Direct Observed Therapy With Ledipasvir/Sofosbuvir in Treatment-naïve Patients With Chronic Genotype 1 HCV (Hepatitis C Virus) Infection Receiving Opiate Substitution Therapy
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percentage of pills taken during the treatment phase will be calculated as a parameter for adherence to therapy for each individual subject.
研究概览
简要总结
Patients with chronic hepatitis C that are under opiate substitution therapy are likely to have psychiatric comorbidities such as depression; hence an Interferon based therapy is contraindicated. Additionally many of these patients have a borderline compliance, which makes it impossible to treat them at specialized hepatological centers. An ideal opportunity to treat this patients is treatment with DAAs (Direct Acting Antiviral) which can be administered daily together with the opiate substitution therapy at a low threshold facility.
详细描述
Background:
Patients with active or previous i.v.-drug abuse and patients receiving opiate substitution therapy (OST) represent a major subgroup of the patients with chronic hepatitis C (CHC). Till some years ago it was held, that patients with a history of i.v.-drug abuse and patients receiving OST should not be considered for interferon-based antiviral treatment because of their poor compliance. However, during the past years it became clear, that patients on OST who are considered to be stable by their physicians are good candidates for antiviral therapy. Several studies have shown that SVR (sustained virological response rates) achieved in these patients are similar to results in patients without a history of i.v. drug abuse.
Subgroups of patients receiving OST:Patients receiving OST represent a very heterogeneous population. However, based on empirical observation of the behavior/compliance of each individual patient they can be assigned to one of the following three groups:
Group 1: Patients with very good compliance. These patients do not take drugs anymore and demonstrate a very good compliance. If anti HCV therapy is indicated, these patients can be referred to and treated at a hepatologic Center (i.e. hospital). Such patients have been included in various phase III trials of new direct acting antiviral agents (DAAs).
Group 2: Patients with a very poor compliance. These patients do not keep appointments (regardless whether it is at a low threshold facility or at a hospital). Due to their lack of compliance antiviral therapy of these patients is not feasible.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic genotype 1 HCV infection
- •Fibrosis F0-F3 (i.e. non-cirrhotic confirmed by Fibroscan <12.5kPa)
- •Stable opiate substitution therapy
- •Regular visits at the low threshold facility during the last month
排除标准
- •Lack or unwillingness of safe contraception, pregnancy
- •Liver cirrhosis (Fibroscan ≥12.5kPa)
- •Coinfection with HBV (Hepatitis B Virus) or HIV (coinfection with HIV is excluded only because there are very few coinfected patients under care at the "Ambulatorium Suchthilfe Wien" and hence this subpopulation would be very small)
- •Severe comorbidities resulting in a life expectancy of less than five years
- •HCC (Hepatocellular carcinoma)
研究组 & 干预措施
Sofosbuvir 400mg/Ledipasvir 90 mg
Subjects will receive sofosbuvir 400mg q.d p.o and ledipasvir 90 mg q.d p.o (FDC) for 8 weeks
干预措施: Sofosbuvir 400mg / Ledipasvir 90 mg (FDC) (Drug)
结局指标
主要结局
Percentage of pills taken during the treatment phase will be calculated as a parameter for adherence to therapy for each individual subject.
时间窗: 8 Weeks
Study drugs will administered daily together with the opiate substitution therapy under the supervision of qualified site personnel and recorded on a worksheet for each subject. At the end of the treatment phase, the total number of DAA pills taken will be assessed as percentage for each subject and for the whole study population.
次要结局
- Sustained Virologic Response (SVR) 12 Weeks after End of Therapy (SVR 12)(12 Weeks after end of Therapy)
- Sustained Virologic Response (SVR) 24 Weeks after End of Therapy (SVR 24)(24 Weeks after end of Therapy)
- Safety and tolerability (total number of observed adverse events)(20 weeks)
研究者
Michael Gschwantler
Prof.Dr
Wilhelminenspital Vienna