Long-Term Efficacy and Safety of Protease Inhibitor Switching to Nevirapine in HIV-Infected Patients with Undetectable Virus Load

• Published in: Clinical infectious diseases Vol. 39; no. 7; pp. 1024 - 1029
• Main Authors: Gil, Paloma, de Górgolas, Miguel, Estrada, Vicente, Arranz, Alberto, Rivas, Pablo, Yera, Carmen, García, Rosa, Granizo, Juan J., Fernández-Guerrero, Manuel
• Format: Journal Article
• Language: English
• Published: Chicago, IL The University of Chicago Press 01.10.2004; University of Chicago Press
• Subjects: Adult; Aged; AIDS; Anti-HIV Agents - adverse effects; Anti-HIV Agents - therapeutic use; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antiretroviral Therapy, Highly Active; Antiretrovirals; Antiviral agents; Biological and medical sciences; CD4 Lymphocyte Count; Cholesterols; Drug toxicity and drugs side effects treatment; Female; Hepatotoxicity; Highly active antiretroviral therapy; HIV Infections - drug therapy; HIV/AIDS; Human immunodeficiency virus 1; Human viral diseases; Humans; Hypercholesterolemia - chemically induced; Hypertriglyceridemia - chemically induced; Infectious diseases; Lipodystrophy; Longitudinal Studies; Male; Medical sciences; Memory interference; Middle Aged; Miscellaneous (drug allergy, mutagens, teratogens...); Nevirapine - adverse effects; Nevirapine - therapeutic use; Pharmacology. Drug treatments; Prospective Studies; Side effects; Triglycerides; Viral diseases; Viral diseases of the lymphoid tissue and the blood. Aids; Viral Load; Viruses; Skin disease; Antiretroviral agent; RNA-directed DNA polymerase; Nevirapine; Compliance; HIV-1 virus; Toxicity; Non nucleoside compound; Lipids; Hyperlipoproteinemia; Lipoprotein; Enzymopathy; Immunological investigation; Reverse transcriptase inhibitor; Secondary effect; Nucleoside analog; Antiviral; Serum; Dyslipemia; Human; Immunopathology; Enzyme; Transferases; Enzyme inhibitor; Retroviridae; Metabolic diseases; AIDS; Immune deficiency; Lentivirus; Infection; Virus; Nucleotidyltransferases; Chemotherapy; Viral disease; Lipodystrophy; Adipose tissue disorders; Human immunodeficiency virus; Protease inhibitor
• ISSN: 1058-4838; 1537-6591
• DOI: 10.1086/423385

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/µL (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.