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1. A Receptor Story: Insulin Resistance Pathophysiology and Physiologic Insulin Resensitization's Role as a Treatment Modality.

Author

Lewis, Stanley T, Greenway, Frank, Tucker, Tori R, Alexander, Michael, Jackson, Levonika K, Hepford, Scott A, Loveridge, Brian, and Lakey, Jonathan RT

Subjects
Humans, Diabetes Mellitus, Type 2, Insulin Resistance, Insulin, Blood Glucose, Ligands, Insulin, Regular, Human, T2D, carbohydrate metabolism, diabetes, insulin resistance, physiologic insulin resensitization, Clinical Research, Diabetes, Prevention, Metabolic and endocrine, Other Chemical Sciences, Genetics, Other Biological Sciences, Chemical Physics
Abstract

Physiologic insulin secretion consists of an oscillating pattern of secretion followed by distinct trough periods that stimulate ligand and receptor activation. Apart from the large postprandial bolus release of insulin, β cells also secrete small amounts of insulin every 4-8 min independent of a meal. Insulin resistance is associated with a disruption in the normal cyclical pattern of insulin secretion. In the case of type-2 diabetes, β-cell mass is reduced due to apoptosis and β cells secrete insulin asynchronously. When ligand/receptors are constantly exposed to insulin, a negative feedback loop down regulates insulin receptor availability to insulin, creating a relative hyperinsulinemia. The relative excess of insulin leads to insulin resistance (IR) due to decreased receptor availability. Over time, progressive insulin resistance compromises carbohydrate metabolism, and may progress to type-2 diabetes (T2D). In this review, we discuss insulin resistance pathophysiology and the use of dynamic exogenous insulin administration in a manner consistent with more normal insulin secretion periodicity to reverse insulin resistance. Administration of insulin in such a physiologic manner appears to improve insulin sensitivity, lower HgbA1c, and, in some instances, has been associated with the reversal of end-organ damage that leads to complications of diabetes. This review outlines the rationale for how the physiologic secretion of insulin orchestrates glucose metabolism, and how mimicking this secretion profile may serve to improve glycemic control, reduce cellular inflammation, and potentially improve outcomes in patients with diabetes.

Published
2023

2. Physiologic Insulin Resensitization as a Treatment Modality for Insulin Resistance Pathophysiology

Author

Greenway, Frank, Loveridge, Brian, Grimes, Richard M, Tucker, Tori R, Alexander, Michael, Hepford, Scott A, Fontenot, Justin, Nobles-James, Candi, Wilson, Carol, Starr, Adam M, Abdelsaid, Mohammed, Lewis, Stanley T, and Lakey, Jonathan RT

Subjects
Biochemistry and Cell Biology, Biological Sciences, Medicinal and Biomolecular Chemistry, Chemical Sciences, Microbiology, Diabetes, Metabolic and endocrine, Diabetes Mellitus, Type 2, Glycated Hemoglobin, Humans, Insulin Resistance, Insulin Secretion, Insulin, Regular, Human, Pancreas, insulin resistance, diabetes, metabolic disorder, obesity, insulin infusion, physiologic insulin resensitization, PIR, treatment modality, neuropathy, nephropathy, retinopathy, cardiovascular disease, chronic kidney disease, CKD, Other Chemical Sciences, Genetics, Other Biological Sciences, Chemical Physics, Biochemistry and cell biology, Medicinal and biomolecular chemistry
Abstract

Prevalence of type 2 diabetes increased from 2.5% of the US population in 1990 to 10.5% in 2018. This creates a major public health problem, due to increases in long-term complications of diabetes, including neuropathy, retinopathy, nephropathy, skin ulcers, amputations, and atherosclerotic cardiovascular disease. In this review, we evaluated the scientific basis that supports the use of physiologic insulin resensitization. Insulin resistance is the primary cause of type 2 diabetes. Insulin resistance leads to increasing insulin secretion, leading to beta-cell exhaustion or burnout. This triggers a cascade leading to islet cell destruction and the long-term complications of type 2 diabetes. Concurrent with insulin resistance, the regular bursts of insulin from the pancreas become irregular. This has been treated by the precise administration of insulin more physiologically. There is consistent evidence that this treatment modality can reverse the diabetes-associated complications of neuropathy, diabetic ulcers, nephropathy, and retinopathy, and that it lowers HbA1c. In conclusion, physiologic insulin resensitization has a persuasive scientific basis, significant treatment potential, and likely cost benefits.

Published
2022

3. Safety and efficacy of doravirine as first-line therapy in adults with HIV-1: week 192 results from the open-label extensions of the DRIVE-FORWARD and DRIVE-AHEAD phase 3 trials

