A Clinical and Pharmacokinetic Study of the Effectiveness of Hepatitis C Treatment (Sofosbuvir+Daclatasvir) in HIV Co-infected and Non HIV Co-infected Patients at the Level of Non-hospital Based Management in Myanmar
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- SVR12
研究概览
简要总结
Hepatitis C is an important health problem in Myanmar affecting around 3% of the population. New drugs have been developed which have transformed the treatment of this disease around the world with very high success rates. Two of these drugs are now registered for use in Myanmar. In this study 200 patients with chronic hepatitis C(100 with HIV co-infection) will be assessed and started on the new treatment. We will observe them and measure treatment effectiveness and tolerability. In 24 patients extra blood samples will be taken for drug measurements to describe the effect of the drugs on patients in Myanmar in more detail.
详细描述
Data concerning Hepatitis C virus (HCV) prevalence in Myanmar is scarce. Preliminary results of a survey, conducted in 2015 in different areas in Myanmar estimated a seroprevalence of HCV of around 2.65 %, which represents 1.3 million infected patients. Genotype 6 was mostly found in the northern cities and genotype 3 in the southern and western cities of Myanmar. However, treatment options for HCV in Myanmar remain limited currently, including for patients with HIV co-infection who are generally considered high priority given their increased risk for liver disease.
New direct acting antiviral therapies which can achieve high rates of sustained virological response (SVR) (>90%), defined as complete suppression of the virus 12 weeks after completion of antiviral therapy, are becoming increasingly available worldwide.
In Myanmar, in mid-2015, the guideline for the treatment of chronic hepatitis C infection of the Myanmar GI and Liver Society was revised in line with the recent development of Directly Acting Antiviral (DAA) drugs. This observational study will follow the recommendations for patient care presented in this guideline. Two hundred patients with chronic hepatitis C (100 with HIV co-infection) will be recruited in this observational study of routine care with two newly available antiviral drugs (sofosbuvir+ daclatasvir) in two different groups of patients (with and without HIV coinfection) at two centres in Yangon, Myanmar. Their response to treatment will be monitored. In addition a pharmacokinetic study is planned in a subset of patients to characterise any determinants of treatment response or tolerability in patients in Myanmar. This study will be conducted in compliance with the protocol, GCP and the applicable regulatory requirements
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age > 18- years, male or female
- •Willing and able to comply with program assessment, including routine tests, attendance for follow up and compliance with medicine taking.
- •Able to provide written agreement (or witnessed in the case of patients who cannot read and write)
- •Have a diagnosis of hepatitis C (based on a hepatitis C point-of-care test and then confirmed by PCR) with or without HIV
- •Additional inclusion criteria for PK sub-study
- •HIV well-controlled on current therapy (co-infected patients only)
- •Willing and able to comply with the additional blood sampling in the PK-PD sub-study protocol for the duration of the study
- •Exclusion Criteria
- •Current pregnancy (pregnancy test to be performed in women of child-bearing age)
- •Previous HCV therapy.
- •HCV PCR negative
- •Patients with significant renal impairment with Cr Cl < 50 ml/min.
- •Known hypersensitivity to any part of the drug regime.
- •Presence of significant comorbidity with life expectancy of less than 12 months.
- •Clinical evidence of decompensated cirrhosis with current or previous episode of ascites, variceal bleed, encephalopathy, and treated hepatocellular cancer (HCC) [Child-Pugh score B or C].
- •Presence of concomitant medical or social situation that would make it difficult for the patient to comply with program protocol or put the patient at additional risk
- •Concomitant medications that cause unacceptable drug-drug interactions. Additional exclusion criteria for PK sub-study
- •Anaemia (Hb <100 mg/L)
排除标准
- 未提供
研究组 & 干预措施
Hepatitis C monoinfection
Sofosbuvir 400 mg tablet once a day + Daclatasvir 60mg tablet once a day
Patients with evidence of cirrhosis will be offered treatment for 24 weeks, those who are not cirrhotic will be offered 12 weeks of treatment.
干预措施: Sofosbuvir 400 mg (Drug)
Hepatitis C and HIV co-infection
Sofosbuvir tablet 400 mg once a day + Daclatasvir tablet 90 mg once a day (increased dose in patients receiving efavirenz. Patients on an alternative HIV drug regimen will receive standard dose i.e. 60 mg)
Patients with evidence of cirrhosis will be offered treatment for 24 weeks, those who are not cirrhotic will be offered 12 weeks of treatment.
干预措施: Sofosbuvir 400 mg (Drug)
结局指标
主要结局
SVR12
时间窗: 12 weeks
Sustained Virological Response 12 weeks after completion of therapy
次要结局
- AEs(12-24 weeks)