Federal Drug Administration Approval Research Articles

Third-Line Therapeutic Interventions for Non-Neurogenic Bladder Dysfunction in Children.

The aim of this article is to review considerations and efficacy of third-line treatments for pediatric non-neurogenic bladder dysfunction, including Botulinum toxin A (BoTNA), Posterior Tibial Nerve Stimulation (PTNS), and Sacral Neuromodulation (SNM). Federal Drug Administration approval for use of beta-3-agonists in overactive detrusor activity in pediatric patients may provide an additional step prior to third-line therapies. New long-term data on pediatric SNM efficacy, complications, and revision rates will provide valuable information for counseling families. BoTNA offers a safe and efficacious treatment to decrease detrusor contractility and improve bladder capacity but is limited by the half-life of BoNTA agent. Percutaneous or transcutaneous PTNS offers improved voided volumes or cure in some patients but is time-intensive. SNM can be utilized in a variety of LUTD pathology with high success rate and cure but should consider cumulative anesthetic and fluoroscopic exposures for battery replacements and re-positioning for patient growth.

Identification of Barriers Preventing Biosimiliar Oncology Medication Adoption.

(1) Background: A biosimilar is a biologic medical product that has been approved by the United States Food and Federal Drug Administration (FDA) and is an almost identical copy of an original biologic product yet manufactured by a different company. Biosimilars are often assumed to be the same as generic medications, while often made from living organisms. Through clinical trials, biosimilars have been shown to be both as safe and as effective as their originator products. Biosimilars have also proven they can reduce the costs to both insurance companies and patients in many circumstances. However, despite their cost savings, biosimilar manufacturers continue to face barriers in having oncologists and cancer centers prescribe them for their patients. This review aims to identify barriers associated with medical provider prescriptive behaviors related to biosimilars for patients. (2) Methods: Reviewers analyzed 27 articles and identified common themes. (3) Results: After a thorough literature review, the researchers identified seven barriers to prescribing of biosimilars: physician comfort in originators instead of biosimilars, patient reluctance to switch from a current biologic to a biosimilar, provider profits associated with an originator biologic, lack of stakeholder education on biosimilars, lack of provider team knowledge of biosimilars, lack of knowledge surrounding the biosimilar FDA approval process, and hesitancy to stock multiple drugs for a specific indication. (4) Conclusions: This review's findings of identified barriers to use of biosimilars provides insight for healthcare providers and organizations surrounding prescribing practices and potential treatment benefits for cancer patients who may benefit from biosimilar treatment medications.

Adoption of newly FDA-approved targeted immunomodulatory therapies by dermatologists: a cross-sectional analysis of Medicare Part D claims from 2013 to 2018.

Although targeted immunomodulatory medications are increasingly utilized for inflammatory skin conditions like plaque psoriasis, little is known of the trends in the adoption of newly Federal Drug Administration (FDA)-approved immunomodulators by dermatologists. We performed a retrospective, cross-sectional analysis of Medicare Part D Prescriber datasets to identify dermatologists filing Medicare prescription claims for immunomodulatory drugs FDA-approved for plaque psoriasis between 2013 and 2018. Differences in dermatologist characteristics were determined between dermatologists prescribing a psoriasis treatment within two years of its FDA approval, "early adopters" and non-prescriber dermatologists over the same time period. Biologics approved for psoriasis from 2013 to 2018 included certolizumab pegol, secukinumab, brodalumab, ixekizumab, guselkumab, and apremilast. Early adopter dermatologists (n = 783) accounted for 5% of all Medicare Part D prescribing dermatologists. Early adopters were more likely to be male, in practice longer, and had a greater number of average annual beneficiaries than dermatologists who did not. Only six (< 1%) early adopters practiced in a small town or rural areas. We believe these data show that the adoption of novel biologic treatments for psoriasis by dermatologists to Medicare beneficiaries may be associated with clinician experience and practice volume. Additionally, we identified low absolute numbers of dermatologists prescribing biologics overall in non-metropolitan areas, which may represent delayed access to novel psoriasis treatments for many Medicare beneficiaries.

What is in the Neuromuscular Junction Literature?

This update covers a number of treatment topics starting with Fc receptor inhibitors and the Federal Drug Administration approval of efgartigimod. Some uncertainties regarding the use of corticosteroids are addressed, namely the risk of exacerbation with initiation of treatment and how to taper. The presence and potential importance of antibody overshoot following plasmapheresis is noted and the evolving increase in usefulness of acetylcholine receptor antibodies in diagnosing ocular myasthenia. Several recent series and case reports regarding coronavirus 2019 and myasthenia gravis are reviewed. The topics of myasthenia gravis and pregnancy, and another look at thymectomy in MG are provided. Finally, a couple of case reports on Lambert-Eaton myasthenic syndrome concentrate on the ice pack test and an autoantibody association with paraneoplastic cerebellar degeneration and Lambert-Eaton myasthenic syndrome in the same patient.

Perspectives about COVID-19 vaccination among the paralysis community in the United States.

