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1. The Health Gym: Synthetic Health-Related Datasets for the Development of Reinforcement Learning Algorithms

Author

Kuo, Nicholas I-Hsien, Polizzotto, Mark N., Finfer, Simon, Garcia, Federico, Sönnerborg, Anders, Zazzi, Maurizio, Böhm, Michael, Jorm, Louisa, and Barbieri, Sebastiano

Subjects
Computer Science - Machine Learning
Abstract

In recent years, the machine learning research community has benefited tremendously from the availability of openly accessible benchmark datasets. Clinical data are usually not openly available due to their highly confidential nature. This has hampered the development of reproducible and generalisable machine learning applications in health care. Here we introduce the Health Gym - a growing collection of highly realistic synthetic medical datasets that can be freely accessed to prototype, evaluate, and compare machine learning algorithms, with a specific focus on reinforcement learning. The three synthetic datasets described in this paper present patient cohorts with acute hypotension and sepsis in the intensive care unit, and people with human immunodeficiency virus (HIV) receiving antiretroviral therapy in ambulatory care. The datasets were created using a novel generative adversarial network (GAN). The distributions of variables, and correlations between variables and trends over time in the synthetic datasets mirror those in the real datasets. Furthermore, the risk of sensitive information disclosure associated with the public distribution of the synthetic datasets is estimated to be very low.

Published
2022

2. Evaluating Primary Endpoints for COVID-19 Therapeutic Trials to Assess Recovery.

Author

Douin, David J, Siegel, Lianne, Grandits, Greg, Phillips, Andrew, Aggarwal, Neil R, Baker, Jason, Brown, Samuel M, Chang, Christina C, Goodman, Anna L, Grund, Birgit, Higgs, Elizabeth S, Hough, Catherine L, Murray, Daniel D, Paredes, Roger, Parmar, Mahesh, Pett, Sarah, Polizzotto, Mark N, Sandkovsky, Uriel, Self, Wesley H, Young, Barnaby E, Babiker, Abdel G, Davey, Victoria J, Kan, Virginia, Gelijns, Annetine C, Matthews, Gail, Thompson, B Taylor, Lane, H Clifford, Neaton, James D, Lundgren, Jens D, and Ginde, Adit A

Subjects
Humans, Antibodies, Monoclonal, Treatment Outcome, Aftercare, Patient Discharge, Aged, COVID-19, SARS-CoV-2, monoclonal antibodies, outcomes assessment, Clinical Trials and Supportive Activities, Clinical Research, Good Health and Well Being, Medical and Health Sciences, Respiratory System
Abstract

Rationale: Uncertainty regarding the natural history of coronavirus disease (COVID-19) led to difficulty in efficacy endpoint selection for therapeutic trials. Capturing outcomes that occur after hospital discharge may improve assessment of clinical recovery among hospitalized patients with COVID-19. Objectives: Evaluate 90-day clinical course of patients hospitalized with COVID-19, comparing three distinct definitions of recovery. Methods: We used pooled data from three clinical trials of neutralizing monoclonal antibodies to compare: 1) the hospital discharge approach; 2) the TICO (Therapeutics for Inpatients with COVID-19) trials sustained recovery approach; and 3) a comprehensive approach. At the time of enrollment, all patients were hospitalized in a non-ICU setting without organ failure or major extrapulmonary manifestations of COVID-19. We defined discordance as a difference between time to recovery. Measurements and Main Results: Discordance between the hospital discharge and comprehensive approaches occurred in 170 (20%) of 850 enrolled participants, including 126 hospital readmissions and 24 deaths after initial hospital discharge. Discordant participants were older (median age, 68 vs. 59 years; P

Published
2022

4. Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO): a randomised controlled trial

Author

Group, ACTIV-3 Therapeutics for Inpatients with COVID-19 Study, Self, Wesley H, Sandkovsky, Uriel, Reilly, Cavan S, Vock, David M, Gottlieb, Robert L, Mack, Michael, Golden, Kevin, Dishner, Emma, Vekstein, Andrew, Ko, Emily R, Der, Tatyana, Franzone, John, Almasri, Eyad, Fayed, Mohamed, Filbin, Michael R, Hibbert, Kathryn A, Rice, Todd W, Casey, Jonathan D, Hayanga, J Awori, Badhwar, Vinay, Leshnower, Bradley G, Sharifpour, Milad, Knowlton, Kirk U, Peltan, Ithan D, Bakowska, Elizieta, Kowalska, Justyna, Bowdish, Michael E, Sturek, Jeffrey M, Rogers, Angela J, Files, D Clark, Mosier, Jarrod M, Gong, Michelle N, Douin, David J, Hite, R Duncan, Trautner, Barbara W, Jain, Mamta K, Gardner, Edward M, Khan, Akram, Jensen, Jens-Ulrik, Matthay, Michael A, Ginde, Adit A, Brown, Samuel M, Higgs, Elizabeth S, Pett, Sarah, Weintrob, Amy C, Chang, Christina C, Murrary, Daniel D, Günthard, Huldrych F, Moquete, Ellen, Grandits, Greg, Engen, Nicole, Grund, Birgit, Sharma, Shweta, Cao, Huyen, Gupta, Rajesh, Osei, Suzette, Margolis, David, Zhu, Qing, Polizzotto, Mark N, Babiker, Abdel G, Davey, Victoria J, Kan, Virginia, Thompson, B Taylor, Gelijns, Annetine C, Neaton, James D, Lane, H Clifford, Jundgren, Jens D, Tierney, John, Barrett, Kevin, Herpin, Betsey R, Smolskis, Mary C, Voge, Susan E, McNay, Laura A, Cahill, Kelly, Crew, Page, Kirchoff, Matthew, Sardana, Ratna, Raim, Sharon Segal, Chiu, Joseph, Hensley, Lisa, Lorenzo, Josua, Mock, Rebecca, Shaw-Saliba, Katy, Zuckerman, Judith, Adam, Stacey J, Currier, Judy, Read, Sarah, Hughes, Eric, Amos, Laura, Carlsen, Amy, Carter, Anita, Davis, Bionca, Denning, Eileen, DuChene, Alain, Harrison, Merrie, Kaiser, Payton, Koopmeiners, Joseph, Meger, Sue, and Murray, Thomas

Subjects
Clinical Trials and Supportive Activities, Lung, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Adolescent, Adult, Aged, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Antibodies, Neutralizing, Double-Blind Method, Female, Humans, Male, Middle Aged, SARS-CoV-2, Treatment Outcome, COVID-19 Drug Treatment, ACTIV-3/Therapeutics for Inpatients with COVID-19 (TICO) Study Group, Clinical Sciences, Medical Microbiology, Public Health and Health Services, Microbiology
Abstract

BackgroundWe aimed to assess the efficacy and safety of two neutralising monoclonal antibody therapies (sotrovimab [Vir Biotechnology and GlaxoSmithKline] and BRII-196 plus BRII-198 [Brii Biosciences]) for adults admitted to hospital for COVID-19 (hereafter referred to as hospitalised) with COVID-19.MethodsIn this multinational, double-blind, randomised, placebo-controlled, clinical trial (Therapeutics for Inpatients with COVID-19 [TICO]), adults (aged ≥18 years) hospitalised with COVID-19 at 43 hospitals in the USA, Denmark, Switzerland, and Poland were recruited. Patients were eligible if they had laboratory-confirmed SARS-CoV-2 infection and COVID-19 symptoms for up to 12 days. Using a web-based application, participants were randomly assigned (2:1:2:1), stratified by trial site pharmacy, to sotrovimab 500 mg, matching placebo for sotrovimab, BRII-196 1000 mg plus BRII-198 1000 mg, or matching placebo for BRII-196 plus BRII-198, in addition to standard of care. Each study product was administered as a single dose given intravenously over 60 min. The concurrent placebo groups were pooled for analyses. The primary outcome was time to sustained clinical recovery, defined as discharge from the hospital to home and remaining at home for 14 consecutive days, up to day 90 after randomisation. Interim futility analyses were based on two seven-category ordinal outcome scales on day 5 that measured pulmonary status and extrapulmonary complications of COVID-19. The safety outcome was a composite of death, serious adverse events, incident organ failure, and serious coinfection up to day 90 after randomisation. Efficacy and safety outcomes were assessed in the modified intention-to-treat population, defined as all patients randomly assigned to treatment who started the study infusion. This study is registered with ClinicalTrials.gov, NCT04501978.FindingsBetween Dec 16, 2020, and March 1, 2021, 546 patients were enrolled and randomly assigned to sotrovimab (n=184), BRII-196 plus BRII-198 (n=183), or placebo (n=179), of whom 536 received part or all of their assigned study drug (sotrovimab n=182, BRII-196 plus BRII-198 n=176, or placebo n=178; median age of 60 years [IQR 50-72], 228 [43%] patients were female and 308 [57%] were male). At this point, enrolment was halted on the basis of the interim futility analysis. At day 5, neither the sotrovimab group nor the BRII-196 plus BRII-198 group had significantly higher odds of more favourable outcomes than the placebo group on either the pulmonary scale (adjusted odds ratio sotrovimab 1·07 [95% CI 0·74-1·56]; BRII-196 plus BRII-198 0·98 [95% CI 0·67-1·43]) or the pulmonary-plus complications scale (sotrovimab 1·08 [0·74-1·58]; BRII-196 plus BRII-198 1·00 [0·68-1·46]). By day 90, sustained clinical recovery was seen in 151 (85%) patients in the placebo group compared with 160 (88%) in the sotrovimab group (adjusted rate ratio 1·12 [95% CI 0·91-1·37]) and 155 (88%) in the BRII-196 plus BRII-198 group (1·08 [0·88-1·32]). The composite safety outcome up to day 90 was met by 48 (27%) patients in the placebo group, 42 (23%) in the sotrovimab group, and 45 (26%) in the BRII-196 plus BRII-198 group. 13 (7%) patients in the placebo group, 14 (8%) in the sotrovimab group, and 15 (9%) in the BRII-196 plus BRII-198 group died up to day 90.InterpretationNeither sotrovimab nor BRII-196 plus BRII-198 showed efficacy for improving clinical outcomes among adults hospitalised with COVID-19.FundingUS National Institutes of Health and Operation Warp Speed.

