Effectiveness of entecavir in chronic hepatitis B NUC-naive patients in
routine clinical practice
International Journal of Clinical Practice, 07/20/2011 Clinical Article
Ridruejo E et al. - The entecavir (ETV) monotherapy showed high virological
response rates, a favourable safety profile for NUC-naive HBeAg-positive
and negative patients treated in routine clinical practice.
Methods
• Sixty-nine HBeAg positive and negative NUC naïve chronic HBV patients
were treated with ETV for 110 weeks.
• 63% were HBeAg positive, 16% were cirrhotics, mean HBV-DNA was 7.09 log
IU/ml and mean ALT was 157 IU/ml.
Results
• Sixty-one (88%) patients achieved undetectable DNA, with 46%, 77% and
100% virological response rates at week 24, 48 and 96 of treatment,
respectively.
• Thirty-seven (84%) patients in the HBeAg-positive population achieved
undetectable DNA, with 67% and 100% virological response rates at week 48
and 96 of treatment, respectively.
• Twenty-four (96%) patients in the HBeAg-negative population achieved
undetectable DNA, with 91% and 100% virological response rates at week 48
and 96 of treatment, respectively.
• Twenty-three (53%) patients cleared HBeAg and 19 (44%) patients
seroconverted to antiHBe positive status; seven (10%) patients cleared
hepatitis B surface antigen and five (7%) patients developed antiHBs.
• At the end of the study, 10 patients successfully stopped therapy: nine
HBeAg positive (four developed antiHBs positive) and one HBeAg negative.
• None of the patients had primary non-response.
• ETV resistance was not tested.
• None of the patients developed hepatocellular carcinoma, underwent
liver transplantation or died because of liver-related events.
• No serious adverse events were reported.
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