The findings from a retrospective database analysis of patients with chronic hepatitis C virus ( HCV ) genotype ( GT ) 1 or 4 infection who have chronic kidney disease ( CKD ) and were treated with Zepatier ( Elbasvir and Grazoprevir ) in the U.S. Department of Veterans Affairs ( VA ) healthcare system, were presented at The Liver Meeting 2017 in Washington, D.C.
Among patients who completed therapy, the analysis showed 95.6% ( 714/747 ) of patients with severe CKD ( stages 4-5, defined as estimated glomerular filtration rate [ eGFR ] less than 30 mL/min/1.73 m2 ) and 97.1% ( 758/781 ) of patients with moderate CKD ( stage 3, defined as eGFR 30-59 mL/min/1.73 m2 ) achieved sustained virologic response ( SVR ), defined as HCV RNA below the limit of quantification at least 10-12 weeks after the end of treatment.
For patients with missing HCV RNA data after at least 10-12 weeks after treatment completion, analyses were conducted on a post-hoc basis using the last HCV RNA data available after week 4 after therapy completion.
The retrospective observational analysis included 5,845 patients with chronic HCV infection who received Zepatier ( Elbasvir and Grazoprevir ) between February 1 and December 31, 2016.
Patients were identified from the VA Corporate Data Warehouse, a national repository of VA electronic medical records.
Presence of chronic kidney disease was measured via eGFR, per the National Kidney Foundation’s Modification of Diet in Renal Disease equation.
Of 4,693 patients evaluated in the per protocol population, 16.6% ( 781/4693 ) had CKD stage 3 and 15.9% ( 747/4693 ) had CKD stages 4 or 5.
Adverse event data were not collected as part of this real-world data analysis.
Most patients with chronic kidney disease in the analysis were male ( 96.9%, 1481/1528 ); African American ( 67.5%, 1031/1528 ) and either had GT1a infection ( 52.2%, 798/1528 ) or GT1b infection ( 42.1%, 644/1528 ).
The mean age for patients in the study with chronic kidney disease was 64.9 years.
Comorbid conditions as defined by ICD-9/10 codes in the VA database included depression ( 58.5%, 894/1528 ), diabetes ( 69.2%, 1057/1528 ), compensated cirrhosis ( 18.6%, 284/1528 ), and HIV ( 5.0%, 76/1528 ).
In the study, 19.9% of patients ( 304/1528 ) were coded as having decompensated cirrhosis; Zepatier is not for use in patients with moderate or severe hepatic impairment ( Child Pugh B or C ).
The database included patients ages 18 and older with chronic HCV infection who initiated treatment with Zepatier between February 1, 2016, and December 31, 2016, and had at least one inpatient or outpatient visit within a year prior to treatment ( n=5845 ).
The study excluded patients without greater than or equal to 2 eGFR values at least 90 days apart or on-treatment HCV RNA data, patients who did not receive 12-16 weeks of treatment with Zepatier and patients who received RBV more than 1 month after initiating treatment ( n=1152 ).
SVR ( sustained virologic response ) was defined in the protocol for these analyses as HCV RNA below the limit of quantification at least 10-12 weeks after the end of treatment.
For patients with missing HCV RNA data at week 10-12 after treatment completion, analyses were conducted on a post-hoc basis using HCV RNA data captured starting from week 4 after therapy completion.
SVR data at least 12 weeks after completion of therapy was available for 81.9% of the analysis population.
Real-world studies analyze data generated outside of randomized clinical trials, such as through analyses of electronic medical records or claims databases, to provide insight into how medicines perform or are used from a clinical and economic viewpoint in real-world clinical settings.
Information from real-world analyses alone does not provide sufficient evidence to validate efficacy or safety of a therapeutic regimen and does not provide a substitute for evidence obtained from randomized controlled clinical trials.
This study is subject to certain limitations. The VA population may not be generalizable to the entire U.S. population, due in part to the potential for a differing demographic make-up and/or risk factors. ( Xagena )
Source: Merck, 2017