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Background:
HIV+ patients (pt) on HAART may experience mild-to moderate
side effects (SE) related to the PI or NNRTI in their antiretroviral
regimen. These SE may affect depression. This analysis evaluates
whether an 8-week substitution with LPV/r can alleviate SE and improve
symptoms of depression while maintaining viral control
(HIV RNA <400 copies/ml).
Methods:
PLATO is a randomized,
open-label, multicentre (169 sites, 14 countries), Phase IV trial. t
experiencing Grade 2 PI/NNRTI-associated side effects were to substitute
LPV/r for the suspect PI/NNRTI and remain on baseline (BL) NRTIs. The Center
for the Epidemiologic Studies Depression Scale (CES-D), a validated
self-report questionnaire, was administered at BL and week (Wk) 8. In
addition, plasma viral load, safety, and QOL measures [ACTG Symptoms
Distress Module, with two additional items for nephrolithiasis (ASDM); and
MOS-HIV] were
followed.
Results:
585 pt have data available through Wk 8 of Tx
with
LPV/r (80% male, mean age 42 years), including 194, 128, 134, 97 and 32 pt
previously on NFV, IDV, IDV/RTV, EFV or another PI/NNRTI, respectively. At
BL, depression (CES-D score
=16)
was reported for 40%, 41%, 48%, 51% and 48%, and decreased to 31%, 26%, 27%,
28% and 42% with 8 weeks of LPV/r therapy for pt previously on NFV, IDV,
IDV/RTV, EFV or another PI/NNRTI, respectively. Mean improvements in CES-D
were seen from BL to Wk
8 in pt previously on
NFV (–1.9 from 14.7;
P=0.002),
IDV (–3.8 from 15.2;
P<0.001),
IDV/RTV (–5.2 from 16.4;
P<0.001),
EFV (–6.7 from 18.0;
P<0.001)
or another PI/NNRTI (–2.7 from 16.5;
P=0.1).
Higher ASDM and lower MOS-HIV scores (BL and Wk 8;
P<0.001),
female gender (BL;
P=0.04)
and younger age (Wk 8;
P=0.002)
were associated
with depression. In addition, 97% of
pt maintained or improved
viral control.
Conclusion:
In patients with Grade 2 toxicities, prevalence
of depression (CES-D score
=16)
was reduced after substitution with LPV/r. Factors associated with
depression included QOL, gender and age. |
