Randomized Open-label and Non-inferiority Clinical Trial to Evaluate the Safety, Adherence, and Cost-effectiveness of Simplified and Decentralized Hepatitis C Treatment in Primary Health Care Compared to Standard-of-care in the Brazilian Public Health System

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Up to 650,000 people in Brazil are living with chronic hepatitis c virus (HCV) infection. Hepatitis C is a silent disease, and up to 20% of cases can progress to liver cirrhosis and its complications. Rapid tests for diagnosis of HCV infection and non-invasive methods for detecting liver cirrhosis are available in the Brazilian Public Health System. Additionally, safe and highly effective drugs (direct-acting antivirals, DAAs) have been delivered for free for hepatitis C treatment by the Brazilian Unified Health System (Sistema Único de Saúde, SUS) since 2015. Sustained virological response (SVR) rates with DAAs in studies conducted in Brazil and Latin America were higher than 90%. Despite the availability of rapid tests for early diagnosis and effective drugs, the HCV continuum of care remains deficient in Brazil. It is estimated that only 10% of individuals known to have hepatitis C achieve HCV cure (SVR). This is explained by multiple barriers from diagnosis to treatment access, such as low rates of population screening (HCVST are not available in Brazil) and few available slots in tertiary centers for hepatitis C treatment by specialists. International studies have described that SVR rates by simplified hepatitis C treatment performed by non-specialists in the Primary Care System were similar to those treated in tertiary centers by specialists (standard-of-care). However, the optimal strategy for managing hepatitis C within the Brazilian-SUS remains unclear.This project aims to evaluate the improve of the HCV continuum of care by a implementation of a test-and-treat strategy in the Primary Care System in Brazil. The project consists of two parallel studies (and a sub-study). The project consists of two parallel studies (and a sub-study). Study I is a population-based cross-sectional screening study using rapid tests to determine the prevalence of HCV infection in people attending a Basic Health Care Unit. The sub-study associated with Study I is a cross-sectional study to assess the usability of a self-test for the detection of HCV antibodies in oral fluid (participants included in Study I). Study II is a phase IV open-label randomized clinical trial to evaluate the non-inferiority of simplified and decentralized hepatitis C treatment (Simplified-and-Decentralized (SD) HCV treatment; experimental arm) compared to specialist reference treatment (Standard-of-Care (SC) HCV treatment; control arm) within the SUS.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 79
Healthy Volunteers: t
View:

⁃ \- Age between 18-79 years-old

• Age between 18 and 79 years old.

• Presence of active/chronic hepatitis C, defined by a positive HCVab test and detectable HCV-RNA

Locations
Other Locations
Brazil
Evandro Chagas National Institute of Infectious Diseases
RECRUITING
Rio De Janeiro
Hugo Perazzo
RECRUITING
Rio De Janeiro
Contact Information
Primary
Hugo Perazzo, PhD
hugo.perazzo@ini.fiocruz.br
+552138659587
Time Frame
Start Date: 2022-07-04
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 30000
Treatments
No_intervention: Study I
Study I is a population-based cross-sectional screening study (n=30,000 individuals) using rapid tests to determine the prevalence of HCV infection in people attending a Basic Health Care Unit.
No_intervention: Substudy I
The sub-study associated with Study I is a cross-sectional study to assess the usability of a self-test for the detection of HCV antibodies in oral fluid (n=1,500 participants included in Study I).
Active_comparator: Study II - Specialist
HCV standard-of-care treatment; control arm. Participants randomized for the Standard-of-Care HCV treatment arm will be referred for the usual treatment of hepatitis C by specialists (hepatologists and/or infectious disease specialists) at a tertiary center \[INI/FIOCRUZ or Hospital Universitário Clementino Fraga Filho (HUCFF/UFRJ)\]. Participants will be treated with the pan-genotypic therapeutic regimen single-pill daily, at a fixed dose and duration: sofosbuvir/velpatasvir 400/100 mg (Epclusa, Gilead Sciences, USA) 1 tablet orally per day for 12 weeks.
Active_comparator: Study II - Non Specialist
Decentralized hepatitis C treatment (DS HCV treatment; experimental arm).Participants randomized for the Decentralized-and-Simplified HCV treatment (DS HCV treatment) arm will be referred for simplified treatment of chronic hepatitis C at the Primary Health Care unit where participants were included in Study I and are registered for care. The treatment will be conducted by a non-specialist physician (general practitioner or family doctor) after training provided by a specialist (hepatologist) on the treatment of patients with hepatitis C using DAAs. Participants will be treated with a pan-genotypic therapeutic regimen, a fixed-dose, single-pill daily: sofosbuvir/velpatasvir 400/100 mg (Epclusa, Gilead Sciences, USA), 1 tablet orally per day for 12 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico
Leads: Oswaldo Cruz Foundation

This content was sourced from clinicaltrials.gov