Safety and Efficacy of Decentralized HCV Treatment vs Standard-of-Care in Rio de Janeiro (Brazil) - Trial NCT06306300

Timeline & Enrollment

Primary Outcome

Prevalence of HCV infection,The effectiveness of the HCV treatment with test results.,Usability of the result of a self-test HCV

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.

ICD-10 Classifications