Bedaquiline-pretomanid-moxifloxacin-pyrazinamide for drug-sensitive and drug-resistant pulmonary tuberculosis treatment: a phase 2c, open-label, multicentre, partially randomised controlled trial

Authors: Bruinenberg, Paul, Beumont, Maria, Nedelman, Jerry, Li, Mengchun, Zuma-Gwala, Ntokozo, Rajaram, Shakira, Choo, Louise, Wills, Genevive, Betteridge, Matt, Leandra, Leandra, Olugbosi, Morounfolu, Borisov, Sergey, Cevik, Muge ^{a, *}, Thompson, Lindsay C ^b, Upton, Caryn ^d, Rolla, Valéria Cavalcanti ^e, Malahleha, Mookho ^f, Mmbaga, Blandina ^g, Ngubane, Nosipho ^h, Abu Bakar, Zamzurina ⁱ, Rassool, Mohammed ^j, Variava, Ebrahim ^k, Dawson, Rodney ^l, Staples, Suzanne ^m, Lalloo, Umesh ⁿ, Louw, Cheryl ^o, Conradie, Francesca ^p, Eristavi, Marika ^q, Samoilova, Anastasia ^r, Skornyakov, Sergey N ^s, Ntinginya, Niyanda Elias ^t, Haraka, Frederick ^u, Praygod, George ^v, Mayanja-Kizza, Harriett ^w, Caoili, Janice ^x, Balanag, Vincent ^y, Dalcolmo, Margareth Pretti ^z, McHugh, Timothy ^c, Hunt, Robert ^c, Solanki, Priya ^c, Bateson, Anna ^c, Crook, Angela M ^b, Fabiane, Stella ^b, Timm, Juliano ^aa, Sun, Eugene ^aa, Spigelman, Melvin ^aa, Sloan, Derek J ^a, Gillespie, Stephen H ^a

Source: In The Lancet Infectious Diseases September 2024 24(9):1003-1014

JNJ-73763989 and bersacapavir treatment in nucleos(t)ide analogue-suppressed patients with chronic hepatitis B: REEF-2

Authors: Agarwal, Kosh, Buti, Maria, van Bömmel, Florian, Lampertico, Pietro, Janczewska, Ewa, Bourliere, Marc, Vanwolleghem, Thomas, Lenz, Oliver, Verbinnen, Thierry, Kakuda, Thomas N., Mayer, Cristiana, Jezorwski, John, Muenz, Daniel, Beumont, Maria, Kalmeijer, Ronald, Biermer, Michael, Lonjon-Domanec, Isabelle

Source: In Journal of Hepatology September 2024 81(3):404-414

Efficacy and safety of the siRNA JNJ-73763989 and the capsid assembly modulator JNJ-56136379 (bersacapavir) with nucleos(t)ide analogues for the treatment of chronic hepatitis B virus infection (REEF-1): a multicentre, double-blind, active-controlled, randomised, phase 2b trial

