Localized on -Site Testing and Treatment of Hepatitis C in Homeless Persons in South London: a Pilot Non-randomised Phase 4 Interventional Clinical Trial of Grazoprevir and Elbasvir ± Ribavirin in Participants With Genotype 1a, 1b or 4 to Measure Efficacy and Adherence to Treatment in a Homeless Population
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- SVR
研究概览
简要总结
The study is looking at the potential of utilizing a "point of care" test and treat pathway; using the DDA called Zepatier for achieving SVR in an homeless population who have tested positive for genotype 1 or 4 HCV.
详细描述
Direct acting antivirals (DAA) are new medications that have been approved for the management of HCV. These drugs have proven to be very effective in curing the HCV, without the need for interferon injections; which have always been used in the past. There are many combinations of DAAs, which treat specific types of HCV. Persons who test positive for the virus are typically referred to be seen and treated by a specialist hepatitis service based in hospital. This means that individuals may sometimes not attend the hospital to commence treatment; or follow up on their management.
The study is designed to explore if testing and treating individuals close to their own "local" setting will be an improvement to the current treatment pathway and encourage better involvement with the health care team; as well as looking at what the health care team can do to ensure participants in this test-and-treat trial receive the entire course of drug treatment prescribed to treat their HCV infection.
Participants infected with either genotype 1 or 4 HCV infection will be treated with Zepatier, a DAA which works by stopping the hepatitis C virus from (multiplying). The study medication is taken for 12 or 16 weeks depending on the genotype (or strain of HCV). Some participants will be given an additional drug called ribavirin. The study will examine the effectiveness of Zepatier at clearing the hepatitis C virus from the blood and body; and also what particular effects may be experienced by participants who may also be taking treatment for other conditions. Participants affected with other genotypes (not 1 and 4)will be offered standard NHS treatment with the appropriate antiviral combination for these strains.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants 18 years or older with chronic hepatitis C genotype 1 or 4 will be eligible.
- •Able and wiling to provide written informed consent.
- •Both interferon treatment naïve and experienced participants will be included.
- •Participants without cirrhosis will be eligible if HCV RNA positive, documented chronic hepatitis C and a FibroScan of ≤ 12.
- •Participants with cirrhosis (Fibroscan > 12.5 or APRI > 2) will be eligible if the serum albumin is > 3.5 g/dl, platelets > 100,000 and INR < 1.5 and there is no prior history of hepatic decompensation.
- •Participants with well controlled HIV coinfection will be included, but should be stabilized on antiretrovirals for which no clinically significant interaction is expected.
- •Participants who are HBsAg positive will be included, but will require antiviral prophylaxis for HepB. Anti- HbC positive participants will be included. Prophylaxis will not be given, but these participants will require careful monitoring of their ALT levels.
排除标准
- •Persons with prior HCV DAA treatment
- •Individuals younger than 18 years of age
- •Individuals infected with genotypes other than 1a or 1b or 4 HCV identified on screening; however such participants identified on screening will be offered appropriate NHS England standard of treatment for the genotype.
- •Unable or unwilling to give informed consent
- •Active tuberculosis
- •Females who are pregnant, planning pregnancy or breastfeeding
- •Concurrent and/or recent involvement in other research that is likely to interfere with the intervention within three months of study enrolment
- •Clinically-significant medical or psychiatric illness (other than chronic HCV) in the past, present, or being evaluated, that may interfere with participant treatment, safety, assessment or compliance with the protocol
- •Participants with cirrhosis (Fibroscan > 12.5 or APRI > 2) and serum albumin is < 3.5 g/dl, platelets <100,000 and INR > 1.5 or a prior history of hepatic decompensation
- •Severe renal impairment with eGFR <30 mL/min/1.73m2 or requiring dialysis
研究组 & 干预措施
Single arm
A phase 4, open label, non-randomised study, conducted in hostels and homeless shelters in London; as well as mobile clinics in collaboration with the Hep C trust and the NHS Find and Treat program.
Treatment: 12 or 16 weeks of Zepatier, based on genotypes; with Ribavarin for certain subtypes. The study drug is administered as a single tablet; which is a combination of 100 mg of grazoprevir and 50 mg of elbasvir; as outlined below:
Genotypes 1a/b and 4: once daily dose for 12 weeks, taken with / without food. Genotype 1a and 4: (HCV RNA> 800,000 iu/ml or baseline NS5A resistance): once daily dose for 16 weeks, taken with / without food.
NO dose modifications with the study drug.
干预措施: ZEPATIER 50Mg-100Mg Tablet (Drug)
结局指标
主要结局
SVR
时间窗: 24 months
The percentage of participants achieving an SVR, defined as an HCV RNA evel less than the lower limit of quantification by sensitive PCR; by means of a short directed test and treat program in the homeless community.
次要结局
- prevalence of HCV infection(24 months)
- Baseline knowledge evaluation(24 months)
- Change From Baseline (BL) to SVR12 timepoint in 36-Item Short-Form Health Survey (SF-36) Scores(baseline, SVR 12 (twelve weeks post end of active treatment/ last dose of study drug))
- Change From Baseline (BL) to SVR 12 in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV)(baseline , SVR 12 (twelve weeks post end of active treatment/last dose of study drug))
- Percentage of Participants Who Were Compliant With Treatment According To Moriskey, Green And Levine Adherence Scale (MAS4)(Subset Analysis)(12 or 16 weeks)
- Percentage of Participants Who Were Compliant With Treatment According To Medication Count (Subset Analysis)(12 or 16 weeks)