ABSTRACT
Background: In France, prescribing authorization for hepatitis C virus (HCV) treatment has been expanded to all physicians including non-specialists working in addiction and psychiatric centers and in jails. Patient management includes a Test and Treat approach (TnT) to expedite treatment initiation and a pathway for severe patients followed-up by specialists. This is a descriptive, interim analysis of an ongoing study to assess the efficacy and safety of Sofosbuvir/Velpatasvir (SOF/VEL) for 12 weeks after prescription expansion in patients treated by specialists and non-specialists. Method(s): Included patients are HCV-infected adults following SOF/VEL-based regimens prescribed by primary care physicians and specialists. Data collected from available information in medical records include patient characteristics, number of days between positive PCR/fibrosis assessment and start of therapy, and proportion of patients with sustained virologic response (SVR) 12 weeks after treatment end. Qualitative variables are described as number and percentage (%);quantitative measures as mean (standard deviation;SD) or median (range) as indicated. Result(s): Table) As of January 2022, 286 patients had received at least one dose of SOF/VEL treatment;217 were managed by specialists and 69 by non-specialists. Median patient age was 53.14 years (19.8-88.7), 80 (28%) were F3/F4 and 185 (64.7%) were male. Occasional and excessive consumption of alcohol was reported in 43 (62.3%) and 87 (40.8 %) patients managed by specialists and non-specialists respectively. Current recreational drug use was reported more frequently in 37 patients (53.6%) managed by non-specialists and 40 patients (18.6%) managed by specialists. Mean number of days between SOF/VEL initiation and fibroscan and Fib 4 were 62.16 +/- 306.39 and 40.35 +/- 60.24, respectively. Median number of days between positive PCR and start of therapy was 89.19 +/- 311.17 and 60.65 +/- 80.71 for patients managed by specialists and non-specialists respectively, and only 2 were lost to follow-up. Among 167 eligible patients who achieved an SVR12, 124 (97.6%) [93.28;99.19] were managed by specialists and 40 (100.0%) [91.24;100.00] by non-specialists;according to fibrosis stage, 107 F0-F2 patients (100.0%) and 39 F3-F4 (92.9%) achieved SVR12. Overall, at least one adverse event was observed in 34 patients (11.9%), of which only 2 (0.7%) lead to drug withdrawal. Conclusion(s): This interim analysis describes a French study population benefiting from SOF/VEL in real world use after treatment prescription expansion. SVR12 rates were high, regardless of the type of patient management and stage of fibrosis suggesting that HCV patients could be treated by SOF/VEL for 12 weeks by non-specialists. Despite the COVID 19 situation this study suggested that HCV patient pathway could be more optimized regarding fibrosis assessment or genotype determination.
ABSTRACT
Background Primary biliary cholangitis (PBC) is a chronic autoimmune cholestatic liver disease that can progress to liver fibrosis and cirrhosis, and requires timely diagnosis, optimal treatment, and risk stratification. Several guidelines for the management of PBC have been published, including the American Association for the Study of Liver Disease (AASLD) and European Association for the Study of the Liver (EASL) Clinical Practice Guidelines, which include goals for standards of PBC care. However, recent audits have identified deficiencies in real-world PBC care. In addition, the global coronavirus (COVID-19) pandemic has generally reduced access to care, diminished healthcare resources and accelerated the use of remote patient management. There is therefore a need for simple, actionable guidance that physicians can implement in order to maintain standards of care in PBC in the new environment. Aims A working group of ten PBC specialists from Europe and Canada were convened by Intercept Pharmaceuticals in January 2020 with the aim of defining key criteria for the care of patients with PBC. Methods Following the outbreak of the COVID-19 pandemic, based on these criteria, a smaller working group of six PBC specialists developed practical recommendations to assist physicians in maintaining standards of care and to guide remote management of patients. Results The working group defined five key criteria for care in PBC, encompassing PBC diagnosis, initiation of first line therapy with ursodeoxycholic acid (UDCA), risk stratification on UDCA, symptom management, and initiation of 2L therapy. The group developed 21 practical recommendations for the management of patients with PBC in the COVID-19 environment including modality, frequency and timing of investigations and monitoring. (Figure 1). Conclusions The delivery of PBC care during the COVID-19 pandemic carries significant challenges. These consensus criteria and practical recommendations provide guidance for the management of PBC during the pandemic era and beyond. Funding Agencies NoneIntercept Pharmaceutical
ABSTRACT
Background: Primary biliary cholangitis (PBC) is a chronic autoimmune cholestatic liver disease that can progress to liver fibrosis and cirrhosis, and requires timely diagnosis, optimal treatment, and risk stratification. Several guidelines for the management of PBC have been published, including the American Association for the Study of Liver Disease (AASLD) and European Association for the Study of the Liver (EASL) Clinical Practice Guidelines, which include goals for standards of PBC care. However, recent audits have identified deficiencies in real-world PBC care. In addition, the global coronavirus (COVID-19) pandemic has generally reduced access to care, diminished healthcare resources and accelerated the use of remote patient management. There is therefore a need for simple, actionable guidance that physicians can implement in order to maintain standards of care in PBC in the new environment. Methods: A working group of ten PBC specialists from Europe and Canada were convened by Intercept Pharmaceuticals in January 2020 with the aim of defining key criteria for the care of patients with PBC. Following the outbreak of the COVID-19 pandemic, based on these criteria, a smaller working group of six PBC specialists developed practical recommendations to assist physicians in maintaining standards of care and to guide remote management of patients. Results: The working group defined five key criteria for care in PBC, encompassing PBC diagnosis, initiation of first line therapy with ursodeoxycholic acid (UDCA), risk stratification on UDCA, symptom management, and initiation of 2L therapy. The group developed 21 practical recommendations for the management of patients with PBC in the COVID-19 environment including modality, frequency and timing of investigations and monitoring. (Figure 1). Conclusion: The delivery of PBC care during the COVID-19 pandemic carries significant challenges. These consensus criteria and practical recommendations provide guidance for the management of PBC during the pandemic era and beyond.
ABSTRACT
This document, written by the French Association for the Study of the Liver (AFEF) board, aims to provide information to physicians involved in the care of patients with liver disease during the Coronavirus disease (COVID-19) epidemic. These are not based on a systematic review of the literature and a rigorous evaluation using the GRADE method. These are recommendations based on feedback from China available in the form of original articles or letters - for which the scientific evidence is often modest - and the rules put forward by American (1) and European (Boettler et al, 2020) hepatology societies, the French National Digestive Cancer Thesaurus (Di Fiore et al., 2020) and the Francophone Transplantation Society (4). These suggestions require adjustment according to the geographical particularities of the epidemic, available standard procedures and access to local resources. This document will be updated as regularly as possible according to the evolution of our knowledge and characteristics on the epidemic.