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1. 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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4. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate is Non-inferior to Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment-naive Adults With Human Immunodeficiency Virus–1 Infection : Week 48 Results of the DRIVE-AHEAD Trial

Author

DRIVE-AHEAD Study Group, Orkin, Chloe, Squires, Kathleen E., Molina, Jean-Michel, Sax, Paul E., Wong, Wing-Wai, Sussmann, Otto, Kaplan, Richard, Lupinacci, Lisa, Rodgers, Anthony, Xu, Xia, Lin, Gina, Kumar, Sushma, Sklar, Peter, Nguyen, Bach-Yen, Hanna, George J., Hwang, Carey, and Martin, Elizabeth A.

Published
2019

5. Doravirine versus ritonavir-boosted darunavir in antiretroviral-naive adults with HIV-1 (DRIVE-FORWARD): 96-week results of a randomised, double-blind, non-inferiority, phase 3 trial

Author

Hagins, Debbie P., Osiyemi, Olayemi O., Prelutsky, David James, Ramgopal, Moti N., Scarsella, Anthony John, Dretler, Robin, DeJesus, Edwin, Bettacchi, Christopher J., Sims, James, III, Clay, Patrick G., Bellos, Nicholaos C., Thompson, Melanie A., Montero, Jose, McDonald, Cheryl K., Creticos, Catherine, Shamblaw, David, Mogyoros, Miguel, Terrelonge, Antonio E., Valdes, Martin, Tashima, Karen T., Robbins, William J., Felizarta, Franco Antonio, Elion, Richard A., Slim, Jihad, Win, Sandra S., Lalla-Reddy, Sujata N., Ruane, Peter Jerome, Mills, Anthony, Cade, Jerry L., Dietz, Craig A., Rubin, David Scott, Mayer, Cynthia, Rondon, Juan Carlos, Cook, Paul P., Daar, Eric, Kumar, Princy N., Swindells, Susan, Castro, Jose Guillermo, Melendez-Rivera, Ivan, Morales-Ramirez, Javier O., Santiago, Lizette, Santana-Bagur, Jorge L., 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, Maria Isabel, 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, de Jager, Marleen, Portilla Segorb, Joaquin, Mallolas, Josep, Perez Elias, Maria Jesus, Gatell, Josep M., Arribas Lopez, Jose Ramon, Negredo Puigmal, Eugenia, Podzamczer Palter, Daniel, Pulido Ortega, Federico, Troya Garcia, Jesus, De los Santos Gil, Ignacio, Berenguer Berenguer, Juan, Williams, Ian G., Johnson, Margaret A., Schembri, Gabriel, Clarke, Amanda, Gompels, Mark, Fox, Julie Meriel, Taylor, Steven John, Dockrell, David Harold, Kegg, Stephen, Squires, Kathleen, Sax, Paul E, Cahn, Pedro, Lombaard, Johan, Lai, Ming-Tain, Rodgers, Anthony, Lupinacci, Lisa, Kumar, Sushma, Sklar, Peter, Hanna, George J, Hwang, Carey, and Martin, Elizabeth Anne

Published
2020
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6. Host-gut microbiota derived secondary metabolite mediated regulation of Wnt/β-catenin pathway: a potential therapeutic axis in IBD and CRC.

Author

Kumar, Sushma S., Fathima, Ashna, Srihari, Preeti, and Jamma, Trinath

Subjects
SHORT-chain fatty acids, AMINO acid derivatives, METABOLITES, BILE acids, MICROBIAL metabolites
Abstract

