Real-world prevalence of integrase inhibitor resistance and virological failure since adoption as guideline-preferred therapy.

Background: Limited data reporting real-world prevalence of integrase strand transfer inhibitor resistance (INSTI-R) in the USA are available because their recommendation as first-line treatment in 2017. Reported national surveillance data in the USA estimated INSTI-R to be 6.3% as of 2018. This article aims to describe estimated prevalence of INSTI-R within a single clinic network in Chicago, IL, USA, and identify risk factors for resistance and virological failure (VF). Methods: This was a retrospective, single-centre study of adults with HIV starting an INSTI-containing regimen between September 2017 and 2020. The primary endpoint was the difference in INSTI-R of the sample population compared with the national prevalence. Other outcomes included VF and documented INSTI-R mutations. Results: Of 948 participants screened, 321 were included. Eight people had baseline INSTI-R testing results available, of which five had INSTI-R at baseline for an estimated prevalence of 1.6%. This estimation was significantly less than the national estimated prevalence of 6.3% (p<0.001). VF occurred in 26 (7.8%) individuals. Because no participants acquired INSTI-R during the study period, investigators were unable to identify risk factors associated with the development of INSTI-R. People with high pre-treatment viral loads had 1.21 (95% CI 1.05-1.39) higher odds of VF. Conclusions: Amongst participants on INSTI-containing regimens, INSTI-R rates were estimated to be lower than the estimated national prevalence. Detectable pre-switch viral loads were more associated with VF than undetectable viral loads.

Antiretroviral Therapy in Children and Adolescents: A Look Into Modern Single Tablet Regimens.

Single tablet regimens (STRs) have simplified antiretroviral therapy (ART) over the years in the adult human immunodeficiency virus (HIV) population. However, there is still a prevalent need to simplify regimens in children and adolescents living with HIV. Finding the optimal regimen requires a multi-factorial approach due to their complex pharmacokinetic profiles throughout childhood and the challenges and limitations of medication non-adherence in the pediatric population. These challenges include pill size, available formulations, palatability, and caregiver health literacy, which can all affect the proper administration of medications. The complexity of this population implies the importance of customizing everyone's antiretroviral regimen so that the patient and family can successfully adhere to the therapy. The current recommendations for ART in the adult and pediatric populations are similar, yet the use of STRs are limited. The goal of this review was to assess current data on available STRs and determine their utility as ART in the pediatric population.

Real-world impact of switching from tenofovir disoproxil fumarate to tenofovir alafenamide.

Although tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF) have been evaluated in various clinical trials, limited safety and efficacy data exist in real-world settings. The goal of this retrospective analysis is to assess changes in virological suppression, immunological status, renal function, weight and body mass index (BMI) amongst people living with HIV who switched from a TDF-based to a TAF-based regimen. Of 130 patients included in the final analysis, 53 patients experienced an increase in their viral load upon switching from TDF to TAF therapy whilst 62 patients remained undetectable. For those who experienced a viral blip, 33 (62%) resuppressed by the time of last follow-up, 15 (28%) patients did not have additional labs beyond the last follow-up and concern for failure occurred in 5 (9%) patients. No differences in immunological function, renal function, weight or BMI were observed from before switching to the last follow-up. Although a loss of virological suppression was found upon switching to TAF at subsequent follow-up visits, resuppression ultimately occurred in most patients.

The race to a COVID-19 vaccine: opportunities and challenges in development and distribution.

The unprecedented toll of severe acute respiratory syndrome coronavirus 2, the virus responsible for coronavirus 2019 disease (COVID-19), jumpstarted the race towards the development and distribution of effective treatment and prevention options. With an urgent need to slow viral transmission, lessen disease severity, and reduce mortality, biopharmaceutical companies rapidly began investigating potential COVID-19 vaccinations. While typical vaccine development can take upwards of 10-15 years, COVID-19 vaccines were developed in less than a year after the identification of COVID-19. To accomplish this feat, clinical development, manufacturing scale-up and distribution are occurring in parallel for the four COVID-19 vaccine front-runners. This remarkable opportunity will forever change the drug development process and would not be possible without tremendous dedication from the public and private sectors, researchers, and clinical trial volunteers. However, many challenges still lie ahead. Comprehensive plans for equitable vaccine education, distribution, administration and post-marketing surveillance must be implemented successfully to overcome vaccine hesitancy, supply-chain obstacles and healthcare provider shortages in an already overburdened healthcare system. We are moving forward at a remarkable pace but worldwide immunity through vaccination will take time to achieve. Thus, current prevention efforts of masking, hand hygiene and social distancing must remain in effect for the foreseeable future. We must remain diligent and not fatigue in our efforts. Ending the COVID-19 pandemic cannot rest on the promise of vaccination alone - it will require a continued, robust and multi-faceted approach to disease treatment and prevention.

