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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-06-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Hepatitis C Cirrhosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Subjects will receive sofosbuvir, daclatasvir and ribavirin

Group Type EXPERIMENTAL

Sofosbuvir

Intervention Type DRUG

400 mg, included in a combination pill (Sovodak) with 60 mg daclatasvir

Daclatasvir

Intervention Type DRUG

60 mg, included in a combination pill (Sovodak) with 400 mg sofosbuvir

Ribavirin

Intervention Type DRUG

1000 mg/day if \<75 kg, 1200 mg/day for \>75 kg. Divided into two daily doses

Interventions

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Sofosbuvir

400 mg, included in a combination pill (Sovodak) with 60 mg daclatasvir

Intervention Type DRUG

Daclatasvir

60 mg, included in a combination pill (Sovodak) with 400 mg sofosbuvir

Intervention Type DRUG

Ribavirin

1000 mg/day if \<75 kg, 1200 mg/day for \>75 kg. Divided into two daily doses

Intervention Type DRUG

Other Intervention Names

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Sovodak Sovodak RBV

Eligibility Criteria

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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)