Real-World Clinical Application of 12-Week Sofosbuvir/Velpatasvir Treatment for Decompensated Cirrhotic Patients with Ge
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ORIGINAL RESEARCH
Real-World Clinical Application of 12-Week Sofosbuvir/Velpatasvir Treatment for Decompensated Cirrhotic Patients with Genotype 1 and 2: A Prospective, Multicenter Study Masanori Atsukawa . Akihito Tsubota . Chisa Kondo . Hidenori Toyoda . Makoto Nakamuta . Koichi Takaguchi . Tsunamasa Watanabe . Atsushi Hiraoka . Haruki Uojima . Toru Ishikawa . Motoh Iwasa . Toshifumi Tada . Akito Nozaki . Makoto Chuma . Shinya Fukunishi . Akira Asai . Toru Asano . Chikara Ogawa . Hiroshi Abe . Naoki Hotta . Toshihide Shima . Etsuko Iio . Shigeru Mikami . Yoshihiko Tachi . Shinichi Fujioka . Hironao Okubo . Noritomo Shimada . Joji Tani . Isao Hidaka . Akio Moriya . Kunihiko Tsuji . Takehiro Akahane . Naoki Yamashita . Tomomi Okubo . Taeang Arai . Kiyoshi Morita . Kazuhito Kawata . Yasuhito Tanaka . Takeshi Okanoue . Shin Maeda . Takashi Kumada . Katsuhiko Iwakiri on behalf of KTK49 Liver Study Group Received: July 11, 2020 Ó The Author(s) 2020
ABSTRACT Introduction: Clinical trials of direct-acting antivirals for patients with decompensated
Digital Features To view digital features for this article go to https://doi.org/10.6084/m9.figshare.12770987. The members of KTK49 Liver Study Group are listed in Acknowledgements. Akihito Tsubota and Masanori Atsukawa contributed equally to the preparation of this manuscript.
Electronic supplementary material The online version of this article (https://doi.org/10.1007/s40121020-00329-y) contains supplementary material, which is available to authorized users. M. Atsukawa (&) C. Kondo T. Okubo T. Arai K. Iwakiri Division of Gastroenterology and Hepatology, Department of Internal Medicine, Nippon Medical School, Tokyo, Japan e-mail: [email protected] A. Tsubota (&) Core Research Facilities for Basic Science, The Jikei University School of Medicine, Tokyo, Japan e-mail: [email protected]
cirrhosis have been conducted, but there is limited information on the medicinal applications in clinical settings. We aimed to evaluate the safety and efficacy of sofosbuvir/velpatasvir for decompensated cirrhotic patients with genotypes 1 and 2 in real-world clinical practice. Methods: A prospective, multicenter study of 12-week sofosbuvir/velpatasvir was conducted for patients with decompensated cirrhosis at 33 institutions. Results: The cohort included 71 patients (52 genotype 1, 19 genotype 2): 7 with Child–Pugh class A, 47 with class B, and 17 with class C (median score 8; range 5–13). The albumin–bilirubin (ALBI) score ranged from - 3.01 to - 0.45 (median - 1.58). Sixty-nine patients H. Toyoda T. Kumada Department of Gastroenterology, Ogaki Municipal Hospital, Ogaki, Gifu, Japan M. Nakamuta N. Yamashita National Hospital Organization Kyushu Medical Center, Fukuoka, Japan K. Takaguchi Department of Hepatology, Kagawa Prefectural Central Hospital, Takamatsu, Kagawa, Japan
Infect Dis Ther
(97.2%) completed treatment as scheduled. The overall rate of sustained virologic response at 12 weeks post-treatment (SVR12) was 94.4% (67/71). SVR12 rates in the patients with Chil
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