Chronic hepatitis C virus (genotypes 1 and 6) Infections and Infestations Hepatitis C virus genotype 1 Hepatitis C virus genotype 6
Conditions
Interventions
Participants will be recruited in Ho Chi Minh City, Vietnam at the Hospital for Tropical Diseases. Potential participants will be identified and approached by clinic staff to participate in the trial.
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For all participants enrolled in Stratum A (mild disease) or Stratum B (cirrhosis): 1. Aged 18 years or older 2. At least one detectable viraemia prior to the screening visit (by quantitative HCV RNA, qualitative assay or HCV genotype), with no intervening undetectable results 3. Plasma HCV RNA >LLOQ at screening 4. BMI of 18 kg/m² or greater 5. Laboratory tests: 5.1. Creatinine clearance (estimated using Cockcroft-Gault) = 60 ml/min, 5.2. International normalised ratio (INR) 51.3 3.2. Albumin (g/l): (1) > 35 (2) 28-35 (3) 2.2 3.4. Ascites: (1) Absent (2) Slight (3) Moderate 3.5. Encephalopathy: (1) None (2) Grade 1-2 (3) Grade 3-4 * Fibroscan must be a valid result (based on at least 10 readings) performed by an experienced (as evidenced by CV and/or training logs) technician.
Exclusion criteria
Exclusion criteria: 1. Previous Hepatitis C (treatment with DAAs, and/or pegylated-interferon and/or ribavirin) 2. HIV infected 3. Solid Organ Malignancy within 5 years prior to screening 4. Any condition in the judgement of the investigator which might limit the patient’s life expectancy within the duration of the study 5. Any disorder or circumstance which in the opinion of the investigator may have a significant negative impact on the ability of the patient to adhere to the trial regimen 6. HBsAg positive 7. Disorder which may cause ongoing liver disease including, but not limited to, ongoing alcohol misuse 8. Currently receiving medication known to interact with study medications for which dose adjustment for daclatasvir or sofosbuvir would be recommended in the Summary of Product Characteristics. 9. Use of other investigational products in clinical studies within 60 days of screening 10. History of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease, in the previous six months 11. Patients currently using amiodarone or other anti-arrhythmics (including patients with permanent pacemakers). 12. Pregnancy 13. Symptomatic haemoglobinopathy (e.g. thalassemia major, sickle-cell anaemia). 14. Unlikely to be able to attend follow-up visits for any reason, as judged by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained virological response (SVR12), defined as plasma HCV RNA LLOQ, taken at least 1 week apart, after 2 consecutive visits with HCV RNA 2000 IU/ml 2. 2 consecutive measurements of HCV RNA, taken at least 1 week apart, that are > 1 log10 increase above HCV RNA nadir on treatment and > 2000 IU/ml at any time | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sustained virological response (SRV) after the end of the combined first treatment phase and any re-treatment phases (only applicable to mild patients), defined as per primary outcome measure 2. Lack of initial virological response in which measurements of HCV RNA (at any time, taken at least 1 week apart from baseline) are 3.0 - 10.0 x ULN if baseline was normal OR >3.0 - 10.0 x baseline if baseline was abnormal 7.2. Grade 4 defined as >10.0 x ULN if baseline was normal OR >10.0 x baseline if baseline was abnormal | — |
Countries
Viet Nam
Outcome results
None listed