Sofosbuvir With Ribavirin or Simeprevir With HCV GT4 Egyptian Patients

Sponsor

Beni-Suef University (Other)

Overall Status

Completed

CT.gov ID

NCT04385407

Collaborator

(none)

203

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

Brief Summary

A total of 201 participants with chronic HCV GT4 infection were allocated into two groups. One group participants were treated with SOF plus RBV (24 weeks). The second group was treated with SOF plus SMV (12 weeks).

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis C Virus Infection	Drug: Sofosbuvir + Simeprevir + Ribavirin	Phase 2

Detailed Description

A total of 201 participants, treatment-naïve and experienced, with chronic HCV GT4 infection were allocated into two groups based on the type of the regimen used. All eligible participants were treated orally with SOF plus daily oral weight-based RBV (24 weeks; group 1), or SOF plus daily oral SMV (12 weeks; group 2).

Study Design

Study Type:

Interventional

Actual Enrollment :

203 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Sofosbuvir in Combination With Ribavirin or Simeprevir: Real-life Study of Patients With Hepatitis C Genotype 4

Actual Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: SOF + RBV (Naive) For treatment-naive participants, SOF was given in a dose of 400 mg/day + RBV was given orally in the morning and in the evening (total daily dose was based on body weight:<75 kg, 1000 mg; >75 kg, 1200 mg).	Drug: Sofosbuvir + Simeprevir + Ribavirin Other Names: Olysio is a trade name of simeprevir Sovaldi is a trade name of sofosbuvir
Active Comparator: SOF + RBV (Experienced) For treatment-experienced participants, SOF was given in a dose of 400 mg/day + RBV was given orally in the morning and in the evening (total daily dose was based on body weight:<75 kg, 1000 mg; >75 kg, 1200 mg).	Drug: Sofosbuvir + Simeprevir + Ribavirin Other Names: Olysio is a trade name of simeprevir Sovaldi is a trade name of sofosbuvir
Active Comparator: SOF + SMV (Naive) For treatment-naive participants, SOF was given in a dose of 400 mg/day + SMV orally as a single 150 mg q.d. capsule.	Drug: Sofosbuvir + Simeprevir + Ribavirin Other Names: Olysio is a trade name of simeprevir Sovaldi is a trade name of sofosbuvir
Active Comparator: SOF + SMV (Expereined) For treatment-experienced participants, SOF was given in a dose of 400 mg/day + SMV orally as a single 150 mg q.d. capsule.	Drug: Sofosbuvir + Simeprevir + Ribavirin Other Names: Olysio is a trade name of simeprevir Sovaldi is a trade name of sofosbuvir

Outcome Measures

Primary Outcome Measures

Percentage of Participants With HCV 12 [12 weeks after last dose]
HCV 12 is HCV RNA level <15 IU/mL at 12 weeks after planned end of treatment (EOT).
Number of Participants With Adverse Events [up for 12 weeks after planned EOT.]
An adverse event (AE) is defined as any untoward medical occurrence in a participant clinical investigation administered the drugs of the study. A serious adverse event (SAE) is an event that results in death, life-threatening, participant hospitalization, or disability/incapacity

Secondary Outcome Measures

Percentage of Participants With Virologic relapse [12 weeks after the last dose]
Viral relapse was HCV RNA level <15 IU/mL at EOT, but >15 IU/mL levels through 12 weeks after planned EOT
Percentage of Participants With Virologic null response [24 or 36 weeks stating from the first dose]
Virologic null response is defined as HCV RNA >15 IU/mL levels throughout the entire treatment period

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participants with plasma HCV RNA level >10,000 IU/L for the two groups.
Treatment-experienced patients in group 1 were those who had previously failed treatment with classical peg-IFN/RBV therapy.
Treatment-experienced patients in group 2 were those who had previously failed treatment with SOF/RBV

Exclusion Criteria:

coinfected with hepatitis B virus or human immunodeficiency virus infection,
any cause of liver disease other than HCV GT4 infection;
liver decompensation,
hepatocellular carcinoma,
major severe illness, such as renal failure, congestive heart failure, thyroid dysfunction, respiratory failure, autoimmune disease and poorly controlled diabetes (HbA1C >9)
Participants with blood picture abnormalities, such as anemia (hemoglobin concentration of 10 g/or less) and thrombocytopenia (platelet count <50,000 cells/mm3)