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

共 26 条

[11]

Fuchs M., 2016, INT LIV C ILC 2016 B

[12] Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): a randomised, open-label trial [J].

Hezode, Christophe ;

Asselah, Tarik ;

Reddy, K. Rajender ;

Hassanein, Tarek ;

Berenguer, Marina ;

Fleischer-Stepniewska, Katarzyna ;

Marcellin, Patrick ;

Hall, Coleen ;

Schnell, Gretja ;

Pilot-Matias, Tami ;

Mobashery, Niloufar ;

Redman, Rebecca ;

Vilchez, Regis A. ;

Pol, Stanislas .

LANCET, 2015, 385 (9986) :2502-2509

[13]

Lubel JS, 2016, INT LIV C ILC 2016 B

[14]

McGinnis J., 2016, INT LIV C ILC 2016 B

[15] Efficacy of Direct-Acting Antiviral Combination for Patients With Hepatitis C Virus Genotype 1 Infection and Severe Renal Impairment or End-Stage Renal Disease [J].

Pockros, Paul J. ;

Reddy, K. Rajender ;

Mantry, Parvez S. ;

Cohen, Eric ;

Bennett, Michael ;

Sulkowski, Mark S. ;

Bernstein, David E. ;

Cohen, Daniel E. ;

Shulman, Nancy S. ;

Wang, Deli ;

Khatri, Amit ;

Abunimeh, Manal ;

Podsadecki, Thomas ;

Lawitz, Eric .

GASTROENTEROLOGY, 2016, 150 (07) :1590-1598

[16] Real-world experience with ombitasvir/paritaprevir boosted with ritonavir and possibly combined with dasabuvir and ribavirin in HCV infection [J].

Pogorzelska, Joanna ;

Flisiak, Robert .

CLINICAL AND EXPERIMENTAL HEPATOLOGY, 2016, 2 (02) :34-37

[17] ABT-450/r-Ombitasvir and Dasabuvir with Ribavirin for Hepatitis C with Cirrhosis [J].

Poordad, Fred ;

Hezode, Christophe ;

Trinh, Roger ;

Kowdley, Kris V. ;

Zeuzem, Stefan ;

Agarwal, Kosh ;

Shiffman, Mitchell L. ;

Wedemeyer, Heiner ;

Berg, Thomas ;

Yoshida, Eric M. ;

Forns, Xavier ;

Lovell, Sandra S. ;

Da Silva-Tillmann, Barbara ;

Collins, Christine A. ;

Campbell, Andrew L. ;

Podsadecki, Thomas ;

Bernstein, Barry .

NEW ENGLAND JOURNAL OF MEDICINE, 2014, 370 (21) :1973-1982

[18] Advances in hepatitis C research and treatment [J].

Rehermann, Barbara .

NATURE REVIEWS GASTROENTEROLOGY & HEPATOLOGY, 2016, 13 (02) :70-71

[19] S3 guideline hepatitis C addendum [J].

Sarrazin, C. ;

Berg, T. ;

Buggisch, P. ;

Dollinger, M. M. ;

Hinrichsen, H. ;

Hofer, H. ;

Hueppe, D. ;

Manns, M. P. ;

Mauss, S. ;

Petersen, J. ;

Simon, K. -G. ;

van Thiel, I. ;

Wedemeyer, H. ;

Zeuzem, S. .

ZEITSCHRIFT FUR GASTROENTEROLOGIE, 2015, 53 (04) :320-334

[20]

Sarrazin C., 2016, INT LIV C ILC 2016 B

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