Sofosbuvir With Ribavirin or Simeprevir With HCV GT4 Egyptian Patients

A total of 201 participants with chronic HCV GT4 infection were allocated into two groups. One group participants were treated with SOF plus RBV (24 weeks). The second group was treated with SOF plus SMV (12 weeks).

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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 2

About this study

A total of 201 participants, treatment-naïve and experienced, with chronic HCV GT4 infection were allocated into two groups based on the type of the regimen used. All eligible participants were treated orally with SOF plus daily oral weight-based RBV (24 weeks; group 1), or SOF plus daily oral SMV (12 weeks; group 2).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Participants with plasma HCV RNA level >10,000 IU/L for the two groups.
Treatment-experienced patients in group 1 were those who had previously failed treatment with classical peg-IFN/RBV therapy.
Treatment-experienced patients in group 2 were those who had previously failed treatment with SOF/RBV

Exclusion criteria

coinfected with hepatitis B virus or human immunodeficiency virus infection,
any cause of liver disease other than HCV GT4 infection;
liver decompensation,
hepatocellular carcinoma,
major severe illness, such as renal failure, congestive heart failure, thyroid dysfunction, respiratory failure, autoimmune disease and poorly controlled diabetes (HbA1C >9)
Participants with blood picture abnormalities, such as anemia (hemoglobin concentration of 10 g/or less) and thrombocytopenia (platelet count <50,000 cells/mm3)

Treatment and study plan

Sofosbuvir + Simeprevir + Ribavirin

Drug

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

Primary outcomes

Percentage of Participants With HCV 12

Time frame: 12 weeks after last dose

HCV 12 is HCV RNA level <15 IU/mL at 12 weeks after planned end of treatment (EOT).
Number of Participants With Adverse Events

Time frame: up for 12 weeks after planned EOT.

An adverse event (AE) is defined as any untoward medical occurrence in a participant clinical investigation administered the drugs of the study.

A serious adverse event (SAE) is an event that results in death, life-threatening, participant hospitalization, or disability/incapacity

Secondary outcomes

Percentage of Participants With Virologic relapse

Time frame: 12 weeks after the last dose

Viral relapse was HCV RNA level <15 IU/mL at EOT, but >15 IU/mL levels through 12 weeks after planned EOT
Percentage of Participants With Virologic null response

Time frame: 24 or 36 weeks stating from the first dose

Virologic null response is defined as HCV RNA >15 IU/mL levels throughout the entire treatment period

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

Sofosbuvir in Combination With Ribavirin or Simeprevir: Real-life Study of Patients With Hepatitis C Genotype 4

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: May 12, 2020
Registry last updated: May 12, 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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Completed