Active clinical trials for "Hepatitis C"

Molbio Diagnostics Ltd. (India) has developed the Truelab™ Real Time quantitative PCR system that is widely used in India for diagnostics of tuberculosis (TB). The system consists of two portable machines and two microfluidic cartridges and can be used in point-of-care settings. The manufacturer has recently developed a new assay that detects HCV RNA, the Truenat™ HCV RNA assay. It is a simple two-step assay for RNA extraction and amplification with a total turnaround time of 60 min, using whole blood, plasma and serum as sample types. Most importantly, the assay can be performed from a drop of capillary blood eliminating the need for venous access and blood draw and increasing its usability in the settings where phlebotomy service are not available. To date, validation of the assay was performed using archived plasma specimens and contrived whole blood specimens. FIND aims to conduct a multicentre evaluation to assess the assay's sensitivity, specificity and quantitative accuracy in freshly collected whole blood, plasma and serum specimens from target populations. The evaluation aims to gather performance data in line with the requirements set forth in the Common Technical Specifications 2009/886/EC (CTS) of the CE In Vitro Diagnostics Medical Devices Directive 98/79/CE (CE-IVDD), as well as the World Health Organization (WHO) Technical Specification Series 10 (draft) (TSS-10) for In vitro diagnostic (IVDs) medical devices used for the qualitative and quantitative detection of HCV RNA.

Hepatitis C (HCV) is a chronic infection with significant morbidity and mortality. The development of directly acting antivirals (DAA) has dramatically improved the cure rate of HCV treatment. People who experience incarceration are disproportionately infected and often involved in ongoing transmission of disease. However, despite availability of effective treatment, people who experience incarceration are often unable to access this curative therapy, and are often not readily engaged in medical care upon release. This perpetuates transmission and progression of disease in an incredibly high risk, marginalized population. Therefore, in order to effectively eliminate HCV, it is imperative that the epidemic of HCV in prisons is addressed, and that models of care are established for treatment of HCV in incarcerated individuals, both during and after incarceration. As such, the investigators propose a comprehensive model of care to engage incarcerated individuals in treatment of HCV upon release from prison. This care is provided in conjunction with collocated services to prevent HCV reinfection, including opioid agonist therapy. This pilot trial will demonstrate whether a comprehensive model of care can effectively cure HCV in recently incarcerated individuals, while simultaneously treating opioid use disorder and preventing HCV reinfection.

The purpose of this study is to determine the most effective way to give patients information regarding hepatitis C virus infection. The investigators plan to compare the information retained by some patients who are given a brochure alone versus patients who watch an interactive video about hepatitis C.

Background: The global response to the HCV infection epidemic has been transformed by the availability of low-cost curative short course direct acting antiviral (DAA) therapy. Egypt has one of the highest burdens of HCV infection worldwide, and a large treatment programme, but reaching rural communities represents a major challenge. We report the feasibility and effectiveness of a comprehensive community-based HCV prevention, testing and treatment model in 73 villages across Egypt, with the goal to eliminate infection from all adult villagers. Methods: An HCV "educate, test and treat" programme was implemented in 73 villages across 7 governorates in Egypt between 06/2015 and 06/2018. The programme model comprised community mobilization facilitated by a network of village promoters to support the education, test and treat campaign as well as fund raising in the local community; a comprehensive testing, linkage to care and treatment of all eligible villagers aged 12 to 80 years using HCV antibody and HBsAg rapid diagnostic tests (RDTs), HCV RNA confirmation of positive cases, staging of liver disease using transient elastography (FibroScan), treatment with 12 or 24 weeks of a direct acting antiviral (DAA) regimen according to national standard of HCV care, and an assessment of cure at 12 weeks after completion of treatment (SVR12); and an education campaign to raise awareness and disseminate messages about safer practices to reduce transmission through public events, promotional materials and house-to-house visits. Key outcomes assessed in each village were: uptake of serological HCV and HBV testing, linkage to assessment and HCV viral load confirmation, uptake of treatment, and SVR12.

The purpose of the study is to determine if combination therapy with daclatasvir (DCV) and sofosbuvir (SOF) for 8 weeks is safe and effective in patients who have never been treated previously without liver cirrhosis who are chronically infected with hepatitis C virus (HCV)/HIV-1 Coinfection genotype (GT) 1, 2, 3, 4 patients.

ANRS HC 33 is a pilot study to assess efficacy and safety of a DCV 3DAA therapy with Asunaprevir, Daclatasvir and BMS-791325 in HCV genotype 4-infected patients after failure of pegylated Interferon-Ribavirin regimen. Proportion of patients with cirrhosis will be limited to 50% of all patients included, cirrhosis being defined as a METAVIR score of F4 on the liver biopsy or an hepatic impulse elastometry ≥ 14 kPa or a Fibrotest® result > 0,75.

The purpose of this study is to evaluate the percentage of participants with sustained virologic response 12 weeks after the actual end of study treatment (SVR12)

Counseling intervention: Primary objective: to evaluate and compare, in at-risk populations, the efficacy of three different counseling methods in terms of propensity to come back for a HIV re-test. Secondary objectives: to evaluate and compare the efficacy of the counseling methods in terms of reported risk behavior and HIV knowledge as well as their acceptability and cost-effectiveness; describe the distribution of duration from HIV primary infection to detection; and estimate the prevalence of chronic hepatitis B and C, and syphilis in HIV-uninfected participants of targeted populations. Reminder intervention Primary objective: to evaluate and compare, in at-risk individuals who require frequent testing, the efficacy of reminders in terms of propensity to come back for a HIV re-test within 7 months. Secondary objective: to assess the cost-effectiveness of reminders. The interim analyses have shown that that some strategies are better than the others and the Advisory Committee recommended to use only the most efficient strategies (Computer assisted counseling and Scheduling an appointment and sending reminder to clients). In addition, CD4 cell count normal ranges in 30 HIV uninfected individuals in Thailand will be assessed. Transient elastometry (FibroScan) will be used to assess liver fibrosis in participants with and without viral hepatitis.

The purpose of this study is to test the safety and efficacy of Civacir® to prevent the recurrence of Hepatitis C Virus (HCV) after liver transplant.

HYPOTHESIS: The investigators hypothesize that sonoelastography (SE) will provide accurate quantitative measurements that can be used to stage liver fibrosis in patients with chronic liver disease. To measure liver stiffness with sonoelastography in adults with suspect diffuse liver disease who will undergo non-focal liver biopsy as part of their routine clinical care To assess the sensitivity and specificity of sonoelastography for the detection and staging of liver fibrosis To evaluate the effect of steatosis and inflammation on the estimation of liver fibrosis using sonoelastography