PL-4
192 weeks tenofovir disoproxil fumarate monotherapy in Chinese
patients with chronic hepatitis B
Jinlin Hou1, Zhiliang Gao2, Qing Xie3, Jiming Zhang4, Jifang
Sheng5, Jun Cheng6, Chengwei Chen7, Qing Mao8, Wei Zhao9,
Hong Ren10, Deming Tan11, Junqi Niu12, Shijun Chen13, Chen
Pan14, Hong Tang15, Hao Wang16, Yimin Mao17, Jidong Jia18, Qin
Ning19, Min Xu20
1Nanfang Hospital, Southern Medical University, Guangzhou, China;
23rd Affiliated Hospital of Sun Yat-Sen University, Guangzhou,
China; 3Ruijin Hospital Affiliated to Jiaotong University, Shanghai,
China; 4Huashan Hospital Affiliated to Fudan University, Shanghai,
China; 51st Affiliated Hospital of ZheJiang University, Hangzhou,
China; 6Beijing Ditan Hospital, Beijing, China; 7Shanghai the 85th
Hospital Affiliated to Nanjing Military, Shanghai, China; 8Southwest
Hospital, Third Military Medical University, Chongqing, China; 92nd
Hospital of Nanjing, Nanjing, China; 102nd Affiliated Hospital
Chongqing Medical University, Chongqing, China; 11Xiangya
Hospital Central-South University, Changsha, China; 121st Affiliated
Hospital of Jilin University, Changchun, China; 13Jinan Hospital for
Infectious Disease, Jinan, China; 14Fuzhou Infectious Disease
Hospital, Fuzhou, China; 15West China Hospital, Sichuan University,
Chengdu, China; 16Peking University People’s Hospital, Beijing,
China; 17Renji Hospital Affiliated to Shanghai JiaoTong University,
Shanghai, China; 18Beijing Friendship Hospital Affiliated to Capital
University, Beijing, China; 19Tongji Hospital of Tongji Medical
College, Wuhan, China; 20Guangzhou Eighth Municipal People’s
Hospital, Guangzhou, China
Aims: Tenofovir disoproxil fumarate (TDF) has demonstrated shortterm
efficacy and a high resistance barrier in chronic hepatitis B
(CHB) populations in China. This Phase III study provides long-term
data on TDF treatment in Chinese CHB patients.
Methods: This was an open-label study period, involving TDF
monotherapy following a 48-week double-blind randomized treatment
period of either TDF 300 mg QD or Adefovir Dipivoxil (ADV)
10 mg QD. HBeAg-positive and negative subjects with HBV DNA
C105 copies/mL were eligible for initial randomization. Totally
497/512 (97 %) subjects (198 HBeAg positive and 299 HBeAg
negative) entered the open-label phase; 252 subjects originally randomized
to TDF (TDF-TDF) and 245 subjects randomized to ADV
(ADV-TDF). The majority of subjects (95.5 %) were treatment naı¨ve.
Virologic, serologic, biochemical, safety and resistance were monitored
throughout the study.
Results: At Week 192, virologic suppression (HBV DNA \400
copies/mL) was achieved in the majority of treated subjects (TDFTDF
Vs. ADV-TDF) in HBeAg positive (91.3 vs. 92.9 %, p[0.05)
and HBeAg negative (92.9 vs. 92.2 %, p[0.05). More than 80 %
subjects achieved ALT normalization. A higher proportion of subjects
in the TDF-TDF group experienced HBeAg loss and HBeAg seroconversion
but these differences were not statistically significant. No
subject experienced durable HBsAg loss/seroconversion. No TDF
resistance mutations were identified. More than 92 % subjects completed
192-week treatment and TDF long-term safety profile was as
previously established.
Conclusions: TDF demonstrated high potency, no resistance, and
good tolerability in Chinese CHB subjects receiving 192 week TDF
monotherapy.