Author

Martins, Marcelo D, Cahn, Pedro E, Lopardo, Gustavo D, Porteiro, Norma, Bloch, Mark Theo, Baker, David Alfred, Roth, Norman, Moore, Richard J, Finlayson, Robert James, McMahon, James, Rieger, Armin, Zoufaly, Alexander, Schmied, Brigitte, Hartl, Sylvia, Zangerle, Robert, Smaill, Fiona, Walmsley, Sharon L, Conway, Brian, Rachlis, Anita, Smith, Graham H R, Perez Cortes, Carlos, Afani, Alejandro, Campos Barker, Maria Isabel E, Chahin Anania, Carolina Eugenia, Reyes, Marcelo J. Wolff, Gerstoft, Jan, Weis, Nina, Laursen, Alex Lund, Molina, Jean-Michel, Yazdanpanah, Yazdan, Cotte, Laurent, Raffi, Francois, Slama, Laurence, Morlat, Philippe, Girard, Pierre-Marie, Katlama, Christine, Rockstroh, Juergen K, Arasteh, Keikawus, Esser, Stefan, Stoehr, Albrecht, Stellbrink, Hans-Juergen, Stoll, Matthias, Schuermann, Dirk, Faetkenheuer, Gerd, Bogner, Johannes Richard, Lutz, Thomas, Baumgarten, Axel, Jaeger, Hans, Wiese, Carmen, Gori, Andrea, Migliorino, Guglielmo Marco, Coltan, Gabriel, Constandis, Felicia, Erscoiu, Simona M, Prisacariu, Liviu-Jany, Rugina, Sorin, Streinu-Cercel, Adrian, Pokrovsky, Vadim V, Zakharova, Natalia, Shuldyakov, Andrey Anatolyevich, Ryamova, Elena Pavlovna, Kulagin, Valeriy Viktorovich, Tsybakova, Olga Aleksandrovna, Orlova-Morozova, Elena, Nagimova, Firaya, Voronin, Evgeniy, Shimonova, Tatiana Evgenyevna, Kozyrev, Oleg Anatolyevich, Orrell, Catherine, Lombaard, Johannes Jurgens, Botes, Margaretha Elizabeth, de Jager, Marleen, Segorb, Joaquin Portilla, Gatell Artigas, Josep Maria, Mallolas Masferrer, Josep, Guillen, Santiago Moreno, Perez Elias, Maria Jesus, Arribas Lopez, Jose R, Puigmal, Eugenia Negredo, Podzamczer Palter, Daniel, Ortega, Frederico Pulido, Garcia, Jesus Troya, de los Santos Gil, Ignacio, Berenguer, Juan, Nelson, Mark Richard, Williams, Ian G, Johnson, Margaret A, Khoo, Saye, Schembri, Gabriel, Clarke, Amanda, Gompels, Mark, Fox, Julie Meriel, Lwanga, Julianne, Taylor, Steven John, Dockrell, David Harold, Kegg, Stephen, Hagins, Debbie P, Osiyemi, Olayemi O, Prelutsky, David James, Ramgopal, Moti N, Scarsella, Anthony J, Dretler, Robin, DeJesus, Edwin, Bettacchi, Christopher J, Sims III, James, Clay, Patrick G, Bellos, Nicholaos C, Thompson, Melanie A, Montero, Jose, McDonald, Cheryl K, Creticos, Catherine, Shamblaw, David, Terrelonge, Antonio E, Valdes, Martin, Tashima, Karen T, Robbins, William J, Elion, Richard A, Goldstein, Deborah, Slim, Jihad, Lalezari, Jacob Paul, Pushkin, Richard, Lalla-Reddy, Sujata N, Win, Sanda S, Ruane, Peter Jerome, Mills, Anthony Martin, Cade, Jerry L, Campo, Rafael, Dietz, Craig A, Hoffman-Terry, Margaret, Blick, Gary, Rubin, David Scott, Mayer, Cynthia, Rondon, Juan Carlos, Cook, Paul P, Daar, Eric, Kumar, Princy N, Swindells, Susan, Castro, Jose Guillermo, Morales-Ramirez, Javier O, Santiago, Lizette, Santana-Bagur, Jorge L, Vandekerckhove, Linos, Florence, Eric, De Wit, Stephane, Derdelinckx, Inge, Vandercam, Bernard, Belkhir, Leila, De Wet, Joseph, Lebouche, Bertrand, Trottier, Benoit, Longpre, Daniele, Szabo, Jason, LeBlanc, Roger P, Jensen, Werner, Gonzalez, Alvaro Rojas, Beltran, Carlos, Sussmann, Otto Alberto, Velez, Juan Diego, Onate, Jose Millan, Nielsen, Henrik, Degen, Olaf, Stephan, Christoph, Arathoon, Eduardo, Lopez, Rudy Manuel, Rojas Alvarado, Evelyn Michelle, Gonzalez Patzan, Luis Demetrio, Meija, Carlos R, Pinzon, Rodolfo, Parchment, Charles, Sthoeger, Zev, Chowers, Michal, Riesenberg, Klaris, Shahar, Eduardo, Levy, Itzchak, Quintero Perez, Nora Patricia, Andrade-Villanueva, Jaime Federico, Crabtree Ramirez, Brenda Eloisa, Rijnders, Bart, den Hollander, Jan G, Handy, Rupert, Morales, Nilo Bonifacio, Hidalgo, Jose Alfredo, Infante, Rosa Mercedes, Matos Prado, Eduardo Demetrio, Campos, Pablo E, Ticona Chaves, Eduardo Romulo, Pinedo, Yvett, Pacheco, Patricia, Maltez, Fernando Manuel, Cunha, Jose, Neves, Isabel, Serrao, Rosario, Melendez-Rivera, Ivan, Mendoza-Rodriguez, Rafael O, Maldonado-Rivera, Sandra, Ortiz-Lasanta, Grisell, Kizhlo, Svetlana, Freud, Hernando Knobel, Moreno, Jose Sanz, Mendez, Francisco Vera, Mohapi, Lerato, Mitha, Essack Aziz, Mahomed, Akbar Anvar, Fouche, Leon Frederik, Kaplan, Richard, Siddique, Naeem, Hoosen, Farzana, Rassool, Mohammed Siddique, Baraldi, Ezio, Calmy, Alexandra, Cavassini, Matthias, Fehr, Jan, Tsai, Hung-Chin, Lin, Hsi-Hsun, Huang, Chun-Kai, Ko, Wen-Chien, Lin, Yu-Hui, Chen, Su-Jung, Hung, Chien-Ching, Avihingsanon, Anchalee, Kiertiburanakul, Sasisopin, Ratanasuwan, Winai, Supparatpinyo, Khuanchai, Chetchotisakd, Ploenchan, Changpradub, Dhitiwat, Orkin, Chloe, Fox, Ashini, Winston, Alan, Ustianowski, Andrew, Yangco, Bienvenido G, Asmuth, David Michael, Vigil, Karen J, Berger, Daniel S, Bhatti, Laveeza, Campbell, Thomas, Casey, Kathleen K, Liu, Edward, Crofoot, Gordon E, Cunningham, Douglas, Feinberg, Judith, Fichtenbaum, Carl, Balamban Felizarta, Franco Antonio, Jefferson, Thomas T, Johnson, Marc Alexander, Lewis, Stanley T, Luque, Amneris E, Novak, Richard M, Sloan, Louis, Sweet, Donna E, Towner, William J, Zane, Ryan, Riedel, David J, Loftus, Richard Anton, Shon, Alyssa So Young, Mogyoros, Miguel, Tebas, Pablo, Scott, Mia Louise, Parenti, David M, Inciarte Portillo, Alexy, Cahn, Pedro, Lombaard, Johannes, Kumar, Sushma, Campbell, Havilland, Wan, Hong, Teal, Valerie, Jin Xu, Zhi, Asante-Appiah, Ernest, Sklar, Peter, Teppler, Hedy, and Lahoulou, Rima

