To assess a potential difference between randomized and nonrandomized untreated patients, Saracatinib cost we compared their baseline
characteristics using χ2 tests or Kruskal–Wallis tests, if appropriate, and their HRQL at baseline and at each follow-up visit using Student t-tests. Additionally, we repeated the mixed linear models including only those patients who were enrolled in the RCT. Analyses were according to intent-to-treat, regardless of treatment changes or discontinuation. Two-sided P-values <0.05 were considered statistically significant. Data were analysed using spss version 16.0 (SPSS Inc., Chicago, Illinois, USA). Of the 168 participants enrolled in the Primo-SHM RCT, 100 (60%) were included in the present study: 16 in the no-treatment group, 45 in the group
receiving 24 weeks of early cART and 39 in the group receiving 60 weeks of early cART. For 25 of the 168 participants (15%), no baseline HRQL questionnaire was available, and they were therefore excluded from further Ipatasertib manufacturer analyses. The reasons for excluding the other 43 participants (26%) were that the patient had insufficient language skills or did not want to complete the HRQL questionnaires, or that the specific study site did not participate in this substudy. Twelve of the 16 eligible nonrandomized untreated patients in the Primo-SHM cohort completed HRQL questionnaires and were included in the present analysis. A total of 631 questionnaires were completed, with a median of 5 [interquartile range (IQR) 4–8] per patient. Most patients (85%) were men who have sex with men (MSM), 71% had a negative or indeterminate western blot (Fiebig stage I–IV) and 80% were symptomatic during PHI. Patient characteristics are summarized in Table S1 (supporting online Monoiodotyrosine information). At baseline, patients receiving no treatment had significantly lower mental health
scores (P = 0.02), lower energy/fatigue scores (P = 0.03) and lower MHS scores (P = 0.04) than patients receiving 60 weeks of cART. Model results were adjusted for these baseline differences. We found a significant difference among the three groups in five of the 10 MOS-HIV subscales and in the PHS score over the follow-up period of 96 weeks. Patients receiving 24 or 60 weeks of early cART showed better cognitive functioning than patients receiving no treatment (P = 0.005; Fig. 1a). Participants receiving 60 weeks of early cART experienced less pain (P = 0.004), showed better role (P = 0.001) and physical functioning (P = 0.02) and had a better PHS score (P = 0.006) than patients receiving no treatment or 24 weeks of early cART (Fig. 1b–e). Patients receiving 24 weeks of early cART showed better mental health than patients receiving no treatment or 60 weeks of early cART (P = 0.02; Fig. 1f). Social functioning, health distress, overall quality of life, energy/fatigue and the MHS score improved significantly from baseline to 96 weeks of follow-up irrespective of the treatment group (data not shown).