Consensus recommendations for the use of novel antiretrovirals in persons with HIV who are heavily treatment-experienced and/or have multidrug-resistant HIV-1: Endorsed by the American Academy of HIV Medicine, American College of Clinical Pharmacy: An executive summary.

Treatment options are currently limited for persons with HIV-1 (PWH) who are heavily treatment-experienced and/or have multidrug-resistant HIV-1. Three agents have been approved by the U.S. Food and Drug Administration (FDA) since 2018, representing a significant advancement for this population: ibalizumab, fostemsavir, and lenacapavir. However, there is a paucity of recommendations endorsed by national and international guidelines describing the optimal use (e.g., selection and monitoring after initiation) of these novel antiretrovirals in this population. To address this gap, a modified Delphi technique was used to develop these consensus recommendations that establish a framework for initiating and managing ibalizumab, fostemsavir, or lenacapavir in PWH who are heavily treatment-experienced and/or have multidrug-resistant HIV-1. In addition, future areas of research are also identified and discussed in the main document.

Consensus recommendations for the use of novel antiretrovirals in persons with HIV who are heavily treatment-experienced and/or have multidrug-resistant HIV-1: Endorsed by the American Academy of HIV Medicine, American College of Clinical Pharmacy.

Treatment options are currently limited for persons with HIV-1 (PWH) who are heavily treatment-experienced and/or have multidrug-resistant HIV-1. Three agents have been approved by the U.S. Food and Drug Administration (FDA) since 2018, representing a significant advancement for this population: ibalizumab, fostemsavir, and lenacapavir. However, there is a paucity of recommendations endorsed by national and international guidelines describing the optimal use (e.g., selection and monitoring after initiation) of these novel antiretrovirals in this population. To address this gap, a modified Delphi technique was used to develop these consensus recommendations that establish a framework for initiating and managing ibalizumab, fostemsavir, or lenacapavir in PWH who are heavily treatment-experienced and/or have multidrug-resistant HIV-1. In addition, future areas of research are also identified and discussed.

Practical dosing guidance for the management of clinician-administered injections of long-acting cabotegravir and rilpivirine.

Cabotegravir (CAB) and rilpivirine (RPV) is the first complete long-acting (LA) injectable regimen recommended by treatment guidelines for the maintenance of HIV-1 virologic suppression in people with HIV-1 who are virologically suppressed on a stable antiretroviral regimen that is administered monthly (Q1M) or every 2 months (Q2M). As an alternative regimen to lifelong daily oral antiretroviral therapy, Q1M or Q2M dosing schedules are associated with increased patient satisfaction and treatment preference. In addition, it may address challenges associated with daily oral dosing, including fear of treatment disclosure or stigma, anxiety related to oral dosing adherence, and the daily reminder of HIV disease status. Cabotegravir + RPV LA is administered by clinical staff as two intramuscular injections dosed Q1M or Q2M. In this review, we share practical dosing guidance for CAB+RPV LA injectable therapy, including how to initiate therapy, schedule injection visits, manage dosing interruptions due to missed or delayed injection visits, manage errors in dosing, and transition to alternative antiretroviral therapy after discontinuation. Practical guidance on the clinical management of CAB+RPV LA dosing, including a detailed discussion using case-based scenarios that may be encountered in clinical practice, is provided. The clinician-administered CAB+RPV LA regimen has dosing management considerations that are flexible and considerate of the patient and has the potential to provide a highly desirable and efficacious alternative to daily oral antiretroviral therapy for many people with HIV-1.

Guidance for clinicians on the management of long-acting Cabotegravir and Rilpivirine Injectable Therapy for HIV-1 Cabotegravir (CAB) and rilpivirine (RPV) is the first long-acting (LA) injectable therapy for people with HIV-1 who previously achieved undetectable virus levels using other HIV-1 medications. People with HIV-1 receive CAB+RPV LA as two injections given by their clinician every 1 month or every 2 months, providing an alternative treatment option to lifelong daily oral medications. People with HIV-1 receiving CAB+RPV LA every 1 or 2 months have higher levels of treatment satisfaction and often prefer CAB+RPV LA compared with daily oral medications. Cabotegravir+RPV LA may also address challenges associated with daily oral medications, including fear of inadvertently sharing HIV status, anxiety related to taking daily medications, and having a daily reminder of HIV. In this review, we provide guidance for clinicians on how to administer CAB+RPV LA injectable therapy, including how to start patients on CAB+RPV LA injections, schedule injection visits, manage missed or delayed injection visits, manage dosing errors, and switch patients to a different treatment if CAB+RPV LA is discontinued. This review also includes a detailed discussion of potential scenarios related to the administration and scheduling of CAB+RPV LA injections that may occur in clinical practice. Overall, this review serves as a practical guide for managing CAB+RPV LA injectable therapy in clinical practice that will be useful for HIV clinicians.