The intestinal tract encompasses one of the largest mucosal surfaces with a wellstructured layer of intestinal epithelial cells supported by a network of underlying lamina propria immune cells maintaining barrier integrity. The commensal microflora in this environment is a major contributor to such functional outcomes due to its prominent role in the production of secondary metabolites. Of the several known metabolites of gut microbial origin, such as Short Chain Fatty Acids (SCFAs), amino acid derivatives, etc., secondary bile acids (BAs) are also shown to exhibit pleiotropic effects maintaining gut homeostasis in addition to their canonical role in dietary lipid digestion. However, dysbiosis in the intestine causes an imbalance in microbial diversity, resulting in alterations in the functionally effective concentration of these secondary metabolites, including BAs. This often leads to aberrant activation of the underlying lamina propria immune cells and associated signaling pathways, causing intestinal inflammation. Sustained activation of these signaling pathways drives unregulated cell proliferation and, when coupled with genotoxic stress, promotes tumorigenesis. Here, we aimed to discuss the role of secondary metabolites along with BAs in maintaining immune-gut homeostasis and regulation of inflammation-driven tumorigenesis with emphasis on the classical Wnt/b- Catenin signaling pathway in colon cancer. [ABSTRACT FROM AUTHOR]

Published
2024
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7. 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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9. Probiotics-based Anticancer Immunity in Head and Neck Cancer

Author

Shanth Kumar Sushma, Shivaraju Amrutha, and Alwarappan Sankaranarayanan

Abstract

Every day we are used to hearing about cancer and its effects. Head and neck cancer is one of the types of cancer which is leading to mortality. Treatment of cancer is crucial to lead a happy and healthy life. Till today several medical strategies, such as radiotherapy, chemotherapy, etc., have come forward to eradicate cancer, but along with these approaches, probiotics are also taking part to dissolve this problem. In simple words, probiotics are microorganisms that are present in fermented foods like yogurt, cheese, creams, fermented milk, etc., which, when administered to the host, provide health benefits. Some familiar probiotics are Lactobacillus bulgaricus, L. casei and Streptococcus thermophilus, which are involved in cancer treatment. Much evidence has proven its health benefits. This chapter focuses on how probiotics act on cancer cells with an introduction to head and neck cancer, thereby triggering our interest to probe into further research on treating cancer using probiotics.&nbsp

Published
2023
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10. 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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11. 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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17. Stranded: A Mainstream VR Quantum Game For Novices

Author

Sreekuttan, L S, primary, Thampy, Rohit P, additional, Thota, Sairupa, additional, Mohan Sharma, Adarsh, additional, Tarun Vikas, Vinnakota, additional, John Chemban, Jowin, additional, Raj Kumar, Sushma, additional, and Bhattacharya, Supratip, additional

Published
2022
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19. Effects of a novel estrogen-free, progesterone receptor modulator contraceptive vaginal ring on inhibition of ovulation, bleeding patterns and endometrium in normal women

Author

Brache, Vivian, Sitruk-Ware, Regine, Williams, Alistair, Blithe, Diana, Croxatto, Horacio, Kumar, Narender, Kumar, Sushma, Tsong, Yun-Yen, Sivin, Irving, Nath, Anita, Sussman, Heather, Cochon, Leila, Miranda, Maria Jose, Reyes, Verónica, Faundes, Anibal, and Mishell, Daniel, Jr.

Published
2012
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20. 626. The Efficacy and Safety of Maintenance with Doravirine Plus Two NRTIs after Initial Suppression in Adults with HIV-1 in the DRIVE-FORWARD Clinical Trial: Results from the Study Extension through 192 Weeks

Author

Cahn, Pedro, primary, Molina, Jean-michel, additional, Lombaard, Johan, additional, Squires, Kathleen, additional, Kumar, Sushma, additional, Wan, Hong, additional, Teal, Valerie, additional, Asante-Appiah, Ernest, additional, Sklar, Peter, additional, Martin, Elizabeth A, additional, and Lahoulou, Rima, additional

Published
2021
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23. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (TDF) Versus Efavirenz/Emtricitabine/TDF in Treatment-naive Adults With Human Immunodeficiency Virus Type 1 Infection: Week 96 Results of the Randomized, Double-blind, Phase 3 DRIVE-AHEAD Noninferiority Trial