Pharmacotherapy considerations in transgender individuals living with human immunodeficiency virus.

Pharmacotherapy considerations are often a concern for transgender individuals who are living with human immunodeficiency virus (HIV) due to concerns for drug-drug interactions between their hormone and antiretroviral therapies. Many of the first-line therapies offered to patients for the management of HIV have reduced concerns for safety, resistance, and drug-drug interactions. In this review, we highlight common medications and important considerations for caring for transgender people living with HIV.

Impact of Pharmacist-Driven Antiretroviral Stewardship and Transitions of Care Interventions on Persons With Human Immunodeficiency Virus.

BACKGROUND: Persons with human immunodeficiency virus (HIV) experience high rates of medication-related errors when admitted to the inpatient setting. Data are lacking on the impact of a combined antiretroviral (ARV) stewardship and transitions of care (TOC) program. We investigated the impact of a pharmacist-driven ARV stewardship and TOC program in persons with HIV. METHODS: This was a retrospective, quasi-experimental analysis evaluating the impact of an HIV-trained clinical pharmacist on hospitalized persons with HIV. Patients included in the study were adults following up, or planning to follow up, at the University of Illinois (UI) outpatient clinics for HIV care and admitted to the University of Illinois Hospital. Data were collected between July 1, 2017 and December 31, 2017 for the preimplementation phase and between July 1, 2018 and December 31, 2018 for the postimplementation phase. Primary and secondary endpoints included medication error rates related to antiretroviral therapy (ART) and opportunistic infection (OI) medications, all-cause readmission rates, medication access at time of hospital discharge, and linkage to care rates. RESULTS: A total of 128 patients were included in the study: 60 in the preimplementation phase and 68 in the postimplementation phase. After the implementation of this program, medication error rates associated with ART and OI medications decreased from 17% (10 of 60) to 6% (4 of 68) (P = .051), 30-day all-cause readmission rates decreased significantly from 27% (16 of 60) to 12% (8 of 68) (P = .03), and linkage to care rates increased significantly from 78% (46 of 59) to 92% (61 of 66) (P = .02). CONCLUSIONS: A pharmacist-led ARV stewardship and TOC program improved overall care of persons with HIV through reduction in medication error rates, all-cause readmission rates, and an improvement in linkage to care rates.

A HAART-Breaking Review of Alternative Antiretroviral Administration: Practical Considerations with Crushing and Enteral Tube Scenarios.

Selection of an appropriate antiretroviral regimen for the patient infected with human immunodeficiency virus can be challenging, as various considerations must be taken into account including viral resistance mutations, patient comorbidities, drug interactions, and the potential for drug-related adverse effects and toxicities. Treatment is further complicated when a clinical scenario arises requiring an alteration in the dosage form. Factors ranging from dysphagia to administration through an enteral feeding tube can affect decisions regarding antiretroviral dosage forms. Limited pharmacokinetic data exist regarding the alteration of antiretroviral medications from their original form. Bioavailability may vary substantially between dosage forms, which can lead to unpredictable drug concentrations. Supratherapeutic or subtherapeutic antiretroviral drug concentrations can result in increased toxicity, virologic failure, or the emergence of drug resistance. We performed a systematic literature search to review the available antiretroviral literature on the modification of solid dosage forms as well as alternative routes of administration of oral antiretroviral agents and their application to clinical practice.

Associations of Parent Health Behaviors and Parenting Practices with Sleep Duration in Overweight and Obese Children.

STUDY OBJECTIVES: To examine the extent to which parent health behaviors and parenting practices are associated with school-age children's sleep duration. METHODS: We surveyed 790 parents of children, aged 6 to 12 y, who had a body mass index (BMI) ≥ 90th percentile and were participating in a randomized controlled obesity trial. The main exposures were parent sleep duration, screen time and physical activity, parental limits placed on child TV viewing time and TV content, and parents' confidence regarding their ability to help their child get enough sleep. The primary outcome was child sleep duration. We used linear regression models to examine associations of parent behaviors and parenting practices with child sleep duration. RESULTS: On average, children slept 9.2 h per night, whereas parents slept 6.9 h. Parents reported having an average of 1.9 h of screen time per day and 0.6 h of physical activity. There were 57.3% of parents who reported feeling very/extremely confident that they could help their child get enough sleep. In adjusted multivariate analyses, child sleep duration was 0.09 h/day (95% confidence interval: 0.03, 0.15) longer for each 1-h increment in parent sleep duration. Additionally, children whose parents reported being very/extremely confident they could help their child get age-appropriate sleep duration slept 0.67 h/day longer (95% confidence interval: 0.54, 0.81) than those whose parents were not/somewhat confident. CONCLUSIONS: Educating parents about their own sleep health and enhancing parent confidence to help their children get enough sleep are potential areas of intervention to increase child sleep duration.

