Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir and Ribavirin for Hepatitis C Virus Genotype 4 Patients

Study Overview
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Brief Summary
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enrolled participants were treated orally with SOF plus a fixed dose combination of OBV/PTV/r plus RBV.

Detailed Description
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Enrolled participants were treated orally with SOF plus a fixed dose combination of Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir plus Ribavirin (OBV/PTV/r plus RBV), which was administered orally based on the participants' tolerability. The primary end point was a sustained virological response (HCV RNA level < 15 IU/ mL), observed 12 weeks after the end of the treatment (SVR12).

Official Title
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Retreatment Efficacy of Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir + Ribavirin for Hepatitis C Virus Genotype 4 Patients

Conditions
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Chronic Hepatitis C Virus Infection

Intervention / Treatment
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* Drug: SOF plus (OBV/PTV/r) plus RBV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The experienced participants who were treated previously with (SOF/DCV) , (SOF/SMV), (SOF/RBV), or (SOF/pegINF/RBV). The presence of compensated liver cirrhosis was documented by ultrasonographic examination, liver biopsy, results of Fibroscan or FIB-4 score, and laboratory markers, like FIB-4 > 3.25 (advanced fibrosis or cirrhosis), albumin < 3.5, total bilirubin > 1.2, and also confirmed by clinical characteristics such as lower limb edema, splenomegaly, esophageal varices. Exclusion Criteria: liver disease of non-HCV GT4 etiology, coinfection with hepatitis B or HIV poorly controlled diabetes (HbA1C > 8) participants, hepatocellular carcinoma, a history of extrahepatic malignancy in the 5 years prior to the study renal failure evidence of hepatic decompensation blood picture abnormalities such as anemia (hemoglobin concentration of < 10 g/dL) thrombocytopenia (platelets count < 50,000 cells/mm3). major severe illness such as congestive heart failure and respiratory failure.

Ages Eligible for Study
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Minimum Age: 18 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: Cirrhotic Participants<br>The experienced participants(113 participants) who failed prior DAA treatments. They were allocated to cirrhotic (30 participants) and treated for 12 weeks. | Drug: SOF plus (OBV/PTV/r) plus RBV<br>* They were given SOF in a dose of 400 mg/day, and a fixed dose combination of OBV (25 mg), PTV (150 mg), and r (100 mg) taken with food once daily. RBV was supplied in 200 mg capsules, and the recommended dose was 600 mg/ day to reach 1200 mg/day based on patient's body weight and tolerability.<br>* Other names: Ombitasvir (ABT 267) is an NS5A inhibitor;|
| Active Comparator: Non-cirrhotic Participants<br>The experienced non-cirrhotic participants(83 participants) who failed prior DAA treatments. They were treated for 12 weeks. | Drug: SOF plus (OBV/PTV/r) plus RBV<br>* They were given SOF in a dose of 400 mg/day, and a fixed dose combination of OBV (25 mg), PTV (150 mg), and r (100 mg) taken with food once daily. RBV was supplied in 200 mg capsules, and the recommended dose was 600 mg/ day to reach 1200 mg/day based on patient's body weight and tolerability.<br>* Other names: Ombitasvir (ABT 267) is an NS5A inhibitor;|

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 is defined as hepatitis C virus ribonucleic acid (HCV RNA) level < 15 IU/ml 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 | Screening up to 12 weeks after last dose] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Viral relapse | Viral relapse was HCV RNA level undetectable at End of Treatment (EOT) (≤ 15 IU/ml), but detectable HCV RNA ( > 15 IU/ml) levels 12 weeks after planned EOT. | Up to 12 weeks after last dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cirrhotic, Sofosbuvir, Ombitasvir, Paritaprevir, Ribavirin, Ritonavir, HCV GT 4, Experienced Egyptian Patients, Non-Cirrhotic