Long-term efficacy and safety of protease inhibitor switching to nevirapine in HIV-infected patients with undetectable virus load.
BACKGROUND
Simplified highly active antiretroviral therapy (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.


METHODS
We performed a prospective study of 110 patients infected with human immunodeficiency virus type 1 (HIV-1) with undetectable virus load who discontinued PI therapy and initiated therapy with nevirapine without changing nucleoside analogues. Reasons for switching were treatment simplification (45%), lipodystrophy (24%), renal 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/microL (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
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, Fundación Jiménez Díaz, Universidad Autónoma de Madrid, Madrid, Spain.
Paloma
P
Gil
Miguel
M
de Górgolas
Vicente
V
Estrada
Alberto
A
Arranz
Pablo
P
Rivas
Carmen
C
Yera
Rosa
R
García
Juan J
JJ
Granizo
Manuel
M
Fernández-Guerrero
D000328:Adult; D000368:Aged; D019380:Anti-HIV Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D006937:Hypercholesterolemia / Q000139:chemically induced; D015228:Hypertriglyceridemia / Q000139:chemically induced; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D019829:Nevirapine / Q000009:adverse effects* / Q000627:therapeutic use*; D011446:Prospective Studies; D019562:Viral Load
D019380:Anti-HIV Agents; D019829:Nevirapine