Antiviral efficacies of currently available rescue therapies for multidrug-resistant chronic hepatitis B.
- Author:
Mi Sung PARK
1
;
Beom Kyung KIM
;
Kyung Sik KIM
;
Ja Kyung KIM
;
Seung Up KIM
;
Jun Yong PARK
;
Do Young KIM
;
Oidov BAARTARKHUU
;
Kwang Hyub HAN
;
Chae Yoon CHON
;
Sang Hoon AHN
Author Information
- Publication Type:Original Article ; Controlled Clinical Trial ; Research Support, Non-U.S. Gov't
- Keywords: Hepatitis B virus; Multidrug resistance; Hepatitis B; Entecavir; Adefovir
- MeSH: Adenine/analogs & derivatives/therapeutic use; Adult; Aged; Antiviral Agents/*therapeutic use; DNA, Viral/blood; Drug Resistance, Viral; Drug Therapy, Combination; Female; Follow-Up Studies; Genotype; Guanine/analogs & derivatives/therapeutic use; Hepatitis B e Antigens/blood; Hepatitis B virus/genetics; Hepatitis B, Chronic/*drug therapy; Humans; Lamivudine/therapeutic use; Male; Middle Aged; Organophosphonates/therapeutic use; Treatment Outcome
- From:Clinical and Molecular Hepatology 2013;19(1):29-35
- CountryRepublic of Korea
- Language:English
- Abstract: BACKGROUND/AIMS: The incidence of multidrug-resistant (MDR) chronic hepatitis B (CHB) during sequential lamivudine (LAM) and adefovir dipivoxil (ADV) treatment is increasing. We investigated the antiviral efficacies of various rescue regimens in patients who failed sequential LAM-ADV treatment. METHODS: Forty-eight patients (83.3% of whom were HBeAg-positive) who failed sequential LAM-ADV treatment were treated with one of the following regimens: entecavir (ETV) (1 mg) monotherapy (n=16), LAM+ADV combination therapy (n=20), or ETV (1 mg)+ADV combination therapy (n=12). All patients had confirmed genotypic resistance to both LAM and ADV and were evaluated every 12 weeks. RESULTS: The baseline characteristics and treatment duration did not differ significantly among the study groups. During the treatment period (median duration: 100 weeks), the decline of serum HBV DNA from baseline tended to be greatest in the ETV+ADV group at all-time points (week 48: -2.55 log10 IU/mL, week 96: -4.27 log10 IU/mL), but the difference was not statistically significant. The ETV+ADV group also tended to have higher virologic response rates at 96 weeks compared to the ETV monotherapy or LAM+ADV groups (40.0% vs. 20.0% or 20.0%, P=0.656), and less virologic breakthrough was observed compared to the ETV monotherapy or LAM+ADV groups (8.3% vs. 37.5% or 30.0%; P=0.219), but again, the differences were not statistically significant. HBeAg loss occurred in one patient in the ETV+ADV group, in two in the ETV monotherapy group, and in none of the LAM+ADV group. The safety profiles were similar in each arm. CONCLUSIONS: There was a nonsignificant tendency toward better antiviral efficacy with ETV+ADV combination therapy compared to LAM+ADV combination therapy and ETV monotherapy for MDR CHB in Korea, where tenofovir is not yet available.
