Weight gain before and after switch from TDF to TAF in a U.S. cohort study.

INTRODUCTION: Although weight gain has been reported with the use of integrase strand transfer inhibitors (InSTI), concurrent use of tenofovir alafenamide (TAF) has been implicated in recent studies. This study examined weight changes in people living with HIV (PLWH) who switched from tenofovir disoproxil fumarate (TDF) to TAF, to clarify the relative contribution to weight gain of core agents versus TDF to TAF switch. METHODS: Antiretroviral-experienced, virologically suppressed PLWH in the U.S. OPERA cohort were included if they switched from TDF to TAF (5NOV2015-28FEB2019) and either maintained all other antiretrovirals or switched from a non-InSTI to an InSTI. Linear mixed models were used to assess weight changes before/after the switch to TAF (restricted cubic splines on time) and rates of change over time (linear splines on time, based on the shape of the weight change curves). Changes in weight on TDF or TAF were assessed among those who maintained other antiretrovirals (overall, by core class), and those who maintained an InSTI or switched to an InSTI (by core agent). All models were adjusted for age, sex, race, (age-sex, race-sex interactions), BMI, CD4 cell count, endocrine disorders and concurrent medications that could affect weight. RESULTS: A total of 6908 PLWH were included, with 5479 maintaining all other antiretrovirals (boosted protease inhibitor: 746, non-nucleoside reverse transcriptase inhibitor: 1452, InSTI: 3281) and 1429 switching from a non-InSTI to an InSTI (elvitegravir/cobicistat: 1120, dolutegravir: 174, bictegravir: 129). In adjusted models, modest weight gain was observed over time on TDF for most (0.24 to 0.71 kg/year); raltegravir was the exception with weight loss. Switching to TAF was associated with early, pronounced weight gain for all (1.80 to 4.47 kg/year). This effect with TAF switch was observed both in PLWH maintaining other antiretrovirals and those switching to an InSTI, regardless of which InSTI agent was used. Weight gain tended to slow down or plateau approximately nine months after switch to TAF. CONCLUSIONS: In this large, diverse U.S. cohort of PLWH, switching from TDF to TAF was associated with pronounced weight gain immediately after switch, regardless of the core class or core agent, suggesting an independent effect of TAF on weight gain.

Healthcare resource utilization and costs in patients with HIV-1 who switched first-line antiretroviral therapy.

Objectives: This study compared healthcare utilization and costs associated with switching the first-line protease inhibitor (PI) or non-nucleoside reverse transcriptase inhibitor (NNRTI) based antiretroviral (ARV) regimen due to reasons other than virologic failure among patients with HIV-1. Methods: This was a retrospective analysis of commercial and Medicare Advantage with Part D enrollees in two US administrative claims databases. The study population comprised adults with HIV-1 infection initiating antiretroviral therapy (ART) on PI- or NNRTI-containing regimens from 1 January 2006 to 31 December 2015. Patients with a subsequent change in anchor agent were assigned to the switch cohort; the non-switch cohort was constructed using propensity score matching of three non-switching patients for each patient in the switch cohort. Patient characteristics and per patient per month healthcare resource utilization and costs were compared between the cohorts during the pre-switch, switch (15 days before and after switching) and post-switch periods. Costs during the switch period were also estimated with a multivariable-adjusted model. Results: The matched study population consisted of 1204 patients who switched their first-line PI- or NNRTI-based regimen and 3612 patients who did not. Compared with the non-switch cohort, patients who switched had higher healthcare resource utilization during the pre-switch, switch and post-switch periods. Mean unadjusted non-ART costs in the switch cohort were nearly double ($2944 versus $1530, p < .001), more than double ($2562 versus $1215, p < .001) and 1.5 times higher ($1473 versus $968, p < .001) than costs in the non-switch cohort in the pre-switch, switch and post-switch periods, respectively. Conclusions: Patients with HIV-1 who initiated PI- or NNRTI-based regimens and switched ARTs for reasons other than virologic failure used more healthcare resources and incurred greater costs relative to patients in the non-switch cohort. This study highlights the importance of initiating patients on appropriate first-line ART to avoid the need to switch due to reasons other than virologic failure.

Assessing the reliability and validity of a newly developed insomnia treatment satisfaction questionnaire (ITSAT-Q).

PURPOSE: To produce a valid insomnia treatment satisfaction questionnaire (ITSAT-Q) to assess treatment satisfaction with pharmacotherapy for use in patients with insomnia. PATIENTS AND METHODS: Items developed for a self-administered questionnaire were analyzed using exploratory factor analysis (EFA), which produced 5 dimensions. Confirmatory factor analysis was used to verify results from EFA, and structural equation modeling was used to test the hypothesized relationship among the dimensions. Data were collected from patients as part of a Sleep Research Project from January 2008 until October of 2008. RESULTS: Approximately 69.8% of the sample (n=298) was female. Item-to-total correlations were 0.66 for convenience, ranged from 0.52 to 0.62 for expectations, from 0.54 to 0.69 for value, from 0.50 to 0.57 for effectiveness, and from 0.58 to 0.72 for treatment satisfaction. All standardized parameter estimates from confirmatory factor analysis were significant (p<0.01). Goodness of fit measures for the final structural equation model were chi(2)=45.2 (d.f.=45); p=0.465; CFI=1.00; TLI=1.00; and RMSEA=0.004. Treatment satisfaction was a strong and significant predictor of value, and effectiveness was a strong predictor of treatment satisfaction (p<0.01). Expectations were a strong and equal predictor of both treatment satisfaction and value (p<0.001). CONCLUSION: The ITSAT-Q provided acceptable results for instrument reliability and validity. Findings from this study will provide additional insight regarding patient perceptions of treatment satisfaction and other related therapeutic dimensions to help prescribers assess pharmacotherapy.