Sofosbuvir With Ribavirin or Simeprevir With HCV GT4 Egyptian Patients

Beni-Suef University203 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

203

Conditions

Chronic Hepatitis C Virus Infection

Interventions

Sofosbuvir + Simeprevir + RibavirinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Percentage of Participants With HCV 12

HCV 12 is HCV RNA level \<15 IU/mL at 12 weeks after planned end of treatment (EOT).

Time frame: 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

Time frame: up for 12 weeks after planned EOT.

Secondary Outcomes

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

Time frame: 12 weeks after the last dose

Percentage of Participants With Virologic null response

Virologic null response is defined as HCV RNA \>15 IU/mL levels throughout the entire treatment period

Time frame: 24 or 36 weeks stating from the first dose

Data from ClinicalTrials.gov

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