Sofosbuvir-Containing Regimens in Patients with Renal Disease HCV-TARGET Trial Results
This study evaluated the efficacy and safety of sofosbuvir-containing regimens in patients with renal disease participating in the HCV-TARGET trial. Results showed sustained viral clearance in 83% of patients with renal impairment, emphasizing the need for close monitoring and experienced providers for treatment. Higher rates of adverse events were noted in these patients, highlighting the importance of individualized care.
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Phase 3b Renal Disease Treatment Na ve and Treatment Experienced Sofosbuvir-Containing Regimens in Patients with Renal Disease HCV TARGET (Renal) Source: Saxena V, et al. Liver Int. 2016;36:807-16.
Sofosbuvir-Containing Regimens in Patients with Renal Disease HCV-TARGET Trial: Study Features HCV-Target and Patients with Renal Disease: Features Design: Longitudinal, treatment cohort study with sofosbuvir-containing regimens, including patients with renal disease Setting: 56 centers in US, Germany, and Canada Entry Criteria - Chronic HCV treated with sofosbuvir-containing regimen - Age 18 or older - Includes patients with baseline renal insufficiency - Includes patients with cirrhosis Primary End-Points - Efficacy (SVR12) and safety Source: Saxena V, et al. Liver Int. 2016;36:807-16.
Sofosbuvir-Containing Regimens in Patients with Renal Disease HCV -TARGET HCV TARGET: SVR12, by Baseline eGFR 100 88 Patients with SVR 12 (%) 82 81 80 60 40 20 15/17 38/47 1220/1495 0 31-45 >45 30 Estimated Glomerular Filtration Rate (eGFR mL/min/1.73 m2) Source: Saxena V, et al. Liver Int. 2016;36:807-16.
Sofosbuvir-Containing Regimens in Patients with Renal Disease HCV-TARGET Trial: Result HCV-TARGET Trial: SVR12 Results by Baseline eGFR and Regimen All eGFR >45* eGFR 45* 100 100 Patients with SVR 12 (%) 87 87 86 80 82 81 81 80 80 75 74 60 50 40 20 0 SOF/PEG/RBV SOF/RBV SOF/SMV SOF/SMV/RBV *eGFR units = mL/min/1.73 m2 Source: Saxena V, et al. Liver Int. 2016;36:807-16.
Sofosbuvir-Containing Regimens in Patients with Renal Disease HCV-TARGET Trial: Conclusions Conclusion: Sustained viral clearance was achieved in 83% of patients with renal impairment (eGFR 45 ml/min/1.73 m2) treated with sofosbuvir-containing regimens. However, these patients had higher rates of anaemia, worsening renal dysfunction and serious adverse events regardless of use of RBV. Patient with renal impairment require close monitoring and should be treated by providers extensively experienced with SOF-containing regimens. Source: Saxena V, et al. Liver Int. 2016;36:807-16.
This slide deck is from the University of Washingtons Hepatitis C Online and Hepatitis Web Study projects. Hepatitis C Online www.hepatitisc.uw.edu Hepatitis Web Study http://depts.washington.edu/hepstudy/ Funded by a grant from the Centers for Disease Control and Prevention.
