Treating Hepatitis C in Pakistan. Strategies to Avoid Resistance to Antiviral Drugs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25,000
- 试验地点
- 1
- 主要终点
- SVR
研究概览
简要总结
We will determine how best to manage the hepatitis C virus (HCV) epidemic in Pakistan by measuring effectiveness of Pakistan-government sponsored current therapies, emergence of viral resistance, consequences of infection (chiefly liver cancer) and through developing models, based on incidence data, determine the proportion of people who need curative treatment to eliminate HCV, and assess whether targeting can optimise this.
详细描述
Chronic infection with the hepatitis C virus (HCV) causes liver damage and, in many, liver cancer. We have effective drugs allowing us to cure most infected people and this stops the liver becoming damaged. Hepatitis C is common in Pakistan and the government is planning a massive national program to find and treat everyone who is infected. The government funded treatment program will fund therapy and assumes that the drugs will cure the vast majority of infected people and hence, in line with international recommendations they are not planning to evaluate treatment outcomes. The efficacy of the drugs used in Pakistan (sofosbuvir plus daclatasvir) have not been widely assessed in the Pakistani population and their efficacy is not yet proven. We therefore do not yet know how effective the drugs that will be used in Pakistan will be and we will study this by testing people after treatment to determine treatment effectiveness. This approach has been welcomed by the Pakistani government who recognise the importance of the data that we will generate from this observational study.
We will additionally look at the impact of hepatitis C on an individual's quality of life and how much they spend on healthcare by using questionnaires administered by the trial team.
We will look at viral factors influencing treatment failure by studying viral resistance by sequencing the virus from people who do and do not respond to treatment.
To determine whether or not re-infection is a significant problem in Pakistan we will look at people who have been cured of hepatitis C and retest them one year later. We will also retest people who initially tested negative to determine the annual infection rates in previously uninfected people. To determine risk factors for infection reinfected people and some of the non-reinfected cohort will be asked to complete a questionnaire on risk factors for infection.
One of the major effects of hepatitis C is induction of liver cancer. We will look at people who did and did not develop liver cancer following hepatitis C infection and we will compare viral sequences to see if there are viral variants that predispose to liver cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults over 18yrs old
- •Willing to undergo hepatitis C testing
- •Able and willing to give informed consent
- •Willing to return in 12 months time for repeat testing
- •Resident in area and not planning to leave the region
排除标准
- •Unwilling to give consent
- •Unwilling or unable to undergo the necessary procedures
- •Clinically significant illness (other than HCV) or other major medical condition that may interfere with the subject's treatment, assessment or compliance with protocol.
- •Co-morbidities limiting life expectancy to less than 12 months
结局指标
主要结局
SVR
时间窗: 12 weeks after treatment completion
After first-line treatment, SVR will be measured to record treatment failure or success
Incidence of new infections
时间窗: 12 months after screening
Measure HCV antibodies in people who initially tested HCV antibody negative at screening.
Incidence of re-infection
时间窗: 12 months after first SVR test.
In patients who achieved an SVR after first-line treatment will then be tested for HCV core antigen over 12 months.
次要结局
- Health related Quality of Life(Screening stage)
- Health care costs and productivity assessment associated with HCV infection(screening stage)
- Risk assessment(12 months)
- Viral polymorphisms in HCV(2 years)
- Viral polymorphisms in HCV associated with hepatocellular carcinoma(4 years)
研究者
Naheed Choudhry
Senior Project Manager
Queen Mary University of London