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Physicians routinely consider modifying antiretroviral therapy (ART) regimen for their patients with HIV. Little is known about the factors associated with patients' willingness to accept providers' recommended ART changes. This multicenter prospective observational study examined factors associated with willingness to accept ART changes recommended by their providers among HIV-infected adults from six urban outpatient HIV clinics. Patients were surveyed using the Patient Attitudes about Altering Antiretroviral Therapy Survey questionnaire (PAAARTS). Factors associated with willingness to accept ART changes were assessed using a multivariate generalized estimating equation (GEE) model to account for correlated responses. The Classification and Regression Trees (CART) analysis was also performed to determine subgroups of patients with higher acceptance of change. 216 of 289 patients (75%) definitely accepted recommended changes. Odds for acceptance were 3.2, 2.3, and 2.8 times higher for patients with higher attitudes and beliefs about ART (p < 0.01; 95% confidence interval [CI] = 1.59, 6.52), patients who rated their provider's care as excellent (p < 0.05; 95% CI = 1.07, 4.78), and non-Hispanic patients (p < 0.05; 95% CI 1.03, 7.57), respectively. CART analysis showed similar results and identified that when patients had less positive attitude about ART, acceptance rates were higher for non-Hispanic patients with higher assessments of their patient-provider communication. While most patients accepted providers' recommendation for ART changes, this willingness was influenced by both patients' attitudes and beliefs about ART and their assessment of either the effectiveness of patient-provider communication or their rating of providers' care. ART acceptance rates among Hispanic patients were lower. [ABSTRACT FROM AUTHOR]

BACKGROUND: Abacavir sulfate is a recent addition to the nucleoside reverse-transcriptase inhibitor class of antiretroviral agents used in the treatment of HIV infection. It is approved for use in combination with other antiretroviral agents. Its tolerability has been studied, but the overall clinical relevance of the findings has yet to be determined. OBJECTIVES: This review investigates available data on the abacavir hypersensitivity reaction (HSR) and provides a clinical perspective on maximizing this agent's tolerability and effective incorporation into antiretroviral regimens. METHODS: Relevant data were identified through MEDLINE and AIDSLINE searches of the English-language literature from 1966 through 2002 using the terms abacavir and 1592U89, the investigational new drug designation for abacavir. The reference lists of identified articles were searched for additional documents. Additional information was obtained from the US Food and Drug Administration and the drug's manufacturer. RESULTS: The abacavir HSR occurs in <5% of all patients started on therapy; the incidence appears to be unaffected by specific demographic characteristics or disease stage. Accurate diagnosis and appropriate patient education are essential, because reintroduction of abacavir in a patient with a history of possible HSR has been shown to result in a profound worsening of symptoms, including acute, severe hypersensitivity syndrome and possible death-even with aggressive treatment. Careful evaluation is necessary to distinguish an HSR from other manifestations of antiretroviral therapy. Despite the risk of HSR, compared with other anti-HIV medications, abacavir has demonstrated an overall favorable adverse-event profile. CONCLUSIONS: The risk of abacavir HSR must be taken into consideration when selecting initial antiretroviral therapy for patients with HIV infection. Careful, appropriate evaluation is necessary to rule out an HSR and determine whether the medication can be continued. [ABSTRACT FROM AUTHOR]

The Patient-centered HIV Care Model (PCHCM) integrated community-based pharmacists with medical providers and required sharing of patient clinical information and collaborative therapy-related action planning. We determined the proportions of participants with HIV and mental health conditions who were retained in care and the proportion virally suppressed, pre- and post-implementation. Overall, we found a relative 13% improvement in both retention [60% to 68% (p = 0.009)] and viral suppression [79% to 90% (p < 0.001)]. Notable improvements were seen among persons triply diagnosed with HIV, mental illness and substance use [+ 36% (50% to 68%, p = 0.036) and + 32% (66% to 86%, p = 0.001) in retention and viral suppression, respectively]. There were no differences in the proportions of persons adherent to psychiatric medications, pre- to post-implementation, nor were there differences in the proportions of persons retained in care or virally suppressed by psychiatric medication adherence, post-implementation. PCHCM demonstrated that collaborations between community-based pharmacists and medical providers can improve HIV care continuum outcomes among persons with mental health conditions.

