Bictegravir/emtricitabine/tenofovir alafenamide in older individuals with HIV: Results of a 96-week,phase 3b,open-label,switch trial in virologically suppressed people ≥65 years of age

Objectives

Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is an effective treatment for HIV-1 infection; however, clinical trial data in older people living with HIV (PLWH) are lacking. The primary 24-week and secondary 48-week analyses of study GS-US-380-4449 (NCT03405935), which assessed the efficacy and safety of switching to B/F/TAF in older PLWH, have been published. Here we report the results of the final 96-week analyses from the study.

Methods

In this 96-week, phase 3b, open-label, single-arm trial, virologically suppressed PLWH aged ≥65 years switched from elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or a tenofovir disoproxil fumarate-based regimen to B/F/TAF. Viral suppression, resistance, immune response, safety, tolerability and adherence were evaluated through week 96.

Results

Of 90 participants screened, 86 were enrolled and switched to B/F/TAF. No participants had HIV-1 RNA ≥50 copies/ml (by FDA Snapshot algorithm) at weeks 72 or 96; virologic suppression rates were 94.2% (81/86; 95% CI 87.0–98.1) and 74.4% (64/86; 95% CI 63.9–83.2), respectively. No treatment-emergent resistance was observed, and CD4 counts remained stable. There were no study drug-related serious adverse events. Three participants experienced drug-related treatment-emergent adverse events that led to premature drug discontinuation. There were no clinically relevant changes from baseline to week 96 in fasting lipid parameters, and the median change in body weight at week 96 was 0.0 kg (IQR −2.3, 2.0). Median self-reported adherence was 100% (IQR 100–100%).

Conclusions

Switching to B/F/TAF is an effective long-term option for virologically suppressed adults ≥65 years of age, with favourable safety and tolerability profiles in this population.     

Prevalence and risk factors for pain-specific school absenteeism in adolescents with recurrent pain: A prospective population-based design

Background

Adolescents with recurrent pain miss out from school more often than pain-free peers. Research has so far used cross-sectional designs, focusing on non-specific absenteeism in clinical samples. Hence, it is unknown whether estimates of absenteeism are specifically linked to the pain itself or reflects the characteristics of clinical samples.

Objectives

This study aimed to prospectively explore pain-related school absenteeism in a non-clinical sample, its variance and potential risk factors.

Methods

This prospective study followed a cohort of 1300 Sweden-based adolescents (mean age = 16.9; 17.2% immigrants; 62.7% girls) with recurrent pain (headache, abdominal and/or musculoskeletal pain) through self-reports at two assessment points 12 months apart.

Results

Overall, 64.2% reported any absenteeism at follow-up and about half of these (26.2%) reported frequent absenteeism. Adolescents who indicated missing school were more often girls, slightly older and had a higher overall pain burden and stressor levels. Yet, after adjusting for previous absenteeism, independent predictors were age, pain intensity, medication use and stress associated with school attendance. Further to this, immigrant status predicted frequent absenteeism.

Conclusions

Many adolescents with pain frequently miss out from school due to pain. Identified risk factors points at pain characteristics and coping, stressors associated with participation and advancing age. Taken together, the burden of pain and its correlates emerge earlier and escalate with increasing age hence, early interventions targeting broader domains are needed.

Significance

This study adds substantially to the field by estimating the prevalence of pain-specific school absenteeism in a large sample of adolescents with recurrent pain in the general population using a prospective design. Furthermore, it identifies risk factors of pain-specific absenteeism from a broader context of the adolescent's life with independent predictors being the previous history of absenteeism, age, immigrant status, pain intensity, medication use and stress related to school attendance.