Real-world use, effectiveness and safety of anti-viral treatment in chronic hepatitis C genotype 3 infection

被引：38

作者：

Cornberg, M. ^{[1
,2
]}

Petersen, J. ^{[3
]}

Schober, A. ^{[4
,6
]}

Mauss, S. ^{[5
]}

Boeker, K. H. W. ^{[11
,12
]}

Link, R. ^{[7
]}

Guenther, R. ^{[8
]}

Serfert, Y. ^{[9
]}

Pfeiffer-Vornkahl, H. ^{[10
]}

Manns, M. P. ^{[1
,2
]}

Sarrazin, C. ^{[11
,12
]}

Hueppe, D. ^{[13
]}

Berg, T. ^{[14
]}

Niederau, C. ^{[15
]}

机构：

[1] Hannover Med Sch, Dept Gastroenterol Hepatol & Endocrinol, Carl Neuberg Str 1, D-30625 Hannover, Germany

[2] German Ctr Infect Res DZIF, Partner Site Hannover, Braunschweig, Germany

[3] IFI Inst Interdisciplinary Med, Hamburg, Germany

[4] Hepatol Praxis, Gottingen, Germany

[5] Ctr HIV & Hepatogastroenterol, Dusseldorf, Germany

[6] Hepatol Praxis, Hannover, Germany

[7] MVZ Offenburg, Offenburg, Germany

[8] UKSH, Campus Kiel, Kiel, Germany

[9] Leberstiftungs GmbH Deutschland, Hannover, Germany

[10] E Factum GmbH, Butzbach, Germany

[11] St Josefs Hosp Wiesbaden, Frankfurt, Germany

[12] Univ Hosp Frankfurt, Frankfurt, Germany

[13] Hepatol Schwerpunktpraxis Herne, Herne, Germany

[14] Univ Hosp Leipzig, Leipzig, Germany

[15] Katholisches Klinikum Oberhausen, St Josef Hosp, D-46045 Oberhausen, Germany

来源：

ALIMENTARY PHARMACOLOGY & THERAPEUTICS | 2017年 / 45卷 / 05期

关键词：

DACLATASVIR PLUS SOFOSBUVIR; HCV; RIBAVIRIN; VELPATASVIR; CIRRHOSIS; REGIMENS; EFFICACY; ARTICLE;

D O I：

10.1111/apt.13925

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

Background Treatment of chronic hepatitis C genotype 3 (GT3) is more challenging compared with other genotypes. Since 2014, several new treatment regimens have been approved but sometimes based on limited data. Aim To validate the use, effectiveness and safety of anti-viral treatment in chronic hepatitis C genotype 3 infection under real-word conditions. Methods The German Hepatitis C-Registry is a large national non-interventional real-world study for patients with chronic hepatitis C. A total of 1322 GT3 patients were enrolled (211 untreated and 1111 treated patients). Results Between February 2014 and September 2015, five different treatment strategies have been used (PegIFN+RBV, PegIFN+RBV+SOF, SOF+RBV, DCV+SOF +/- RBV, LDV/SOF +/- RBV). Treatment uptake and use of treatment concepts changed markedly and rapidly during the study influenced by new approvals, guideline recommendations, and label updates. PegIFN-based therapies constantly declined while DCV-based therapies increased with one interruption after the approval of LDV/SOF, which was frequently used until new guidelines recommended not using this combination for GT3. Per-protocol SVR ranged from 80.9% in the PegIFN+RBV group to 96.1% in PegIFN+RBV+SOF treated patients. Treatment-experienced patients with cirrhosis showed a suboptimal SVR of 68% for SOF+RBV but a high SVR of 90-95% for DCV+SOF +/- RBV. The safety analysis showed more adverse events and a stronger decline of haemoglobin for RBV containing regimens. Conclusions Real-world data can validate the effectiveness and safety for treatment regimens that had previously been approved with limited data, in particular for specific subgroups of patients. The present study demonstrates how rapid new scientific data, new treatment guidelines, new drug approvals and label changes are implemented into routine clinical practice today.

引用

页码：688 / 700

页数：13

共 29 条

[1] Review article: HCV genotype 3 - the new treatment challenge [J].

Ampuero, J. ;

Romero-Gomez, M. ;

Reddy, K. R. .

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 2014, 39 (07) :686-698

[2] Review article: the efficacy and safety of daclatasvir in the treatment of chronic hepatitis C virus infection [J].

Bunchorntavakul, C. ;

Reddy, K. R. .

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 2015, 42 (03) :258-272

[3] Hepatitis C: individualised medicine versus one pill fits all [J].

Cornberg, Markus ;

Manns, Michael P. .

LANCET GASTROENTEROLOGY & HEPATOLOGY, 2016, 1 (02) :86-87

[4] Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis [J].

