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.
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 ≥70 years (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.
Department of Medicine 1, University Hospital, J.W. Goethe University, Frankfurt am Main, Germany.
T M
TM
Welzel
Gastroenterology-Hepatology Center Kiel, Kiel, Germany.
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H
Hinrichsen
Department of Medicine 1, University Hospital, J.W. Goethe University, Frankfurt am Main, Germany.|Medical Department II, Gastroenterology, Hepatology, Infectiology, St. Josefs-Hospital, Wiesbaden, Germany.
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C
Sarrazin
Liver Unit, Asklepios Clinic St. Georg, IFI-Institute, Hamburg, Germany.
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P
Buggisch
Center for Infectiology Berlin, Berlin, Germany.
A
A
Baumgarten
Center for Interdisciplinary Medicine (CIM), Münster, Germany.
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S
Christensen
Section of Hepatology, Clinic for Gastroenterology and Rheumatology, University Hospital Leipzig, Leipzig, Germany.
T
T
Berg
Center for HIV and Hepatogastroenterology, Düsseldorf, Germany.
S
S
Mauss
Private Practice, Frankfurt am Main, Germany.
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G
Teuber
Hepatologie - Magdeburg, Magdeburg, Germany.
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K
Stein
Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.
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K
Deterding
Section of Hepatology, Clinic for Gastroenterology and Rheumatology, University Hospital Leipzig, Leipzig, Germany.
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F
van Bömmel
Leberzentrum am Checkpoint Berlin, Berlin, Germany.
R
R
Heyne
Private Practice for Internal Medicine, Berlin, Germany.
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C
John
Department of Medicine I, University Medical Center of the Johannes Gutenberg University, Mainz, Germany.
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T
Zimmermann
Infektiologikum, Frankfurt am Main, Germany.
T
T
Lutz
Department of Hepatology and Gastroenterology, Charité Universitätsmedizin Berlin, Berlin, Germany.
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E
Schott
AbbVie Deutschland GmbH & Co KG, Wiesbaden, Germany.
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0000-0002-1024-0732
J
Hettinger
AbbVie Deutschland GmbH & Co KG, Wiesbaden, Germany.
H
H
Kleine
AbbVie Deutschland GmbH & Co KG, Wiesbaden, Germany.
B
B
König
Center for Gastroenterology and Hepatology, Herne.
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D
Hüppe
Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.
H
H
Wedemeyer
D015081:2-Naphthylamine; D000328:Adult; D000368:Aged; D000813:Anilides / Q000008:administration & dosage* / Q000009:adverse effects; D002219:Carbamates / Q000008:administration & dosage* / Q000009:adverse effects; D015331:Cohort Studies; D003521:Cyclopropanes; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D005858:Germany; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy* / Q000821:virology*; D006801:Humans; D047029:Lactams, Macrocyclic; D008103:Liver Cirrhosis / Q000175:diagnosis / Q000209:etiology; D047028:Macrocyclic Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011392:Proline / Q000031:analogs & derivatives; D019438:Ritonavir / Q000008:administration & dosage* / Q000009:adverse effects; D012720:Severity of Illness Index; D013449:Sulfonamides / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D014498:Uracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D014633:Valine; D019562:Viral Load
D000813:Anilides; D002219:Carbamates; D003521:Cyclopropanes; D047029:Lactams, Macrocyclic; D047028:Macrocyclic Compounds; D013449:Sulfonamides; C586094:ombitasvir; D014498:Uracil; D011392:Proline; D015081:2-Naphthylamine; C588260:dasabuvir; D014633:Valine; D019438:Ritonavir; C585405:paritaprevir
chronic hepatitis C; cirrhosis; dasabuvir; direct-acting antivirals; ombitasvir/paritaprevir/r