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26 results on '"Porteiro, Norma"'

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. Week 96 extension results of a Phase 3 study evaluating long-acting cabotegravir with rilpivirine for HIV-1 treatment

Author

Swindells, Susan, Lutz, Thomas, Van Zyl, Lelanie, Porteiro, Norma, Stoll, Matthias, Mitha, Essack, Shon, Alyssa, Benn, Paul, Huang, Jenny O., Harrington, Conn M., Hove, Kai, Ford, Susan L., Talarico, Christine L., Chounta, Vasiliki, Crauwels, Herta, Van Solingen-Ristea, Rodica, Vanveggel, Simon, Margolis, David A., Smith, Kimberly Y., Vandermeulen, Kati, and Spreen, William R.

Published
2022
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4. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials

Author

Cassetti, Lidia, David, Daniel, Figueras, Laura, Losso, Marcelo, Lopardo, Gustavo, Lupo, Sergio, Porteiro, Norma, Sánchez, Marisa, Bloch, Mark, Cooper, David, Finlayson, Robert, Kelleher, Anthony, Koh, Kenneth, Lewis, David, McMahon, James, Moore, Richard, Roth, Norman, Shields, Matthew, De Wit, Stephane, Florence, Eric, Goffard, Jean-Christophe, Demeester, Remy, Lacor, Patrick, Vandercam, Bernard, Vandekerckhove, Linos, Angel, Jonathan, Baril, Jean-Guy, Conway, Brian, De Pokomandy, Alexandra, Szabo, Jason, Walmsley, Sharon, Bouchaud, Olivier, Chidiac, Christian, Delobel, Pierre, Goujard, Cecile, Katlama, Christine, Molina, Jean-Michel, Pialoux, Gilles, Philibert, Patrick, Bogner, Johannes, Esser, Stefan, Krznaric, Ivanka, Lehmann, Clara, Spinner, Christoph, Stellbrink, Hans-Jurgen, Stephan, Christoph, Stoehr, Albrecht, Barchi, Enrico, Caramello, Pietro, Castelli, Francesco, Cattelan, Anna Maria, D'Arminio Monforte, Antonella, Di Biagio, Antonio, Di Perri, Giovanni, Gori, Andrea, Maggiolo, Franco, Menzaghi, Barbara, Migliorino, Guglielmo, Mussini, Cristina, Penco, Giovanni, Puoti, Massimo, Rizzardini, Giuliano, Gulminetti, Roberto, Lazzarin, Adriano, Quirino, Tiziano, Sighinolfi, Laura, Viale, Pierluigi, Amaya Tapia, Gerardo, Andrade Villanueva, Jaime, Granados Reyes, Enrique R, Perez Rios, Alma, Santoscoy Gomez, Mario, Den Hollander, Jan, Rijnders, Bart, Hidalgo, José A, Hercilla Vasquez, Luis, Illescas, Luis, Olczak, Anita, Mansinho, Kamal, Correia Pacheco, Patricia Paula, Teófilo, Eugénio, Saraiva da Cunha, Jose, Sarmento e Castro, Rui, Serrão, Rosário, Arbune, Manuela, Jianu, Cristian, Oprea, Anca, Preotescu, Liliana, Prisacariu, Liviu-Jany, Belonosova, Elena, Borodkina, Olga, Chernova, Oxana, Gankina, Natalia, Kizhlo, Svetlana, Kulagin, Valeriy, Kurina, Nadezhda, Nagimova, Firaya, Pokrovsky, Vadim, Ryamova, Elena, Voronin, Evgeny, Yakovlev, Alexey, Kaplan, Richard, Lee, Sun Hee, Kim, Shin-Woo, Kim, Sang-Il, Kim, Woo Joo, Antela Lopez, Antonio, Casado Osorio, Jose L, Castaño Carracedo, Manuel A, De Los Santos Gil, Ignacio, Estrada Perez, Vicente, Falco Ferrer, Vicenç, Force, Luis, Galinda Puerto, Maria Jose, Garcia Deltoro, Miguel, Gatell, Josep M, Goenaga Sanchez, Miguel A, González Cordón, Ana, Knobel, Hernando, Lopez Bernaldo de Quiros, Juan Carlos, Losa Garcia, Juan E, Masia, Mar, Montero-Alsonso, Marta, Ocampo Hermida, Antonio, Pasquau Liaño, Juan, Portilla Sogorb, Joaquin, Pulido Ortega, Federico, Rivera Roman, Antonio, Santos Fernandez, Jose Ramon, Torres Perea, Rafael, Troya Garcia, Jesus, Viciana Fernandez, Pompeyo, Calmy, Alexandra, Hauser, Christoph, Fehr, Jan, Cheng, Shu-Hsing, Ko, Wen-Chien, Lin, Hsi-Hsun, Lu, Po-Liang, Tseng, Yu-Ting, Wang, Ning-Chi, Wong, Wing-Wai, Yang, Chia-Jui, Arduino, Roberto, Benson, Paul, Berhe, Mezgebe, Bredeek, Fritz, Brinson, Cynthia, Campbell, Thomas, Crofoot, Gordon, Cunningham, Douglas, DeJesus, Edwin, Dretler, Robin, Eron, Joseph, Fife, Kenneth, Fichtenbaum, Carl, Flamm, Jason, Goldstein, Deborah, Gupta, Samir, Hagins, Debbie, Hoffman-Terry, Margaret, Jayaweera, Dushyantha, Kinder, Clifford, Klein, Daniel, McDonald, Cheryl, Mills, Anthony, Nahass, Ronald, Osiyemi, Olayemi, Overton, Edgar, Parks, David, Prelutsky, David, Ramgopal, Moti, Schrader, Shannon, Sha, Beverly, Simon, Gary, Sims, James, Skiest, Daniel, Slim, Jihad, Tashima, Karen, Thedinger, Blair, Gazzard, Brian, Fox, Julie, Johnson, Margaret, Kegg, Stephen, Khoo, Saye, Mazhude, Charles, Orkin, Chloe, Schembri, Gabriel, Ustianowski, Andrew, Cahn, Pedro, Madero, Juan Sierra, Arribas, José Ramón, Antinori, Andrea, Ortiz, Roberto, Clarke, Amanda E, Hung, Chien-Ching, Rockstroh, Jürgen K, Girard, Pierre-Marie, Sievers, Jörg, Man, Choy, Currie, Alexander, Underwood, Mark, Tenorio, Allan R, Pappa, Keith, Wynne, Brian, Fettiplace, Anna, Gartland, Martin, Aboud, Michael, and Smith, Kimberly

