjar, Jon E., Brown, Stephen J., Brown, Katherine, Brown, Sheldon T., Burack, Jedidiah, Bush, Larry M., Cafaro, Virginia, Campbell, Omobolaji, Campbell, John, Carlson, Robert H., Carmichael, Kevin J., Casey, Kathleen K., Cavacuiti, Chris, Celestin, Gregory, Chambers, Steven T., Chez, Nancy, Chirch, Lisa M., Cimoch, Paul J., Cohen, Daniel, Cohn, Lillian E., Conway, Brian, Cooper, David A., Cornelson, Brian, Cox, David T., Cristofano, Michael V., Cuchural, George, Jr., Czartoski, Julie L., Dahman, Joseph M., Daly, Jennifer S., Davis, Benjamin T., Davis, Kristine, Davod, Sheila M., DeJesus, Edwin, Dietz, Craig A., Dunham, Eleanor, Dunn, Michael E., Ellerin, Todd B., Eron, Joseph J., Fangman, John J.W., Farel, Claire E., Ferlazzo, Helen, Fidler, Sarah, Fleenor-Ford, Anita, Frankel, Renee, Freedberg, Kenneth A., French, Neel K., Fuchs, Jonathan D., Fuller, Jon D., Gaberman, Jonna, Gallant, Joel E., Gandhi, Rajesh T., Garcia, Efrain, Garmon, Donald, Gathe, Joseph C., Jr., Gaultier, Cyril R., Gebre, Wondwoosen, Gilman, Frank D., Gilson, Ian, Goepfert, Paul A., Gottlieb, Michael S., Goulston, Claudia, Groger, Richard K., Gurley, Douglas T., Haber, Stuart, Hardwicke, Robin, Hardy, David W., Harrigan, Richard P., Hawkins, Trevor N., Heath, Sonya, Hecht, Frederick M., Henry, Keith W., Hladek, Melissa, Hoffman, Robert P., Horton, James M., Hsu, Ricky K., Huhn, Gregory D., Hunt, Peter, Hupert, Mark J., Illeman, Mark L., Jaeger, Hans, Jellinger, Robert M., John, Mina, Johnson, Jennifer A., Johnson, Kristin L, Johnson, Heather, Johnson, Kay, Joly, Jennifer, Jordan, Wilbert C., Kauffman, Carol A., Khanlou, Homayoon, Kiltian, Robert K., Kim, Arthur Y., Kim, David D., Kinder, Clifford A., Kirchner, Jeffrey T., Kogelman, Laura, Kojic, Ema Milunka, Korthuis, Todd P., Kurisu, Wayne, Kwon, Douglas S., LaMar, Melissa, Lampiris, Harry, Lanzafame, Massimiliano, Lederman, Michael M., Lee, David M., Lee, Jean M.L, Lee, Marah J., Lee, Edward T.Y., Lemoine, Janice, Levy, Jay A., Llibre, Josep M., Liguori, Michael A., Little, Susan J., Liu, Anne Y., Lopez, Alvaro J., Loutfy, Mono R., Loy, Dawn, Mohammed, Debbie Y., Man, Alan, Mansour, Michael K., Marconi, Vincent C., Markowitz, Martin, Marques., Rui, Martin, Jeffrey N., Martin, Harold L., Jr., Mayer, Kenneth Hugh, McElrath, Juliana M., McGhee, Theresa A, McGovem, Barbara H., McGowan, Katherine, Mclntyre, Dawn, Mcleod, Gavin X., Menezes, Prema, Mesa, Greg, Metroka, Craig E., Meyer-Olson, Dirk, Miller, Andy O., Montgomery, Kate, Mounzer, Karam C., Nagami, Ellen H., Nagin, Iris, Nahass, Ronald G., Nelson, Margret O., Nielsen, Craig, Norene, David L, OʼConnor, David H., Ojikutu, Bisola O., Okulicz, Jason, Oladehin, Olakunle O., Oldfield, Edward C, III, Olender, Susan A., Ostrowski, Mario, Owen, William F., Jr., Pae, Eunice, Parsonnet, Jeffrey, Pavlatos, Andrew M., Perlmutter, Aaron M., Pierce, Michael N., Pincus, Jonathan M., Pisani, Leandro, Price, Lawrence Jay, Proia, Laurie, Prokesch, Richard C., Pujet, Heather Calderon, Ramgopal, Moti, Rathod, Almas, Rausch, Michael, Ravishankar, J., Rhame, Frank S., Richards, Constance Shamuyarira, Richman, Douglas D., Robbins, Gregory K., Rodes, Berta, Rodriguez, Milagros, Rose, Richard C., III, Rosenberg, Eric S., Rosenthal, Daniel, Ross, Polly E., Rubin, David S., Rumbaugh, Elease, Saenz, Luis, Salvaggio, Michelle R., Sanchez, William C., Sanjana, Veeraf M., Santiago, Steven, Schmidt, Wolfgang, Schuitemaker, Hanneke, Sestak, Philip M., Shalit, Peter, Shay, William, Shirvani, Vivian N., Silebi, Vanessa I., Sizemore, James M., Jr., Skolnik, Paul R., Sokol-Anderson, Marcia, Sosman, James M., Stabile, Paul, Stapleton, Jack T., Starrett, Sheree, Stein, Francine, Stellbrink, Hans-Jurgen, Sterman, Lisa F., Stone, Valerie E., Stone, David R., Tambussi, Giuseppe, Taplitz, Randy A., Tedaldi, Ellen M., Theisen, William, Torres, Richard, Tosiello, Lorraine, Tremblay, Cecile, Tribble, Marc A., Trinh, Phuong D., Tsao, Alice, Ueda, Peggy, Vaccaro, Anthony, Valadas, Emilia, Vanig, Thanes J., Vecino, Isabel, Vega, Vilma M., Veikley, Wenoah, Wade, Barbara H., Walworth, Charles, Wanidworanun, Chingchai, Ward, Douglas J., Warner, Daniel A., Weber, Robert D., Webster, Duncan, Weis, Steve, Wheeler, David A., White, David J., Wilkins, Ed, Winston, Alan, Wlodaver, Clifford G., vanʼt Wout, Angelique, Wright, David P., Yang, Otto O., Yurdin, David L, Zabukovic, Brandon W., Zachary, Kimon C., Zeeman, Beth, and Zhao, Meng

