Entecavir treatment for chronic hepatitis B
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Entecavir treatment for chronic hepatitis B : adaptation is not needed for the majority of naïve patients with a partial virological response. / Zoutendijk, Roeland; Reijnders, Jurriën G P; Brown, Ashley; Zoulim, Fabien; Mutimer, David; Deterding, Katja; Petersen, Jörg; Hofmann, Wolf Peter; Buti, Maria; Santantonio, Teresa; van Bömmel, Florian; Pradat, Pierre; Oo, Ye; Lütgehetmann, Marc; Berg, Thomas; Hansen, Bettina E; Wedemeyer, Heiner; Janssen, Harry L A; VIRGIL Surveillance Study Group.
in: HEPATOLOGY, Jahrgang 54, Nr. 2, 08.2011, S. 443-51.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Entecavir treatment for chronic hepatitis B
T2 - adaptation is not needed for the majority of naïve patients with a partial virological response
AU - Zoutendijk, Roeland
AU - Reijnders, Jurriën G P
AU - Brown, Ashley
AU - Zoulim, Fabien
AU - Mutimer, David
AU - Deterding, Katja
AU - Petersen, Jörg
AU - Hofmann, Wolf Peter
AU - Buti, Maria
AU - Santantonio, Teresa
AU - van Bömmel, Florian
AU - Pradat, Pierre
AU - Oo, Ye
AU - Lütgehetmann, Marc
AU - Berg, Thomas
AU - Hansen, Bettina E
AU - Wedemeyer, Heiner
AU - Janssen, Harry L A
AU - VIRGIL Surveillance Study Group
N1 - Copyright © 2011 American Association for the Study of Liver Diseases.
PY - 2011/8
Y1 - 2011/8
N2 - UNLABELLED: Entecavir (ETV) is a potent inhibitor of viral replication in nucleos(t)ide analogue (NA)-naïve chronic hepatitis B (CHB) patients. The aim of this study was to investigate the long term efficacy and safety of ETV in NA-naïve CHB patients, particularly in those with detectable hepatitis B virus (HBV) DNA after 48 weeks, in whom treatment adaptation is suggested by current guidelines. In a multicenter cohort study, we investigated 333 CHB patients treated with entecavir monotherapy. The NA-naïve population consisted of 243 patients, whereas 90 were NA-experienced. Virological response (VR) (HBV DNA<80 IU/mL) was achieved in 48%, 76%, and 90% of hepatitis B e antigen (HBeAg)-positive and in 89%, 98%, and 99% of HBeAg-negative NA-naïve patients at weeks 48, 96, and 144, respectively. Thirty-six of 175 (21%) NA-naïve patients with at least 48 weeks of follow-up had a detectable load at week 48 (partial virological response [PVR]). Twenty-nine (81%) patients with PVR reached VR during prolonged ETV monotherapy, and none of them developed ETV-resistance. Among 22 patients with HBV DNA<1,000 IU/mL at week 48, VR was achieved in 21 (95%) patients, compared with eight of 14 (57%) patients with HBV DNA≥1,000 IU/mL. Continuous HBV DNA decline was observed in most patients without VR during follow-up, and in three patients adherence was suboptimal according to the treating physician. ETV was safe and did not affect renal function or cause lactic acidosis.CONCLUSION: ETV monotherapy can be continued in NA-naïve patients with detectable HBV DNA at week 48, particularly in those with a low viral load because long-term ETV leads to a virological response in the vast majority of patients.
AB - UNLABELLED: Entecavir (ETV) is a potent inhibitor of viral replication in nucleos(t)ide analogue (NA)-naïve chronic hepatitis B (CHB) patients. The aim of this study was to investigate the long term efficacy and safety of ETV in NA-naïve CHB patients, particularly in those with detectable hepatitis B virus (HBV) DNA after 48 weeks, in whom treatment adaptation is suggested by current guidelines. In a multicenter cohort study, we investigated 333 CHB patients treated with entecavir monotherapy. The NA-naïve population consisted of 243 patients, whereas 90 were NA-experienced. Virological response (VR) (HBV DNA<80 IU/mL) was achieved in 48%, 76%, and 90% of hepatitis B e antigen (HBeAg)-positive and in 89%, 98%, and 99% of HBeAg-negative NA-naïve patients at weeks 48, 96, and 144, respectively. Thirty-six of 175 (21%) NA-naïve patients with at least 48 weeks of follow-up had a detectable load at week 48 (partial virological response [PVR]). Twenty-nine (81%) patients with PVR reached VR during prolonged ETV monotherapy, and none of them developed ETV-resistance. Among 22 patients with HBV DNA<1,000 IU/mL at week 48, VR was achieved in 21 (95%) patients, compared with eight of 14 (57%) patients with HBV DNA≥1,000 IU/mL. Continuous HBV DNA decline was observed in most patients without VR during follow-up, and in three patients adherence was suboptimal according to the treating physician. ETV was safe and did not affect renal function or cause lactic acidosis.CONCLUSION: ETV monotherapy can be continued in NA-naïve patients with detectable HBV DNA at week 48, particularly in those with a low viral load because long-term ETV leads to a virological response in the vast majority of patients.
KW - Adult
KW - Antiviral Agents
KW - Cohort Studies
KW - Female
KW - Guanine
KW - Hepatitis B, Chronic
KW - Humans
KW - Male
KW - Prospective Studies
KW - Time Factors
KW - Treatment Outcome
U2 - 10.1002/hep.24406
DO - 10.1002/hep.24406
M3 - SCORING: Journal article
C2 - 21563196
VL - 54
SP - 443
EP - 451
JO - HEPATOLOGY
JF - HEPATOLOGY
SN - 0270-9139
IS - 2
ER -