Changes in Patient-reported Neuropsychiatric Outcomes during the SENSE Trial: First-line Treatment with Two Nucleoside Analogues plus Etravirine or Efavirenz

Background

Efavirenz treatment has been associated with an increased risk of neuropsychiatric adverse events, some of which may last for only the first few weeks of treatment.

Methods

In this double-blind placebo-controlled trial, 157 treatment-naïve patients with human immunodeficiency virus (HIV) RNA >5000 copies/mL, were randomized 1:1 to either etravirine 400 mg once daily (n = 79), or efavirenz 600 mg once daily (n = 78), plus 2 nucleoside analogues. At screening, baseline, and during the trial, subjects completed the HIV-Patient Symptoms Profile (HPSP) questionnaire on the impact of adverse events associated with their treatment. There were 14 symptom domains, with 5 classified as neuropsychiatric and 9 other domains. The mean scores of each domain were compared between the arms at the Week 2 and Week 48 visits.

Results

The treatment arms were comparable at baseline (overall median CD4 count 302 cells/uL, median HIV RNA 4.8 log10 copies/mL). In the analysis of the HPSP questionnaire, the mean score for the domains of dizziness and sleep of the etravirine arm was significantly better than the efavirenz arm at Week 2. There were no significant differences between the arms at Week 48, for any of the domains. At the baseline visit, patients with a medical history of neuropsychiatric adverse events had significantly worse scores in the neuropsychiatric domains (P < 0.01). During the trial, patients with at least one neuropsychiatric adverse event had significantly worse scores in the neuropsychiatric domains of the HPSP questionnaire (P < 0.01).

Conclusions

In the SENSE trial, dizziness and sleep disorders showed significantly worse HPSP scores in the efavirenz arm, compared with the etravirine arm at the Week 2 visit. However, at Week 48 there were no significant differences between the treatment arms in any domain of the patient HPSP. This suggests that the impact of efavirenz on quality of life may be short term for the majority of patients.