Published
2024
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5. Doravirine versus ritonavir-boosted darunavir in antiretroviral-naive adults with HIV-1 (DRIVE-FORWARD): 48-week results of a randomised, double-blind, phase 3, non-inferiority trial

Author

Martins, Marcelo, Cahn, Pedro Enrique, Lopardo, Gustavo D., Porteiro, Norma, Bloch, Mark Theo, Baker, David Alfred, Roth, Norman, Moore, Richard James, Finlayson, Robert James, McMahon, James, Rieger, Armin, Zoufaly, Alexander, Hartl, Sylvia, Zangerle, Robert, Smaill, Fiona, Walmsley, Sharon L., Conway, Brian, Rachlis, Anita, Smith, Graham H.R., Perez, Carlos, Afani, Alejandro, Campos Barker, Maria Isabel E., Chahin, Carolina Eugenia, Wolff Reyes, Marcelo, Gerstoft, Jan, Weis, Nina, Laursen, Alex Lund, Molina, Jean-Michel, Yazdanpanah, Yazdan, Cotte, Laurent, Raffi, Francois, Morlat, Philippe, Girard, Pierre-Marie, Katlama, Christine, Rockstroh, Juergen K., Arasteh, Keikawus, Esser, Stefan, Stoehr, Albrecht, Stellbrink, Hans-Juergen, Stoll, Matthias, Schuermann, Dirk, Faetkenheuer, Gerd, Bogner, Johannes, Lutz, Thomas, Baumgarten, Axel, Jaeger, Hans, Gori, Andrea, Coltan, Gabriel, Constandis, Felicia, Erscoiu, Simona Manuela, Prisacariu, Liviu-Jany, Rugina, Sorin, Streinu-Cercel, Adrian, Pokrovsky, Vadim Valentinovich, Zakharova, Natalia V., Shuldyakov, Andrey Anatolyevich, Ryamova, Elena Pavlovna, Kulagin, Valeriy Viktorovich, Tsybakova, Olga Aleksandrovna, Orlova-Morozova, Elena, Nagimova, Firaya, Voronin, Evgeniy, Shimonova, Tatyana Evgenyevna, Kozyrev, Oleg Anatolyevich, Orrell, Catherine, Lombaard, Johannes Jurgens, Botes, Margaretha Elizabeth, Portilla, Joaquin, Gatell, Josep Maria, Perez, Maria Jesus, Arribas, Jose Ramon, Negredo, Eugenia, Podzamczer, Daniel, Pulido, Federico, Troya, Jesus, De los Santos, Ignacio, Berenguer, Juan, Williams, Ian G., Johnson, Margaret A., Schembri, Gabriel, Clarke, Amanda, Gompels, Mark, Fox, Julie Meriel, Taylor, Steven John, Kegg, Stephen, Hagins, Debbie P., Osiyemi, Olayemi O., Prelutsky, David James, Ramgopal, Moti N., Dretler, Robin, DeJesus, Edwin, Sloan, Louis, Lewis, Stanley T., Clay, Patrick G., Bellos, Nicholaos C., Thompson, Melanie A., Montero, Jose, McDonald, Cheryl K., Creticos, Catherine, Shamblaw, David, Terrelonge, Antonio E., Valdes, Martin, Tashima, Karen T., Robbins, William J., Felizarta, Franco Antonio, Elion, Richard A., Slim, Jihad, Lalezari, Jacob Paul, Lalla-Reddy, Sujata N., Ruane, Peter Jerome, Mills, Anthony, Cade, Jerry L., Campo, Rafael E., Dietz, Craig A., Blick, Gary, Mayer, Cynthia, Rondon, Juan Carlos, Cook, Paul P., Daar, Eric, Kumar, Princy N., Swindells, Susan, Castro, Jose Guillermo, Morales-Ramirez, Javier O., Santiago, Lizette, Santana-Bagur, Jorge L., Squires, Kathleen, Sax, Paul E, Cahn, Pedro, Lombaard, Johan, Lai, Ming-Tain, Xu, Xia, Rodgers, Anthony, Lupinacci, Lisa, Kumar, Sushma, Sklar, Peter, Nguyen, Bach-Yen, Hanna, George J, and Hwang, Carey

