Quality of life, emotional status, and adherence of HIV-1-infected patients treated with efavirenz versus protease inhibitor-containing regimens

We assessed the impact of an efavirenz-containing regimen versus a protease emotional status, and adherence inhibitor-containing regimen on quality of life. of HIV-1-infected patients, In addition. we,,ought to define the adverse events associated with these treatments. with a special focus on central nervous system disorders in the efavirenz treatment group. This prospective. randomized, two-arm, controlled patient,. for whom initial treatment with a protease inhibitor-study included 100 containing regimen failed. Patients were randomized to start treatment with two nucleoside retrotranscriptase inhibitors plus ebavirenz (group 1: 51 patients) or two nucleoside retrotranscriptase inhibitors plus one or more new protease inhibitors (group 2: 49 patients). Quality of life was assessed by a five-point item adapted front the HIV questionnaire of the Medical Outcomes Study. emotional status was evaluated by the Profile of Mood State questionnaire, and patients self-reported adherence. Data were analyzed by both an as-treated method and an intention-to-treat-last observation carried forward method, Patients in group I reported the following findings at week, 4: dizziness (66%). abnormal dreaming (48%). light-headedness (37,), and difficulty sleeping (35%). At week 24, dizziness (13%: p < 001), abnormal dreaming (18%; p = .002). light-headedness (13%: p = .01), difficulty sleeping (7%: p = .001) and nervousness (13%:p = .01) decreased in these patients. Irritability, abnormal dreaming, and nervousness persisted at week 48 in 13%. 10% and 8% of group 1 patients, respectively. Patients in group 2 reported the following findings at Week 4: lightheadedness (8%), dizziness (5%), difficulty sleeping (4%), nervousness (4%), and headaches (3%). Patients in group 2 reported the following findings at week 48: difficulty sleeping (4%) nervousness (3%), headache (3%), and light-headedness (2%). In group 1, quality of life (p < .001) and emotional status (week 48:p = .004) improved. both of which were better than those in group 2 (p = .001). Both groups maintained high levels of medication adherence, and no significant differences in the number of patients who had viral loads of <200 copies/mL at week 48 were found (78% of group 1 patient vs. 85% of group 2 patients: p = not significant). At week 48 the mean CD4 cell count +/- SID was 497 +/- 224/mm(3) in group 1 and 539 +/- 298/mm(3) in group 2 (p = not significant). Despite similar immunologic and virologic outcomes, a second-line efairenz-containing regimen improved quality of life of HIV-1-infected patients compared with a second-line protease inhibitor-containing regimen, however. close follow-up of patients receiving treatment with efavirenz-based regimens is recommended. especially for those with previous emotional disturbances due to central nervous system disorders in the short term and those with persistence of a low percentage 4 these disorders in the long term.