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

Author

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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4. Successful treatment of human immunodeficiency virus-associated highly active antiretroviral therapy-resistant vacuolar myelopathy with intravenous immunoglobulin

Author

Prakhova, Lidiia, Ilves, Aleksandr, Kizhlo, Svetlana, and Savintseva, Zhanna

Subjects
HIV infections -- Case studies -- Complications and side effects, Intravenous immunoglobulins -- Case studies -- Usage, Spinal diseases -- Case studies -- Care and treatment -- Causes of, HIV patients, Time, Immunoglobulins, HIV, Darunavir, Antiretroviral agents, Highly active antiretroviral therapy, Central nervous system, Diseases, Health
Abstract

Byline: Lidiia. Prakhova, Aleksandr. Ilves, Svetlana. Kizhlo, Zhanna. Savintseva For the first time, human immunodeficiency virus (HIV)-associated vacuolar myelopathy (VM) was detailed in an autopsy-based study of 89 cases in [...]

Published
2020

5. Elbasvir/Grazoprevir for HCV Infection in Russia: A Randomized Trial

Author

Zhdanov, Konstantin, Isakov, Vasily, Burnevich, Eduard, Kizhlo, Svetlana, Bakulin, Igor, Pokrovsky, Vadim, Liang, Liwen, Hwang, Peggy, Talwani, Rohit, Haber, Barbara A, and Robertson, Michael N

Subjects
therapy, placebo, virus diseases, hepatitis C, viral drug resistance, Evidence and Research [Hepatic Medicine], Original Research, Russia
Abstract

Konstantin Zhdanov,1 Vasily Isakov,2 Eduard Burnevich,3 Svetlana Kizhlo,4 Igor Bakulin,5 Vadim Pokrovsky,6 Liwen Liang,7 Peggy Hwang,7 Rohit Talwani,7 Barbara A Haber,7 Michael N Robertson7 1Military Medical Academy n.a. S.M. Kirov, St. Petersburg, Russia; 2Department of Gastroenterology & Hepatology, Federal Research Centre of Nutrition, Biotechnology and Food Safety, Moscow, Russia; 3I.M. Sechenov First Moscow State Medical University, Moscow, Russia; 4City Center for AIDS and Infectious Diseases Treatment and Prophylaxis, St. Petersburg, Russia; 5I.I. Mechnikov North-Western State Medical University of the Ministry of Health of the Russian Federation, St. Petersburg, Russia; 6Department of AIDS, Central Research Institute of Epidemiology, Moscow, Russia; 7Merck & Co., Inc., Kenilworth, NJ, USACorrespondence: Barbara A HaberMerck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USATel +1 267-305-3729Email barbara.haber@merck.comPurpose: Hepatitis C virus (HCV) infection is a major healthcare concern in Russia, where almost 5 million individuals are viremic. Elbasvir/grazoprevir is a fixed-dose combination therapy for the treatment of HCV genotype 1 and genotype 4 infection. The present analysis aimed to assess the safety and efficacy of elbasvir/grazoprevir in individuals with HCV infection enrolled at Russian study sites in the C-CORAL study.Patients and Methods: C-CORAL (Protocol PN-5172-067; NCT02251990) was a Phase 3, placebo-controlled, double-blind study conducted throughout Asia and Russia. Treatment-naive participants with chronic HCV infection were randomly assigned to receive immediate or deferred treatment with elbasvir 50 mg/grazoprevir 100 mg once daily for 12 weeks. Participants in the immediate-treatment group received elbasvir/grazoprevir for 12 weeks, and those in the deferred-treatment group received placebo for 12 weeks, followed by open-label elbasvir/grazoprevir for 12 weeks. The primary endpoint was sustained virologic response at 12 weeks after completion of therapy (SVR12).Results: One hundred and nineteen Russian participants were randomized (immediate-treatment group, n=88; deferred-treatment group, n=31). Most participants were white (99%) with HCV genotype 1b infection (97%) and mild-to-moderate (F0–F2) fibrosis (70%). SVR12 was achieved by 98.9% participants in the immediate-treatment group and by 100% of those receiving deferred elbasvir/grazoprevir in the deferred-treatment group. One participant relapsed with nonstructural protein 5A (NS5A) L28M and Y93H resistance-associated substitutions at baseline and at time of failure. Drug-related adverse events were reported by 19% of participants receiving elbasvir/grazoprevir in the immediate-treatment group and by 16% of those receiving placebo in the deferred-treatment group. No serious adverse event or deaths occurred, and no participant discontinued treatment owing to an adverse event.Conclusion: Elbasvir/grazoprevir for 12 weeks was highly effective in treatment-naive Russian individuals with HCV genotype 1b infection.Keywords: hepatitis C, therapy, placebo, Russia, viral drug resistance

Published
2020

7. Elbasvir/Grazoprevir for HCV Infection in Russia: A Randomized Trial

Author

Zhdanov,Konstantin, Isakov,Vasily, Burnevich,Eduard, Kizhlo,Svetlana, Bakulin,Igor, Pokrovsky,Vadim, Liang,Liwen, Hwang,Peggy, Talwani,Rohit, Haber,Barbara A, Robertson,Michael, Zhdanov,Konstantin, Isakov,Vasily, Burnevich,Eduard, Kizhlo,Svetlana, Bakulin,Igor, Pokrovsky,Vadim, Liang,Liwen, Hwang,Peggy, Talwani,Rohit, Haber,Barbara A, and Robertson,Michael