Background: The patient-centered HIV care model (PCHCM) is an evidence-informed structural intervention that integrates community-based pharmacists with primary medical providers to improve rates of HIV viral suppression. This report assesses the costs and cost-effectiveness of the PCHCM., Setting: Patient-centered HIV care model., Methods: Three project sites, each composed of a medical clinic and 1 or 2 community-based HIV-specialized pharmacies, were included in the analyses. PCHCM required patient data sharing between medical providers and pharmacists and collaborative therapy-related decision making. Intervention effectiveness was measured as the incremental number of patients virally suppressed (HIV RNA <200 copies/mL at the last test in a 12-month measurement period). Microcosting direct measurement methods were used to estimate intervention costs. The cost per patient, cost per patient visit, and incremental cost per patient virally suppressed were calculated from the health care providers' perspective. Additionally, the number of HIV transmissions averted, lifetime HIV treatment cost saved, quality-adjusted life years (QALYs) saved, and cost per QALY saved were calculated from the societal perspective, using standard methods and reported values from the published literature., Results: Overall, the PCHCM annual intervention cost for the 3 project sites was $226,741. The average cost per patient, cost per patient visit, and incremental cost per patient virally suppressed were $813, $48, and $5,039, respectively. The intervention averted 2.75 HIV transmissions and saved 12.22 QALYs and nearly $1.28 million in lifetime HIV treatment costs. The intervention was cost saving overall and at each project site., Conclusions: The PCHCM can be delivered at a relatively low cost and is a cost-saving intervention to assist patients in achieving viral suppression and preventing HIV transmission.

The objective of this project was to collect and analyze information about work systems and processes that community pharmacy-medical clinic partnerships used for implementing the Patient-Centered HIV Care Model (PCHCM). Paired collaborations of 10 Walgreens community pharmacies and 10 medical clinics were formed in 10 cities located throughout the United States that had relatively high HIV prevalence rates and existing Walgreens HIV Centers of Excellence. Patient service provision data and most significant change stories were collected from key informants at each of the clinic and pharmacy sites over an 8 week period in 2016 and through in-depth phone interviews. Written notes were reviewed by two authors (J.C.S. and O.W.G.) and analyzed using the most significant change technique. The findings showed that half of the partnerships (n = 5) were unable to fully engage in service implementation due to external factors or severe staff turnover during the project period. The other half of the partnerships (n = 5) were able to engage in service implementation, with the most impactful changes being related to strong patient care systems, having a point person at the clinic who served as a connector between sites, and having pharmacists integrated fully into the health care team.

Background: Human immunodeficiency virus (HIV) viral suppression (VS) decreases morbidity, mortality, and transmission risk., Methods: The Patient-centered HIV Care Model integrated community-based pharmacists with HIV medical providers and required them to share patient clinical information, identify therapy-related problems, and develop therapy-related action plans.Proportions adherent to antiretroviral therapy (proportion of days covered [PDC] ≥90%) and virally suppressed (HIV RNA <200 copies/mL), before and after model implementation, were compared. Factors associated with postimplementation VS were determined using multivariable logistic regression; participant demographics, baseline viral load, and PDC were explanatory variables. PDC was modified to account for time to last viral load in the year postimplementation, and stratified as <50%, 50% to <80%, 80% to <90%, and ≥90%., Results: The 765 enrolled participants were 43% non-Hispanic black, 73% male, with a median age of 48 years; 421 and 649 were included in the adherence and VS analyses, respectively. Overall, proportions adherent to therapy remained unchanged. However, VS improved a relative 15% (75% to 86%, P < .001). Higher PDC (adjusted odds ratio [AOR], 1.74 per 1-level increase in PDC category [95% confidence interval {CI}, 1.30-2.34]) and baseline VS (AOR, 7.69 [95% CI, 3.96-15.7]) were associated with postimplementation VS. Although non-Hispanic black persons (AOR, 0.29 [95% CI, .12-.62]) had lower odds of suppression, VS improved a relative 23% (63% to 78%, P < .001)., Conclusions: Integrated care models between community-based pharmacists and primary medical providers may identify and address HIV therapy-related problems and improve VS among persons with HIV., (Published by Oxford University Press for the Infectious Diseases Society of America 2019.)