Author

Orkin, Chloe, primary, Squires, Kathleen E, additional, Molina, Jean-Michel, additional, Sax, Paul E, additional, Sussmann, Otto, additional, Lin, Gina, additional, Kumar, Sushma, additional, Hanna, George J, additional, Hwang, Carey, additional, Martin, Elizabeth, additional, and Teppler, Hedy, additional

Published
2020
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30. Doravirine versus ritonavir-boosted darunavir in antiretroviral-naive adults with HIV-1 (DRIVE-FORWARD): 96-week results of a randomised, double-blind, non-inferiority, phase 3 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, Rodgers, Anthony, additional, Lupinacci, Lisa, additional, Kumar, Sushma, additional, Sklar, Peter, additional, Hanna, George J, additional, Hwang, Carey, additional, Martin, Elizabeth Anne, additional, Hagins, Debbie P., additional, Osiyemi, Olayemi O., additional, Prelutsky, David James, additional, Ramgopal, Moti N., additional, Scarsella, Anthony John, additional, Dretler, Robin, additional, Bettacchi, Christopher J., additional, Sims, James, 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, Mogyoros, Miguel, 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, Win, Sandra S., additional, Lalla-Reddy, Sujata N., additional, Ruane, Peter Jerome, additional, Mills, Anthony, additional, Cade, Jerry L., additional, Dietz, Craig A., additional, Rubin, David Scott, 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, Melendez-Rivera, Ivan, additional, Morales-Ramirez, Javier O., additional, Santiago, Lizette, additional, Santana-Bagur, Jorge L., 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, Maria Isabel, 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, de Jager, Marleen, additional, Portilla Segorb, Joaquin, additional, Mallolas, Josep, additional, Perez Elias, Maria Jesus, additional, Gatell, Josep M., additional, Arribas Lopez, Jose Ramon, additional, Negredo Puigmal, Eugenia, additional, Podzamczer Palter, Daniel, additional, Pulido Ortega, Federico, additional, Troya Garcia, Jesus, additional, De los Santos Gil, Ignacio, additional, Berenguer 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, Dockrell, David Harold, additional, and Kegg, Stephen, additional

Published
2020
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32. Once-daily Doravirine for Initial Treatment of Adults Living With Human Immunodeficiency Virus–1: An Integrated Safety Analysis

Author

Thompson, Melanie, primary, Orkin, Chloe, additional, Molina, Jean-Michel, additional, Sax, Paul, additional, Cahn, Pedro, additional, Squires, Kathleen, additional, Xu, Xia, additional, Rodgers, Anthony, additional, Kumar, Sushma, additional, Teppler, Hedy, additional, Martin, Elizabeth, additional, Hanna, George, additional, and Hwang, Carey, additional

Published
2019
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33. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (TDF) Versus Efavirenz/Emtricitabine/TDF in Treatment-naive Adults With Human Immunodeficiency Virus Type 1 Infection: Week 96 Results of the Randomized, Double-blind, Phase 3 DRIVE-AHEAD Noninferiority Trial

Author

Orkin, Chloe, Squires, Kathleen E, Molina, Jean-Michel, Sax, Paul E, Sussmann, Otto, Lin, Gina, Kumar, Sushma, Hanna, George J, Hwang, Carey, Martin, Elizabeth, and Teppler, Hedy

Subjects
HIV infections, DRUG efficacy, RESEARCH, HIV-positive persons, CLINICAL trials, CONFIDENCE intervals, TENOFOVIR, EFAVIRENZ-emtricitabine-tenofovir (Drug), MEDICAL cooperation, RNA, LAMIVUDINE, NON-nucleoside reverse transcriptase inhibitors, BLIND experiment, DESCRIPTIVE statistics, STATISTICAL sampling, HIV, EVALUATION, ADULTS
Abstract

