Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06306300
Status:
RECRUITING
Last Update Posted:
2024-03-25
First Post:
2024-02-26
Brief Title:
Safety and Efficacy of Decentralized HCV Treatment vs Standard-of-Care in Rio de Janeiro Brazil
Sponsor:
Oswaldo Cruz Foundation
Organization:
Oswaldo Cruz Foundation
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HCVPCL0520
Brief Summary:
Up to 650000 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 unclearThis 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
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
Detailed Description:
In Brazil liver cirrhosis was the cause of death for over 265000 people between 2000 and 2012 The mortality rate from cirrhosis in 2012 was 12 deaths per 100000 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 andor 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 stageliver 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 organs fibrosis degree through liver stiffness measurement LSM Currently portablesemi-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 andor those with difficult access to healthcare The hepatitis C treatment cascade can be improved especially with recent advances in techniques for diagnosingconfirming 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 fibrosisliver 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 complicationsliver 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
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 andor 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 stageliver 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 organs fibrosis degree through liver stiffness measurement LSM Currently portablesemi-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 andor those with difficult access to healthcare The hepatitis C treatment cascade can be improved especially with recent advances in techniques for diagnosingconfirming 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 fibrosisliver 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 complicationsliver 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None