ArticleClinics (Sao Paulo, Brazil)2025
TeleHCV: A single-visit protocol and minimal passive remote monitoring are sufficient to achieve high SVR with a sofosbuvir-velpatasvir regimen.
Article in Clinics (Sao Paulo, Brazil), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04039698 (Monitoring of Hepatitis C Therapy Using Telemedicine in a Simplified Protocol With Pangenotypic Regimen in Non-cirrhotic Patients - a Single Group Clinical Trial in the National Public Health System in Brazil), which is not on this map. Not yet cited in PubMed.
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Monitoring of Hepatitis C Therapy Using Telemedicine in a Simplified Protocol With Pangenotypic Regimen in Non-cirrhotic Patients - a Single Group Clinical Trial in the National Public Health System in Brazil
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11 authors.
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Abstract
aimChronic 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
methodsChronic 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.
resultsThe 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.
conclusionThis 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.
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