Long-term TDF therapy offers sustained HBV suppression without

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TDF beneficial
Long-term
TDF
in chronic
therapyHBV
offers
patients
sustained
with
suboptimal
responsewithout
to lamivudine
plus adefovir
HBV suppression
resistance
By Shreeya Nanda, Senior medwireNews Reporter
2015; 21: 2746‒2753
medwireNews: Patients with lamivudine-resistant
chronic hepatitis B virus (HBV) infection who
respond poorly to lamivudine plus adefovir dipivoxil
(ADV) can benefit from switching to tenofovir
disoproxil fumarate (TDF) monotherapy, research
findings indicate.
TDF treatment “significantly suppressed” HBV
replication in this patient population, say Hong-Ying
Pan (Zhejiang Provincial People’s Hospital,
Hangzhou, China) and co-authors in the World
Journal of Gastroenterology.
Of the 28 patients who received TDF, 17.86%
achieved a virological response, defined as serum
HBV DNA below 103 copies/mL, at week 4, with the
proportion of patients achieving a response increasing
to 75%, 82.14%, 89.29% and 96.43% at weeks 12,
24, 36 and 48, respectively.
This compared with a virological response rate of
6.45%, 16.13%, 22.58%, 25.81% and 29.03% at
the equivalent timepoints in the 31 patients who
remained on lamivudine plus ADV. The difference
between the groups was statistically significant at
all timepoints except at week 4.
At week 12, normalisation of alanine aminotransferase
(ALT) levels occurred in 75% of TDF-treated patients
and in 17.86% of participants in the lamivudine plus
ADV group, a significant difference. But the difference
between the groups was no longer significant at weeks
24 (78.57 vs 54.84%) and 48 (89.26 vs 67.74%).
Hepatitis B e antigen (HBeAg) loss was achieved by
one of the 25 patients in the TDF group and none of
the 27 in the lamivudine plus ADV group who had
been HBeAg-positive at baseline, a nonsignificant
difference, leading the researchers to comment that “a
greater HBV DNA reduction may not necessarily
accelerate HBeAg loss”.
TDF monotherapy was “well tolerated” during the
course of the study, they say, with no patient reducing
their dose or discontinuing the drug early. And no
incidences of ALT flares or rises in creatinine or
serum phosphorus levels were reported.
Pan et al point out, however, that postmarketing
surveillance found an association between TDF
t r e a t m e n t a n d n e p h r o t o x i c i t y, i n c l u d i n g
hypophosphatemia and renal insufficiency or failure,
and suggest that renal function be monitored during
long-term TDF therapy.
They conclude: “Our findings suggest that suboptimal
responders to [lamivudine] plus ADV should be
switched as soon as possible to antiviral agents with
higher potency, and TDF would be a viable option.”
medwireNews (www.medwirenews.com) is an independent clinical
news service provided by Springer Healthcare Limited. © Springer
Healthcare Ltd; 2015
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