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

Study Overview
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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.

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.

Official Title
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Efficacy and Safety of Sofosbuvir Plus Daclatasvir With or Without Ribavirin: Large Real-life Results of Patients With Chronic Hepatitis C Genotype 4

Conditions
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Chronic Hepatitis C Virus Infection

Intervention / Treatment
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* Drug: (SOF and DCV)
* Drug: (SOF, DCV, and RBV)


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SOF/DCV<br>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 | Drug: (SOF and DCV)<br> <br> * Other names: Sovaldi is a trade name of sofosbuvir;|
| Active Comparator: SOF/DCV/RBV + Cirrhosis<br>This difficult-to-treat arm included 111 cirrhotic participants who were treated with a triple therapy (SOF, DCV, and RBV) for 12 weeks. | Drug: (SOF, DCV, and RBV)<br> <br> * Other names: Sovaldi is a trade name of sofosbuvir;|
| Active Comparator: SOF/DCV/RBV + Non-Cirrhosis<br>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. | Drug: (SOF, DCV, and RBV)<br> <br> * Other names: Sovaldi is a trade name of sofosbuvir;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm SVR12 | SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level < 15 IU/m 12 weeks after the last dose of drugs. | 12 weeks after last dose | 
| Number of Participants With Adverse Events in Each Treatment Arm | An adverse event (AE) is defined as any untoward medical occurrence in a participant clinical investigation after administering a pharmaceutical drugs Serious adverse event (SAE) is an event that results in death, life-threatening, requires hospitalization, or significant disability/incapacity | up for 12 weeks after planned End of Treatment (EOT). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Viral relapse | Viral relapse was HCV RNA level ≤ 15 IU/ml at EOT, but detectable HCV RNA level > 15 IU/ml 12 weeks after planned EOT. | 12 weeks after last dose | 
| Percentage of Participants With On-treatment Virologic Failure | On-treatment virologic failure was defined as quantifiable HCV RNA throughout the entire treatment period with HCV RNA greater than 15 IU/ml | up tp 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sofosbuvir, Daclatasvir, Ribavirin, HCV GT 4