Cabotegravir: The First Long-Acting Injectable for HIV Preexposure Prophylaxis.

OBJECTIVE: Review the pharmacology, pharmacokinetics, efficacy, safety, and role of long-acting injectable cabotegravir (CAB-LA) in HIV preexposure prophylaxis (PrEP). DATA SOURCES: A literature search was performed using PubMed and Google Scholar (2012 to April 2022) with the search terms cabotegravir, preexposure prophylaxis, and PrEP. Other resources included abstracts presented at recent conferences, the manufacturer's Web site, prescribing information, and review articles. STUDY SELECTION AND DATA EXTRACTION: All English-language articles of studies assessing the efficacy and safety of CAB-LA for PrEP were included. DATA SYNTHESIS: CAB-LA is the first long-acting injectable therapy approved for HIV-1 PrEP in both men and women. It is a suspension given intramuscularly every other month. CAB-LA has been shown to be more effective than daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in preventing HIV-1 infection among high-risk individuals. Two phase 3 trials were stopped early on the basis of superior efficacy of CAB-LA. The most common adverse effects were injection site reactions (ISRs), although they tended to decrease over time, and few participants in clinical trials discontinued use due to ISRs. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: CAB-LA may be particularly useful for individuals with known adherence problems to oral therapy, those with renal impairment, and those with decreased bone mineral density. However, CAB-LA is more expensive than generic TDF/FTC and may be associated with weight gain. CONCLUSIONS: CAB-LA is the first long-acting injectable agent for HIV PrEP. It is more effective than oral TDF/FTC, is well-tolerated aside from ISRs, and has few clinically significant drug-drug interactions.

Qualitative analysis of community pharmacy-based COVID-19 immunization service operations.

BACKGROUND: The unprecedented coronavirus disease 2019 (COVID-19) pandemic has generated worldwide impacts while positioning community pharmacies as easily accessible immunizers to rollout the COVID-19 vaccine. OBJECTIVES: This study describes community pharmacists' experiences, success stories, and lessons learned from providing COVID-19 immunization services. METHODS: This study was conducted in February to March 2022 using semistructured interviews with licensed pharmacists practicing full-time in Alabama community pharmacies. Transcribed interviews' content analysis was conducted by 2 independent coders in ATLAS.ti software. RESULTS: Nineteen interviews were completed. Pharmacists' experiences in the implementation of COVID-19 immunization services are described across 4 themes: (1) on-site and off-site immunization locations, (2) roles and responsibilities of pharmacy personnel, (3) vaccine storage and administration, and (4) vaccine waste reduction and immunization uptake strategies. This study found that pharmacists' ability to adapt is vital to maintaining their ability to offer immunization services and other services. Pharmacists' capacity for adapting is exemplified through their ability to acclimate to becoming a primary hub of outpatient health care services, accommodating to COVID-19 social distancing and vaccine guidelines, and disseminating a novel vaccine with varying supply and demand. In addition, pharmacies gathered and maintained waitlists of patients and adopted an appointment-based model as to predict, plan, and provide for patients. Pharmacists also used reactive techniques and workflow aspects to dissuade COVID-19 vaccine waste such as in contacting interested patients on waitlists or switching to a walk-in acceptance model. The COVID-19 pandemic elicited unprecedented alterations to the legal, health care responsibilities granted to pharmacy staff with participants describing pharmacy technicians as making a considerable impact to pharmacies' workflow. CONCLUSIONS: Pharmacists stepped up as frontline providers during a time of public health emergency with their diverse experiences granting policy makers and researchers much to learn from as, in their communities, pharmacists have continued to increase access to care during a national health crisis.

Evaluation of a Capped Dosing Telavancin Regimen Compared to Standard Dosing at a Large Community Teaching Hospital.

Telavancin, a lipoglycopeptide antibiotic, is traditionally dosed at 10 mg/kg based on total body weight but is associated with toxicities that limit its use. This study supports the use of a capped dosing regimen of 750 mg in obese patients, which is associated with equal efficacy and fewer adverse effects compared to traditional dosing.

Weight Changes With Integrase Strand Transfer Inhibitor Therapy in the Management of HIV Infection: A Systematic Review.

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.

Evaluation of Monoclonal Antibodies in Preventing Hospitalizations, Emergency Department Visits, and Mortality in High-Risk COVID-19 Patients.

