Hye Won Lee1, Jun Yong Park1, Jin Woo Lee2, Ki Tae Yoon3, Chang Wook Kim4, Hana Park5, Young Seok Kim6, Soon Ku Paik7, Jung Il Lee1, Beom Kyung Kim1, Kwang-Hyub Han1, Sang Hoon Ahn8. 1. Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea. 2. Department of Internal Medicine, Inha University School of Medicine, Incheon, Republic of Korea. 3. Department of Internal Medicine, Pusan National University School of Medicine, Yangsan, Republic of Korea. 4. Department of Internal Medicine, Catholic University College of Medicine, Seoul, Republic of Korea. 5. Department of Internal Medicine, CHA University College of Medicine, Bundang, Republic of Korea. 6. Department of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon, Republic of Korea. 7. Department of Internal Medicine, Wonju College of Medicine, Yonsei University, Wonju, Republic of Korea. 8. Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea. Electronic address: ahnsh@yuhs.ac.
Abstract
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.
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.
Authors: Jung Hun Kim; Jeong Han Kim; Won Hyeok Choe; So Young Kwon; Byung-Chul Yoo; Eileen L Yoon; Seong Hee Kang Journal: Antimicrob Agents Chemother Date: 2022-07-13 Impact factor: 5.938