title: Quality of life, emotional status, and adherence of HIV-1-infected patients treated with efavirenz versus protease inhibitor-containing regimens.
abstract: We assessed the impact of an efavirenz-containing regimen versus a protease inhibitor-containing regimen on quality of life, emotional status, and adherence of HIV-1-infected patients. In addition, we sought 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 study included 100 patients for whom initial treatment with a protease inhibitor-containing regimen failed. Patients were randomized to start treatment with two nucleoside retrotranscriptase inhibitors plus efavirenz (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 from 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 1 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: light-headedness (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%), headaches (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 patients vs. 85% of group 2 patients; p = not significant). At week 48, the mean CD4 cell count +/- SD was 497 +/- 224/mm3 in group 1 and 539 +/- 298/mm3 in group 2 (p = not significant). Despite similar immunologic and virologic outcomes, a second-line efavirenz-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 of these disorders in the long term.
authors.affiliation: HIV Unit, Fundació Lluita SIDA and IrsiCaixa Retrovirology Laboratory, Germans Trias i Pujol University Hospital, Badalona, Catalonia, Spain. cfumaz@ns.hugtip.scs.es
authors.forename: Carmina R
authors.initials: CR
authors.lastname: Fumaz
authors.forename: Albert
authors.initials: A
authors.lastname: Tuldrà
authors.forename: Ma José
authors.initials: MJ
authors.lastname: Ferrer
authors.forename: Roger
authors.initials: R
authors.lastname: Paredes
authors.forename: Anna
authors.initials: A
authors.lastname: Bonjoch
authors.forename: Toni
authors.initials: T
authors.lastname: Jou
authors.forename: Eugènia
authors.initials: E
authors.lastname: Negredo
authors.forename: Joan
authors.initials: J
authors.lastname: Romeu
authors.forename: Guillem
authors.initials: G
authors.lastname: Sirera
authors.forename: Cristina
authors.initials: C
authors.lastname: Tural
authors.forename: Bonaventura
authors.initials: B
authors.lastname: Clotet
mesh_terms: D000328:Adult; D000480:Alkynes; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D048588:Benzoxazines; D002493:Central Nervous System Diseases / Q000139:chemically induced; D003521:Cyclopropanes; D004359:Drug Therapy, Combination; D004644:Emotions; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000523:psychology* / Q000821:virology; D015497:HIV-1; D006801:Humans; D008297:Male; D008875:Middle Aged; D010078:Oxazines / Q000009:adverse effects / Q000627:therapeutic use*; D010349:Patient Compliance; D011446:Prospective Studies; D011788:Quality of Life; D018894:Reverse Transcriptase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D010078:Oxazines; D018894:Reverse Transcriptase Inhibitors; C098320:efavirenz