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Title: Real-world efficacy and safety of ritonavir-boosted paritaprevir, ombitasvir, dasabuvir ± ribavirin for hepatitis C genotype 1 - final results of the REV1TAL study.
Authors: Lubel, John;Strasser, Simone;Stuart, Katherine A;Dore, Gregory;Thompson, Alexander;Pianko, Stephen;Bollipo, Steven;Mitchell, Joanne L;Fragomeli, Vincenzo;Jones, Tracey;Chivers, Sarah;Gow, Paul J;Iser, David;Levy, Miriam;Tse, Edmund;Gazzola, Alessia;Cheng, Wendy;Nazareth, Saroj;Galhenage, Sam;Wade, Amanda;Weltman, Martin;Wigg, Alan;MacQuillan, Gerry;Sasadeusz, Joe;George, Jacob;Zekry, Amany;Roberts, Stuart K
Affiliation: Department of Gastroenterology and Hepatology, St George Hospital, Sydney, NSW, Australia
Storr Liver Centre, Westmead Institute for Medical Research, Sydney, NSW, Australia
University of Sydney, Sydney, NSW, Australia
Department of Gastroenterology, Eastern Health, Melbourne, VIC, Australia
Eastern Health Clinical School, Monash University, Melbourne, VIC, Australia
AW Morrow Gastroenterology and Liver Centre, Royal Prince Alfred Hospital, Sydney, NSW, Australia
Department of Gastroenterology and Hepatology, Princess Alexandra Hospital, Brisbane, QLD, Australia
HIV, Immunology, Infectious Diseases Department, St Vincent's Hospital, Sydney, NSW, Australia
Department of Gastroenterology, St Vincent's Hospital, Melbourne, VIC, Australia
University of Melbourne, Melbourne, VIC, Australia
Department of Gastroenterology, Monash Health, Melbourne, VIC, Australia
Department of Gastroenterology, John Hunter Hospital, Newcastle, NSW, Australia
Department of Gastroenterology, Alfred Health, Melbourne, VIC, Australia
Victorian Liver Transplant Unit, Austin Health, Heidelberg, Victoria, Australia
Department of Gastroenterology, Liverpool Hospital, Sydney, NSW, Australia
Department of Gastroenterology, Royal Adelaide Hospital, Adelaide, SA, Australia
Department of Gastroenterology, Royal Perth Hospital, Perth, WA, Australia
Department of Gastroenterology, Fiona Stanley Hospital, Perth, WA, Australia
Infectious Diseases, Barwon Health, Geelong, VIC, Australia
Department of Gastroenterology, Nepean Hospital, Sydney, NSW, Australia
Hepatology and Liver Transplant Medicine Unit, Flinders Medical Centre, Adelaide, SA, Australia
WA Liver Transplantation Service, Department of Hepatology, Sir Charles Gairdner Hospital, Perth, WA, Australia
School of Medicine and Pharmacology, University of Western Australia, Perth, WA, Australia
VIDS and Peter Doherty Institute, Royal Melbourne Hospital, Melbourne, VIC, Australia
Issue Date: 2017
Citation: Antiviral therapy 2017; 22(8): 699-710
Abstract: Limited data exist on the outcomes of ritonavir-boosted paritaprevir with ombitasvir and dasabuvir (PrOD) ± ribavirin in a real-world setting. The aim of this study was to compare the efficacy and safety of PrOD-based therapy in hepatitis C genotype 1 patients with and without cirrhosis, and to explore pre-treatment factors predictive of sustained viral response (SVR) and serious adverse events (SAEs) on treatment. 451 patients with hepatitis C genotype 1 treated in 20 centres across Australia were included. Baseline demographic, clinical and laboratory information, on-treatment biochemical, virological and haematological indices and details on serious adverse events were collected locally. Cirrhosis was present in 340 patients (75.4%). Overall SVR was 95.1% with no differences in SVR between the cirrhosis and non-cirrhosis groups (94.7% versus 96.4%). SVR in subgenotypes 1a and 1b was 93.1% and 99.2%, respectively. On multivariate analysis, baseline bilirubin level and early treatment cessation predicted SVR. SAEs occurred in 10.9% of patients including hepatic decompensation (2.7%) and hepatocellular carcinoma (1.8%). On multivariate analysis of factors predictive of SAEs in the overall group, Child-Turcotte-Pugh (CTP) B was the only significant factor, while in those with cirrhosis, baseline albumin and creatinine levels were significant. In this large real-world cohort of HCV genotype 1 subjects, treatment with PrOD was highly effective and similar to clinical trials. Important determinants of reduced SVR include early cessation of therapy and baseline bilirubin concentration. SAEs were not infrequent with CTP B patients being at greatest risk.
DOI: 10.3851/IMP3168
PubMed URL: 28422043
Type: Journal Article
Appears in Collections:Journal articles

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