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Long-Term
Efficacy and Safety of Switch a from Protease Inhibitor to NNRTI
Nevirapine in Patients with Undetectable HIV Viral Load
Simplified
HAART regimens are becoming widely used, particularly
as a result of the side effects of and
difficult compliance with protease
inhibitor (PI) therapy. However, the long-term
efficacy of HAART has not been properly assessed.
Spanish
researchers performed a prospective study of 110
patients infected with HIV-1 with undetectable virus
load who discontinued PI therapy and initiated therapy
with nevirapine (Viramune)
without changing nucleoside
analogues (NRTIs).
Reasons
for switching were treatment
simplification (45%), lipodystrophy (24%), renal
(kidney) problems (23%), and dyslipidemia
(8%). HIV-1
load, CD4 cell count, and
fasting biochemistry profiles were performed at
the time of switching (baseline) and every
3 4 months thereafter.
The
aim of the study was to evaluate the long-term
efficacy and safety of this combination.
Results
Sixty-eight
patients (61.8%) had a duration of follow-up of
3 years. The mean increase in the CD4 cell
count after 3 years was 90 cells/ L (13.8%
from baseline). Virus loads remained undetectable in
all patients but 9 (8.2%).
Triglyceride levels dramatically improved at 12 months (a
75% decrease; P < .02) and remained statistically
significant over time (P < .04). The same
occurred with serum
cholesterol levels: there was an
initial reduction of 25% (P < .02) and
at the end of the follow-up period (P
< .015).
However,
at the long-term evaluation, complete normalization
of mean serum cholesterol and triglyceride levels
could not be achieved. Sixteen patients (14.5%)
had to stop therapy as a result of nevirapine-associated
side effects.
Conclusions
In
conclusion, the authors write, “The switching of a PI
to nevirapine is a safe and well-tolerated
option for maintaining long-term virological
suppression and immunological control.”
“Three
years after starting nevirapine therapy, rates
of hypercholesterolemia and hypertriglyceridemia improved,
although normal cholesterol and triglyceride values
were not achieved.”
Division of Infectious Diseases,
Department of Immunology, and
Epidemiology Unit, Fundación Jiménez
Díaz, Universidad Autónoma de
Madrid, Hospital Clínico de
San Carlos, Universidad Complutense
de Madrid, and Hospital
Príncipe de Asturias, Univesidad
de Alcaláde Henares, Madrid,
Spain.
09/22/04
Reference
P
Gil and others. Long-Term Efficacy
and Safety of Protease
Inhibitor Switching to Nevirapine
in HIV-Infected Patients with
Undetectable Virus Load. Clinical Infectious Diseases 39(7): 1024-1029. October 1,
2004.
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