The treatment of multidrug-resistant (MDR) chronic hepatitis B (CHB) is challenging. Herein, we report a multicenter prospective cohort study for the evaluation of tenofovir disoproxil fumarate (TDF)-based therapy for MDR CHB in a real-life setting. The inclusion criteria comprised patients with resistance to more than two nucleos(t)ide analogue (NA) classes and hepatitis B virus (HBV) DNA level of ≥200 IU/mL. The primary end-point was virologic response (VR), defined as undetectable HBV DNA (<20 IU/mL) after 60 months. A total of 236 patients met the inclusion criteria. The mean HBV DNA level was 4.16 ± 1.44 log IU/mL; 26.7% of patients had liver cirrhosis. Before the initiation of TDF, 33.5%, 44.9% and 21.6% of patients had mutations resistant to L-NA + adefovir, L-NA + entecavir (ETV) and L-NA + adefovir + ETV, respectively. A total of 184 patients received TDF-based combination therapy [TDF + ETV (n = 178) or TDF + L-NA (n = 6)], and 52 patients received TDF monotherapy. In the entire cohort, the VR rates were 77.2%, 89.9% and 92.2% at 12, 36 and 60 months, respectively. The VR rates were not significantly different between the combination therapy and the monotherapy group after 12 (76.2% vs 80.4%, P =.533), 36 (89.8% vs 90.3%, P = 1.000) or 60 (92.9% vs 87.5%, P =.499) months. Also, there was no significant difference in the cumulative VR rates for 5 years between the treatment groups (P =.910). Newly developed antiviral resistance was not observed. TDF-based therapy was effective for the treatment of MDR CHB. The efficacy of TDF monotherapy was not different from that of the TDF-based combination therapy.
|Number of pages||13|
|Journal||Journal of Viral Hepatitis|
|Publication status||Published - 2020 Dec 1|
Bibliographical noteFunding Information:
This work was funded partly by the Korean Association for the Study of the Liver and partly by Korea University Research Grants. The authors are grateful to Prof. Jaehyung Cha at Department of Biostatics, Korea University for analysing the data set.
This work was funded partly by the Korean Association for the Study of the Liver and partly by Korea University Research Grants.
© 2020 John Wiley & Sons Ltd
All Science Journal Classification (ASJC) codes
- Infectious Diseases