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Background and Aim: The efficacy and safety profiles of elbasvir-grazoprevir (EBR/GZR) has been established in more than 10 clinical trials. However, the characteristics of patients treated in routine clinical practice may differ. The present study was therefore designed to assess the real-life effectiveness of EBR/GZR therapy in the general population and among subgroups with a high hepatitis C virus (HCV) prevalence in France. Methods: The Zephyr study was designed as a French, multicentre, prospective, observational study on EBR/GZR use and effectiveness in current practice in chronic hepatitis C patients. These results are based on data regarding the adult patients who received at least one dose of EBR/GZR between December 2017 and June 2019 in 67 French hospitals and clinics. Results: Overall, 478 patients were included. The Full Analysis Set corresponded to the 467 patients who met all the inclusion criteria and none of the exclusion criteria. Gender was balanced and the mean age was 55.7 ± 13.3 years. The patients were mainly treatment-naive (89.5%) and infected with Genotype 1b (70.4%). Among the 75 patients with HCV Gt1a genotype, 56% had HCV RNA ≥ 800,000 IU/ml. F3-F4 fibrosis stage involved 24.2% of our population. Our subgroups were distributed among 110 migrants (23.6%), 58 (15.3%) using opioid agonist treatment, including people who inject drugs, 30 (6.8%) with chronic kidney disease Stages 3-5, 9 (1.9%) with an inherited blood disorder, and 4 (0.9%) coinfected with HIV. The remaining 269 (58.7%) were included in the general population subgroup. Overall, sustained virologic response 12 weeks after the end of treatment reached 98.0% and remained consistent among genotype, HCV RNA values, fibrosis stage, and the subgroup of interest. The rate of Alcohol Use Disorders Identification Test-Consumptionâââ and Life Habit questionnaire completion was high at each visit, with data suggesting alcohol consumption decrease and an improvement in quality of life. Conclusions: Using real-world evidence data on a French population representative of HCV patients, we confirmed the results obtained during EBR/GZR development program.
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PURPOSE: Robotic partial nephrectomy (RPN) is a minimally-invasive technique used to treat renal tumors. A clinical pathway and prospective research protocol (AMBU-REIN) were specifically set up to establish and assess the routine use of day-case RPN. METHODS: The AMBU-REIN study was conducted in the framework of the French research network on kidney cancer UroCCR (NCT03293563). We present our initial experience of patients treated using day-case RPN and released from our hospital on the same day, focusing on patient selection, safety and patient satisfaction using the EVAN-G validated questionnaire. RESULTS: Between September 2016 and September 2019, 429 RPN were performed and 82 patients were consecutively selected for day-case RPN. Patients were managed using transperitoneal RPN with off-clamp tumorectomy for 66/82 cases. Mean tumor size was 2.7 ± 1.2 cm. There were no immediate severe postoperative complications; 7/82 patients were kept under observation overnight and discharged the following day. The follow-up at day 30 indicated postoperative complications, readmissions, and mortality rates of 1.2, 1.2, and 0%, respectively. Next-day patient satisfaction questionnaires indicated that patients were generally highly satisfied, with a mean ± standard deviation global score of 83.6 ± 10.3%. "Attention" was rated the highest overall (mean 94.8 ± 10.5%), while "pain management" scored the lowest (61.2 ± 20.5%). CONCLUSIONS: This prospective case series is the first to demonstrate the safety and feasibility of day-case RPN. For selected patients and through a dedicated, nurse-led clinical pathway, it provided a high level of patient satisfaction. Expected benefits on healthcare cost savings warrant further investigation.
