A Phase 4 interventional study of Specialist - Epclusa 400Mg-100Mg Tablet and Non- specialist - Epclusa 400Mg-100Mg Tablet in Hepatitis C, sponsored by Oswaldo Cruz Foundation. Recruiting at 2 sites in Brazil. Open to participants aged 18 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Oswaldo Cruz Foundation · Phase 4, Interventional, and Health services research
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.
In Brazil, liver cirrhosis was the cause of death for over 265,000 people between 2000 and 2012. The mortality rate from cirrhosis in 2012 was 12 deaths per 100,000 inhabitants, and the number of deaths from liver cirrhosis increased by about 22% in the last decade.
Recently, hepatitis C treatment has been revolutionized by the use of direct-acting antivirals (DAAs), which are safe and highly effective oral medications. Cure rates for hepatitis C, known as sustained virological response (SVR), in studies conducted in Brazil and Latin America were higher than 90%. Hepatitis C cure (SVR) is associated with a reduction in the incidence of HCC, the need for liver transplantation, improvement in quality of life, and a decrease in HCV transmission. These new medications have been available for hepatitis C treatment through the Brazilian Public Health System, known as Sistema Único de Saúde (SUS) since 2015.
The Ministry of Health of Brazil signed an agreement with the WHO in 2016 and with the goal of defining public health strategies to eliminate viral hepatitis by 2030, reducing new infections by 90% and global hepatitis-related mortality by 65%.
Identifying individuals with HCV infection is crucial for the (micro) elimination of hepatitis C. The majority of chronically infected HCV patients are asymptomatic until the development of liver cirrhosis and/or its complications. Therefore, screening for HCV infection should be performed in individuals, even when asymptomatic, through HCV antibody (HCVab) test. Currently, HCV rapid tests (HCVRT) in fingerstick blood with results in 15-20 minutes are available in Brazil.
Historically, HCV screening was recommended for individuals over 40 years of age and high-risk populations for HCV infection, such as people who inject drugs (PWID), prisoners, and men who have sex with men (MSM). However, recent international guidelines recommend screening for all individuals aged 18-79. Active HCV infection should be confirmed by detecting HCV viral load using molecular tests by polymerase chain reaction (PCR). Currently, the identification of HCV-RNA by PCR as a point-of-care tests (PoCT), GeneXpert® System, is also possible. The Xpert HCV VL Fingerstick test has excellent accuracy for detecting HCV-RNA in fingerstick blood, providing results in up to 105 minutes.. Liver elastography is a rapid imaging method (\< 5 minutes), similar to abdominal ultrasound, painless, and free of complications, that can be performed at the bedside and provides real-time results for fibrosis stage/liver cirrhosis diagnosis. The technical principle of this method is based on measuring the propagation of ultrasound waves, called shear waves, through the liver parenchyma, estimating the organ's fibrosis degree through liver stiffness measurement (LSM). Currently, portable/semi-portable hepatic elastography devices are available, allowing for the staging of liver fibrosis in regions with difficult access to healthcare.
Globally, the HCV continuum of care is still deficient, as only about 10% of identified hepatitis C patients achieve SVR. Brazil also observes a similar scenario of deficiencies in the HCV cascade of care. People living with HCV are typically treated in tertiary centers by specialists (infectious disease specialists, hepatologists, gastroenterologists). Multiple pre-treatment visits (diagnostic confirmation, biological analyses, and staging of liver fibrosis) are required, along with visits during treatment (clinical visits and biological analyses) and after medication use (evaluation of hepatitis C cure). This process can be even more complicated in certain stigmatized, highly vulnerable populations, and/or those with difficult access to healthcare. The hepatitis C treatment cascade can be improved, especially with recent advances in techniques for diagnosing/confirming HCV infection and the availability of pan-genotypic and simple therapeutic regimens (one tablet orally per day for 12 weeks, "one-size-fits-all"), extremely safe and highly effective (even in patients with advanced fibrosis/liver cirrhosis). The simplification of hepatitis C treatment leads to higher detection and treatment rates (increased access to treatment), rapid initiation of treatment post-diagnosis (rapid linkage-to-care), reduced HCV transmission (treatment as a prevention tool), and cost reduction associated with cirrhosis complications/liver transplantation. Additionally, international studies have described that the response rates to hepatitis C treatment by non-specialists in the Primary Health Care System with DAAs seems to be similar to those treated by specialists. However, the best strategy for managing hepatitis C within the Brazilian-SUS is not yet widely defined.
