Real-world single-center experience with entecavir and tenofovir disoproxil fumarate in treatment-naïve and experienced patients with chronic hepatitis B

Abstract

Background/Aim:The goal of antiviral therapy for chronic hepatitis B (CHB) is to improve survival of the patients by achieving a complete virological response (CVR). This study aimed to evaluate long-term efficacy of entecavir (ETV) and tenofovir disoproxil fumarate (TDF) in nucleos(t)ide analog (NA)-naïve and NA-experienced Korean patients with CHB and to determine the incidence of cirrhosis-related complications in these patients.Patients and Methods:We retrospectively reviewed medical records of all patients treated with ETV or TDF from July 2007 to January 2017. We examined CVR and analyzed the predictive factors influencing the rate of CVR and evaluated the incidences of cirrhosis-related complications.Results:The proportion of patients who achieved CVR was 94.2% in the ETV group and 91.1% in the TDF group (P = 0.358). Among patients who achieved CVR, the mean time to CVR was 13.5 ± 14.3 months in the ETV group and 11.5 ± 10.6 months in the TDF group (P = 0.169). Positive predictive factors for CVR included the current treatment with TDF, a low hepatitis B virus DNA level, negative hepatitis B e-antigen status, and high alanine aminotransferase level in baseline laboratory test. The annual incidence rate of HCC was 127 per 10,000 patient-years (1.27% per year) in ETV group, and 85 per 10,000 patient-years (0.85% per year) in TDF group (P = 0.526).Conclusion:Both ETV and TDF therapy resulted in a high CVR, and the annual incidence rates of HCC and other cirrhosis-related complications were not significantly different between the two treatment groups.

Risk of hepatocellular carcinoma after curative treatment when switching from tenofovir disoproxil fumarate or entecavir to tenofovir alafenamide: A real‐world multicenter cohort study

“…These clinical studies demonstrated results comparable to those of ETV or TDF, suggesting that TAF is non‐inferior to a first‐line NA treatment 14,15,24 . However, the results of the studies should be interpreted with caution due to bias in favor of groups with shorter observation periods, as TAF has only been used to treat CHB in recent years 7,25,26 . Similarly, recent controversy about the efficacy of ETV and TDF against HCC development and other liver‐related complications has been largely attributed to key confounders, such as varying observation periods, time differences over the years, and gradual improvements in the efficacy of curative treatments over time 27–30 .…”

“…14,15,24 bias in favor of groups with shorter observation periods, as TAF has only been used to treat CHB in recent years. 7,25,26 Similarly, recent controversy about the efficacy of ETV and TDF against HCC development and other liver-related complications has been largely attributed to key confounders, such as varying observation periods, time differences over the years, and gradual improvements in the efficacy of curative treatments over time. [27][28][29][30] In the present study, the results were obtained after adjusting for these major confounders, which was considered a valid method for evaluating NA's efficacy.…”

Antiviral Therapy of Chronic Hepatitis B Virus between Present and Future

“…Kim YM et al [79] monitored the virological response (HBV DNA level of less than 20 IU/mL) in HBV patients who had not received any antiviral treatment before and in patients who had previously tried another antiviral and developed resistance (antivirals such as lamivudine, adefovir). It was observed that treatment-naive patients achieved virological response much faster: 12.3 ± 10.5 months compared to 20.7 ± 27.4 months in experienced NA patients (p = 0.138).…”

Collaborating with AI in literature search—An important frontier

“…Thus, although 50,027/119,053 (42.0%) patients in the meta-analysis were missed in the Elicit search, only 1 (596 patients) out of 9 comparative studies was missed. 4 Of the 37 additional papers “gained,” only 1 was an original research article (303 patients) 5 , which would have met our study criteria.…”