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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.

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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.

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OBJECTIVE: To describe weight changes with integrase strand transfer inhibitor (INSTI) therapy. DATA SOURCES: A literature search was performed (through December 15, 2021) using the PubMed and CINAHL databases using the search terms: "integrase inhibitors," "integrase strand transfer inhibitors," and "weight." STUDY SELECTION AND DATA EXTRACTION: Studies were included that provided relevant information on weight or body mass index (BMI) changes on INSTI therapy. Controlled or observational studies comparing different INSTI therapies or compared INSTI therapy to another class of antiretroviral therapy were included. DATA SYNTHESIS: Forty-three articles met criteria for inclusion, and data are presented. Although some trials have observed similar weight gains between INSTI, protease inhibitor, and non-nucleoside inhibitor therapies, the increase appears to be greater with INSTI therapy, particularly during initiation of therapy. Risk factors for weight gain with INSTI therapy include female gender, lower CD4 count, and combined use of tenofovir alafenamide. Within the INSTI class, dolutegravir and bictegravir appear to have the greatest propensity for weight gain. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: INSTI-based therapies are the preferred initial management of HIV infection. Discerning the factors contributing to weight changes on INSTI therapy and risks of associated health-related outcomes is important to both the management of weight gain and HIV medical management. CONCLUSIONS: Within the INSTI class, dolutegravir and bictegravir may be associated with the greatest risk for weight gain particularly when combined with tenofovir alafenamide. Further research is needed to determine mechanisms for observed weight changes and any contributions to clinically significant metabolic and cardiovascular adverse outcomes associated with INSTI therapy.

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BACKGROUND AND PURPOSE: Students must have experience communicating and interacting with healthcare professionals throughout pharmacy school curricula to effectively develop interprofessional communication abilities and confidence. This study's purpose was to assess student confidence in interprofessional communication utilizing a rubric and checklist inspired by the situation-background-assessment-recommendation (SBAR) technique throughout five-week primary care advanced pharmacy practice experiences (APPEs). EDUCATIONAL ACTIVITY AND SETTING: A six-item rubric was created for student self-evaluation of interprofessional communication throughout their APPE. Students completed the rubric twice to evaluate change in confidence. Additionally, a pre-post rotation survey was developed to assess students' comfort level rounding with healthcare professionals and interacting/intervening with other healthcare professionals to address a medication-related problem. A paired t-test was used to evaluate changes in perceived student confidence in rubric self-evaluations and pre- and post-APPE surveys. FINDINGS: From May 2017 to April 2019, 93 students completed primary care APPEs with faculty authors, and 181 encounters were self-evaluated using the rubric. Forty-eight students completed all rubric sections twice; their mean self-evaluation score increased significantly from 15.25/18 to 17.10/18 (P < .001). Self-evaluation scores increased significantly on all rubric sections (P < .05) except professional language (P = .133). Student comfort level rounding with healthcare professionals and interacting/intervening with healthcare professionals to address a medication-related problem increased significantly (P < .001). SUMMARY: Interprofessional communication practice, preceptor observations and feedback, and utilization of an interprofessional SBAR-inspired communication rubric contributed to improved student confidence in making patient care recommendations to physicians.

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Objective: To compare and contrast doravirine (DOR) with other agents in the nonnucleoside reverse transcriptase inhibitor (NNRTI) class, review safety and efficacy data from both completed and ongoing clinical trials, and outline the potential place in therapy of DOR. Data Sources: A literature search using the PubMed database (inception to June 2019) was conducted using the search terms HIV, doravirine, non-nucleoside reverse transcriptase inhibitor, NNRTI, and MK-1439. Study Selection and Data Extraction: Clinical data were limited to those published in the English language from phase 2 or 3 clinical trials. Ongoing trials were identified through ClinicalTrials.gov. Data Synthesis: DOR was approved by the US Food and Drug Administration on the strength of 2 phase 3 randomized, double-blind, noninferiority clinical trials with additional studies currently underway examining its utility in other clinical scenarios. Relevance to Patient Care and Clinical Practice: The role of NNRTIs as part of antiretroviral (ARV) therapy has diminished in recent years given the introduction of more tolerable individual ARV agents and regimens. Despite this, new agents are still needed in the therapeutic arena because treatment failure as well as intolerance can still occur with many first-line therapies. The optimal place in therapy of DOR remains to be defined. Conclusions: DOR is a new NNRTI that represents a potential treatment option for treatment-naïve patients, without many of the previously described untoward effects of the NNRTI class.