Published
2018
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7. Fixed-dose combination dolutegravir, abacavir, and lamivudine versus ritonavir-boosted atazanavir plus tenofovir disoproxil fumarate and emtricitabine in previously untreated women with HIV-1 infection (ARIA): week 48 results from a randomised, open-label, non-inferiority, phase 3b study

Author

Cahn, Pedro Enrique, Cassetti, Lidia Isabel, Porteiro Barreira, Norma, Angel, Jonathan Benjamin, de Pokomandy, Alexandra, Harris, Marianne, Rachlis, Anita R., Walmsley, Sharon L., Allavena, Clotilde, Bouchaud, Oliver, Gatey, Caroline, Rami, Agathe, Casari, Salvatore, Di Perri, Giovanni, Lazzarin, Adriano, Maggiolo, Franco, Penco, Giovanni, Quirino, Tiziana, Rizzardini, Giuliano, Andrade-Villanueva, Jaime-Federico, Sierra-Madero, Juan G., Branco, Teresa, Serrao, Rosario, Teofilo, Eugenio JR., Melendez-Rivera, Ivan, Santiago, Lizette, Zorrilla, Carmen D., Belonosova, Elena, Chernova, Oksana E., Pokrovsky, Vadim, Rakhmanova, Aza Gasanovna, Tsybakova, Olga, Voronin, Eugene, Orrell, Catherine, Vally, Tasneem, Farisani, Livhuwani ML., Sebopa, Boitumelo Lucrecia, Barros, Carlos Aguado, Cano Sánchez, Alfredo, Castaño, Manuel, Falcó Ferrer, Vicens, González García, Juan J., Hernandez-Quero, Jose, Negredo Puigmal, Eugenia, Pérez Elías, María Jesús, Podzamczer Palter, Daniel, Portilla, Joaquin Sogorb, Viciana Fernández, Pompeyo, Manosuthi, Weerawat, Ruxrungtham, Kiat, Dockrell, David H., Hay, Phillip E., Johnson, Margaret A., Mackie, Nicola E., Orkin, Chloe M., Taylor, Steve, Bhatti, Laveeza, Brar, Indira, Brennan, Robert Owen, Cade, Jerry L., Casanas, Beata, Casey, Kathleen, Cunningham, Douglas, DeJesus, Edwin, Dietz, Craig, Dretler, Robin Henry, Eron, Joseph J., Jr., Felizarta, Franco Antoni B., Fife, Kenneth H., Hagins, Debbie P., Hoffman-Terry, Margaret, Jain, Mamta, Johnson, Marc Alexander, Kinder, Clifford A., Kumar, Princy N., Lewis, Stanley T., Jr., McDonald, Cheryl Kay, Meza, Armando D., Mounzer, Karam C., Newman, Cheryl L., Osiyemi, Olayemi O., Poblete, Ronald, Presti, Rachel M., Ramgopal, Moti, Rosenstock, Joel, Samuel, Rafik, Sandkovsky, Uriel Sebastian, Shon, Alyssa So Young, Skiest, Daniel J., Sloan, Louis M., Small, Catherine B., Tebas, Pablo, Van Dam, Cornelius N., Hagins, Debbie P, Porteiro, Norma, Walmsley, Sharon, Falcó, Vicenç, Man, Choy Y, Aylott, Alicia, Buchanan, Ann M, Wynne, Brian, Vavro, Cindy, Aboud, Michael, and Smith, Kimberly Y

Published
2017
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8. Safety and efficacy of doravirine as first-line therapy in adults with HIV-1: week 192 results from the open-label extensions of the DRIVE-FORWARD and DRIVE-AHEAD phase 3 trials