Abstract

Konstantin Zhdanov,1 Vasily Isakov,2 Eduard Burnevich,3 Svetlana Kizhlo,4 Igor Bakulin,5 Vadim Pokrovsky,6 Liwen Liang,7 Peggy Hwang,7 Rohit Talwani,7 Barbara A Haber,7 Michael N Robertson7 1Military Medical Academy n.a. S.M. Kirov, St. Petersburg, Russia; 2Department of Gastroenterology & Hepatology, Federal Research Centre of Nutrition, Biotechnology and Food Safety, Moscow, Russia; 3I.M. Sechenov First Moscow State Medical University, Moscow, Russia; 4City Center for AIDS and Infectious Diseases Treatment and Prophylaxis, St. Petersburg, Russia; 5I.I. Mechnikov North-Western State Medical University of the Ministry of Health of the Russian Federation, St. Petersburg, Russia; 6Department of AIDS, Central Research Institute of Epidemiology, Moscow, Russia; 7Merck & Co., Inc., Kenilworth, NJ, USACorrespondence: Barbara A HaberMerck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USATel +1 267-305-3729Email barbara.haber@merck.comPurpose: Hepatitis C virus (HCV) infection is a major healthcare concern in Russia, where almost 5 million individuals are viremic. Elbasvir/grazoprevir is a fixed-dose combination therapy for the treatment of HCV genotype 1 and genotype 4 infection. The present analysis aimed to assess the safety and efficacy of elbasvir/grazoprevir in individuals with HCV infection enrolled at Russian study sites in the C-CORAL study.Patients and Methods: C-CORAL (Protocol PN-5172-067; NCT02251990) was a Phase 3, placebo-controlled, double-blind study conducted throughout Asia and Russia. Treatment-naive participants with chronic HCV infection were randomly assigned to receive immediate or deferred treatment with elbasvir 50 mg/grazoprevir 100 mg once daily for 12 weeks. Participants in the immediate-treatment group received elbasvir/grazoprevir for 12 weeks, and those in the deferred-treatment group received placebo for 12 weeks, followed by open-label elbasvir/grazoprevir for 12 weeks. The primary endpoint was sustain

Published
2020

8. SAT-174-Formation of the occult chronic hepatitis B during antiviral therapy in patients with HIV + HBV + HDV + HCV infection: Clinical cases

Author

Zhdanov, Konstantin, primary, Gabdrakhmanov, Ilnur, additional, Ostankova, Yulia, additional, Kozlov, Konstantin, additional, Sukachev, Vitalii, additional, Gusev, Denis, additional, Semenov, Aleksandr, additional, Romanova, Svetlana, additional, Kizhlo, Svetlana, additional, Ignat’ev, Sergey, additional, and Schakhmanov, Dmitrii, additional

Published
2019
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9. 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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10. Elbasvir/grazoprevir in Asia‐Pacific/Russian participants with chronic hepatitis C virus genotype 1, 4, or 6 infection.

Author

George, Jacob, Burnevich, Eduard, Sheen, I‐Shyan, Heo, Jeong, Kinh, Nguyen Van, Tanwandee, Tawesak, Cheng, Pin‐Nan, Kim, Do Young, Tak, Won Young, Kizhlo, Svetlana, Zhdanov, Konstantin, Isakov, Vasily, Liang, Liwen, Lindore, Pauline, Ginanni, Joy, Nguyen, Bach‐Yen, Wahl, Janice, Barr, Eliav, Robertson, Michael, and Ingravallo, Paul

Subjects
HEPATITIS C treatment, VIROLOGY, DRUG efficacy
Abstract

The prevalence of hepatitis C virus (HCV) infection in Asian countries is high. This study assessed the efficacy and safety of elbasvir/grazoprevir (EBR/GZR) in participants with HCV infection from Asia‐Pacific countries and Russia. In this phase 3, randomized, placebo‐controlled, double‐blind study, treatment‐naive participants with HCV genotype (GT) 1, 4, or 6 infection were randomized to EBR 50 mg/GZR 100 mg (immediate‐treatment group [ITG]) or placebo (deferred‐treatment group [DTG]) once daily for 12 weeks (Protocol PN‐5172‐067, NCT02251990). The primary efficacy variable was a nonrandomized comparison of sustained virologic response at 12 weeks after the end of therapy (SVR12) for the ITG with a historical control. The primary safety outcome was a randomized comparison between the ITG and DTG. Three hundred thirty‐seven participants were randomized to the ITG (n = 251) or DTG (n = 86); 199 (59.2%) participants were Asian, and 250 (74.4%) had HCV GT1b infection. Overall, 232/250 (92.8%) participants in the ITG achieved SVR12 (97.5% confidence interval, 89.1, 96.5). Of the 18 participants who failed to attain SVR12, 1 was lost to follow‐up and 17 had virologic failure, 13 of whom had HCV GT6 infection. The incidence of adverse events was similar between participants receiving EBR/GZR and placebo (50.8% versus 51.2%; difference, −0.3%; 95% confidence interval, −12.3, 11.9). Conclusion: EBR/GZR for 12 weeks provides an effective and well‐tolerated regimen for chronic HCV GT1 infection in treatment‐naive people from Asia‐Pacific countries and Russia, particularly for the large population with GT1b infection. EBR/GZR is not recommended for the treatment of individuals with HCV GT6 infection. (Hepatology Communications 2018;2:595‐606) [ABSTRACT FROM AUTHOR]

Published
2018
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