ٍٍSofosbuvir/Simeprevir/Daclatasvir/Ribavirin and HCV Genotype 4-infected Egyptian Experienced Participants

Sponsor

Beni-Suef University (Other)

Overall Status

Completed

CT.gov ID

NCT04387539

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

11.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Experienced participants who had HCV GT4 infection were treated with Sofosbuvir/Simeprevir/Daclatasvir/Ribavirin (SOF/SMV/DCV/RBV)

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis C Virus Infection	Drug: SOF/SMV/DCV/RBV	Phase 1/Phase 2

Detailed Description

Experienced participants, who had chronic infection with HCV GT4 , and failed prior DAA treatments, SOF/DCV (71/92) or SOF/SMV (15/92) or SOF/pegylated interferon/RBV (2/92) or SOF/RBV (4/92) were enrolled in the current study.

In the present study, the regimen used was designed by the combination of triple DAAs with different mechanisms of action and non-overlapping resistance profiles, SOF/SMV/DCV, plus RBV.

Study Design

Study Type:

Interventional

Actual Enrollment :

94 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Sofosbuvir-based Quadruple Regimen is Highly Effective in HCV Type 4-infected Egyptian Patients With DAA Treatment Failure

Actual Study Start Date :

Mar 1, 2017

Actual Primary Completion Date :

Oct 31, 2017

Actual Study Completion Date :

Oct 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Non-Cirrhotic SOF plus DCV/SMV/RBV regimen was administered to Egyptian non-cirrhotic experienced HCV GT4 participants for 12 weeks	Drug: SOF/SMV/DCV/RBV SOF was given orally at a dose of 400 mg/day DCV was given orally at a dose of 60 mg/day SMV was given orally at a dose of 150 mg/day. RBV was given in a total daily oral dose of 600 mg/day up to 1,200 mg/day according to the participant's weight and tolerability. Other Names: Olysio is a trade name of simeprevir Sovaldi is a trade name of sofosbuvir Daklinza is a trade name of daclatasvir
Active Comparator: Cirrhotic SOF plus DCV/SMV/RBV regimen was administered to Egyptian cirrhotic experienced HCV GT4 participants for 12 weeks	Drug: SOF/SMV/DCV/RBV SOF was given orally at a dose of 400 mg/day DCV was given orally at a dose of 60 mg/day SMV was given orally at a dose of 150 mg/day. RBV was given in a total daily oral dose of 600 mg/day up to 1,200 mg/day according to the participant's weight and tolerability. Other Names: Olysio is a trade name of simeprevir Sovaldi is a trade name of sofosbuvir Daklinza is a trade name of daclatasvir

Arm

Intervention/Treatment

Active Comparator: Non-Cirrhotic

SOF plus DCV/SMV/RBV regimen was administered to Egyptian non-cirrhotic experienced HCV GT4 participants for 12 weeks

Drug: SOF/SMV/DCV/RBV

SOF was given orally at a dose of 400 mg/day DCV was given orally at a dose of 60 mg/day SMV was given orally at a dose of 150 mg/day. RBV was given in a total daily oral dose of 600 mg/day up to 1,200 mg/day according to the participant's weight and tolerability.

Other Names:

Olysio is a trade name of simeprevir

Sovaldi is a trade name of sofosbuvir

Daklinza is a trade name of daclatasvir

Active Comparator: Cirrhotic

SOF plus DCV/SMV/RBV regimen was administered to Egyptian cirrhotic experienced HCV GT4 participants for 12 weeks

Drug: SOF/SMV/DCV/RBV

Other Names:

Olysio is a trade name of simeprevir

Sovaldi is a trade name of sofosbuvir

Daklinza is a trade name of daclatasvir

Outcome Measures

Primary Outcome Measures

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm [12 weeks after last dose]
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) level < 15 IU/m 12 weeks after the last dose of drugs.
Number of Participants With Adverse Events in Each Treatment Arm [Screening up to 12 weeks after last dose]
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

Secondary Outcome Measures

Percentage of Participants With Viral relapse [Up to 12 weeks after last dose]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Experienced Egyptian participants with HCV GT4 infection who had failed prior DAA treatments [SOF/DCV or SOF/SMV or SOF/pegylated interferon/RBV or SOF/RBV]
Fibrosis-4 score in non-cirrhotic participants is <1.45-3.25: (None or moderate fibrosis)
Fibrosis-4 score in cirrhotic participants is >3.25: (Advanced fibrosis or cirrhosis)

Exclusion Criteria:

HCV coinfected with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
had any liver disease other than chronic HCV GT4 infection.
had a history of liver decompensation
serum a-fetoprotein (AFP) > 100 ng/ml
evidence of hepatocellular carcinoma
major severe illness such as respiratory, renal, heart failure or autoimmune disease
non-compliance with treatment.