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Objective: To review the efficacy and safety of dolutegravir (DTG) with rilpivirine (RPV) as a dual therapy regimen in the treatment of HIV-1 infection. Data Sources: A literature search was performed using PubMed (1966 to January 2019) and Google Scholar (2014 to January 2019) with the search terms dolutegravir, rilpivirine, dual, and switch. Other resources included review articles and the manufacturer product label. Study Selection and Data Extraction: All relevant English-language articles of studies assessing the efficacy and safety of switch therapy to DTG with RPV and review articles were included. Data Synthesis: The fixed-dose combination tablet of DTG and RPV is the first dual therapy approved for the treatment of HIV-1 infection in adult patients who have achieved virological suppression for least 6 months on current antiretroviral therapy. This single-tablet regimen is dosed once daily and has been compared with standard triple therapy antiretroviral regimens for safety and efficacy. The dual therapy regimen demonstrated comparable maintenance of virological suppression evaluated up to 100 weeks, with low rates of virological failure. Common adverse effects include headache and diarrhea. Relevance to Patient Care and Clinical Practice: This dual therapy represents an attractive option with a high barrier to resistance in patients without hepatitis B coinfection with adverse effects or significant drug-drug interactions on current therapy, polypharmacy, or end-stage renal disease, who are controlled on triple therapy. Conclusions: This dual therapy combination of DTG-RPV provides maintenance of virological suppression as a switch strategy with few drug interactions and positive effects on lipids and renal and bone health.

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Objective. To develop and establish validity for a grading rubric to evaluate diabetes subjective, objective, assessment, plan (SOAP) note writing on primary care (PC) advanced pharmacy practice experiences (APPEs), and to assess reliability and student perceptions of the rubric. Methods. Ten PC APPE faculty members collaborated to develop a rubric to provide formative and summative feedback on three written SOAP notes per APPE student over a 10-month period. Correlation analyses were conducted between rubric scores and three criterion variables to assess criterion-related validity: APPE grades, Pharmaceutical Care Ability Profile Scores, and Global Impression Scores. Inter-rater and intra-rater reliability testing were completed using Cohen's kappa and Intraclass Correlation Coefficients (ICC). Student perceptions were assessed through an anonymous student survey. Results. Fifty-one students and 167 SOAP notes were evaluated using the final rubric. The mean score significantly increased from the first to second SOAP note and from the first to third SOAP note. Statistically significant positive correlations were found between final rubric scores and criterion variables. The ICC for inter-rater reliability was fair (.59) for final rubric scores and excellent for intra-rater reliability (.98 to1.00). Students responded that the rubric improved their ability (84.9%) and confidence (92.4%) to write SOAP notes. Conclusion. The rubric may be used to make valid decisions about students' SOAP note writing ability and may increase their confidence in this area. The use of the rubric allows for greater reliability among multiple graders, supporting grading consistency.

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BACKGROUND: Once-daily (QD), combination antiretroviral therapy (ART) can impact the willingness and ability of patients to take medications as directed. The impact of antiretroviral (ARV) drug adherence influenced by single-tablet (STR) versus multi-tablet regimens (MTR) among patients enrolled in the AIDS Drug Assistance Program (ADAP) in a rural environment has not yet been assessed. MATERIAL AND METHODS: A retrospective chart review evaluated adherence and outcomes in adult HIV-infected patients enrolled in the ADAP at 2 ambulatory clinics in the Southeast, taking either a QD STR (efavirenz [EFV]/emtricitabine/tenofovir [TDF]) or a QD protease inhibitor (PI)-based, MTR (atazanavir [ATV], ritonavir [RTV], and emtricitabine/TDF) by evaluating pharmacy refill records, patient self-reported adherence, and virologic response. RESULTS: A total of 389 patient records were analyzed (STR, n = 165 versus MTR, n = 224). There were more males, a higher percentage of treatment-naive patients, and more patients with a baseline CD4 count of >200 cells/mm(3) in the MTR group. Based on refill records, more patients on MTR were >90% adherent (61.6% versus 51.5%, P = .047). In a multivariable analysis, being treatment experienced was a negative predictor (odds ratio [OR] = 0.48, 0.29-0.78) for adherence. Regimen choice was not associated with adherence. More patients taking MTR were virologically suppressed at the end of the observation period. Regardless of the regimen, being >90% adherent was a significant predictor of virologic suppression (OR = 3.51, 1.98-6.23). CONCLUSION: Treatment-experienced patients enrolled in ADAP are less likely to be adherent. A QD PI-based MTR may result in comparable adherence to an STR in a rural HIV-infected population.