Published
2019
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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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8. 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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9. Maraviroc, as a Switch Option, in HIV-1–infected Individuals With Stable, Well-controlled HIV Replication and R5-tropic Virus on Their First Nucleoside/Nucleotide Reverse Transcriptase Inhibitor Plus Ritonavir-boosted Protease Inhibitor Regimen: Week 48 Results of the Randomized, Multicenter MARCH Study

Author

Maraviroc Switch (MARCH) Study Group, Pett, Sarah Lilian, Amin, Janaki, Horban, Andrejz, Andrade-Villanueva, Jaime, Losso, Marcelo, Porteiro, Norma, Madero, Juan Sierra, Belloso, Waldo, Tu, Elise, Silk, David, Kelleher, Anthony, Harrigan, Richard, Clark, Andrew, Sugiura, Wataru, Wolff, Marcelo, Gill, John, Gatell, Jose, Fisher, Martin, Clarke, Amanda, Ruxrungtham, Kiat, Prazuck, Thierry, Kaiser, Rolf, Wolley, Ian, Arnaiz, Juan Alberto, Cooper, David, Rockstroh, Jürgen K., Mallon, Patrick, and Emery, Sean

Published
2016

10. Long-Acting Cabotegravir and Rilpivirine Dosed Every 2 Months in Adults With Human Immunodeficiency Virus 1 Type 1 Infection: 152-Week Results From ATLAS-2M, a Randomized, Open-Label, Phase 3b, Noninferiority Study

Author

Overton, Edgar T, primary, Richmond, Gary, additional, Rizzardini, Giuliano, additional, Thalme, Anders, additional, Girard, Pierre-Marie, additional, Wong, Alexander, additional, Porteiro, Norma, additional, Swindells, Susan, additional, Reynes, Jacques, additional, Noe, Sebastian, additional, Harrington, Conn, additional, Español, Carlos Martín, additional, Acuipil, Carolina, additional, Aksar, Asma, additional, Wang, Yuanyuan, additional, Ford, Susan L, additional, Crauwels, Herta, additional, van Eygen, Veerle, additional, Van Solingen-Ristea, Rodica, additional, Latham, Christine L, additional, Thiagarajah, Shanker, additional, D’Amico, Ronald, additional, Smith, Kimberly Y, additional, Vandermeulen, Kati, additional, and Spreen, William R, additional

Published
2023
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11. 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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13. Week 96 extension results of a Phase 3 study evaluating long-acting cabotegravir with rilpivirine for HIV-1 treatment

Author

Swindells, Susan, primary, Lutz, Thomas, additional, Van Zyl, Lelanie, additional, Porteiro, Norma, additional, Stoll, Matthias, additional, Mitha, Essack, additional, Shon, Alyssa, additional, Benn, Paul, additional, Huang, Jenny O., additional, Harrington, Conn M., additional, Hove, Kai, additional, Ford, Susan L., additional, Talarico, Christine L., additional, Chounta, Vasiliki, additional, Crauwels, Herta, additional, Van Solingen-Ristea, Rodica, additional, Vanveggel, Simon, additional, Margolis, David A., additional, Smith, Kimberly Y., additional, Vandermeulen, Kati, additional, and Spreen, William R., additional

Published
2021
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14. 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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15. Long-acting cabotegravir+rilpivirine every 2 months: ATLAS-2M week 152 results.

