Περίληψη:
Background
In patients with chronic hepatitis B, tenofovir disoproxil fumarate
(TDF) plus pegylated interferon (PEG-IFN) for 48-weeks results in higher
rates of hepatitis B surface antigen (HBsAg) loss than either
monotherapy.
Aim
To identify baseline and on-treatment factors associated with HBsAg loss
at Week 72 and provide a model for predicting HBsAg loss in patients
receiving combination therapy for 48 weeks.
Methods
A secondary analysis of data from an open-label study where patients
were randomised to TDF (300 mg/day, oral) plus PEG-IFN (PI, 180 mu
g/week, subcutaneous) for 48 weeks (TDF/PI-48w); TDF plus PEG-IFN for 16
weeks, TDF for 32 weeks (TDF/PI-16w+TDF-32w); TDF for 120 weeks
(TDF-120w) or PEG-IFN for 48 weeks (PI-48w). Logistic regression methods
were used to identify models that best predicted HBsAg loss at Week 72.
Results
Rates of HBsAg loss at Week 72 were significantly higher in the
TDF/PI-48w group (6.5%) than in the TDF/PI-16w+TDF-32w (0.5%),
TDF-120w (0%) and PI-48w (2.2%) groups (P = 0.09). The only baseline
factor associated with response was genotype A. HBsAg decline at Week 12
or 24 of treatment was associated with HBsAg loss at Week 72 (P <
0.001). HBsAg decline >3.5 log(10) IU/mL at Week 24 in the TDF/PI-48w
group resulted in a positive predictive value of 85% and a negative
predictive value of 99% for HBsAg loss at Week 72.
Conclusions
HBsAg decline at Week 24 of TDF plus PEG-IFN combination therapy may
identify patients who, after completing 48 weeks of treatment, have a
better chance of achieving HBsAg loss at Week 72.
Συγγραφείς:
Marcellin, P.
Ahn, S. H.
Chuang, W. -L.
Hui, A. J. and
Tabak, F.
Mehta, R.
Petersen, J.
Lee, C. -M.
Ma, X. and
Caruntu, F. A.
Tak, W. Y.
Elkhashab, M.
Lin, L.
Wu, G.
and Martins, E. B.
Charuworn, P.
Yee, L. J.
Lim, S. G. and
Foster, G. R.
Fung, S.
Morano, L.
Samuel, D.
Agarwal, K.
and Idilman, R.
Strasser, S. I.
Buti, M.
Gaeta, G. B. and
Papatheodoridis, G.
Flisiak, R.
Chan, H. L. Y.