Author

Orkin, Chloe, Molina, Jean-Michel, Cahn, Pedro, Lombaard, Johannes, Supparatpinyo, Khuanchai, Kumar, Sushma, Campbell, Havilland, Wan, Hong, Teal, Valerie, Jin Xu, Zhi, Asante-Appiah, Ernest, Sklar, Peter, Teppler, Hedy, Lahoulou, Rima, Martins, Marcelo D, Cahn, Pedro E, Lopardo, Gustavo D, Porteiro, Norma, Bloch, Mark Theo, Baker, David Alfred, Roth, Norman, Moore, Richard J, Finlayson, Robert James, McMahon, James, Rieger, Armin, Zoufaly, Alexander, Schmied, Brigitte, Hartl, Sylvia, Zangerle, Robert, Smaill, Fiona, Walmsley, Sharon L, Conway, Brian, Rachlis, Anita, Smith, Graham H R, Perez Cortes, Carlos, Afani, Alejandro, Campos Barker, Maria Isabel E, Chahin Anania, Carolina Eugenia, Reyes, Marcelo J. Wolff, Gerstoft, Jan, Weis, Nina, Laursen, Alex Lund, Molina, Jean-Michel, Yazdanpanah, Yazdan, Cotte, Laurent, Raffi, Francois, Slama, Laurence, Morlat, Philippe, Girard, Pierre-Marie, Katlama, Christine, Rockstroh, Juergen K, Arasteh, Keikawus, Esser, Stefan, Stoehr, Albrecht, Stellbrink, Hans-Juergen, Stoll, Matthias, Schuermann, Dirk, Faetkenheuer, Gerd, Bogner, Johannes Richard, Lutz, Thomas, Baumgarten, Axel, Jaeger, Hans, Wiese, Carmen, Gori, Andrea, Migliorino, Guglielmo Marco, Coltan, Gabriel, Constandis, Felicia, Erscoiu, Simona M, Prisacariu, Liviu-Jany, Rugina, Sorin, Streinu-Cercel, Adrian, Pokrovsky, Vadim V, Zakharova, Natalia, Shuldyakov, Andrey Anatolyevich, Ryamova, Elena Pavlovna, Kulagin, Valeriy Viktorovich, Tsybakova, Olga Aleksandrovna, Orlova-Morozova, Elena, Nagimova, Firaya, Voronin, Evgeniy, Shimonova, Tatiana Evgenyevna, Kozyrev, Oleg Anatolyevich, Orrell, Catherine, Lombaard, Johannes Jurgens, Botes, Margaretha Elizabeth, de Jager, Marleen, Segorb, Joaquin Portilla, Gatell Artigas, Josep Maria, Mallolas Masferrer, Josep, Guillen, Santiago Moreno, Perez Elias, Maria Jesus, Arribas Lopez, Jose R, Puigmal, Eugenia Negredo, Podzamczer Palter, Daniel, Ortega, Frederico Pulido, Garcia, Jesus Troya, de los Santos Gil, Ignacio, Berenguer, Juan, Nelson, Mark Richard, Williams, Ian G, Johnson, Margaret A, Khoo, Saye, Schembri, Gabriel, Clarke, Amanda, Gompels, Mark, Fox, Julie Meriel, Lwanga, Julianne, Taylor, Steven John, Dockrell, David Harold, Kegg, Stephen, Hagins, Debbie P, Osiyemi, Olayemi O, Prelutsky, David James, Ramgopal, Moti N, Scarsella, Anthony J, Dretler, Robin, DeJesus, Edwin, Bettacchi, Christopher J, Sims III, James, Clay, Patrick G, Bellos, Nicholaos C, Thompson, Melanie A, Montero, Jose, McDonald, Cheryl K, Creticos, Catherine, Shamblaw, David, Terrelonge, Antonio E, Valdes, Martin, Tashima, Karen T, Robbins, William J, Elion, Richard A, Goldstein, Deborah, Slim, Jihad, Lalezari, Jacob Paul, Pushkin, Richard, Lalla-Reddy, Sujata N, Win, Sanda S, Ruane, Peter Jerome, Mills, Anthony Martin, Cade, Jerry L, Campo, Rafael, Dietz, Craig A, Hoffman-Terry, Margaret, Blick, Gary, Rubin, David Scott, Mayer, Cynthia, Rondon, Juan Carlos, Cook, Paul P, Daar, Eric, Kumar, Princy N, Swindells, Susan, Castro, Jose Guillermo, Morales-Ramirez, Javier O, Santiago, Lizette, Santana-Bagur, Jorge L, Vandekerckhove, Linos, Florence, Eric, De Wit, Stephane, Derdelinckx, Inge, Vandercam, Bernard, Belkhir, Leila, De Wet, Joseph, Lebouche, Bertrand, Trottier, Benoit, Longpre, Daniele, Szabo, Jason, LeBlanc, Roger P, Jensen, Werner, Gonzalez, Alvaro Rojas, Beltran, Carlos, Sussmann, Otto Alberto, Velez, Juan Diego, Onate, Jose Millan, Nielsen, Henrik, Degen, Olaf, Stephan, Christoph, Arathoon, Eduardo, Lopez, Rudy Manuel, Rojas Alvarado, Evelyn Michelle, Gonzalez Patzan, Luis Demetrio, Meija, Carlos R, Pinzon, Rodolfo, Parchment, Charles, Sthoeger, Zev, Chowers, Michal, Riesenberg, Klaris, Shahar, Eduardo, Levy, Itzchak, Quintero Perez, Nora Patricia, Andrade-Villanueva, Jaime Federico, Crabtree Ramirez, Brenda Eloisa, Rijnders, Bart, den Hollander, Jan G, Handy, Rupert, Morales, Nilo Bonifacio, Hidalgo, Jose Alfredo, Infante, Rosa Mercedes, Matos Prado, Eduardo Demetrio, Campos, Pablo E, Ticona Chaves, Eduardo Romulo, Pinedo, Yvett, Pacheco, Patricia, Maltez, Fernando Manuel, Cunha, Jose, Neves, Isabel, Serrao, Rosario, Melendez-Rivera, Ivan, Mendoza-Rodriguez, Rafael O, Maldonado-Rivera, Sandra, Ortiz-Lasanta, Grisell, Kizhlo, Svetlana, Freud, Hernando Knobel, Moreno, Jose Sanz, Mendez, Francisco Vera, Mohapi, Lerato, Mitha, Essack Aziz, Mahomed, Akbar Anvar, Fouche, Leon Frederik, Kaplan, Richard, Siddique, Naeem, Hoosen, Farzana, Rassool, Mohammed Siddique, Baraldi, Ezio, Calmy, Alexandra, Cavassini, Matthias, Fehr, Jan, Tsai, Hung-Chin, Lin, Hsi-Hsun, Huang, Chun-Kai, Ko, Wen-Chien, Lin, Yu-Hui, Chen, Su-Jung, Hung, Chien-Ching, Avihingsanon, Anchalee, Kiertiburanakul, Sasisopin, Ratanasuwan, Winai, Supparatpinyo, Khuanchai, Chetchotisakd, Ploenchan, Changpradub, Dhitiwat, Orkin, Chloe, Fox, Ashini, Winston, Alan, Ustianowski, Andrew, Yangco, Bienvenido G, Asmuth, David Michael, Vigil, Karen J, Berger, Daniel S, Bhatti, Laveeza, Campbell, Thomas, Casey, Kathleen K, Liu, Edward, Crofoot, Gordon E, Cunningham, Douglas, Feinberg, Judith, Fichtenbaum, Carl, Balamban Felizarta, Franco Antonio, Jefferson, Thomas T, Johnson, Marc Alexander, Lewis, Stanley T, Luque, Amneris E, Novak, Richard M, Sloan, Louis, Sweet, Donna E, Towner, William J, Zane, Ryan, Riedel, David J, Loftus, Richard Anton, Shon, Alyssa So Young, Mogyoros, Miguel, Tebas, Pablo, Scott, Mia Louise, Parenti, David M, and Inciarte Portillo, Alexy