Background: The coronavirus disease 2019 (COVID-19) is a novel coronavirus that has caused an unprecedented global pandemic, with few treatment options currently available. Neutralizing monoclonal antibodies (mAbs) are a promising treatment approach to reduce hospitalizations in high-risk patients with mild-to-moderate COVID-19 infections. Objective: The primary objective is to compare hospitalization rates of high-risk patients who tested positive for COVID-19 within 28 days between those who received mAb infusions versus those who did not. Secondary objectives were emergency department (ED) visits and mortality within 28 days of a positive test. Methods: This single-center, institutional review board-approved, retrospective, observational cohort study included patients aged 19 years and older who tested positive for COVID-19 between December 2, 2020 and February 28, 2021. Patients who received the mAbs bamlanivimab or casirivimab/imdevimab were compared with patients who did not receive mAb infusions to examine hospitalization rates, ED visits, and mortality within 28 days of the positive COVID-19 test. Results: A total of 2780 patients were evaluated for inclusion using electronic chart review via Cerner. Of the 1612 patients who met inclusion criteria, 568 received an mAb infusion (mAb group) and 1044 did not (non-mAb group). Baseline characteristics were similar between the 2 groups. Of the patients in the mAb group, 34 (6%) were hospitalized versus 397 (38%) in the non-mAb group. Patients with ED visits included 111 (20%) and 672 (64%) in the mAb and non-mAb groups, respectively. Finally, 5 patients in the mAb group experienced mortality (0.9%) versus 83 (8%) in the non-mAb group. Each endpoint achieved statistical significance with a P value of <0.0001. Conclusion: Monoclonal antibody infusions are effective in preventing hospitalization, ED visits, and mortality in high-risk patients with mild-to-moderate COVID-19.

A Continuing Education Activity Durably Addressed Knowledge Gaps Related to Penicillin Allergies Among Pharmacists and Pharmacy Technicians.

Background: Penicillin allergy is one of the most frequent self-reported allergies; however, only about 10% of reported allergies are accurate. Objectives: Through the creation of a continuing pharmacy education (CPE) activity, we sought to assess knowledge gaps and comfort levels in the management of penicillin allergies. Methods: A 1-hour enduring-content CPE activity was offered as an interactive course from September 20, 2019, to September 20, 2020. Participants completed 3 surveys (pre-survey, post-survey, and follow-up survey). Participants were pharmacists and pharmacy technicians who completed, at a minimum, the activity and both pre- and post-surveys. The primary outcome was the percentage of participants scoring >80% on knowledge-based questions on the post-survey compared with the pre-survey. Secondary outcomes included pre-post comparisons on knowledge-based questions, participants' self-report of an allergy, and comfort levels dispensing cephalosporins in a patient with a self-reported penicillin allergy. Results: A total of 389 participants completed the CPE activity, with 176 included for analysis. Significantly more participants scored >80% on knowledge-based questions on the post-survey compared with the pre-survey (71.6% vs 22.7%, P < .001). There was no significant difference between the percentage of participants scoring >80% on the post-survey and the follow-up survey (71.6% vs 65%, P = .119). The majority of participants (74%) felt comfortable dispensing a cephalosporin in a patient with a penicillin allergy on the pre-survey, with similar percentages on the post- and follow-up surveys (77% and 90%, respectively). Conclusion: A targeted continuing education program improved overall knowledge, which was sustained for up to 2 months.

Cabotegravir-Rilpivirine: The First Complete Long-Acting Injectable Regimen for the Treatment of HIV-1 Infection.

OBJECTIVE: To review the efficacy and safety of cabotegravir (CAB) with rilpivirine (RPV) in the treatment of HIV-1 infection. DATA SOURCES: A literature search was performed using PubMed and Google Scholar (2010 to January 2021) with the search terms cabotegravir and rilpivirine. Other resources included abstracts presented at recent conferences and the manufacturer's website and prescribing information. STUDY SELECTION: All English-language articles of studies assessing the efficacy and safety of CAB with RPV were included. DATA SYNTHESIS: The combination of CAB, a new integrase strand transfer inhibitor, and RPV, an established nonnucleoside reverse transcriptase inhibitor, is the first long-acting dual therapy approved for the treatment of HIV-1 infection in adults who have achieved viral suppression on a standard antiretroviral therapy (ART). This regimen demonstrated comparable maintenance of viral suppression evaluated up to 160 weeks, with low rates of virological failure. CAB and RPV are available as suspension given intramuscularly in 2 separate injections every 4 weeks. Common adverse effects include injection site reactions, pyrexia, fatigue, and headache. CAB and RPV are also available as tablets given orally for bridging therapy. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: This long-acting dual therapy represents an attractive option with a high barrier to resistance for adults who have achieved viral suppression on standard ART and who prefer monthly injections over daily oral therapy. CONCLUSIONS: CAB-RPV is the first complete long-acting injectable that provides a convenient way to maintain viral suppression with no negative effects on renal and bone health and few drug interactions.

