Sofosbuvir With Ribavirin or Simeprevir With HCV GT4 Egyptian Patients

NCT04385407 | Completed Phase 2 DMC

• 1 other identifier: SOF-SMV-RBV
• Study Type: interventional
• Target: 203
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Chronic Hepatitis C Virus Infection

Keywords

Egyptian patients; HCV GT4; Naive; Ribavirin; Simeprevir; Sofosbuvir; Experinced

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Percentage of Participants With Virologic relapse

  12 weeks after the last dose

• Percentage of Participants With Virologic null response

  24 or 36 weeks stating from the first dose

Study Arms (4)

SOF + RBV (Naive)

ACTIVE COMPARATOR

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

SOF + RBV (Experienced)

ACTIVE COMPARATOR

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

SOF + SMV (Naive)

ACTIVE COMPARATOR

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

SOF + SMV (Expereined)

ACTIVE COMPARATOR

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

Interventions

Sofosbuvir + Simeprevir + Ribavirin DRUG

Also known as: Olysio is a trade name of simeprevir, Sovaldi is a trade name of sofosbuvir

SOF + RBV (Experienced); SOF + RBV (Naive); SOF + SMV (Expereined); SOF + SMV (Naive)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Beni-Suef University: lead

Related 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.2018.0327. Epub 2018 Nov 24.

  PMID: 30598598 RESULT

Related 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.

MeSH Terms

Interventions

Sofosbuvir; Simeprevir; Ribavirin

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Ribonucleosides; Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Prof

Study Record Dates

• First Submitted: May 9, 2020
• First Posted: May 12, 2020
• Study Start: April 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: May 12, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share