Treatment
with Atazanavir with or without Ritonavir Results in Clinically Important Improvements
in Health-related Quality of Life Health-related
quality of life (HRQoL) declines in HIV-infected patients in the absence of effective
therapy or with older, more symptomatic ARV regimens.
Atazanavir
is potent and well tolerated as a once daily protease inhibitor in both treatment-naïve
and treatment-experienced patients. Data on HRQoL in treatment naïve patients
on ATV/r or ATV regimens are limited.
In a randomized open label study
comparing ATV/r 300mg/100mg with ATV 400mg, both in combination with 3TC and extended-release
d4T, HRQoL was assessed using the EQ-5D, a generic questionnaire, and the MOS-HIV,
a disease specific questionnaire.
HRQoL was assessed at baseline and at
Weeks 24 and 48.
Primary endpoints were the physical (PHS) and mental
(MHS) summary scores (mean score 50±10) for the MOS-HIV; and the health
index score (HIS, range 0-1), and visual analogue scale (VAS, range 0-100) for
the EQ-5D.
Clinically important changes include a 2 point change (MOS-HIV
summary scores) and 0.03 change (EQ-5D HIS).
Primary outcomes were changes
in scores from baseline.
Results
Of 199 treated subjects,
approximately 88% of the subjects completed the EQ-5D and approximately 75% of
the subjects completed the MOS-HIV at Weeks 24 and 48.
|
|
Change
from Baseline Score
[Mean(SE)] |
|
|
Baseline
[Mean(SE)] |
Week
24 |
Week
28 | |
ATV300/r |
ATV400 |
ATV300/r |
ATV400 |
ATV300/r |
ATV400 |
|
MOS-HIV Sample |
81 |
84 |
69 |
68 |
65 |
71 |
|
PHS |
52.0 (1.21) |
53.7(0.92) |
3.5(1.19) |
3.0(0.90) |
3.6(1.30) |
2.1(1.07) |
|
MHS |
49.9 (1.21) |
50.0 (1.19) |
5.1 (1.23) |
3.8 (1.28) |
3.9 (1.23) |
2.0 (1.50) |
|
EQ-5D Sample |
94 |
104 |
88 |
96 |
84 |
91 |
|
HIS |
0.8 (0.02) |
0.8 (0.02) |
0.1 (0.02) |
0.0 (0.02) |
0.1 (0.02) |
0.0 (0.03) |
|
VAS |
78.5 (2.10) |
80.5 (1.51) |
9.7 (2.30) |
9.0 (1.62) |
10.3 (2.35) |
7.7 (1.74) |
The authors conclude,
"Treatment with atazanavir with or without ritonavir resulted in clinically
important improvements in the HRQoL of these treatment naïve HIV-infected
persons." 08/22/06 Reference
U
Iloeje, K Kastango, N Malan, and others. Health related quality of life (HRQoL)
changes in antiretroviral (ARV) naïve HIV-infected patients on atazanavir
based regimens, with (ATV/r) and without (ATV) ritonavir: week 48 results from
AI424-089. 16th International AIDS Conference. August 13-18, 2006. Toronto, Canada.
Abstract TUPE0065.
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