Background Doravirine (DOR) is a nonnucleoside reverse-transcriptase inhibitor. In the phase 3 DRIVE-AHEAD trial in treatment-naive adults with human immunodeficiency virus type 1 (HIV-1) infection, DOR demonstrated noninferior efficacy compared with efavirenz (EFV) and superior profiles for neuropsychiatric tolerability and lipids at 48 weeks. We present data through week 96. Methods DRIVE-AHEAD is a phase 3, multicenter, double-blind, noninferiority trial in antiretroviral treatment-naive adults with HIV-1 RNA ≥1000 copies/mL. Participants were randomized to a daily fixed-dose tablet of DOR (100 mg), lamivudine (3TC; 300 mg) and tenofovir disoproxil fumarate (TDF; 300 mg) (DOR/3TC/TDF) or EFV (600 mg), emtricitabine (FTC; 200 mg) and TDF (300 mg) (EFV/FTC/TDF). The efficacy end point of interest at week 96 was the proportion of participants with HIV-1 RNA levels <50 copies/mL (Food and Drug Administration Snapshot Approach) with a predefined noninferiority margin of 10% to support week 48 results. Safety end points of interest included prespecified neuropsychiatric adverse events and the mean change in fasting lipids at week 96. Results Of 734 participants randomized, 728 received study drugs and were included in analyses. At week 96, HIV-1 RNA <50 copies/mL was achieved by 77.5% of DOR/3TC/TDF vs 73.6% of EFV/FTC/TDF participants, with a treatment difference of 3.8% (95% confidence interval, –2.4% to 10%). Virologic failure rates were low and similar across treatment arms, with no additional resistance to DOR observed between weeks 48 and 96. Prespecified neuropsychiatric adverse events and rash were less frequent in DOR/3TC/TDF than in EFV/FTC/TDF participants through week 96. At week 96, fasting low-density lipoprotein cholesterol and non–high-density lipoprotein cholesterol (HDL-C) levels increased in the EFV/FTC/TDF group but not in the DOR/3TC/TDF group; the mean changes from baseline in total cholesterol/HDL-C ratio were similar. Clinical Trials Registration NCT02403674. [ABSTRACT FROM AUTHOR]

Published
2021
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35. Once-daily Doravirine in Human Immunodeficiency Virus Type 1–Infected, Antiretroviral-naive Adults: An Integrated Efficacy Analysis.

Author

Orkin, Chloe, Molina, Jean-Michel, Lombaard, Johan, DeJesus, Edwin, Rodgers, Anthony, Kumar, Sushma, Martin, Elizabeth, Hanna, George, and Hwang, Carey

Subjects
COMPARATIVE studies, HIV, HIV infections, HIV-positive persons, RNA, VIRAL load, RANDOMIZED controlled trials, HIGHLY active antiretroviral therapy, LAMIVUDINE, ABACAVIR, DARUNAVIR, EFAVIRENZ-emtricitabine-tenofovir (Drug), EMTRICITABINE-tenofovir, TENOFOVIR, NON-nucleoside reverse transcriptase inhibitors, DESCRIPTIVE statistics, EFAVIRENZ, CD4 lymphocyte count, RITONAVIR, ADULTS
Abstract