Background: A benchmark of near-perfect adherence (≥95%) to antiretroviral therapy (ART) is often cited as necessary for HIV viral suppression. However, given newer, more effective ART medications, the threshold for viral suppression may be lower. We estimated the minimum ART adherence level necessary to achieve viral suppression., Settings: The Patient-centered HIV Care Model demonstration project., Methods: Adherence to ART was calculated using the proportion of days covered measure for the 365-day period before each viral load test result, and grouped into 5 categories (<50%, 50% to <80%, 80% to <85%, 85% to <90%, and ≥90%). Binomial regression analyses were conducted to determine factors associated with viral suppression (HIV RNA <200 copies/mL); demographics, proportion of days covered category, and ART regimen type were explanatory variables. Generalized estimating equations with an exchangeable working correlation matrix accounted for correlation within subjects. In addition, probit regression models were used to estimate adherence levels required to achieve viral suppression in 90% of HIV viral load tests., Results: The adjusted odds of viral suppression did not differ between persons with an adherence level of 80% to <85% or 85% to <90% and those with an adherence level of ≥90%. In addition, the overall estimated adherence level necessary to achieve viral suppression in 90% of viral load tests was 82% and varied by regimen type; integrase inhibitor- and nonnucleoside reverse transcriptase inhibitor-based regimens achieved 90% viral suppression with adherence levels of 75% and 78%, respectively., Conclusions: The ART adherence level necessary to reach HIV viral suppression may be lower than previously thought and may be regimen-dependent.

Objectives: To develop a pharmacist patient care services intervention reporting checklist to be used in conjunction with existing primary reporting tools. The tool should enhance consistent reporting of pharmacist patient care interventions. Tool use in pharmacist-patient care intervention reporting may increase: (1) likelihood for inclusion in higher order analyses and (2) successful replication., Methods: Adhering to principles of the Equator Network, a modified Delphi approach was used. An expert group identified guidance need, conducted a thorough literature search confirming need, developed a comprehensive list of potential elements, refined the list via multiple rounds, finalized language and structure, and published the checklist. Multiple rounds of iterative input were completed face to face, in conference calls, and during public comment periods. The finalized list of elements was organized into a logical flow with the use of clear and concise language and then transformed into an intuitive checklist., Results: The core task force identified 9 critical components over a 4-year period Collectively, the input represented more than 200 stakeholders. Stakeholders overwhelmingly supported the inclusion (89%; n = 29) and clarity (91%; n = 26) of each element. The final 9 elements were organized into a checklist to enhance pharmacist patient care intervention reporting (PaCIR). Accompanying each element is a specific explanation justifying its inclusion. An appendix containing published and created examples of how authors may satisfactorily meet each element is provided., Conclusion: Use of the PaCIR checklist will enhance the quality of reporting of pharmacist patient care intervention studies. This enhanced quality can support replication of the studies and increase the likelihood these studies will be considered for inclusion in systematic reviews and meta-analyses. Researchers are urged to consider use of reporting guides such as PaCIR during the project design phase., (Copyright © 2019 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

