HCV Related Cirrhosis
Conditions
Brief summary
In this prospective randomized trial, A Minimum of 300 consecutive patients of decompensated HCV (Hepatitis C Virus) related cirrhosis, presenting to the Institute of Liver and Biliary Sciences hospital will be included and those patients meeting the entry criteria received treatment with 400 mg of Sofosbuvir, administered orally once daily, and Ribavirin administered orally twice daily, with doses determined according to body weight(600 mg daily in patients with a body weight of ≤60 kg,800 mg daily in patients weighing \>60 and ≤80 kg, and1000 mg daily in patients with a body weight of \>80 kg). Based on the treatment duration, patients would be randomized in either of the 3 treatment groups - * Group 1 - Sofosbuvir + Ribavirin x 24 weeks * Group 2 - Sofosbuvir + Ribavirin x 36 weeks * Group 3 - Sofosbuvir + Ribavirin x 48 weeks
Interventions
DRUGSofosbuvir + Ribavirin 1
DRUGSofosbuvir + Ribavirin 2
DRUGSofosbuvir + Ribavirin 3
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or Female ≥ 18 yrs * Baseline HCV RNA \> 1000 IU/ml * Cirrhosis with current or prior decompensation * HCV (Hepatitis C Infection) Genotype 3 * Treatment naïve or treatment experienced
Exclusion criteria
* HIV or HBV (Hepatitis B Virus) co-infection * Recent Variceal bleed * Pregnancy * Haemolytic anaemia * Platelet counts \<20,000/ml * Advanced HCC (Hepatocellular Carcinoma) * Renal dysfunction, GFR (glomerular filtration rate) \< 30 ml/min * Haemoglobin \< 10 g/dl * MELD (Model for End Stage Liver Disease) \>25, CTP (Child-Turcotte-Pugh score) \>12 * Post organ transplant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Primary efficacy end point is SVR 24 defined as HCV RNA <LLOQ (lower limit of quantification) | 48 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Mortality at 6 months post therapy in all the 3 groups. | 48 weeks |
| Improvement in the liver function as determined by CTP (Child-Turcotte-Pugh score), MELD (Model for End Stage liver Disease)more than 2 points at 6 months and 1 year. | 48 weeks |
| Number of new cases of Hepatocellular Carcinoma at end of therapy and at 6 months post therapy in all the 3 groups. | 48 weeks |
| The secondary endpoint is any AE (Adverse Event) leading to permanent discontinuation of study drugs. | 3 years |
| SVR 4 defined as HCV RNA <LLOQ (lower limit of quantification) | 24 weeks |
| SVR 12 defined as HCV RNA <LLOQ (lower limit of quantification) | 36 weeks |
| Reduction in HVPG >20% to baseline after 1 year in all the 3 groups. | 48 weeks |
Countries
India
Outcome results
None listed