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

Assiut University

Status: Completed

Conditions: HCV Coinfection

Treatments: Drug: Ribavirin; Drug: Simeprevir; Drug: Ombitasvir/paritaprevir/ritonavir; Drug: Daclatasvir; Drug: Sofosbuvir

Study type: Interventional

Funder types: Other

Identifiers

NCT03549832

IRB17300204

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

sof/sim/dac

Active Comparator group

Description:

Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin

Treatment:

Drug: Simeprevir

Drug: Daclatasvir

Drug: Sofosbuvir

Drug: Ribavirin

sof/omb/parit

Active Comparator group

Description:

Sofosbuvir /Ombitasvir/ Paritaprevir /Ritonavir/Ribavirin

Treatment:

Drug: Ombitasvir/paritaprevir/ritonavir

Drug: Sofosbuvir

Drug: Ribavirin