LB01 SIX WEEKS OF SOFOSBUVIR/LEDIPASVIR TREATMENT OF ACUTE HEPATITIS C VIRUS GENOTYPE 1 MONOINFECTION: FINAL RESULTS OF THE THE GERMAN HEPNET ACUTE HCV IV STUDY
Wiley; Volume: 4; Issue: 6 Linguagem: Inglês
10.1177/2050640616678364
ISSN2050-6414
AutoresKatja Deterding, Christoph D. Spinner, E. Schott, Tania M. Welzel, Guido Gerken, Hartwig Klinker, Ulrich Spengler, Johannes Wiegand, Julian Schulze zur Wiesch, Anita Pathil, Markus Cornberg, Andreas Umgelter, Caroline Zöllner, Stefan Zeuzem, Armin Papkalla, Kassandra Weber, Svenja Hardtke, Heiko von der Leyen, Alvaro Koch, Dorothee von Witzendorff, Michael P. Manns, H. Wedemeyer, Carmen Monica Preda, Cristina Popescu, Cristian Băicuş, Mircea Mănuc, R Voiosu, Emanoil Ceaușu, Larisa Elena Fulger, A.A. Nisanian, Corina Silvia Pop, A Oproiu, Alberto Arezzo, Roberto Passera, A. Bullano, Yoav Mintz, Archana Kedar, Laura de Boni, E. Cassinotti, Riccardo Rosati, Uberto Fumagalli, Mario Sorrentino, Marco Brizzolari, Nicola Di Lorenzo, Achille Gaspari, D. Andreone, Elena De Stefani, Giuseppe Navarra, S Lazzara, Maurizio Degiuli, K Shishin, Igor Khatkov, I︠U︡riĭ Kazakov, R. Schrittwieser, Th. Carus, A. Corradi, G. Sitzman, Antonio M. Lacy, S. Uranues, Amir Szold, Marco Augusto Bonino, Mina Morino, Jonas Strömberg, Gabriel Sandblom, Robert J.S. Coelen, Marcia P. Gaspersz, Tim A. Labeur, Jeroen L.A. van Vugt, Susan van Dieren, François E.J.A. Willemssen, C. Yung Nio, Jan N.M. IJzermans, Heinz‐Josef Klümpen, Bas Groot Koerkamp, Thomas van Gulik, Richard Sturgess, Darrell Palmer, Jörg Trojan, Albrecht Hoffmeister, Bruno Neu, Siegfried Kasper, Alexander Dechêne, Christian Jürgensen, J Schirra, Ralf Jakobs, Anders Høgset, L. Finnesand, Abd Elrazek Abd Elrazek, Sammy Saab, Tamer Z. Salem, Mahmoud Abdelaty, Baha Hawary, Ali Ismail, M. Zayied, Mohamed Alboraie, Robert Orenstein, Erik R. Dubberke, C.H. Lee, Sanjay Khanna, Gail Hecht, Shane Shucheng Wong, Thomas N.Y. Kwong, X. Wang, Raymond S. Tang, Sandy Ng, Joseph J.�Y. Sung, Jing Yu, Stefan Ott, Georg H. Waetzig, Ateequr Rehman, Jacqueline Moltzau Anderson, Richa Bharti, Juris A. Grasis, Liam Cassidy, Andreas Tholey, Helmut Fickenscher, Dirk Seegert, Philip Rosenstiel, Stefan Schreiber, Tarek Mazzawi, Gülen Arslan Lied, Magdy El‐Salhy, Odd Helge Gilja, Jan Gunnar Hatlebakk, Trygve Hausken, Suzanne T. Witt, Olga Bednarska, Adriane Icenhour, Sigrid Elsenbruch, Morten B. Strøm, J.D. Söderholm, Maria Engström, Emeran A. Mayer, Åsa V. Keita, Susanna Walter, Patrizia Kump, Philipp Wurm, H Gröchenig, H Wenzl, W Petritsch, Bettina Halwachs, Matthew A. Wagner, Vanessa Stadlbauer, Andreas Eherer, K. Martin Hoffmann, A Deutschmann, G Reicht, Ludwig Reiter, P. Slawitsch, Gregor Gorkiewicz, Christoph Höegenauer, You Zhou, Raja Kakuturu, Dong‐Hwan Jung, Kristin Kaasen Jørgensen, Inge Christoffer Olsen, Guro Løvik Goll, M Lorentzen, Nils Bolstad, Espen A. Haavardsholm, Knut E.A. Lundin, Cato Mørk, Jørgen Jahnsen, T.K. Kvien, Brian G. Feagan, Bruce E. Sands, Guillermo Rossiter, X. Li, Keith Usiskin, Xi Zhan, Jean‐Frédéric Colombel, Brian G. Feagan, W. Sandborn, Julián Panés, Marc Ferrante, Édouard Louis, Geert R. DʼHaens, D Franchimont, Arthur Kaser, Olivier Dewit, U Seidler, K.