48-Week
Amprenavir Update
This randomized,
double-blind, phase III study compares amprenavir (APV) plus AZT/3TC to AZT/3TC
in treatment-naïve individuals. Participants with viral load >400 copies/ml
at week 16 were permitted to switch to open-label APV. 221 of the 232 randomized
received treatment.
Baseline – median
viral load and CD4 in the APV arm were 44,000 copies/ml and 442 in the APV +
AZT/3TC arm.
Viral Load Results:
At week 48, 93% (n=54)
had <400 copies/ml using the As-Treated analysis which is less stringent
than the ITT analysis.
Using the ITT (n=116)
where discontinuations are considered failures 42% had <400 copies/ml.
CD4s increased about
199 from baseline to week 48.
APV
Viral Load Changes By Baseline Viral Load (See
Table 15):
|
Table 15. |
||
|
Baseline
Viral Load |
As
Treated Analysis <400 |
<400
ITT |
|
10,000–
30,000 |
87%
(20/23) |
51%
(19/37) |
|
30,000-100,000 |
24/24
(100%) |
42%
(23/55) |
|
>100,000 |
86%
(6/7) |
25%
(6/24) |
Investigators reported
an ITT Observed Data analysis (<50 copies/ml) which is not as stringent as an
ITT analysis but also not as liberal as an as-treated analysis. At week 16, 59%
had <50 copies/ml (n=88). At
week 48 they reported 69% had <50 copies but this included individuals who
switched to APV after week 16 because their viral load was >400 copies/ml.
Adverse
Events. Investigators
reported the incidence of treatment-related adverse events of at least moderate
intensity through week 48:
Nausea 30%: grade 1 -
62%; grade 2 - 34%; grade 3 – 4%
Flatulence 10%
Fatigue 11%
Headache 11%
Vomiting 11%: grade 1
– 73%; grade 2 – 25%; grade 3 – 2%
Diarrhea 10%
Rash 19%: grade 1 –
31%; grade 2 – 58%; grade 3 – 11%