Authors: Bourgeois, Stefan, Vanwolleghem, Thomas, Nevens, Frederik, Horsmans, Yves, Van Vlierberghe, Hans, Nastri, Ana Catharina, Lacerda, Marcus, Ramji, Alnoor, Conway, Brian, Coffin, Carla, Janssen, Harry, Fung, Scott, Shafran, Stephen, Hou, Jin Lin, Sperl, Jan, Urbanek, Petr, Plisek, Stanislav, Hejda, Vaclav, Samuel, Didier, Lacombe, Karine, Zoulim, Fabien, Guyader, Dominique, Raffi, Francois, Asselah, Tarik, Bourliere, Marc, Hilleret, Marie-Noelle, Wedemeyer, Heiner, Schulze zur Wiesch, Julian, Sprinzl, Kathrin, van Boemmel, Florian, Hilgard, Gudrun, Sabranski, Michael, Arasteh, Keikawus, Chan, Henry LY, Yuen, Man Fung, Wong, Vincent Ws, Brunetto, Maurizia Rossana, Taliani, Gloria, Andreone, Pietro, Lampertico, Pietro, Kurosaki, Masayuki, Yatsuhashi, Hiroshi, Fujiwara, Kei, Takehara, Tetsuo, Kawaoka, Tomokazu, Asahina, Yasuhiro, Enomoto, Hirayuki, Yabushita, Kazuhisa, Notsumata, Kazuo, Takaguchi, Koichi, Kawabe, Naoto, Kato, Naoya, Koji, Ogawa, Namisaki, Tadashi, Suzuki, Yoshiyuki, Yoon, Jung-Hwan, Ahn, SangHoon, Lim, Young-Suk, Paik, Seung Woon, Kiew, Kuang Kiat, Mohamed, Rosmawati, Tan, Soek Siam, Lee, Yeong Yeh, Hlebowicz, Maria, Berak, Hanna, Gasiorowski, Jacek, Halota, Waldemar, Janczewska, Ewa, Geyvandova, Natalia, Morozov, Viacheslav, Andreeva, Alla, Gusev, Denis, Bessonova, Elena, Osipenko, Marina, Romanova, Svetlana, Gankina, Natalia, Sagalova, Olga, Stepanova, Tatiana, Crespo Garcia, Javier, Diago, Moises, Inmaculada, Fernandez, Calleja, Jose Luis, Forns, Xavier, Buti, Maria, Tangkijvanich, Pisit, Tanwandee, Tawesak, Piratvisuth, Teerha, Leerapun, Apinya, Yilmaz, Gurdal, Tabak, Ömer Fehmi, Akarca, Ulus Salih, Akova, Murat, Idilman, Ramazan, Forton, Daniel, Bell, David, Agarwal, Kosh, Kennedy, Patrick, Felizarta, Franco, Sulkowski, Mark, Nahass, Ronald, Rojter, Sergio, Jacobson, Ira, Korenblat, Kevin, Gitlin, Norman, Yuen, Man-Fung ^*, Jacobson, Ira M, Janssen, Harry L A, Kakuda, Thomas N, Lambrecht, Tom, Beumont, Maria, Kalmeijer, Ronald, Guinard-Azadian, Carine, Mayer, Cristiana, Jezorwski, John, Verbinnen, Thierry, Lenz, Oliver, Shukla, Umesh, Biermer, Michael

Source: In The Lancet Gastroenterology & Hepatology September 2023 8(9):790-802

Combination treatments including the small-interfering RNA JNJ-3989 induce rapid and sometimes prolonged viral responses in patients with CHB

Authors: Yuen, Man-Fung, Locarnini, Stephen, Lim, Tien Huey, Strasser, Simone I., Sievert, William, Cheng, Wendy, Thompson, Alex J., Given, Bruce D., Schluep, Thomas, Hamilton, James, Biermer, Michael, Kalmeijer, Ronald, Beumont, Maria, Lenz, Oliver, De Ridder, Filip, Cloherty, Gavin, Ka-Ho Wong, Danny, Schwabe, Christian, Jackson, Kathy, Lai, Ching Lung, Gish, Robert G., Gane, Edward

Source: In Journal of Hepatology November 2022 77(5):1287-1298

Efficacy and safety of simeprevir with PegIFN/ribavirin in naïve or experienced patients infected with chronic HCV genotype 4

Authors: Moreno, Christophe, Hezode, Christophe, Marcellin, Patrick, Bourgeois, Stefan, Francque, Sven, Samuel, Didier, Zoulim, Fabien, Grange, Jean-Didier, Shukla, Umesh, Lenz, Oliver, Ouwerkerk-Mahadevan, Sivi, Fevery, Bart, Peeters, Monika, Beumont, Maria, Jessner, Wolfgang

Source: In Journal of Hepatology May 2015 62(5):1047-1055

Virology analyses of HCV isolates from genotype 1-infected patients treated with simeprevir plus peginterferon/ribavirin in Phase IIb/III studies