Author

Overton, Edgar T., Richmond, Gary, Rizzardini, Giuliano, Thalme, Anders, Girard, Pierre-Marie, Wong, Alexander, Porteiro, Norma, Martín Español, Carlos, Acuipil, Carolina, Aksar, Asma, Yuanyuan Wang, D’Amico, Ronald, Talarico, Christine, Vandermeulen, Kati, Yeon-Sook Kim, and Spreen, William R.

Subjects
HIV, CONFIDENCE intervals, SECONDARY analysis, RNA
Abstract

배경 Cabotegravir (CAB) + rilpivirine (RPV) dosed intramuscularly monthly or every 2 months is a complete long-acting (LA) regimen for the maintenance of HIV-1 virologic suppression. The ATLAS-2M (NCT03299049) Week (W) 48 primary and W96 secondary analyses demonstrated noninferiority of CAB+RPV LA administered every 8 weeks (Q8W) vs. every 4 weeks (Q4W). Here, we report the W152 results. 방법 ATLAS-2M is a Phase 3b, randomized, multicenter study assessing the efficacy and safety of CAB+RPV LA Q8W vs. Q4W. Virologically suppressed (HIV-1 RNA <50 copies/mL) individuals receiving CAB+RPV LA Q4W (ATLAS [NCT02951052] study rollover) or oral therapy were randomized 1:1 to receive CAB+RPV LA Q8W or Q4W. The primary endpoint was the proportion of participants with plasma HIV-1 RNA ≥50 copies/mL (FDA Snapshot; 4% noninferiority margin). Other endpoints included pro- portion of participants with plasma HIV-1 RNA <50 copies/mL, incidence of confirmed virologic failure (CVF; two consecutive plasma HIV-1 RNA ≥200 copies/mL), tolerability, and safety. 결과 1045 participants received CAB+RPV LA (Q8W, n=522; Q4W, n=523). Median (range) age was 42 years (19-83); 27% were female (sex at birth) and 73% were White. At W152, CAB+RPV LA Q8W demonstrated noninferior efficacy vs. Q4W dosing, with 2.7% (n=14) and 1.0% (n=5) of participants having HIV-1 RNA ≥50 copies/mL in each arm, and the confidence interval excluded the noninferiority margin (Figure). High levels of virologic suppression were observed; 86-87% of participants maintained HIV-1 RNA <50 copies/mL. Further, 11 (2.1%) and 2 (0.4%) participants in the Q8W and Q4W arms had CVF, representing an additional 2 since the W96 analysis. Both were in the Q8W arm and had treatment-emergent resistance-associated mutations to RPV (E138A+Y181Y/C; E138A+M230M/L) and CAB (Q148R). Safety profiles were comparable, with no new significant safety information observed. Injection site reactions were the most common adverse event; most were mild or moderate in severity (98.9%), with a median duration of 3 days, and few participants discontinued due to injection-related reasons. 결론 Efficacy of CAB+RPV LA Q8W continued to be noninferior to Q4W at W152, with both regimens maintaining high levels of virologic suppression. The overall incidence of CVF was low, with two additional cases reported in the Q8W arm after W96. These data further support CAB+RPV LA as a complete regimen for the maintenance of HIV-1 virologic suppression. [ABSTRACT FROM AUTHOR]

