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1. Safety and antiviral effect of a triple combination of HIV-1 broadly neutralizing antibodies: a phase 1/2a trial

Author

Julg, Boris, Walker-Sperling, Victoria E. K., Wagh, Kshitij, Aid, Malika, Stephenson, Kathryn E., Zash, Rebecca, Liu, Jinyan, Nkolola, Joseph P., Hoyt, Amelia, Castro, Mike, Serebryannyy, Leonid, Yanosick, Katherine, Speidel, Tessa, Borducchi, Erica N., Murzda, Tetyana, Maxfield, Lori, Arduino, Roberto, McDermott, Adrian B., Gama, Lucio, Giorgi, Elena E., Koup, Richard A., Seaman, Michael S., Rolle, Charlotte-Paige, DeJesus, Edwin, Li, Wenjun, Korber, Bette, and Barouch, Dan H.

Published
2024
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2. A Pooled Analysis of Eight Clinical Studies Suggests a Link Between Influenza-Like Symptoms and Pharmacodynamics of the Toll-Like Receptor-7 Agonist Vesatolimod

Author

Riddler, Sharon A., Benson, Constance A., Brinson, Cynthia, Deeks, Steven G., DeJesus, Edwin, Mills, Anthony, Para, Michael F., Ramgopal, Moti N., Cai, Yanhui, Zheng, Yanan, Zhang, Liao, Jiang, Wendy, Liu, Xiaopeng, Verrill, Donovan, Lim, Daina, de Vries, Christiaan R., Wallin, Jeffrey J., Vendrame, Elena, and SenGupta, Devi

Published
2024
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3. Post-acute COVID-19 outcomes including participant-reported long COVID: amubarvimab/romlusevimab versus placebo in the ACTIV-2 trial

