Infectious Diseases and Therapy (Sep 2020)
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,
- KTK49 Liver Study Group
Affiliations
- Masanori Atsukawa
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Nippon Medical School
- Akihito Tsubota
- Core Research Facilities for Basic Science, The Jikei University School of Medicine
- Chisa Kondo
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Nippon Medical School
- Hidenori Toyoda
- Department of Gastroenterology, Ogaki Municipal Hospital
- Makoto Nakamuta
- National Hospital Organization Kyushu Medical Center
- Koichi Takaguchi
- Department of Hepatology, Kagawa Prefectural Central Hospital
- Tsunamasa Watanabe
- Department of Internal Medicine, St. Marianna University School of Medicine
- Atsushi Hiraoka
- Gastroenterology Center, Ehime Prefectural Central Hospital
- Haruki Uojima
- Department of Gastroenterology, Internal Medicine, Kitasato University School of Medicine
- Toru Ishikawa
- Department of Hepatology, Saiseikai Niigata Hospital
- Motoh Iwasa
- Department of Gastroenterology and Hepatology, Mie University School of Medicine
- Toshifumi Tada
- Department of Gastroenterology, Himeji Red Cross Hospital
- Akito Nozaki
- Gastroenterological Center, Yokohama City University Medical Center
- Makoto Chuma
- Gastroenterological Center, Yokohama City University Medical Center
- Shinya Fukunishi
- Second Department of Internal Medicine, Osaka Medical College
- Akira Asai
- Second Department of Internal Medicine, Osaka Medical College
- Toru Asano
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Tokyo Metropolitan Bokutoh Hospital
- Chikara Ogawa
- Department of Gastroenterology and Hepatology, Takamatsu Red Cross Hospital
- Hiroshi Abe
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Shinmatusdo Central General Hospital
- Naoki Hotta
- Division of Hepatology, Department of Internal Medicine, Masuko Memorial Hospital
- Toshihide Shima
- Department of Gastroenterology and Hepatology, Saiseikai Suita Hospital
- Etsuko Iio
- Department of Virology and Liver Unit, Graduate School of Medical Sciences, Nagoya City University
- Shigeru Mikami
- Division of Gastroenterology, Department of Internal Medicine, Kikkoman General Hospital
- Yoshihiko Tachi
- Bantane Hospital, Fujita Health University School of Medicine
- Shinichi Fujioka
- Department of Gastroenterology, Okayama Saiseikai General Hospital
- Hironao Okubo
- Department of Gastroenterology, Juntendo Nerima University Hospital
- Noritomo Shimada
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Otakanomori Hospital
- Joji Tani
- Department of Gastroenterology, Kagawa University Graduate School of Medicine
- Isao Hidaka
- Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine
- Akio Moriya
- Department of Gastroenterology, Mitoyo General Hospital
- Kunihiko Tsuji
- Gastroenterology Center, Teine Keijinkai Hospital
- Takehiro Akahane
- Department of Gastroenterology, Japanese Red Cross Ishinomaki Hospital
- Naoki Yamashita
- National Hospital Organization Kyushu Medical Center
- Tomomi Okubo
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Nippon Medical School
- Taeang Arai
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Nippon Medical School
- Kiyoshi Morita
- Gastroenterology, Toyota Kosei Hospital
- Kazuhito Kawata
- Hepatology Division, Department of Internal Medicine II, Hamamatsu University School of Medicine
- Yasuhito Tanaka
- Department of Virology and Liver Unit, Graduate School of Medical Sciences, Nagoya City University
- Takeshi Okanoue
- Department of Gastroenterology and Hepatology, Saiseikai Suita Hospital
- Shin Maeda
- Gastroenterological Center, Yokohama City University Medical Center
- Takashi Kumada
- Department of Gastroenterology, Ogaki Municipal Hospital
- Katsuhiko Iwakiri
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Nippon Medical School
- KTK49 Liver Study Group
- DOI
- https://doi.org/10.1007/s40121-020-00329-y
- Journal volume & issue
-
Vol. 9,
no. 4
pp. 851 – 866
Abstract
Abstract Introduction Clinical trials of direct-acting antivirals for patients with decompensated 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 (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 Child–Pugh classes A, B, and C were 85.7%, 97.9%, and 88.2%, respectively. Among 22 patients with a history of hepatocellular carcinoma treatment, 20 (90.9%) achieved SVR12. The Child–Pugh score and ALBI grade significantly improved after achieving SVR12 (p = 7.19 × 10−4 and 2.42 × 10−4, respectively). Notably, the use of diuretics and branched-chain amino acid preparations significantly reduced after achieving SVR12. Adverse events were observed in 19.7% of the patients, leading to treatment discontinuation in two patients with cholecystitis and esophageal varices rupture, respectively. Conclusion Twelve weeks of sofosbuvir/velpatasvir in real-world clinical practice yielded high SVR rates and acceptable safety profiles in decompensated cirrhotic patients with genotypes 1 and 2. Achievement of SVR not only restored the liver functional reserve but also reduced or spared the administration of drugs for related complications. Trial Registration UMIN registration no, 000038587.
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