1,743 studies on the registry are indexed under Hepatitis C; 97 are open to participants now.
This study's planned enrollment of 30,000 is above the median of 72 across 1,223 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →Oswaldo Cruz Foundation is the lead sponsor of 42 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Study I and Sub-Study
Inclusion Criteria:
- Age between 18-79 years-old
Exclusion Criteria:
Study II
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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).
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
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
People randomized for this arm will receive an HCV self-testing kit (oral fluid or blood-based) for HCV testing
Diagnostic Test: HCV Self-Testing kit (Ora-Quick HCV ST or Wond-Foo HCV ST)
People randomized for this arm will receive a prescription for HCV testing
Diagnostic Test: HCV Rapid Testing kit
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
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
HCV Self-Testing kit (oral fluid or blood-based) for HCV testing
Standard-of-care: HCV Rapid Test
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.
Time frame: 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
Time frame: 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.
Time frame: 1 month
Proportion between positive and negative
Proportion of individuals with positive HCV anti-body (HCVab) test and undetectable HCV-RNA (spontaneous HCV clearance or false negative HCV ab test)
Time frame: 1 month
Participants with fibrosis/cirrhosis
Prevalence of advanced liver fibrosis/cirrhosis (hepatic elastography ≥ 9.5 kPa) in people with chronic hepatitis C (reactive HCVab test \& detectable HCV-RNA).
Time frame: 1 month
Participants who denied the treatment
Proportion of patients who refuse treatment for chronic hepatitis C.
Time frame: 1 month
cost per detected participant
Cost per case detected with HCV infection
Time frame: 1 month
Unscheduled visits during treatment
Rate of unplanned clinical visits during HCV treatment (from Day 0 to Week 12)
Time frame: 3 months
Improvement of liver fibrosis stage
Change in liver fibrosis stage, measured by hepatic elastography between the entry study assessment (Day 0) and the end-of-study assessment (Week 36 ± 12) among participants with SVR.
Time frame: 1 year
Quality of life data
Quality of life (health-related utility) before and after HCV cure (SVR).
Time frame: 1 month
Cost of treatment for participant
Cost per case who achieved SVR
Time frame: 1 month
Adherence to treatment
Adherence to SOF/VEL treatment measured by attendance at scheduled visits and reported by participants
Time frame: 1 month
Participant´s Ability to use the test
Assess the ability to perform the oral fluid HCV self-test
Time frame: 1 month
Participant preference for types of tests
The participant's information will be collected in the questionnaire, which will contain data on their preference between the two types of tests HCV self-testing using oral fluid and the conventional rapid test (fingerstick blood sample performed by a healthcare professional) .
Time frame: 1 month
Participant understanding to interpret his result
By comparing the results of the tests carried out by the participant and the health professional, it will be identified whether the participant performed the correct reading.
Time frame: 1 month
Test Performance
By comparing the results of the tests carried out by the participant and the health professional, it will be identified whether the participant performed the test correctly.
Time frame: 1 month
Test Accuracy
Comparison of the results of the self-test for HCV in oral fluid (self-testing and performed by a healthcare professional) compared to the conventional rapid test, whether they have the same precision of results. .
Time frame: 1 month
Plan to share: No — There is a confidentiality of participant data.
No publications or documents are linked to this record.
Started Jul 2022 (actual). Primary completion is estimated for Dec 2026, 53 months after the start.
Of 56 non-industry phase 4 interventional studies under Hepatitis C, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 49. This study's planned 53 months is above that.
Counting every sponsor, half of 58 studies reached it within 24 months; a quarter within 16 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
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Oswaldo Cruz Foundation