Author

Chew, Kara, Smith, David (Davey), Daar, Eric, Wohl, David, Currier, Judith, Eron, Joseph, Javan, Arzhang Cyrus, Hughes, Michael, Moser, Carlee, Giganti, Mark, Ritz, Justin, Hosey, Lara, Roa, Jhoanna, Patel, Nilam, Colsh, Kelly, Rwakazina, Irene, Beck, Justine, Sieg, Scott, Li, Jonathan, Fletcher, Courtney, Fischer, William, Evering, Teresa H., Ignacio, Rachel Bender, Cardoso, Sandra, Corado, Katya, Jagannathan, Prasanna, Jilg, Nikolaus, Perelson, Alan, Pillay, Sandy, Riviere, Cynthia, Singh, Upinder, Taiwo, Babafemi, Gottesman, Joan, Newell, Matthew, Pedersen, Susan, Dragavon, Joan, Jennings, Cheryl, Greenfelder, Brian, Murtaugh, William, Kosmyna, Jan, Gapara, Morgan, Shahkolahi, Akbar, Margolis, David, Lacal, Verónica, Salusso, Diego, Nuñez, Sebastian, Rodriguez, Marcelo Rodrigo, Laborde, Luciana, Papasidero, Marcelo, Wehbe, Luis, Gonzalez, Mariana, Voena, Felicitas Fernandez, Alvarez, Tomas, Lopez, Amaru, Huhn, Virginia, D'Andrea Nores, Ulises, Dieser, Pablo, Bordese, Fernando, Mussi, Marisa, de Carvalho Santana, Rodrigo, Tiraboschi Bárbaro, Adriana Aparecida, Santos, Breno, de Cássia Alves Lira, Rita, Machado da Silva, Andre Luiz, Cardoso, Sandra Wagner, Diniz Ribeiro, Maria Pia, Soliva, Nathália, Vasconcellos, Eduardo, Ribeiro, Jorge Eurico, Enéas, Miriam Amaral, Pinto, Jorge, Fonseca de Morais Caporali, Julia, Faleiro Ferreira, Flávia Gomes, Rivera Martinez, Norma Erendira, Bohorquez Lopez, Victor Casildo, Frias, Melchor Victor, Fetalvero, Krystle, Maranan, Alyxzza, Rosa, Jennifer, Coetzer, Thomas, Mohata, Maureen, Sr., Lalloo, Umesh, Madlala, Penelope, Pillay-Ramaya, Larisha, Bennet, Jaclyn Ann, Mwelase, Noluthando, Mbhele, Nokuphiwa, Petrick, Frederick, Joubert, Leonard, Mbali, Rose, Sr., Joseph, Natasha, Manentsa, Mmatsie, van der Walt, Eugene, Lawrance Masilela, Mduduzi Sandile, Zwane, Zinhle, Chiperera, Tendai, Mohapi, Lerato, Moonsamy, Suri, Singh, Usha, McHarry, Kirsten, Snyman, Elizma, Lennox, Pieter, Innes, James Craig, Letlape, Oteng, Jonkane, Olebogeng, Brumskine, William, Adonis, Tania, Sein, Ni Ni, Sebe, Modulakgotla, Vahed, Yacoob, Hussen, Nazreen Jeewa, Mitha, Ismail, Cheekati, Vasundhara, Cheekati, Purna, Lummus, Christie, Idarraga, Samuel, Kim, Andrew, Pham, David N., Kao, Wei-Hsin, Pfeffer, Michael M., Dominguez, Miriam Batule, Malik, Anju, Bryan, Anna, Arnold, Melanie, Fernandez, Idania, Karpf, Cinzia, Ruiz, Aniuska, Taylor, David, Folkens, Eric, Manne, Jennifer, Yawetz, Sigal, Keenan, Cheryl, Eziri, Emeka, Fichtenbaum, Carl, Baer, Jenifer, Trentman, Sarah, Call, Robert, Vaughan, Leroy, Milstone, Aaron, Slandzicki, Jamie Alex, Wallan, Jessica, Guillory, Clinton, Andrews, Nancy, Hughes, Leslie, Berardi, Jonathan, Arar, Celine, Quinn, Randall, Amaya, Jorge P., Gomez-Martinez, Marissa, Cantu, Luis, Betancourt-Garcia, Monica, Okeke, Nwora Lance, Burns, Charles M., Haddad, Fadi, Haddad, Victoria, Focil, Augusto, Rosas, Griselda, Moyano, Susana, Rojas, Yaneicy Gonzalez, Aswad, Ahmad, Bukhman, Yevgeniy, Jain, Manish, Bukhman, Eugene, Farah, Humam, McClain, Rebekah, Shaik, Sadia, Hatlen, Timothy, Gotur, Deepa, Surber, Joseph, Kingsley, Jeffrey, Pixler, April, Zopo, Alex, Herman, Jack, Herman, Craig, Leon, Ramon, Nikolov, Boris, Vergara, Fernando Gonzalez, Gonzalez, Ana I., Gonzalez, Noemi, Gelman, Michael, Andriunas, Olga, Jagizarov, Zarema, Westerman, Jan, Davis, David, Sherer, Donna, Dooley, Kelly, Becker, Becky, Wilkins, Adaliah, Pérez, Jose, Roman, Eloy, Fernández, Heriberto, Mocherla, Bharat, Beck, Kelly, Maldonado, Valarie, Veltman, Jennifer, Gandhi, Rajesh, Shea, Katrina, Planchon, Matthew, Herpel, Laura Bogan, Tripathi, Kaushlendra K., Day, Donald C., Pullman, John, Sr., Williams-Leber, Erin, Johnson, Misty, Hecker, Michelle, Avery, Ann, Hoover, Keila, Monlux, George W., Juneja, Elizabeth, Jr., Wernick, Arthur, Ruiz, Karelia, Hernández, Maureen, Pérez, Yadilys, Taiwo, Babafemi O., Hawkins, Claudia, Berzins, Baiba, Malvestutto, Carlos, Harber, Heather, Cicarella, Robyn, DeJesus, Edwin, Rolle, Charlotte-Paige, Free, Almena L., Pulliam, Sallie D., Weinstein, Debra, Suarez, Rosa M., Socorro, Ezequiel, Socorro, Estefania, Neytman, Gene, Easley, Raymond, Aziz, Mariam, Swiatek, Joan, Nagpal, Avish, Kompelien, Breanna, McEvoy, Kathryn, Hoover, Susan E., Lutz, Allison, Just, Jessica, Hernandez, Manuel, Victoria, Yanly B., Rodriguez, Gabriel, Pathak, Divya, Ordway, Joshua J., Heffner, Megan, Weston, Patrick, Weston, Khalilah, Choudhary, Madhu, Sullivano, Jennifer, Osiyemi, Olayemi, Izquierdo, Myriam, Torna, Odelsey, Clemency, Brian, Varughese, Renoj, Lynch, Joshua, Khodabakhshian, Aleen, Fortier, Samantha, Coyne, Christopher, Cronin, Alexandrea, Benson, Constance, Hendrickx, Steven, Ramirez, Rosemarie, Luetkemeyer, Anne, Hendler, Suzanne, Dentoni-Lasofsky, Dennis, Rathore, Mobeen, Mahmoudi, Saniyyah, Riaz, Amna, Castro, Mario, Spikes, Leslie, Hall, Chase, Oakes, Jonathan, Loftis, Amy James, Tebas, Pablo, Short, William, Dube, Michael P., Khan, Saahir, Mendez, Luis M., McGuffin, Sarah, Jonsson, Chris, Jain, Mamta K., Senthil, Smruthi, Turner-Gray, Kimberly, Mehta, Sanjay, Lewinski, Mary, Azizad, Masoud, Chow, Christopher, Nakatani, Lisa, Williamson, Derrick, Atriss, Hisham, Caloura, Matthew, Malla, Midhun, Hazard-Jenkins, Hannah, Wilkin, Aimee, Fayssoux, Jamraus, Seagle, Hannah, Presti, Rachel, Haile, Alem, Wohl, David A., Li, Jonathan Z., Eron, Joseph J., Currier, Judith S., Daar, Eric S., Smith, Davey M., Hughes, Michael D., and Chew, Kara W.

