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Completed

NCT Number: NCT04387539

ٍٍSofosbuvir/Simeprevir/Daclatasvir/Ribavirin and HCV Genotype 4-infected Egyptian Experienced Participants

Experienced participants who had HCV GT4 infection were treated with Sofosbuvir/Simeprevir/Daclatasvir/Ribavirin (SOF/SMV/DCV/RBV)

Completed

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Key information

Conditions

Chronic Hepatitis C Virus Infection

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Health Administration at Beni-Seuf

Bani Sweif, Egypt

About this study

Experienced participants, who had chronic infection with HCV GT4 , and failed prior DAA treatments, SOF/DCV (71/92) or SOF/SMV (15/92) or SOF/pegylated interferon/RBV (2/92) or SOF/RBV (4/92) were enrolled in the current study.

In the present study, the regimen used was designed by the combination of triple DAAs with different mechanisms of action and non-overlapping resistance profiles, SOF/SMV/DCV, plus RBV.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Experienced Egyptian participants with HCV GT4 infection who had failed prior DAA treatments [SOF/DCV or SOF/SMV or SOF/pegylated interferon/RBV or SOF/RBV]
  • Fibrosis-4 score in non-cirrhotic participants is <1.45-3.25: (None or moderate fibrosis)
  • Fibrosis-4 score in cirrhotic participants is >3.25: (Advanced fibrosis or cirrhosis)

Exclusion criteria

  • HCV coinfected with hepatitis B virus (HBV) or 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.

Treatment and study plan

SOF/SMV/DCV/RBV

Drug

SOF was given orally at a dose of 400 mg/day DCV was given orally at a dose of 60 mg/day SMV was given orally at a dose of 150 mg/day. RBV was given in a total daily oral dose of 600 mg/day up to 1,200 mg/day according to the participant's weight and tolerability.

Other names: Olysio is a trade name of simeprevir, Sovaldi is a trade name of sofosbuvir, Daklinza is a trade name of daclatasvir

Primary outcomes

  1. Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm

    Time frame: 12 weeks after last dose

    SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) level < 15 IU/m 12 weeks after the last dose of drugs.

  2. Number of Participants With Adverse Events in Each Treatment Arm

    Time frame: Screening up to 12 weeks after last dose

    An adverse event (AE) is defined as any untoward medical occurrence in a participant 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

Secondary outcomes

  1. Percentage of Participants With Viral relapse

    Time frame: Up to 12 weeks after last dose

    Viral relapse was HCV RNA level undetectable at End of Treatment (EOT) (≤ 15 IU/ml), but detectable HCV RNA ( > 15 IU/ml) levels 12 weeks after planned EOT.

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

A Sofosbuvir-based Quadruple Regimen is Highly Effective in HCV Type 4-infected Egyptian Patients With DAA Treatment Failure

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 14, 2020
Registry last updated
May 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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