Efficacy of tenofovir-based rescue therapy for chronic hepatitis B patients with resistance to lamivudine and entecavir.
- Author:
Hee Jeong JEON
1
;
Seok Won JUNG
;
Neung Hwa PARK
;
Yujin YANG
;
Jin Hee NOH
;
Jae Sung AHN
;
Hyung Rae KIM
;
Jae Ho LEE
;
Jung Woo SHIN
Author Information
- Publication Type:Original Article
- Keywords: Tenofovir; Resistance; Lamivudine; Entecavir; Chronic hepatitis B
- MeSH: Antiviral Agents; DNA; Hepatitis B virus; Hepatitis B, Chronic*; Hepatitis, Chronic*; Humans; Lamivudine*; Multivariate Analysis; Tenofovir; Treatment Outcome
- From:Clinical and Molecular Hepatology 2017;23(3):230-238
- CountryRepublic of Korea
- Language:English
- Abstract: BACKGROUND/AIMS: Tenofovir disoproxil fumarate (TDF) monotherapy for 48 weeks provided a virological response comparable to that of TDF and entecavir (ETV) combination therapy in patients infected with ETV-resistant hepatitis B virus (HBV). Little long-term data in routine clinical practice are available regarding the optimal treatment of patients with ETV-resistant HBV. METHODS: We investigated the long-term antiviral efficacy of combination therapy of TDF+lamivudine (LAM) or TDF+ETV compared to that of TDF monotherapy in 73 patients with resistance to both LAM and ETV. RESULTS: Patients were treated with TDF monotherapy (n=12), TDF+LAM (n=19), or TDF+ETV (n=42) for more than 6 months. The median duration of TDF-based rescue therapy was 37 months. Virologic response (VR) was found in 63 patients (86.3%). The rates of VR among the three groups (TDF monotherapy, TDF+LAM, and TDF+ETV) were not statistically different (log-rank P=0.200) at 12 months (59.3%, 78.9%, and 51.8%, respectively) or at 24 months (88.4%, 94.7%, and 84.2%). In addition, treatment efficacy of TDF-based combination or TDF monotherapy was not statistically different with ETV-resistant strains or exposure to other antiviral agents. In multivariate analysis, only lower baseline HBV DNA level was an independent predictor for VR (hazard ratio, 0.723; 95% confidence interval, 0.627-0.834; P<0.001). CONCLUSIONS: TDF monotherapy was as effective as combination therapy of TDF+LAM or TDF+ETV in maintaining long-term viral suppression in chronic hepatitis B patients with resistance to both LAM and ETV. HBV DNA level at the start of TDF rescue therapy was the only independent predictor of subsequent VR.
