View clinical trials related to Hepatitis C.
Filter by:Hepatitis C infection is a major cause of chronic liver disease and death with approximately 3% of the world's population is infected with hepatitis C virus (HCV). New drug therapies called new direct-acting antivirals (DAAs) have been developed and have proven to be well tolerated with minimal side effects. The current costs of these agents are extremely high, however, they provide an opportunity to cure most patients of HCV if they can access and adhere to treatment. The bigger challenge is to engage and cure underserved groups who are not accessing medical care, or who have other complex problems, including homelessness, incarceration, and substance misuse problems. Strategies to improve HCV case detection and case management have much to learn from other infectious diseases. Tuberculosis (TB) disproportionately affects in large part the same group of individuals and community models of care have been used with great success. Strategies such as active case finding, community based screening and treatment, directly observed therapy (DOT) and peer support have all shown high rates of case detection and treatment completion. These strategies are currently being used by the Find&Treat team, UCLH NHS Trust and this study will ain in evaluating it's effectiveness. Previously used to aid homeless patients engage with treatment services for TB, it is now being used with other disease groups such as HCV. This observational study aims to assess the effectiveness of community based interventions with peer support to improve case detection, carry out pre-treatment assessments and assist underserved populations through HCV treatment by the Find&Treat service.
Patients who are Hepatitis C Negative (HCV negative) and are on the waiting list for a lung transplant at NYULH who consent to participate in this study will receive a lung transplant from a deceased donor that is HCV positive. Patients will initiate treatment for HCV with the pan-genotypic agent, Mavyret, on the day of surgery and will complete the full 8-week treatment course. Patients will be monitored post-transplant for the development of viremia, and for the time course of clearance of viremia among those who develop viremia.
Background: Chronic hepatitis C infects the liver. It may scar the liver. This is called cirrhosis and may lead to liver cancer or death. Current chronic hepatitis C treatments cure most people. But some keep getting complications even after it is cured. Researchers want to study why. Objective: To study the course and complications of liver disease after cure of hepatitis C infection. Eligibility: Adults 18 years and older infected with chronic hepatitis C virus who were never treated or were treated and not cured and those who were cured Design: Participants will be screened with: Blood and urine tests Questionnaires Liver ultrasound Fibroscan. A probe vibrates the liver, testing stiffness. In Phase 1, people with chronic hepatitis C will: Have a 3-day hospital admission to repeat some screening tests and have a liver biopsy. A small piece of liver is removed by needle passed through the skin. Take 1 tablet containing 2 hepatitis C drugs once a day for 12 weeks. Repeat some blood tests at 3 visits in those 12 weeks while on treatment, then 4 additional visits in the next 24 weeks with more blood work collected. Phase 1 participants who test negative for hepatitis C and all other eligible participants will enter Phase 2. Phase 2 participants will have a visit every 24 weeks for 10 years. These may include: Repeats of screening tests Questionnaires Scans Stool tests Chest x-ray Heart function test Endoscopy. A tube guides a camera into the upper digestive system. At about 5 years, participants will have another liver biopsy. Some participants will give separate consent for genetic testing and a special blood procedure.
EVERYONES HCV is a retrospective review of all previous Hepatitis C (HCV) testing and diagnosis in NHS Tayside. The aim of this study is to analyse and compare the different Hepatitis C diagnostic pathways with a view to determining the most cost effective combination of methods of diagnosing HCV infection in a typical developed world population.
