Denis Ouzan, Laurent Cattan, Vincent Leroy, Jean Pierre Bronowicki, Alexandra Heurgué, Dan Pospait, Ghassan Riachi, Christophe Renou, Michel Antoni, Laure Ekrief, Laurent Cuissard, Magdalena Meszaros, Jean-Jacques Meurisse, Laurent Roudiere, Thierry Constant, Kouadjo Joseph Koffi, Hatem Salloum, Juliette Foucher, Philippe Gouiry, Malek Bentayeb, Laura E. Telep, Teri Chew, Nicolas J.-P. Martin, Stanislas Pol, the HELIOS study group
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引用次数: 0
Abstract
To eliminate hepatitis C virus (HCV) infection in France, prescribing rights for sofosbuvir/velpatasvir (SOF/VEL) were extended to non-specialists, and a simplified care pathway for non-severe patients was implemented. Patients can thus be treated once diagnosis is confirmed (“Test and Treat” model). The study's objective was to describe the effectiveness and safety of SOF/VEL when prescribed in routine practice in France. This French multicenter, prospective, noninterventional study included adults with chronic HCV infection, treated with SOF/VEL for 12 weeks. Data on patient characteristics, fibrosis stage and HCV RNA were collected from medical charts. The primary endpoint was the proportion of patients with sustained virologic response 12 weeks post-treatment (SVR12). Secondary endpoints included safety profile, time between tests and treatment initiation, and demographics of treated patients. A total of 371 eligible patients received at least one dose of SOF/VEL: 77.4% were treated by specialists, and 22.6% by non-specialists. In the specialist group, more patients had ongoing comorbidities (29.6% vs. 7.1%), and advanced fibrosis (26.3% vs. 18.4%). In the non-specialist group, more patients reported alcohol consumption (39.3% vs. 34.4%) and drug abuse (23.8% vs. 16.4%). Among the 303 patients eligible for SVR12 analysis, SVR12 rates were nearly identical between the groups: 98.4% (95% CI: 95.84–99.36) with the specialists and 98.3% (95% CI: 91.14–99.71) with the non-specialists. Median time between positive PCR test and treatment initiation was 30 days in both groups. SOF/VEL was well tolerated, and adherence was high regardless of the prescriber. Non-specialists successfully treated chronic HCV infection with a simplified care pathway.
期刊介绍:
The Journal of Viral Hepatitis publishes reviews, original work (full papers) and short, rapid communications in the area of viral hepatitis. It solicits these articles from epidemiologists, clinicians, pathologists, virologists and specialists in transfusion medicine working in the field, thereby bringing together in a single journal the important issues in this expanding speciality.
The Journal of Viral Hepatitis is a monthly journal, publishing reviews, original work (full papers) and short rapid communications in the area of viral hepatitis. It brings together in a single journal important issues in this rapidly expanding speciality including articles from:
virologists;
epidemiologists;
clinicians;
pathologists;
specialists in transfusion medicine.