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.
Citations
Citations to this article as recorded by
Efficacy and Safety of Tenofovir Plus Entecavir Combination Therapy Versus Tenofovir Monotherapy in Chronic Hepatitis B Virus Patients With Resistance or Partial Response to Entecavir: A Systematic Review and Meta-analysis Syed H. Ali, Muhammad H. Shah, Sakshi Roy, Hareesha R. Bharadwaj, Joecelyn K. Tan, Medha S. Rao, Muhtasim Fuad, Arjun Ahluwalia, Aditya Gaur, Priyal Dalal, Arkadeep Dhali, Harishankar Gopakumar Journal of Clinical and Experimental Hepatology.2025; 15(4): 102541. CrossRef
Tenofovir-Associated Kidney Dysfunction and Bone Fracture: A Case Report and Literature Review KK Athish, Shobhana Nayak Rao, Venkat H Marimuthu, Vamsi Krishna, Anwadevi Arun Cureus.2024;[Epub] CrossRef
Bilateral atraumatic neck of femur fractures secondary to tenofovir-induced fanconi syndrome Vikaesh Moorthy, Kelvin Guoping Tan Journal of Orthopaedic Reports.2023; 2(1): 100123. CrossRef
Molecular characterization of hepatitis B virus (HBV) isolated from a pediatric case of acute lymphoid leukemia, with a delayed response to antiviral treatment: a case report Chien-Yu Chen, Christina Hajinicolaou, Priya Walabh, Luicer Anne Olubayo Ingasia, Ernest Song, Anna Kramvis BMC Pediatrics.2022;[Epub] CrossRef
Tenofovir Alafenamide Fumarate, Tenofovir Disoproxil Fumarate and Entecavir: Which is the Most Effective Drug for Chronic Hepatitis B? A Systematic Review and Meta-analysis Xuefeng Ma, Shousheng Liu, Mengke Wang, Yifen Wang, Shuixian Du, Yongning Xin, Shiying Xuan Journal of Clinical and Translational Hepatology.2021; 000(000): 000. CrossRef
Asociación Mexicana de Hepatología A.C. Clinical guideline on hepatitis B F. Higuera-de-la-Tijera, G.E. Castro-Narro, J.A. Velarde-Ruiz Velasco, E. Cerda-Reyes, R. Moreno-Alcántar, I. Aiza-Haddad, M. Castillo-Barradas, L.E. Cisneros-Garza, M. Dehesa-Violante, J. Flores-Calderón, M.S. González-Huezo, E. Márquez-Guillén, L.E. Muñ Revista de Gastroenterología de México (English Edition).2021; 86(4): 403. CrossRef
Asociación Mexicana de Hepatología A.C. Guía Clínica de Hepatitis B F. Higuera-de-la-Tijera, G.E. Castro-Narro, J.A. Velarde-Ruiz Velasco, E. Cerda-Reyes, R. Moreno-Alcántar, I. Aiza-Haddad, M. Castillo-Barradas, L.E. Cisneros-Garza, M. Dehesa-Violante, J. Flores-Calderón, M.S. González-Huezo, E. Márquez-Guillén, L.E. Muñ Revista de Gastroenterología de México.2021; 86(4): 403. CrossRef
Entecavir+tenofovir vs. lamivudine/telbivudine+adefovir in chronic hepatitis B patients with prior suboptimal response Hyun Young Woo, Jun Yong Park, Si Hyun Bae, Chang Wook Kim, Jae Young Jang, Won Young Tak, Dong Joon Kim, In Hee Kim, Jeong Heo, Sang Hoon Ahn Clinical and Molecular Hepatology.2020; 26(3): 352. CrossRef
Tenofovir‐based combination therapy or monotherapy for multidrug‐resistant chronic hepatitis B: Long‐term data from a multicenter cohort study Hyung Joon Yim, Sang Jun Suh, Young Kul Jung, Seong Gyu Hwang, Yeon Seok Seo, Soon Ho Um, Sae Hwan Lee, Young Seok Kim, Jae Young Jang, In Hee Kim, Hyoung Su Kim, Ji Hoon Kim, Young Sun Lee, Eileen L. Yoon, Myeong Jun Song, Jun Yong Park Journal of Viral Hepatitis.2020; 27(12): 1306. CrossRef
Efficacy and cost-effectiveness of antiviral regimens for entecavir-resistant hepatitis B: A systematic review and network meta-analysis Si-Si Yang, Cheng-Wei Cai, Xue-Qing Ma, Jia Xu, Cheng-Bo Yu Hepatobiliary & Pancreatic Diseases International.2020; 19(6): 507. CrossRef
Long-term Efficacy of Tenofovir Disoproxil Fumarate Monotherapy for Multidrug-Resistant Chronic HBV infection Hye Won Lee, Jun Yong Park, Jin Woo Lee, Ki Tae Yoon, Chang Wook Kim, Hana Park, Young Seok Kim, Soon Ku Paik, Jung Il Lee, Beom Kyung Kim, Kwang-Hyub Han, Sang Hoon Ahn Clinical Gastroenterology and Hepatology.2019; 17(7): 1348. CrossRef
Risk factors associated with hypophosphatemia in chronic Hepatitis B patients treated with tenofovir disoproxil fumarate Dohyeong Lee, Byung Cheol Yun, Kwang Il Seo, Byung Hoon Han, Sang Uk Lee, Eun Taek Park, Jin Wook Lee, Joonho Jeong Medicine.2019; 98(50): e18351. CrossRef
Effect of tenofovir on renal function in patients with chronic hepatitis B Woo Jin Jung, Jae Young Jang, Won Young Park, Soung Won Jeong, Hee Jeong Lee, Sang Joon Park, Sae Hwan Lee, Sang Gyune Kim, Sang-Woo Cha, Young Seok Kim, Young Deok Cho, Hong Soo Kim, Boo Sung Kim, Suyeon Park, Baigal Baymbajav Medicine.2018; 97(7): e9756. CrossRef
Long-term Outcomes in Patients with HBV Treated with Antiviral Agents Mauro Viganò, Alessandro Loglio, Pietro Lampertico Current Hepatology Reports.2018; 17(4): 502. CrossRef
Is tenofovir monotherapy a sufficient defense line against multi-drug resistant hepatitis B virus? Yun Bin Lee, Jeong-Hoon Lee Clinical and Molecular Hepatology.2017; 23(3): 219. CrossRef
First
Prev
