Sofosbuvir, Daclatasvir, Ribavirin for Hepatitis C Virus (HCV) Cirrhotics

Phase 3

Completed

• Conditions: Cirrhosis; Hepatitis C
• Interventions: Drug: Sofosbuvir; Drug: Daclatasvir; Drug: Ribavirin

• Registration Number: NCT02596880
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

The investigators will treat 100 patients with cirrhosis due to hepatitis C with sofosbuvir 400 mg daily, daclatasvir 60 mg daily and weight-based ribavirin (1000 mg/d if \<75 kg, 1200 mg/d if \>75 kg, divided in two daily doses) for 12 weeks and calculate the sustained viral response rate at 12 weeks.

Detailed Description

Cirrhosis due to Hepatitis C presents a rather difficult treatment problem as many cannot tolerate interferon, the previous standard of treatment. The new direct acting antivirals have provided these patients with a new hope. One such combination is sofosbuvir (SOF) 400 mg and daclatasvir (DCV) 60 mg given once daily with or without weight-based ribavirin (RBV) for 12 or 24 weeks. The current recommendation for cirrhotics is SOF/DCV/RBV for 24 weeks but that recommendation is based on the lack of data for shorter periods. In order to evaluate the response rate to the combination of SOF/DCV/RBV the investigators decided to treat 100 HCV cirrhotics with this combination for 12 weeks. Subjects include genotype 1 and 3 patients, the prevalent genotypes in Iran. Patients with Model for End stage Liver Disease (MELD) \> 20 are excluded. The investigators will calculate the sustained viral response rate at 12 weeks (SVR12).

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-11-03
• Study First Submitted QC: 2015-11-03
• Study First Posted: 2015-11-04
• Primary Completion: 2016-04
• Study Completion: 2016-06
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-18
• Last Update Posted: 2023-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Positive qualitative HCV RNA test on two occasions at least 6 months apart
• Cirrhosis proven by either of: 1. Liver biopsy, 2. Liver elasticity > 12 kilopascal (KPa), 3. Clinical certainty (ascites, splenomegaly, small liver, low albumin, low platelet)

Exclusion Criteria

• Renal failure (eGFR < 30 cc/min),
• MELD score > 20,
• Child's C (CTP score > 12),
• Heart rate < 50/min,
• Taking amiodarone

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Sofosbuvir	Subjects will receive sofosbuvir, daclatasvir and ribavirin
Treatment	Ribavirin	Subjects will receive sofosbuvir, daclatasvir and ribavirin
Treatment	Daclatasvir	Subjects will receive sofosbuvir, daclatasvir and ribavirin

Primary Outcome Measures

Name	Time	Method
The sustained viral response rate	week 24 (12 weeks after end of treatment)	Qualitative HCV RNA polymerase chain reaction (PCR)

Secondary Outcome Measures

Name	Time	Method
Adverse drug events	week 2, 4, 8, 12, 24	Questionnaire

Trial Locations

Locations (1)

Shariati Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of