Real-world efficacy and safety of ritonavir-boosted paritaprevir, ombitasvir, dasabuvir ± ribavirin for hepatitis C genotype 1 - final results of the REV1TAL study.

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.

Nurse-led hepatocellular carcinoma surveillance clinic provides an effective method of monitoring patients with cirrhosis.

The aim of this study is to examine the acceptability and effectiveness of a nurse-led hepatocellular carcinoma (HCC) surveillance clinic in high-risk patients with cirrhosis/advanced fibrosis. Early detection of HCC is associated with better treatment outcomes and improved survival. International guidelines recommend 6-monthly surveillance of patients at risk of developing HCC. A nurse-led HCC surveillance protocol was established to support patients in adherence to surveillance protocols. The design used was retrospective document analysis. Retrospective analysis of healthcare records of patients referred to the clinic between August 2009 and December 2015. Extracted data included attendance of clinic visits, blood testing, ultrasound or other imaging, and outcomes. Ultrasound was attended within 6 months in 30.3% of cases and within 7 months in 71.2% of cases. The median time between Nurse-Led Clinic appointments, ultrasound scans and blood testing did not exceed 9 months. First year FibroScans were attended by 82.9% (63/76) patients; endoscopy was indicated for 42 and attended by 35 (83.3%) patients. Lesions were identified in 16 patients (21.5%) and HCC diagnosed in two patients. One patient died because of HCC and one to sub-dural haematoma. Nurse-led HCC surveillance was an effective method of monitoring patients with cirrhosis at high risk of developing HCC. Well-defined protocols enable timely identification of patients with HCC or hepatic decompensation so that management strategies can be implemented without delay. The potential benefits identified by this study warrant further, rigorous evaluation.

Statewide hepatitis C model of care for rural and remote regions.

The evolution of management of hepatitis C virus (HCV) has seen a majority of patients treated being regarded as cured. Despite this development, uptake of treatment remains low in Australia, and this is particularly true in rural and remote areas. The largest state in Australia, Western Australia (WA), covers an area of 2500 km(2). As the rural and remote population of WA is scattered in small areas rather than major centers, poor accessibility to remote areas and lack of adequate of medical and nursing resources pose major problems in providing equity of care to patients with chronic HCV. A statewide hepatitis model of care, established in 2009, has led to an increase in identification and treatment of patients living with HCV. Strategies used to facilitate these changes include telehealth, a nurse practitioner model, and general practitioner shared-care model. The statewide program will be modified to meet the changing needs of patients as all-oral treatment regimens become available, with further emphasis being placed on the role of rural and remote health professionals in identifying patients with HCV and initiating and monitoring treatment.