Abstract
Background
Current clinical guidelines recommend treating chronic hepatitis B virus (HBV) infection in a minority of cases, but there are relatively scarce data on evolution or progression of liver inflammation and fibrosis in cases of chronic HBV (CHB) that do not meet treatment criteria. We aimed to assess the impact of TDF on liver disease, and the risk of renal impairment in treated CHB patients in comparison to untreated patients.
Methods
We studied a longitudinal ethnically diverse CHB cohort in the UK attending out-patient clinics between 2005 and 2018. We examined TDF treatment (vs. untreated) as the main exposure, with HBV DNA viral load (VL), ALT, elastography scores and eGFR as the main outcomes, using paired tests and mixed effects model for longitudinal measurements. Additionally, decline of eGFR during follow-up was quantified within individuals by thresholds based on clinical guidelines. Baseline was defined as treatment initiation for TDF group and the beginning of clinical follow-up for untreated group respectively.
Results
We included 206 adults (60 on TDF, 146 untreated), with a median ± IQR follow-up duration of 3.3 ± 2.8 years. The TDF group was significantly older (median age 39 vs. 35 years, p = 0.004) and more likely to be male (63% vs. 47%, p = 0.04) compared to the untreated group. Baseline difference between TDF and untreated groups reflected treatment eligibility criteria. As expected, VL and ALT declined significantly over time in TDF-treated patients. Elastography scores normalised during treatment in the TDF group reflecting regression of inflammation and/or fibrosis. However, 6/81 (7.4%) of untreated patients had a progression of fibrosis stage from F0-F1 to F2 or F3. There was no evidence of difference in rates or incidence of renal impairment during follow-up in the TDF vs. untreated group.
Conclusions
Risk of liver inflammation and fibrosis may be raised in untreated patients compared to those receiving TDF, and TDF may benefit a larger percentage of the CHB population.
Current clinical guidelines recommend treating chronic hepatitis B virus (HBV) infection in a minority of cases, but there are relatively scarce data on evolution or progression of liver inflammation and fibrosis in cases of chronic HBV (CHB) that do not meet treatment criteria. We aimed to assess the impact of TDF on liver disease, and the risk of renal impairment in treated CHB patients in comparison to untreated patients.
Methods
We studied a longitudinal ethnically diverse CHB cohort in the UK attending out-patient clinics between 2005 and 2018. We examined TDF treatment (vs. untreated) as the main exposure, with HBV DNA viral load (VL), ALT, elastography scores and eGFR as the main outcomes, using paired tests and mixed effects model for longitudinal measurements. Additionally, decline of eGFR during follow-up was quantified within individuals by thresholds based on clinical guidelines. Baseline was defined as treatment initiation for TDF group and the beginning of clinical follow-up for untreated group respectively.
Results
We included 206 adults (60 on TDF, 146 untreated), with a median ± IQR follow-up duration of 3.3 ± 2.8 years. The TDF group was significantly older (median age 39 vs. 35 years, p = 0.004) and more likely to be male (63% vs. 47%, p = 0.04) compared to the untreated group. Baseline difference between TDF and untreated groups reflected treatment eligibility criteria. As expected, VL and ALT declined significantly over time in TDF-treated patients. Elastography scores normalised during treatment in the TDF group reflecting regression of inflammation and/or fibrosis. However, 6/81 (7.4%) of untreated patients had a progression of fibrosis stage from F0-F1 to F2 or F3. There was no evidence of difference in rates or incidence of renal impairment during follow-up in the TDF vs. untreated group.
Conclusions
Risk of liver inflammation and fibrosis may be raised in untreated patients compared to those receiving TDF, and TDF may benefit a larger percentage of the CHB population.
| Original language | English |
|---|---|
| Article number | 610 |
| Number of pages | 1 |
| Journal | BMC Infectious Diseases |
| Volume | 21 |
| DOIs | |
| Publication status | Published - 26 Jun 2021 |
Bibliographical note
Funding Information:We conducted a longitudinal retrospective study on an adult CHB cohort in the United Kingdom between 06/2005 and 10/2018. Data were collected from Oxford University Hospitals (OUH) National Health Service (NHS) Foundation Trust, a large teaching hospital trust in the South East of the UK, using a clinical informatics pipeline supported by the National Institute for Health Research Health Informatics Collaborative (NIHR HIC) [, ].
Funding Information:
This work has been supported by the National Institute for Health Research (NIHR) Biomedical Research Centre (BRC) at Oxford and funded by the NIHR Health Informatics Collaborative (HIC). CC is a doctoral student who receives partial doctoral funding from GlaxoSmithKline. EB is supported by the Oxford NIHR Biomedical Research Centre and is an NIHR Senior Investigator. PCM is supported by a Wellcome intermediate fellowship (grant ref. 110110/Z/15/Z). The views expressed in this article are those of the author and not necessarily those of the NHS, the NIHR, or the Department of Health.
Publisher Copyright:
© 2021, The Author(s).
Keywords
- Liver fibrosis
- eGFR
- Tenofovir Disoproxil fumarate (TDF) therapy
- Chronic hepatitis B
- Renal impairment