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

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)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03549832

Enrollment

Registered

2018-06-08

Start date

2018-01-01

Completion date

2019-01-30

Last updated

2019-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCV Coinfection

Keywords

HCV, DAAs, Non-responder

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.

Interventions

DRUGSofosbuvir

Sofosbuvir 400 mg oral pills

DRUGSimeprevir

Simeprevir 150 mg oral pills

DRUGDaclatasvir

Daclatasvir 60 mg oral pills

DRUGRibavirin

Ribavirin 200 mg oral pills

DRUGOmbitasvir/paritaprevir/ritonavir

Ombitasvir/paritaprevir/ritonavir oral pills

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026