Background Doravirine (DOR) demonstrated noninferior efficacy to darunavir plus ritonavir (DRV+r) and efavirenz (EFV) in 2 ongoing phase 3 trials: DRIVE-FORWARD (NCT02275780) and DRIVE-AHEAD (NCT02403674). Methods This prespecified analysis pooled efficacy data through the first 48 weeks of DRIVE-FORWARD and DRIVE-AHEAD from the DOR groups (DOR/lamivudine [3TC]/tenofovir disoproxil fumarate [TDF] or DOR [100 mg daily] with emtricitabine [FTC]/TDF or abacavir [ABC]/3TC [n = 747]) compared with DRV+r (800/100 mg daily) with FTC/TDF or ABC/3TC (n = 383) or EFV/FTC/TDF (600/200/300 mg daily; n = 364). Efficacy assessments included the proportion of participants with human immunodeficiency virus type 1 (HIV-1) RNA <50 copies/mL and change in CD4+ T-cell count. Results At week 48, DOR demonstrated noninferior efficacy to DRV+r and EFV, with 84.1% of DOR-treated participants achieving HIV-1 RNA <50 copies/mL compared with 79.9% of the DRV+r and 80.8% of the EFV groups. Results were similar across demographic/prognostic subpopulations, including baseline plasma HIV-1 RNA, gender, race, and HIV-1 subtype. Mean increases from baseline in CD4+ T-cell count through 48 weeks were 195.5 cells/mm3 for DOR, 185.6 cells/mm3 for DRV+r, and 188.4 cells/mm3 for EFV/FTC/TDF. Conclusions DOR, as a single entity (in combination with other antiretroviral agents) and as a fixed-dose combination (DOR/3TC/TDF), demonstrated noninferior efficacy to DRV+r and EFV as assessed by the proportion of HIV-1-infected, treatment-naive adults with HIV-1 RNA <50 copies/mL. Clinical Trials Registration NCT02275780 and NCT02403674. [ABSTRACT FROM AUTHOR]

Published
2020
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36. Once-daily Doravirine for Initial Treatment of Adults Living With Human Immunodeficiency Virus–1: An Integrated Safety Analysis.

Author

Thompson, Melanie, Orkin, Chloe, Molina, Jean-Michel, Sax, Paul, Cahn, Pedro, Squires, Kathleen, Xu, Xia, Rodgers, Anthony, Kumar, Sushma, Teppler, Hedy, Martin, Elizabeth, Hanna, George, and Hwang, Carey

Subjects
COMBINATION drug therapy, COMPARATIVE studies, CONFIDENCE intervals, DIARRHEA, DRUG tolerance, DRUG side effects, HIV, HIV infections, HIV-positive persons, LIPIDS, PATIENT safety, TERMINATION of treatment, TREATMENT duration, ABACAVIR-lamivudine (Drug), DARUNAVIR, EMTRICITABINE-tenofovir, NON-nucleoside reverse transcriptase inhibitors, DESCRIPTIVE statistics, EFAVIRENZ, RITONAVIR, ADULTS
Abstract

Background A prespecified integrated safety analysis was conducted for 3 doravirine (DOR) double-blind trials (Phase IIb: P007 [NCT01632345]; Phase III: DRIVE-FORWARD [NCT02275780] and DRIVE-AHEAD [NCT02403674]). Methods DOR (100 mg) arms from these trials were compared with darunavir plus ritonavir (DRV+r) in DRIVE-FORWARD and efavirenz (EFV) in P007 and DRIVE-AHEAD. Background therapies were emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in P007; abacavir/lamivudine (ABC/3TC) or FTC/TDF in DRIVE-FORWARD; and 3TC/TDF for DOR and FTC/TDF for EFV in DRIVE-AHEAD. The primary endpoint was the proportion of participants discontinuing due to adverse events (AEs) through Week 48. Results Discontinuation rates due to AEs were similar for participants on DOR and DRV+r (2.5% vs 3.1%, respectively) and lower for those on DOR than for those on EFV (2.5% vs 6.6%, respectively). Rates of drug-related AEs for DOR, DRV+r, and EFV were 30.9%, 32.1%, and 61.4%, respectively. In an analysis of DOR versus EFV, the treatment difference for discontinuations due to AEs was −3.4%, favoring DOR (95% confidence interval −6.2 to −0.8; P =.012). Fewer participants experienced neuropsychiatric AEs on DOR than on EFV (25.0% vs 55.9%, respectively), and fewer experienced diarrhea on DOR than on DRV+r (12.4% vs 22.5%, respectively). Changes from baseline in most lipid parameters also favored DOR. Conclusions At Week 48, DOR at 100 mg had a favorable safety profile compared with EFV or DRV+r and a favorable tolerability profile compared with EFV. Clinical Trials Registration NCT01632345; NCT02275780 and NCT02403674. [ABSTRACT FROM AUTHOR]

