Sofosbuvir/velpatasvir with or without low-dose ribavirin for patients with chronic hepatitis C virus infection and severe renal impairment

被引：32

作者：

Liu, Chen-Hua ^{[1
,2
,3
]}

Chen, Chi-Yi ^{[4
]}

Su, Wei-Wen ^{[5
]}

Tseng, Kuo-Chih ^{[6
,7
]}

Lo, Ching-Chu ^{[8
]}

Liu, Chun-Jen ^{[1
]}

Chen, Jyh-Jou ^{[9
]}

Peng, Cheng-Yuan ^{[10
,11
]}

Shih, Yu-Lueng ^{[12
]}

Yang, Sheng-Shun ^{[13
,14
,15
]}

Huang, Chia-Sheng ^{[16
]}

Huang, Ke-Jhang ^{[17
]}

Chang, Chi-Yang ^{[18
]}

Tsai, Ming-Chang ^{[19
]}

Kao, Wei-Yu ^{[20
,21
,22
]}

Fang, Yo-Jen ^{[3
]}

Chen, Po-Yueh ^{[4
]}

Su, Pei-Yuan ^{[5
]}

Tseng, Chih-Wei ^{[6
,7
]}

Huang, Jow-Jyh ^{[8
]}

Lee, Pei-Lun ^{[9
]}

Lai, Hsueh-Chou ^{[10
,11
]}

Hsieh, Tsai-Yuan ^{[12
]}

Chang, Chung-Hsin ^{[13
,20
,21
,22
]}

Huang, Yi-Jie ^{[13
]}

Lee, Fu-Jen ^{[18
]}

Chang, Chun-Chao

Kao, Jia-Horng ^{[1
,2
,23
]}

机构：

[1] Natl Taiwan Univ Hosp, Dept Internal Med, Taipei, Taiwan

[2] Natl Taiwan Univ Hosp, Hepatitis Res Ctr, Taipei, Taiwan

[3] Natl Taiwan Univ Hosp, Dept Internal Med, Yun Lin Branch, Taipei, Taiwan

[4] Ditmanson Med Fdn Chiayi Christian Hosp, Div Gastroenterol & Hepatol, Dept Internal Med, Chiayi, Taiwan

[5] Changhua Christian Hosp, Div Gastroenterol, Dept Internal Med, Changhua, Taiwan

[6] Dalin Tzu Chi Hosp, Dept Internal Med, Buddhist Tzu Chi Med Fdn, Chiayi, Taiwan

[7] Tzuchi Univ, Sch Med, Hualien, Taiwan

[8] St Martin Porres Hosp, Dept Internal Med, Chiayi, Taiwan

[9] Chi Mei Med Ctr, Div Gastroenterol & Hepatol, Liouying, Taiwan

[10] China Med Univ Hosp, Dept Internal Med, Ctr Digest Med, Taichung, Taiwan

[11] China Med Univ, Sch Med, Taichung, Taiwan

[12] Tri Serv Gen Hosp, Div Gastroenterol, Dept Internal Med, Natl Def Med Ctr, Taipei, Taiwan

[13] Taichung Vet Gen Hosp, Div Gastroenterol & Hepatol, Dept Internal Med, Taichung, Taiwan

[14] Chung Shan Med Univ, Sch Med, Taichung, Taiwan

[15] Natl Chung Hsing Univ, Inst Biomed Sci, Taichung, Taiwan

[16] Yang Ming Hosp, Div Gastroenterol & Hepatol, Dept Internal Med, Chiayi, Taiwan

[17] China Med Univ Beigang Hosp, Div Gastroenterol & Hepatol, Dept Internal Med, Yunlin, Yunlin, Taiwan

[18] Fu Jen Catholic Univ Hosp, Div Gastroenterol & Hepatol, Dept Internal Med, Taipei, Taiwan

[19] Chung Shan Med Univ Hosp, Div Gastroenterol & Hepatol, Dept Internal Med, Taichung, Taiwan

[20] Taipei Med Univ Hosp, Div Gastroenterol & Hepatol, Dept Internal Med, Taipei, Taiwan

[21] Taipei Med Univ, Sch Med, Dept Internal Med, Coll Med, Taipei, Taiwan

[22] Taipei Med Univ, Grad Inst Clin Med, Coll Med, Taipei, Taiwan

[23] Natl Taiwan Univ, Grad Inst Clin Med, Coll Med, Taipei, Taiwan

来源：

GUT | 2022年 / 71卷 / 01期

关键词：

SIMPLE NONINVASIVE INDEX; TREATMENT-NAIVE PATIENTS; RECEIVING HEMODIALYSIS; SIGNIFICANT FIBROSIS; GENOTYPE; SOFOSBUVIR; HCV; VELPATASVIR; THERAPY; RISK;

D O I：

10.1136/gutjnl-2020-323569

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

Objective Data regarding the real-world effectiveness and safety of sofosbuvir/velpatasvir (SOF/VEL) with or without low-dose ribavirin (RBV) in patients with chronic hepatitis C virus (HCV) infection and severe renal impairment (RI) are limited. We evaluated the performance of SOF/VEL with or without low-dose RBV in HCV-infected patients with chronic kidney disease stage 4 or 5. Design 191 patients with compensated (n=181) and decompensated (n=10) liver diseases receiving SOF/VEL (400/100 mg/day) alone and SOF/VEL with low-dose RBV (200 mg/day) for 12 weeks were retrospectively recruited at 15 academic centres in Taiwan. The effectiveness was determined by sustained virological response at off-treatment week 12 (SVR12) in evaluable (EP) and per-protocol populations (PP). The safety profiles were assessed. Results The SVR12 rates by EP and PP analyses were 94.8% (95% CI 90.6% to 97.1%) and 100% (95% CI 97.9% to 100%). In patients with compensated liver disease, the SVR12 rates were 95.0% and 100% by EP and PP analyses. In patients with decompensated liver disease, the SVR12 rates were 90.0% and 100% by EP and PP analyses. Ten patients who failed to achieve SVR12 were attributed to non-virological failures. Among the 20 serious adverse events (AEs), none were judged related to SOF/VEL or RBV. The AEs occurring in >= 10% included fatigue (14.7%), headache (14.1%), nausea (12.6%), insomnia (12.0%) and pruritus (10.5%). None had >= grade 3 total bilirubin or alanine aminotransferase elevations. Conclusion SOF/VEL with or without low-dose RBV is effective and well-tolerated in HCV-infected patients with severe RI.

引用

页码：176 / 184

页数：9

共 46 条

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