Monitoring of Hepatitis C Treatment Using Telemedicine - a Clinical Trial in Public Health System in Brazil

NCT04039698 | Unknown

• 2 other identifiers: 2018-0290Plataforma Brasil (CAAE)
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a non-randomized, single group clinical trial on monitoring hepatitis C therapy using telemedicine. Patients with chronic hepatitis C without cirrhosis will be treated with the pangenotypic regimen of direct acting antivirals sofosbuvir and velpatasvir for 12 weeks after a single visit to the clinic, in which treatment will be prescribed. Patients will be then monitored by telemedicine tools, like instant message application, telephone and video calls and by his or her primary physician when needed. Twelve weeks after treatment conclusion, hepatitis C virus RNA levels will be measured on a blood sample, indicating the cure rate and efficacy of this protocol on HCV treatment. The primary objective of the study is to address the feasibility and applicability of the usage of telemedicine tools to increase access and monitor HCV treatment with direct-acting antivirals in public health in Brazil.

Conditions

Chronic Hepatitis C

Keywords

Hepatitis C; Telemedicine; Direct acting antivirals; Public Health

Outcome Measures

Primary Outcomes (1)

• Sustained virologic response

  Proportion of treated patients with undetectable hepatitis C virus RNA levels measured by a real time polymerase chain reaction (PCR) with a lower limit of detection ≤ 12 IU/mL

  12 weeks post end of antiviral therapy (SVR12)

Secondary Outcomes (4)

• Adherence to antiviral treatment

  12 weeks after antiviral treatment initiation

• Patient satisfaction with the treatment

  12 weeks post end of antiviral therapy (SVR12)

• Adverse effects

  12 weeks post end of antiviral therapy (SVR12)

• Severe adverse effects

  12 weeks post end of antiviral therapy (SVR12)

Other Outcomes (1)

• Rate of primary physicians participation after invitation to project ECHO®

  12 weeks post end of antiviral therapy (SVR12)

Study Arms (1)

Telemedicine

EXPERIMENTAL

Sofosbuvir 400mg and velpatasvir 100mg qd for 12 weeks Telemedicine support

Other: Telemedicine; Drug: Velpatasvir/Sofosbuvir

Interventions

Telemedicine OTHER

Telemedicine monitoring and teleconsultation by video calls

Telemedicine

Velpatasvir/Sofosbuvir DRUG

Velpatasvir 100mg / Sofosbuvir 400mg once a day for twelve weeks

Also known as: Epclusa

Telemedicine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have voluntarily signed the informed consent form;
• Chronic hepatitis C confirmed by positive HCV-RNA;
• Have been referred to specialized consultation in gastroenterology or infectious disease in the Brazilian Public Health System in Porto Alegre;
• Have previous fibrosis staging (eg. liver biopsy, Fibroscan®) or laboratory tests for APRI score calculation.

You may not qualify if:

• Suspicion or diagnosis of cirrhosis based on:
• Hepatic elastography ≥12.5 kPa on Fibroscan®;
• APRI score ≥2.0;
• Clinical, ultrasound or endoscopic evidence of cirrhosis or portal hypertension;
• Previous HCV treatment with direct acting antivirals;
• HIV coinfection with antiretroviral treatment incompatible with HCV antivirals;
• Previous solid organ transplant;
• Significant comorbidity that may interfere with the HCV treatment
• Creatinine clearance \< 30 mL/min;
• Platelets \< 150.000/mL;
• Pregnant or breastfeeding female;
• Woman of childbearing age without use or that does not accept to use effective contraception during treatment and during the 30 days after treatment end;
• Inability or unwillingness to provide informed consent or abide by the requirements of the study.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Ministry of Health, Brazil: collaborator
• State Secretary of Health of Rio Grande do Sul: collaborator
• TelessaúdeRS / UFRGS: collaborator

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-007, Brazil

Location

Related Publications (1)

• Oliveira JC, Schacher FC, Costa MB, Kolling MG, Costa RB, Scherer HC, Fernandes PM, Katz N, Goncalves MR, Rados DV, Alvares-da-Silva MR. TeleHCV: A single-visit protocol and minimal passive remote monitoring are sufficient to achieve high SVR with a sofosbuvir-velpatasvir regimen. Clinics (Sao Paulo). 2025 Apr 23;80:100643. doi: 10.1016/j.clinsp.2025.100643. eCollection 2025.

  PMID: 40273497 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

Telemedicine; sofosbuvir-velpatasvir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Mario R Alvares-da-Silva, PhD

  Hospital de Clínicas de Porto Alegre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: July 31, 2019
• Study Start: August 23, 2019
• Primary Completion: December 16, 2020
• Study Completion: November 1, 2021
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: starting after the publication
• Access Criteria: Researchers or public health policy makers interested in perform analyses to replicate the study or protocol of telemonitoring.

Locations

BR (1)