John Lubel1,2, Simone Strasser3, Katherine A Stuart4, Gregory Dore5, Alexander Thompson6,7, Stephen Pianko8, Steven Bollipo9, Joanne L Mitchell10, Vincenzo Fragomeli11, Tracey Jones9, Sarah Chivers2, Paul Gow12, David Iser6, Miriam Levy13, Edmund Tse14, Alessia Gazzola10, Wendy Cheng15, Saroj Nazareth15, Sam Galhenage16, Amanda Wade17, Martin Weltman11, Alan Wigg18, Gerry MacQuillan19,20, Joe Sasadeusz21, Jacob George22,23, Amany Zekry24, Stuart K Roberts10. 1. Department of Gastroenterology, Eastern Health, Melbourne, VIC, Australia. 2. Eastern Health Clinical School, Monash University, Melbourne, VIC, Australia. 3. AW Morrow Gastroenterology and Liver Centre, Royal Prince Alfred Hospital, Sydney, NSW, Australia. 4. Department of Gastroenterology and Hepatology, Princess Alexandra Hospital, Brisbane, QLD, Australia. 5. HIV, Immunology, Infectious Diseases Department, St Vincent's Hospital, Sydney, NSW, Australia. 6. Department of Gastroenterology, St Vincent's Hospital, Melbourne, VIC, Australia. 7. University of Melbourne, Melbourne, VIC, Australia. 8. Department of Gastroenterology, Monash Health, Melbourne, VIC, Australia. 9. Department of Gastroenterology, John Hunter Hospital, Newcastle, NSW, Australia. 10. Department of Gastroenterology, Alfred Health, Melbourne, VIC, Australia. 11. Department of Gastroenterology, Nepean Hospital, Sydney, NSW, Australia. 12. Victorian Liver Transplant Unit, Austin Health, Melbourne, VIC, Australia. 13. Department of Gastroenterology, Liverpool Hospital, Sydney, NSW, Australia. 14. Department of Gastroenterology, Royal Adelaide Hospital, Adelaide, SA, Australia. 15. Department of Gastroenterology, Royal Perth Hospital, Perth, WA, Australia. 16. Department of Gastroenterology, Fiona Stanley Hospital, Perth, WA, Australia. 17. Infectious Diseases, Barwon Health, Geelong, VIC, Australia. 18. Hepatology and Liver Transplant Medicine Unit, Flinders Medical Centre, Adelaide, SA, Australia. 19. WA Liver Transplantation Service, Department of Hepatology, Sir Charles Gairdner Hospital, Perth, WA, Australia. 20. School of Medicine and Pharmacology, University of Western Australia, Perth, WA, Australia. 21. VIDS and Peter Doherty Institute, Royal Melbourne Hospital, Melbourne, VIC, Australia. 22. Storr Liver Centre, Westmead Institute for Medical Research, Sydney, NSW, Australia. 23. University of Sydney, Sydney, NSW, Australia. 24. Department of Gastroenterology and Hepatology, St George Hospital, Sydney, NSW, Australia.
Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
BACKGROUND: 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. METHODS: 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. RESULTS: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. CONCLUSIONS: 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.
Authors: Carmen M Preda; Cristian Baicus; Irina Sandra; Alexandru Oproiu; Teodora Manuc; Ileana Constantinescu; Daniel Gavrila; Mircea Diculescu; Radu Dumitru; Catalin Vasilescu; Cristian Tieranu; Doina Istratescu; Theodor Voiosu; Mircea Manuc Journal: United European Gastroenterol J Date: 2019-03-29 Impact factor: 4.623
Authors: Peter Ferenci; Stefan Bourgeois; Peter Buggisch; Suzanne Norris; Manuela Curescu; Dominique Larrey; Fiona Marra; Henning Kleine; Patrick Dorr; Mariem Charafeddine; Eric Crown; Mark Bondin; David Back; Robert Flisiak Journal: J Viral Hepat Date: 2019-03-05 Impact factor: 3.728