Published
2022

6. Associations between change in BMI and the risk of hypertension and dyslipidaemia in people receiving integrase strand-transfer inhibitors, tenofovir alafenamide, or both compared with other contemporary antiretroviral regimens: a multicentre, prospective observational study from the RESPOND consortium cohorts

Author

Byonanebye, Dathan M, Polizzotto, Mark N, Maltez, Fernando, Rauch, Andri, Grabmeier-Pfistershammer, Katharina, Wit, Ferdinand, De Wit, Stéphane, Castagna, Antonella, d'Arminio Monforte, Antonella, Mussini, Cristina, Wasmuth, Jan-Christian, Fontas, Eric, Abela, Irene, Sarcletti, Mario, Bansi-Matharu, Loveleen, Jaschinski, Nadine, Peters, Lars, Hosein, Sean R, Vannappagari, Vani, Cohen, Cal, Bissio, Emiliano, Mocroft, Amanda, Law, Matthew, Ryom, Lene, and Petoumenos, Kathy

Published
2024
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7. Hyperimmune immunoglobulin for hospitalised patients with COVID-19 (ITAC): a double-blind, placebo-controlled, phase 3, randomised trial

Author

Group, The ITAC Study, Polizzotto, Mark N, Nordwall, Jacqueline, Babiker, Abdel G, Phillips, Andrew, Vock, David M, Eriobu, Nnakelu, Kwaghe, Vivian, Paredes, Roger, Mateu, Lourdes, Ramachandruni, Srikanth, Narang, Rajeev, Jain, Mamta K, Lazarte, Susana M, Baker, Jason V, Frosch, Anne EP, Poulakou, Garyfallia, Syrigos, Konstantinos N, Arnoczy, Gretchen S, McBride, Natalie A, Robinson, Philip A, Sarafian, Farjad, Bhagani, Sanjay, Taha, Hassan S, Benfield, Thomas, Liu, Sean TH, Antoniadou, Anastasia, Jensen, Jens Ulrik Stæhr, Kalomenidis, Ioannis, Susilo, Adityo, Hariadi, Prasetyo, Jensen, Tomas O, Morales-Rull, Jose Luis, Helleberg, Marie, Meegada, Sreenath, Johansen, Isik S, Canario, Daniel, Fernández-Cruz, Eduardo, Metallidis, Simeon, Shah, Amish, Sakurai, Aki, Koulouris, Nikolaos G, Trotman, Robin, Weintrob, Amy C, Podlekareva, Daria, Hadi, Usman, Lloyd, Kathryn M, Røge, Birgit Thorup, Saito, Sho, Sweerus, Kelly, Malin, Jakob J, Lübbert, Christoph, Muñoz, Jose, Cummings, Matthew J, Losso, Marcelo H, Turner, Dan, Shaw-Saliba, Kathryn, Dewar, Robin, Highbarger, Helene, Lallemand, Perrine, Rehman, Tauseef, Gerry, Norman, Arlinda, Dona, Chang, Christina C, Grund, Birgit, Holbrook, Michael R, Holley, Horace P, Hudson, Fleur, McNay, Laura A, Murray, Daniel D, Pett, Sarah L, Shaughnessy, Megan, Smolskis, Mary C, Touloumi, Giota, Wright, Mary E, Doyle, Mittie K, Popik, Sharon, Hall, Christine, Ramanathan, Roshan, Cao, Huyen, Mondou, Elsa, Willis, Todd, Thakuria, Joseph V, Yel, Leman, Higgs, Elizabeth, Kan, Virginia L, Lundgren, Jens D, Neaton, James D, and Lane, H Clifford

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Prevention, Emerging Infectious Diseases, Clinical Research, Vaccine Related, Clinical Trials and Supportive Activities, Lung, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adenosine Monophosphate, Alanine, Antibodies, Neutralizing, Antiviral Agents, COVID-19, COVID-19 Vaccines, Double-Blind Method, Female, Hospitalization, Humans, Inpatients, Internationality, Male, Middle Aged, Treatment Outcome, Vaccines, Inactivated, ITAC (INSIGHT 013) Study Group, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundPassive immunotherapy using hyperimmune intravenous immunoglobulin (hIVIG) to SARS-CoV-2, derived from recovered donors, is a potential rapidly available, specific therapy for an outbreak infection such as SARS-CoV-2. Findings from randomised clinical trials of hIVIG for the treatment of COVID-19 are limited.MethodsIn this international randomised, double-blind, placebo-controlled trial, hospitalised patients with COVID-19 who had been symptomatic for up to 12 days and did not have acute end-organ failure were randomly assigned (1:1) to receive either hIVIG or an equivalent volume of saline as placebo, in addition to remdesivir, when not contraindicated, and other standard clinical care. Randomisation was stratified by site pharmacy; schedules were prepared using a mass-weighted urn design. Infusions were prepared and masked by trial pharmacists; all other investigators, research staff, and trial participants were masked to group allocation. Follow-up was for 28 days. The primary outcome was measured at day 7 by a seven-category ordinal endpoint that considered pulmonary status and extrapulmonary complications and ranged from no limiting symptoms to death. Deaths and adverse events, including organ failure and serious infections, were used to define composite safety outcomes at days 7 and 28. Prespecified subgroup analyses were carried out for efficacy and safety outcomes by duration of symptoms, the presence of anti-spike neutralising antibodies, and other baseline factors. Analyses were done on a modified intention-to-treat (mITT) population, which included all randomly assigned participants who met eligibility criteria and received all or part of the assigned study product infusion. This study is registered with ClinicalTrials.gov, NCT04546581.FindingsFrom Oct 8, 2020, to Feb 10, 2021, 593 participants (n=301 hIVIG, n=292 placebo) were enrolled at 63 sites in 11 countries; 579 patients were included in the mITT analysis. Compared with placebo, the hIVIG group did not have significantly greater odds of a more favourable outcome at day 7; the adjusted OR was 1·06 (95% CI 0·77-1·45; p=0·72). Infusions were well tolerated, although infusion reactions were more common in the hIVIG group (18·6% vs 9·5% for placebo; p=0·002). The percentage with the composite safety outcome at day 7 was similar for the hIVIG (24%) and placebo groups (25%; OR 0·98, 95% CI 0·66-1·46; p=0·91). The ORs for the day 7 ordinal outcome did not vary for subgroups considered, but there was evidence of heterogeneity of the treatment effect for the day 7 composite safety outcome: risk was greater for hIVIG compared with placebo for patients who were antibody positive (OR 2·21, 95% CI 1·14-4·29); for patients who were antibody negative, the OR was 0·51 (0·29-0·90; pinteraction=0·001).InterpretationWhen administered with standard of care including remdesivir, SARS-CoV-2 hIVIG did not demonstrate efficacy among patients hospitalised with COVID-19 without end-organ failure. The safety of hIVIG might vary by the presence of endogenous neutralising antibodies at entry.FundingUS National Institutes of Health.