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The Accreditation Council for Pharmacy Education issued revised standards (Standards 2007) for professional programs leading to the Doctor of Pharmacy degree in July 2007. The new standards require colleges and schools of pharmacy to provide pharmacy practice experiences that include direct interaction with diverse patient populations. These experiences are to take place in multiple practice environments (e.g., community, ambulatory care, acute care medicine, specialized practice areas) and must include face-to-face interactions between students and patients, and students and health care providers. In 2009, the American College of Clinical Pharmacy (ACCP) identified concerns among their members that training for some students during the fourth year of pharmacy curriculums are essentially observational experiences rather than encounters where students actively participate in direct patient care activities. These ACCP members also stated that there is a need to identify effective mechanisms for preceptors to balance patient care responsibilities with students' educational needs in order to fully prepare graduates for contemporary, patient-centered practice. The 2010 ACCP Educational Affairs Committee was charged to provide recommendations to more effectively foster the integration of pharmacy students into direct patient care activities during advanced pharmacy practice experiences (APPEs). In this commentary, the benefits to key stakeholders (pharmacy students, APPE preceptors, clerkship sites, health care institutions, academic pharmacy programs) of this approach are reviewed. Recommendations for implementation of direct patient care experiences are also provided, together with discussion of the practical issues associated with delivery of effective APPE. Examples of ambulatory care and acute care APPE models that successfully integrate pharmacy students into the delivery of direct patient care are described. Enabling students to engage in high-quality patient care experiences and to assume responsibility for drug therapy outcomes is achievable in a variety of practice settings. In our opinion, such an approach is mandatory if contemporary pharmacy education is to be successful in producing a skilled workforce capable of affecting drug therapy outcomes.

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In the past 30 years, medical advances for those with human immunodeficiency virus (HIV) have reduced morbidity and mortality to extend life with highly active antiretroviral therapy (HAART) and with the continued development of new therapies. With this success, HIV is being managed chronically, but other health issues of an aging HIV-infected population have emerged. The challenges of treating HIV infection have shifted from AIDS-related mortality improvements to drug-induced disease from HAART, including cardiovascular disease, metabolic disorders, and bone health. Prolonged use of antiretroviral therapy maintaining immune restoration appears to represent additional, ongoing risk factors for the development of these metabolic complications. These drug-related problems continue to challenge patients and clinicians in the management of HIV disease, as well as ongoing research for drug development improvements to minimize these risks. These health risks imposed by HAART must be vigilantly monitored and aggressively addressed to improve the overall health of those treated for HIV infection.

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Pharmacists' clinical interventions have been the subject of a substantial body of literature that focuses on the process and outcomes of establishing an intervention documentation program within the acute care setting. Few reports describe intervention documentation as a component of doctor of pharmacy (PharmD) programs; none describe the process of selecting an intervention documentation application to support the complete array of pharmacy practice and experiential sites. The process that a school of pharmacy followed to select and implement a school-wide intervention system to document the clinical and financial impact of an experiential program is described. Goals included finding a tool that allowed documentation from all experiential sites and the ability to assign dollar savings (hard and soft) to all documented interventions. The paper provides guidance for other colleges and schools of pharmacy in selecting a clinical intervention documentation system for program-wide use.

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OBJECTIVE: To assess patient knowledge regarding acetaminophen dosing, toxicity, and recognition of acetaminophen-containing products. DESIGN: Descriptive, nonexperimental, cross-sectional study. SETTING: Alabama, January 2007 to February 2008. PATIENTS: 284 patients at four outpatient medical facilities. INTERVENTION: 12-item investigator-administered questionnaire. MAIN OUTCOME MEASURES: Degree of patient knowledge regarding acetaminophen safety, dosing recommendations, toxicity, alternative names and abbreviations, and products. RESULTS: Two-thirds of the 284 patients completing the survey reported current or recent use of pain, cold, or allergy medication. Of these, 25% reported knowing the active ingredient. Of patients, 46% and 13% knew that "acetaminophen" and "APAP," respectively, were synonymous with "Tylenol." Several patients (12%) believed that ingesting a harmful amount of acetaminophen was difficult or impossible. One-third of patients correctly identified the maximum daily dose, 10% reported a dose greater than 4 g, 25% were unsure of the dose, and 7% were unsure whether a maximum dose existed. One-half recognized liver damage as the primary toxicity. Results were similar between acetaminophen users and nonusers. CONCLUSION: Deficiencies were found in patient knowledge regarding acetaminophen recognition, dosing, and potential for toxicity. The development of effective educational initiatives is warranted to ensure patient awareness and limit the potential for acetaminophen overdose.