Published
2022

16. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials

Author

Cahn, Pedro, primary, Madero, Juan Sierra, additional, Arribas, José Ramón, additional, Antinori, Andrea, additional, Ortiz, Roberto, additional, Clarke, Amanda E, additional, Hung, Chien-Ching, additional, Rockstroh, Jürgen K, additional, Girard, Pierre-Marie, additional, Sievers, Jörg, additional, Man, Choy, additional, Currie, Alexander, additional, Underwood, Mark, additional, Tenorio, Allan R, additional, Pappa, Keith, additional, Wynne, Brian, additional, Fettiplace, Anna, additional, Gartland, Martin, additional, Aboud, Michael, additional, Smith, Kimberly, additional, Cassetti, Lidia, additional, David, Daniel, additional, Figueras, Laura, additional, Losso, Marcelo, additional, Lopardo, Gustavo, additional, Lupo, Sergio, additional, Porteiro, Norma, additional, Sánchez, Marisa, additional, Bloch, Mark, additional, Cooper, David, additional, Finlayson, Robert, additional, Kelleher, Anthony, additional, Koh, Kenneth, additional, Lewis, David, additional, McMahon, James, additional, Moore, Richard, additional, Roth, Norman, additional, Shields, Matthew, additional, De Wit, Stephane, additional, Florence, Eric, additional, Goffard, Jean-Christophe, additional, Demeester, Remy, additional, Lacor, Patrick, additional, Vandercam, Bernard, additional, Vandekerckhove, Linos, additional, Angel, Jonathan, additional, Baril, Jean-Guy, additional, Conway, Brian, additional, De Pokomandy, Alexandra, additional, Szabo, Jason, additional, Walmsley, Sharon, additional, Bouchaud, Olivier, additional, Chidiac, Christian, additional, Delobel, Pierre, additional, Goujard, Cecile, additional, Katlama, Christine, additional, Molina, Jean-Michel, additional, Pialoux, Gilles, additional, Philibert, Patrick, additional, Bogner, Johannes, additional, Esser, Stefan, additional, Krznaric, Ivanka, additional, Lehmann, Clara, additional, Spinner, Christoph, additional, Stellbrink, Hans-Jurgen, additional, Stephan, Christoph, additional, Stoehr, Albrecht, additional, Barchi, Enrico, additional, Caramello, Pietro, additional, Castelli, Francesco, additional, Cattelan, Anna Maria, additional, D'Arminio Monforte, Antonella, additional, Di Biagio, Antonio, additional, Di Perri, Giovanni, additional, Gori, Andrea, additional, Maggiolo, Franco, additional, Menzaghi, Barbara, additional, Migliorino, Guglielmo, additional, Mussini, Cristina, additional, Penco, Giovanni, additional, Puoti, Massimo, additional, Rizzardini, Giuliano, additional, Gulminetti, Roberto, additional, Lazzarin, Adriano, additional, Quirino, Tiziano, additional, Sighinolfi, Laura, additional, Viale, Pierluigi, additional, Amaya Tapia, Gerardo, additional, Andrade Villanueva, Jaime, additional, Granados Reyes, Enrique R, additional, Perez Rios, Alma, additional, Santoscoy Gomez, Mario, additional, Den Hollander, Jan, additional, Rijnders, Bart, additional, Hidalgo, José A, additional, Hercilla Vasquez, Luis, additional, Illescas, Luis, additional, Olczak, Anita, additional, Mansinho, Kamal, additional, Correia Pacheco, Patricia Paula, additional, Teófilo, Eugénio, additional, Saraiva da Cunha, Jose, additional, Sarmento e Castro, Rui, additional, Serrão, Rosário, additional, Arbune, Manuela, additional, Jianu, Cristian, additional, Oprea, Anca, additional, Preotescu, Liliana, additional, Prisacariu, Liviu-Jany, additional, Belonosova, Elena, additional, Borodkina, Olga, additional, Chernova, Oxana, additional, Gankina, Natalia, additional, Kizhlo, Svetlana, additional, Kulagin, Valeriy, additional, Kurina, Nadezhda, additional, Nagimova, Firaya, additional, Pokrovsky, Vadim, additional, Ryamova, Elena, additional, Voronin, Evgeny, additional, Yakovlev, Alexey, additional, Kaplan, Richard, additional, Lee, Sun Hee, additional, Kim, Shin-Woo, additional, Kim, Sang-Il, additional, Kim, Woo Joo, additional, Antela Lopez, Antonio, additional, Casado Osorio, Jose L, additional, Castaño Carracedo, Manuel A, additional, De Los Santos Gil, Ignacio, additional, Estrada Perez, Vicente, additional, Falco Ferrer, Vicenç, additional, Force, Luis, additional, Galinda Puerto, Maria Jose, additional, Garcia Deltoro, Miguel, additional, Gatell, Josep M, additional, Goenaga Sanchez, Miguel A, additional, González Cordón, Ana, additional, Knobel, Hernando, additional, Lopez Bernaldo de Quiros, Juan Carlos, additional, Losa Garcia, Juan E, additional, Masia, Mar, additional, Montero-Alsonso, Marta, additional, Ocampo Hermida, Antonio, additional, Pasquau Liaño, Juan, additional, Portilla Sogorb, Joaquin, additional, Pulido Ortega, Federico, additional, Rivera Roman, Antonio, additional, Santos Fernandez, Jose Ramon, additional, Torres Perea, Rafael, additional, Troya Garcia, Jesus, additional, Viciana Fernandez, Pompeyo, additional, Calmy, Alexandra, additional, Hauser, Christoph, additional, Fehr, Jan, additional, Cheng, Shu-Hsing, additional, Ko, Wen-Chien, additional, Lin, Hsi-Hsun, additional, Lu, Po-Liang, additional, Tseng, Yu-Ting, additional, Wang, Ning-Chi, additional, Wong, Wing-Wai, additional, Yang, Chia-Jui, additional, Arduino, Roberto, additional, Benson, Paul, additional, Berhe, Mezgebe, additional, Bredeek, Fritz, additional, Brinson, Cynthia, additional, Campbell, Thomas, additional, Crofoot, Gordon, additional, Cunningham, Douglas, additional, DeJesus, Edwin, additional, Dretler, Robin, additional, Eron, Joseph, additional, Fife, Kenneth, additional, Fichtenbaum, Carl, additional, Flamm, Jason, additional, Goldstein, Deborah, additional, Gupta, Samir, additional, Hagins, Debbie, additional, Hoffman-Terry, Margaret, additional, Jayaweera, Dushyantha, additional, Kinder, Clifford, additional, Klein, Daniel, additional, McDonald, Cheryl, additional, Mills, Anthony, additional, Nahass, Ronald, additional, Osiyemi, Olayemi, additional, Overton, Edgar, additional, Parks, David, additional, Prelutsky, David, additional, Ramgopal, Moti, additional, Schrader, Shannon, additional, Sha, Beverly, additional, Simon, Gary, additional, Sims, James, additional, Skiest, Daniel, additional, Slim, Jihad, additional, Tashima, Karen, additional, Thedinger, Blair, additional, Gazzard, Brian, additional, Fox, Julie, additional, Johnson, Margaret, additional, Kegg, Stephen, additional, Khoo, Saye, additional, Mazhude, Charles, additional, Orkin, Chloe, additional, Schembri, Gabriel, additional, and Ustianowski, Andrew, additional