Published
2022

8. The influence of immunodeficiency, disease features, and patient characteristics on survival in plasmablastic lymphoma

Author

Di Ciaccio, Pietro R., Polizzotto, Mark N., Cwynarski, Kate, Gerrie, Alina S., Burton, Catherine, Bower, Mark, Kuruvilla, John, Montoto, Silvia, McKay, Pam, Fox, Christopher P., Milliken, Samuel, Jiamsakul, Awachana, Osborne, Wendy, Collins, Graham P., Manos, Kate, Linton, Kim M., Iyengar, Sunil, Kassam, Shireen, Limei, Michelle Poon, Kliman, David, Wong Doo, Nicole, Watson, Anne-Marie, Fedele, Pasquale, Yannakou, Costas K., Hunt, Stewart, Ku, Matthew, Sehn, Laurie H., Smith, Alexandra, Renshaw, Hanna, Maxwell, Alice, Liu, Qin, Dhairyawan, Rageshri, Ferguson, Graeme, Pickard, Keir, Painter, Daniel, Thakrar, Nisha, Song, Kevin W., and Hamad, Nada

Published
2024
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12. Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO): a randomised controlled trial

Author

Self, Wesley H., Sandkovsky, Uriel, Reilly, Cavan S., Vock, David M., Gottlieb, Robert L., Mack, Michael, Golden, Kevin, Dishner, Emma, Vekstein, Andrew, Ko, Emily R., Der, Tatyana, Franzone, John, Almasri, Eyad, Fayed, Mohamed, Filbin, Michael R., Hibbert, Kathryn A., Rice, Todd W., Casey, Jonathan D., Hayanga, J. Awori, Badhwar, Vinay, Leshnower, Bradley G., Sharifpour, Milad, Knowlton, Kirk U., Peltan, Ithan D., Bakowska, Elizieta, Kowalska, Justyna, Bowdish, Michael E., Sturek, Jeffrey M., Rogers, Angela J., Files, D. Clark, Mosier, Jarrod M., Gong, Michelle N., Douin, David J., Hite, R. Duncan, Trautner, Barbara W., Jain, Mamta K., Gardner, Edward M., Khan, Akram, Jensen, Jens-Ulrik, Matthay, Michael A., Ginde, Adit A., Brown, Samuel M., Higgs, Elizabeth S., Pett, Sarah, Weintrob, Amy C., Chang, Christina C., Murrary, Daniel D., Günthard, Huldrych F., Moquete, Ellen, Grandits, Greg, Engen, Nicole, Grund, Birgit, Sharma, Shweta, Cao, Huyen, Gupta, Rajesh, Osei, Suzette, Margolis, David, Zhu, Qing, Polizzotto, Mark N., Babiker, Abdel G., Davey, Victoria J., Kan, Virginia, Thompson, B. Taylor, Gelijns, Annetine C., Neaton, James D., Lane, H. Clifford, Jundgren, Jens D., Tierney, John, Barrett, Kevin, Herpin, Betsey R., Smolskis, Mary C., Voge, Susan E., McNay, Laura A., Cahill, Kelly, Crew, Page, Kirchoff, Matthew, Sardana, Ratna, Raim, Sharon Segal, Chiu, Joseph, Hensley, Lisa, Lorenzo, Josua, Mock, Rebecca, Shaw-Saliba, Katy, Zuckerman, Judith, Adam, Stacey J., Currier, Judy, Read, Sarah, Hughes, Eric, Amos, Laura, Carlsen, Amy, Carter, Anita, Davis, Bionca, Denning, Eileen, DuChene, Alain, Harrison, Merrie, Kaiser, Payton, Koopmeiners, Joseph, Meger, Sue, Murray, Thomas, Quan, Kien, Quan, Siu Fun, Thompson, Greg, Walski, Jamie, Wentworth, Deborah, Moskowitz, Alan J., Bagiella, Emilia, O'Sullivan, Karen, Marks, Mary E., Accardi, Evan, Kinzel, Emily, Bedoya, Gabriela, Gupta, Lopa, Overbey, Jessica R., Padillia, Maria L., Santos, Milerva, Gillinov, Marc A., Miller, Marissa A., Taddei-Peters, Wendy C., Fenton, Kathleen, Berhe, Mezgebe, Haley, Clinton, Bettacchi, Christopher, Duhaime, Erin, Ryan, Madison, Burris, Sarah, Jones, Felecia, Villa, Samantha, Want, Samantha, Robert, Raven, Coleman, Tanquinisha, Clariday, Laura, Baker, Rebecca, Hurutado-Rodriguez, Marian, Iram, Nazia, Fresnedo, Michelle, Davis, Allyson, Leonard, Kiara, Ramierez, Noelia, Thammavong, Jon, Duque, Krizia, Turner, Emma, Fisher, Tammy, Robinson, Dianna, Ransom, Desirae, Lusk, Erica, Killian, Aaron, Palacious, Adriana, Solis, Edilia, Jerrow, Janet, Watts, Matthew, Whitacre, Heather, Cothran, Elizabeth, Smith, Peter K., Barkauskas, Christina E., Dreyer, Grace R., Witte, Marie, Mosaly, Nilima, Mourad, Ahmad, Holland, Thomas L., Lane, Kathleen, Bouffler, Andrew, McGowan, Lauren M., Motta, Marry, Tipton, Gregory, Stallings, Ben, Stout, Gennifer, McLendon-Arvik, Beth, Hollister, Beth A., Giangiacomo, Dana M., Sharma, Sunil, Pappers, Brian, McCarthy, Paul, Krupica, Troy, Sarwari, Arif, Reece, Rebecca, Fornaresio, Lisa, Glaze, Chad, Evans, Raquel, Preamble, Katarina, Sutton, Lisa Giblin, Buterbaugh, Sabrina, Bartolo, Elizabeth Berry, Williams, Roger, Bunner, Robin, Bender, William, Miller, Jeffrey, Baio, Kim T., McBride, Mary K., Fielding, Michele, Mathewson, Sonya, Porte, Kristina, Maton, Missy, Ponder, Chari, Haley, Elizabeth, Spainhour, Christine, Rogers, Susan, Tyler, Derrick, Wald-Dickler, Noah, Hutcheon, Douglass, Towfighi, Amytis, Lee, May M., Lewis, Meghan R., Spellberg, Brad, Sher, Linda, Sharma, Aniket, Olds, Anna P., Justino, Chris, Lozano, Edward, Romero, Chris, Leong, Janet, Rodina, Valentina, Possemato, Tammie, Escobar, Jose, Chiu, Charlene, Weissman, Kevin, Barros, Andrew, Enfield, Kyle B., Kadl, Alexandra, Green, China J., Simon, Rachel M., Fox, Ashley, Thornton, Kara, Parrino, Patrick E., Spindel, Stephen, Bansal, Aditya, Baumgarten, Katherine, Hand, Jonathan, Vonderhaar, Derek, Nossaman, Bobby, Laudun, Sylvia, Ames, DeAnna, Broussard, Shane, Hernandez, Nilmo, Isaac, Geralyn, Dinh, Huan, Zheng, Yiling, Tran, Sonny, McDaniel, Hunter, Crovetto, Nicolle, Miller, Leslie, Schelle, Beth, McLean, Sherry, Rothbaum, Howard R., Alvarez, Michael S., Kalan, Shivam P., Germann, Heather H., Hendershot, Jennifer, Maroney, Karen, Herring, Karen, Cook, Sharri, Paul, Pam, Madathil, Ronson J., Rabin, Joseph, Levine, Andrea, Saharia, Kapil, Tabatabai, Ali, Lau, Christine, Gammie, James S., Peguero, Maya-Loren, McKernan, Kimberley, Audette, Matthew, Fleischmann, Emily, Akbari, Freshta, Lee, Maia, Lee, Myounghee, Chi, Andrew, Salehi, Hanna, Pariser, Alan, Nguyen, Phuong Tran, Moore, Jessica, Gee, Adrienne, Vincent, Shelika, Zuckerman, Richard A., Iribarne, Alexander, Metzler, Sara, Shipman, Samantha, Caccia, Taylor, Johnson, Haley, Newton, Crystallee, Parr, Doug, Rodriguez, Vicente, Bokhart, Gordon, Eichman, Sharon M., North, Crystal, Oldmixon, Cathryn, Ringwood, Nancy, Fitzgerald, Laura, Morin, Haley D., Muzikansky, Ariela, Morse, Richard, Brower, Roy G., Reineck, Lora A., Aggarwal, Neil R., Bienstock, Karen, Hou, Peter, Steingrub, Jay, Tidswell, Mark A., Kozikowski, Lori-Ann, Kardos, Cynthia, DeSouza, Leslie, Thornton-Thompson, Sherell, Talmor, Daniel, Shapiro, Nathan, Banner-Goodspeed, Valerie, Boyle, Katherine