Bonora, S

Calcagno, A

Viganò, O

Bigliano, P

Rusconi, S

Trentini, L

Tettoni, MC

Orofino, G

Salassa, B

Bramato, C

D'Avolio, A

Siccardi, M

Colella, E

Galli, M

Di Perri, G

English

PubMed

S Bonora

A Calcagno

O Viganò

P Bigliano

S Rusconi

L Trentini

MC Tettoni

G Orofino

B Salassa

C Bramato

A D'Avolio

M Siccardi

E Colella

M Galli

G Di Perri

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POSTER PRESENTATION Open Access
Analysis of determinants of long-term efficacy of
unboosted atazanavir-based regimens in the
clinical setting
S Bonora1*, A Calcagno1, O Viganò2, P Bigliano1, S Rusconi2, L Trentini1, MC Tettoni1, G Orofino3, B Salassa1,
C Bramato1, A D’Avolio4, M Siccardi4, E Colella2, M Galli2, G Di Perri1
From Tenth International Congress on Drug Therapy in HIV Infection
Glasgow, UK. 7-11 November 2010
Background
Switch to unboosted atazanavir (ATV 400 mg qd),
although not licensed in Europe, is an attractive off-label
option due to convenience and tolerability. However
there is a substantial lack of data concerning efficacy of
ATV 400 mg-based regimens outside the trial setting.
Our aim was to perform a retrospective study of determi-
nants of long term efficacy in 2 Italian large HIV clinics.
Materials and methods
A retrospective analysis of virological (responder = last
viral load < 50 copies/ml) and PK data of patients (pts)
administered with ATV 400 mg QD + 2 N(Nt)RTIs for
at least 3 months was performed. Genotypic Sensitivity
Score (GSS) and ATV resistance associated mutations
(RAMs) were calculated according to Stanford database
using cumulative genotype. ATV Ctrough was measured
by a validated HPLC method.
Results
246 patients [65% male, mean age 47.5 years (±9), mean
BMI 23.8 Kg/m2 (±3,4)] were considered. 40.7% and 6.6%
were HCV- or HBV-coinfected, respectively, of whom 23
(9.3% of total) were cirrhotic. 32,9% and 17.9% of pts
showed previous virological failure to NNRTIs and to PIs,
respectively. Switch to ATV was mainly (48,4%) due to
toxicity [dyslipidemia (21,5%) and gastrointestinal side
effects (9,7%)] and to simplification (28,5%); last regimen
was boosted PI-based in 178 patients (72.3%, 48% of whom
ATV/r) and NNRTI-based in 24 (9.8%). At baseline CD4+
cell count was 428 cell/mm3 (±223) and 58,1% showed
undetectable viral load. 212 (86.5%) patients had previous
genotype available: backbone GSS was < 2 in 36,9% of
patients and 6,7% had at least 1 ATV-RAM. Mean (±SD)
follow-up was 120 weeks (± 64), and 235 (95.5%) pts were
responders (74.4% still on treatment) while 11 (4.5%)
showed a virological failure (3 showed selection of ATV-
RAMs). ATV Ctrough (available in 84 patients) was higher
in responders (median value 130 vs. 70 ng/ml), although
this was not statistically significant (p>0.05). At multivari-
ate analysis, GSS<2, ATV-RAMs ≥1 and self-reported non-
adherence were associated with failure. ATV was stopped
only in 4 patients (1.6%) for side effects.
Conclusions
Over a mean follow up of more than 2 years, unboosted
ATV showed high efficacy with good tolerability even in
a clinical cohort including moderately experienced pts.
However, due to the impact of GSS of backbone and
presence of ATV-RAMs on the risk of failure, pts need
to be accurately selected. The role of ATV plasma expo-
sure deserves to be clarified on a larger sample size.
Author details
1University of Torino, Department of Infectious Diseases, Torino, Italy.
2University of Milano, Luigi Sacco Hospital, Department of Infectious
Diseases, Milano, Italy. 3Ospedale Amedeo di Savoia, ASLTO2, Department of
Infectious Diseases, Divisione, Torino, Italy. 4University of Torino,
Pharmacokinetics and Pharmacogenetics Laboratory, Torino, Italy.
Published: 8 November 2010
doi:10.1186/1758-2652-13-S4-P48
Cite this article as: Bonora et al.: Analysis of determinants of long-term
efficacy of unboosted atazanavir-based regimens in the clinical setting.
Journal of the International AIDS Society 2010 13(Suppl 4):P48.
1University of Torino, Department of Infectious Diseases, Torino, Italy
Full list of author information is available at the end of the article
Bonora et al. Journal of the International AIDS Society 2010, 13(Suppl 4):P48
http://www.jiasociety.org/content/13/S4/P48
© 2010 Bonora et al; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons
Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in
any medium, provided the original work is properly cited.


Analysis of determinants of long-term efficacy of unboosted atazanavir-based regimens in the clinical setting

Analysis of determinants of long-term efficacy of unboosted atazanavir-based regimens in the clinical setting

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