META-INSTI: metabolic adverse events following integrase strand transfer inhibitor administration in spontaneous adverse event reports.

Background: Metabolic effects of integrase strand transfer inhibitors (INSTIs) have been reported. The FDA Adverse Event Reporting System (FAERS) is a publicly available database that captures spontaneously reported adverse events. The objective of this study was to evaluate the relationship between INSTIs and metabolic adverse events using the FAERS database. Methods: FAERS data were queried from quarter 4 of 2007 through quarter 4 of 2019 and limited to adults. The Standardized MedDRA Query for 'hyperglycaemia/new-onset diabetes mellitus' (H/DM) was used to identify metabolic adverse events of interest. Weight gain was analysed as a separate event. Reporting odds ratios (RORs) and 95% CIs were calculated for the INSTI class and individual agents. Results: Over 10.1 million FAERS reports were identified. Any INSTI was mentioned as a primary and/or secondary suspect agent in 18,400 (0.18%) reports (bictegravir: 1414 [0.01%]; dolutegravir: 7840 [0.08%]; elvitegravir: 4034 [0.04%]; raltegravir: 5551 [0.05%]). RORs (95% CI) for H/DM and weight gain for any INSTI were 1.20 (1.15-1.27) and 2.16 (1.96-2.38). For individual agents, RORs (95% CI) for H/DM and weight gain were as follows: bictegravir, 1.23 (1.10-1.37) and 6.82 (5.50-8.41); dolutegravir, 1.28 (1.19-1.39) and 1.86 (1.58-2.18); elvitegravir, 0.76 (0.56-1.02) and 1.63 (1.37-1.92); and raltegravir, 1.00 (0.90-1.11) and 3.29 (2.77-3.91). H/DM was noted in 159 bictegravir and 712 dolutegravir reports. Conclusion: Overall, H/DM was associated with bictegravir and dolutegravir and weight gain with all INSTIs. Clinicians should know the potential relationship between INSTIs and metabolic effects and institute appropriate monitoring. This paper was previously presented: META-INSTI: Metabolic Adverse Events Following Integrase Strand Transfer Inhibitor Administration in Spontaneous Adverse Event Reports. Platform Presentation. ID Week. Virtual 2020.

Necessity of vancomycin trough concentrations to manage uncomplicated acute bacterial skin and skin structure infections: a laboratory stewardship analysis.

Background: Recent recommendations by the American Society of Health System Pharmacists and Infectious Disease Society of America have provided guidance regarding vancomycin dosing and monitoring in serious infections (including methicillin-resistant Staphylococcus aureus); however, trough monitoring for uncomplicated acute bacterial skin and skin structure infections (ABSSSI) were not addressed. Vancomycin use appears to lead to a low incidence of acute kidney injury with short durations and a low trough goal (10-15 mg/L). Nevertheless, clinical studies have found no difference in clinical outcomes for ABSSSI regardless of vancomycin level. Therefore, it can be posed whether trough monitoring is necessary in this patient population. Methods: This is a retrospective cohort study comparing vancomycin therapy duration for ABSSSI in adult, general medicine patients who received scheduled vancomycin with an initial creatinine clearance rate of ≥50 mL/minute and had at least one vancomycin trough. The objective of this study was to determine if vancomycin treatment duration differs for patients with ABSSSI with a sub-therapeutic vancomycin trough (ST; <10 mg/L) compared with therapeutic trough (TT; ≥10 mg/L). Results: There were 39 (67.2%) patients with ST compared with 19 (32.8%) with TT. A similar median vancomycin treatment duration for ST (48.25 hours) and TT (59.5 hours; p=0.65) was found. There was no statistical difference for hospital duration, time from last trough to vancomycin discontinuation, or incidence of acute kidney injury (p>0.05 for all). Conclusion: Patients with ST and TT had similar vancomycin durations and clinical outcomes. It may be prudent for institutions to address vancomycin trough laboratory stewardship and associated costs.

Considerations for select transitions of care for people with HIV: adolescent to adult, prison to society and the postpartum period.

