Clinical trial NCT03158857: Hepatitis C Treatment Study in Myanmar
Official title: 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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hepatitis C
Keywords: Myanmar
HIV
Lead sponsor: Myanmar Oxford Clinical Research Unit
Sponsor class: OTHER
Collaborators: name: Myanmar Liver Foundation
name: Medical Action Myanmar
First posted: 2017-05-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients with hepatitis C attending the clinics of Medical Action Myanmar and the Myanmar Liver Foundation

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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)

Primary outcomes:
measure: SVR12
timeFrame: 12 weeks
Secondary outcomes:
measure: AEs
timeFrame: 12-24 weeks
Other outcomes:
measure: Maximum plasma concentration
timeFrame: 2 years
measure: Area under the curve
timeFrame: 2 years
measure: Elimination half-life
timeFrame: 2 years
Locations:
city: Yangon
country: Myanmar
facility: Medical Action Myanmar
Study officials:
affiliation: Medical Action Myanmar; MOCRU
name: Ni Ni Tun, MB BS
role: PRINCIPAL_INVESTIGATOR
affiliation: Myanmar Liver Foundation
name: Khin Pyone Kyi, MB BS
role: PRINCIPAL_INVESTIGATOR
References: