Treatment of hepatitis B e antigen positive chronic hepatitis with telbivudine or adefovir: a randomized trial.
BACKGROUND
The efficacy of nucleoside and nucleotide analogues for hepatitis B has been linked to the magnitude and durability of hepatitis B virus (HBV) suppression.


OBJECTIVE
To compare the antiviral efficacy of telbivudine and adefovir dipivoxil, and the effects of switching from adefovir to telbivudine, in hepatitis B e antigen (HBeAg)-positive patients with chronic hepatitis B.


METHODS
Randomized, controlled, open-label trial.


METHODS
16 outpatient clinics.


METHODS
135 treatment-naive, HBeAg-positive adults with chronic hepatitis B.


METHODS
Patients were randomly assigned in a 1:1:1 ratio to 52 weeks of telbivudine (group A) or adefovir (group B), or 24 weeks of adefovir and then telbivudine for the remaining 28 weeks (group C). One hundred thirty-one patients completed 52 weeks of treatment.


METHODS
The primary efficacy comparison was serum HBV DNA reduction at week 24, with a secondary comparison at week 52.


RESULTS
At week 24, mean HBV DNA reduction was greater in group A than in pooled groups B and C (-6.30 vs. -4.97 log10 copies/mL; difference, -1.33 log10 copies/mL [95% CI, -1.99 to -0.66 log(10) copies/mL]; P < 0.001), and more patients in group A were polymerase chain reaction-negative (39% vs. 12%; odds ratio, 4.46 [CI, 1.86 to 10.72]; P = 0.001). At week 52, the mean residual HBV DNA level was lower in group A and group C than in group B (3.01 log10 copies/mL [group A] and 3.02 log10 copies/mL [group C] vs. 4.00 log10 copies/mL [group B]; difference, -0.99 log10 copies/mL [CI, -1.67 to -0.32 log10 copies/mL] and -0.98 log10 copies/mL [CI, -1.64 to -0.32 log10 copies/mL]; P = 0.004). Adverse events were similar across groups; the most common were upper respiratory symptoms, headache, back pain, and diarrhea.


CONCLUSIONS
The trial was open-label and was not of sufficient size or duration to compare clinical outcomes and long-term efficacy.


CONCLUSIONS
Telbivudine demonstrated greater and more consistent HBV DNA suppression than adefovir after 24 weeks of treatment. After 52 weeks, HBV DNA suppression was greater in patients who had received continuous telbivudine or were switched to telbivudine after 24 weeks than in those who received continuous adefovir.
Chan
Henry L Y
HL
The Chinese University of Hong Kong, Shatin, Hong Kong, China. hlychan@cuhk.edu.hk
Heathcote
E Jenny
EJ
Marcellin
Patrick
P
Lai
Ching-Lung
CL
Cho
Mong
M
Moon
Young M
YM
Chao
You-Chen
YC
Myers
Robert P
RP
Minuk
Gerald Y
GY
Jeffers
Lennox
L
Sievert
William
W
Bzowej
Natalie
N
Harb
George
G
Kaiser
Ralf
R
Qiao
Xin-Jian
XJ
Brown
Nathaniel A
NA
D000225:Adenine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D004279:DNA, Viral / Q000097:blood; D004359:Drug Therapy, Combination; D005260:Female; D006513:Hepatitis B e Antigens / Q000097:blood*; D006515:Hepatitis B virus / Q000235:genetics / Q000276:immunology; D019694:Hepatitis B, Chronic / Q000097:blood / Q000188:drug therapy* / Q000821:virology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009705:Nucleosides / Q000009:adverse effects / Q000627:therapeutic use*; D063065:Organophosphonates / Q000009:adverse effects / Q000627:therapeutic use*; D011744:Pyrimidinones / Q000009:adverse effects / Q000627:therapeutic use*; D000077712:Telbivudine; D013936:Thymidine / Q000031:analogs & derivatives; D019562:Viral Load
D000998:Antiviral Agents; D015415:Biomarkers; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D009705:Nucleosides; D063065:Organophosphonates; D011744:Pyrimidinones; D000077712:Telbivudine; D000225:Adenine; C106812:adefovir dipivoxil; D013936:Thymidine