Sofosbuvir Plus Daclatasvir With or Without Ribavirin and Chronic HCV Genotype (GT) 4

NCT04387526 | Completed Phase 2 DMC

• 1 other identifier: SOF-DCV-RBV
• Study Type: interventional
• Target: 946
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate the efficacy and safety of DCV plus sofosbuvir (SOF) with or without ribavirin (RBV) for treatment of Egyptian participants infected with HCV GT4.

Conditions

Chronic Hepatitis C Virus Infection

Keywords

Sofosbuvir; Daclatasvir; Ribavirin; HCV GT 4

Outcome Measures

Primary Outcomes (2)

• 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) level \< 15 IU/m 12 weeks after the last dose of drugs.

  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 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

  up for 12 weeks after planned End of Treatment (EOT).

Secondary Outcomes (2)

• Percentage of Participants With Viral relapse

  12 weeks after last dose

• Percentage of Participants With On-treatment Virologic Failure

  up tp 24 weeks

Study Arms (3)

SOF/DCV

ACTIVE COMPARATOR

Easy to treat arm: Participants were treated with a dual therapy (SOF and DCV) for 12 weeks. This arm included non-cirrhotic treatment-naïve patients

Drug: (SOF and DCV)

SOF/DCV/RBV + Cirrhosis

ACTIVE COMPARATOR

This difficult-to-treat arm included 111 cirrhotic participants who were treated with a triple therapy (SOF, DCV, and RBV) for 12 weeks.

Drug: (SOF, DCV, and RBV)

SOF/DCV/RBV + Non-Cirrhosis

ACTIVE COMPARATOR

This difficult-to-treat arm included treatment-experienced non-cirrhotic participants (77 participants) who were treated with a triple therapy (SOF, DCV, and RBV) for 12 weeks.

Drug: (SOF, DCV, and RBV)

Interventions

(SOF and DCV) DRUG

Also known as: Daklinza is a trade name of daclatasvir, Sovaldi is a trade name of sofosbuvir

SOF/DCV

(SOF, DCV, and RBV) DRUG

Also known as: Daklinza is a trade name of daclatasvir, Sovaldi is a trade name of sofosbuvir

SOF/DCV/RBV + Cirrhosis; SOF/DCV/RBV + Non-Cirrhosis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-cirrhotic treatment-naïve participants
• FIB-4 \< 3.25
• albumin \> 3.5
• total bilirubin \< 1.2 mg/dl
• international normalized ratio (INR) \< 1.2
• platelet count \> 150,000 mm3.
• experienced participants who had previously failed treatment with peg-IFN-α-/RBV, SOF/peg-IFN-α +RBV, or SOF/SMV
• Naïve cirrhotic participants were confirmed by ultrasonographic features of cirrhosis

You may not qualify if:

• liver disease of non-HCV etiology
• hepatitis B or human immune-deficiency virus (HIV) infection
• poorly controlled diabetic (HbA1C \> 9) participants
• hepatocellular carcinoma
• a history of extra-hepatic malignancy within 5 years prior to the study
• pregnant or breast feeding
• renal disease; serum creatinine \> 2.5 mg/dl or eGFR \< 30 ml/min
• evidence of hepatic decompensation; INR \> 1.7, serum albumin \< 2.8 g/dl, total bilirubin \> 3 mg/dl
• blood picture abnormalities such as anemia (hemoglobin concentration of 10 g/dl or less) and thrombocytopenia (platelet count \< 50,000 cells/mm3)
• major severe illnesses such as congestive heart failure and respiratory failure.

Sponsors & Collaborators

• Beni-Suef University: lead

Related Publications (1)

• Abdel-Moneim A, Aboud A, Abdel-Gabaar M, Zanaty MI, Ramadan M. Efficacy and safety of sofosbuvir plus daclatasvir with or without ribavirin: large real-life results of patients with chronic hepatitis C genotype 4. Hepatol Int. 2018 Jul;12(4):348-355. doi: 10.1007/s12072-018-9868-8. Epub 2018 May 12.

  PMID: 29754329 RESULT

Related Links

• This link describes the efficacy and safety of DCV plus sofosbuvir (SOF) with or without ribavirin (RBV) for treatment of Egyptian patients infected with HCV GT4.

MeSH Terms

Interventions

daclatasvir; Ribavirin

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Prof

Study Record Dates

• First Submitted: May 10, 2020
• First Posted: May 14, 2020
• Study Start: April 1, 2016
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: May 15, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share