L., Hayes, Sharon, Jones, Alan E., Galbraith, James, Nandi, Utsav, Peacock, Rebekah K., Parry, Blair Alden, Margolin, Justin D., Brait, Kelsey, Beakes, Caroline, Kangelaris, Kirsten N., Yee, Kimberly J., Ashktorab, Kimia, Jauregui, Alejandra E., Zhuo, Hanjing, Hendey, Gregory, Hubel, Kinsley A., Hughes, Alyssa R., Garcia, Rebekah L., Wilson, Jennifer G., Vojnik, Rosemary, Roque, Jonasel, Perez, Cynthia, Lim, George W., Chang, Steven Y., Beutler, Rebecca, Agarwal, Trisha, Vargas, Julia, Moss, Marc, Baduashvili, Amiran, Chauhan, Lakshmi, Finck, Lani L., Howell, Michelle, Hyzy, Robert C., Park, Pauline K., Nelson, Kristine, McSparron, Jake I., Co, Ivan N., Wang, Bonnie R., Jia, Shijing, Sullins, Barbara, Hanna, Sinan, Olbrich, Norman, Richardson, Lynne D., Nair, Rahul, Offor, Obiageli, Lopez, Brenda, Amosu, Omowunmi, Tzehaie, Hiwet, Terndrup, Thomas E., Wiedemann, Herbert P., Duggal, Abhijit, Thiruchelvam, Nirosshan, Ashok, Kiran, King, Alexander H., Mehkri, Omar, Hudock, Kristin, Kiran, Simra, More, Harshada, Roads, Tammy, Martinkovic, Jamie, Kennedy, Sarah, Robinson, Bryce H., Hough, Catherine L., Krol, Olivia F., Kinjal, Mistry, Mills, Emmanuel, McDougal, Madeline, Deshmukh, Rupali, Chen, Peter, Torbati, Sam S., Matusov, Yuri, Choe, June, Hindoyan, Niree A., Jackman, Susan E., Bayoumi, Emad, Wynter, Timothy, Caudill, Antonina, Pascual, Ethan, Clapham, Gregg J., Herrera, Lisa, Ojukwu, Cristabelle, Mehdikhani, Shaunt, O'Mahony, D. Shane, Nyatsatsang, Sonam T., Wilson, David M., Wallick, Julie A., Miller, Chadwick, Gibbs, Keven W., Flores, Lori S., LaRose, Mary E., Landreth, Leigha D., Morris, Peter E., Sturgill, Jamie L., Cassity, Evan P., Dhar, Sanjay, Montgomery-Yates, Ashley A., Pasha, Sara N., Mayer, Kirby P., Bissel, Brittany, Bledsoe, Joseph, Brown, Samuel, Lanspa, Michael, Leither, Lindsey, Armbruster, Brent P., Montgomery, Quinn, Applegate, Darrin, Kumar, Naresh, Fergus, Melissa, Serezlic, Erna, Imel, Karah, Palmer, Ghazal, Webb, Brandon, Aston, Valerie T., Johnson, Jakea, Gray, Christopher, Hays, Margaret, Roth, Megan, Sánchez, Adriana, Popielski, Laura, Rivasplata, Heather, Turner, Melissa, Vjecha, Michael, Petersen, Tianna, Kamel, Dena, Hansen, Laura, Lucas, Claudia Sanchez, DellaValle, Natalie, Gonzales, Sonia, Scott, James, Wyles, David, Douglas, Ivor, Haukoos, Jason, Kamis, Kevin, Robinson, Caitlin, Baker, Jason V., Frosch, Anne, Goldsmith, Rachael, Jibrell, Hodan, Lo, Melanie, Klaphake, Jonathan, Mackedanz, Shari, Ngo, Linh, Garcia-Myers, Kelly, Markowitz, Norman, Pastor, Erika, Ramesh, Mayur, Brar, Indira, Rivers, Emanuel, Kumar, Princy, Menna, Maximiliano, Biswas, Kousick, Harrington, Cristin, Delp, Alex, Pandit, Lavannya, Hines-Munson, Casey, Van, John, Dillon, Laura, Want, Yiqun, Lichtenberger, Paola, Baracco, Gio, Ramos, Carol, Bjork, Lauren, Sueiro, Melyssa, Tien, Phyllis, Freasier, Heather, Buck, Theresa, Nekach, Hafida, Nagy-Agren, Stephanie, Vasudeva, Shikha, Ochalek, Tracy, Roller, Brentin, Nguyen, Chinh, Mikail, Amani, Raben, Dorthe, Jensen, Tomas O., Aagaard, Bitten, Nielsen, Charlotte B., Krapp, Katharina, Nykjær, Bente Rosdahl, Kanne, Katja Lisa, Grevsen, Anne Louise, Joensen, Zillah Maria, Bruun, Tina, Bojesen, Ane, Woldbye, Frederik, Normand, Nick E., Esmann, Frederik V.L., Clausen, Clara Lundetoft, Hovmand, Nichlas, Pedersen, Karen Brorup, Thorlacius-Ussing, Louise, Tinggaard, Michaela, Høgsberg, Dorthe S., Rastoder, Ema, Kamstrup, Thobias, Bergsøe, Christina Marisa, Østergaard, Lars, Stærke, Nina Breinholt, Johansen, Isik S., Knudtzen, Fredrikke C., Larsen, Lykke, Hertz, Mathias A., Fabricius, Thilde, Helleberg, Marie, Gerstoft, Jan, Jensen, Tomas Østergaard, Lindegaard, Birgitte, Pedersen, Thomas Ingemann, Røge, Birgit Thorup, Løfberg, Sandra Valborg, Hansen, Thomas Michael, Nielsen, Ariella Denize, von Huth, Sebastian Leicht, Nielsen, Henrik, Thisted, Rikke Krog, Podlekareva, Daria, Johnsen, Stine, Andreassen, Helle Frost, Pedersen, Lars, Lindnér, Cecilia Ebba Clara Ellinor, Wiese, Lothar, Knudsen, Lene Surland, Nytofte, Nikolaj Julian Skrøder, Havmøller, Signe Ravn, Paredes, Roger, Exposito, Maria, Fernández-Cruz, Eduardo, Muñoz, José, Arribas, Jose R., Estrada, Vicente, Horcajada, Juan P., Burgos, Joaquin, Morales-Rull, Jose Luis, Braun, Dominique L., West, Emily, M'Rabeth-Bensalah, Khadija, Eichinger, Mareile L., Grüttner-Durmaz, Manuela, Grube, Christina, Zink, Veronika, Horban, Andrzej, Bednarska, Agnieszka, Jurek, Natalia, Fätkenheuer, Gerd, Malinm, Jakob J., Matthews, Gail, Kelleher, Anthony, Cabrera, Gesalit, Carey, Catherine, Hough, Sally, Virachit, Sophie, Zhong, Amy, Young, Barnaby E., Chia, Po Ying, Lee, Tau Hong, Lin, Ray J., Lye, David, Ong, Sean, Puah, Ser Hon, Yeo, Tsin Wen, Diong, Shiau Hui, Ongko, Juwinda, Hudson, Fleur, Parmar, Mahesh KB, Goodman, Anna, Badrock, Jonathan, Gregory, Adam, Harris, Nicola, Touloumi, Giota, Pantaz, Nikos, Gioukari, Vicky, Lutaakome, Joseph, Kityo, Cissy M., Mugerwa, Henry, Kiweewa, Francis, Osinusi, Anu, Tipple, Craig, Willis, Angela, Peppercorn, Amanda, Watson, Helen, Alexander, Elizabeth, Mogalian, Erik, Lin, Leo, Ding, Xiao, Yan, Li, Girardet, Jean-Luc, Ma, Ji, Hong, Zhi, Adams, Amy, Albert, Sara, Balde, Abby, Baracz, Michelle, Baseler, Beth, Becker, Nancy, Bielica, Mona, Billouin-Frazier, Shere, Cash, Jennifer, Choudhary, Jay, Dolney, Suzanne, Dixon, Mary, Eyler, Carolyn, Frye, Leanna, Galcik, Michael, Gertz, Jensen, Giebeig, Lisa, Gulati, Neelam, Hankinson, Liz, Hissey, Debbie, Hogarty, Debi, Hohn, Matt, Holley, H Preston, Hoopengardner, Lisa, Huber, Lynda, Jankelevich, Shirley, Krauss, Gary, Lake, Eileen, Linton, Jessica, MacDonald, Leah, Manandhar, Meryan, Spinelli-Nadzam, Mary, Oluremi, Charles, Proffitt, Calvin, Rudzinski, Erin, Sandrus, Jen, Schaffhauser, Marylu, Schechner, Adam, Suders, Connie, Gerry, Norman P., Smith, Kenneth, Solomon, Courtney, Kubernac, Amanda, Rashid, Marium, Patel, Bhakti, Kubernac, Robert, Murphy, Joseph, Hoover, Marie L., Brown, Craig, DuChateau, Nadine, Flosi, Adam, Johnson, Les, Treagus, Amy, and Wenner, Christine

Published
2022
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13. Hyperimmune immunoglobulin for hospitalised patients with COVID-19 (ITAC): a double-blind, placebo-controlled, phase 3, randomised trial

