TeleHCV: A single-visit protocol and minimal passive remote monitoring are sufficient to achieve high SVR with a sofosbuvir-velpatasvir regimen

TL;DR

A simplified treatment protocol with minimal monitoring and a single visit achieved high cure rates for hepatitis C in areas with limited access to specialized care.

Contribution

Demonstrates that a single-visit protocol with remote monitoring can achieve high sustained virological response rates for hepatitis C treatment.

Findings

A single-day visit protocol achieved a 90.3% sustained virological response (SVR) rate in intention-to-treat analysis.

Remote monitoring handled 93% of adverse events without scheduled on-treatment appointments.

The per-protocol SVR rate was 99.2% after 12 weeks of sofosbuvir-velpatasvir treatment.

Abstract

•Direct-acting antivirals are highly efficacious for hepatitis C virus cure.•Access to specialized care and antivirals are difficult in some areas.•Simplifying delivery and follow-up of therapy can facilitate hepatitis C cure.•A single-day visit protocol achieved acceptable cure rates in this study.•This strategy.

Direct-acting antivirals are highly efficacious for hepatitis C virus cure.

Access to specialized care and antivirals are difficult in some areas.

Simplifying delivery and follow-up of therapy can facilitate hepatitis C cure.

A single-day visit protocol achieved acceptable cure rates in this study.

This strategy.

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.

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.

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.

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.

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