Hepatitis C Treatment Study in Myanmar
Hepatitis C Treatment Study in Myanmar
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
Inclusion Criteria:

 1. Age > 18- years, male or female

 2. Willing and able to comply with program assessment, including routine tests,
 attendance for follow up and compliance with medicine taking.

 3. Able to provide written agreement (or witnessed in the case of patients who cannot
 read and write)

 4. 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

 1. HIV well-controlled on current therapy (co-infected patients only)

 2. 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

 1. Current pregnancy (pregnancy test to be performed in women of child-bearing age)

 2. Previous HCV therapy.

 3. HCV PCR negative

 4. Patients with significant renal impairment with Cr Cl < 50 ml/min.

 5. Known hypersensitivity to any part of the drug regime.

 6. Presence of significant comorbidity with life expectancy of less than 12 months.

 7. 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].

 8. 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

 9. Concomitant medications that cause unacceptable drug-drug interactions. Additional
 exclusion criteria for PK sub-study

 1. Anaemia (Hb <100 mg/L)