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

Condition(s) studied

Investigational drug(s) / intervention(s)

Specialist - Epclusa 400Mg-100Mg Tablet: HCV-positive participants from study 1 will be randomized to be treated in the specialist arm, which consists of follow-up by a specialized doctor.

Non- specialist - Epclusa 400Mg-100Mg Tablet: HCV-positive participants from study 1 will be randomized to be treated in the specialist arm, which consists of follow-up by non-specialized doctor.

HCV Self-Testing kit (Ora-Quick HCV ST or Wond-Foo HCV ST): HCV Self-Testing kit (oral fluid or blood-based) for HCV testing

HCV Rapid Testing kit: Standard-of-care: HCV Rapid Test

Study 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

Primary outcome measure(s)

• Prevalence of HCV infection — 1 month
  The primary outcome of Study I will be the assessment of the prevalence of HCV infection in users of the Felippe Cardoso Family Clinic, Zilda Arns Family Clinic, and/or Klebel de Oliveira Rocha Family Clinic, located in the municipality of Rio de Janeiro.
• The effectiveness of the HCV treatment with test results. — 1 month
  The primary outcome of Study II will be the effectiveness of the HCV treatment in both arms, translated by sustained virological response (SVR12), characterized by undetectable HCV-RNA by the PCR method at least 12 weeks after the end of treatment with SOF/VEL. Comparison of test results at the beginning and end of treatment
• Usability of the result of a self-test HCV — 1 month
  Evaluate the interpretability of the result of a self-test for the detection of HCV antibodies (HCVab) in oral fluid in a subset of participants included in Study I (adults performing HCV testing). Comparison of the results of the tests carried out by the participant with those of the professional.

Trial sites (2)

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