Published
2024
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4. Phase 3 Safety and Efficacy of AZD1222 (ChAdOx1 nCoV-19) Covid-19 Vaccine

Author

Falsey, Ann R, Sobieszczyk, Magdalena E, Hirsch, Ian, Sproule, Stephanie, Robb, Merlin L, Corey, Lawrence, Neuzil, Kathleen M, Hahn, William, Hunt, Julie, Mulligan, Mark J, McEvoy, Charlene, DeJesus, Edwin, Hassman, Michael, Little, Susan J, Pahud, Barbara A, Durbin, Anna, Pickrell, Paul, Daar, Eric S, Bush, Larry, Solis, Joel, Carr, Quito Osuna, Oyedele, Temitope, Buchbinder, Susan, Cowden, Jessica, Vargas, Sergio L, Guerreros Benavides, Alfredo, Call, Robert, Keefer, Michael C, Kirkpatrick, Beth D, Pullman, John, Tong, Tina, Brewinski Isaacs, Margaret, Benkeser, David, Janes, Holly E, Nason, Martha C, Green, Justin A, Kelly, Elizabeth J, Maaske, Jill, Mueller, Nancy, Shoemaker, Kathryn, Takas, Therese, Marshall, Richard P, Pangalos, Menelas N, Villafana, Tonya, and Gonzalez-Lopez, Antonio

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Trials and Supportive Activities, Coronaviruses Vaccines, Infectious Diseases, Vaccine Related, Clinical Research, Immunization, Emerging Infectious Diseases, Coronaviruses, Prevention, 6.1 Pharmaceuticals, Infection, Good Health and Well Being, Adolescent, Adult, Aged, Aged, 80 and over, Antibodies, Neutralizing, Antibodies, Viral, COVID-19, ChAdOx1 nCoV-19, Chile, Double-Blind Method, Female, Humans, Immunogenicity, Vaccine, Male, Middle Aged, Peru, SARS-CoV-2, Spike Glycoprotein, Coronavirus, United States, Vaccine Efficacy, Young Adult, AstraZeneca AZD1222 Clinical Study Group, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundThe safety and efficacy of the AZD1222 (ChAdOx1 nCoV-19) vaccine in a large, diverse population at increased risk for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the United States, Chile, and Peru has not been known.MethodsIn this ongoing, double-blind, randomized, placebo-controlled, phase 3 clinical trial, we investigated the safety, vaccine efficacy, and immunogenicity of two doses of AZD1222 as compared with placebo in preventing the onset of symptomatic and severe coronavirus disease 2019 (Covid-19) 15 days or more after the second dose in adults, including older adults, in the United States, Chile, and Peru.ResultsA total of 32,451 participants underwent randomization, in a 2:1 ratio, to receive AZD1222 (21,635 participants) or placebo (10,816 participants). AZD1222 was safe, with low incidences of serious and medically attended adverse events and adverse events of special interest; the incidences were similar to those observed in the placebo group. Solicited local and systemic reactions were generally mild or moderate in both groups. Overall estimated vaccine efficacy was 74.0% (95% confidence interval [CI], 65.3 to 80.5; P

Published
2021

5. Patterns of Antiretroviral Therapy Use and Immunologic Profiles at Enrollment in the REPRIEVE Trial

Author

Fichtenbaum, Carl J, Ribaudo, Heather J, Leon-Cruz, Jorge, Overton, Edgar T, Zanni, Markella V, Malvestutto, Carlos D, Aberg, Judith A, Kileel, Emma M, Fitch, Kathleen V, Van Schalkwyk, Marije, Kumarasamy, Nagalingeswaran, Martinez, Esteban, Santos, Breno Riegel, Joseph, Yvetot, Lo, Janet, Siminski, Sue, Melbourne, Kathleen, Sponseller, Craig A, Desvigne-Nickens, Patrice, Bloomfield, Gerald S, Currier, Judith S, Hoffmann, Udo, Douglas, Pamela S, Grinspoon, Steven K, Curran, Adrian, Baranauskas, Adrienne, Wilkin, Aimee, Abrams-Downey, Alexandra J, Eckard, Allison Ross, Wurcel, Alysse G, González-Cordón, Ana, Paez, Armando, Sha, Beverly E, Santos, Breno, Yoshida, Carina Beppu, Rolle, Charlotte-Paige, Somboonwit, Charurut, Funk, Connie, Gómez-Ayerbe, Cristina, Frank, Cynthia, Nixon, Daniel E, Skiest, Daniel J, Choi, David, Mushatt, David M, Rial-Crestelo, David, Perez, Deborah K, Burke, Deirdre J, dos Santos, Desirée VG, Jayaweera, Dushyantha T, Gardner, Edward M, DeJesus, Edwin, Connick, Elizabeth, Lam, Emerline G, Hecker, Emily J, Kallas, Esper G, Waters, Evan, Rhame, Frank, Sattler, Fred R, Wang, Gary P, Enrile Seedhom, Helen May, Tavares, Isabel CF, Stapleton, Jack T, Bennet, Jaclyn, Brock, James B, Scott, James, Forcht, Janet, Lama, Javier R, Valencia, Javier, Brumfield, Jennifer K, Portilla, Joaquin, Kumar, Jonathan, Navarro, Jordi, Pinto, Jorge A, Castro, Jose G, Bernardino, Jose I, Casado, Jose L, Madruga, José Valdez, Baraiaetxaburu, Josu, Berenguer, Juan, Tashima, Karen T, Ho, Ken, Costa, Laura VL, Perez Latorre, Leire, Mohapi, Lerato, López-González, L, Fantry, Lori E, Domínguez-Domínguez, Lourdes, Martín-Carbonero, Luz, Cornelissen, Lynne M, Jain, Mamta K, Masiá, Mar, Lacerda, Marcus VG, Saumoy, Maria, Villalobos-Hernández, Marina, and Mall, Mark

