To Evaluate the Safety and Efficacy of Sofosbuvir and Ribavirin in Patients With HCV (Genotype 3) Related Decompensated Cirrhosis

Institute of Liver and Biliary Sciences, India62 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HCV Related Cirrhosis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The Primary efficacy end point is SVR 24 defined as HCV RNA <LLOQ (lower limit of quantification)

Time frame: 48 weeks

Secondary Outcomes

The secondary endpoint is any AE (Adverse Event) leading to permanent discontinuation of study drugs.

Time frame: 3 years

Mortality at 6 months post therapy in all the 3 groups.

Time frame: 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.

Time frame: 48 weeks

Number of new cases of Hepatocellular Carcinoma at end of therapy and at 6 months post therapy in all the 3 groups.

Time frame: 48 weeks

Reduction in HVPG >20% to baseline after 1 year in all the 3 groups.

Time frame: 48 weeks

SVR 4 defined as HCV RNA <LLOQ (lower limit of quantification)

Time frame: 24 weeks

SVR 12 defined as HCV RNA <LLOQ (lower limit of quantification)

Time frame: 36 weeks

To Evaluate the Safety and Efficacy of Sofosbuvir and Ribavirin in Patients With HCV (Genotype 3) Related Decompensated Cirrhosis

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes