Renal Safety and Racial Disparity in Patients on Antiviral Treatment for Chronic Hepatitis B

Background: Many African Americans (AA) are chronically infected with Hepatitis B (HBV). While antiviral therapy is highly effective, clinical trials suggest a treatment-related decline in kidney function is possible. Given that chronic HBV predominately affects Asians worldwide, most studies have contained few AA patients. We evaluated these treatment-related kidney function changes in our predominately AA patient population. Methods: From 225 HBV patients, we identified 42 patients who were not co-infected with HIV or HCV, had a recent visit, and at least one earlier visit (before Jan 2017). If on treatment with antivirals it must have been for at least 2 years. There were 27 AA (65%) and 15 non-AA (7 Asian, 6 Caucasian, 2 other). There were 24 patients on antiviral treatment and 18 patients not on treatment. Most patients were treated with tenofovir disoproxil fumarate (TDF; n= 19), with the remaining 5 treated with entecavir. Serum creatinine levels (mg/dL) and glomerular filtration rate (GFR; mL/min/1.73m2) were obtained from the earliest visit and the most recent visit. The average time between measurements was 7.4 years (range from 2-15; median 6.5). Results : The data in the figure below presents the average creatinine and GFR for all patients by race both before and after treatment. The p-value is for pairwise analysis of the change between the two visits. Patients treated with antivirals had nearly double the increase in serum creatinine as compared to untreated patients (treated: 0.091± 0.0439, p\u3c0.05; vs untreated: 0.047 ± 0.045, not significant). There was also a greater decrease in kidney function as defined by GFR for patients on treatment as compared to untreated patients (treated: -13.9 ± 5.0, p\u3c0.05; vs untreated: -11.3 ± 5.9, not significant). The creatinine increase was also significant in AA but not in non-AA (+0.76 for AA, p\u3c0.05; vs +0.11 for non-AA). Racial disparity for GFR was not as noticeable (-12.2/95.2= 13% decrease; p\u3c0.005 for AA, and -16.2/92.3= 18% decrease; p\u3c0.05 for non-AA). When limited to just TDF, the induced increase in creatinine (+0.10; p\u3c0.05) and the decline in GFR (-14; p\u3c0.005) were statistically significant. Conclusions: While few patients had a clinically relevant rise in creatinine and/or decrease in GFR to raise the issue of stopping medication, the value of continuing to monitor especially the AA patients on anti-viral treatment is revealed by our data. The data supports the counselling of AA patients that switching to the newer formulation of tenofovir alafenamide (TAF) which is associated with less renal toxicity than TDF should be strongly considered

Racial disparity in chronic hepatitis B infection in a predominately African American urban clinic population

African Americans (AA) are 4 times as likely as Caucasians to have chronic Hepatitis B (CHB) and yet are under represented in the literature especially with respect to treatment response. The objective of this study was to compare demographics, treatment decisions and outcomes of AA to Non-AA patients seen in the same GI clinic. Of the 92 patients with CHB, 60% were AA. AA patients had similar ALT and viral load at early visits as compared to Non-AA but significantly less fibrosis as defined by AST Platelet Ratio Index. Treatment rates were lower but not statistically different for AA (38%) vs. Non-AA (46%) and the majority of patients (80%) were HBeAntigen (HBeAg) negative. The patients responded well to treatment, although HBeAg positive AA were less likely to have a decline in HBV DNA than HBeAg negative AA patients. The primary conclusions of this study are that AA as compared to Non-AA patients are less likely to have fibrosis and appear to have a dissimilar response to anti-viral therapy