Abstract
We characterized the early viral kinetic profiles of telbivudine and entecavir and the effects of these potent nucleoside analogs on hepatitis B virus (HBV) DNA and alanine aminotransferase levels in adults with hepatitis B e antigen-positive compensated chronic hepatitis B. Forty-four patients were enrolled in this open-label, parallel-group, multicenter study and randomized to receive telbivudine or entecavir for 12 weeks. Reductions in hepatitis B virus DNA and alanine aminotransferase levels from baseline to weeks 2, 4, 8, and 12 were assessed. Viral kinetic parameters, including viral clearance per day, loss of infected cells per day, and efficiency of inhibition of viral production, were estimated by using a biphasic mathematical model. Statistical analyses were limited to descriptive analyses. The 2 treatment groups achieved similar reductions in HBV DNA and alanine aminotransferase levels. Mean reductions in levels of hepatitis B virus DNA at week 12 were 6.6 ± 1.6 and 6.5 ± 1.5 log10 copies/ml for the telbivudine- and entecavir-treated patients, respectively. There were no significant differences between groups in values for mean viral clearance per day, mean loss of infected cells per day, or efficiency of blocking viral production. The safety profiles for both medications were favorable. During the first 12 weeks of treatment, telbivudine and entecavir demonstrated similar antiviral potencies, resulting in a rapid and profound suppression of serum hepatitis B virus DNA and reduction of alanine aminotransferase levels. No differences in the effects of these 2 agents on early viral kinetics were observed. Both medications were well tolerated.
| Original language | English |
|---|---|
| Pages (from-to) | 1242-1247 |
| Number of pages | 6 |
| Journal | Antimicrobial Agents and Chemotherapy |
| Volume | 54 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - 2010 Mar 1 |
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ASJC Scopus subject areas
- Pharmacology
- Pharmacology (medical)
- Infectious Diseases
Cite this
Early viral kinetics of telbivudine and entecavir : Results of a 12-week randomized exploratory study with patients with HBeAg-positive chronic hepatitis B. / Suh, Dong Jin; Um, Soon-Ho; Herrmann, Eva; Kim, Ju Hyun; Lee, Young Sok; Lee, Heon Ju; Lee, Myung Seok; Lee, Youn Jae; Bao, Weibin; Lopez, Patricia; Lee, Han Chu; Avila, Claudio; Zeuzem, Stefan.
In: Antimicrobial Agents and Chemotherapy, Vol. 54, No. 3, 01.03.2010, p. 1242-1247.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Early viral kinetics of telbivudine and entecavir
T2 - Results of a 12-week randomized exploratory study with patients with HBeAg-positive chronic hepatitis B
AU - Suh, Dong Jin
AU - Um, Soon-Ho
AU - Herrmann, Eva
AU - Kim, Ju Hyun
AU - Lee, Young Sok
AU - Lee, Heon Ju
AU - Lee, Myung Seok
AU - Lee, Youn Jae
AU - Bao, Weibin
AU - Lopez, Patricia
AU - Lee, Han Chu
AU - Avila, Claudio
AU - Zeuzem, Stefan
PY - 2010/3/1
Y1 - 2010/3/1
N2 - We characterized the early viral kinetic profiles of telbivudine and entecavir and the effects of these potent nucleoside analogs on hepatitis B virus (HBV) DNA and alanine aminotransferase levels in adults with hepatitis B e antigen-positive compensated chronic hepatitis B. Forty-four patients were enrolled in this open-label, parallel-group, multicenter study and randomized to receive telbivudine or entecavir for 12 weeks. Reductions in hepatitis B virus DNA and alanine aminotransferase levels from baseline to weeks 2, 4, 8, and 12 were assessed. Viral kinetic parameters, including viral clearance per day, loss of infected cells per day, and efficiency of inhibition of viral production, were estimated by using a biphasic mathematical model. Statistical analyses were limited to descriptive analyses. The 2 treatment groups achieved similar reductions in HBV DNA and alanine aminotransferase levels. Mean reductions in levels of hepatitis B virus DNA at week 12 were 6.6 ± 1.6 and 6.5 ± 1.5 log10 copies/ml for the telbivudine- and entecavir-treated patients, respectively. There were no significant differences between groups in values for mean viral clearance per day, mean loss of infected cells per day, or efficiency of blocking viral production. The safety profiles for both medications were favorable. During the first 12 weeks of treatment, telbivudine and entecavir demonstrated similar antiviral potencies, resulting in a rapid and profound suppression of serum hepatitis B virus DNA and reduction of alanine aminotransferase levels. No differences in the effects of these 2 agents on early viral kinetics were observed. Both medications were well tolerated.
AB - We characterized the early viral kinetic profiles of telbivudine and entecavir and the effects of these potent nucleoside analogs on hepatitis B virus (HBV) DNA and alanine aminotransferase levels in adults with hepatitis B e antigen-positive compensated chronic hepatitis B. Forty-four patients were enrolled in this open-label, parallel-group, multicenter study and randomized to receive telbivudine or entecavir for 12 weeks. Reductions in hepatitis B virus DNA and alanine aminotransferase levels from baseline to weeks 2, 4, 8, and 12 were assessed. Viral kinetic parameters, including viral clearance per day, loss of infected cells per day, and efficiency of inhibition of viral production, were estimated by using a biphasic mathematical model. Statistical analyses were limited to descriptive analyses. The 2 treatment groups achieved similar reductions in HBV DNA and alanine aminotransferase levels. Mean reductions in levels of hepatitis B virus DNA at week 12 were 6.6 ± 1.6 and 6.5 ± 1.5 log10 copies/ml for the telbivudine- and entecavir-treated patients, respectively. There were no significant differences between groups in values for mean viral clearance per day, mean loss of infected cells per day, or efficiency of blocking viral production. The safety profiles for both medications were favorable. During the first 12 weeks of treatment, telbivudine and entecavir demonstrated similar antiviral potencies, resulting in a rapid and profound suppression of serum hepatitis B virus DNA and reduction of alanine aminotransferase levels. No differences in the effects of these 2 agents on early viral kinetics were observed. Both medications were well tolerated.
UR - http://www.scopus.com/inward/record.url?scp=77149167555&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=77149167555&partnerID=8YFLogxK
U2 - 10.1128/AAC.01163-09
DO - 10.1128/AAC.01163-09
M3 - Article
C2 - 20028815
AN - SCOPUS:77149167555
VL - 54
SP - 1242
EP - 1247
JO - Antimicrobial Agents and Chemotherapy
JF - Antimicrobial Agents and Chemotherapy
SN - 0066-4804
IS - 3
ER -