To evaluate efficacy and safety of Ombitasvir, paritaprevir, and ritonavir plus ribavirin based therapy for chronic hepatitis C with or without compensated cirrhosis in haemodialysis patients.
The aim of this study is; To evaluate the efficacy and safety of ombitasvir, paritaprevir, and ritonavir based therapy for chronic hepatitis C with or without compensated cirrhosis in HCV treatment naïve patients receiving long-term haemodialysis through assessment of: 1. The proportion of patients with a sustained virological response (HCV RNA \<25 IU/mL) 12 weeks after the last dose of study drug (SVR12). 2. To determine withdrawal rate related to side effects and /or adverse effects for patients receiving at least 1 dose of the study medication.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
A total of 40 HCV treatment naïve patients with or without compensated cirrhosis on regular hemodialysis will be enrolled in the study. * These patients will receive an intervention of '25 mg ombitasvir, 150 mg paritaprevir, and 100 mg ritonavir' (2 capsules Qurevo®) plus ribavirin 200 mg daily for 12 weeks. * Qurevo will be given once daily (on the day of dialysis, it will be given after dialysis session). * Ribavirin will be given once daily (on the day of dialysis, it will be given 4 hrs before dialysis session ).
Maadi armed forces hospital
Cairo, Maadi, Egypt
RECRUITINGSustained Virological Response
The proportion of patients with a sustained virological response (HCV RNA \<25 IU/mL) 12 weeks after the last dose of study drug (SVR12).
Time frame: After 12 weeks after the last dose
Treatment related withdrawal rate
To determine withdrawal rate related to side effects and /or adverse effects for patients receiving at least 1 dose of the study medication.
Time frame: during treatment period, average duration 3 months
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