At a glance
ClinicalIndex Comparison Record- ✓Age 20–70 years
- ✓BMI 18.5–35.0 kg/m²
- ✓Chronic HCV infection with anti-HCV antibody or HCV RNA >1,000 IU/mL for ≥6 months, or positive HCV RNA >1,000 IU/mL at screening
- ✓HCV genotype 1b infection
- ✕HCV genotype other than 1b
- ✕HBV or HIV co-infection
- ✕Cirrhosis (Child-Pugh class A, B, or C)
- ✕Primary liver disease other than chronic HCV (hemochromatosis, alpha-1 antitrypsin deficiency, Wilson's disease, autoimmune hepatitis, alcoholic liver disease, drug-induced hepatitis)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Paritaprevir/Ritonavir/Ombitasvir Plus Dasabuvir for Treatment-Naive and Treatment-Experienced Non-Cirrhotic Patients With Hepatitis C Virus Genotype 1b Receiving Hemodialysis
In Brief
A Phase 4 clinical trial evaluating PTV/r/OBV/DSV for Hepatitis Viruses. Completed, enrolled 46 participants across 8 sites.
Detailed Summary
Hepatitis C virus (HCV) infection is common in patients receiving hemodialysis. The uptake of antiviral therapy for these patients is limited in the era of interferon (IFN) plus ribavirin (RBV), probably because the sustained virologic response (SVR) rates are low and the risk of treatment-related adverse events (AEs) are high. In the era of IFN-free direct acting antiviral agents (DAAs), several studies have indicated high rates of SVR and excellent safety profiles to treat patients with severe renal impairment. With regard to ombitasvir/paritaprevir/ritonavir plus dasabuvir (PrOD) treatment, a phase 2 study (RUBY-1) study has shown 90% of SVR in treatment-naive HCV-1 patients with chronic kidney disease (CKD) stage 4 or 5. Among the HCV-1b patients, who received PrOD for 12 weeks, all 7 patients achieved SVR. Although the data confirmed the excellent safety and efficacy in HCV-1b patients with severe renal impairment, the patient number was small and the data with regard to treatment-experienced patients was lacking. Therefore, we aimed to evaluated the safety and efficacy of ProD for 12 weeks in treatment-naive and treatment-experienced HCV-1b patients receiving hemodialysis.
Study Details
Timeline
Interventions
Viekirax/Exviera for 12 weeks