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A
Retrospective Cohort-Based Survey of Patients Using Twice-Daily
Indinavir + Ritonavir Combinations: Pharmacokinetics, Safety, and
Efficacy [Burger DM, et al. JAIDS 2001;26:218]: The
authors provide a retrospective analysis of patients receiving indinavir
plus ritonavir in two regimens: 800/100 mg bid or 400/400 mg bid.
The peak indinavir levels with the 800/100 mg regimen was approximately
the same as reported for indinavir alone with 800 mg q8h, but the
trough concentration was about 10-fold higher. The 400/400 mg regimen
showed a lower peak level and a trough that was somewhat lower than
that achieved with the 800/100 mg regimen. Clinical efficacy as
measured by viral load was approximately the same. GI side effects
were somewhat more common with the 400/400 mg regimen, and nephrotoxicity
was modestly greater with the 800/100 mg regimen. However, the most
significant difference was the number who discontinued treatment,
which was 70% in the 400/400 mg regimen compared to 26% in the 800/100
mg regimen. These results are summarized in the table below:
|
|
IDV
800
RTV 100
Bid
N = 100 |
IDV
400
RTV 400
Bid
Nn = 32 |
| Peak
IDV (median) |
6.8
mg/L |
2.6
mg/L |
| Trough
IDV (median) |
0.77
mg/L |
0.45
mg/L |
| ADR
- Nausea/vomiting |
22% |
35% |
| Nephrotoxicity |
14% |
9% |
| Viral
load <400 c/mL |
77% |
70% |
| Discontinued
therapy |
26% |
70%* |
|
* p = 0.008 |
The authors conclude
that this combination provides improved pharmacokinetic properties
and comparable virologic efficacy, but the 800/100 mg regimen had
a significantly lower discontinuation rate. Nevertheless, the reason
for discontinuation was not entirely clear since the side effect profile
and the viral load changes were about the same in both groups.
posted
4/13/2001
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