Comparative Study of Two Regiemns in Management of Sofosbuvir/Daclatasvir Failure

Not Applicable

Completed

• Conditions: HCV Coinfection
• Interventions: Drug: Sofosbuvir; Drug: Simeprevir; Drug: Daclatasvir; Drug: Ombitasvir/paritaprevir/ritonavir; Drug: Ribavirin

• Registration Number: NCT03549832
• Lead Sponsor: Assiut University

Brief Summary

Now many cases reported failure to HCV treatment with Sofosbuvir/ Daclatasvir. retreat those patients is challenging. So, we aimed to Study the efficacy and safety of Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin versus Sofosbuvir /ombitasvir/ paritaprevir/ritonavir/ribavirin in the management of hepatitis C patients who failed to prior Sofosbuvir/ Daclatasvir regimens in an open-labeled randomized trial.

Detailed Description

HCV management with new DAAs is now promising. However, many cases reporting treatment failure either non-responder or relapse to HCV treatment with Sofosbuvir/ Daclatasvir. retreat those patients is challenging. So, we aimed to Study the efficacy and safety of Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin versus Sofosbuvir /ombitasvir/ paritaprevir/ritonavir/ribavirin in the management of hepatitis C patients who failed to prior Sofosbuvir/ Daclatasvir regimens in a multicenter open-labeled randomized trial.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-05-27
• Study First Submitted QC: 2018-05-27
• Study First Posted: 2018-06-08
• Primary Completion: 2019-01-30
• Study Completion: 2019-01-30
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-17
• Last Update Posted: 2019-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients with proven CHC genotype 4
• 18 years old or more,
• prior HCV treatment failure to sofosbuvir /daclatasvir
• compensated liver disease.

Exclusion Criteria

• Patients with combined HCV/HBV co-infection, hepatocellular carcinoma (HCC), decompensated liver cirrhosis (Child-Pugh score above 6), and non-genotype 4 were excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sof/sim/dac	Daclatasvir	Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin
sof/sim/dac	Sofosbuvir	Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin
sof/sim/dac	Simeprevir	Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin
sof/sim/dac	Ribavirin	Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin
sof/omb/parit	Sofosbuvir	Sofosbuvir /Ombitasvir/ Paritaprevir /Ritonavir/Ribavirin
sof/omb/parit	Ombitasvir/paritaprevir/ritonavir	Sofosbuvir /Ombitasvir/ Paritaprevir /Ritonavir/Ribavirin
sof/omb/parit	Ribavirin	Sofosbuvir /Ombitasvir/ Paritaprevir /Ritonavir/Ribavirin

Primary Outcome Measures

Name	Time	Method
SVR rate	12 weeks	The primary endpoint was the achievement of SVR at week 12 (SVR12) post-treatment. The potential adverse events were evaluated in each visit for the development of adverse events or any significant interactions.

Trial Locations

Locations (1)

Assiut University Hopsital; 🇪🇬 Assiut, Egypt