Jerônimo De Conto Oliveira , Fernando Comunello Schacher , Marisa Boff Costa , Maurício Godinho Kolling , Raquel Boff Costa , Henrique Cabral Scherer , Paula Martins Fernandes , Natan Katz , Marcelo Rodrigues Gonçalves , Dimitris Varvaki Rados , Mário Reis Álvares-da-Silva
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引用次数: 0
Abstract
Aim
Chronic Hepatitis-C Virus (HCV) treatment has evolved significantly in recent years with Direct-Acting Antivirals (DAAs). The traditional care cascade includes several steps that limit its impact, and simplification protocols have emerged. Therefore, the authors explore a simplified treatment strategy for HCV in a healthcare system with limited access to specialized care.
Subject and methods
Chronic HCV, DAA-naïve patients waiting for in-person specialized care were invited to a single-arm non-inferiority trial to evaluate a simplified treatment protocol with a single face-to-face appointment and minimal monitoring of antiviral therapy. The unique visit consisted of an HCV presentation followed by individual medical consultation, blood tests, and delivery of sofosbuvir-velpatasvir pills for a 12-week treatment. Patients were remotely monitored without scheduled on-treatment appointments or phone calls. After treatment, teleconsultation using video was offered. The primary outcome was Sustained Virological Response (SVR) 12-weeks post-treatment. It was analyzed with Intention-To-Treat (ITT) and Per-Protocol (PP) approaches. ClinicalTrials.gov: NCT04039698.
Results
The authors included 144 patients, of which 54.2 % were male, mean age was 52 years. Most individuals (84.7 %) had an APRI score < 1. All patients received at least one dose of DAA, 139 completed antiviral therapy, and 131 had SVR evaluation. The ITT SVR rate was 90.3 % (130/144 patients; 95 % CI 84.2 %‒94.6 %), and the PP SVR was 99.2 % (130/131 patients; 95 % CI 95.8 %‒100 %). Eighty-three adverse events were reported, and 93 % were handled with remote care.
Conclusion
This simplified strategy achieved a high SVR rate in a population with restricted access to specialized care. Telehealth tools and minimal monitoring are promising components for policies aimed at HCV elimination.
期刊介绍:
CLINICS is an electronic journal that publishes peer-reviewed articles in continuous flow, of interest to clinicians and researchers in the medical sciences. CLINICS complies with the policies of funding agencies which request or require deposition of the published articles that they fund into publicly available databases. CLINICS supports the position of the International Committee of Medical Journal Editors (ICMJE) on trial registration.