Sofosbuvir Plus Daclatasvir With or Without Ribavirin and Chronic HCV Genotype (GT) 4

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

PHASE2/PHASE3

Total Enrollment

946 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2017-05-31

Brief Summary

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This study aims to evaluate the efficacy and safety of DCV plus sofosbuvir (SOF) with or without ribavirin (RBV) for treatment of Egyptian participants infected with HCV GT4.

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Detailed Description

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Egyptian participants infected with HCV GT4 were classified into two groups: group 1 (easy to treat) was treated with a dual therapy of SOF/DCV daily for 12 weeks and group 2 (difficult to treat) was treated with a triple therapy of SOF/DCV/RBV daily for 12 weeks.

SOF dose was 400 mg/day given orally DCV was given in a dose of 60 mg/day, orally. RBV was given as oral tablets in the morning and in the evening based on patient's weight and tolerability (starting dose 600 mg/day to reach 1200 mg/day.

Conditions

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Chronic Hepatitis C Virus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SOF/DCV

Easy to treat arm: Participants were treated with a dual therapy (SOF and DCV) for 12 weeks.

This arm included non-cirrhotic treatment-naïve patients

Group Type ACTIVE_COMPARATOR

(SOF and DCV)

Intervention Type DRUG

SOF/DCV/RBV + Cirrhosis

This difficult-to-treat arm included 111 cirrhotic participants who were treated with a triple therapy (SOF, DCV, and RBV) for 12 weeks.

Group Type ACTIVE_COMPARATOR

(SOF, DCV, and RBV)

Intervention Type DRUG

SOF/DCV/RBV + Non-Cirrhosis

This difficult-to-treat arm included treatment-experienced non-cirrhotic participants (77 participants) who were treated with a triple therapy (SOF, DCV, and RBV) for 12 weeks.

Group Type ACTIVE_COMPARATOR

(SOF, DCV, and RBV)

Intervention Type DRUG

Interventions

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(SOF and DCV)

Intervention Type DRUG

(SOF, DCV, and RBV)

Intervention Type DRUG

Other Intervention Names

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Daklinza is a trade name of daclatasvir Sovaldi is a trade name of sofosbuvir Daklinza is a trade name of daclatasvir Sovaldi is a trade name of sofosbuvir

Eligibility Criteria

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Inclusion Criteria

* Non-cirrhotic treatment-naïve participants
* FIB-4 \< 3.25
* albumin \> 3.5
* total bilirubin \< 1.2 mg/dl
* international normalized ratio (INR) \< 1.2
* platelet count \> 150,000 mm3.
* experienced participants who had previously failed treatment with peg-IFN-α-/RBV, SOF/peg-IFN-α +RBV, or SOF/SMV
* Naïve cirrhotic participants were confirmed by ultrasonographic features of cirrhosis

Exclusion Criteria

* liver disease of non-HCV etiology
* hepatitis B or human immune-deficiency virus (HIV) infection
* poorly controlled diabetic (HbA1C \> 9) participants
* hepatocellular carcinoma
* a history of extra-hepatic malignancy within 5 years prior to the study
* pregnant or breast feeding
* renal disease; serum creatinine \> 2.5 mg/dl or eGFR \< 30 ml/min
* evidence of hepatic decompensation; INR \> 1.7, serum albumin \< 2.8 g/dl, total bilirubin \> 3 mg/dl
* blood picture abnormalities such as anemia (hemoglobin concentration of 10 g/dl or less) and thrombocytopenia (platelet count \< 50,000 cells/mm3)
* major severe illnesses such as congestive heart failure and respiratory failure.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No