Background & aims: There are no globally agreed upon treatment guidelines for patients with chronic hepatitis B virus (HBV) with multidrug resistance (MDR). We conducted a multicenter, prospective, real-world cohort study of effects of tenofovir disoproxyl fumarate (TDF) monotherapy and TDF-based combination therapy, as rescue therapy, in patients with multidrug-resistant chronic HBV infections. Methods: We recruited patients with chronic HBV infection with resistance to antivirals from 8 tertiary hospitals in Korea. Patients (n=423) received rescue therapy with TDF monotherapy (n=174) or TDF-based combination therapy (n=249). The median follow-up period was 180 weeks. A virologic response was defined as a serum HBV DNA level of <20 IU/mL. Results: Cumulative rates of virologic response did not differ significantly between the groups that received TDF monotherapy vs combination therapy at 48 weeks (71.7% vs 68.9%), 96 weeks (85.1% vs 84.2%), 144 weeks (92.1% vs 92.7%), 192 weeks (93.4% vs 95.7%), or 240 weeks (97.7% vs 97.2%). Serum levels of HBV DNA below 4.0 log10 IU/mL (odds ratio, 2.478; 95% CI 1.959–3.135; P < .001) and the absence of mutations associated with resistance to adefovir (odds ratio, 1.570; 95% CI 1.279–1.926; P < .001) were associated with virologic response in patients with MDR. There was no significant difference of virologic response among patients of different ages, sex, patients with vs without cirrhosis, positivity for hepatitis B e antigen, or renal function (all P > .05). Conclusion: In a multicenter, real-world cohort study, long-term use of TDF monotherapy showed non-inferior antiviral efficacy compared with that of TDF-based combination therapy in patients with MDR.
Bibliographical noteFunding Information:
Funding This study was supported by an unrestricted grant from Gilead Sciences for the investigator-initiated trials. This research was supported by a fund (2016-ER5103-01) by Research of Korea Centers for Disease Control and Prevention. Conflicts of interest This author discloses the following: Sang-Hoon Ahn has served as an advisor and lecturer for Bristol-Myers Squibb, Gilead Sciences, Roche, MSD, Abbvie, and Green Cross; and has received unrestricted grant support from Bristol-Myers Squibb, Gilead Sciences, and Roche for the investigator-initiated trials. The other authors disclose no conflicts Funding This study was supported by an unrestricted grant from Gilead Sciences for the investigator-initiated trials. This research was supported by a fund ( 2016-ER5103-01) by Research of Korea Centers for Disease Control and Prevention.
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