Published
2019
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17. 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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18. Prevalencia de interacciones medicamentosas con fármacos anti-retrovirales en Buenos Aires, Argentina

Author

Córdova, Ezequiel, Porteiro, Norma, Loiza, Eliana, and Mingrone, Horacio

Subjects
concomitant medications, antiretroviral treatment, medicación concomitante, interacciones medicamentosas, HIV, VIH, tratamiento anti-retroviral, drug interactions
Abstract

Introducción: Los fármacos anti-retrovirales (ARVs) tienen un alto potencial de interaccionar farmacológicamente con otros medicamentos. Sin embargo, los datos sobre la prevalencia y los factores de riesgo para la presencia de interacciones medicamentosas clínicamente significativas (IMCS) con ARVs en países latinoamericanos son limitados. Objetivo: Evaluar la prevalencia y los factores de riesgo para estas IMCS en dos centros de atención ambulatoria en Buenos Aires, Argentina. Métodos: Estudio transversal y descriptivo (septiembre-noviembre de 2012). Se evaluó la presencia de medicación concomitante en pacientes infectados por VIH bajo tratamiento ARV. Para evaluar la presencia de IMCS se utilizó la base de datos de interacciones de la Universidad de Liverpool (www.hiv-druginteractions.org). Resultados: Se incluyeron 217 pacientes. Sexo masculino: 64% (IC 95: 57-70). Mediana de edad (IQR): 41 (36-48). Presencia de co-morbilidades: 19%. Tratamiento ARV basado en INNTI: 48%, basado en IP: 50% y basado en INNTI más IP: 2%. Mediana de linfocitos T-CD4 (IQR): 402 céls/ml (235-588). Carga viral < 50 copias/ml: 78%. El 64% (IC 95: 57-70) de los pacientes tenían > 1 medicación concomitante: antimicrobianos (40%), fármacos cardiovasculares (25%) y gastrointestinales (22%). De los pacientes que presentaban medicación concomitante 68 (49%) tenían > 1 IMCS y sólo tres (2%) presentaban una asociación contraindicada. Además, dos pacientes tenían una IMCS entre ARVs. En el análisis multivariado, el número de medicamentos concomitantes y el uso psicofármacos se asociaron con una mayor chance de presentar IMCS. Conclusiones: La presencia de medicación concomitante e IMCS fue común en nuestra población. En este contexto, la formación de profesionales de la salud en la detección de interacciones medicamentosas es de suma importancia para un manejo adecuado de pacientes con infección por VIH que reciban tratamiento ARV. Introduction: Antiretroviral agents (ARVs) have a high potential for drug interactions. However, the prevalence and risk factors for clinically significant drug-drug interactions (CSDDIs) with ARVs from Latin American countries is unknown. Aim: To evaluate the prevalence and risk factors for CSDDIs in HIV outpatients attending at two centers in Buenos Aires, Argentina. Methods: Descriptive cross-sectional study (september to november 2012). HIV-1 infected patients under ARV treatment at the time of the study were randomly assessed for concomitant medication. CSDDIs were screened using the University of Liverpool Drug Interactions Program (www.hiv-druginteractions.org). Results: A total of 217 patients were included. Male sex: 64% (CI 95: 57-70). Median age (IQR): 41 (36-48). Presence of comorbidities: 19%. ARV regimen: NNRTI-based: 48%, PI-based: 50% and NNRTI plus PI: 2%. Median of CD4 T-cell count (IQR): 402 cells/mL (235-588). Viral load < 50 copies/mL: 78%. Overall, 64% (CI 95: 57-70) of patients had > 1 co-medication of whom a 49% had at least one CSDDI. Two patients had a CSDDI between ARVs. The most frequent co-medications observed were antimicrobial (40%), cardiovascular (25%) and gastrointestinal agents (22%). In the multivariate analysis the number of co-medications and use of CNS agents were associated with the presence of CSDDIs. Conclusions: Co-medications and CSDDIs were common in our setting. In this context, training of HIV physicians in drug interactions is of major importance for adequate management of these patients.

