Comparison of Tenofovir Alafenamide and Entecavir Therapy in Patients with Chronic Hepatitis B Initially Treated with Tenofovir Disoproxil: A Retrospective Observational Survey

In chronic hepatitis B patients with or exposed to the risk of osteoporosis or renal dysfunction, switching from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide fumarate (TAF) or entecavir (ETV) may be the right choice.

This study aimed to present real-life data in terms of the efficacy and safety of a TAF/ETV treatment change while receiving TDF.

This retrospective study was conducted on 344 adult patients from 10 centers. The data of patients who had changed to ETV (n = 107) and TAF (n = 237) while receiving TDF were analyzed. The data collected at 0 and 6 months of treatment were analyzed. The virological response was assessed based on undetected hepatitis B virus (HBV) DNA. Serum alanine aminotransferase (ALT) values were used to evaluate the biochemical response. For renal function, serum creatinine and phosphorus, as well as estimated glomerular filtration rate (eGFR), were recorded. Moreover, lumbar spine and hip T-scores along with the serum lipid profile were evaluated.

The mean age of patients was 41.14 ± 13.46 years, and 224 (65.1%) of the participants were male. The treatment arms were not significantly different in terms of demographic characteristics, comorbid diseases, infection duration, family history of HBV infection, blood platelet count, serum biomarkers, such as ALT, phosphorus, creatinine, total bilirubin, albumin, lipid profile, and HBV DNA levels at the beginning. No statistically significant difference was found between the proportion of undetectable HBV DNA of the two treatment groups after 6 months (P = 0.221). The ALT normalization in the ETV and TAF groups at the sixth month compared to the baseline levels was not significantly different (P = 0.853, P = 0.330, respectively). There was no statistically significant difference between the two treatment arms regarding changes in eGFR, creatinine, phosphorus, hip, and spine T-scores from baseline to 6 months (P = 0.296, P = 0.78, P = 0.141, P = 0.832, P = 0.947, respectively). In those who switched to TAF or ETV, low-density lipoproteins cholesterol were observed to be significantly higher after 6 months compared to baseline values (P = 0.002, P = 0.049, respectively). The TC increased significantly in the TAF group (P = 0.035).

Our study showed that switching to ETV and TAF sustained the viral suppression and biochemical response achieved by TDF therapy. The treatment switch to TAF of ETV can control renal dysfunction and reduce bone mineral density caused by TDF.