Poor retention in HIV care is associated with higher morbidity and mortality and greater risk of HIV transmission. The Patient-Centered HIV Care Model (PCHCM) integrated community-based pharmacists with medical providers. The model required sharing of patient clinical information and collaborative therapy-related action planning. The proportion of persons retained in care (≥1 medical visit in each 6-month period of a 12-month measurement period with ≥60 days between visits), pre- and post-PCHCM implementation, was modeled using log binomial regression. Factors associated with post-implementation retention were determined using multi-variable regression. Of 765 enrolled persons, the plurality were male (n = 555) and non-Hispanic black (n = 331), with a median age of 48 years (interquartile range = 38-55); 680 and 625 persons were included in the pre- and post-implementation analyses, respectively. Overall, retention improved 12.9% (60.7-68.5%, p = 0.002). The largest improvement was seen among non-Hispanic black persons, 22.6% increase (59.7-73.2%, p < 0.001). Persons who were non-Hispanic black [adjusted risk ratio (ARR) 1.27, 95% confidence interval (CI) 1.08-1.48] received one or more pharmacist-clinic developed action plan (ARR 1.51, 95% CI 1.18-1.93), had three or more pharmacist encounters (ARR 1.17, 95% CI 1.05-1.30), were more likely to be retained post-implementation. In the final multi-variable models, only race/ethnicity [non-Hispanic black (ARR 1.27, 95% CI 1.09-1.48) and "other or unknown" race/ethnicity (ARR 1.36, 95% CI 1.14-1.63)] showed an association with post-implementation retention. PCHCM demonstrated how collaborations between community-based pharmacists and primary medical providers can improve retention in HIV care. This care model may be particularly useful for non-Hispanic black persons who often are less likely to be retained in care.

Objectives: To compare outcomes with single tablet regimens (STR) versus multi-tablet regimens (MTR) for human immunodeficiency virus (HIV) treatment using published data., Design: Systematic review and random-effects meta-analysis of literature on approved and investigational HIV regimens., Methods: The research followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Single or un-blinded studies reporting a direct comparison between STR and MTR were eligible for the meta-analysis. Double-blinded studies were excluded due to lack of difference in pill burden between cohorts. The key outcomes of interest included: adherence rates/proportion meeting target, efficacy, safety/tolerability, non-clinical and economic outcomes., Results: After screening 63 full-text articles and posters, 14 studies were eligible for the meta-analysis. The analysis showed that patients taking STR had improved outcomes over those taking MTR. Patients were significantly more adherent regardless of daily dosing frequency (odds ratio [OR]: 1.96, p < 0.001) and were more likely to achieve virological suppression (relative risk [RR]: 1.05, p = 0.002). There was a trend toward a lower discontinuation risk in the STR cohort, together with reported higher therapy satisfaction, better symptom control, improved health status, reduced healthcare resource utilization and demonstrated cost-effectiveness compared to MTR. There were no differences in CD4 cell count increase (at 48 weeks) or safety outcomes., Conclusions: The findings of this study confirm previously reported preliminary findings of the advantages of STR over MTR for HIV treatment in adherence, therapy continuation, viral suppression, tolerability, quality of life improvement, cost-effectiveness and healthcare resource utilization.

Availability of a single source review of once-daily fixed-dose single tablet regimen (STR) and multiple tablet fixed-dose regimen (MTR) would optimally inform healthcare providers and policy makers involved in the management of population with human immunodeficiency virus (HIV).We conducted a meta-analysis of published literature to compare patient adherence, clinical, and cost outcomes of STR to MTR.Published literature in English between 2005 and 2014 was searched using Embase, PubMed (Medline in-process), and ClinicalTrials.Gov databases. Two-level screening was undertaken by 2 independent researchers to finalize articles for evidence synthesis. Adherence, efficacy, safety, tolerability, healthcare resource use (HRU), and costs were assessed comparing STR to MTR. A random-effects meta-analysis was performed and heterogeneity examined using meta-regression.Thirty-five articles were identified for qualitative evidence synthesis, of which 9 had quantifiable data for meta-analysis (4 randomized controlled trials and 5 observational studies). Patients on STR were significantly more adherent when compared to patients on MTR of any frequency (odds ratio [OR]: 2.37 [95% CI: 1.68, 3.35], P < 0.001; 4 studies), twice-daily MTR (OR: 2.53 [95% CI: 1.13, 5.66], P = 0.02; 2 studies), and once-daily MTR (OR: 1.81 [95% CI: 1.15, 2.84], P = 0.01; 2 studies). The relative risk (RR) for viral load suppression at 48 weeks was higher (RR: 1.09 [95% CI: 1.04, 1.15], P = .0003; 3 studies) while RR of grade 3 to 4 laboratory abnormalities was lower among patients on STR (RR: 0.68 [95% CI: 0.49, 0.94], P = 0.02; 2 studies). Changes in CD4 count at 48 weeks, any severe adverse events (SAEs), grade 3 to 4 AEs, mortality, and tolerability were found comparable between STR and MTR. Several studies reported significant reduction in HRU and costs among STR group versus MTR.Study depicted comparable tolerability, safety (All-SAE and Grade 3-4 AE), and mortality and fewer Grade 3 to 4 lab abnormalities and better viral load suppression and adherence among patients on FDC-containing STR versus MTR; literature depicted favorable HRU and costs for STRs.These findings may help decision makers especially in resource-poor settings to plan for optimal HIV disease management when the choice of both STRs and MTRs are available.

