Sofosbuvir/Pegylated-interferon Plus Ribavirin With HCV Genotype 4

Hepatitis C Virus Infection Clinical Trial

— HCV  

Official title:

Effectiveness of Sofosbuvir/Pegylated-interferon Plus Ribavirin in Treatment of Hepatitis C Virus Genotype 4 Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04382339
• Other study ID #: SOF-PEG
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 2015
• Est. completion date: November 2015

Study information

• Verified date: May 2020
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

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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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Hepatitis C Virus Infection
• Virus Diseases

Intervention

Drug:
• SOF/RBV/PegINFa-2
SOF: block the hepatitis C NS5B protein. RBV: a nucleoside inhibitor PegINFa-2: chemically modified form of the standard interferon that treats hepatitis C

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

References & Publications (1)

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. Epu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm SVR12	SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) < 15 IU/m 12 weeks after the last dose of drugs.	12 weeks after last dose
Primary	Number of Participants With Adverse Events in Each Treatment Arm	An adverse event (AE) is defined as any untoward medical occurrence in a participant or i clinical investigation after administering a pharmaceutical drugs serious adverse event (SAE) is an event that results in death, life-threatening, requires hospitalization, or significant disability/incapacity	Screening until 30 days after last dose
Secondary	Percentage of Participants With Viral relapse	Viral relapse was HCV RNA undetectable at EOT, but detectable HCV RNA > 15 IU/ml levels 12 weeks after planned EOT.	12 weeks after last dose
Secondary	Percentage of Participants With On-treatment Virologic Failure	On-treatment virologic failure was defined as quantifiable HCV RNA throughout the entire treatment period with HCV RNA greater than 15 IU/ml	up tp 24 weeks

External Links

•   The link clarify the effectiveness of sofosbuvir/pegylated-interferon plus ribavirin in treatment of hepatitis C virus genotype 4 patients