Abstract

In two phase 3 trials for first-line therapy in adults with HIV-1, doravirine showed non-inferior efficacy, a favourable safety profile, and a superior lipid profile to darunavir and efavirenz through to 48 and 96 weeks. Here we report 192-week results from both studies.

Published
2024
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14. Doravirine versus ritonavir-boosted darunavir in antiretroviral-naive adults with HIV-1 (DRIVE-FORWARD): 48-week results of a randomised, double-blind, phase 3, non-inferiority trial

Author

Molina, Jean-Michel, primary, Squires, Kathleen, additional, Sax, Paul E, additional, Cahn, Pedro, additional, Lombaard, Johan, additional, DeJesus, Edwin, additional, Lai, Ming-Tain, additional, Xu, Xia, additional, Rodgers, Anthony, additional, Lupinacci, Lisa, additional, Kumar, Sushma, additional, Sklar, Peter, additional, Nguyen, Bach-Yen, additional, Hanna, George J, additional, Hwang, Carey, additional, Martins, Marcelo, additional, Cahn, Pedro Enrique, additional, Lopardo, Gustavo D., additional, Porteiro, Norma, additional, Bloch, Mark Theo, additional, Baker, David Alfred, additional, Roth, Norman, additional, Moore, Richard James, additional, Finlayson, Robert James, additional, McMahon, James, additional, Rieger, Armin, additional, Zoufaly, Alexander, additional, Hartl, Sylvia, additional, Zangerle, Robert, additional, Smaill, Fiona, additional, Walmsley, Sharon L., additional, Conway, Brian, additional, Rachlis, Anita, additional, Smith, Graham H.R., additional, Perez, Carlos, additional, Afani, Alejandro, additional, Campos Barker, Maria Isabel E., additional, Chahin, Carolina Eugenia, additional, Wolff Reyes, Marcelo, additional, Gerstoft, Jan, additional, Weis, Nina, additional, Laursen, Alex Lund, additional, Molina, Jean-Michel, additional, Yazdanpanah, Yazdan, additional, Cotte, Laurent, additional, Raffi, Francois, additional, Morlat, Philippe, additional, Girard, Pierre-Marie, additional, Katlama, Christine, additional, Rockstroh, Juergen K., additional, Arasteh, Keikawus, additional, Esser, Stefan, additional, Stoehr, Albrecht, additional, Stellbrink, Hans-Juergen, additional, Stoll, Matthias, additional, Schuermann, Dirk, additional, Faetkenheuer, Gerd, additional, Bogner, Johannes, additional, Lutz, Thomas, additional, Baumgarten, Axel, additional, Jaeger, Hans, additional, Gori, Andrea, additional, Coltan, Gabriel, additional, Constandis, Felicia, additional, Erscoiu, Simona Manuela, additional, Prisacariu, Liviu-Jany, additional, Rugina, Sorin, additional, Streinu-Cercel, Adrian, additional, Pokrovsky, Vadim Valentinovich, additional, Zakharova, Natalia V., additional, Shuldyakov, Andrey Anatolyevich, additional, Ryamova, Elena Pavlovna, additional, Kulagin, Valeriy Viktorovich, additional, Tsybakova, Olga Aleksandrovna, additional, Orlova-Morozova, Elena, additional, Nagimova, Firaya, additional, Voronin, Evgeniy, additional, Shimonova, Tatyana Evgenyevna, additional, Kozyrev, Oleg Anatolyevich, additional, Orrell, Catherine, additional, Lombaard, Johannes Jurgens, additional, Botes, Margaretha Elizabeth, additional, Portilla, Joaquin, additional, Gatell, Josep Maria, additional, Perez, Maria Jesus, additional, Arribas, Jose Ramon, additional, Negredo, Eugenia, additional, Podzamczer, Daniel, additional, Pulido, Federico, additional, Troya, Jesus, additional, De los Santos, Ignacio, additional, Berenguer, Juan, additional, Williams, Ian G., additional, Johnson, Margaret A., additional, Schembri, Gabriel, additional, Clarke, Amanda, additional, Gompels, Mark, additional, Fox, Julie Meriel, additional, Taylor, Steven John, additional, Kegg, Stephen, additional, Hagins, Debbie P., additional, Osiyemi, Olayemi O., additional, Prelutsky, David James, additional, Ramgopal, Moti N., additional, Dretler, Robin, additional, Sloan, Louis, additional, Lewis, Stanley T., additional, Clay, Patrick G., additional, Bellos, Nicholaos C., additional, Thompson, Melanie A., additional, Montero, Jose, additional, McDonald, Cheryl K., additional, Creticos, Catherine, additional, Shamblaw, David, additional, Terrelonge, Antonio E., additional, Valdes, Martin, additional, Tashima, Karen T., additional, Robbins, William J., additional, Felizarta, Franco Antonio, additional, Elion, Richard A., additional, Slim, Jihad, additional, Lalezari, Jacob Paul, additional, Lalla-Reddy, Sujata N., additional, Ruane, Peter Jerome, additional, Mills, Anthony, additional, Cade, Jerry L., additional, Campo, Rafael E., additional, Dietz, Craig A., additional, Blick, Gary, additional, Mayer, Cynthia, additional, Rondon, Juan Carlos, additional, Cook, Paul P., additional, Daar, Eric, additional, Kumar, Princy N., additional, Swindells, Susan, additional, Castro, Jose Guillermo, additional, Morales-Ramirez, Javier O., additional, Santiago, Lizette, additional, and Santana-Bagur, Jorge L., additional

