Sofosbuvir/Pegylated-interferon Plus Ribavirin With HCV Genotype 4

Beni-Suef University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hepatitis C Virus Infection

Treatments: Drug: SOF/RBV/PegINFα-2

Study type: Interventional

Funder types: Other

Identifiers

NCT04382339

SOF-PEG

Details and patient eligibility

About

This study aims to assess the efficacy and safety of sofosbuvir (SOF) with pegylated interferon (PegINF)/ribavirin (RBV) for chronic HCV GT4 participants

Full description

Between March 2015 and November 2015, 99 participants (59 naïve and 40 experienced) infected with HCV GT4 were enrolled in the study. Eligible participants received daily oral 400 mg SOF ( (Sovaldi, Gilead Sciences, Inc., USA), RBV (Copegus, Roche, Europe) based on body weight: < 75 kg, 1000 mg; ≥75 kg, 1200 mg), the dose modified according to participants tolerability, plus 180 μg PegINFα-2 once weekly for 12 weeks.

Experienced participants included participants with a prior relapse or a null response to PegINF/RBV therapy.

Enrollment: 99 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

The study population consisted of treatment-naïve and treatment-experienced adults patients aged 20-65 with HCV RNA level > 10,000 IU/ml.

Experienced participants included those with a prior relapse or a null response to PegINF/RBV therapy.

Exclusion Criteria:Participants with one or more of

• HCV coinfected with hepatitis B virus (HBV)
• human immunodeficiency virus (HIV)
• had any liver disease other than chronic HCV GT4 infection.
• had a history of liver decompensation
• serum a-fetoprotein (AFP) > 100 ng/ml
• evidence of hepatocellular carcinoma
• major severe illness such as respiratory, renal, heart failure or autoimmune disease
• non-compliance with treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 2 patient groups

Treatment-naive

Active Comparator group

Description:

Naive Egyptians having HCV GT4 received SOF, RBV, and PegINFα-2 once weekly for 12 weeks Intervention: 1 DDA: Sofosobuvir (SOF) plus Ribavirin (RBV) and pegylated-interferon (PegINFα-2)

Treatment:

Drug: SOF/RBV/PegINFα-2

Treatment-experienced

Active Comparator group

Description:

Experienced Egyptians having HCV GT4 received SOF, RBV, and PegINFα-2 once weekly for 12 weeks Intervention: 1 DDA: Sofosobuvir (SOF) plus Ribavirin (RBV) and pegylated-interferon (PegINFα-2)

Treatment:

Drug: SOF/RBV/PegINFα-2