Hepatitis C Treatment Study in Myanmar

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03158857
• Other study ID #: OXTREC 3-17
• Status: Withdrawn
• Start date: January 2022
• Est. completion date: January 2024

Study information

• Verified date: February 2020
• Source: Myanmar Oxford Clinical Research Unit
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• Sofosbuvir 400 mg
These drugs are being offered as part of routine care

Locations

Country	Name	City	State
Myanmar	Medical Action Myanmar	Yangon

Sponsors (3)

Lead Sponsor	Collaborator
Myanmar Oxford Clinical Research Unit	Medical Action Myanmar, Myanmar Liver Foundation

Country where clinical trial is conducted

Myanmar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maximum plasma concentration	C max	2 years
Other	Area under the curve	AUC	2 years
Other	Elimination half-life	t1/2	2 years
Primary	SVR12	Sustained Virological Response 12 weeks after completion of therapy	12 weeks
Secondary	AEs	Frequency of adverse events	12-24 weeks