Published
2020
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37. LB1. Doravirine/Lamivudine/Tenofovir DF Continues to Be NonInferior to Efavirenz/Emtricitabine/Tenofovir DF in Treatment-Naïve Adults With HIV-1 Infection: Week 96 Results of the DRIVE-AHEAD Trial

Author

Orkin, Chloe, primary, Squires, Kathleen, additional, Molina, Jean-Michel, additional, Sax, Paul, additional, Wong, Wingwai, additional, Sussmann, Otto, additional, Lin, Gina, additional, Kumar, Sushma, additional, Hanna, George, additional, Hwang, Carey, additional, Martin, Elizabeth, additional, and Teppler, Hedy, additional

Published
2018
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38. 543. An Integrated Safety Analysis Comparing Once-Daily Doravirine (DOR) to Darunavir+Ritonavir (DRV+r) and Efavirenz (EFV) in HIV-1-Infected, Antiretroviral Therapy (ART)-Naïve Adults

Author

Thompson, Melanie, primary, Orkin, Chloe, additional, Molina, Jean-Michel, additional, Gatell, Jose, additional, Sax, Paul, additional, Cahn, Pedro, additional, Squires, Kathleen, additional, Zhou, Yan, additional, Xu, Xia, additional, Rodgers, Anthony, additional, Kumar, Sushma, additional, Teppler, Hedy, additional, Martin, Elizabeth, additional, Hanna, George, additional, and Hwang, Carey, additional

Published
2018
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39. LB2. Switch to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) Maintains Virologic Suppression Through 48 Weeks: Results of the DRIVE-SHIFT Trial

Author

Kumar, Princy, primary, Johnson, Margaret, additional, Molina, Jean-Michel, additional, Rizzardini, Giuliano, additional, Cahn, Pedro, additional, Bickel, Markus, additional, Mallolas, Josep, additional, Zhou, Yan, additional, Morais, Cristiana, additional, Kumar, Sushma, additional, Sklar, Peter, additional, Hanna, George J, additional, Hwang, Carey, additional, and Greaves, Wayne, additional

Published
2018
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40. Doravirine dose Selection and 96-Week Safety and Efficacy versus Efavirenz in Antiretroviral Therapy-Naive Adults with HIV-1 Infection in a Phase IIb Trial

Author

Gatell, Jose M, primary, Morales-Ramirez, Javier O, additional, Hagins, Debbie P, additional, Thompson, Melanie, additional, Arastéh, Keikawus, additional, Hoffmann, Christian, additional, Raffi, François, additional, Osiyemi, Olayemi, additional, Dretler, Robin, additional, Harvey, Charlotte, additional, Xu, Xia, additional, Plettenberg, Andreas, additional, Smith, Don E, additional, Portilla, Joaquín, additional, Rugina, Sorin, additional, Kumar, Sushma, additional, Frobose, Colleen, additional, Wan, Hong, additional, Rodgers, Anthony, additional, Hwang, Carey, additional, and Teppler, Hedy, additional

Published
2018
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41. 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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42. Levonorgestrel Intrauterine System (LNG IUS) in Menorrahgia: A Follow-Up Study

Author

Gupta Nupur, Kumar Sushma, Jain Jyoti, Bhatia Pushpa, Gupta Taru, and Gupta Sangeeta

Subjects
medicine.medical_specialty, Hysterectomy, Obstetrics, business.industry, medicine.medical_treatment, Follow up studies, medicine.disease, Surgery, Blood loss, medicine, Effective treatment, Levonorgestrel, Adenomyosis, Adverse effect, business, Contraindication, medicine.drug
Abstract