Proper transitions of care for people with HIV (PWH) are necessary to ensure continuity of care, medication adherence and maintenance of successful clinical outcomes. Three transitions of care may lead to suboptimal outcomes if PWH are not correctly engaged: adolescent to adult, prison to society and the postpartum period. The management of these care transitions is a vital part of engagement in treatment. Evidence highlighting the gaps in care transitions provides a potential framework to optimize outcomes for PWH.

Risk Factors Associated With Nephrotoxicity During Outpatient Intravenous Vancomycin Administration.

Background: Many studies have described an association between intravenous vancomycin and nephrotoxicity; however, the majority have evaluated incidence and risk factors among hospitalized patients. Outpatient administration of intravenous antibiotics is a growing practice and presents its own set of unique challenges. Objective: The aim of this study was to identify risk factors for vancomycin-associated nephrotoxicity in the outpatient setting. Methods: A case-control study of patients who received intravenous vancomycin through an Outpatient Parenteral Antimicrobial Therapy (OPAT) program was conducted. Patients were identified who developed an acute kidney injury (AKI) during treatment. The primary outcome was the incidence of AKI during treatment. Results: A total of 37 out of 130 patients (28.5%) met the criteria for AKI. AKI was more likely to occur in patients with a longer duration of therapy, higher maximum trough concentration, co-administration of a fluoroquinolone or metronidazole, and those who received another potentially nephrotoxic medication. Co-administration of a fluoroquinolone (OR = 5.96, P = 0.009, [CI: 1.59, 24.38]), any nephrotoxic medication (OR = 11.17, P < 0.001, [CI 3.14, 51.23]), and a higher maximum vancomycin trough (OR = 1.29, P < 0.001, [CI 1.17, 1.44]) were all indicative of a higher odds of an AKI. Conclusion: In this cohort, vancomycin-associated nephrotoxicity was common during outpatient intravenous antibiotic therapy. Co-administration of a fluoroquinolone, any nephrotoxic medication, and a higher maximum vancomycin trough were associated with AKI development. Further study is needed to determine how this impacts long-term clinical outcomes and what measures can be taken to reduce nephrotoxicity risk.

A Call for Person-Centered Language and Consistent Terminology Regarding Cannabis Use.

The increased availability of medical and recreational cannabis has facilitated a need for a change in health care practices. The language surrounding substance use disorders (SUDs) needs to be destigmatized. The necessity for utilizing "person-first" or "person-centered language" is fundamental to ensure that there is consistency among health care personnel for treating patients with an SUD and providing quality patient care. There also lies an enhanced need to more clearly define recreational cannabis use on a state versus federal level, in the workplace, and within higher education.

Less common bacterial, fungal and viral infections: review of management in the pregnant patient.

This review is a comprehensive summary of treatment options for pregnant patients with less common bacterial, fungal, and viral infections. It offers guidance to clinicians based on the most recently published evidence-based research and expert recommendations. A search of MEDLINE (inception to March 2021) and the CDC website was performed. Liposomal amphotericin B is the preferred therapy for cryptococcosis, histoplasmosis, oesophageal candidiasis, and coccidioidomycosis, especially during the first trimester due to teratogenic concerns with azole antifungals. For oral candidiasis, clotrimazole troches or miconazole mucoadhesive buccal tablets are recommended. A ß-lactam antimicrobial is preferred over doxycycline for various manifestations of Lyme disease and the drug of choice for Pneumocystis pneumonia is trimethoprim/sulfamethoxazole. Acyclovir is the preferred antiviral for varicella zoster virus. Fluoroquinolones, macrolides, and aminoglycosides should be avoided if possible and there are alternate agents available for an effective treatment regimen. There is a scarcity of clinical data in pregnant patients with less common bacterial, fungal and viral infections. This population lacks definitive recommendations in many clinical practice guidelines. The key to optimizing therapy is a comprehensive review of the available evidence and a careful balance of risks and benefits before final treatment decisions.

Stress and Basic Need Satisfaction of First-Year Healthcare Professional Students.

