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

RecruitingPhase 4Ages 18 Years - 79 YearsAllOswaldo Cruz Foundation
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In plain words

What the trial is, and whether it could suit you

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 ac

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Study I and Sub-Study Inclusion Criteria: \- Age between 18-79 years-old Exclusion Criteria: * 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 Inclusion Criteria: * Age between 18 and 79 years old. * Presence of active/chronic hepatitis C, defined by a positive HCVab test and detectable HCV-RNA Exclusion Criteria: * 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)
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What it tests

  • Specialist - Epclusa 400Mg-100Mg Tablet
  • Non- specialist - Epclusa 400Mg-100Mg Tablet
  • HCV Self-Testing kit (Ora-Quick HCV ST or Wond-Foo HCV ST)
  • HCV Rapid Testing kit
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Where

2 sites
Hugo Perazzo
Rio de Janeiro, Brazil
Evandro Chagas National Institute of Infectious Diseases
Rio de Janeiro, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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