Real-world experience with the all-oral, interferon-free regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir for the treatment of chronic hepatitis C virus infection in the German Hepatitis C Registry

被引：43

作者：

Welzel, T. M. ^{[1
]}

Hinrichsen, H. ^{[2
]}

Sarrazin, C. ^{[1
,3
]}

Buggisch, P. ^{[4
]}

Baumgarten, A. ^{[5
]}

Christensen, S. ^{[6
]}

Berg, T. ^{[7
]}

Mauss, S. ^{[8
]}

Teuber, G.

Stein, K. ^{[9
]}

Deterding, K. ^{[10
]}

van Boemmel, F. ^{[7
]}

Heyne, R. ^{[11
]}

John, C.

Zimmermann, T. ^{[12
]}

Lutz, T. ^{[13
]}

Schott, E. ^{[14
]}

Hettinger, J. ^{[15
]}

Kleine, H. ^{[15
]}

Koenig, B. ^{[15
]}

Hueppe, D. ^{[16
]}

Wedemeyer, H. ^{[10
]}

机构：

[1] Goethe Univ Frankfurt, Univ Hosp, Dept Med 1, Frankfurt, Germany

[2] Gastroenterol Hepatol Ctr Kiel, Kiel, Germany

[3] St Josefs Hosp, Med Dept 2, Gastroenterol, Hepatol,Infectiol, Wiesbaden, Germany

[4] IFI Inst, Asklepios Clin St Georg, Liver Unit, Hamburg, Germany

[5] Ctr Infectiol Berlin, Berlin, Germany

[6] Ctr Interdisciplinary Med CIM, Munster, Germany

[7] Univ Hosp Leipzig, Sect Hepatol, Clin Gastroenterol & Rheumatol, Leipzig, Germany

[8] Ctr HIV & Hepatogastroenterol, Dusseldorf, Germany

[9] Hepatol Magdeburg, Magdeburg, Germany

[10] Hannover Med Sch, Dept Gastroenterol Hepatol & Endocrinol, Hannover, Germany

[11] Leberzentrum Checkpoint Berlin, Berlin, Germany

[12] Johannes Gutenberg Univ Mainz, Univ Med Ctr, Dept Med 1, Mainz, Germany

[13] Infektiologikum, Frankfurt, Germany

[14] Charite Univ Med Berlin, Dept Gastroenterol & Hepatol, Berlin, Germany

[15] AbbVie Deutschland GmbH & Co KG, Wiesbaden, Germany

[16] Ctr Gastroenterol & Hepatol, Herne, Germany

来源：

JOURNAL OF VIRAL HEPATITIS | 2017年 / 24卷 / 10期

关键词：

chronic hepatitis C; cirrhosis; dasabuvir; direct-acting antivirals; ombitasvir/paritaprevir/r; SUSTAINED VIROLOGICAL RESPONSE; RIBAVIRIN; HCV; ABT-450/R-OMBITASVIR; RITONAVIR; OMBITASVIR;

D O I：

10.1111/jvh.12708

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

Real-world studies are relevant to complement clinical trials on novel antiviral therapies against chronic hepatitis C; however, clinical practice data are currently limited. This study investigated effectiveness and safety of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r)+/- dasabuvir (DSV)+/- ribavirin (RBV) for treatment of HCV genotype (GT) 1 and GT4 infection in a large real-world cohort. The German Hepatitis C Registry is an observational cohort study prospectively collecting clinical practice data on direct-acting antiviral therapies. Patients with GT1/4 infection treated with OBV/PTV/r +/- DSV +/- RBV were analysed. Effectiveness was assessed by sustained virologic response in 558 patients who reached post-treatment week 12 (SVR12). Safety is reported in 1017 patients who initiated treatment. Of the patients, 892 (88%) had GT1 and 125 (12%) had GT4 infection. Prior treatment experience and cirrhosis were reported in 598 (59%) and 228 (22%) patients, respectively. Overall, SVR12 (mITT) was 96% (486/505) in GT1- and 100% (53/53) in GT4 patients. SVR12 rates were high across subgroups including patients with cirrhosis (95%, 123/129), patients with moderate to severe renal impairment (100%, 34/34), and subgroups excluded from registrational trials like patients 70years (96%, 64/67) and failures to prior protease inhibitor treatment (96%, 46/48). Adverse events (AEs) and serious AEs were reported in 52% (525/1017) and 2% (21/1017) of patients, respectively, and led to treatment discontinuation in 1.5% (15/1017) of patients. OBV/PTV/r +/- DSV +/- RBV was effective and generally well tolerated for treatment of HCV infection in clinical practice.

引用

页码：840 / 849

页数：10

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