PURPOSE: Transitioning to graduate-level professional school can trigger stressful feelings for many students. The purpose of this study was to determine the stress levels and unmet basic needs of first-year graduate healthcare students during their transition from undergraduate institutions to professional school. METHODS: The study was conducted at Midwestern University, a private, graduate-level, professional health sciences university located in the Midwest, during the 2018-2019 academic year. The survey was administered to all first-year students within the colleges of dentistry, medicine, optometry, and pharmacy. The Perceived Stress Scale (PSS-10) was used to evaluate participants' stress levels and the Basic Need Satisfaction Inventory (BNSI) was used to evaluate unmet basic needs. RESULTS: Of the 523 prospective participants, 404 survey responses were included (77.2% response rate). Female students showed higher perceived stress and lower basic need satisfaction. Perceived stress levels did not differ by professional program when taking into consideration the differences in gender distribution by program. A regression model indicated that gender and basic need satisfaction were the main predictors of perceived stress for healthcare professional students. CONCLUSIONS: Higher basic need satisfaction was predictive of lower perceived stress in healthcare professional students. Perceived stress levels remain higher for female students compared to male students.

Role of the specialty pharmacist in public health: A focus on sharps disposal.

An intersection of the pharmacy profession and public health is the role of the specialty pharmacist. The specialty pharmacist is in a unique position to prevent unnecessary financial burden on the health care system by preventing community-acquired needlestick injuries through patient education regarding the proper disposal of sharps. Many specialty medications are injectable agents with varying injection frequencies ranging from multiple injections per day to 1 dose per year. Programs should be implemented at specialty pharmacies to fill this patient education gap. This distinct service to patients and the profession will continue to grow alongside the niche of specialty pharmacy.

Barriers to and factors influencing the pursuit of pharmacy student research.

INTRODUCTION: The objective of this study was to identify perceived barriers and factors influencing student pursuit of research during pharmacy school. METHODS: A voluntary, paper-based or electronic questionnaire was administered to all pharmacy students at a private college of pharmacy in mandatory courses during the 2016-2017 academic year. Survey questions collected information pertaining to demographics, factors influencing student pursuit of research, and barriers to pursuit of research. Participation was incentivized with gift cards. RESULTS: A total of 623 students completed the survey (79% response rate). The average respondent was female (69.1%), 25-years old (IQR 23-26 years), employed (69.9%), and had a prior degree (66.6%). During pharmacy school, 27.3% of respondents pursued a research project. Of students not pursuing a research project during pharmacy school, the amount of interest to complete a project differed significantly between professional years (P < .01) with the second-year class having the highest interest. Lack of time (91.3%), unfamiliarity with the research process (81.8%), and too much coursework (80.5%) were cited as the top three perceived barriers that prevented students from pursuing research. A mandatory research class (87.6%), presentations describing faculty research interests (83.4%), and ability to work with a friend (83.9%) would most strongly influence students to complete research. CONCLUSIONS: Students report additional information regarding research opportunities would positively influence their decision to pursue research while in pharmacy school. Future studies should evaluate strategies to familiarize students with the research process.

Potential risk of drug-drug interactions with hormonal contraceptives and antiretrovirals: prevalence in women living with HIV.

BACKGROUND: Family planning services are vital for women living with HIV (WLH); however, the use of concomitant antiretroviral therapy (ART) and hormonal contraceptives (HCs) may pose challenges due to the risk of potential drug-drug interactions (DDIs). The objectives of this study were to assess ART and HC use among WLH and quantify the frequency of potential DDIs between ART and HCs. METHODS: This was a retrospective, observational, cohort study of WLH aged 18-55 years, prescribed ART, with at least one clinic visit from January 1, 2010 to April 30, 2014. Potential DDIs between HCs and ART were assessed using the University of Liverpool HIV Drug Interactions website (www.hiv-druginteractions.org) and categorized as 'weak potential interaction,' 'potential interaction,' or 'do not co-administer.' RESULTS: Overall, a contraceptive method was reported in 167 (54%) of the 309 women included in the study. Of those using contraception, 73 (43.7%) reported using HCs, which was most frequently a progestin intrauterine device (n=43), progestin injection (n=17), or combination oral contraceptive pills (n=9). Out of a total of 449 ART regimens, a potential DDI was identified in 21 of 115 (18.3%) ART-HC combinations from 19 women using ART and HCs. Atazanavir/ritonavir was the most common potentially interacting ART (10, 47.6%); for HCs, these were combination oral contraceptive pills (16, 76.2%) and progestin implants (2, 9.5%). CONCLUSION: In this cohort, one-quarter of WLH on ART-HCs had a potential DDI. Future studies should investigate the impact of DDIs on unintended pregnancies, the side effects of DDIs, and the effects of HC DDIs on ART concentrations.