Curry, M. P. ;

O'Leary, J. G. ;

Bzowej, N. ;

Muir, A. J. ;

Korenblat, K. M. ;

Fenkel, J. M. ;

Reddy, K. R. ;

Lawitz, E. ;

Flamm, S. L. ;

Schiano, T. ;

Teperman, L. ;

Fontana, R. ;

Schiff, E. ;

Fried, M. ;

Doehle, B. ;

An, D. ;

McNally, J. ;

Osinusi, A. ;

Brainard, D. M. ;

McHutchison, J. G. ;

Brown, R. S., Jr. ;

Charlton, M. .

NEW ENGLAND JOURNAL OF MEDICINE, 2015, 373 (27) :2618-2628

[5] Improvement of liver function parameters in advanced HCV-associated liver cirrhosis by IFN-free antiviral therapies [J].

Deterding, K. ;

Siederdissen, C. Hoener Zu ;

Port, K. ;

Solbach, P. ;

Sollik, L. ;

Kirschner, J. ;

Mix, C. ;

Cornberg, J. ;

Worzala, D. ;

Mix, H. ;

Manns, M. P. ;

Cornberg, M. ;

Wedemeyer, H. .

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 2015, 42 (07) :889-901

[6] EASL Recommendations on Treatment of Hepatitis C 2016 [J].

European Association for the Study of the Liver easloffice@easloffice.eu .

JOURNAL OF HEPATOLOGY, 2017, 66 (01) :153-194

[7] Effectiveness and Safety of Sofosbuvir-Based Regimens for Chronic HCV Genotype 3 Infection: Results of the HCV-TARGET Study [J].

Feld, Jordan J. ;

Maan, Raoel ;

Zeuzem, Stefan ;

Kuo, Alexander ;

Nelson, David R. ;

Di Bisceglie, Adrian M. ;

Manns, Michael P. ;

Sherman, Ken ;

Frazier, Lynn M. ;

Sterling, Richard ;

Mailliard, Mark ;

Schmidt, Monica ;

Akushevich, Lucy ;

Vainorius, Monika ;

Fried, Michael W. .

CLINICAL INFECTIOUS DISEASES, 2016, 63 (06) :776-783

[8] Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection [J].

Foster, G. R. ;

Afdhal, N. ;

Roberts, S. K. ;

Braeu, N. ;

Gane, E. J. ;

Pianko, S. ;

Lawitz, E. ;

Thompson, A. ;

Shiffman, M. L. ;

Cooper, C. ;

Towner, W. J. ;

Conway, B. ;

Ruane, P. ;

Bourliere, M. ;

Asselah, T. ;

Berg, T. ;

Zeuzem, S. ;

Rosenberg, W. ;

Agarwal, K. ;

Stedman, C. A. M. ;

Mo, H. ;

Dvory-Sobol, H. ;

Han, L. ;

Wang, J. ;

McNally, J. ;

Osinusi, A. ;

Brainard, D. M. ;

McHutchison, J. G. ;

Mazzotta, F. ;

Tran, T. T. ;

Gordon, S. C. ;

Patel, K. ;

Reau, N. ;

Mangia, A. ;

Sulkowski, M. .

NEW ENGLAND JOURNAL OF MEDICINE, 2015, 373 (27) :2608-2617

[9] Impact of direct acting antiviral therapy in patients with chronic hepatitis C and decompensated cirrhosis [J].

Foster, Graham R. ;

Irving, William L. ;

Cheung, Michelle C. M. ;

Walker, Alex J. ;

Hudson, Benjamin E. ;

Verma, Suman ;

McLauchlan, John ;

Mutimer, David J. ;

Brown, Ashley ;

Gelson, William T. H. ;

MacDonald, Douglas C. ;

Agarwal, Kosh .

JOURNAL OF HEPATOLOGY, 2016, 64 (06) :1224-1231

[10] Efficacy of Sofosbuvir Plus Ribavirin With or Without Peginterferon-Alfa in Patients With Hepatitis C Virus Genotype 3 Infection and Treatment-Experienced Patients With Cirrhosis and Hepatitis C Virus Genotype 2 Infection [J].

Foster, Graham R. ;

Pianko, Stephen ;

Brown, Ashley ;

Forton, Daniel ;

Nahass, Ronald G. ;

George, Jacob ;

Barnes, Eleanor ;

Brainard, Diana M. ;

Massetto, Benedetta ;

Lin, Ming ;

Han, Bin ;

McHutchison, John G. ;

Subramanian, G. Mani ;

Cooper, Curtis ;

Agarwal, Kosh .

GASTROENTEROLOGY, 2015, 149 (06) :1462-1470

← 1 2 3 →