Author

Polizzotto, Mark N., Nordwall, Jacqueline, Babiker, Abdel G., Phillips, Andrew, Vock, David M., Eriobu, Nnakelu, Kwaghe, Vivian, Paredes, Roger, Mateu, Lourdes, Ramachandruni, Srikanth, Narang, Rajeev, Jain, Mamta K., Lazarte, Susana M., Baker, Jason V., Frosch, Anne E.P., Poulakou, Garyfallia, Syrigos, Konstantinos N., Arnoczy, Gretchen S., McBride, Natalie A., Robinson, Philip A., Sarafian, Farjad, Bhagani, Sanjay, Taha, Hassan S., Benfield, Thomas, Liu, Sean T.H., Antoniadou, Anastasia, Jensen, Jens Ulrik Stæhr, Kalomenidis, Ioannis, Susilo, Adityo, Hariadi, Prasetyo, Jensen MD, Tomas O., Morales-Rull, Jose Luis, Helleberg, Marie, Meegada, Sreenath, Johansen, Isik S., Canario, Daniel, Fernández-Cruz, Eduardo, Metallidis, Simeon, Shah, Amish, Sakurai, Aki, Koulouris, Nikolaos G., Trotman, Robin, Weintrob, Amy C., Podlekareva, Daria, Hadi, Usman, Lloyd, Kathryn M., Røge, Birgit Thorup, Saito, Sho, Sweerus, Kelly, Malin, Jakob J., Lübbert, Christoph, Muñoz, Jose, Cummings, Matthew J., Losso, Marcelo H., Turner, Dan, Shaw-Saliba, Kathryn, Dewar, Robin, Highbarger, Helene, Lallemand, Perrine, Rehman, Tauseef, Gerry, Norman, Arlinda, Dona, Chang, Christina C., Grund, Birgit, Holbrook, Michael R., Holley, Horace P., Hudson, Fleur, McNay, Laura A., Murray, Daniel D., Pett, Sarah L., Shaughnessy, Megan, Smolskis, Mary C., Touloumi, Giota, Wright, Mary E., Doyle, Mittie K., Popik, Sharon, Hall, Christine, Ramanathan, Roshan, Cao, Huyen, Mondou, Elsa, Willis, Todd, Thakuria, Joseph V., Yel, Leman, Higgs, Elizabeth, Kan, Virginia L., Lundgren, Jens D., Neaton, James D., and Lane, H. Clifford

Published
2022
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14. Characteristics and outcomes of KSHV-associated multicentric Castleman disease with or without other KSHV diseases

Author

Ramaswami, Ramya, Lurain, Kathryn, Polizzotto, Mark N., Ekwede, Irene, Waldon, Kirsta, Steinberg, Seth M., Mangusan, Ralph, Widell, Anaida, Rupert, Adam, George, Jomy, Gonçalves, Priscila H., Marshall, Vickie A., Whitby, Denise, Wang, Hao-Wei, Pittaluga, Stefania, Jaffe, Elaine S., Little, Richard F., Uldrick, Thomas S., and Yarchoan, Robert

Published
2021
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15. Sequencing of Kaposi's Sarcoma Herpesvirus (KSHV) genomes from persons of diverse ethnicities and provenances with KSHV-associated diseases demonstrate multiple infections, novel polymorphisms, and low intra-host variance.

Author

Marshall, Vickie A., Cornejo Castro, Elena M., Goodman, Charles A., Labo, Nazzarena, Liu, Isabella, Fisher, Nicholas C., Moore, Kyle N., Nair, Ananthakrishnan, Immonen, Taina, Keele, Brandon F., Polizzotto, Mark N., Uldrick, Thomas S., Mu, Yunxiang, Saswat, Tanuja, Krug, Laurie T., McBride, Kevin M., Lurain, Kathryn, Ramaswami, Ramya, Yarchoan, Robert, and Whitby, Denise

Subjects
KAPOSI'S sarcoma, GENETIC polymorphisms, VIRAL genetics, MIXED infections, GENOMES
Abstract

Recently published near full-length KSHV genomes from a Cameroon Kaposi sarcoma case-control study showed strong evidence of viral recombination and mixed infections, but no sequence variations associated with disease. Using the same methodology, an additional 102 KSHV genomes from 76 individuals with KSHV-associated diseases have been sequenced. Diagnoses comprise all KSHV-associated diseases (KAD): Kaposi sarcoma (KS), primary effusion lymphoma (PEL), KSHV-associated large cell lymphoma (KSHV-LCL), a type of multicentric Castleman disease (KSHV-MCD), and KSHV inflammatory cytokine syndrome (KICS). Participants originated from 22 different countries, providing the opportunity to obtain new near full-length sequences of a wide diversity of KSHV genomes. These include near full-length sequence of genomes with KSHV K1 subtypes A, B, C, and F as well as subtype E, for which no full sequence was previously available. High levels of recombination were observed. Fourteen individuals (18%) showed evidence of infection with multiple KSHV variants (from two to four unique genomes). Twenty-six comparisons of sequences, obtained from various sampling sites including PBMC, tissue biopsies, oral fluids, and effusions in the same participants, identified near complete genome conservation between different biological compartments. Polymorphisms were identified in coding and non-coding regions, including indels in the K3 and K15 genes and sequence inversions here reported for the first time. One such polymorphism in KSHV ORF46, specific to the KSHV K1 subtype E2, encoded a mutation in the leucine loop extension of the uracil DNA glycosylase that results in alteration of biochemical functions of this protein. This confirms that KSHV sequence variations can have functional consequences warranting further investigation. This study represents the largest and most diverse analysis of KSHV genome sequences to date among individuals with KAD and provides important new information on global KSHV genomics. Author summary: The prevalence of KSHV infection, one of eight viruses associated with human cancer, differs geographically as does the incidence of Kaposi sarcoma and other KSHV-associated diseases. Distribution of KSHV subtypes, defined solely by the sequence of the K1 gene, also differs by region. One hundred and two near full-length KSHV genomes from people with associated diseases from a wide variety of countries were sequenced, substantially increasing the number and diversity of KSHV genomes publicly available, thereby allowing the analysis of variance across geographical regions, potential contributions of viral genetics to the risk of disease, and viral evolution. Our data demonstrate that viral recombination is common, as previously published, and that infections with multiple KSHV genomes may also be frequent, which has not been widely reported. We did not find evidence of an association between viral subtypes and disease nor indications that different sampling sites from the same individual, including tumor specimens, harbored substantially different KSHV genomes. Our data significantly inform the current efforts to study epidemiology and the prevention of KSHV infection, including vaccine development, as well as the pathogenesis of associated diseases. [ABSTRACT FROM AUTHOR]

Published
2024
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16. Castleman disease

Author

Carbone, Antonino, Borok, Margaret, Damania, Blossom, Gloghini, Annunziata, Polizzotto, Mark N., Jayanthan, Raj K., Fajgenbaum, David C., and Bower, Mark

Published
2021
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17. HIV-Associated Cancers

Author

Yarchoan, Robert, Uldrick, Thomas S., Polizzotto, Mark N., Hope, Thomas J., editor, Richman, Douglas D., editor, and Stevenson, Mario, editor

Published
2018
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19. Anti-influenza hyperimmune intravenous immunoglobulin for adults with influenza A or B infection (FLU-IVIG): a double-blind, randomised, placebo-controlled trial

