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

Chronic Hepatitis C Virus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04387539
• Other study ID #: SOF/SMV/DCV/RBV
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 1, 2017
• Est. completion date: October 31, 2017

Study information

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

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis C Virus Infection
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• SOF/SMV/DCV/RBV
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.

Locations

Country	Name	City	State
Egypt	Health Administration at Beni-Seuf	Bani Sweif

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Abdel-Moneim A, Aboud A, Abdel-Gabbar M, Zanaty MI, Ramadan M. A sofosbuvir-based quadruple regimen is highly effective in HCV type 4-infected Egyptian patients with DAA treatment failure. J Hepatol. 2018 Jun;68(6):1313-1315. doi: 10.1016/j.jhep.2018.03.0 — 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 is defined as hepatitis C virus ribonucleic acid (HCV RNA) level < 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 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 up to 12 weeks after last dose
Secondary	Percentage of Participants With Viral relapse	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.	Up to 12 weeks after last dose

External Links

•   This link shows the investigation performed in the retreatment with SOF plus DCV/SMV/RBV regimen in EgyptianHCV GT4 participants