Published
2010
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46. Remdesivir for Severe Coronavirus Disease 2019 (COVID-19) Versus a Cohort Receiving Standard of Care.

Author

Olender, Susan A, Perez, Katherine K, Go, Alan S, Balani, Bindu, Price-Haywood, Eboni G, Shah, Nirav S, Wang, Su, Walunas, Theresa L, Swaminathan, Shobha, Slim, Jihad, Chin, BumSik, Wit, Stéphane De, Ali, Shamim M, Viladomiu, Alex Soriano, Robinson, Philip, Gottlieb, Robert L, Tsang, Tak Yin Owen, Lee, I-Heng, Hu, Hao, and Haubrich, Richard H

Subjects
*DRUG efficacy, *COVID-19, *CONFIDENCE intervals, *MULTIPLE regression analysis, *ANTIVIRAL agents, *RETROSPECTIVE studies, *OXYGEN saturation, *TREATMENT effectiveness, *COMPARATIVE studies, *ODDS ratio
Abstract

Background We compared the efficacy of the antiviral agent, remdesivir, versus standard-of-care treatment in adults with severe coronavirus disease 2019 (COVID-19) using data from a phase 3 remdesivir trial and a retrospective cohort of patients with severe COVID-19 treated with standard of care. Methods GS-US-540–5773 is an ongoing phase 3, randomized, open-label trial comparing two courses of remdesivir (remdesivir-cohort). GS-US-540–5807 is an ongoing real-world, retrospective cohort study of clinical outcomes in patients receiving standard-of-care treatment (non-remdesivir-cohort). Inclusion criteria were similar between studies: patients had confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, were hospitalized, had oxygen saturation ≤94% on room air or required supplemental oxygen, and had pulmonary infiltrates. Stabilized inverse probability of treatment weighted multivariable logistic regression was used to estimate the treatment effect of remdesivir versus standard of care. The primary endpoint was the proportion of patients with recovery on day 14, dichotomized from a 7-point clinical status ordinal scale. A key secondary endpoint was mortality. Results After the inverse probability of treatment weighting procedure, 312 and 818 patients were counted in the remdesivir- and non-remdesivir-cohorts, respectively. At day 14, 74.4% of patients in the remdesivir-cohort had recovered versus 59.0% in the non-remdesivir-cohort (adjusted odds ratio [aOR] 2.03: 95% confidence interval [CI]: 1.34–3.08, P <.001). At day 14, 7.6% of patients in the remdesivir-cohort had died versus 12.5% in the non-remdesivir-cohort (aOR 0.38, 95% CI:.22–.68, P =.001). Conclusions In this comparative analysis, by day 14, remdesivir was associated with significantly greater recovery and 62% reduced odds of death versus standard-of-care treatment in patients with severe COVID-19. Clinical Trials Registration NCT04292899 and EUPAS34303. [ABSTRACT FROM AUTHOR]

