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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Assiut University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- SVR rate
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
sof/sim/dac
Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin
Intervention: Sofosbuvir (Drug)
sof/sim/dac
Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin
Intervention: Simeprevir (Drug)
sof/sim/dac
Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin
Intervention: Daclatasvir (Drug)
sof/sim/dac
Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin
Intervention: Ribavirin (Drug)
sof/omb/parit
Sofosbuvir /Ombitasvir/ Paritaprevir /Ritonavir/Ribavirin
Intervention: Sofosbuvir (Drug)
sof/omb/parit
Sofosbuvir /Ombitasvir/ Paritaprevir /Ritonavir/Ribavirin
Intervention: Ribavirin (Drug)
sof/omb/parit
Sofosbuvir /Ombitasvir/ Paritaprevir /Ritonavir/Ribavirin
Intervention: Ombitasvir/paritaprevir/ritonavir (Drug)
Outcomes
Primary Outcomes
SVR rate
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Mohamed Abdelsabour Mekky
Ass. Professor
Assiut University