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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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2. 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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3. 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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4. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral regimens for virologically suppressed adults with HIV-1 infection: a randomised, active-controlled, multicentre, open-label, phase 3, non-inferiority study

Author

Mills, Anthony, Arribas, Jose R, Andrade-Villanueva, Jaime, DiPerri, Giovanni, Van Lunzen, Jan, Koenig, Ellen, Elion, Richard, Cavassini, Matthias, Madruga, Jose Valdez, Brunetta, Jason, Shamblaw, David, DeJesus, Edwin, Orkin, Chloe, Wohl, David A, Brar, Indira, Stephens, Jeffrey L, Girard, Pierre-Marie, Huhn, Gregory, Plummer, Andrew, Liu, Ya-Pei, Cheng, Andrew K, and McCallister, Scott

Published
2016
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5. 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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6. Simplification to rilpivirine/emtricitabine/tenofovir disoproxil fumarate from ritonavir-boosted protease inhibitor antiretroviral therapy in a randomized trial of HIV-1 RNA-suppressed participants

Author

Palella, Frank J., Jr, Fisher, Martin, Tebas, Pablo, Gazzard, Brian, Ruane, Peter, Van Lunzen, Jan, Shamblaw, David, Flamm, Jason, Ebrahimi, Ramin, Porter, Danielle, White, Kirsten, Hindman, Jason, Elbert, Elizabeth, De-Oertel, Shampa, and Fralich, Todd

Published
2014
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10. 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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12. 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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14. Efficacy and Safety of Tenofovir Alafenamide vs. Tenofovir Disoproxil Fumarate in HIV-infected, Virologically Suppressed Black and Non-Blacks Adults Through Week 96: Subgroup Analysis of a Randomized Switch Study

Author

Flamm, Jason A, primary, Vanig, Thanes, additional, Gathe, Joseph, additional, Kinder, Clifford, additional, Para, Michael, additional, Rashbaum, Bruce, additional, Segal-Maurer, Sorana, additional, Shamblaw, David, additional, Wohlfeiler, Michael, additional, Young, Benjamin, additional, Zurawski, Christine, additional, and Rhee, Martin S, additional

Published
2017
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15. Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate in the First Protease Inhibitor–Based Single-Tablet Regimen for Initial HIV-1 Therapy

Author

Mills, Anthony, primary, Crofoot, Gordon, additional, McDonald, Cheryl, additional, Shalit, Peter, additional, Flamm, Jason A., additional, Gathe, Joseph, additional, Scribner, Anita, additional, Shamblaw, David, additional, Saag, Michael, additional, Cao, Huyen, additional, Martin, Hal, additional, Das, Moupali, additional, Thomas, Anne, additional, Liu, Hui C., additional, Yan, Mingjin, additional, Callebaut, Christian, additional, Custodio, Joseph, additional, Cheng, Andrew, additional, and McCallister, Scott, additional

Published
2015
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16. 1567Simplification to elvitegravir/cobicistat/emtricitabine/tenofovir DF from ritonavir-boosted protease inhibitor plus emtricitabine/tenofovir DF maintains HIV suppression and improves fasting triglycerides at week 48

Author

Cunningham, Douglas, primary, Shamblaw, David, additional, Zurawski, Christine, additional, Robbins, William, additional, Scarsella, Anthony, additional, Nguyen, Thai, additional, Hindman, Jason, additional, Ebrahimi, Ramin, additional, and Piontkowsky, David, additional

Published
2014
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18. Atherosclerotic Cardiovascular Disease Risk Profile of Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate.

Author

Huhn, Gregory D, Shamblaw, David J, Baril, Jean-Guy, Hsue, Priscilla Y, Mills, Brittany L, Nguyen-Cleary, Thai, McCallister, Scott, and Das, Moupali

Subjects
*DYSLIPIDEMIA, *CARDIOVASCULAR diseases, *TENOFOVIR, *HIGH density lipoproteins, *HIV
Abstract