Ibalizumab: The First Monoclonal Antibody for the Treatment of HIV-1 Infection.

OBJECTIVE: To review the efficacy and safety of ibalizumab (IBA) in the treatment of HIV-1 infection. DATA SOURCES: A literature search was performed using PubMed and Google Scholar (2010 to mid-June 2020) with the search terms TMB-355, TNX-355, and ibalizumab. Other resources included abstracts presented at recent conferences and the manufacturer's website and prescribing information. STUDY SELECTION AND DATA EXTRACTION: All relevant English-language articles of studies assessing the efficacy and safety of IBA were included. DATA SYNTHESIS: IBA is a monoclonal antibody that blocks HIV-1 from infecting CD4+ T cells. IBA is approved by the Food and Drug Administration, in combination with other antiretrovirals (ARVs), for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant (MDR) HIV-1 infection failing their current ARVs. IBA demonstrated significant and sustained antiviral activity in patients with MDR HIV-1 infection who had advanced disease and limited treatment options. It carries a warning regarding the development of immune reconstitution inflammatory syndrome. Common adverse reactions include diarrhea, dizziness, nausea, and rash. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: IBA represents an attractive option for treatment-experienced adults with advanced HIV-1 infection who are no longer able to achieve viral suppression on oral ARV therapy alone and who are able to adhere to an infusion therapy every 2 weeks. As with other biologics, there is a potential for the development of antibodies to IBA that can compromise its efficacy and safety. CONCLUSION: IBA provides a needed treatment option to achieve and maintain viral suppression in heavily treatment-experienced adults with MDR HIV-1 infection.

Hepatotoxicity upon using niacin to pass a drug test: A case report.

OBJECTIVES: To report a case of hepatotoxicity when niacin was used by a patient with HIV to pass a drug test. METHODS: Niacin is a soluble pyridine derivative widely used in the management of dyslipidemia. Common adverse effects include flushing, nausea, gastrointestinal discomfort, and hepatotoxicity. The use of niacin for nonmedical purposes has been increasing in prevalence in recent years, particularly in attempts to alter or mask results of urine drug tests. Although there is no scientific evidence that niacin can alter a urine drug screen result, easily retrievable information exists on the Internet touting niacin as a potential way to prevent detection of tetrahydrocannabinol (THC). The following report describes a case of hepatotoxicity in an HIV-infected adult who reported using niacin to mask THC in urine drug screen results. RESULTS: The patient developed marked elevations in his liver enzymes (aspartate aminotransferase greater than 25 times the upper limit of normal and alanine aminotransferase greater than 3 times the upper limit of normal) that resolved after discontinuation of the drug. Because of the patient's self-reported use and discontinuation of niacin, the Naranjo Adverse Drug Reaction Probability Scale demonstrated a "definite" relationship between the development of hepatotoxicity and the ingestion of over-the-counter sustained-release niacin. The patient did not develop further clinical abnormalities proposed to be secondary to niacin toxicity in previously published case reports, including glucose abnormalities, coagulopathies, metabolic acidosis, QTc prolongation, and myalgias. CONCLUSION: Health care providers should be aware of this nonmedical use of niacin to alter or mask a drug test, especially when discerning the cause of hepatotoxicity. In addition, pharmacists in the community setting should be aware of this use of niacin when encountering patients purchasing over-the-counter niacin, particularly in patients who may be more likely to use illicit substances.

Cranberry Products for the Prophylaxis of Urinary Tract Infections in Pediatric Patients.