Published
2021
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47. Retained in HIV care but not on antiretroviral treatment: a qualitative patient-provider dyadic study

Author

Christopoulos, Katerina A., Olender, Susan, Lopez, Andrea M., Lekas, Helen-Maria, Jaiswal, Jessica, Mellman, Will, Geng, Elvin, and Koester, Kimberly A.

Subjects
HIV patients -- Care and treatment, Biological sciences
Abstract

Background Patients retained in HIV care but not on antiretroviral therapy (ART) represent an important part of the HIV care cascade in the United States. Even in an era of more tolerable and efficacious ART, decision making in regards to ART offer and uptake remains complex and calls for exploration of both patient and provider perspectives. We sought to understand reasons for lack of ART usage in patients meeting the Health Resources Services Administration definition of retention as well as what motivated HIV primary care appointment attendance in the absence of ART. Methods and Findings We conducted a qualitative study consisting of 70 in-depth interviews with ART-naive and ART-experienced patients off ART and their primary care providers in two urban safety-net HIV clinics in San Francisco and New York. Twenty patients and their providers were interviewed separately at baseline, and 15 dyads were interviewed again after at least 3 mo and another clinic visit in order to understand any ART use in the interim. We applied dyadic analysis to our data. Nearly all patients were willing to consider ART, and 40% of the sample went on ART, citing education on newer antiretroviral drugs, acceptance of HIV diagnosis, social support, and increased confidence in their ability to adhere as facilitators. However, the strength of the provider recommendation of ART played an important role. Many patients had internalized messages from providers that their health was too good to warrant ART. In addition, providers, while demonstrating patient-centered care through sensitivity to patients experiencing psychosocial instability, frequently muted the offer of ART, at times unintentionally. In the absence of ART, lab monitoring, provider relationships, access to social services, opiate pain medications, and acute symptoms motivated care. The main limitations of this study were that treatment as prevention was not explored in depth and that participants were recruited from academic HIV clinics in the US, making the findings most generalizable to this setting. Conclusions Provider communication with regard to ART is a key focus for further exploration and intervention in order to increase ART uptake for those retained in HIV care., Introduction Maintaining HIV-infected individuals in consistent care is a priority in improving the lives and health outcomes of individuals living with HIV in the US [1]. The HIV care cascade [...]

Published
2015
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48. Pre-exposure Prophylaxis Use Among Predominantly African American and Hispanic Women at Risk for HIV Acquisition in New York City

Author

Theodore, Deborah A., primary, Zucker, Jason, additional, Carnevale, Caroline, additional, Grant, William, additional, Adan, Matthew, additional, Borsa, Alexander, additional, Richards, Paul, additional, Olender, Susan, additional, Cohall, Alwyn, additional, Gordon, Peter, additional, and Sobieszczyk, Magdalena E., additional

Published
2020
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49. Engaging a Predominantly Latino Community in HIV Prevention: Laying the Groundwork for Pre-exposure Prophylaxis and HIV Sexual Health Programs

Author

Carnevale, Caroline, primary, Zucker, Jason, additional, Borsa, Alexander, additional, Northland, Bianka, additional, Castro, Jonathan, additional, Molina, Emma, additional, Richards, Paul, additional, Dominguez, Jose, additional, George, William, additional, Cohall, Alwyn, additional, Olender, Susan, additional, Gordon, Peter, additional, and Sobieszczyk, Magdalena E., additional

Published
2020
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