Lenacapavir: A first-in-class capsid inhibitor for the treatment of highly treatment-resistant HIV.

PURPOSE: The purpose of this article is to review the pharmacology, efficacy, and safety of the capsid inhibitor lenacapavir for the treatment of multidrug-resistant human immunodeficiency virus type 1 (HIV-1) infection. SUMMARY: A review of the literature was performed by searching PubMed/MEDLINE for all relevant articles published between February 2021 and March 2023 using the keywords "lenacapavir," "Sunlenca," "human immunodeficiency virus," and "treatment" together with "multidrug resistant human immunodeficiency virus." All English-language articles describing clinical trials assessing the efficacy and safety of lenacapavir when used in humans for the treatment of HIV infection were included. Review articles, conference abstracts, and article references were evaluated for relevant information, and data were also obtained from the manufacturer's website and the package insert. Lenacapavir has been approved by the Food and Drug Administration (FDA) for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistance for whom the current antiretroviral regimen is failing due to resistance, intolerance, or safety considerations. It is the first in a new class of drugs called capsid inhibitors to receive FDA approval. Lenacapavir is a long-acting subcutaneous injectable to be administered once every 6 months. The phase 3 clinical trial evaluating lenacapavir has demonstrated its efficacy in viral load reduction from baseline compared to placebo in patients receiving optimized background therapy. The most common adverse events reported in the clinical trial were injection site reactions, occurring in 63% of participants. CONCLUSION: Lenacapavir is a novel capsid inhibitor indicated, in combination with other antiretroviral therapy, for treatment of multidrug-resistant HIV-1 infection.

Cabotegravir: The first long-acting injectable for HIV pre-exposure prophylaxis.

PURPOSE: The purpose of this article is to review the pharmacology, efficacy, and safety of the integrase inhibitor cabotegravir for HIV pre-exposure prophylaxis, including data from clinical trials. SUMMARY: A narrative review was performed by searching PubMed/MEDLINE databases to identify relevant articles published between March 2014 and December 2021 using the keyword terms cabotegravir and Apretude and the search strings "long-acting injectable AND human immunodeficiency virus" and "pre-exposure prophylaxis AND human immunodeficiency virus." All relevant English-language articles evaluating the pharmacology, efficacy, or safety of cabotegravir in humans for HIV pre-exposure prophylaxis were included. Additional data were obtained from prescribing information, references of identified articles, and abstracts from scientific meetings. Cabotegravir has been approved by the Food and Drug Administration and is considered both safe and effective for HIV pre-exposure prophylaxis. It is the first long-acting injectable medication approved for this indication. Phase 3 clinical trials have demonstrated the noninferiority of cabotegravir to currently recommended oral once-daily dosing regimens. Injection-site reactions were common in clinical trials of cabotegravir and occurred in up to 81% of trial participants. Costs associated with the long-acting injectable formulation must also be considered. CONCLUSION: Cabotegravir is a novel bimonthly, injectable option for pre-exposure HIV prophylaxis for high-risk adolescents and adults weighing at least 35 kg.

Evaluation of Provider Implementation of the 2019 American College of Cardiology and American Heart Association Aspirin for Primary Prevention Guideline Recommendations for Older People.

Design Retrospective chart review study using electronic medical record data from Inova Health System patients. Setting All cardiology, endocrinology, and primary care outpatient clinics operated by Inova Medical Group (IMG) in Northern Virginia. Participants Participants included were 70 years of age or older and taking aspirin 81 mg as of April 1, 2019. They had completed at least one visit with an IMG provider in primary care, cardiology, or endocrinology clinics between April 1, 2019, and February 17, 2020. Main Outcome Measures The primary outcome of this study was percentage of older people seen by a primary care physician, cardiologist, or endocrinologist since guideline publication who were continued on aspirin for primary prevention. Results The percentage of participants continued on aspirin for primary prevention was 92% versus 8.0% who were discontinued (P < 0.0001). Differences in subgroup analyses based on smoking history, diagnosis of diabetes, or history of venous thromboembolism were not statistically significant. Conclusion There was a significantly greater rate of aspirin continuation versus discontinuation among patients 70 years of age and older in the setting of primary cardiovascular prevention. Based on this result, most primary care physicians, endocrinologists, and cardiologists at this institution have chosen to continue aspirin in older people following the 2019 American College of Cardiology/American Heart Association guideline statement publication.

Romosozumab: A first-in-class sclerostin inhibitor for osteoporosis.

PURPOSE: The purpose of this article is to review the pharmacology, efficacy, and safety of the sclerostin inhibitor romosozumab for the treatment of osteoporosis, including data from clinical trials of the drug. SUMMARY: A review of the literature was performed by searching PubMed and MEDLINE for all relevant articles published between January 2014 and February 2020 using the keywords romosozumab, romosozumab-aqqg, osteoporosis, and fracture. All relevant English-language articles evaluating the pharmacology, efficacy, or safety of romosozumab for the treatment of osteoporosis in humans were included; poster presentations were excluded. Romosozumab has been approved by the Food and Drug Administration and is considered both safe and effective for the treatment of osteoporosis in high-risk postmenopausal females. Phase 2 and phase 3 clinical trials have shown a statistically significant decrease in new vertebral fractures and an increase in bone mineral density with romosozumab use, as compared with both placebo use and use of alternative osteoporosis therapies. The primary safety concern is a potential risk of cardiovascular events; additionally, hypocalcemia must be corrected prior to initiation. Romosozumab is the first anabolic medication that both increases bone formation and decreases bone resorption. Data suggest that romosozumab is more effective than oral bisphosphonates in preventing osteoporotic fractures, though cost and safety concerns must be considered. CONCLUSION: Romosozumab is a novel, 12-month treatment option for postmenopausal women at high risk for osteoporotic fracture that both increases bone formation and decreases bone resorption.

A Diabetes Screening and Educational Event in Rural Alabama.

Type 2 diabetes mellitus is an increasingly urgent public health issue in the United States. Prevention through early detection and education can help decrease the prevalence and complications of the disease. A nursing faculty member and a postgraduate year one pharmacy resident collaborated to provide diabetes screening and education at a local festival in rural Alabama. The prevalence of diabetes in Alabama is approximately 1.6 times higher than the national average. A glycated hemoglobin (HbA1c) test is the gold standard for diabetes diagnosis and is relatively quick and inexpensive. At the event, 38 participants received point of care HbA1c testing, results, and counseling. Seven participants had an HbA1c level of 5.7% to 6.4%, which indicates prediabetes, and one participant had an HbA1c level of 6.5% or higher, which indicates possible diabetes mellitus. Many patients were surprised by their results and by the simplicity of the test. The purpose of this article is to describe a cost-effective interdisciplinary educational event to increase diabetes awareness in a rural community.