Author

Davey, Richard T, Fernández-Cruz, Eduardo, Markowitz, Norman, Pett, Sarah, Babiker, Abdel G, Wentworth, Deborah, Khurana, Surender, Engen, Nicole, Gordin, Fred, Jain, Mamta K, Kan, Virginia, Polizzotto, Mark N, Riska, Paul, Ruxrungtham, Kiat, Temesgen, Zelalem, Lundgren, Jens, Beigel, John H, Lane, H Clifford, Neaton, James D, Butts, Jessica, Denning, Eileen, DuChene, Alain, Krum, Eric, Harrison, Merrie, Meger, Sue, Peterson, Ross, Quan, Kien, Shaughnessy, Megan, Thompson, Greg, Vock, David, Metcalf, Julia, Dewar, Robin, Rehman, Tauseef, Natarajan, Ven, McConnell, Rose, Flowers, Emily, Smith, Kenny, Hoover, Marie, Coyle, Elizabeth M, Munroe, David, Aagaard, Bitten, Pearson, Mary, Cursley, Adam, Webb, Helen, Hudson, Fleur, Russell, Charlotte, Sy, Aminata, Purvis, Cara, Jackson, Brooke, Collaco-Moraes, Yolanda, Carey, Dianne, Robson, Rosemary, Sánchez, Adriana, Finley, Elizabeth, Conwell, Donna, Losso, Marcelo H, Gambardella, Luciana, Abela, Cecilia, Lopez, Paco, Alonso, Helena, Touloumi, Giota, Gioukari, Vicky, Anagnostou, Olga, Avihingsanon, Anchalee, Pussadee, Kanitta, Ubolyam, Sasiwimol, Omotosho, Bola, Solórzano, Clemencia, Petersen, Tianna, Vysyaraju, Kranthi, Rizza, Stacey A, Whitaker, Jennifer A, Nahra, Raquel, Baxter, John, Coburn, Patricia, Gardner, Edward M, Scott, James A, Faber, Leslie, Pastor, Erica, Makohon, Linda, MacArthur, Rodger A, Hillman, L Monique, Farrough, Marti J, Polenakovik, Hari M, Clark, Linda A, Colon, Roberto J, Kunisaki, Ken M, DeConcini, Miranda, Johnson, Susan A, Wolfe, Cameron R, Mkumba, Laura, Carbonneau, June Y, Morris, Alison, Fitzpatrick, Meghan E, Kessinger, Cathy J, Salata, Robert A, Arters, Karen A, Tasi, Catherine M, Panos, Ralph J, Lach, Laura A, Glesby, Marshall J, Ham, Kirsis A, Hughes, Valery G, Schooley, Robert T, Crouch, Daniel, Muttera, Leticia, Novak, Richard M, Bleasdale, Susan C, Zuckerman, Ariel E, Manosuthi, Weerawat, Thaonyen, Supeda, Chiewcharn, Thaniya, Suwanpimolkul, Gompol, Gatechumpol, Sivaporn, Bunpasang, Sirikunya, Angus, Brian J, Anderson, Monique, Morgan, Marcus, Minton, Jane, Gkamaletsou, Maria N, Hambleton, Joe, Price, David A, Llewelyn, Martin J, Sweetman, Jonathan, Carbone, Javier, Arribas, Jose R, Montejano, Rocio, Lobo Beristain, Jose L, Martinez, Iñaki Z, Barberan, Jose, Hernandez, Paola, Dwyer, Dominic E, Kok, Jen, Borges, Alvaro, Brandt, Christian T, Knudsen, Lene S, Sypsas, Nikolaos, Constantinou, Costas, Markogiannakis, Antonios, Zakynthinos, Spyros, Katsaounou, Paraskevi, Kalomenidis, Ioannis, Mykietiuk, Analia, Alzogaray, Maria F, Obed, Mora, Macias, Laura M, Ebensrtejin, Juan, Burgoa, Patricia, Nannini, Esteban, Lahitte, Matias, Perez-Patrigeon, Santiago, Martínez-Orozco, José Arturo, Ramírez-Hinojosa, Juan Pablo, and Davey, Richard T, Jr

Published
2019
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20. Viral, immunologic, and clinical features of primary effusion lymphoma

Author

Lurain, Kathryn, Polizzotto, Mark N., Aleman, Karen, Bhutani, Manisha, Wyvill, Kathleen M., Gonçalves, Priscila H., Ramaswami, Ramya, Marshall, Vickie Ann, Miley, Wendell, Steinberg, Seth M., Little, Richard F., Wilson, Wyndham, Filie, Armando C., Pittaluga, Stefania, Jaffe, Elaine S., Whitby, Denise, Yarchoan, Robert, and Uldrick, Thomas S.

Published
2019
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21. The Influence of Immunodeficiency, Disease Features and Patient Characteristics on Survival in Plasmablastic Lymphoma

Author

Di Ciaccio, Pietro R, primary, Polizzotto, Mark N, additional, Cwynarski, Kate, additional, Gerrie, Alina S., additional, Burton, Catherine, additional, Bower, Mark, additional, Kuruvilla, John, additional, Montoto, Silvia, additional, McKay, Pamela, additional, Fox, Christopher P., additional, Milliken, Samuel, additional, Jiamsakul, Awachana, additional, Osborne, Wendy, additional, Collins, Graham P., additional, Manos, Kate, additional, Linton, Kim M, additional, Iyengar, Sunil, additional, Kassam, Shireen, additional, Poon Limei, Michelle, additional, Kliman, David S, additional, Wong Doo, Nicole, additional, Watson, Anne-Marie, additional, Fedele, Pasquale, additional, Yannakou, Costas K, additional, Hunt, Stewart, additional, Ku, Matthew, additional, Sehn, Laurie H, additional, Smith, Alexandra, additional, Renshaw, Hanna, additional, Maxwell, Alice, additional, Liu, Qin, additional, Dhairyawan, Rageshri, additional, Ferguson, Graeme, additional, Pickard, Keir, additional, Painter, Daniel, additional, Thakrar, Nisha, additional, Song, Kevin W., additional, and Hamad, Nada, additional

Published
2023
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22. Incomplete ART adherence is associated with higher inflammation in individuals who achieved virologic suppression in the START study

Author

Castillo-Mancilla, Jose R., Phillips, Andrew N., Neaton, James D., Neuhaus, Jacqueline, Sharma, Shweta, Baker, Jason V., Collins, Simon, Mannheimer, Sharon, Pett, Sarah, Touzeau-Romer, Veronique, Polizzotto, Mark N., Lundgren, Jens D., and Gardner, Edward M.

Subjects
Efavirenz -- Health aspects -- Analysis, Interleukins -- Health aspects -- Analysis, Highly active antiretroviral therapy -- Health aspects -- Analysis, HIV infections -- Health aspects -- Analysis, Inflammation -- Health aspects -- Analysis, C-reactive protein -- Health aspects -- Analysis, Infection -- Health aspects -- Analysis, Biological products industry -- Health aspects -- Analysis, T cells -- Health aspects -- Analysis, Health
Abstract

Introduction: Suboptimal ART adherence, despite HIV viral suppression, has been associated with chronic residual inflammation. Whether this association extends to individuals who initiate ART during early HIV infection remains unknown, which was the objective of this study. Methods: Plasma levels of interleukin-6 (IL-6), high-sensitivity C-reactive protein, serum amyloid A protein (SAA), IL-27, soluble intercellular adhesion molecule-1, soluble vascular adhesion molecule-1, D-dimer and the [CD4.sup.+]/[CD8.sup.+] T-cell ratio, were analysed at baseline and eight months after ART initiation in treatment-naive participants with HIV and CD4+ T-cells >500 cells/[mm.sup.3] enrolled in the immediate arm of START. Adherence was assessed by seven-day self-report. Multivariable linear regression was utilized to analyse the association between ART adherence and each biomarker at the eight-month visit in participants who achieved virologic suppression ( Results: We evaluated 1627 participants (422 female) who achieved virologic suppression at the eight-month visit in the period between 2009 and 2013. Median (IQR) CD4+ T-cell count before ART was 651 (585, 769) cells/[mm.sup.3]. Incomplete adherence was reported in 109 (7%) participants at the eight month visit. After adjusting for covariates, plasma IL-6 was 1.12 (95% CI, 1.00 to 1.26; p = 0.047) fold higher in participants reporting incomplete versus 100% adherence. A similar association for SAA was observed in an exploratory analysis (1.29 (95% CI 1.04 to 1.60); p = 0.02). No significant differences in other biomarkers were observed. Conclusions: Incomplete ART adherence was associated with higher IL-6 levels in individuals who achieved virologic suppression early after ART initiation in START. A potential similar association for SAA requires confirmation. These findings suggest a role for identifying strategies to maximize ART adherence even during virologic suppression. ClinicalTrials.gov number: NCT00867048. Keywords: adherence; inflammation; antiretroviral therapy; inteleukin-6; serum amyloid A protein; START study, 1 INTRODUCTION People living with HIV (PLHIV) continue to benefit from antiretroviral therapy (ART) by preventing progression to AIDS [1,2] and transmission to their partners [3]. However, even in the [...]

