Efficacy of long-term tenofovir disoproxil fumarate therapy in chronic hepatitis B patients with partial virologic response in real practice
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Background/Aims: The optimal management of chronic hepatitis B (CHB) patients with partial virologic response (PVR) to tenofovir disoproxil fumarate (TDF) remains unclear. We aimed to evaluate the long-term efficacy of prolonged TDF therapy in treatment-naïve CHB patients with PVR to TDF therapy in real practice. Methods: We retrospectively investigated the efficacy of prolonged TDF therapy in treatment-naïve CHB patients with PVR to TDF. PVR was defined as a decrease in serum hepatitis B virus (HBV) DNA over 2 log10 IU/mL from baseline, with detectable HBV DNA by real-time polymerase chain reaction at week 48. Results: We included 232 patients who underwent TDF therapy for over 48 weeks. Forty-two patients (18.1%) showed PVR. In multivariate analysis, hepatitis B e antigen (HBeAg) positivity, and high levels of serum HBV DNA at baseline and week 12 were independent predictive factors for PVR during TDF therapy. Out of 42 patients with PVR, 39 (92.9%) achieved virologic response (VR) during continuous TDF treatment; the cumulative VR rates at 24, 36, and 48 months were 79.8%, 88.2%, and 95.6%, respectively. With an additional 12 months of therapy, VR was achieved in 28/31 (90.3%) patients with HBV DNA < 100 IU/mL, compared to 5/11 (45.5%) patients with HBV DNA ≥ 100 IU/mL, at week 48. Conclusions: The vast majority of patients achieved VR through prolonged TDF therapy, thus TDF treatment can be maintained in nucleos(t)ide-naïve patients with PVR at week 48, especially in those with low viremia.
Abstract
Background/Aims: The optimal management of chronic hepatitis B (CHB) patients with partial virologic response (PVR) to tenofovir disoproxil fumarate (TDF) remains unclear. We aimed to evaluate the long-term efficacy of prolonged TDF therapy in treatment-naïve CHB patients with PVR to TDF therapy in real practice. Methods: We retrospectively investigated the efficacy of prolonged TDF therapy in treatment-naïve CHB patients with PVR to TDF. PVR was defined as a decrease in serum hepatitis B virus (HBV) DNA over 2 log10 IU/mL from baseline, with detectable HBV DNA by real-time polymerase chain reaction at week 48. Results: We included 232 patients who underwent TDF therapy for over 48 weeks. Forty-two patients (18.1%) showed PVR. In multivariate analysis, hepatitis B e antigen (HBeAg) positivity, and high levels of serum HBV DNA at baseline and week 12 were independent predictive factors for PVR during TDF therapy. Out of 42 patients with PVR, 39 (92.9%) achieved virologic response (VR) during continuous TDF treatment; the cumulative VR rates at 24, 36, and 48 months were 79.8%, 88.2%, and 95.6%, respectively. With an additional 12 months of therapy, VR was achieved in 28/31 (90.3%) patients with HBV DNA < 100 IU/mL, compared to 5/11 (45.5%) patients with HBV DNA ≥ 100 IU/mL, at week 48. Conclusions: The vast majority of patients achieved VR through prolonged TDF therapy, thus TDF treatment can be maintained in nucleos(t)ide-naïve patients with PVR at week 48, especially in those with low viremia.
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