Chronic Hepatitis C Virus Infection
Conditions
Keywords
Egyptian patients, HCV GT4, Naive, Ribavirin, Simeprevir, Sofosbuvir, Experinced
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).
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).
Interventions
DRUGSofosbuvir + Simeprevir + Ribavirin
Sponsors
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed