Kidney Week

Abstract: FR-PO531

Effectiveness of 12 Week Elbasvir/Grazoprevir (EBR/GZR) in Patients with Genotype 1 (GT1) Chronic Hepatitis C (HCV) and CKD

Session Information

• CKD: Epidemiology, Outcomes - Non-Cardiovascular - I
  November 03, 2017 | Location: Hall H, Morial Convention Center
  Abstract Time: 10:00 AM - 10:00 AM

Category: Chronic Kidney Disease (Non-Dialysis)

• 304 CKD: Epidemiology, Outcomes - Non-Cardiovascular

Authors

• Nwankwo, Chizoba, Merck & Co, Lebanon, New Jersey, United States

Chizoba Nwankwo,

• Bacon, Bruce R., Saint Louis University School of Medicine, Saint Louis, Missouri, United States

Bruce R. Bacon,

• Curry, Michael P., Beth Israel Deaconess Medical Center, Boston, Alabama, United States

Michael P. Curry,

• Flamm, Steven, Northwestern Feinberg School of Medicine, Chicago, Illinois, United States

Steven Flamm,

• Kowdley, Kris V, Swedish Medical Center, Seattle, Washington, United States

Kris V Kowdley,

• Milligan, Scott, Trio Health Analytics, La Jolla, California, United States

Scott Milligan,

• Tsai, Naoky, University of Hawaii, Kailua, Hawaii, United States

Naoky Tsai,

Background

Elbasvir/grazoprevir (EBR/GZR) is recommended for use in the treatment of chronic HCV genotype (GT) 1 and 4 patients including those with renal impairment. The puprose of this study is to describe the real-world effectiveness of 12 week EBR/GZR in patients with GT1 chronic HCV and CKD.

Methods

Data were collected from US providers and specialty pharmacies through Trio Health’s disease management platform. Patients with CKD and GT1 HCV who initiated 12 week EBR/GZR therapy between Jan 28, 2016 (FDA approval) to Dec 31, 2016 were included in the analyses. CKD was defined as renal impairment of baseline eGFR <90 ml/min. Effectiveness was defined as attainment of per protocol sustained virological response at week 12 post-treatment (PP SVR12).

Results

228 patients with GT1 HCV and CKD were treated for 12 weeks with EBR/GZR and ribavirin (RBV) was added for 6 patients. 25% (56/228) of patients had mild stage 2 CKD, 21% (48/228) had moderate stage 3 CKD and 54% (124/228) had severe renal impairment (CKD stages 4-5). Other characteristics provided in (TABLE). At time of abstract submission, 144 of 228 were evaluable for PP SVR12; 98% (135/138) of patients treated with EBR/GZR and 100% (6/6) of patients treated with EBR/GZR+RBV achieved PP SVR12.

Conclusion

In the treatment of patients with GT1 chronic HCV and CKD, 12 week EBR/GZR was highly effective with an overall SVR12 (PP) of 98% (141/144).

Funding

• Commercial Support –