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

NCT06306300 | Recruiting Phase 4

• 1 other identifier: 445957/2020-4
• Study Type: interventional
• Target: 30,000
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hepatitis C

Keywords

Hepatitis C virus; Primary health care; Hepatitis C virus self-test

Outcome Measures

Primary Outcomes (3)

• Prevalence of HCV infection

  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.

  1 month

• The effectiveness of the HCV treatment with test results.

  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

  1 month

• Usability of the result of a self-test HCV

  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.

  1 month

Secondary Outcomes (9)

• Proportion between positive and negative

  1 month

• Participants with fibrosis/cirrhosis

  1 month

• Participants who denied the treatment

  1 month

• cost per detected participant

  1 month

• Unscheduled visits during treatment

  3 months

Other Outcomes (5)

• Participant´s Ability to use the test

  1 month

• Participant preference for types of tests

  1 month

• Participant understanding to interpret his result

  1 month

Study Arms (4)

Study I

NO INTERVENTION

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.

Substudy I

NO INTERVENTION

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).

Study II - Specialist

ACTIVE COMPARATOR

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.

Drug: Specialist - Epclusa 400Mg-100Mg Tablet

Study II - Non Specialist

ACTIVE COMPARATOR

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.

Drug: Non- specialist - Epclusa 400Mg-100Mg Tablet

Interventions

Specialist - Epclusa 400Mg-100Mg Tablet DRUG

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.

Also known as: Standard-of-Care (SC) HCV treatment

Study II - Specialist

Non- specialist - Epclusa 400Mg-100Mg Tablet DRUG

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.

Also known as: Simplified-and-Decentralized (SD) HCV treatment

Study II - Non Specialist

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Age between 18-79 years-old

You may not qualify if:

• 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
• Age between 18 and 79 years old.
• Presence of active/chronic hepatitis C, defined by a positive HCVab test and detectable HCV-RNA
• 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)

Sponsors & Collaborators

• Oswaldo Cruz Foundation: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (2)

Evandro Chagas National Institute of Infectious Diseases

Rio de Janeiro, Rio de Janeiro/RJ, 21040-360, Brazil

RECRUITING

Hugo Perazzo

Rio de Janeiro, Brazil

RECRUITING

MeSH Terms

Conditions

Hepatitis C

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Hugo Perazzo, PhD

CONTACT

+552138659587; hugo.perazzo@ini.fiocruz.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Study I is a population-based cross-sectional screening study (n=30,000 individuals) 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 (n=1,500 participants included in Study I). Study II is a phase IV open-label randomized clinical trial (1:1) 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.

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 12, 2024
• Study Start: July 4, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)