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1841 ♦
Switching to Tenofovir versus Continuing Entecavir
in Chronic Hepatitis B Patients with Partial Virologic
Response during Entecavir Therapy: STEEP Study
Hyung Joon Yim1, In Hee Kim2, Sang Jun Suh1, Young Kul Jung1,8,
Ji Hoon Kim6, Yeon Seok Seo7, Jong Eun Yeon6, Chang Wook
Kim3, So Young Kwon4, Sang Hoon Park5, Myung Seok Lee5,
Soon Ho Um7, Kwan Soo Byun6; 1Internal Medicine, Korea University
Ansan Hospital, Ansan, Korea (the Republic of); 2Internal Medicine,
Chonbuk National University Hospital, JeonJu, Korea (the
Republic of); 3Internal Medicine, The Catholic University of Korea
Uijeongbu St. Mary’s Hospital, Uijeongbu, Korea (the Republic
of); 4Internal Medicine, Konkuk University Hospital, Seoul, Korea
(the Republic of); 5Internal Medicine, Hallym University Kangnam
Sacred Heart Hospital, Seoul, Korea (the Republic of); 6Internal
Medicine, Korea University Guro Hospital, Seoul, Korea (the
Republic of); 7Internal Medicine, Korea University Anam Hospital,
Seoul, Korea (the Republic of); 8Internal Medicine, Gachon University
Gil Hospital, Incheon, Korea (the Republic of)
Background Entecavir has been widely used for treatment-naïve
chronic hepatitis B (CHB) patients. However, about 20% of
patients show partial virologic response (PVR) after 2 year of
entecavir therapy [Yoon, et al, 2011]. If the HBV DNA continues
to be detected, underlying liver disease may progress, and
the risk of hepatocellular carcinoma can be increased. Therefore,
switching to a more effective and potent antiviral therapy
may be needed. In this study, we compared the efficacy of
switching to tenofovir with continuing entecavir in CHB patients
who showed PVR to entecavir. Patients and Methods This is an
investigator initiated open label randomized controlled trial
conducted in Korea between April 2013 and December 2015.
Primary end point was a virologic response (HBV DNA < 20
IU/mL) rate at year 1 (12 months). Secondary end points were
degree of HBV DNA reduction, mean levels of HBV DNA, biochemical
and serologic response rates, virologic breakthrough,
antiviral resistance, and adverse events. We included CHB
patients receiving entecavir 0.5 mg more than 12 months,
but having datable HBV DNA over 60 IU/mL despite no resistance
to entecavir. Results A total of 45 patients were enrolled.
Twenty two patients were randomized to tenofovir arm and
23 patients to entecavir arm. Baseline characteristics were not
significantly different between the groups. After 12 months
of treatment, virologic response rate was significantly higher
in the tenofovir group compared with in the entecavir group
by per protocol analysis (55% vs 20%, P = 0.022) as well as
intention-to-treat analysis (50% vs 17.4%, P = 0.020). At month
12, the mean HBV DNA level was lower (1.54 vs. 2.01 log
IU/mL, P = 0.011) and the degree of HBV DNA reduction was
greater (-1.13 vs. -0.67 log IU/mL, P = 0.024) in the tenofovir
group than in the entecavir group, respectively. Proportions of
patients with normal ALT and HBeAg loss/seroconversion rates
were not different between the groups. There was no virologic
breakthrough in both groups, and no significant adverse events
were observed. We also analyzed factors related to virologic
response by multivariate logistic regression model. Baseline
serum HBV DNA level (Odds ratio 0.152 [0.030-0.786], P =
0.025) and type of antiviral agent (Odds ratio 6.661 [1.421-
31.233], P = 0.016) were significant factors. Conclusion In
CHB patients with PVR to entecavir, switching to tenofovir
resulted in higher virologic response rate and better suppression
of viral replication than continuing entecavir. Therefore,
switching to tenofovir would be a better strategy in entecavir
partial responders to achieve optimal response.
Disclosures:
Chang Wook Kim - Consulting: Gilead Korea; Grant/Research Support: BMS
Korea, Gilead Korea, Daewoong, Pharmicell; Speaking and Teaching: BMS
Korea, Daewoong
Kwan Soo Byun - Grant/Research Support: Gilead, BMS
The following people have nothing to disclose: Hyung Joon Yim, In Hee Kim,
Sang Jun Suh, Young Kul Jung, Ji Hoon Kim, Yeon Seok Seo, Jong Eun Yeon, So
Young Kwon, Sang Hoon Park, Myung Seok Lee, Soon Ho Um
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