Real-World Clinical Application of 12-Week Sofosbuvir/Velpatasvir Treatment for Decompensated Cirrhotic Patients with Genotype 1 and 2: A Prospective, Multicenter Study

被引：17

作者：

Atsukawa, Masanori ^{[1
]}

Tsubota, Akihito ^{[2
]}

Kondo, Chisa ^{[1
]}

Toyoda, Hidenori ^{[3
]}

Nakamuta, Makoto ^{[4
]}

Takaguchi, Koichi ^{[5
]}

Watanabe, Tsunamasa ^{[6
]}

Hiraoka, Atsushi ^{[7
]}

Uojima, Haruki ^{[8
]}

Ishikawa, Toru ^{[9
]}

Iwasa, Motoh ^{[10
]}

Tada, Toshifumi ^{[11
]}

Nozaki, Akito ^{[12
]}

Chuma, Makoto ^{[12
]}

Fukunishi, Shinya ^{[13
]}

Asai, Akira ^{[13
]}

Asano, Toru ^{[14
]}

Ogawa, Chikara ^{[15
]}

Abe, Hiroshi ^{[16
]}

Hotta, Naoki ^{[17
]}

Shima, Toshihide ^{[18
]}

Iio, Etsuko ^{[19
,20
]}

Mikami, Shigeru ^{[21
]}

Tachi, Yoshihiko ^{[22
]}

Fujioka, Shinichi ^{[23
]}

Okubo, Hironao ^{[24
]}

Shimada, Noritomo ^{[25
]}

Tani, Joji ^{[26
]}

Hidaka, Isao ^{[27
]}

Moriya, Akio ^{[28
]}

Tsuji, Kunihiko ^{[29
]}

Akahane, Takehiro ^{[30
]}

Yamashita, Naoki ^{[4
]}

Okubo, Tomomi ^{[1
]}

Arai, Taeang ^{[1
]}

Morita, Kiyoshi ^{[31
]}

Kawata, Kazuhito ^{[32
,33
]}

Tanaka, Yasuhito ^{[19
,20
]}

Okanoue, Takeshi ^{[18
]}

Maeda, Shin ^{[12
]}

Kumada, Takashi ^{[3
]}

Iwakiri, Katsuhiko ^{[1
]}

机构：

[1] Nippon Med Sch, Dept Internal Med, Div Gastroenterol & Hepatol, Tokyo, Japan

[2] Jikei Univ, Sch Med, Core Res Facil Basic Sci, Tokyo, Japan

[3] Ogaki Municipal Hosp, Dept Gastroenterol, Ogaki, Gifu, Japan

[4] Natl Hosp Org Kyushu Med Ctr, Fukuoka, Japan

[5] Kagawa Prefectural Cent Hosp, Dept Hepatol, Takamatsu, Kagawa, Japan

[6] St Marianna Univ, Sch Med, Dept Internal Med, Kawasaki, Kanagawa, Japan

[7] Ehime Prefectural Cent Hosp, Gastroenterol Ctr, Matsuyama, Ehime, Japan

[8] Kitasato Univ, Sch Med, Dept Gastroenterol, Internal Med, Sagamihara, Kanagawa, Japan

[9] Saiseikai Niigata Hosp, Dept Hepatol, Niigata, Japan

[10] Mie Univ, Sch Med, Dept Gastroenterol & Hepatol, Tsu, Mie, Japan

[11] Himeji Red Cross Hosp, Dept Gastroenterol, Himeji, Hyogo, Japan

[12] Yokohama City Univ, Gastroenterol Ctr, Med Ctr, Yokohama, Kanagawa, Japan

[13] Osaka Med Coll, Dept Internal Med 2, Osaka, Japan

[14] Tokyo Metropolitan Bokutoh Hosp, Dept Internal Med, Div Gastroenterol & Hepatol, Tokyo, Japan

[15] Takamatsu Red Cross Hosp, Dept Gastroenterol & Hepatol, Takamatsu, Kagawa, Japan

[16] Shinmatusdo Cent Gen Hosp, Dept Internal Med, Div Gastroenterol & Hepatol, Matsudo, Chiba, Japan

[17] Masuko Mem Hosp, Dept Internal Med, Div Hepatol, Nagoya, Aichi, Japan

[18] Saiseikai Suita Hosp, Dept Gastroenterol & Hepatol, Suita, Osaka, Japan

[19] Nagoya City Univ, Grad Sch Med Sci, Dept Virol, Nagoya, Aichi, Japan

[20] Nagoya City Univ, Grad Sch Med Sci, Liver Unit, Nagoya, Aichi, Japan

[21] Kikkoman Gen Hosp, Dept Internal Med, Div Gastroenterol, Noda, Chiba, Japan

[22] Fujita Hlth Univ, Bantane Hosp, Sch Med, Nagoya, Aichi, Japan

[23] Okayama Saiseikai Gen Hosp, Dept Gastroenterol, Okayama, Japan

[24] Juntendo Nerima Univ Hosp, Dept Gastroenterol, Tokyo, Japan

[25] Otakanomori Hosp, Dept Internal Med, Div Gastroenterol & Hepatol, Kashiwa, Chiba, Japan

[26] Kagawa Univ, Dept Gastroenterol, Grad Sch Med, Kita, Kagawa, Japan

[27] Yamaguchi Univ, Dept Gastroenterol & Hepatol, Grad Sch Med, Ube, Yamaguchi, Japan

[28] Mitoyo Gen Hosp, Dept Gastroenterol, Kannonji, Japan

[29] Teine Keijinkai Hosp, Gastroenterol Ctr, Sapporo, Hokkaido, Japan

[30] Japanese Red Cross Ishinomaki Hosp, Dept Gastroenterol, Ishinomaki, Japan

[31] Toyota Kosei Hosp, Gastroenterol, Toyota, Japan

[32] Hamamatsu Univ Sch Med, Dept Internal Med 2, Hepatol Div, Hamamatsu, Shizuoka, Japan

[33] KTK49 Liver Study Grp, Kanto Tokai Shikoku Kyus, Japan

来源：

INFECTIOUS DISEASES AND THERAPY | 2020年 / 9卷 / 04期

基金：

日本学术振兴会;

关键词：

ALBI grade; Child-Pugh class; Decompensated cirrhosis; Hepatitis C virus; Sofosbuvir; Velpatasvir; CHRONIC HEPATITIS-C; SOFOSBUVIR PLUS RIBAVIRIN; LIVER-DISEASE; VIRUS-INFECTION; THERAPY; LEDIPASVIR; HCV;

D O I：

10.1007/s40121-020-00329-y

中图分类号：

R51 [传染病];

学科分类号：

100401 ;

摘要：

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 x 10(-4)and 2.42 x 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.

引用

页码：851 / 866

页数：16

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