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

Sponsor

Assiut University (Other)

Overall Status

Completed

CT.gov ID

NCT03549832

Collaborator

Sohag University (Other), South Valley University (Other)

Enrollment

Location

Arms

12.9

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HCV Coinfection	Drug: Sofosbuvir Drug: Simeprevir Drug: Daclatasvir Drug: Ribavirin Drug: Ombitasvir/paritaprevir/ritonavir	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin Versus Sofosbuvir /Ombitasvir/ Paritaprevir /Ritonavir/Ribavirin in the Management of Hepatitis C Patients Fauilre to Prior Sofosbuvir/ Daclatasvir (An Open-labeled Randomized Trial)

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Jan 30, 2019

Actual Study Completion Date :

Jan 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: sof/sim/dac Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin	Drug: Sofosbuvir Sofosbuvir 400 mg oral pills Drug: Simeprevir Simeprevir 150 mg oral pills Drug: Daclatasvir Daclatasvir 60 mg oral pills Drug: Ribavirin Ribavirin 200 mg oral pills
Active Comparator: sof/omb/parit Sofosbuvir /Ombitasvir/ Paritaprevir /Ritonavir/Ribavirin	Drug: Sofosbuvir Sofosbuvir 400 mg oral pills Drug: Ribavirin Ribavirin 200 mg oral pills Drug: Ombitasvir/paritaprevir/ritonavir Ombitasvir/paritaprevir/ritonavir oral pills

Arm

Intervention/Treatment

Active Comparator: sof/sim/dac

Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin

Drug: Sofosbuvir

Sofosbuvir 400 mg oral pills

Drug: Simeprevir

Simeprevir 150 mg oral pills

Drug: Daclatasvir

Daclatasvir 60 mg oral pills

Drug: Ribavirin

Ribavirin 200 mg oral pills

Active Comparator: sof/omb/parit

Sofosbuvir /Ombitasvir/ Paritaprevir /Ritonavir/Ribavirin

Drug: Sofosbuvir

Sofosbuvir 400 mg oral pills

Drug: Ribavirin

Ribavirin 200 mg oral pills

Drug: Ombitasvir/paritaprevir/ritonavir

Ombitasvir/paritaprevir/ritonavir oral pills

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.