Objectives:

To assess the effects of switching from HIV-1 protease inhibitors (PI) to nevirapine on metabolic abnormalities in patients with fat redistribution and on CD4 T lymphocytes and plasma HIV-1 RNA.

Design:

Longitudinal data analysis of 23 consecutive patients treated with two nucleoside reverse transcriptase inhibitors and at least one PI who decided to stop PI despite sustained virological supression (< 200 copies/ml) because of psychological repercussions caused by body changes. PI were replaced by nevirapine in all patients.

Methods:

Physical examination [including measurements of body mass index (BMI) and waist: hip ratio (WHR)], fasting cholesterol, triglycerides, glucose, insulin, CD4 T lymphocytes and plasma HIV-1 RNA were performed at baseline and every 3 months.

Results:

Awareness of body changes occurred after a median of 12 months (range, 6-26 months) from the commencement of PI. Seventeen patients complained of increased abdominal girth (in 15 also of peripheral fat wasting) and six of peripheral fat wasting only. Hypertriglyceridemia (≥ 200mg/dl) was present in 23 (100%), hypercholesterolemia (≥ 200mg/dl) in 18 (78%), and impaired fasting glucose (≥ 110mg/dl) in seven (30%) patients. Baseline CD4 T lymphocytes were 514¥ 10 6/l (range, 83-994¥ 10 6/l). HIV-1 RNA had been< 200 copies/ml a median of 9 months (range, 3-14 months) prior to withdrawal of PI. Median follow-up from the replacement of PI by nevirapine was 8 months (range, 7-11 months). Six months after PI withdrawal there was a significant improvement in cholesterol (decrease of 22%; P= 0.0005), triglycerides (decrease of 57%; P= 0.0001), glucose (decrease of 15%; P= 0.008), and fasting insulin resistance index (decrease of 45%; P= 0.0001). CD4 T-lymphocyte counts remained unchanged (401¥ 10 6/l; range, 57-941¥ 10 6/l; P= 0.13) and in only one patient did the viral load become detectable at a low count (546 copies/ml; P= 0.32). BMI did not vary (23.30 versus 23.56 kg/m 2; P= 0.73), but WHR decreased significantly from 0.91 to 0.85 (P= 0.048). Twenty-one patients (91%) subjectively reported a partial improvement in their body shape (particularly in peripheral fat wasting), although none admitted to have their body shaped as prior to body changes.

Conclusions:

Metabolic abnormalities associated with potent antiretroviral regimens including PI may revert at least partially, whereas the suppression achieved may be preserved at least at mid-term after replacing PI by nevirapine.