Published
2016

19. 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. Maraviroc, as a Switch Option, in HIV-1-infected Individuals With Stable, Well-controlled HIV Replication and R5-tropic Virus on Their First Nucleoside/Nucleotide Reverse Transcriptase Inhibitor Plus Ritonavir-boosted Protease Inhibitor Regimen: Week 48 Results of the Randomized, Multicenter MARCH Study

Author

Pett, Sarah Lilian, Amin, Janaki, Horban, Andrejz, Andrade-Villanueva, Jaime, Losso, Marcelo, Porteiro, Norma, Sierra Madero, Juan, Belloso, Waldo, Tu, Elise, Silk, David, Kelleher, Anthony, Harrigan, Richard, Clark, Andrew, Sugiura, Wataru, Wolff, Marcelo, Gill, John, Gatell, Jose, Fisher, Martin, Clarke, Amanda, Ruxrungtham, Kiat, Prazuck, Thierry, Kaiser, Rolf, Woolley, Ian, Alberto Arnaiz, Juan, Cooper, David, Rockstroh, Jurgen K., Mallon, Patrick, Emery, Sean, Pett, Sarah Lilian, Amin, Janaki, Horban, Andrejz, Andrade-Villanueva, Jaime, Losso, Marcelo, Porteiro, Norma, Sierra Madero, Juan, Belloso, Waldo, Tu, Elise, Silk, David, Kelleher, Anthony, Harrigan, Richard, Clark, Andrew, Sugiura, Wataru, Wolff, Marcelo, Gill, John, Gatell, Jose, Fisher, Martin, Clarke, Amanda, Ruxrungtham, Kiat, Prazuck, Thierry, Kaiser, Rolf, Woolley, Ian, Alberto Arnaiz, Juan, Cooper, David, Rockstroh, Jurgen K., Mallon, Patrick, and Emery, Sean

Abstract

Background. Alternative combination antiretroviral therapies in virologically suppressed human immunodeficiency virus (HIV)-infected patients experiencing side effects and/or at ongoing risk of important comorbidities from current therapy are needed. Maraviroc (MVC), a chemokine receptor 5 antagonist, is a potential alternative component of therapy in those with R5-tropic virus. Methods. The Maraviroc Switch Study is a randomized, multicenter, 96-week, open-label switch study in HIV type 1-infected adults with R5-tropic virus, virologically suppressed on a ritonavir-boosted protease inhibitor (PI/r) plus double nucleoside/nucleotide reverse transcriptase inhibitor (2 N(t)RTI) backbone. Participants were randomized 1: 2: 2 to current combination antiretroviral therapy (control), or replacing the protease inhibitor (MVC + 2 N(t)RTI arm) or the nucleoside reverse transcriptase inhibitor backbone (MVC + PI/r arm) with twice-daily MVC. The primary endpoint was the difference (switch minus control) in proportion with plasma viral load (VL) <200copies/mL at 48 weeks. The switch arms were judged noninferior if the lower limit of the 95% confidence interval (CI) for the difference in the primary endpoint was <-12% in the intention-to-treat (ITT) population. Results. The ITT population comprised 395 participants (control, n = 82; MVC + 2 N(t) RTI, n = 156; MVC + PI/r, n = 157). Baseline characteristics were well matched. At week 48, noninferior rates of virological suppression were observed in those switching away from a PI/r (93.6% [95% CI, -9.0% to 2.2%] and 91.7% [95% CI, -9.6% to 3.8%] with VL <200 and <50 copies/mL, respectively) compared to the control arm (97.6% and 95.1% with VL <200 and <50 copies/mL, respectively). In contrast, MVC + PI/r did not meet noninferiority bounds and was significantly inferior (84.1% [95% CI, -19.8% to -5.8%] and 77.7% [95% CI, -24.9% to -8.4%] with VL <200 and <50 copies/mL, respectively) to the control arm in the ITT analysis. Conclusion

