Sofosbuvir/Pegylated-interferon Plus Ribavirin With HCV Genotype 4

Beni-Suef University99 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis C Virus Infection

Interventions

SOF/RBV/PegINFα-2DRUG

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 12 weeks after last dose

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

Time frame: Screening until 30 days after last dose

Secondary Outcomes

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.

Time frame: 12 weeks after last dose

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

Time frame: up tp 24 weeks

Data from ClinicalTrials.gov

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