RecruitingPhase 4NCT06306300

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

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

Sponsor

Oswaldo Cruz Foundation

Enrollment

30,000 participants

Start Date

Jul 4, 2022

Study Type

INTERVENTIONAL

Conditions

Hepatitis C

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

Min Age: 18 YearsMax Age: 79 Years

Inclusion Criteria4

Study I and Sub-Study
\- 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

Exclusion Criteria10

Presence of a disease that need urgent/emergency treatment and/or acute febrile illness, such as COVID-19, Dengue, Zyca virus infection or Chikungunya
Lack of capacity to sign the informed consent or refuse to participate
Study II
Children and adolescents (\< 18 years old)
Pregnancy, defined by a positive β-HCG urinary test
Lactating individuals
Co-infection with HBV or HIV
Regular use of medications with potential drug interactions or contraindication for co-administration with SOF/VEL
Presence of severe acute illness, active neoplasia, solid organ transplant, or use of immunosuppressive medications
Presence of clinical signs of decompensated liver cirrhosis (ascites, hepatic encephalopathy, report of a recent episode of gastrointestinal bleeding within the last 12 weeks)