The role of neighborhood characteristics and the built environment in understanding racial/ethnic disparities in childhood obesity.

BACKGROUND: Childhood obesity prevalence remains high and racial/ethnic disparities may be widening. Studies have examined the role of health behavioral differences. Less is known regarding neighborhood and built environment mediators of disparities. The objective of this study was to examine the extent to which racial/ethnic disparities in elevated child body mass index (BMI) are explained by neighborhood socioeconomic status (SES) and built environment. METHODS: We collected and analyzed race/ethnicity, BMI, and geocoded address from electronic health records of 44,810 children 4 to 18years-old seen at 14 Massachusetts pediatric practices in 2011-2012. Main outcomes were BMI z-score and BMI z-score change over time. We used multivariable linear regression to examine associations between race/ethnicity and BMI z-score outcomes, sequentially adjusting for neighborhood SES and the food and physical activity environment. RESULTS: Among 44,810 children, 13.3% were black, 5.7% Hispanic, and 65.2% white. Compared to white children, BMI z-scores were higher among black (0.43units [95% CI: 0.40-0.45]) and Hispanic (0.38 [0.34-0.42]) children; black (0.06 [0.04-0.08]), but not Hispanic, children also had greater increases in BMI z-score over time. Adjusting for neighborhood SES substantially attenuated BMI z-score differences among black (0.30 [0.27-0.34]) and Hispanic children (0.28 [0.23-0.32]), while adjustment for food and physical activity environments attenuated the differences but to a lesser extent than neighborhood SES. CONCLUSIONS: Neighborhood SES and the built environment may be important drivers of childhood obesity disparities. To accelerate progress in reducing obesity disparities, interventions must be tailored to the neighborhood contexts in which families live.

Comparative effectiveness of childhood obesity interventions in pediatric primary care: a cluster-randomized clinical trial.

IMPORTANCE: Evidence of effective treatment of childhood obesity in primary care settings is limited. OBJECTIVE: To examine the extent to which computerized clinical decision support (CDS) delivered to pediatric clinicians at the point of care of obese children, with or without individualized family coaching, improved body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) and quality of care. DESIGN, SETTING, AND PARTICIPANTS: We conducted a cluster-randomized, 3-arm clinical trial. We enrolled 549 children aged 6 to 12 years with a BMI at the 95% percentile or higher from 14 primary care practices in Massachusetts from October 1, 2011, through June 30, 2012. Patients were followed up for 1 year (last follow-up, August 30, 2013). In intent-to-treat analyses, we used linear mixed-effects models to account for clustering by practice and within each person. INTERVENTIONS: In 5 practices randomized to CDS, pediatric clinicians received decision support on obesity management, and patients and their families received an intervention for self-guided behavior change. In 5 practices randomized to CDS + coaching, decision support was augmented by individualized family coaching. The remaining 4 practices were randomized to usual care. MAIN OUTCOMES AND MEASURES: Smaller age-associated change in BMI and the Healthcare Effectiveness Data and Information Set (HEDIS) performance measures for obesity during the 1-year follow-up. RESULTS: At baseline, mean (SD) patient age and BMI were 9.8 (1.9) years and 25.8 (4.3), respectively. At 1 year, we obtained BMI from 518 children (94.4%) and HEDIS measures from 491 visits (89.4%). The 3 randomization arms had different effects on BMI over time (P = .04). Compared with the usual care arm, BMI increased less in children in the CDS arm during 1 year (-0.51 [95% CI, -0.91 to -0.11]). The CDS + coaching arm had a smaller magnitude of effect (-0.34 [95% CI, -0.75 to 0.07]). We found substantially greater achievement of childhood obesity HEDIS measures in the CDS arm (adjusted odds ratio, 2.28 [95% CI, 1.15-4.53]) and CDS + coaching arm (adjusted odds ratio, 2.60 [95% CI, 1.25-5.41]) and higher use of HEDIS codes for nutrition or physical activity counseling (CDS arm, 45%; CDS + coaching arm, 25%; P < .001 compared with usual care arm). CONCLUSIONS AND RELEVANCE: An intervention that included computerized CDS for pediatric clinicians and support for self-guided behavior change for families resulted in improved childhood BMI. Both interventions improved the quality of care for childhood obesity. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01537510.

The use of pro-ana blogs for online social support.

The aim of this research was to document the content on pro-ana blogs and to uncover how the unique socio-technical features of blogs (interactivity, self-disclosure, masspersonal communication) facilitate social support among members. A final sample of 48 pro-ana blogs provided 624 individual units for coding. Results indicate that prevalent forms of social support were emotional support, esteem support, and informational support. A new category, reciprocal self-disclosure, was also revealed to be quite frequent. Blogs are spaces where social support is sought and communicated among members of the pro-ana network. Interpretation of blog communication and implications for treatment and research are discussed.