Clinical trial NCT04382339: Sofosbuvir/Pegylated-interferon Plus Ribavirin With HCV Genotype 4
Official title: Effectiveness of Sofosbuvir/Pegylated-interferon Plus Ribavirin in Treatment of Hepatitis C Virus Genotype 4 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hepatitis C Virus Infection
Keywords: HCV genotype 4
sofosbuvir
Peg-interferon α-2
ribavirin
Egyptian patients
Experinced
Naive
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2020-05-11
Enrollment: 99
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm SVR12
timeFrame: 12 weeks after last dose
measure: Number of Participants With Adverse Events in Each Treatment Arm
timeFrame: Screening until 30 days after last dose
Secondary outcomes:
measure: Percentage of Participants With Viral relapse
timeFrame: 12 weeks after last dose
measure: Percentage of Participants With On-treatment Virologic Failure
timeFrame: up tp 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Biochemistry Dep., Faculty of Science, Beni-Suef University, P.O. Box 52621
name: Mohammed Abdel-Gabbar, Ass. Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abdel-Moneim A, Abood A, Abdel-Gabaar M, Zanaty MI, Ramadan M. Effectiveness of sofosbuvir/pegylated-interferon plus ribavirin in treatment of hepatitis C virus genotype 4 patients. Clin Exp Hepatol. 2018 Sep;4(3):191-196. doi: 10.5114/ceh.2018.78123. Epub 2018 Sep 10.