OBJECTIVE: To evaluate the existing data regarding the use of cranberry products for the prevention of urinary tract infections (UTIs) in pediatric patients. DATA SOURCES: A literature search of Medline databases from 1966 to June 2015 was conducted. STUDY SELECTION AND DATA EXTRACTION: The databases were searched using the terms "pediatrics," "children," "cranberry," "cranberry juice," and "urinary tract infections." The identified trials were then searched for additional references applicable to this topic. DATA SYNTHESIS: A total of 8 clinical trials were identified that examined the use of cranberry products, mostly juice, for the prevention of UTIs in children. Three trials examined the use in otherwise healthy children. Five trials examined the use in pediatric patients with underlying urogenital abnormalities of which 2 compared cranberry to antibiotics. In healthy pediatric patients, cranberry use was associated with a reduction in the overall number of UTIs and a decrease in the number of antibiotic days per year for UTI treatment. In patients with urogenital abnormalities, results were conflicting, with some studies showing no reduction in UTIs compared with placebo, but others demonstrating a significant reduction. However, cranberry products had similar efficacy when compared with both cefaclor and trimethoprim. All studies used a wide variety of doses and frequencies of cranberry, making specific product recommendations difficult. CONCLUSIONS: Cranberry appears effective for the prevention of UTIs in otherwise healthy children and is at least as effective as antibiotics in children with underlying urogenital abnormalities. However, recommendations for cranberry dosing and frequency cannot be confidently made at this time. Larger, well-designed trials are recommended.

Expanding expedited partner therapy and HIV prophylaxis in the emergency department.

PURPOSE: Sexually transmitted infections (STIs) continue to have a disproportionate impact on individuals belonging to sexual, gender, and racial minorities. Across the nation, many emergency medicine pharmacists (EMPs) possess the skills and knowledge to expand the provision of expedited partner therapy (EPT) for STIs and provide HIV prophylaxis within existing practice frameworks. This report serves as a call to action for expanded provision of EPT and HIV prophylaxis by EMPs and highlights current barriers and solutions to increase pharmacist involvement in these practice areas. SUMMARY: Emergency medicine pharmacy practice continues to expand to allow for limited prescribing authority through collaborative practice agreements (CPAs). In recent years, CPA restrictions have been changed to facilitate treatment of more patients with less bureaucracy. This report addresses the unique challenges and opportunities for expanding EPT and HIV pre- and postexposure prophylaxis provision by pharmacists in emergency departments (EDs). Furthermore, current strategies and treatments for EPT, such as patient-delivered partner therapy and HIV prophylaxis, are discussed. Pharmacist involvement in STI treatment and HIV prevention is a key strategy to increase access to high-risk populations with high ED utilization and help close current gaps in care. CONCLUSION: Expanding EMP provision of EPT and HIV prophylaxis may be beneficial to reducing the incidence of STIs and HIV infection in the community. CPAs offer a feasible solution to increase pharmacist involvement in the provision of these treatments. Legislative efforts to expand pharmacist scope of practice can also contribute to increasing access to EPT and HIV prophylaxis. With these efforts, EMPs can play an essential role in the fight against STIs and HIV.

Factors Associated with the Implementation of Pediatric Immunization Services: A Survey of Community Pharmacies.

Pharmacists are well-positioned to help increase pediatric immunization rates. This study assessed the types of pediatric vaccines offered in community pharmacies, compared participant/pharmacy characteristics and participants' perceptions of barriers and pharmacists' role in providing pediatric immunizations between pharmacy-based providers and non-providers, and assessed factors associated with pharmacy-based pediatric immunization provision. A cross-sectional survey was sent to Alabama community pharmacies from February to April 2023, of which 240 responded (20.5% response rate). Measures included whether they offered childhood vaccines in 2022 and the types of vaccines administered, participants' perceptions of pharmacists' role in pediatric immunization, and perceived barriers to providing pharmacy-based pediatric immunizations. Roughly half of pharmacies (50.8%) provided pediatric immunization services with influenza vaccines (91.0%) the most commonly provided vaccines and poliovirus-inactivated vaccines (4.9%) the least. Pharmacies providing pediatric immunization services significantly differed from non-providers. That is, the majority of providers practiced within a grocery or retail store; they were younger and practiced in a pharmacy with higher average daily prescription volume and a higher average pharmacy practice full-time equivalent; and they perceived lower implementation logistics barriers and a lower role of pharmacists regarding pediatric immunization. Multivariable logistic regression analysis indicated that implementation logistics is significantly associated with pharmacies offering pediatric immunization services after controlling for pharmacy/participant characteristics (p = 0.01). Therefore, ameliorating implementation logistics barriers should be considered when devising strategies to promote pediatric immunization services in community pharmacies.

