studies

1204A AASLD ABSTRACTS HEPATOLOGY, October, 2015
Disclosures:
Cheng-Yuan Peng - Advisory Committees or Review Panels: AbbVie, BMS, Gilead,
MSD, Roche
The following authors have nothing to disclose: Chao-Jen Shih, Pei-Shuan Lo,
Chia-Lin Huang, Chia-Hsin Lin, Hsueh-Chou Lai, Wen-Pang Su
2041
WITHDRAWN
2042
Is efficacy of tenofovir in nucleos(t)ide analogue-experienced
chronic hepatitis B patients comparable to that in
nucleos(t)ide analogue-naïve patients?
Eun Ju Cho 1 , Jeong-Hoon Lee 1 , Jeong-Ju Yoo 1 , Yuri Cho 1 , Donghyeon
Lee 1 , Yun Bin Lee 2 , Su Jong Yu 1 , Yoon Jun Kim 1 , Jung-Hwan
Yoon 1 ; 1 Internal Medicine, Seoul National University Hospital,
Seoul, Korea (the Republic of); 2 Internal Medicine, CHA Bundang
Medical Center, Seoungnam, Korea (the Republic of)
Background/Aim: Recent study reported that entecavir fails to
show comparable efficacy in nucleos(t)ide analogue (NA)-experienced
chronic hepatitis B (CHB) patients as compared
to NA-naïve ones. We evaluated the efficacy of tenofovir in
NA-experienced CHB patients in comparison with NA-naïve
patients. Methods: We retrospectively included 221 consecutive
patients who had serum hepatitis B virus (HBV) DNA
level > 2,000 IU/mL at the initiation of tenofovir treatment
and received tenofovir for > 3 months. Complete virologic
response (CVR) was defined as undetectable serum HBV DNA
by real-time PCR. CVR rates were calculated by Kaplan-Meier
analysis, and a multivariate Cox proportional-hazard model
was generated in order to find predictive factors independently
associated with the time to a CVR. Results: Of the 221 patients
(129 males; mean age, 48.2 years), 149 were NA-naïve and
72 were NA-experienced patients. Ninety-eight patients had
hepatitis B e antigen (HBeAg)-positive CHB. The median duration
of tenofovir treatment was 47.4 (interquartile range, 36.2
to 56.6) weeks. The CVR rates of the NA-naïve and NA-experienced
groups were comparable in both HBeAg-negative
(49.4% vs 58.1 at week 24, P=0.53; 96.4% vs 93.3% at
week 48, P=0.60) and HBeAg-positive patients (22.2% vs
16.7% at week 24, P=0.60; 75.6% vs 75.9% at week 48,
P=1.00). According to the multivariate Cox regression model,
only HBeAg positivity (hazard ratio [HR], 0.40; 95% confidence
interval [CI], 0.29 to 0.56; P< 0.001) and baseline
HBV DNA levels (HR, 0.77 for 1 log10 IU/mL increase; 95%
CI, 0.69 to 0.86; P< 0.001) had a significant influence on the
time to a CVR. The presence of resistance mutations to lamivudine/telbivudine/entecavir
did not influence the response
rates, however, patients with adefovir resistance showed significantly
lower CVR rate (25%; P=0.03). Conclusion: Tenofovir
has comparable efficacy in NA-naïve and NA-experienced
patients without adefovir resistance.
Disclosures:
Yoon Jun Kim - Grant/Research Support: Bristol-Myers Squibb, Roche, JW Creagene,
Bukwang Pharmaceuticals, Handok Pharmaceuticals, Hanmi Pharmaceuticals,
Yuhan Pharmaceuticals; Speaking and Teaching: Bayer HealthCare
Pharmaceuticals, Gilead Science, MSD Korea, Yuhan Pharmaceuticals, Samil
Pharmaceuticals, CJ Pharmaceuticals, Bukwang Pharmaceuticals, Handok Pharmaceuticals
The following authors have nothing to disclose: Eun Ju Cho, Jeong-Hoon Lee,
Jeong-Ju Yoo, Yuri Cho, Donghyeon Lee, Yun Bin Lee, Su Jong Yu, Jung-Hwan
Yoon
2043
Serologic and Virologic Changes Following ALT flares
in adolescents With Chronic Hepatitis B during therapy
with Tenofovir Disoproxil Fumarate or Placebo.
Karen F. Murray 1 , Leszek Szenborn 2 , Jacek Wysocki 3 , Benedetta
Massetto 4 , Anuj Gaggar 4 , Kyungpil Kim 4 , Mani Subramanian 4 ,
Luminita Luminos 5 , Malgorzata Pawlowska 6 , Jacek Mizerski 7 ;
1 Children’s Hospital, Seattle, WA; 2 Wroclaw Medical University,
Wroclaw, Poland; 3 Poznan University of Medical Sciences,
Poznan, Poland; 4 Gilead Sciences, Inc., Foster City, CA; 5 Prof. Dr.
Matei Bals Institute for Infectious Diseases, Bucharest, Romania;
6 Wojewodzki Szpital Obserwacyjno-Zakazny im. T. Browicza,
Bydgoszcz, Poland; 7 John Paul II Hospital, Kraków, Poland
Background and Aims: We previously described the safety and
antiviral efficacy of TDF in adolescents aged 12 to 2x baseline and
>5x upper limit of normal during the first 48 weeks. HBeAg
loss, HBV DNA decline and HBsAg decline were evaluated 24
weeks following a flare. Results: Twelve of the 52 (23%) evaluable
PBO patients and 1 of the 52 (2%) TDF-treated patients
had ALT flares during the first 48 weeks. PBO patients with
ALT flare had an increased rate of 1-log 10
HBV DNA decline
and HBeAg loss compared to those without ALT flare (Table,
p