Sofosbuvir With Ribavirin or Simeprevir With HCV GT4 Egyptian Patients

Beni-Suef University

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis C Virus Infection

Treatments: Drug: Sofosbuvir + Simeprevir + Ribavirin

Study type: Interventional

Funder types: Other

Identifiers

NCT04385407

SOF-SMV-RBV

Details and patient eligibility

About

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).

Full 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).

Enrollment: 203 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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203 participants in 4 patient groups

SOF + RBV (Naive)

Active Comparator group

Description:

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).

Treatment:

Drug: Sofosbuvir + Simeprevir + Ribavirin

SOF + RBV (Experienced)

Active Comparator group

Description:

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).

Treatment:

Drug: Sofosbuvir + Simeprevir + Ribavirin

SOF + SMV (Naive)

Active Comparator group

Description:

For treatment-naive participants, SOF was given in a dose of 400 mg/day + SMV orally as a single 150 mg q.d. capsule.

Treatment:

Drug: Sofosbuvir + Simeprevir + Ribavirin

SOF + SMV (Expereined)

Active Comparator group

Description:

For treatment-experienced participants, SOF was given in a dose of 400 mg/day + SMV orally as a single 150 mg q.d. capsule.

Treatment:

Drug: Sofosbuvir + Simeprevir + Ribavirin