Efficacy of switching from adefovir to tenofovir in chronic hepatitis B patients who exhibit suboptimal responses to adefovir-based combination rescue therapy due to resistance to nucleoside analogues (SATIS study).
- Author:
Hye Won LEE
1
;
Jun Yong PARK
;
Beom Kyung KIM
;
Moon Young KIM
;
Jung Il LEE
;
Young Suk KIM
;
Ki Tae YOON
;
Kwang Hyub HAN
;
Sang Hoon AHN
Author Information
- Publication Type:Comparative Study ; Original Article ; Multicenter Study ; Randomized Controlled Trial
- Keywords: Adefovir; Chronic hepatitis B; Complete virological response; Suboptimal response; Tenofovir
- MeSH: Adenine/*analogs & derivatives/therapeutic use; Alanine Transaminase/blood; Antiviral Agents/*therapeutic use; DNA, Viral/blood; Drug Resistance, Viral; Drug Therapy, Combination; Female; Genotype; Hepatitis B e Antigens/blood; Hepatitis B virus/genetics; Hepatitis B, Chronic/*drug therapy; Humans; Lamivudine/therapeutic use; Male; Middle Aged; Organophosphonates/*therapeutic use; Prospective Studies; Tenofovir/*therapeutic use; Treatment Outcome
- From:Clinical and Molecular Hepatology 2016;22(4):443-449
- CountryRepublic of Korea
- Language:English
- Abstract: BACKGROUND/AIMS: It remains to be determined whether switching from adefovir (ADV) to tenofovir (TDF) provides better virological outcomes in patients exhibiting suboptimal responses to ADV plus nucleoside analogue (ADV+NA) therapy for NA-resistant chronic hepatitis B (CHB). METHODS: In this prospective trial, patients who showed partial responses (defined as serum hepatitis B virus [HBV] DNA >60 IU/mL) to ADV+NA therapy for NA resistance were randomly allocated to receive TDF plus NA (TDF+NA group, n=16) or to continue their current therapy (ADV+NA group, n=16). The primary end point was the proportion of patients with complete virological response (CVR, defined as serum HBV DNA <60 IU/mL) at 48 weeks. RESULTS: The median age was 52 years (16 men), and 28 were positive for hepatitis B e antigen (HBeAg). The baseline characteristics did not differ significantly between the two groups. The proportion with CVR was significantly higher in the TDF+NA group than in the ADV+NA group at 24 weeks (81.3% vs. 25.0%, P=0.001) and 48 weeks (87.5% vs. 37.5%, P=0.002). Furthermore, a decrease in the serum HBV DNA level of >2log10 IU/mL was more likely in the TDF+NA group at both 24 and 48 weeks (68.8% vs. 56.3%, P=0.014 vs. 81.3% vs. 56.3%, P=0.001, respectively). During the follow-up, the rate of HBeAg seroconversion was higher in the TDF+NA group than the ADV+NA group (12.5% vs. 6.25%, P=0.640), as was that for the hepatitis B surface antigen (6.25% vs. 0%, P=0.080). No serious adverse events due to antiviral agents occurred. CONCLUSIONS: In patients exhibiting suboptimal responses to ADV+NA therapy for NA-resistant CHB, switching from ADV to TDF might provide better virological outcomes.