Objective: To study the acceptability, efficacy, adverse effect and user satisfaction of Levonorgestrel intrauterine system (LNG IUS) for treatment of menorrahgia. Method: This was an observational descriptive study conducted in ESI PGIMSR over a period from Jan 2008-June 2011. 70 women presented in O.P.D with heavy menstrual bleeding having no contraindication for device, consenting for LNG IUS underwent its insertion. Menstrual pattern, pictorial blood loss assessment chart score, adverse effects, and rate of acceptability and satisfaction were recorded at 3, 6 and 12 months after procedure. Results: The mean age of the sample was 39.92 yrs ± 3.27. Indication for device insertion was DUB in 81.42% (57), fibroid 8.57% (6), adenomyosis in 10% (7). The expulsion rate was 4.2% (3), removal rate was 7.14% (5) and continuation rate is 88.57% (62). 2.28% (3) patients underwent hysterectomy because of continuous bleeding even after 3 - 4 months of insertion. On follow-up at one year out of 62 patients, 33.87% (21) were amenorrhic and 51.61% (32) have regular period, while 3.07% (2) patients had irregular period. Conclusion: LNG IUS is a less invasive, effective treatment modality for menorrahgia with reasonable efficacy.

Published
2014
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43. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate is Non-inferior to Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment-naive Adults With Human Immunodeficiency Virus–1 Infection: Week 48 Results of the DRIVE-AHEAD Trial.

Author

Orkin, Chloe, Squires, Kathleen E, Molina, Jean-Michel, Sax, Paul E, Wong, Wing-Wai, Sussmann, Otto, Kaplan, Richard, Lupinacci, Lisa, Rodgers, Anthony, Xu, Xia, Lin, Gina, Kumar, Sushma, Sklar, Peter, Nguyen, Bach-Yen, Hanna, George J, Hwang, Carey, Martin, Elizabeth A, and Group, DRIVE-AHEAD Study

Subjects
COMBINATION drug therapy, CONFIDENCE intervals, DIZZINESS, HIGH density lipoproteins, HIV, HIV infections, LOW density lipoproteins, RNA, SLEEP disorders, RANDOMIZED controlled trials, TREATMENT effectiveness, LAMIVUDINE, EFAVIRENZ-emtricitabine-tenofovir (Drug), TENOFOVIR, NON-nucleoside reverse transcriptase inhibitors, THERAPEUTICS
Abstract

Background Doravirine (DOR), a novel non-nucleoside reverse-transcriptase inhibitor (NNRTI), is active against wild-type Human Immunodeficiency Virus (HIV)-1 and the most common NNRTI-resistant variants, and has a favorable and unique in vitro resistance profile. Methods DRIVE-AHEAD is a phase 3, double-blind, non-inferiority trial. Antiretroviral treatment–naive adults with ≥1000 HIV-1 RNA copies/mL were randomized (1:1) to once-daily, fixed-dose DOR at 100 mg, lamivudine at 300 mg, and tenofovir disoproxil fumarate (TDF) at 300 mg (DOR/3TC/TDF) or to efavirenz at 600 mg, emtricitabine at 200 mg, and TDF at 300 mg (EFV/FTC/TDF) for 96 weeks. The primary efficacy endpoint was the proportion of participants with <50 HIV-1 RNA copies/mL at week 48 (Food and Drug Administration snapshot approach; non-inferiority margin 10%). Results Of the 734 participants randomized, 728 were treated (364 per group) and included in the analyses. At week 48, 84.3% (307/364) of DOR/3TC/TDF recipients and 80.8% (294/364) of EFV/FTC/TDF recipients achieved <50 HIV-1 RNA copies/mL (difference 3.5%, 95% CI, -2.0, 9.0). DOR/3TC/TDF recipients had significantly lower rates of dizziness (8.8% vs 37.1%), sleep disorders/disturbances (12.1% vs 25.2%), and altered sensorium (4.4% vs 8.2%) than EFV/FTC/TDF recipients. Mean changes in fasting low-density lipoprotein cholesterol (LDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C) (-3.83 vs +13.26 mg/dL) were significantly different between DOR/3TC/TDF and EFV/FTC/TDF (−1.6 vs +8.7 mg/dL and −3.8 vs +13.3 mg/dL, respectively). Conclusions In HIV-1 treatment-naive adults, DOR/3TC/TDF demonstrated non-inferior efficacy to EFV/FTC/TDF at week 48 and was well tolerated, with significantly fewer neuropsychiatric events and minimal changes in LDL-C and non–HDL-C compared with EFV/FTC/TDF. Clinical Trials Registration NCT02403674 [ABSTRACT FROM AUTHOR]

