An observational study in Hepatitis C, sponsored by Myanmar Oxford Clinical Research Unit. Withdrawn at 1 site in Myanmar. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-17.
Sponsored by Myanmar Oxford Clinical Research Unit · Observational
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.
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
Outpatients with hepatitis C attending the clinics of Medical Action Myanmar and the Myanmar Liver Foundation
Additional inclusion criteria for PK sub-study
Exclusion Criteria
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.
Drug: Sofosbuvir 400 mg
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.
Drug: Sofosbuvir 400 mg
These drugs are being offered as part of routine care
Also known as: Daclatasvir 60 mg
SVR12
Sustained Virological Response 12 weeks after completion of therapy
Time frame: 12 weeks
AEs
Frequency of adverse events
Time frame: 12-24 weeks
Maximum plasma concentration
C max
Time frame: 2 years
Area under the curve
AUC
Time frame: 2 years
Elimination half-life
t1/2
Time frame: 2 years
Plan to share: Undecided
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This study is withdrawn, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Myanmar Oxford Clinical Research Unit