Characteristics and renal function in patients with chronic hepatitis B virus infection: baseline data from the phase 2b B-Clear study

Abstract

Background and aims: Chronic hepatitis B (CHB) infection has been associated with the development of chronic kidney disease. Bepirovirsen (BPV; GSK3228836) is an antisense oligonucleotide known to distribute into the kidneys and liver. Here, we aim to characterise the baseline renal parameters in patients ( pts) enrolled in B-Clear and to understand any associations between renal parameters (estimated glomerular filtration rate [eGFR]), nucleos (t)ide analogue (NA) treatment status and other baseline laboratory/clinical characteristics.

Method: B-Clear is an ongoing trial (NCT04449029) to assess the efficacy and safety of BPV in pts with CHB infection on stable NA treatment (+NA) or not on NA (-NA) at study start. Pts were grouped based on eGFR (in ml/min/1.73m2): low (60-<90), normal (90-<120) and high (≥120). Frequency counts, descriptive statistics and 95% confidence intervals (CI) were used for comparison.

Results: A total of 455 pts were enrolled: 225 +NA and 230 -NA (Table). Mean age and length of diagnosis was inversely related to eGFR status for both those +NA and -NA. For both +NA and -NA pts, the highest proportion of pts with low eGFR were Asian (74% and 70%, respectively), and within race groups, Asians had the highest proportion of pts with low eGFR. +NA pts in the high eGFR group had higher HBsAg (mean [95% CI]: 10, 939.4 [6264.0, 15614.8]) vs pts in the low eGFR group (2723.5 [1545.9, 3901.1] IU/ml); this was not observed in -NA pts. In the -NA group, mean eGFR was lower in HBeAg negative pts (mean [95% CI]: 107.1 [105.0, 109.2]) vs HBeAg positive pts (114.4 [110.2, 118.6]). The number of pts with baseline non-steroidal anti-inflammatory drug (NSAID) or angiotensin-converting enzyme inhibitor/angiotensin receptor blocker use, or pts with diabetes or hypertension were low, but mean eGFR tended to be lower in these pt groups than in those without concomitant medication use or comorbidities, except for -NA pts with baseline NSAID use or diabetes. The most common NA used at baseline was entecavir (reported by 41% of those on NA).

Conclusion: Preliminary assessment of pts enrolled in B-Clear indicates that renal function may be associated with characteristics such as age, length of CHB diagnosis, race, HBsAg level, HBeAg status, and concomitant medications/comorbidities. [on behalf of the B-Clear study group].