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A 55-year-old Caucasian man was receiving warfarin therapy after undergoing aortic valve replacement. His international normalized ratio (INR) was stabilized with warfarin 95 mg/week for 5 weeks. Commencement of a low-carbohydrate, high-protein diet resulted in a series of subtherapeutic INRs that led to a 16% increase in the dosage requirement to maintain therapeutic INRs. After the patient discontinued the diet, his INR increased, and several dosage reductions were required until his INR stabilized with his original dosage of 95 mg/week. Two additional case reports have described a possible interaction between warfarin and a high-protein diet. The potential for increased dietary protein intake to raise serum albumin levels and/or cytochrome P450 activity has been postulated as mechanisms for the resulting decrease in INRs. Given the available animal and human data that demonstrate alterations in drug metabolism in the presence of altered dietary protein intake, an increase in warfarin metabolism due to cytochrome P450 activation appears to be the most likely cause. In addition to the previously reported cases, this case indicates a potential interaction between warfarin and a high-protein diet. Because of the popularity of high-protein diets and because of the risks associated with inadequate or excessive warfarin anticoagulation, patients and health care providers should be aware of this interaction to ensure appropriate monitoring when warranted.

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OBJECTIVES: To identify instructional and assessment problems leading to pharmacy students' failure to retain pharmacokinetics abilities into the experiential year and develop an instructional methodology and abilities-based assessment tool to address the problem. METHODS: Pharmacokinetic instructional methods were assessed and an abilities-based assessment tool was developed and utilized as a requirement for curricular progression. Both the instructional methodology and the assessment tool were evaluated using abilities-based outcomes and faculty surveys. ASSESSMENT: Both instructional methods and assessment methods improved student pharmacokinetic skill performance in the direct patient-care environment. CONCLUSIONS: Continual assessment, modification, and implementation of teaching methods and the adoption of a high-stakes abilities-based assessment impacted student learning in a problem-based, integrated course.

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OBJECTIVE: To review the pharmacology, pharmacokinetics, virology, safety, efficacy, and clinical use of fosamprenavir. DATA SOURCES: A MEDLINE (1966-July 2005) search was conducted using fosamprenavir, Lexiva, amprenavir, and GW433908 as key words. Abstracts from infectious diseases and HIV scientific meetings were identified. Bibliographies of cited articles were reviewed. STUDY SELECTION AND DATA EXTRACTION: All publications, meeting abstracts, and unpublished information were reviewed and relevant items included. Information from in vitro, preclinical, and Phase II and III clinical trials was included. DATA SYNTHESIS: Fosamprenavir is a protease inhibitor (PI) prodrug used for the treatment of HIV-1 infection. The active moiety, amprenavir, is extensively metabolized by CYP3A4. In clinical trials, fosamprenavir was at least as effective as amprenavir, with a reduced pill burden. Fosamprenavir was developed with the intention of reducing the pill burden associated with amprenavir. It has demonstrated comparable safety and efficacy with comparator PIs and is associated with limited cross-resistance to other PIs. CONCLUSIONS: Fosamprenavir is a promising antiretroviral agent with favorable efficacy and tolerability. At this time, data indicate the utility of fosamprenavir in treatment-naïve and PI-experienced HIV-infected patients.

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OBJECTIVE: To evaluate options for the management of weight gain associated with olanzapine therapy. DATA SOURCES: MEDLINE (1966-May 2004), International Pharmaceutical Abstracts (1970-August 2003), The Cochrane Library, and EMBASE (1974-August 2003) databases were searched using the key words antipsychotics, atypical antipsychotics, olanzapine, and weight gain. Bibliographies of cited articles were reviewed. STUDY SELECTION AND DATA EXTRACTION: All articles identified from the data sources were evaluated and all information deemed relevant was included for this review. DATA SYNTHESIS: Weight gain is a common adverse effect of olanzapine, a member of the atypical antipsychotic class. Data are limited supporting a specific therapeutic approach to the management of weight gain with olanzapine treatment. Reversal of weight gain with lifestyle modifications and adjunctive pharmacologic therapies such as nizatidine and amantadine has been modest. Experience with adjunctive pharmacologic treatment has been limited to small, observational studies and case reports. Although data are limited, weight reduction has been observed in select patients switching from olanzapine to an alternative atypical antipsychotic. CONCLUSIONS: At this time, targeting lifestyle modifications provides the most reasonable approach to minimize weight gain observed with olanzapine therapy. Preliminary evidence evaluating adjunctive pharmacologic treatment for this indication has demonstrated minimal clinical benefit. Switching to an alternative atypical antipsychotic agent associated with less significant weight gain may be appropriate in select patients. Further clinical trials are needed to support a specific therapeutic approach to managing weight gain with olanzapine.

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