Authors: Lenz, Oliver, Verbinnen, Thierry, Fevery, Bart, Tambuyzer, Lotke, Vijgen, Leen, Peeters, Monika, Buelens, Annemie, Ceulemans, Hugo, Beumont, Maria, Picchio, Gaston, De Meyer, Sandra

Source: In Journal of Hepatology May 2015 62(5):1008-1014

Simeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naive patients: the COSMOS randomised study

Authors: Lawitz, Eric, Sulkowski, Mark S, Ghalib, Reem, Rodriguez-Torres, Maribel, Younossi, Zobair M, Corregidor, Ana, DeJesus, Edwin, Pearlman, Brian, Rabinovitz, Mordechai, Gitlin, Norman, Lim, Joseph K, Pockros, Paul J, Scott, John D, Fevery, Bart, Lambrecht, Tom, Ouwerkerk-Mahadevan, Sivi, Callewaert, Katleen, Symonds, William T, Picchio, Gaston, Lindsay, Karen L, Beumont, Maria, Jacobson, Ira M

Source: In The Lancet 15-21 November 2014 384(9956):1756-1765

Predictable excess hepatotoxicity in the SimpliciTB trial – Authors’ reply

Authors: Cevik, Muge, Beumont, Maria, Sun, Eugene, Sloan, Derek J, Gillespie, Stephen H

Source: In The Lancet Infectious Diseases December 2024 24(12):e728-e728

Limited impact of IL28B genotype on response rates in telaprevir-treated patients with prior treatment failure

Authors: Pol, Stanislas, Aerssens, Jeroen, Zeuzem, Stefan, Andreone, Pietro, Lawitz, Eric J., Roberts, Stuart, Younossi, Zobair, Foster, Graham R., Focaccia, Roberto, Horban, Andrzej, Pockros, Paul J., Van Heeswijk, Rolf P.G., De Meyer, Sandra, Luo, Don, Botfield, Martyn, Beumont, Maria, Picchio, Gaston

Source: In Journal of Hepatology May 2013 58(5):883-889

Sustained virologic response rates with telaprevir by response after 4 weeks of lead-in therapy in patients with prior treatment failure

Authors: Foster, Graham R., Zeuzem, Stefan, Andreone, Pietro, Pol, Stanislas, Lawitz, Eric J., Diago, Moises, Roberts, Stuart, Pockros, Paul J., Younossi, Zobair, Lonjon-Domanec, Isabelle, De Meyer, Sandra, Luo, Don, George, Shelley, Beumont, Maria, Picchio, Gaston

Source: In Journal of Hepatology March 2013 58(3):488-494

Telaprevir Activity in Treatment-Naive Patients Infected Hepatitis C Virus Genotype 4: A Randomized Trial

Authors: Benhamou, Yves, Moussalli, Joseph, Ratziu, Vlad, Lebray, Pascal, De Backer, Katrien, De Meyer, Sandra, Ghys, Anne, Luo, Donghan, Picchio, Gaston R., Beumont, Maria

Source: The Journal of Infectious Diseases, 2013 Sep . 208(6), 1000-1007.

Access URL: http://dx.doi.org/10.1093/infdis/jit274

Evolution of Treatment-Emergent Resistant Variants in Telaprevir Phase 3 Clinical Trials

Authors: Sullivan, James C., De Meyer, Sandra, Bartels, Doug J., Dierynck, Inge, Zhang, Eileen Z., Spanks, Joan, Tigges, Ann M., Ghys, Anne, Dorrian, Jennifer, Adda, Nathalie, Martin, Emily C., Beumont, Maria, Jacobson, Ira M., Sherman, Kenneth E., Zeuzem, Stefan, Picchio, Gaston, Kieffer, Tara L.

Source: Clinical Infectious Diseases, 2013 Jul . 57(2), 221-229.

