Sofosbuvir With Ribavirin or Simeprevir With HCV GT4 Egyptian Patients
- Conditions
- Chronic Hepatitis C Virus Infection
- Interventions
- Registration Number
- NCT04385407
- Lead Sponsor
- Beni-Suef University
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 203
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SOF + SMV (Expereined) Sofosbuvir + Simeprevir + Ribavirin For treatment-experienced participants, SOF was given in a dose of 400 mg/day + SMV orally as a single 150 mg q.d. capsule. SOF + RBV (Naive) Sofosbuvir + Simeprevir + Ribavirin 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). SOF + RBV (Experienced) Sofosbuvir + Simeprevir + Ribavirin 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). SOF + SMV (Naive) Sofosbuvir + Simeprevir + Ribavirin For treatment-naive participants, SOF was given in a dose of 400 mg/day + SMV orally as a single 150 mg q.d. capsule.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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