A recent observational study has shed light on the efficacy and safety of two commonly used antiviral therapies for chronic hepatitis B: entecavir (ETV) and tenofovir alafenamide (TAF). Amid growing concerns about long-term safety profiles, researchers set out to assess the impact of switching from ETV to TAF.
The study, conducted by researchers from Kindai University and published in Scientific Reports, evaluated 77 patients over 240 weeks, comparing those who continued ETV with those who switched to TAF. The findings were significant for the medical community, as they revealed comparable efficacy and safety profiles for both treatments.
The primary outcome measured was the change in serum hepatitis B surface antigen (HBsAg) levels. After monitoring, no significant differences were observed between the two groups with respect to HBsAg levels, which are pivotal indicators of treatment success. While the mean change was −0.365 log IU/mL for ETV and −0.301 log IU/mL for TAF, these results did not indicate marked superiority for either drug. The statistical analysis confirmed the findings were not significantly different (p = 0.39).
Overall clinical assessments also showed no significant differences between the groups concerning renal function, with both therapies maintaining similar levels of estimated glomerular filtration rate (eGFR) and biomarkers indicative of renal tubular damage. For example, the mean change for eGFR was −5.407 vs. −2.666 for ETV and TAF respectively, which again showed no statistically significant difference (p = 0.240).
Interestingly, the study highlighted two cases of hepatocellular carcinoma (HCC) detected exclusively within the ETV group, underscoring the complexity of long-term treatment outcomes. Though the overall incidence of HCC did not present significant difference (p = 0.08), the cases raised questions about the nuanced response of patients to antiviral therapies.
The rationale for investigating the switch from ETV to TAF stemmed from earlier findings indicating lower side effects, particularly renal issues, with TAF. The current observational study bolstered the narrative surrounding both medications, showing ETV and TAF to be comparable, reinforcing clinical confidence for practitioners when considering therapy adjustments for patients.
"The long-term observation of this study demonstrated ETV and TAF have comparable efficacy and safety," said the authors of the article, confirming the clinical applicability of these results.
Looking forward, this study provides valuable insights and suggests the need for larger, randomized trials to bolster the findings presented, particularly exploring the diverse patient demographics and viral characteristics associated with chronic hepatitis B. Clinical guidelines may benefit from such comprehensive evaluations to solidify treatment protocols and improve patient outcomes.