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Sexually Transmitted Infections, HIV/AIDS, Clinical Trials and Supportive Activities, Clinical Research, Infectious Diseases, 6.1 Pharmaceuticals, Infection, Good Health and Well Being, Adult, Anti-Retroviral Agents, CD4 Lymphocyte Count, CD4-CD8 Ratio, Cross-Sectional Studies, Female, HIV Infections, Humans, Male, Middle Aged, Randomized Controlled Trials as Topic, HIV, statins, pitavastatin calcium, antiretroviral therapy, CD4 cell count, CD4/CD8 ratio, REPRIEVE, cardiovascular disease, REPRIEVE Investigators, Biological Sciences, Medical and Health Sciences, Microbiology, Biological sciences, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundPatterns of antiretroviral therapy (ART) use and immunologic correlates vary globally, and contemporary trends are not well described.MethodsThe REPRIEVE trial (Randomized Trial to Prevent Vascular Events in HIV) enrolled persons with human immunodeficiency virus (HIV) who were aged 40-75 years, receiving ART, and had low-to-moderate cardiovascular disease risk. ART use was summarized within Global Burden of Disease (GBD) super-regions, with adjusted linear and logistic regression analyses examining associations with immune parameters and key demographics.ResultsA total of 7770 participants were enrolled, with a median age of 50 years (interquartile range, 45-55 years); 31% were female, 43% were black or African American, 15% were Asian, 56% had a body mass index >25 (calculated as weight in kilograms divided by height in meters squared), and 49% were current or former smokers. The median CD4 T-cell count was 620/µL (interquartile range, 447-826/ µ L), and the median duration of prior ART use, 9.5 years (5.3-14.8) years. The most common ART regimens were nucleoside/nucleotide reverse-transcriptase inhibitor (NRTI) plus nonnucleoside reverse-transcriptase inhibitor (43%), NRTI plus integrase strand transfer inhibitor (25%), and NRTI plus protease inhibitor (19%). Entry ART varied by GBD region, with shifts during the trial enrollment period. In adjusted analyses, entry CD4 cell count and CD4/CD8 ratio were associated with GBD region, sex, entry regimen, duration of ART, and nadir CD4 cell count; CD4 and CD8 cell counts were also associated with body mass index and smoking status.ConclusionsThere were substantial variations in ART use by geographic region and over time, likely reflecting the local availability of specific medications, changes in treatment guidelines and provider/patient preferences. The analyses of CD4 cell counts and CD4/CD8 ratios may provide valuable insights regarding immune correlates and outcomes in people living with HIV.Clinical trials registrationNCT02344290.

Published
2020

7. Safety and antiviral activity of triple combination broadly neutralizing monoclonal antibody therapy against HIV-1: a phase 1 clinical trial

Author

Julg, Boris, Stephenson, Kathryn E., Wagh, Kshitij, Tan, Sabrina C., Zash, Rebecca, Walsh, Stephen, Ansel, Jessica, Kanjilal, Diane, Nkolola, Joseph, Walker-Sperling, Victoria E. K., Ophel, Jasper, Yanosick, Katherine, Borducchi, Erica N., Maxfield, Lori, Abbink, Peter, Peter, Lauren, Yates, Nicole L., Wesley, Martina S., Hassell, Tom, Gelderblom, Huub C., deCamp, Allen, Mayer, Bryan T., Sato, Alicia, Gerber, Monica W., Giorgi, Elena E., Gama, Lucio, Koup, Richard A., Mascola, John R., Monczor, Ana, Lupo, Sofia, Rolle, Charlotte-Paige, Arduino, Roberto, DeJesus, Edwin, Tomaras, Georgia D., Seaman, Michael S., Korber, Bette, and Barouch, Dan H.