Published
2019
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23. Myelodysplastic syndrome and multiple solid tumours in an individual with compound heterozygous deleterious FANCM variants: A case report and review of the literature

Author

Ng, Jun Yen, primary, Warwick, Linda, additional, Craft, Paul, additional, Austen, Lynette, additional, Ashford, Bruce, additional, Gorddard, Nicole, additional, Ballinger, Mandy L., additional, Thomas, David M., additional, Blombery, Piers, additional, Tucker, Kathy, additional, and Polizzotto, Mark N., additional

Published
2023
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24. Clinical and laboratory features of COVID-19 illness and outcomes in immunocompromised individuals during the first pandemic wave in Sydney, Australia

Author

Dharan, Nila J., primary, Sasson, Sarah C., additional, Ahlenstiel, Golo, additional, Andersen, Christopher R., additional, Bloch, Mark, additional, Buckland, Griselda, additional, Hamad, Nada, additional, Han, Win Min, additional, Kelleher, Anthony D., additional, Long, Georgina V., additional, Matthews, Gail V., additional, Mina, Michael M., additional, Papot, Emmanuelle, additional, Petoumenos, Kathy, additional, Swaminathan, Sanjay, additional, Withers, Barbara, additional, Yun, James, additional, and Polizzotto, Mark N., additional

Published
2023
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26. Supplementary Table 1 from A Pilot Study of Liposomal Doxorubicin Combined with Bevacizumab followed by Bevacizumab Monotherapy in Patients with Advanced Kaposi Sarcoma

Author

Ramaswami, Ramya, primary, Uldrick, Thomas S., primary, Polizzotto, Mark N., primary, Wyvill, Kathleen M., primary, Goncalves, Priscila, primary, Widell, Anaida, primary, Lurain, Kathryn, primary, Steinberg, Seth M., primary, Figg, William Douglas, primary, Tosato, Giovanna, primary, Whitby, Denise, primary, and Yarchoan, Robert, primary

Published
2023
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27. Supplementary Figure 2 from A Pilot Study of Liposomal Doxorubicin Combined with Bevacizumab followed by Bevacizumab Monotherapy in Patients with Advanced Kaposi Sarcoma

Author

Ramaswami, Ramya, primary, Uldrick, Thomas S., primary, Polizzotto, Mark N., primary, Wyvill, Kathleen M., primary, Goncalves, Priscila, primary, Widell, Anaida, primary, Lurain, Kathryn, primary, Steinberg, Seth M., primary, Figg, William Douglas, primary, Tosato, Giovanna, primary, Whitby, Denise, primary, and Yarchoan, Robert, primary

Published
2023
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28. Supplementary Figure from Safety, Activity, and Long-term Outcomes of Pomalidomide in the Treatment of Kaposi Sarcoma among Individuals with or without HIV Infection

Author

Ramaswami, Ramya, primary, Polizzotto, Mark N., primary, Lurain, Kathryn, primary, Wyvill, Kathleen M., primary, Widell, Anaida, primary, George, Jomy, primary, Goncalves, Priscila, primary, Steinberg, Seth M., primary, Whitby, Denise, primary, Uldrick, Thomas S., primary, and Yarchoan, Robert, primary

Published
2023
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29. Supplementary Table 2 from A Pilot Study of Liposomal Doxorubicin Combined with Bevacizumab followed by Bevacizumab Monotherapy in Patients with Advanced Kaposi Sarcoma

Author

Ramaswami, Ramya, primary, Uldrick, Thomas S., primary, Polizzotto, Mark N., primary, Wyvill, Kathleen M., primary, Goncalves, Priscila, primary, Widell, Anaida, primary, Lurain, Kathryn, primary, Steinberg, Seth M., primary, Figg, William Douglas, primary, Tosato, Giovanna, primary, Whitby, Denise, primary, and Yarchoan, Robert, primary

Published
2023
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30. Supplementary Figure 1 from A Pilot Study of Liposomal Doxorubicin Combined with Bevacizumab followed by Bevacizumab Monotherapy in Patients with Advanced Kaposi Sarcoma

Author

Ramaswami, Ramya, primary, Uldrick, Thomas S., primary, Polizzotto, Mark N., primary, Wyvill, Kathleen M., primary, Goncalves, Priscila, primary, Widell, Anaida, primary, Lurain, Kathryn, primary, Steinberg, Seth M., primary, Figg, William Douglas, primary, Tosato, Giovanna, primary, Whitby, Denise, primary, and Yarchoan, Robert, primary

Published
2023
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31. Supplementary Table from Safety, Activity, and Long-term Outcomes of Pomalidomide in the Treatment of Kaposi Sarcoma among Individuals with or without HIV Infection

Author

Ramaswami, Ramya, primary, Polizzotto, Mark N., primary, Lurain, Kathryn, primary, Wyvill, Kathleen M., primary, Widell, Anaida, primary, George, Jomy, primary, Goncalves, Priscila, primary, Steinberg, Seth M., primary, Whitby, Denise, primary, Uldrick, Thomas S., primary, and Yarchoan, Robert, primary

Published
2023
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36. Second primary cancers in people with HIV/AIDS: a national data linkage study of incidence and risk factors.

Author

Di Ciaccio, Pietro R., primary, Van Leeuwen, Marina T., additional, Amin, Janaki, additional, Vajdic, Claire M., additional, Mcgregor, Skye, additional, Poynten, Isobel M., additional, Templeton, David J., additional, Law, Matthew, additional, Grulich, Andrew E., additional, Polizzotto, Mark N., additional, and JIN, Fengyi, additional

Published
2023
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37. Outcomes of human immunodeficiency virus‐associated Burkitt lymphoma and diffuse large B‐cell lymphoma treated in Australia: A report from the Australasian Lymphoma Alliance

Author

Lim, Kenneth J. C., primary, Di Ciaccio, Pietro, additional, Polizzotto, Mark N., additional, Milliken, Sam, additional, Cochrane, Tara, additional, Goh, Zhong, additional, Shaw, Briony, additional, Perry, Evelyn, additional, Gilbertson, Michael, additional, Kermode, William, additional, Cheah, Chan Y., additional, Latimer, Maya, additional, Hamad, Nada, additional, and Ku, Matthew, additional

Published
2023
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38. Association between ten-eleven methylcytosine dioxygenase 2 genetic variation and viral load in people with HIV

Author

Murray, Daniel D, Grund, Birgit, Macpherson, Cameron R., Ekenberg, Christina, Zucco, Adrian G., Reekie, Joanne, Dominguez-Dominguez, Lourdes, Leung, Preston, Fusco, Dahlene, Gras, Julien, Gerstoft, Jan, Helleberg, Marie, Borges, Álvaro H., Polizzotto, Mark N., Lundgren, Jens D., Murray, Daniel D, Grund, Birgit, Macpherson, Cameron R., Ekenberg, Christina, Zucco, Adrian G., Reekie, Joanne, Dominguez-Dominguez, Lourdes, Leung, Preston, Fusco, Dahlene, Gras, Julien, Gerstoft, Jan, Helleberg, Marie, Borges, Álvaro H., Polizzotto, Mark N., and Lundgren, Jens D.

Abstract

Introduction:Identifying genetic factors that influence HIV-pathogenesis is critical for understanding disease pathways. Previous studies have suggested a role for the human gene ten-eleven methylcytosine dioxygenase 2 (TET2) in modulating HIV-pathogenesis.Methods:We assessed whether genetic variation in TET2 was associated with markers of HIV-pathogenesis using both gene level and single nucleotide polymorphism (SNP) level association in 8512 HIV-positive persons across five clinical trial cohorts.Results:Variation at both the gene and SNP-level of TET2 was found to be associated with levels of HIV viral load (HIV-VL) consistently in the two cohorts that recruited antiretroviral-naïve participants. The SNPs occurred in two clusters of high linkage disequilibrium (LD), one associated with high HIV-VL and the other low HIV-VL, and were predominantly found in Black participants.Conclusion:Genetic variation in TET2 was associated with HIV-VL in two large antiretroviral therapy (ART)-naive clinical trial cohorts. The role of TET2 in HIV-pathogenesis warrants further investigation.

Published
2023

39. Investigation of Causal Effects of Protein Biomarkers on Cardiovascular Disease in Persons With HIV

Author

Reilly, Cavan S., Borges, Álvaro H., Baker, Jason V., Safo, Sandra E., Sharma, Shweta, Polizzotto, Mark N., Pankow, James S., Hu, Xiaojun, Sherman, Brad T., Babiker, Abdel G., Lundgren, Jens D., Lane, H. Clifford, Reilly, Cavan S., Borges, Álvaro H., Baker, Jason V., Safo, Sandra E., Sharma, Shweta, Polizzotto, Mark N., Pankow, James S., Hu, Xiaojun, Sherman, Brad T., Babiker, Abdel G., Lundgren, Jens D., and Lane, H. Clifford

Abstract

BACKGROUND: There is an incompletely understood increased risk for cardiovascular disease (CVD) among people with HIV (PWH). We investigated if a collection of biomarkers were associated with CVD among PWH. Mendelian randomization (MR) was used to identify potentially causal associations. METHODS: Data from follow-up in 4 large trials among PWH were used to identify 131 incident CVD cases and they were matched to 259 participants without incident CVD (controls). Tests of associations between 460 baseline protein levels and case status were conducted. RESULTS: Univariate analysis found CLEC6A, HGF, IL-6, IL-10RB, and IGFBP7 as being associated with case status and a multivariate model identified 3 of these: CLEC6A (odds ratio [OR] = 1.48, P = .037), HGF (OR = 1.83, P = .012), and IL-6 (OR = 1.45, P = .016). MR methods identified 5 significantly associated proteins: AXL, CHI3L1, GAS6, IL-6RA, and SCGB3A2. CONCLUSIONS: These results implicate inflammatory and fibrotic processes as contributing to CVD. While some of these biomarkers are well established in the general population and in PWH (IL-6 and its receptor), some are novel to PWH (HGF, AXL, and GAS6) and some are novel overall (CLEC6A). Further investigation into the uniqueness of these biomarkers in PWH and the role of these biomarkers as targets among PWH is warranted.