Published
2019
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44. Doravirine dose Selection and 96-Week Safety and Efficacy versus Efavirenz in Antiretroviral Therapy-Naive Adults with HIV-1 Infection in a Phase IIb Trial

Author

Gatell, Jose M, Morales-Ramirez, Javier O, Hagins, Debbie P, Thompson, Melanie, Arastéh, Keikawus, Hoffmann, Christian, Raffi, François, Osiyemi, Olayemi, Dretler, Robin, Harvey, Charlotte, Xu, Xia, Plettenberg, Andreas, Smith, Don E, Portilla, Joaquín, Rugina, Sorin, Kumar, Sushma, Frobose, Colleen, Wan, Hong, Rodgers, Anthony, Hwang, Carey, and Teppler, Hedy

Abstract

Background The safety and efficacy of doravirine were compared with that of efavirenz as initial treatment of adults living with HIV-1 infection (NCT01632345).Methods A Phase IIb double-blind trial with participants stratified by screening HIV-1 RNA (= or >100,000 copies/ml) and randomized 1:1:1:1:1 to receive once-daily doravirine (25, 50, 100 or 200 mg) or efavirenz 600 mg (Part I) for up to 96 weeks, with open-label tenofovir disoproxil fumarate 300 mg/emtricitabine 200 mg (TDF/FTC). After dose selection at week 24, doravirine 100 mg was provided to participants receiving the other doses of doravirine and additional participants were randomized 1:1 to receive once-daily doravirine 100 mg or efavirenz 600 mg for 96 weeks with TDF/FTC (Part II). Primary outcomes were the proportion of participants with HIV-1 RNA <40 copies/ml at week 24, and central nervous system (CNS) adverse events (AEs) by weeks 8 and 24 (Parts I+II combined).Results 210 and 132 participants were randomized in Parts I and II, respectively, and 216 (108 on doravirine 100 mg, 108 on efavirenz) were evaluable for Parts I+II combined. At week 24, the proportion of participants with HIV-1 RNA <40 copies/ml was 72.9% for doravirine 100 mg and 73.1% for efavirenz (difference -0.5 [95% CI -12.3, 11.2]). In addition, CNS AEs were reported by 26.9% and 47.2% of doravirine and efavirenz recipients, respectively (difference -20.4 [95% CI -32.6, -7.5]; P=0.002).Conclusions Doravirine 100 mg with TDF/FTC demonstrated similar antiretroviral activity and superior CNS safety compared with efavirenz 600 mg with TDF/FTC.

Published
2019
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45. 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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50. Isolation of Steroid-Regulated Genes from the Uterus by mRNA Differential Display.

Author

Walker, John M., Lieberman, Benjamin A., Kumar, Sushma, Angervo, Maarit, Bagchi, Milan K., and Bagchi, Indrani C.

Abstract

Steroid hormones, estrogen, and progesterone, promote extensive cell proliferation, differentiation, and remodeling in all compartments of the uterus during pregnancy (1-5). These hormones orchestrate the entry of the fertilized ova into the uterus, prepare the uterus for embryo implantation, and maintain an environment conducive to the growth and development of the implanted embryo. The cellular actions of these hormones are mediated through specific intracellular receptors. These receptors function as ligand-inducible transcription factors (6-8). It is generally believed that the cellular events leading to the establishment and maintenance of pregnancy are mediated through the expression of specific steroid-regulated genes in the uterus. The identification of these steroid-regulated genes is crucial for understanding the molecular and cellular processes that control uterine growth and differentiation during pregnancy. [ABSTRACT FROM AUTHOR]

Published
2001
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