Generic sofosbuvir-based interferon-free direct acting antiviral agents for patients with chronic hepatitis C virus infection: a real-world multicenter observational study

被引：22

作者：

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

Huang, Yi-Jie ^{[4
]}

Yang, Sien-Sing ^{[5
,6
]}

Chang, Chung-Hsin ^{[4
]}

Yang, Sheng-Shun ^{[4
,7
,8
]}

Sun, Hsin-Yun ^{[1
]}

Liu, Chun-Jen ^{[1
,2
,9
]}

Liu, Wen-Chun ^{[1
]}

Su, Tung-Hung ^{[1
,2
]}

Yang, Hung-Chih ^{[1
,2
,10
]}

Hong, Chun-Ming ^{[11
]}

Tseng, Tai-Chung ^{[1
,2
]}

Chen, Pei-Jer ^{[1
,2
,9
]}

Chen, Ding-Shinn ^{[1
,2
,12
]}

Hung, Chien-Ching ^{[1
,13
,14
]}

Kao, Jia-Horng ^{[1
,2
,9
]}

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, Yun Lin Branch, Dept Internal Med, Touliu, Taiwan

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

[5] Cathay Gen Hosp, Med Ctr, Ctr Liver, Taipei, Taiwan

[6] Fu Jen Catholic Univ, Coll Med, Sch Med, Taipei, Taiwan

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

[8] Natl Yang Ming Univ, Fac Med, Taipei, Taiwan

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

[10] Natl Taiwan Univ, Coll Med, Dept Microbiol, Taipei, Taiwan

[11] Natl Taiwan Univ Hosp, Dept Traumatol, Taipei, Taiwan

[12] Acad Sinica, Genom Res Ctr, Taipei, Taiwan

[13] Natl Taiwan Univ, Coll Med, Dept Parasitol, Taipei, Taiwan

[14] China Med Univ Hosp, Dept Med Res, Taichung, Taiwan

来源：

SCIENTIFIC REPORTS | 2018年 / 8卷

关键词：

SUSTAINED VIROLOGICAL RESPONSE; DACLATASVIR PLUS SOFOSBUVIR; HCV GENOTYPE 1; ADVANCED LIVER-DISEASE; CLINICAL-PRACTICE; OPEN-LABEL; PHASE; 3B; RIBAVIRIN; LEDIPASVIR; VELPATASVIR;

D O I：

10.1038/s41598-018-32060-7

中图分类号：

O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];

学科分类号：

07 ; 0710 ; 09 ;

摘要：

Real-world data regarding the effectiveness and safety of generic sofosbuvir (SOF)-based interferonfree direct acting antiviral agents (DAAs) for patients with chronic hepatitis C virus (HCV) infection remain limited. A total of 517 chronic HCV-infected patients receiving 12 or 24 weeks of SOF-based therapies were retrospectively enrolled in 4 academic centers in Taiwan. The rate of sustained virologic response at week 12 off-therapy (SVR12) and that of treatment completion were assessed. The baseline characteristics and on-treatment HCV viral kinetics to predict SVR12 were analyzed. By evaluable population (EP) analysis, the SVR12 rate was 95.4% (95% confidence interval [CI]: 93.2-96.9%). The SVR12 was achieved in 29 of 34 patients (85.3%, 95% CI: 69.6-93.6%), 130 of 139 patients (93.5%, 95% CI: 88.2-96.6%), 119 of 124 patients (96.0%, 95% CI: 90.9-98.3%) and 215 of 220 patients (97.7%, 95% CI: 94.8-99.0%) who received SOF in combination with ribavirin (RBV), ledipasvir (LDV), daclatasvir (DCV) and velpatasvir (VEL), respectively. Of 517 patients, 514 (99.4%) completed the scheduled treatment. All 15 patients with true virologic failures were relapsers. Two decompensated cirrhotic patients had on-treatment deaths which were not related to DAAs. All 7 patients who were lost to follow-up had undetectable HCV RNA level at the last visit. The SVR12 rates were comparable in terms of baseline patient characteristics and viral decline at week 4 of treatment. In conclusion, generic SOF-based regimens are well tolerated and provide high SVR12 rates in patients with chronic HCV infection.

引用

页数：10

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