Published
2022
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8. Safety, pharmacokinetics and antiviral activity of PGT121, a broadly neutralizing monoclonal antibody against HIV-1: a randomized, placebo-controlled, phase 1 clinical trial

Author

Stephenson, Kathryn E., Julg, Boris, Tan, C. Sabrina, Zash, Rebecca, Walsh, Stephen R., Rolle, Charlotte-Paige, Monczor, Ana N., Lupo, Sofia, Gelderblom, Huub C., Ansel, Jessica L., Kanjilal, Diane G., Maxfield, Lori F., Nkolola, Joseph, Borducchi, Erica N., Abbink, Peter, Liu, Jinyan, Peter, Lauren, Chandrashekar, Abishek, Nityanandam, Ramya, Lin, Zijin, Setaro, Alessandra, Sapiente, Joseph, Chen, Zhilin, Sunner, Lisa, Cassidy, Tyler, Bennett, Chelsey, Sato, Alicia, Mayer, Bryan, Perelson, Alan S., deCamp, Allan, Priddy, Frances H., Wagh, Kshitij, Giorgi, Elena E., Yates, Nicole L., Arduino, Roberto C., DeJesus, Edwin, Tomaras, Georgia D., Seaman, Michael S., Korber, Bette, and Barouch, Dan H.

Published
2021
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9. Efficacy, Safety, and Tolerability of Switching From Bictegravir/Emtricitabine/Tenofovir Alafenamide to Dolutegravir/Lamivudine Among Adults With Virologically Suppressed HIV: The DYAD Study.

Author

Rolle, Charlotte-Paige, Castano, Jamie, Nguyen, Vu, Hinestrosa, Federico, and DeJesus, Edwin

Subjects
CLINICAL trials, LAMIVUDINE, TENOFOVIR, EMTRICITABINE, ADULTS
Abstract

Background In TANGO and SALSA, switching to dolutegravir/lamivudine (DTG/3TC) was noninferior to continuing a baseline regimen among adults who were treatment experienced, although few switched from bictegravir (B) / emtricitabine (F) / tenofovir alafenamide (TAF). Here, we present the efficacy and safety of switching to DTG/3TC as compared with continuing with B/F/TAF among adults with virologic suppression. Methods DYAD is an open-label clinical trial that randomized adults with HIV-1 RNA <50 copies/mL and no prior virologic failure (2:1) to switch to once-daily fixed-dose DTG/3TC or maintain B/F/TAF. The primary end point is the proportion with HIV-1 RNA ≥50 copies/mL at week 48 (Food and Drug Administration Snapshot algorithm, intention-to-treat exposed population, 6% noninferiority margin). Results Overall, 222 adults were randomized (16% women, 51% aged ≥50 years, 28% Black). At week 48, 6 (4%) with DTG/3TC and 5 (7%) with B/F/TAF had HIV-1 RNA ≥50 copies/mL (treatment difference, −2.8%; 95% CI, −11.4% to 3.1%), meeting noninferiority criteria. Through week 48, 18 participants (12 with DTG/3TC, 6 with B/F/TAF) met confirmed virologic withdrawal (CVW) criteria, and 2 of 18 had resistance: 1 with B/F/TAF developed M184M/I and G140G/S at week 12, and 1 with DTG/3TC had M184V at week 12. One participant with DTG/3TC and non-CVW developed M184V and K65R at week 12. Drug-related adverse events (AEs) and withdrawals due to AEs occurred in 31 (21%) and 6 (4%) participants with DTG/3TC and 2 (3%) and 0 participants with B/F/TAF, respectively. Conclusions Switching to DTG/3TC was noninferior to continuing B/F/TAF among adults with virologic suppression at week 48. Drug-related AEs and withdrawals were higher in the DTG/3TC arm, which is likely consistent with the open-label nature of this switch study. [ABSTRACT FROM AUTHOR]

Published
2024
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12. Identification and Localization of Wind Turbine Blade Faults Using Deep Learning.

Author

Davis, Mason, Nazario Dejesus, Edwin, Shekaramiz, Mohammad, Zander, Joshua, and Memari, Majid

Subjects
WIND turbine blades, COMPUTER vision, WIND turbines, COMPUTATIONAL complexity, EROSION
Abstract

This study addresses the challenges inherent in the maintenance and inspection of wind turbines through the application of deep learning methodologies for fault detection on Wind Turbine Blades (WTBs). Specifically, this research focuses on defect detection on the blades of small-scale WTBs due to the unavailability of commercial wind turbines. This research compared popular object localization architectures, YOLO and Mask R-CNN, to identify the most effective model to detect common WTB defects, including cracks, holes, and erosion. YOLOv9 C emerged as the most effective model, with the highest scores of mAP50 and mAP50-95 of 0.849 and 0.539, respectively. Modifications to Mask R-CNN, specifically integrating a ResNet18-FPN network, reduced computational complexity by 32 layers and achieved a mAP50 of 0.8415. The findings highlight the potential of deep learning and computer vision in improving WTB fault analysis and inspection. [ABSTRACT FROM AUTHOR]

Published
2024
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14. 1596. Efficacy and Safety of Long-Acting Subcutaneous Lenacapavir in Heavily Treatment-Experienced People with Multi-Drug Resistant HIV: Week 104 Results

