title: Tenofovir versus tenofovir plus entecavir for chronic hepatitis B with lamivudine resistance and entecavir resistance.
abstract: We compared the viral suppressive efficacy of tenofovir disoproxil fumarate (TDF) mono-rescue therapy (TDF group) and TDF plus entecavir (ETV) combination-rescue therapy (TDF + ETV group) in chronic hepatitis B (CHB) patients with lamivudine resistance and entecavir resistance. One hundred and thirty-three CHB patients with lamivudine and entecavir resistance were investigated. Ninety-six patients were treated with TDF and 37 with TDF + ETV for at least 6 months. We compared the virologic response rate (HBV DNA level <20 IU/mL) between the two groups and identified the predictive factors of treatment outcome. There were no significant differences between the two groups in demographic characteristics. Up to 24 months [median: 18 (range 6-24) months], 85.4% and 89.2% of the TDF group and TDF + ETV group, respectively, achieved a virologic response (P=.068). Only the HBV DNA level at baseline was significantly associated with a virologic response in the multivariate analysis. In a subanalysis of patients with HBV DNA levels ≥4 log (IU/mL) at baseline, a higher proportion of patients in the TDF + ETV group than the TDF group achieved a virologic response (92.9% vs 68.3%; P<.001), while 90% of patients with HBV DNA (IU/mL) levels <4 log in all both TDF and TDF + ETV groups achieved a virologic response. TDF mono-rescue therapy is a reasonable option in patients with lamivudine resistance and entecavir resistance. However, the combination strategy should be considered in patients with high baseline HBV DNA levels.
authors.affiliation: Department of Internal Medicine, Catholic Kwandong University College of Medicine, International St. Mary's Hospital, Incheon Metropolitan City, Korea.|Institute for Integrative Medicine, Catholic Kwandong University College of Medicine, International St. Mary's Hospital, Incheon Metropolitan City, Korea.
authors.forename: S
authors.initials: S
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.|Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: S H
authors.initials: SH
authors.lastname: Ahn
authors.affiliation: Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: K S
authors.initials: KS
authors.lastname: Jung
authors.affiliation: Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.|Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: D Y
authors.initials: DY
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.|Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: B K
authors.initials: BK
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.|Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: S U
authors.initials: SU
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.|Department of Infectious Diseases, Mongolian National University of Medical Sciences, Ulaanbaatar, Mongolia.
authors.forename: O
authors.initials: O
authors.lastname: Baatarkhuu
authors.affiliation: Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: H J
authors.initials: HJ
authors.lastname: Ku
authors.affiliation: Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.|Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: K
authors.initials: K
authors.lastname: Han
authors.affiliation: Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.|Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: J Y
authors.initials: JY
authors.lastname: Park
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000998:Antiviral Agents / Q000494:pharmacology / Q000627:therapeutic use*; D004279:DNA, Viral / Q000097:blood; D024882:Drug Resistance, Viral; D005260:Female; D006147:Guanine / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D006515:Hepatitis B virus / Q000187:drug effects* / Q000302:isolation & purification; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D019259:Lamivudine / Q000494:pharmacology; D008297:Male; D008875:Middle Aged; D000068698:Tenofovir / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D019259:Lamivudine; C413685:entecavir; D006147:Guanine; D000068698:Tenofovir
keywords: chronic hepatitis B; entecavir; multidrug resistance; tenofovir; virologic response