|
Abacavir-lamivudine-zidovudine
vs. indinavir-lamivudine-zidovudine in antiretroviral-naïve
HIV-infected adults [Staszewski S, et al. JAMA 2001;285:1155]:
This is clinical
trial CNAAB 3005, which examined two three-drug regimens in 562
treatment-naïve HIV-infected adults with baseline HIV viral
loads of >10,000 c/mL and CD4 cell counts of >100/mm3.
The 48-week results are summarized in the table below:
|
Trizivir
vs. IDV/3TC/AZT in Treatment-Naïve Patients:
48-Week Results
|
|
ABC/AZT/3TC
N = 282 |
IDV/3TC/AZT
N = 280 |
<400
c/mL
Intent-to-treat
As treated |
51%
86% |
51%
94% |
<50
c/mL
Intent-to-treat
As treated |
40%
69% |
46%
82% |
Baseline
VL >100,000
<50 c/mL ITT
As treated |
31%
76% |
45%
88% |
CD4
count increase
(mean/mm3)
|
107
|
93 |
| AIDS-defining
events |
3 |
1 |
| Serious
adverse events |
21% |
22% |
None of the differences
shown for the two groups were statistically significant. The abacavir
group included one death that was attributed to hypersensitivity
with ABC re-challenge.
Comment: This is a study to demonstrate equivalence, which
is an issue that is discussed in the editorial comment by B. Djulbegovic
and M. Clarke. They point out that most therapeutic trials are done
to demonstrate one treatment is better and could be called "superiority
trials." In CNAAB 3005, the limit set for differences in the
primary end point, a viral load <400 c/mL at week 48, was 12%
based on discussions with the FDA [JAMA 2001;285:1208]. These
authors caution about the argument concerning toxicity in an equivalence
trial when this was not formally assessed or at least not demonstrated.
Nevertheless, many HIV care providers will be encouraged by the
simplicity of one pill twice daily and the potential for avoiding
PI-associated toxicity.
posted
3/20/2001
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