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

• Status: Active, not recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital de Clinicas de Porto Alegre
• Collaborators: Ministry of Health, Brazil; State Secretary of Health of Rio Grande do Sul; TelessaúdeRS / UFRGS
• Treatments: Sofosbuvir; Velpatasvir

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.