Introduction: Diarrhea poses a substantial burden for patients with human immunodeficiency virus (HIV), negatively impacting quality-of-life (QoL) and adherence to antiretroviral therapy. During the combination antiretroviral therapy (cART) era, as incidence of opportunistic infection as a cause of diarrhea decreased, incidence of noninfectious diarrhea (including diarrhea as an adverse event [AE] of cART and HIV enteropathy) increased proportionately. A literature search was conducted for information on prevalence, etiology, and treatment options for noninfectious diarrhea in patients with HIV., Results: For marketed antiretroviral therapies, up to 28% of patients live with >4 loose or watery stools per day. The US Food and Drug Administration (FDA) does not require pharmaceutical manufacturers to include, within approved prescribing information, prevalence rates for all grades of diarrhea. Traditionally, noninfectious diarrhea management focused on avoiding use of diarrhea-associated cART; symptom management (nonpharmacologic and/or pharmacologic); and, as a last resort, changing cART. Examining the evidence upon which this approach is based reveals that most strategies rely upon anecdotal information and case reports. This review summarizes the literature and updates clinicians on the most recent options for management of noninfectious diarrhea in patients with HIV., Conclusion: Diarrhea in patients with HIV is a significant unmet clinical need that contributes to worsening QoL and complicates medical management. Approaching management using a stepwise method of nonpharmacologic (diet), nonprescription (over-the-counter) and, finally, prescription agent changes (modification of cART or addition of an evidence-based antidiarrheal) appears reasonable, despite a lack of clear scientific evidence to support the initial two steps of this approach. If diet modifications, including psyllium and fiber introduction, fail to resolve noninfectious diarrhea in patients with HIV, loperamide followed by crofelemer should be considered. Clinicians are encouraged to review the most recent literature, not rely upon prescribing information. Continued vigilance by HIV providers to the presence of gastrointestinal AEs, even in patients taking the most recently approved antiretroviral agents, is warranted. Additional research is justified in identifying the etiology and management of HIV-associated diarrhea in patients on successful cART regimens.

Background: HIV-associated diarrhea remains a significant concern with limited treatment options., Objective: To determine the optimal dose, efficacy, and safety of crofelemer for noninfectious diarrhea., Methods: This randomized, double-blind, phase 3 trial used a 2-stage design. Both stages included 2-week screening, 4-week placebo-controlled treatment, and 20-week placebo-free (open-label) extension phases. In stage I, 196 HIV-seropositive patients with chronic diarrhea were randomized to crofelemer 125 mg, 250 mg, or 500 mg or placebo twice daily. Using a prospective analysis, the 125-mg twice-daily dose was selected for stage II. In stage II, 180 new patients were randomized to crofelemer 125 mg twice daily or placebo for 4 weeks. Primary efficacy analysis was the percentage of patients (stages I/II combined) who achieved clinical response (defined as ≤2 watery stools/week during ≥2 of 4 weeks). During the placebo-free extension phase, response (≤2 watery stools) was assessed weekly., Results: Significantly more patients receiving crofelemer 125 mg achieved clinical response versus placebo (17.6% vs 8.0%; one-sided, P = .01). Crofelemer 125 mg resulted in a greater change from baseline in number of daily watery bowel movements (P = .04) and daily stool consistency score (P = .02) versus placebo. During the placebo-free extension phase, percentages of weekly responders ranged from 40% to 56% at weeks 11 to 24. Crofelemer was minimally absorbed, well tolerated, did not negatively impact clinical immune parameters, and had a safety profile comparable to placebo., Conclusions: In HIV-seropositive patients taking stable antiretroviral therapy, crofelemer provided significant improvement in diarrhea with a favorable safety profile.

