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

DOI
https://doi.org/10.1007/s40121-020-00329-y
Journal volume & issue
Vol. 9, no. 4
pp. 851 – 866

Abstract

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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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