Published
2016

22. Maraviroc, as a Switch Option, in HIV-1–infected Individuals With Stable, Well-controlled HIV Replication and R5-tropic Virus on Their First Nucleoside/Nucleotide Reverse Transcriptase Inhibitor Plus Ritonavir-boosted Protease Inhibitor Regimen: Week 48 Results of the Randomized, Multicenter MARCH Study

Author

Pett, Sarah Lilian, primary, Amin, Janaki, additional, Horban, Andrejz, additional, Andrade-Villanueva, Jaime, additional, Losso, Marcelo, additional, Porteiro, Norma, additional, Sierra Madero, Juan, additional, Belloso, Waldo, additional, Tu, Elise, additional, Silk, David, additional, Kelleher, Anthony, additional, Harrigan, Richard, additional, Clark, Andrew, additional, Sugiura, Wataru, additional, Wolff, Marcelo, additional, Gill, John, additional, Gatell, Jose, additional, Fisher, Martin, additional, Clarke, Amanda, additional, Ruxrungtham, Kiat, additional, Prazuck, Thierry, additional, Kaiser, Rolf, additional, Woolley, Ian, additional, Arnaiz, Juan Alberto, additional, Cooper, David, additional, Rockstroh, Jürgen K., additional, Mallon, Patrick, additional, and Emery, Sean, additional

Published
2016
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24. İki Ayda Bir Enjektabl Uzun Etkili Cabotegravir + Rilpivirin (CAB + RPV) Tedavi Rejimi: ATLAS-2M Çalışması 152. Hafta Sonuçları.

Author

Overton, Edgar T., Richmond, Gary, Rizzardini, Giuliano, Thalme, Anders, Girard, Pierre Marie, Wong, Alexander, Porteiro, Norma, Español, Carlos Martín, Acuipil, Carolina, Aksar, Asma, Yuanyuan Wang, D’amico, Ronald, Talarico, Christine, Vandermeulen, Kati, Spreen, William R., and Paracıklı, Gürcan

Abstract

Copyright of Mediterranean Journal of Infection, Microbes & Antimicrobials is the property of Galenos Yayinevi Tic. LTD. STI and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2022

25. Efficacy of dolutegravir plus lamivudine in treatment-naive people living with HIV without baseline drug-resistance testing available (D2ARLING): 48-week results of a phase 4, randomised, open-label, non-inferiority trial.

Author

Cordova E, Hernandez Rendon J, Mingrone V, Martin P, Arevalo Calderon G, Seleme S, Ballivian J, and Porteiro N

