Clin Mol Hepatol.  2016 Dec;22(4):443-449. 10.3350/cmh.2016.0037.

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)

• Lee HW
• Park JY
• Kim BK
• Kim MY
• Lee JI
• Kim YS
• Yoon KT
• Han KH
• Ahn SH

• KMID: 2373148
• DOI: http://doi.org/10.3350/cmh.2016.0037

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.

Keyword

Adefovir; Chronic hepatitis B; Complete virological response; Suboptimal response; Tenofovir

MeSH Terms

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
Adenine
Alanine Transaminase
Antiviral Agents
DNA, Viral
Hepatitis B e Antigens
Lamivudine
Organophosphonates
Tenofovir