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Switching from a Protease Inhibitor (PI) to Nevirapine Is as Effective
as Continuing with PI for Viral Suppression and Improves Lipodystrophy
In this open-label, multi-center study, researchers
assessed the antiviral efficacy and safety of switching from a protease
inhibitor (PI) to nevirapine
(Viramune) in patients with long-term HIV-1 RNA suppression
on PI-containing regimens, and to assess its influence in adherence
to treatment.
One hundred sixty (160) HIV patients with
undetectable viral load
for at least 6 months on a PI-containing regimen were randomized
to either continue with their PI regimen (n=79) or replace
PI with nevirapine (n=81).
Clinical assessment included plasma HIV-1
RNA, blood chemistry, hematology, lymphocyte counts, and adverse
events reports.
Adherence
to treatment and lipodystrophy
syndrome were assessed by patient self-reporting.
Results
· Treatment
efficacy was equivalent in the two arms, for patients with viral
loads either above or below 100 000 HIV-1 RNA copies/mL.
· The
increase in CD4 cell count was significant in both arms (P<0.00001)
but the average CD4 cell count at 48 weeks was slightly higher in
the nevirapine arm (596 vs. 569; P=0.1588).
·The number of
patients with severe hypertriglyceridemia
(>400 mg/dL) after 48 weeks of treatment decreased in the nevirapine
arm (from 11 to six), but increased in the PI arm (from four to
11) and led to treatment discontinuation in two patients.
·Lipodystrophy
changes increased in 15% of patients in the PI arm but decreased
in 4% of patients in the nevirapine arm.
· Finally,
although adherence was similar in the two arms, patients reported
that it required significantly less effort to stay on treatment
in the nevirapine arm.
Conclusions
The study
authors conclude, “The results indicate that switching from PI to
nevirapine is as effective as continuing with PI for maintaining
viral control, even in patients with baseline viral load above 100
000 copies/mL.”
“In
addition, reductions in hypertriglyceridemia and lipodystrophy and
in the effort required to stay on treatment were observed.”
09/23/05
Reference
J
A Arranz-Caso and others. A randomized
controlled trial investigating the efficacy and safety of switching
from a protease inhibitor to nevirapine in patients with undetectable
viral load. HIV Medicine 6(5): 353-359. September 2005.
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