Background: 2009 H1N1 influenza A disproportionately affected pregnant and postpartum women compared with the general population, with higher rates of hospitalization and severe illness. We present a case of the use and pharmacokinetics of intravenous peramivir in the treatment of a patient with severe influenza., Case: A 28-year-old woman at 37 weeks of gestation presented to the hospital with severe respiratory symptoms. 2009 H1N1 influenza reverse transcriptase polymerase chain reaction returned positive results and intravenous peramivir was started. She showed rapid improvement and was discharged 29 days after admission., Conclusion: The pharmacokinetic parameters in this patient were unexpected because the clearances occurred more quickly than in phase I trials. These differences highlight the need for additional pharmacokinetic reporting of peramivir in pregnant and postpartum women.

Background: KP-1461 is a prodrug to KP-1212. KP-1212 is a viral mutagen designed to increase viral error rate., Methods: We describe 2 phase I studies: KP1461-101 (double-blind, placebo-controlled, single, escalating doses, 100 to 1600 mg study in 42 non-HIV-infected participants) and KP-1461-102 (double-blind placebo-controlled dose escalation 14-day study in HIV-infected participants, 400-3200 mg). Primary objectives were safety/tolerability. Secondary objectives included pharmacokinetic analysis with exploratory objective to characterize KP-1212 effects on viral load., Results: KP-1461 was well tolerated. Majority of adverse events were grade 1 (neurological, gastrointestinal, cardiovascular). Four participants experienced grade 3 and 1 experienced a grade 4 event. Analysis demonstrated no difference in pharmacokinetic parameters at day 1 or 14. Linear pharmacokinetics found in 1600 mg arm. Compared to placebo, only at the 3200 mg dose demonstrated a marginally statistically significant virologic response., Conclusions: These studies provide safety/tolerability information and suggest virologic efficacy. KP-1212, a first-in-class antiretroviral, demonstrates the ability to induce viral eradication in vitro. Viral reduction in vivo may foretell a paradigm shift in HIV pharmacotherapy.

In 2008, the American College of Clinical Pharmacy appointed the Task Force on Research in the Professional Curriculum to review and make recommendations on the essential research curriculum that should be part of doctor of pharmacy (Pharm.D.) degree programs. The essential research curriculum provides all students with critical and analytical thinking and lifelong learning skills, which will apply to current and future practice and stimulate some students to pursue a career in this field. Eight key curricular competencies are as follows: identifying relevant problems and gaps in pharmacotherapeutic knowledge; generating a research hypothesis; designing a study to test the hypothesis; analyzing data results using appropriate statistical tests; interpreting and applying the results of a research study to practice; effectively communicating research and clinical findings to pharmacy, medical, and basic science audiences; interpreting and effectively communicating research and clinical findings to patients and caregivers; and applying regulatory and ethical principles when conducting research or using research results. Faculty are encouraged to use research-related examples across the curriculum in nonresearch courses and to employ interactive teaching methods to promote student engagement. Examples of successful strategies used by Pharm.D. degree programs to integrate research content into the curriculum are provided. Current pharmacy school curricula allow variable amounts of time for instructional content in research, which may or may not include hands-on experiences for students to develop research-related skills. Therefore, an important opportunity exists for schools to incorporate the essential research curriculum. Despite the challenges of implementing these recommendations, the essential research curriculum will position pharmacy school graduates to understand the importance of research and its applications to practice. This perspective is provided as an aid and a challenge to those in leadership and teaching positions within schools and colleges of pharmacy.