Akademik Veri Yönetim Sistemi
EASL Congress 2024, Milan, İtalya, 5 - 08 Haziran 2024, ss.803
Background and Aims: This study aims to investigate antiviral effectiveness, side effects, and disease
outcomes in patients who have been using oral antivirals for a long-term in chronic hepatitis B (CHB).
Method: Patients with CHB who had been using tenofovir disoproxil fumarate (TDF) or entecavir (ETV)
for at least 10 years were included in this retrospective study. Co-infected patients, those receiving
immunosuppressive therapy, and transplant patients were excluded.
Results: Of the total 173 patients (baseline mean age 43.44 ± 11.74 years) in the study, 110 (63.6%)
were men. 33 (19.1%) patients were cirrhotic, and HBeAg was negative in 131 (75.7%) patients at the
beginning of treatment. 94 (54.3%) patients were treatment-naive. 92 (53.2%) patients used TDF and
81 (46.8%) patients used ETV for a mean of 156.76 ± 21.60 (120 – 204) months.
HBV-DNA negativity (< 10 IU/mL) was achieved in 100% of those who received ETV and in 95.5% of
those who received TDF, and there was no statistical difference between them (p = 0.06). Patients who
remained HBV-DNA positive were non-compliant with treatment. HBsAg became negative in only 4
(2.3%) patients, 2 of them developed anti-HBs. In the total group ALT normalization (< 42 U/L) was
observed in 96.8% of patients with elevated baseline ALT.
13 (39.4%) of 33 patients who were cirrhotic at baseline regressed to the noncirrhotic stage, in this
group, platelets were significantly high (> 150 10³/μl) before the treatment (p < 0.05). 8 (5.7%) of 140
noncirrhotic patients at baseline progressed to the cirrhotic stage. 7 (4%) of all patients decompensated.
In the total group, FIB-4 and APRI scores decreased significantly under treatment (p = 0.009 and p =
0.000, respectively).
Hepatocellular carcinoma (HCC) developed in 9 (5.2%) patients. All HCCs occurred after the 5th year
of treatment. PAGE-B score was significantly higher in those who developed HCC (p = 0.009). HCC
was significantly more common in treatment-naive patients (p = 0.033). The age at HBV diagnosis was
significantly higher in HCC patients (p = 0.023), but the most important risk factor for the development
of HCC was cirrhosis at baseline. Cirrhosis increased the risk of HCC by 7.8 times. 8 (4.6%) patients
died in the follow-up, and 2 were due to liver disease and the remaining non-liver disease.
During follow-up, nephropathy (GFR < 60 ml/min) developed in 13 (7.5%) patients, and
hypophosphatemia (P < 2.5 mg/dL) developed in 19 (11%) patients. The rate of side effects in TDF
recipients was significantly higher (p = 0.018).
Conclusion: At the end of 10 years, HBV-DNA negativity was achieved in almost all patients, and
HBsAg sero-clearance was rarely achieved. Treatment-related side effects were more common in TDF.
Nearly half of cirrhotic patients regressed to the noncirrhotic stage. Very few patients developed HCC
and the 10-year mortality rate was similar to the general population.