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.

A Baker's Dozen of Top Antimicrobial Stewardship Intervention Publications in 2022.

Keeping abreast of the antimicrobial stewardship-related articles published each year is challenging. The Southeastern Research Group Endeavor identified antimicrobial stewardship-related, peer-reviewed literature that detailed an actionable intervention during 2022. The top 13 publications were selected using a modified Delphi technique. These manuscripts were reviewed to highlight actionable interventions used by antimicrobial stewardship programs to capture potentially effective strategies for local implementation.

Knowledge of Kratom among Alabama Pharmacists.

Kratom (Mitragyna speciosa) is a botanical substance whose leaves produce stimulant- and opioid-like effects. Kratom use has increased precipitously in the United States (U.S.) over the last decade, yet, in our experience, many pharmacists are unfamiliar with this herb. The purpose of this study was to assess pharmacists' awareness and knowledge of kratom. This cross-sectional study used an online questionnaire to preferentially solicit community pharmacists' knowledge of kratom and collect demographic information. The survey was sent via email to approximately 10,000 pharmacists, targeting those in the state of Alabama, U.S. Data were analyzed using descriptive statistics, and the Chi Square test was used to compare nominal data. A total of 257 participants responded to the survey. Almost 50% of participants had heard of kratom, and 50% had not. Compared to females, males were more likely to have heard of kratom (64% vs. 42%; p = 0.0015), as were pharmacists who worked for an independent pharmacy vs. a chain (61% vs. 41%; p = 0.025). Of the participants who had heard of kratom, only 14% considered themselves knowledgeable or very knowledgeable about the herb, and only 44% knew it was illegal in Alabama. These data indicate a need to further kratom education among community pharmacists in Alabama.

Which "weigh" to Go? Alternative Vancomycin Dosing Strategies in Obese Patients.

PurposeThis study aims to compare the performance of alternative weight-based vancomycin dosing strategies to traditional dosing in obese patients using area under the curve (AUC) monitoring. Methods: This retrospective study compared target attainment of an AUC between 400-600mcg*H/mL using alternative vancomycin dosing strategies. All patients received allometrically dosed vancomycin, with patient-specific AUCs calculated using 2 post-infusion steady-state vancomycin serum concentrations using the trapezoidal rule. Predicted AUCs were calculated using the following: 15 mg/kg total body weight (TBW), 15 mg/kg corrected body weight (CBW), and 12.5 mg/kg TBW. Predicted AUCs from the traditional 15 mg/kg TBW dosing were then compared to alternative dosing strategies using the predicted AUCs from 12.5 mg/kg TBW, 15 mg/kg CBW, and the actual AUCs calculated using allometrically scaled vancomycin dosing. The primary outcome was attainment of initial AUC within the target range of 400-600mcg*H/mL for each dosing method. Results: Eighty-four patients were included. When AUCs were compared to traditional 15 mg/kg dosing strategy, the CBW, 12.5 mg/kg, and allometric dosing strategies were significantly more likely to result in initial attainment of an AUC within a target range of 400-600 mcg*H/mL (P = 0.0003, 0.0135, and 0.0088, respectively). No significant differences were seen between each of the alternative dosing methods (P = 0.73). Conclusion: The 3 alternative vancomycin dosing strategies examined were all significantly more likely to achieve an initial AUC within the target range compared to traditional vancomycin dosing in obese patients. Clinicians should strongly consider one of these alternative dosing strategies for obese patients as opposed to traditional vancomycin dosing.

Personalizing prevention: Advances in pharmacotherapy for HIV prevention.