Published
2018
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16. Fixed-dose combination dolutegravir, abacavir, and lamivudine versus ritonavir-boosted atazanavir plus tenofovir disoproxil fumarate and emtricitabine in previously untreated women with HIV-1 infection (ARIA): week 48 results from a randomised, open-label, non-inferiority, phase 3b study

Author

Orrell, Catherine, primary, Hagins, Debbie P, additional, Belonosova, Elena, additional, Porteiro, Norma, additional, Walmsley, Sharon, additional, Falcó, Vicenç, additional, Man, Choy Y, additional, Aylott, Alicia, additional, Buchanan, Ann M, additional, Wynne, Brian, additional, Vavro, Cindy, additional, Aboud, Michael, additional, Smith, Kimberly Y, additional, Cahn, Pedro Enrique, additional, Cassetti, Lidia Isabel, additional, Porteiro Barreira, Norma, additional, Angel, Jonathan Benjamin, additional, de Pokomandy, Alexandra, additional, Harris, Marianne, additional, Rachlis, Anita R., additional, Walmsley, Sharon L., additional, Allavena, Clotilde, additional, Bouchaud, Oliver, additional, Gatey, Caroline, additional, Rami, Agathe, additional, Casari, Salvatore, additional, Di Perri, Giovanni, additional, Lazzarin, Adriano, additional, Maggiolo, Franco, additional, Penco, Giovanni, additional, Quirino, Tiziana, additional, Rizzardini, Giuliano, additional, Andrade-Villanueva, Jaime-Federico, additional, Sierra-Madero, Juan G., additional, Branco, Teresa, additional, Serrao, Rosario, additional, Teofilo, Eugenio JR., additional, Melendez-Rivera, Ivan, additional, Santiago, Lizette, additional, Zorrilla, Carmen D., additional, Chernova, Oksana E., additional, Pokrovsky, Vadim, additional, Rakhmanova, Aza Gasanovna, additional, Tsybakova, Olga, additional, Voronin, Eugene, additional, Orrell, Catherine, additional, Vally, Tasneem, additional, Farisani, Livhuwani ML., additional, Sebopa, Boitumelo Lucrecia, additional, Barros, Carlos Aguado, additional, Cano Sánchez, Alfredo, additional, Castaño, Manuel, additional, Falcó Ferrer, Vicens, additional, González García, Juan J., additional, Hernandez-Quero, Jose, additional, Negredo Puigmal, Eugenia, additional, Pérez Elías, María Jesús, additional, Podzamczer Palter, Daniel, additional, Portilla, Joaquin Sogorb, additional, Viciana Fernández, Pompeyo, additional, Manosuthi, Weerawat, additional, Ruxrungtham, Kiat, additional, Dockrell, David H., additional, Hay, Phillip E., additional, Johnson, Margaret A., additional, Mackie, Nicola E., additional, Orkin, Chloe M., additional, Taylor, Steve, additional, Bhatti, Laveeza, additional, Brar, Indira, additional, Brennan, Robert Owen, additional, Cade, Jerry L., additional, Casanas, Beata, additional, Casey, Kathleen, additional, Cunningham, Douglas, additional, DeJesus, Edwin, additional, Dietz, Craig, additional, Dretler, Robin Henry, additional, Eron, Joseph J., additional, Felizarta, Franco Antoni B., additional, Fife, Kenneth H., additional, Hagins, Debbie P., additional, Hoffman-Terry, Margaret, additional, Jain, Mamta, additional, Johnson, Marc Alexander, additional, Kinder, Clifford A., additional, Kumar, Princy N., additional, Lewis, Stanley T., additional, McDonald, Cheryl Kay, additional, Meza, Armando D., additional, Mounzer, Karam C., additional, Newman, Cheryl L., additional, Osiyemi, Olayemi O., additional, Poblete, Ronald, additional, Presti, Rachel M., additional, Ramgopal, Moti, additional, Rosenstock, Joel, additional, Samuel, Rafik, additional, Sandkovsky, Uriel Sebastian, additional, Shon, Alyssa So Young, additional, Skiest, Daniel J., additional, Sloan, Louis M., additional, Small, Catherine B., additional, Tebas, Pablo, additional, and Van Dam, Cornelius N., additional

