Decentralized treatment for hepatitis C in Brazil

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of decentralized treatment for hepatitis C using direct-acting antivirals compared to standard-of-care approaches in Rio de Janeiro, Brazil. It aims to address the barriers to diagnosis and treatment access for the estimated 650,000 individuals living with chronic hepatitis C in the country. The study will involve administering the antiviral medication Epclusa to participants aged 18-79 who have a confirmed hepatitis C infection. By leveraging rapid testing and non-invasive methods for liver assessment, the study seeks to improve the continuum of care for hepatitis C patients in Brazil.

Why it matters

Who can join: the full rules

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)

Where it's running

• Hugo Perazzo
  Rio de Janeiro, Rio de Janeiro, Brazil Recruiting
• Evandro Chagas National Institute of Infectious Diseases
  Rio de Janeiro, Rio de Janeiro/RJ, Brazil Recruiting

Study contacts

• Study coordinator: Hugo Perazzo, PhD
• Email: hugo.perazzo@ini.fiocruz.br
• Phone: +552138659587

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.