Background In human immunodeficiency virus (HIV) treatment, tenofovir alafenamide (TAF) is associated with greater increases in all fasting cholesterol subgroups compared with tenofovir disoproxil fumarate (TDF). Because lipid abnormalities may contribute to cardiovascular morbidity and mortality, cardiovascular risk assessment is integral to routine HIV care. This post hoc study evaluates the impact of lipid changes on predicted atherosclerotic cardiovascular disease (ASCVD) risk and statin eligibility in treatment-naive adults living with HIV treated with TAF or TDF. Methods Participants (N = 1744) were randomized (1:1) to initiate TAF or TDF, each coformulated with elvitegravir/cobicistat/emtricitabine (studies GS-US-292-0104 and GS-US-292-0111). Eligibility for statin therapy and estimated 10-year ASCVD risk among adults aged 40–79 years treated with TAF or TDF for 96 weeks (W96) were analyzed based on American College of Cardiology/American Heart Association Pooled Cohort Equations. Categorical shifts in 10-year ASCVD risk from <7.5% to ≥7.5% by W96 on TAF versus TDF were calculated. Results Participants initiating TAF versus TDF in the overall study population showed small but significant increases in median fasting lipid parameters at W96, including total cholesterol (191 vs 177 mg/dL; P <.001), low-density lipoprotein ([LDL] 119 vs 112 mg/dL; P <.001), and high-density lipoprotein ([HDL] 51 vs 48 mg/dL; P <.001), respectively. At baseline, 18% and 23% on TAF versus TDF had a 10-year ASCVD risk score ≥7.5%, with mean risk scores low overall for TAF versus TDF at baseline (4.9% vs 5.4%; P =.35) and W96 (6.1% vs 6.2%; P =.04). Increases in ASCVD risk from baseline to W96 were driven by both increasing age and changes in total cholesterol (TC) and HDL cholesterol. At W96, TC/HDL ratios (median) were 3.7 for both groups (P =.69). There was no difference between shifts in categorical risk for TAF versus TDF (9% vs 5%; P =.19). Eligibility for high-intensity statin therapy were similar for TAF versus TDF groups (19% vs 21%; P =.47). Conclusions Lipid changes with TAF as part of coformulated regimens do not substantively affect CVD risk profiles compared with TDF. [ABSTRACT FROM AUTHOR]

Published
2020
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19. Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate in the First Protease Inhibitor-Based Single-Tablet Regimen for Initial HIV-1 Therapy: A Randomized Phase 2 Study.

Author

Mills A, Crofoot G Jr, McDonald C, Shalit P, Flamm JA, Gathe J Jr, Scribner A, Shamblaw D, Saag M, Cao H, Martin H, Das M, Thomas A, Liu HC, Yan M, Callebaut C, Custodio J, Cheng A, and McCallister S

Subjects
Adenine administration & dosage, Adenine adverse effects, Adenine therapeutic use, Adult, Alanine, Anti-HIV Agents administration & dosage, Female, Humans, Male, Organophosphonates administration & dosage, Organophosphonates adverse effects, RNA, Viral blood, Tenofovir, Adenine analogs & derivatives, Anti-HIV Agents therapeutic use, HIV Infections drug therapy, HIV-1, Organophosphonates therapeutic use
Abstract

Objectives: To evaluate the safety and efficacy of the novel tenofovir prodrug, tenofovir alafenamide (TAF), as part of the first protease inhibitor-based single-tablet regimen (STR) for initial treatment of HIV-1 infection., Methods: Antiretroviral therapy (ART)-naive adults with estimated glomerular filtration rate ≥ 70 mL/min were randomized 2:1 to receive the darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) STR (TAF: N = 103) or darunavir + cobicistat + emtricitabine/tenofovir disoproxil fumarate (TDF: N = 50) once daily with matched placebos for 48 weeks., Results: At week 24, viral suppression (HIV-1 RNA <50 copies/mL) rates were similar (TAF 74.8% vs. TDF 74.0%). At week 48, rates were TAF 76.7% vs. TDF 84.0%; the difference was driven by higher rate of discontinuations in TAF (6.8%) vs. TDF (2%). Among those with virologic failure, none developed resistance. Most adverse events were of mild/moderate severity. The mean change in serum creatinine from baseline at week 48 was 0.06 mg/dL (95% confidence interval: 0.04 to 0.08) for TAF vs. 0.09 mg/dL (95% confidence interval: 0.05 to 0.14) for TDF (P = 0.053). The % change in retinol binding protein/Cr ratio was +9 (TAF) vs. +54 (TDF), P = 0.003; the % change in urine β-2 microglobulin/Cr ratio was -42.0 (TAF) vs. +2.3 (TDF), P = 0.002. The % change in hip bone mineral density (BMD) was -0.84 (TAF) vs. -3.82 (TDF), P < 0.001 and in spine BMD was -1.57 (TAF) vs. -3.62 (TDF), P = 0.003. There were no fractures in either group., Conclusions: The TAF arm had significantly improved renal and bone safety parameters: less proteinuria and less change in hip and spine BMD, consistent with results from a similarly designed study of the elvitegravir/C/F/TAF STR. This D/C/F/TAF STR offers a promising option for initial HIV treatment, with the high barrier to resistance of darunavir, and the potential for improved long-term renal and bone safety with TAF.

Published
2015
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