Decentralized treatment for hepatitis C in 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
PHASE4 · Oswaldo Cruz Foundation · NCT06306300
This study is testing a new way to treat hepatitis C in Brazil using a medication called Epclusa to see if it helps more people get the care they need compared to traditional methods.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30000 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | Oswaldo Cruz Foundation (other) |
| Locations | 2 sites (Rio de Janeiro, Rio De Janeiro/RJ and 1 other locations) |
| Trial ID | NCT06306300 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-79 with active or chronic hepatitis C.
Not a fit: Patients with acute illnesses, severe liver disease, or co-infections such as HIV or HBV may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly increase the rates of hepatitis C cure among patients in Brazil.
How similar studies have performed: Other studies have shown high cure rates with direct-acting antivirals, indicating potential success for this decentralized approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Rio de Janeiro, Rio De Janeiro/RJ and 1 other locations
- Evandro Chagas National Institute of Infectious Diseases — Rio de Janeiro, Rio De Janeiro/RJ, Brazil (RECRUITING)
- Hugo Perazzo — Rio De Janeiro, Brazil (RECRUITING)
Study contacts
- Study coordinator: Hugo Perazzo, PhD
- Email: hugo.perazzo@ini.fiocruz.br
- Phone: +552138659587
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hepatitis C, Hepatitis C virus, Primary health care, Hepatitis C virus self-test