The HIV epidemic continues to pose a significant burden on the healthcare system. Although the incidence of annual new infections is decreasing, health disparities persist and most new infections remain concentrated into different racial, ethnic, and minority groups. Pre-exposure prophylaxis (PrEP), which involves those at high risk of acquiring HIV to take chronic medications to prevent acquisition of the virus, is key to preventing new HIV infections. The purpose of this article is to review medication therapies for PrEP and examine their role in personalizing PrEP in different patient populations. Additionally, new medications currently under development for PrEP are reviewed, as well as treatment as prevention (TasP) and post-exposure prophylaxis (PEP). There are currently four medications available for PrEP: the oral options of co-formulated emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or emtricitabine/tenofovir alafenamide (FTC/TAF); injectable long-acting cabotegravir (CAB-LA); and the vaginal ring dapivirine (DPV-VR). FTC/TAF is not currently indicated for persons at risk for HIV through vaginal sex due to lack of studies, but trials are currently ongoing. DPV-VR is available in Zimbabwe and South Africa and has been endorsed by the World Health Organization but is not currently available in the United States. Several agents are also in development for use in PrEP: the novel long-acting injectable lenacapavir, a first-in-class capsid inhibitor, which has no cross-resistance to any existing HIV drug class; the subdermal implant islatravir, a first-in-class translocation inhibitor; and VRC01, a broadly neutralizing antibody (bnAb) which has been evaluated in proof-of-concept studies that may lead to the development of more potent bnAbs. Overall, PrEP is highly effective at preventing HIV infection in high-risk populations. Identifying optimal PrEP regimens in different patient populations is complex and must consider patient-specific factors and medication cost and access considerations. Lastly, providers should consider individual patient preferences with regard to prevention to improve access, retention in care, and adherence.

Burkholderia cepacia septicemia in a pediatric oncology patient: a pharmacotherapy challenge.

OBJECTIVE: To discuss pharmacotherapy challenges encountered during treatment of a pediatric oncology patient with Burkholderia cepacia septicemia. CASE SUMMARY: An 11-year-old male with a history of aplastic anemia presented to the emergency department with a 1-day history of cough and purulent nasal discharge 6 months after undergoing bone marrow transplant. Blood cultures obtained from the patient's Broviac catheter revealed gram-negative rods. Piperacillin/tazobactam and tobramycin were administered, but the patient worsened clinically, with fever and chills. B. cepacia was identified as the offending pathogen, and the therapy was changed to meropenem and ciprofloxacin, as piperacillin/ tazobactam and tobramycin are ineffective against Burkholderia spp. Intravenous trimethoprim/sulfamethoxazole, the drug of choice for Burkholderia spp. infections, was unavailable as it had been placed on national manufacturer backorder. The patient improved initially, but he later experienced recurrence of fever, and blood culture results were positive for Burkholderia spp. Infection was eradicated after removal of the central line and administration of ceftazidime and oral minocycline. DISCUSSION: Literature reveals few cases of B. cepacia in pediatric oncology patients, and to our knowledge, no cases have been reported in bone marrow transplant patients in the US. Burkholderia spp. is highly resistant to many antibiotics, and commonly used agents for the empiric treatment of febrile neutropenia are not active against this organism. This indicates that most oncology patients who present with this infection would not receive appropriate initial treatment. In addition, antibiotic therapy may need to be modified, based on drug availability. CONCLUSIONS: B. cepacia is an emerging multidrug-resistant pathogen that can produce severe infection in immunocompromised patients. It is pertinent to consider this organism in oncology patients who do not improve with standard therapy, as prompt use of correct pharmacotherapy is necessary to avoid serious morbidity as well as mortality in this population.

The Role of Bezlotoxumab for the Prevention of Recurrent Clostridioides difficile Infections: A Review of the Current Literature and Paradigm Shift after 2021.

Clostridioides difficile infections (CDIs), and particularly recurrent infections, cause a significant burden on the health-care system. Bezlotoxumab is a new agent for the prevention of recurrent CDIs that has shown strong efficacy and high tolerability in clinical trials. The purpose of this review is to evaluate the published literature for bezlotoxumab, with a focus on literature published since the release of the 2021 focused update to the CDI treatment guidelines. A Medline/PubMed search for "bezlotoxumab" was conducted, resulting in 152 articles. Seventeen studies are included in this review, after excluding non-English-language papers, phase I and II trials, and review articles. Studies published since the 2021 focused update support the recommendations in those guidelines. Furthermore, real-world studies have shown similar results to larger clinical trials. Those with more risk factors for recurrent CDI appear to benefit most from bezlotoxumab. Currently, there are no data to support the use of bezlotoxumab outside current guideline recommendations, but future trials may build on the data seen in real-world studies to further elucidate the place in therapy for bezlotoxumab.