Published
2017
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20. Classicism in New York Theatre Architecture: 1825–1850.

Author

Lewis, Stanley T.

Abstract

Nathaniel Currier's spectacular lithograph of the “Great Riot at the Astor Place Opera House, New York” (1), is one of the most well-known images depicting a nineteenth-century U.S. theatre building left to us by the popular pictorial reporting of that prephotographic era. The background of the event in terms of drama history is familiar, when It is the building itself, as a theatrical monument, that we tend to overlook, except for its appeal as a bygone relic, and architecturally it is easy to dismiss it as simply another manifestation of the rage which was caustically described by the New York correspondent of The Architectural Magazine (London) in 1834: One factor which discourages the theatre historian is the difficulty of relating any one theatre of the period with other examples in a city, let alone the country. [ABSTRACT FROM PUBLISHER]

Published
1965
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23. Efficacy, Pharmacokinetics, and Safety Over 48 Weeks With Ibalizumab-Based Therapy in Treatment-Experienced Adults Infected With HIV-1: A Phase 2a Study.

Author

Gathe JC, Hardwicke RL, Garcia F, Weinheimer S, Lewis ST, and Cash RB

Subjects
Anti-HIV Agents adverse effects, Anti-HIV Agents pharmacokinetics, Antibodies, Monoclonal adverse effects, Antibodies, Monoclonal pharmacokinetics, CD4 Lymphocyte Count, HIV-1, Humans, Viral Load drug effects, Anti-HIV Agents therapeutic use, Antibodies, Monoclonal therapeutic use, HIV Infections drug therapy
Abstract

Abstract: Ibalizumab, a humanized monoclonal antibody targeting CD4, blocks HIV-1 entry into cells and is the first Food and Drug Adminstration-approved long-acting agent for HIV-1 treatment. In this phase 2a study, 82 HIV-infected adults failing antiretroviral therapy were assigned an individually optimized background regimen (OBR) and randomized 1:1:1 to arm A (15 mg/kg ibalizumab q2wk), arm B (10 mg/kg weekly for 9 weeks, then q2wk), or placebo. Subjects with an inadequate response at week 16 were permitted to cross over to a new OBR plus 15 mg/kg ibalizumab q2wk. At week 16, viral load (VL) reduction was significantly greater than placebo (0.26 log10) in arms A (1.07 log10; P = 0.002) and B (1.33 log10; P < 0.001); CD4+ T cell counts increased significantly in arm A. After week 16, 11/27 (arm B) and 19/27 (placebo) subjects crossed over to OBR plus 15 mg/kg ibalizumab; 8/28 in arm A initiated a new OBR. Ibalizumab treatment resulted in VL reduction at week 24 (-0.77 and -1.19 log10 for arms A and B, respectively, versus -0.32 log10 for placebo) and 48 weeks (-0.54 and -0.77 versus -0.22 log10). Compared with placebo, VL differences were statistically significant for arm B at week 24 (P = 0.001) and week 48 (P = 0.027). CD4+ T cell counts increased significantly by week 48 in both arm A and arm B, relative to placebo. No ibalizumab-related serious adverse events were reported. The durable antiviral activity and tolerability of ibalizumab support its use in treating individuals harboring multidrug-resistant HIV-1., Competing Interests: R.L.H. is a speaker and consultant of Theratechnologies. S.W. is an employee of TaiMed Biologics USA, Inc. S.T.L. was a former employee and shareholder of TaiMed Biologics USA, Inc. during this clinical study. R.B.C. is an employee of Theratechnologies Inc. The remaining authors have no conflicts of interest to disclose., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.)

Published
2021
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