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
Study Objectives: The novel coronavirus (SARS-CoV-2) pandemic placed unprecedented strain on the supply of personal protective equipment (PPE) in health care settings, particularly the emergency department (ED). Innovative strategies were needed for PPE conservation. Our ED deployed electronic PPE (ePPE) - a telehealth approach to conduct medical screening exams (MSEs) of COVID-19-suspected patients. As part of our plan to scale this intervention, we sought to evaluate provider perceptions of ePPE-based MSEs. Methods: We conducted a qualitative analysis at Vanderbilt University Medical Center in Nashville, TN. Emergency clinicians were identified through use of structured ePPE documentation elements in the EHR. Patients who received ePPE-based MSEs included English-speaking adults with fever or respiratory symptoms (inclusion criteria: age < 50;SpO2 > 94%;RR < 20;HR < 110;no cardiovascular, respiratory, or immunosuppressive history). We invited providers to participate in semi-structured video interviews (Zoom, San Jose, CA). A Likert scale between 1 [Not at all effective] and 5 [Extremely effective] was used to gauge perceived ePPE effectiveness. We recorded and transcribed interviews, subsequently extracting then encoding notable excerpts using Dedoose (SocioCultural Research Consultants, Los Angeles, CA). Thematic analysis was performed using intervention characteristics from the Consolidated Framework for Implementation Research (CFIR): intervention source, evidence strength and quality, relative advantage, adaptability, trialability, complexity, design quality and packaging, and cost. Results: We identified 18 clinicians who documented ePPE use. On review, 2 never used ePPE and 5 only supervised other clinicians who used ePPE. Of the remaining 11, we interviewed 7 attending physicians and 1 physician assistant between 5/15/20 and 6/5/20. Providers gave ePPE a mean effectiveness score of 4.2 (SD 0.53). Identified advantages included improved patient and provider safety, PPE conservation, and improved patient-provider communication. The primary perceived limitation was inability to auscultate the lungs. While noting the risk of missed alternate diagnoses (eg, heart failure), providers asserted that video-based history-taking and respiratory exam sufficed for low-acuity patients and that auscultation’s absence was unlikely to change management. Beyond MSEs, providers used ePPE for patient reassessment and counseling, as well as to facilitate supervision. Many emphasized ePPE’s flexibility: “If I do pick up on a few things…I can always, sort of, abandon [ePPE] and go in and do my exam.” Barriers to use included potential for negative patient perceptions, poor audio quality, difficulty incorporating an interpreter, and workflow challenges related to staff coordination. Clinicians revealed that many ePPE encounters were not fully documented, suggesting ePPE use may be underrepresented in this study. Conclusion: In this trial implementation of ePPE, we found that ED clinicians perceived ePPE as an effective and useful technique for MSEs of COVID-19-suspected patients. The benefits largely outweighed the disadvantages, particularly in the low-acuity population. Our study may have been limited by early adoption from clinicians favorable to such technology, and future work should examine perceptions among clinicians with varying degrees of technology comfort.