Abstract

Background: Dolutegravir plus lamivudine has emerged as a preferred treatment for HIV; however, initiating this regimen without baseline resistance testing raises concerns about the potential presence of pretreatment lamivudine resistance. We aimed to evaluate the efficacy of dolutegravir plus lamivudine in the absence of information on baseline resistance testing in treatment-naive people with HIV., Methods: We did an open-label, non-inferiority, single-centre, phase 4, randomised controlled study (D2ARLING), designed to assess the efficacy and safety of dolutegravir plus lamivudine in treatment-naive people with HIV with no available baseline resistance testing. We included participants aged 18 years or older with HIV-1 diagnosis who were naive to antiretroviral therapy and had no baseline genotypic resistance testing result available. We randomly assigned (1:1) participants to receive dolutegravir 50 mg plus lamivudine 300 mg or a three-drug regimen including dolutegravir 50 mg plus tenofovir disoproxil fumarate 300 mg and either emtricitabine 200 mg or lamivudine 300 mg. Randomisation was stratified by baseline HIV-1 RNA (≤100 000 vs >100 000 copies per mL) and CD4 cell count (<200 vs ≥200 cells per μL). Per protocol, we performed genotypic drug-resistance testing on day 1 and it remained double-masked throughout the study, simulating a scenario of inaccessibility of baseline resistance testing. The primary endpoint was the proportion of participants with plasma HIV-1 RNA less than 50 copies per mL at week 48 (intention-to-treat exposed analysis via the Snapshot algorithm) with prespecified non-inferiority margin of 10%. This trial is registered with ClinicalTrials.gov (NCT04549467)., Findings: Between Nov 17, 2020, and Aug 31, 2022, 214 participants were randomly assigned to and treated with dolutegravir plus lamivudine (n=106) or dolutegravir plus tenofovir disoproxil fumarate and either emtricitabine or lamivudine (n=108). Median age of participants was 31 years (IQR 26-39) and 49 (23%) were female. At baseline, 66 (31%) of participants had an HIV-1 RNA viral load of more than 100 000 copies per mL, and 44 (21%) had a CD4 T-cell count of less than 200 cells per μL. At week 48, 97 (92%) of 106 participants in the dolutegravir plus lamivudine group and 96 (89%) of 108 participants in the dolutegravir plus tenofovir disoproxil fumarate with either emtricitabine or lamivudine group had HIV-1 RNA of less than 50 copies per mL (difference 2·62%; 95% CI -5·3 to 10·6), showing non-inferiority of dolutegravir plus lamivudine to the three-drug regimen. None of the participants in the dolutegravir plus lamivudine group and two in the control group had protocol-defined virological failure, and none developed treatment-emergent resistance mutations to any of the study drugs. Overall adverse event rates were similar between arms. Less than 1% of participants in both groups were discontinued due to adverse events., Interpretation: This study provides evidence supporting the non-inferiority of dolutegravir plus lamivudine compared with a preferred three-drug regimen in treatment-naive individuals without baseline resistance testing. These findings suggest that baseline resistance testing might not be a requirement for initiating treatment with dolutegravir plus lamivudine in settings with low frequency or suspicion of transmitted drug resistance to these drugs., Funding: ViiV Healthcare., Competing Interests: Declaration of interests EC has served on advisory boards for GlaxoSmithKline, ViiV Healthcare, and Janssen; served as an investigator for ViiV Healthcare and Merck; and has received honoraria for his speaking from GlaxoSmithKline, Janssen, Merck, and ViiV Healthcare. NP has served on advisory boards for GlaxoSmithKline, ViiV Healthcare, and Janssen; served as an investigator for ViiV Healthcare and Merck; and has received honoraria for his speaking from GlaxoSmithKline and ViiV Healthcare. VM served as an investigator for ViiV Healthcare; and has received honoraria for his speaking from Janssen. JHR, PM, GAC, SS, and JB declare no competing interests., (Copyright © 2025 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.)

Published
2025
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26. [Prevalence of potential drug-drug interactions involving antiretroviral drugs in Buenos Aires, Argentina].

Author

Córdova E, Porteiro N, Loiza E, and Mingrone H

Subjects
Adult, Argentina epidemiology, Cross-Sectional Studies, Drug Interactions, Female, HIV-1, Humans, Male, Middle Aged, Multivariate Analysis, Prevalence, Risk Factors, Treatment Outcome, Anti-Retroviral Agents pharmacology, Drug-Related Side Effects and Adverse Reactions epidemiology, HIV Infections drug therapy, HIV Infections epidemiology
Abstract

Introduction: Antiretroviral agents (ARVs) have a high potential for drug interactions. However, the prevalence and risk factors for clinically significant drug-drug interactions (CSDDIs) with ARVs from Latin American countries is unknown., Aim: To evaluate the prevalence and risk factors for CSDDIs in HIV outpatients attending at two centers in Buenos Aires, Argentina., Methods: Descriptive cross-sectional study (september to november 2012). HIV-1 infected patients under ARV treatment at the time of the study were randomly assessed for concomitant medication. CSDDIs were screened using the University of Liverpool Drug Interactions Program (www.hiv-druginteractions.org)., Results: A total of 217 patients were included. Male sex: 64% (CI 95: 57-70). Median age (IQR): 41 (36-48). Presence of comorbidities: 19%. ARV regimen: NNRTI-based: 48%, PI-based: 50% and NNRTI plus PI: 2%. Median of CD4 T-cell count (IQR): 402 cells/mL (235-588). Viral load < 50 copies/mL: 78%. Overall, 64% (CI 95: 57-70) of patients had > 1 co-medication of whom a 49% had at least one CSDDI. Two patients had a CSDDI between ARVs. The most frequent co-medications observed were antimicrobial (40%), cardiovascular (25%) and gastrointestinal agents (22%). In the multivariate analysis the number of co-medications and use of CNS agents were associated with the presence of CSDDIs., Conclusions: Co-medications and CSDDIs were common in our setting. In this context, training of HIV physicians in drug interactions is of major importance for adequate management of these patients.

Published
2016
Full Text
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