Author

Ogbuagu, Onyema, primary, DeJesus, Edwin, additional, Berhe, Mezgebe, additional, Richmond, Gary J, additional, Ruane, Peter J, additional, Sinclair, Gary I, additional, Ramgopal, Moti N, additional, Sanchez, William, additional, Crofoot, Gordon E, additional, Margot, Nicolas A, additional, Wang, Hui, additional, Dvory-Sobol, Hadas, additional, Rhee, Martin, additional, Baeten, Jared, additional, and Segal-Maurer, Sorana, additional

Published
2023
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17. Non-nucleoside reverse transcriptase inhibitor (NNRTI) cross-resistance: implications for preclinical evaluation of novel NNRTIs and clinical genotypic resistance testing

Author

Melikian, George L, Rhee, Soo-Yon, Varghese, Vici, Porter, Danielle, White, Kirsten, Taylor, Jonathan, Towner, William, Troia, Paolo, Burack, Jeffrey, DeJesus, Edwin, Robbins, Gregory K, Razzeca, Kristin, Kagan, Ron, Liu, Tommy F, Fessel, W Jeffrey, Israelski, Dennis, and Shafer, Robert W

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Infectious Diseases, Antimicrobial Resistance, Genetics, Anti-HIV Agents, Drug Resistance, Viral, Genotyping Techniques, HIV, HIV Infections, Humans, Microbial Sensitivity Tests, RNA-Directed DNA Polymerase, Reverse Transcriptase Inhibitors, HIV-1, drug resistance, etravirine, linear regression, rilpivirine, Microbiology, Medical Microbiology, Pharmacology and Pharmaceutical Sciences, Clinical sciences, Pharmacology and pharmaceutical sciences
Abstract

ObjectivesThe introduction of two new non-nucleoside reverse transcriptase inhibitors (NNRTIs) in the past 5 years and the identification of novel NNRTI-associated mutations have made it necessary to reassess the extent of phenotypic NNRTI cross-resistance.MethodsWe analysed a dataset containing 1975, 1967, 519 and 187 genotype-phenotype correlations for nevirapine, efavirenz, etravirine and rilpivirine, respectively. We used linear regression to estimate the effects of RT mutations on susceptibility to each of these NNRTIs.ResultsSixteen mutations at 10 positions were significantly associated with the greatest contribution to reduced phenotypic susceptibility (≥10-fold) to one or more NNRTIs, including: 14 mutations at six positions for nevirapine (K101P, K103N/S, V106A/M, Y181C/I/V, Y188C/L and G190A/E/Q/S); 10 mutations at six positions for efavirenz (L100I, K101P, K103N, V106M, Y188C/L and G190A/E/Q/S); 5 mutations at four positions for etravirine (K101P, Y181I/V, G190E and F227C); and 6 mutations at five positions for rilpivirine (L100I, K101P, Y181I/V, G190E and F227C). G190E, a mutation that causes high-level nevirapine and efavirenz resistance, also markedly reduced susceptibility to etravirine and rilpivirine. K101H, E138G, V179F and M230L mutations, associated with reduced susceptibility to etravirine and rilpivirine, were also associated with reduced susceptibility to nevirapine and/or efavirenz.ConclusionsThe identification of novel cross-resistance patterns among approved NNRTIs illustrates the need for a systematic approach for testing novel NNRTIs against clinical virus isolates with major NNRTI-resistance mutations and for testing older NNRTIs against virus isolates with mutations identified during the evaluation of a novel NNRTI.

Published
2014

19. Efficacy and Safety of Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) in Treatment-Naive Adults With HIV-1 and Transmitted Nonnucleoside Reverse Transcriptase Inhibitor Resistance Mutations

Author

Wong, Alexander, Goldstein, Deborah, Mallolas, Josep, DeJesus, Edwin, Johnson, Margaret, Molina, Jean-Michel, Pozniak, Anton, Rodgers, Anthony, Teal, Valerie, Hepler, Deborah, Kumar, Sushma, Sklar, Peter, Hanna, George J., Hwang, Carey, Badshah, Cyrus, and Teppler, Hedy

Published
2019
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20. Switching to Fixed-Dose Bictegravir, Emtricitabine, and Tenofovir Alafenamide (B/F/TAF) in Virologically Suppressed HIV-1 Infected Women: A Randomized, Open-Label, Multicenter, Active-Controlled, Phase 3, Noninferiority Trial

Author

Kityo, Cissy, Hagins, Debbie, Koenig, Ellen, Avihingsanon, Anchalee, Chetchotisakd, Ploenchan, Supparatpinyo, Khuanchai, Gankina, Natalya, Pokrovsky, Vadim, Voronin, Evgeny, Stephens, Jeffrey L., DeJesus, Edwin, Wang, Hui, Acosta, Rima K., Cao, Huyen, Quirk, Erin, Martin, Hal, and Makadzange, Tariro

