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1997
A randomized study of standard vs low-dose tenofovir
for the treatment of chronic hepatitis B
Aline Le Cleach, Genevieve Huard, Claire Fournier, Bernard E.
Willems, Jean-Pierre Villeneuve; Medicine, CHUM, Montreal, QC,
Canada
Tenofovir and entecavir are the most commonly used drugs for
HBV treatment. Because of the very long elimination half-life of
tenofovir active metabolite, we hypothesized that a reduced
dosage of tenofovir might be as effective as standard dosage,
while being less costly. Aims: Evaluate the impact of a standard
(300 mg PO daily) vs reduced (300 mg PO three times a week)
tenofovir posology on HBV viral suppression and renal function.
Methods: Before inclusion, all patients were on a 300 mg
id tenofovir dosage and had an undetectable HBV viral load
(VL). Patients were randomly assigned (1:1) to either continue
tenofovir 300 mg id or reduce dosing to 300 mg three times
a week. Laboratory data were obtained at baseline and every
three months during the study. HBV relapse was defined as a
VL ≥ 2000 IU/ml. Significant chronic kidney disease (CKD)
was defined has a glomerular filtration rate (GFR) ≤ 50 ml/
min. HBeAg seroconversion was defined as the loss of HBeAg
and development of anti-Hbe antibodies (Ab). The study period
extended from 31/05/2010 to 30/04/2015. Results: Thirty-
four patients were included in the study (17 in the standard
and 17 in the reduced tenofovir posology). The majority were
male (28/34, 82.4%) and non-white (18/34, 52.9%) and the
median age was 52 years (IQR 17). The median FU duration
was 63 months (IQR 49). At baseline, the median GFR was 97
ml/min (IQR 31). During FU, one (5.9%) patient in the standard
tenofovir group vs 0 in the reduced dosage group experienced
a HBV relapse. In this patient, the HBV relapse occurred
after 32.1 months was related to an admitted noncompliance
to the medication. No predictive factors of HBV relapse could
be identified upon univariate analyses. HBeAg seroconversion
occurred in one patient in the reduced posology group after
24.7 months. Two patients (one in each group) developed
significant CKD during FU after 9.2 and 25.2 months, respectively.
No predictive factors for the development of significant
CKD could be identified upon univariate analyses. However, in
univariate and multivariate analysis, standard tenofovir dosage
was identified as a predictive factor for lower GFR at the end
of FU (p=0.038). Conclusion: This study suggests that reduced
tenofovir dosage is as effective as standard dosing while being
less costly and appears to confer a protective effect on renal
function.
Disclosures:
Bernard E. Willems - Advisory Committees or Review Panels: Gilead, Vertex,
Behringer-Ingelheim, Abbvie, Roche, Janssen; Grant/Research Support: Gilead,
Vertex, Behringer-Ingelheim, Merck, Cangene, Abbvie; Speaking and Teaching:
Gilead, Janssen
Jean-Pierre Villeneuve - Grant/Research Support: Gilead, Transgene, Immune-
Carta
The following authors have nothing to disclose: Aline Le Cleach, Genevieve
Huard, Claire Fournier
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发表于 2015-10-5 16:37