Published
2023

44. Clinical and laboratory features of COVID-19 illness and outcomes in immunocompromised individuals during the first pandemic wave in Sydney, Australia.

Author

Dharan, Nila J., Sasson, Sarah C., Ahlenstiel, Golo, Andersen, Christopher R., Bloch, Mark, Buckland, Griselda, Hamad, Nada, Han, Win Min, Kelleher, Anthony D., Long, Georgina V., Matthews, Gail V., Mina, Michael M., Papot, Emmanuelle, Petoumenos, Kathy, Swaminathan, Sanjay, Withers, Barbara, Yun, James, and Polizzotto, Mark N.

Subjects
IMMUNOCOMPROMISED patients, SARS-CoV-2 Delta variant, PATHOLOGICAL laboratories, COVID-19, COVID-19 pandemic
Abstract

People with immunocompromising conditions are at increased risk of SARS-CoV-2 infection and mortality, however early in the pandemic it was challenging to collate data on this heterogenous population. We conducted a registry study of immunocompromised individuals with polymerase chain reaction (PCR)-confirmed SARS-CoV-2 infection from March–October 2020 in Sydney, Australia to understand clinical and laboratory outcomes in this population prior to the emergence of the Delta variant. 27 participants were enrolled into the study including people with a haematologic oncologic conditions (n = 12), secondary immunosuppression (N = 8) and those with primary or acquired immunodeficiency (i.e. HIV; N = 7). All participants had symptomatic COVID-19 with the most common features being cough (64%), fever (52%) and headache (40%). Five patients demonstrated delayed SARS-CoV-2 clearance lasting three weeks to three months. The mortality rate in this study was 7% compared to 1.3% in the state of New South Wales Australia during the same period. This study provides data from the first eight months of the pandemic on COVID-19 outcomes in at-risk patient groups. [ABSTRACT FROM AUTHOR]

Published
2023
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45. Chronic lymphocytic leukaemia Australasian consensus practice statement.

Author

Anderson, Mary A., Bennett, Rory, Badoux, Xavier, Best, Giles, Chia, Nicole, Cochrane, Tara, Cull, Gavin, Crassini, Kyle, Harrup, Rosemary, Jackson, Sharon, Kuss, Bryone, Lasica, Masa, Lew, Thomas E., Marlton, Paula, Opat, Stephen, Palfreyman, Emma, Polizzotto, Mark N., Ratnasingam, Sumita, Seymour, John F., and Soosapilla, Asha

Subjects
CHRONIC lymphocytic leukemia diagnosis, CHRONIC lymphocytic leukemia treatment, CHRONIC lymphocytic leukemia, CONSENSUS (Social sciences), FLOW cytometry, SEQUENCE analysis, HOMOGRAFTS, B cell lymphoma, GENETIC testing, MEDICAL protocols, PROTEIN-tyrosine kinase inhibitors, ANTIBIOTIC prophylaxis, CELLS, ALGORITHMS, DISEASE management, SYMPTOMS
Abstract

Chronic lymphocytic leukaemia (CLL) is the most common haematological malignancy in Australia and New Zealand (ANZ). Considerable changes to diagnostic and management algorithms have occurred within the last decade. The availability of next‐generation sequencing and measurable residual disease assessment by flow cytometry allow for advanced prognostication and response assessments. Novel therapies, including inhibitors of Bruton's tyrosine kinase (BTKi) and B‐cell lymphoma 2 (BCL2) inhibitors, have transformed the treatment landscape for both treatment‐naïve and relapsed/refractory disease, particularly for patients with high‐risk genetic aberrations. Recommendations regarding appropriate supportive management continue to evolve, and special considerations are required for patients with CLL with respect to the global SARS‐CoV‐2 pandemic. The unique funding and treatment environments in Australasia highlight the need for specific local guidance with respect to the investigation and management of CLL. This consensus practice statement was developed by a broadly representative group of ANZ experts in CLL with endorsement by peak haematology bodies, with a view to providing this standardised guidance. [ABSTRACT FROM AUTHOR]

Published
2023
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47. Investigation of Causal Effects of Protein Biomarkers on Cardiovascular Disease in Persons With HIV

Author

Reilly, Cavan S, primary, Borges, Álvaro H, additional, Baker, Jason V, additional, Safo, Sandra E, additional, Sharma, Shweta, additional, Polizzotto, Mark N, additional, Pankow, James S, additional, Hu, Xiaojun, additional, Sherman, Brad T, additional, Babiker, Abdel G, additional, Lundgren, Jens D, additional, and Lane, H Clifford, additional

Published
2022
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48. Association between ten-eleven methylcytosine dioxygenase 2 genetic variation and viral load in people with HIV

Author

Murray, Daniel D., primary, Grund, Birgit, additional, MacPherson, Cameron R., additional, Ekenberg, Christina, additional, Zucco, Adrian G., additional, Reekie, Joanne, additional, Dominguez-Dominguez, Lourdes, additional, Leung, Preston, additional, Fusco, Dahlene, additional, Gras, Julien, additional, Gerstoft, Jan, additional, Helleberg, Marie, additional, Borges, Álvaro H., additional, Polizzotto, Mark N., additional, and Lundgren, Jens D., additional

Published
2022
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49. Prevalence and incidence of hypertension in a heavily treatment-experienced cohort of people living with HIV in Uganda

Author

Byonanebye, Dathan M, Polizzotto, Mark N, Parkes-Ratanshi, Rosalind, Musaazi, Joseph, Petoumenos, Kathy, Castelnuovo, Barbara, Byonanebye, Dathan M [0000-0001-9862-4724], and Apollo - University of Cambridge Repository

Subjects
Adult, Male, Multidisciplinary, Risk Factors, Incidence, Hypertension, Prevalence, Humans, Uganda, HIV Infections, Obesity
Abstract

Acknowledgements: The authors declare that they have no conflicts of interest. We thank all study participants for contributing data and all staff for coordinating the study. DBM conceived the analysis, developed the analysis plan, conducted the analysis, and wrote the first draft of the manuscript under the supervision of BC, KP, ML, and MP. BC, JM, and RPR are investigators for the ALT cohort and supervised data curation. All the authors have read and approved the final manuscript., Funder: Johnson & Johnson corporate citizenship trust, INTRODUCTION: The effect of long-term exposure to antiretroviral therapy (ART) on hypertension in sub-Saharan Africa remains unclear. We aimed to determine the prevalence and incidence of hypertension in people living with HIV (PLWH) with more than 10 years of ART in Uganda. METHODS: The analysis was performed within a cohort of adult PLWH with more than 10 years of ART at an HIV clinic in Kampala, Uganda. Participants were eligible for this analysis if they had ≥2 follow-up visits. Hypertension was defined as two consecutive systolic blood pressure (SBP) measures greater than 140 mmHg and/or diastolic blood pressure (DBP) greater than 90 mmHg, and/or documented diagnosis and/or the initiation of antihypertensives. We determined the proportion of PLWH with hypertension at baseline and used multivariable logistic regression to determine the factors associated with prevalent hypertension. To determine the incidence of hypertension, follow-up began from the cohort baseline date and was censored at the last clinic visit or date of the event, whichever occurred earlier. Multivariable Poisson regression was used to determine the adjusted incidence rate ratios (aIRR) of hypertension according to demographic, ART, and clinical characteristics. RESULTS: Of the 1000 ALT participants, 970 (97%) had ≥2 follow-up visits, and 237 (24.4%) had hypertension at baseline. The odds of prevalent hypertension were 1.18 for every 5-year increase in age (adjusted odds ratio (aOR) 1.18, 95% CI 1.10-1.34) and were higher among males (aOR 1.70, 95% CI 1.20-2.34), participants with diabetes mellitus (aOR 2.37, 95% CI 1.10-4.01), obesity (aOR 1.99, 95% CI 1.08-3.60), high cholesterol (aOR 1.47, 95% CI 1.16-2.01), and those with prior exposure to stavudine (aOR 2.10, 95% CI 1.35-3.52), or nevirapine (aOR 1.90, 95% CI 1.25-3.01). Of the 733 participants without hypertension at baseline, 116 (15.83%) developed hypertension during 4671.3 person-years of follow-up (incidence rate 24.8 per 1000 person-years; 95% CI 20.7-29.8). The factors associated with incident hypertension were obesity (adjusted incidence rate ratio (aIRR) 1.80, 95% CI 1.40-2.81), older age (aIRR 1.12 per 5-year increase in age, 95% CI 1.10,1.25), and renal insufficiency (aIRR1.80, 95% CI 1.40-2.81). CONCLUSION: The prevalence and incidence of hypertension were high in this heavily treated PLWH cohort. Therefore, with increasing ART coverage, HIV programs in SSA should strengthen the screening for hypertension in heavily treated PLWH.

Published
2023

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