Published
2019
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25. Week 96 Genotypic and Phenotypic Results of the Fostemsavir Phase 3 BRIGHTE Study in Heavily Treatment-Experienced Adults Living with Multidrug-Resistant HIV-1

Author

Gartland, Margaret, primary, Cahn, Pedro, additional, DeJesus, Edwin, additional, Diaz, Ricardo Sobhie, additional, Grossberg, Robert, additional, Kozal, Michael, additional, Kumar, Princy, additional, Molina, Jean-Michel, additional, Mendo Urbina, Fernando, additional, Wang, Marcia, additional, Du, Fangfang, additional, Chabria, Shiven, additional, Clark, Andrew, additional, Garside, Louise, additional, Krystal, Mark, additional, Mannino, Frank, additional, Pierce, Amy, additional, Ackerman, Peter, additional, and Lataillade, Max, additional

Published
2022
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27. Maraviroc versus Efavirenz, Both in Combination with Zidovudine-Lamivudine, for the Treatment of Antiretroviral-Naive Subjects with CCR5-Tropic HIV-1 Infection

Author

Cooper, David A., Heera, Jayvant, Goodrich, James, Tawadrous, Margaret, Saag, Michael, DeJesus, Edwin, Clumeck, Nathan, Walmsley, Sharon, Ting, Naitee, Coakley, Eoin, Reeves, Jacqueline D., Reyes-Teran, Gustavo, Westby, Mike, Van Der Ryst, Elna, Ive, Prudence, Mohapi, Lerato, Mingrone, Horacio, Horban, Andrzej, Hackman, Frances, Sullivan, John, and Mayer, Howard

Published
2010

31. Long-Term Efficacy, Safety, and Durability of Cabotegravir and Rilpivirine as 2-Drug Oral Maintenance Therapy After 6 Years of Study

Author

Sutton, Kenneth C, primary, De Vente, Jerome, additional, Leblanc, Roger, additional, Dejesus, Edwin, additional, Smith, Graham, additional, Mills, Anthony, additional, Baril, Jean-Guy, additional, St. Clair, Marty, additional, Stancil, Britt S, additional, Vandermeulen, Kati, additional, and Spreen, William R, additional

Published
2022
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38. Tenofovir disoproxil fumarate, emtricitabine, and efavirenz versus fixed-dose zidovudine/lamivudine and efavirenz in antiretroviral-naive patients

Author

Pozniak, Anton L., Gallant, Joel E., DeJesus, Edwin, and Arribas, Jose R.

Subjects
Zidovudine -- Dosage and administration, Antiviral agents -- Health aspects, HIV infection -- Drug therapy, Health
Abstract

A study conducted examined the efficacy and tolerability of 2 regimens composed of efavirenz (EFV) plus twice-daily fixed-dose zidovudine (ZDV)/lamivudine (3TC) or once-daily tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) over 96 weeks. It is concluded that over 96 weeks, the combination of TDF, FTC, and EFV was superior to fixed-dose ZDV/3TC + EFV for achieving and maintaining an HIV RNA level < 400 copies/mL and an increase in CD4 cells.

Published
2006

39. Antiviral activity, pharmacokinetics, and dose response of the HIV-1 integrase inhibitor GS-9137 (JTK-303) in treatment-naive and treatment-experienced patients

Author

Dejesus, Edwin, Berger, Daniel, Markowitz, Martin, Cochen, Calvin, Hawkins, Trevor, Ruane, Peter, Elion, Richard, Farthing, Charles, Lijie Zhong, Cheng, Andrew K., McColl, Damian, and Kearney, Brian P.

Subjects
Integrase inhibitors -- Research, Integrase inhibitors -- Health aspects, Pharmacokinetics -- Research, Viral drug resistance -- Research, HIV patients -- Health aspects, Health
Abstract

A study was conducted to establish that GS-9137 is a potent low nano-molar strand transfer inhibitor of HIV-1 integrase, evaluating its antiviral activity, tolerability, pharmacokinetics, and pharmacodynamics in a randomized, double-blind, placebo-controlled monotherapy study in 40 HIV-1-infected patients. The results showed that GS-9137 demonstrated substantial short-term antiviral activity and was well tolerated as monotherapy, warranting further study.

Published
2006

40. Abacavir and lamivudine fixed-dose combination tablet once daily compared with abacavir and lamivudine twice daily in HIV-infected patients over 48 weeks (ESS30008, SEAL)

Author

Sosa, Nestor, Hill-zabala, Christina, DeJesus, Edwin, Herrera, Gisella, Florance, Allison, Watson, Maria, Vavro, Cindy, and Shaefer, Mark

Subjects
Abacavir -- Dosage and administration, Abacavir -- Comparative analysis, Lamivudine -- Dosage and administration, Lamivudine -- Comparative analysis, HIV infection -- Drug therapy, Drug therapy, Combination -- Research, Health
Abstract

Abacavir (ABC) and lamivudine (3TC) administered twice daily, were compared with an ABC + 3TC fixed-dose combination administered once daily, both in combination with a protease inhibitor (PI) or nonnucleoside reverse transcriptase inhibitor (NNRTI). It was shown that a dual-nucleoside backbone of ABC and 3TC administered once or twice daily is effective, durable and well tolerated.