‐J. Kim, MF Neurath, Paul Scholl, Sudha Visvanathan, Sergio Padula, Iveta Herichová, Nanshi Sha, David R. Hall, W.O. Böcher, Felicia M. Bloemendaal, Arthur A. Levin, Manon E. Wildenberg, Pim J. Koelink, Sjef Verbeek, Jill Claassens, Geert R. DʼHaens, Brian J. McRae, Gestur Vidarsson, Gijs R. van den Brink, M. Badke, Stefan Rose‐John, Martina E. Spehlmann, Laurent Peyrin‐Biroulet, Joel Gatlin, M. Soloman, D. Unett, H. Al‐Shamma, Dee Behan, Jost Langhorst, James B. Boone, Alvaro Koch, Andreas Rueffer, G. Dobos, Karsten Beiderwellen, T. Lauenstein, Wee Sing Ngu, Roisin Bevan, Zacharias Tsiamoulos, Paul Bassett, Zoë Hoare, Matthew D. Rutter, Nikki Totton, T.J. Lee, Arvind Ramadas, John G. Silcock, John Painter, Laura J Neilson, Brian P. Saunders, Colin Rees, A. Schmidt, Stefan Goelder, H Messmann, Matthew Bidwell Goetz, Thomas Kratt, Alexander Meining, Markus Birk, J. Delius, Matthew R. Albert, J Escher, Agnes Lau, Richard M. Hoffman, Katharina Wiest, Caca, Amer Hassan Siddiqui, David Wilson, Michael J. Cangelosi, Zacharias Tsiamoulos, R Rameshshanker, P. T. Wall, Kim Cocks, Timothy Doulton, Aasim Yusuf, C Hancock, Brian P. Saunders, Roland Valori, Matthew D. Rutter, A. Aravani, Jem Rashbass, Suzanne D. Vernon, Eva Morris, Ju‐Yeon Choi, Dong Wan Seo, Tae Jun Song, D.H. Park, S.S. Lee, S.K. Lee, H. Kim, Piyush Somani, Mithun Sharma,
Tópico(s)Hepatitis B Virus Studies
ResumoIntroduction Early treatment of acute hepatitis C virus (HCV) infection with interferon alfa monotherapy is highly effective but is associated with frequent unfavorable side effects. There is no fully published study yet exploring the safety, efficacy and required treatment duration of interferon-free treatment of acute hepatitis C virus monoinfection. Preliminary reports suggested that ledipasvir/sofosbuvir therapy is effective in acute hepatitis C but relapses were reported in HIV-coinfected patients after 6 weeks of treatment. Aims & Methods The German HepNet Acute HCV IV Study was designed as a single-arm, prospective multicenter pilot study to evaluate the efficacy and safety of treatment with sofosbuvir plus ledipasvir (SOF/LDV) for 6 weeks without ribavirin in patients with acute genotype 1 HCV monoinfection. We here report the final 24 weeks’ post-treatment results. Results Twenty patients were included by 10 centers (60% male, mean age 46 ± 12 years; 11 patients HCV genotype 1a, 9 patients genotype 1b). The main risk factors for HCV infection were sexual transmission (n = 11) and medical procedures/needle stick injuries (n = 5). Median alanine aminotransferase (ALT) and median bilirubin levels before start of antiviral treatment were 225 U/l (range 32–2716) and 13.6 µmol/l (range 5.13–111), respectively. ALT levels rapidly declined during therapy and values normalized already by treatment weeks 2 in nine patients and by week 4 in 17 patients. HCV RNA was undetectable by the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test v2.0 by weeks 2, 4 and 6 in eight, 13, and 20 patients, respectively. SVR-12 was 100% and 19 patients have completed FU-week 24 and all remained HCV-RNA negative. One patient was lost to follow-up at week 24 post treatment. Conclusion Treatment for 6 weeks with LDV/SOF was well tolerated and highly effective in HCV genotype 1 monoinfected patients with acute hepatitis C. Virological response was durable after therapy for at least 24 weeks. A rapid improvement in biochemical disease activity was observed during therapy. Short-duration treatment of acute hepatitis C could prevent the spread of HCV in high-risk populations and may be cost-saving as compared with treatment of chronic hepatitis C. Disclosure of Interest Katja Deterding: Lecturer fees and travel grants from Gilead, MSD/Merck and AbbVie
Referência(s)