Epclusa® is a pan-genotypic, once-daily tablet for the treatment of chronic hepatitis C virus (HCV) infection containing the NS5B- polymerase inhibitor sofosbuvir (SOF, nucleotide analogue) 400 mg and the NS5A inhibitor velpatasvir (VEL) 100 mg. Velpatasvir has pH dependent absorption. At higher pH the solubility of velpatasvir decreases. It has been shown that in subjects treated with proton pump inhibitors (PPIs) such as omeprazole, the absorption of velpatasvir is reduced by 26-56%, depending on the dose of omeprazole, concomitant food intake, and timing/sequence of velpatasvir vs. omeprazole intake. As a result, concomitant intake of PPIs with velpatasvir is not recommended. For a number of reasons, the prohibition of PPI use with velpatasvir is a clinically relevant problem. First, PPI use is highly frequent in the HCV-infected subject population with prevalences reported up to 40%. Second, PPIs are available as over-the-counter medications and thus can be used by subjects without informing their physician. Third, although HCV therapy is generally well tolerated, gastro-intestinal symptoms such as abdominal pain and nausea are frequently reported, which my lead to PPI use. One solution of this problem could be the use of other acid-reducing agents such as H2-receptor antagonists or antacids. In general, they have a less pronounced effect on intragastric pH, and are considered less effective than PPIs by many patients and physicians. A second solution would be the choice of another HCV agent or combination that is not dependent on low gastric pH for its absorption such as daclatasvir. Daclatasvir, however, is not a pan-genotypic HCV agent and may be less effective against GT 2 and 3 infections than velpatasvir. Second, not all subjects have access to daclatasvir, depending on health insurance company or region where they live. A third solution, and the focus of this COPA study, is to add a glass of the acidic beverage cola at the time of velpatasvir administration in subjects concurrently treated with PPIs. This intervention has been shown to be effective for a number of drugs from other therapeutic classes who all have in common a reduced solubility (and thus reduced absorption) at higher intragastric pH, namely erlotinib, itraconazole, ketoconazole. The advantages of this approach are: (1) only a temporary decrease in gastric pH at the time of cola intake; the rest of the day the PPI will have its therapeutic effect (2) cola is available worldwide (3) the administration of cola can be done irrespective to the timing of PPI use.
To achieve global hepatitis C virus (HCV) elimination by 2030, 80% of the ~71 million people with chronic HCV infection will need to be treated, necessitating simplification of treatment delivery and associated laboratory monitoring without compromising efficacy or safety. The COVID-19 pandemic has further highlighted the need for innovative models of health care delivery that minimize face-to-face patient-provider contact. The purpose of this study was to evaluate the feasibility, safety, and efficacy of a minimal monitoring (MINMON) strategy to deliver interferon- and RBV-free, pan-genotypic DAA therapy to treat active HCV in HCV treatment naïve participants.
The primary purpose of the ANRS 12332 HepNile study cohort is to assess in "Real-Life" condition the efficacy and the safety profile of new Direct Acting Antivirals (DAAs) introduced in the Egyptian National Treatment Programme for the treatment of Chronic Hepatitis C (CHC).
"Health is a state of complete physical, mental and social well-being, and not merely the absence of disease or infirmity" (World Health Organization, 1948). Diseases such as HIV/AIDS and Hepatitis-C (HCV) thrive in conditions of poverty and marginalization. Research on the quality of life of people living with HIV/AIDS reveals that unemployed individuals report more depression, anxiety, social isolation, and low self-esteem than employed individuals. Moreover, unemployment is a key factor in the contemplation of suicide among people with HIV/AIDS. Alternatively, employment among people living with HIV/AIDS is a strong indicator of improved quality of life. A finding the study investigators confirmed in a research study (PROMPT) supporting 280 members of Ottawa's low income homeless (or at-risk for homelessness) People Who Use Drugs reduce (and in some cases quit) smoking. PROMPT participants repeatedly stated that boredom and a lack of meaningful social connections and employment were major hindrances in their reduction and overall recovery from smoking and drug use. With these PROMPT findings, the investigators propose a Community-Based Participatory Action project that builds the social capital of 80 participants that identify as members of Ottawa and Toronto's low income People Who Use drugs living with or are at-risk for HIV/AIDS/HCV. The proposed multi-site project will include life-skills training, counseling, health services access (testing and treatment), and education on HIV/AIDS/HCV. Most importantly the project will include a poverty reduction intervention that connects participants with education opportunities, short-term work and volunteer opportunities. The education, work and volunteer opportunities' will be made possible with the support of local business owners and networks that support the study's poverty reduction and community building elements. The aim of project will be to demonstrate the feasibility and cost of a holistic healthcare that encourages a state of complete physical, mental, and social well-being.
Open label phase 2a study of two week treatment with CDI-31244 and sofosbuvir and veltapasvir followed by four week treatment of sofosbuvir and velpatasvir in individuals with chronic hepatitis C (HCV) genotype 1 (GT1) infection
Study is a non-interventional, prospective, multicenter post marketing surveillance study to determine the safety of daclatasvir based therapy