Access URL: http://dx.doi.org/10.1093/cid/cit226

Telaprevir Alone or With Peginterferon and Ribavirin Reduces HCV RNA in Patients With Chronic Genotype 2 but Not Genotype 3 Infections

Authors: Foster, Graham R., Hézode, Christophe, Bronowicki, Jean–Pierre, Carosi, Giampiero, Weiland, Ola, Verlinden, Lieselotte, van Heeswijk, Rolf, van Baelen, Ben, Picchio, Gaston, Beumont, Maria

Source: In Gastroenterology 2011 141(3):881-889

Telaprevir Is Effective Given Every 8 or 12 Hours With Ribavirin and Peginterferon Alfa-2a or -2b to Patients With Chronic Hepatitis C

Authors: Marcellin, Patrick, Forns, Xavier, Goeser, Tobias, Ferenci, Peter, Nevens, Frederik, Carosi, Giampiero, Drenth, Joost P., Serfaty, Lawrence, De Backer, Koen, Van Heeswijk, Rolf, Luo, Donghan, Picchio, Gaston, Beumont, Maria

Source: In Gastroenterology 2011 140(2):459-468

Randomised phase 2 study (JADE) of the HBV capsid assembly modulator JNJ-56136379 with or without a nucleos(t)ide analogue in patients with chronic hepatitis B infection.

Authors: Janssen, Harry L. A., Jinlin Hou, Asselah, Tarik, Chan, Henry L . Y., Zoulim, Fabien, Yasuhito Tanaka, Janczewska, Ewa, Nahass, Ronald G., Bourgeois, Stefan, Buti, Maria, Lampertico, Pietro, Lenz, Oliver, Verbinnen, Thierry, Vandenbossche, Joris, Talloen, Willem, Kalmeijer, Ronald, Beumont, Maria, Biermer, Michael, Shukla, Umesh

Source: Gut (0017-5749); Jul2023, Vol. 72 Issue 7, p1385-1398, 14p

Subject Terms: CHRONIC hepatitis B, HEPATITIS B vaccines, ALANINE aminotransferase, HEPATITIS associated antigen, HEPATITIS B virus

HCV Combination Therapies Comprising Pegylated Interferon, Ribavirin and Telaprevir

TELAPREVIR DOSING REGIMEN

Human immunodeficiency virus type 1 in the semen of men receiving highly active antiretroviral therapy.

Authors: Zhang, Hui, Dornadula, Geethanjali, Beumont, Maria

Source: New England Journal of Medicine; December 17 1998, Vol. 339 Issue 25, p1803-1809, 7p

Simeprevir, daclatasvir, and sofosbuvir for hepatitis C virus-infected patients: Long-term follow-up results from the open-label, Phase II IMPACT study.

Authors: Lawitz, Eric, Poordad, Fred, Gutierrez, Julio A., Beumont, Maria, Beets, Greet, Vandevoorde, Ann, Van Remoortere, Pieter, Luo, Donghan, Vijgen, Leen, Van Eygen, Veerle, Gamil, Mohamed

Source: Health Science Reports; Jun2020, Vol. 3 Issue 2, p1-8, 8p

Subject Terms: SOFOSBUVIR, HEPATITIS C treatment, FOLLOW-up studies (Medicine)

Liver safety assessment in clinical trials of new agents for chronic hepatitis B.

Authors: Fontana, Robert J., Avigan, Mark I., Janssen, Harry L. A., Regev, Arie, Mishra, Poonam, Gaggar, Anuj, Brown, Nathaniel, Wat, Cynthia, Mendez, Patricia, Anderson, Ryan T., Given, Bruce, Miller, Veronica, Beumont, Maria

Source: Journal of Viral Hepatitis; Feb2020, Vol. 27 Issue 2, p96-109, 14p

Subject Terms: CHRONIC hepatitis B, HEPATITIS associated antigen, CLINICAL trials, CIRCULAR DNA, REVERSE transcriptase inhibitors, LIVER