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, India

Status: Terminated

Conditions: HCV Related Cirrhosis

Treatments: Drug: Sofosbuvir + Ribavirin 2; Drug: Sofosbuvir + Ribavirin 1; Drug: Sofosbuvir + Ribavirin 3

Study type: Interventional

Funder types: Other

Identifiers

NCT02464631

ILBS-HCV-001

Details and patient eligibility

About

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

Enrollment: 62 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 3 patient groups

Sofosbuvir + Ribavirin 1

Active Comparator group

Description:

Sofosbuvir + Ribavirin x 24 weeks

Treatment:

Drug: Sofosbuvir + Ribavirin 1

Sofosbuvir + Ribavirin 2

Experimental group

Description:

Sofosbuvir + Ribavirin x 36 weeks

Treatment:

Drug: Sofosbuvir + Ribavirin 2

Sofosbuvir + Ribavirin 3

Experimental group

Description:

Sofosbuvir + Ribavirin x 48 weeks

Treatment:

Drug: Sofosbuvir + Ribavirin 3