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Aliment Pharmacol Ther. 2016 Nov;44(9):957-966. doi: 10.1111/apt.13779. Epub 2016 Sep 15.

Predictors of response to tenofovir disoproxil fumarate plus peginterferon alfa-2a combination therapy for chronic hepatitis B.

Author information

1
Paris, France.
2
Seoul, South Korea.
3
Kaohsiung, Taiwan.
4
Hong Kong, China.
5
Istanbul, Turkey.
6
Surat, India.
7
Hamburg, Germany.
8
Philadelphia, USA.
9
Bucharest, Romania.
10
Daegu, South Korea.
11
Toronto, ON, Canada.
12
Gilead Sciences, Inc., Foster City, CA, USA.
13
Singapore.
14
London, UK.
15
Pontevedra, Spain.
16
Villejuif, France.
17
Ankara, Turkey.
18
Sydney, Australia.
19
Barcelona, Spain.
20
Naples, Italy.
21
Athens, Greece.
22
Bialystok, Poland.
23
Hong Kong, China. hlychan@cuhk.edu.hk.

Abstract

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 μg/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 log10 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.

PMID:
27629859
DOI:
10.1111/apt.13779
[Indexed for MEDLINE]
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