Sofosbuvir With Ribavirin or Simeprevir With HCV GT4 Egyptian Patients

Chronic Hepatitis C Virus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04385407
• Other study ID #: SOF-SMV-RBV
• Status: Completed
• Phase: Phase 2
• Start date: April 2015
• Est. completion date: July 2016

Study information

• Verified date: May 2020
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Hepatitis C Virus Infection
• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• Virus Diseases

Intervention

Drug:
• Sofosbuvir + Simeprevir + Ribavirin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

References & Publications (1)

Abdel-Moneim A, Aboud A, Abdel-Gabbar M, Zanaty MI, Elbary AAA, Ramadan M. Sofosbuvir in combination with ribavirin or simeprevir: real-life study of patients with hepatitis C genotype 4. Ann Gastroenterol. 2019 Jan-Feb;32(1):93-98. doi: 10.20524/aog.2018 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With HCV 12	HCV 12 is HCV RNA level <15 IU/mL at 12 weeks after planned end of treatment (EOT).	12 weeks after last dose
Primary	Number of Participants With Adverse Events	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	up for 12 weeks after planned EOT.
Secondary	Percentage of Participants With Virologic relapse	Viral relapse was HCV RNA level <15 IU/mL at EOT, but >15 IU/mL levels through 12 weeks after planned EOT	12 weeks after the last dose
Secondary	Percentage of Participants With Virologic null response	Virologic null response is defined as HCV RNA >15 IU/mL levels throughout the entire treatment period	24 or 36 weeks stating from the first dose

External Links

•   This link describes the effectiveness and safety of two regimens sofosbuvir (SOF) in combination with either ribavirin (RBV) or simeprevir (SMV) in chronic hepatitis C (CHC) genotype (GT) 4 patients in Egypt.