Published
2005

41. Induction with abacavir/lamivudine/zidovudine plus efavirenz for 48 weeks followed by 48-week maintenance with abacavir/lamivudine/zidovudine alone in antiretroviral-naive HIV-1-infected patients

Author

Markowitz, Martin, Lanier, Randall E., Hill-Zabala, Christina, Davis, E. Anne, Lang, Joseph, Shaefer, Mark, DeJesus, Edwin, and Liao, Qiming

Subjects
HIV patients -- Medical examination, Highly active antiretroviral therapy -- Analysis, Health
Abstract

A 4-drug induction was tested followed by 3-drug maintenance as initial antiretroviral therapy (ART) to reduce HIV RNA rapidly and then to simplify to an effective yet more convenient and tolerable regime. It was found that after induction with abacavir/lamivudine/zidovudine + efavirenz (ABC/3TC/ZDV + EFV), simplification to ABC/3TC/ZDV alone maintained virologic control and immunologic response, reduced fasting lipids and ART-associated adverse events, and improved adherence.

Published
2005

42. Abacavir once or twice daily combined with once-daily lamivudine and efavirenz for the treatment of antiretroviral-naive HIV-infected adults

Author

Moyle, Graeme J., DeJesus, Edwin, Cahn, Pedro, Castillo, Steve A., Zhao, Henry, Gordon, David N., Craig, Charles, and Scott, Trevor R.

Subjects
Lamivudine -- Dosage and administration, Abacavir -- Dosage and administration, HIV infection -- Drug therapy, Health, Efavirenz (Medication) -- Dosage and administration
Abstract

A randomized double-blind clinical trial compared the efficacy and safety of 600mg of abacavir (ABC) administered once daily versus 300mg of ABC administered twice daily n combination with 300 mg of lamivudine (3TC) and 600 mg of efavirenz (EFV) administered once daily in antiretroviral-naive patients over 48 weeks. The ABC once-daily and twice-daily regimens were similar with respect to infrequency of virologic failure, and emergence of resistarnce mutations.

Published
2005

43. Abacavir versus zidovudine combined with lamivudine and efavirenz, for the treatment of antiretroviral-naive HIV-infected adults

Author

DeJesus, Edwin, Herrera, Gisela, Teofilo, Eugenio, Gerstoft, Jan, Buendia, Carlos Beltran, Brand, J. David, Brothers, Cynthia H., Hernandez, Jaime, Castillo, Steve A., Bonny, Tab, Lanier, E. Randall, and Scott, Trevor R.

Subjects
Drug therapy, Combination -- Research, HIV (Viruses) -- Drug therapy, HIV (Viruses) -- Research, Lamivudine -- Dosage and administration, Lamivudine -- Research, Zidovudine -- Dosage and administration, Zidovudine -- Comparative analysis, Zidovudine -- Research, Abacavir -- Dosage and administration, Abacavir -- Comparative analysis, Abacavir -- Research, Health, Health care industry, Efavirenz (Medication) -- Research, Efavirenz (Medication) -- Dosage and administration
Published
2004

44. New nucleoside/nucleotide backbone options: A review of recent studies

Author

Ruane, Peter J. and DeJesus, Edwin

Subjects
HIV infection -- Causes of, Nucleotides -- Research, Nucleosides -- Research, Health
Abstract

The nucleoside/nucleotide reverse inhibitor (NRTI/NtRTI) class continues to serve as an important component of the standard of care for HIV infection. Recent efficacy and safety data on emerging NRTI/NtRTI combination backbone is also summarized.

Published
2004

45. Once-daily versus twice-daily lamivudine, in combination with zidovudine and efavirenz, for the treatment of antiretroviral-naive adults with HIV infection: a randomized equivalence trial

Author

DeJesus, Edwin, McCarty, Debra, Farthing, Charles F., Shortino, Denise D., Grinsztejn, Beatriz, Thomas, Deborah A., Schrader, Shannon R., Castillo, Steve A., Sension, Michael G., Gough, Kevin, and Madison, Sam J.

Subjects
Lamivudine -- Health aspects, HIV patients -- Care and treatment, Health, Health care industry
Published
2004

50. 1002. A Daily Single Tablet Regimen (STR) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Virologically-Suppressed Adults Living with HIV and End Stage Renal Disease on Chronic Hemodialysis

Author

Eron, Joseph J, primary, Wilkin, Aimee, additional, Ramgopal, Moti, additional, Osiyemi, Olayemi, additional, McKellar, Mehri, additional, Slim, Jihad, additional, Asmuth, David, additional, DeJesus, Edwin, additional, German, Polina, additional, Blair, Christiana, additional, Carter, Christoph C, additional, Brainard, Diana M, additional, Collins, Sean E, additional, and Martin, Hal, additional

Published
2020
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