We sought to explore perspectives among the paralysis community and caregivers or persons with paralysis (PWP) about the COVID-19 vaccination. Research Method/Design: Data were collected via online survey with multiple choice and open-ended questions from adult PWP and family members and/or caregivers (FC) of PWP. Multiple choice questions were analyzed using descriptive statistics and chi-square analyses were conducted to compare the two groups (PWP and FC); open-ended responses were coded using Hamilton's rapid assessment process. A total of 1,017 respondents (831 PWP, 186 FC). PWP shared the same levels of COVID-19 vaccination hesitancy and received similar levels of information about the vaccine as the general population. Unique concerns about the COVID-19 vaccine expressed solely by PWP included fear of death after the vaccine, concerns about vaccine efficacy, and concerns about Federal Drug Administration approval. At the time, the majority of PWP plan to seek a COVID-19 vaccination and were vaccinated at a higher rate than was the general population. Although PWP share many similar concerns to the general population, there are some concerns unique to PWP that must be noted to ensure that the paralysis community is considered fully and equitably in public health efforts related to the COVID-19 pandemic and beyond. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Pepaxto: A New Peptide-Drug Conjugate for Heavily Pretreated Relapsed and Refractory Multiple Myeloma.

The objective of this article was to review existing data of melflufen (Pepaxto) as an additional treatment option for heavily pretreated relapsed and refractory multiple myeloma. A PubMed search was completed using the search terms melphalan flufenamide; melflufen; melflufen AND relapsed refractory multiple myeloma; melphalan flufenamide and relapsed refractory multiple myeloma between January 1, 2013, and October 18, 2021. Additional information was obtained from the National Institutes of Health Clinical Trial Registry, Federal Drug Administration (FDA) web updates, and Pepaxto prescribing information. Clinical trials including melflufen in relapsed refractory multiple myeloma and trials related to safety and clinical pharmacology were included. The findings of this review show melflufen in combination with dexamethasone can be used as a treatment option for patients with relapsed and refractory multiple myeloma who have previously received greater than 4 previous lines of therapy, and documented resistance to a proteosome inhibitor, an anti-CD38 monoclonal antibody, and an immunomodulator. Melflufen in combination with dexamethasone is a reasonable option for patients with relapsed and refractory multiple myeloma who have received at least 4 previous lines of therapy and considered ineligible for autologous stem cell transplant. Further clinical utilization in earlier lines of therapy is under review, pending the in-depth safety analysis by the FDA. The FDA approval of melflufen in combination with dexamethasone provides an additional therapy option for patients with heavily pretreated relapsed and refractory multiple myeloma.

Personalized Cancer Medicine in the Media: Sensationalism or Realistic Reporting?

Background: Given that media coverage can shape healthcare expectations, it is essential that we understand how the media frames “personalized medicine” (PM) in oncology, and whether information about unproven technologies is widely disseminated. Methods: We conducted a content analysis of 396 news reports related to cancer and PM published between 1 January 1998 and 31 December 2011. Two coders independently coded all the reports using a pre-defined framework. Determination of coverage of “standard” and “non-standard” therapies and tests was made by comparing the media print/broadcast date to the date of Federal Drug Administration approval or incorporation into clinical guidelines. Results: Although the term “personalized medicine” appeared in all reports, it was clearly defined only 27% of the time. Stories more frequently reported PM benefits than challenges (96% vs. 48%, p < 0.001). Commonly reported benefits included improved treatment (89%), prediction of side effects (30%), disease risk prediction (33%), and lower cost (19%). Commonly reported challenges included high cost (28%), potential for discrimination (29%), and concerns over privacy and regulation (21%). Coverage of inherited DNA testing was more common than coverage of tumor testing (79% vs. 25%, p < 0.001). Media reports of standard tests and treatments were common; however, 8% included information about non-standard technologies, such as experimental medications and gene therapy. Conclusion: Confusion about personalized cancer medicine may be exacerbated by media reports that fail to clearly define the term. While most media stories reported on standard tests and treatments, an emphasis on the benefits of PM may lead to unrealistic expectations for cancer genomic care.

Use of gonadotropin-releasing hormone analogs in children.

In this review, we outline the usage and formulations of gonadotropin-releasing hormone analogs (GnRHas) in central precocious puberty (CPP), short stature, and gender diverse individuals, as well as adverse effects, long-term outcomes, and monitoring of therapy. There is a particular focus on citing references published within the last 24 months. Long-acting formulations of GnRHa now include Federal Drug Administration approval for subcutaneous injections. Significant adverse events continue to be rarely reported; extremely rare events include arterial hypertension and pseudotumor cerebri. There continue to be no significant long-term consequences including the impact upon body mass index and bone mineral density, which appear to be transient. GnRHas have been used in differences of sexual development (DSD) and increasingly in the treatment of adolescent transgender individuals. GnRHas remain as the only fully efficacious therapy for CPP and effectively suppress pubertal hormones in other situations. The use of GnRHa therapy in gender incongruent individuals has proven beneficial and has become a standard of care, whereas use in those with DSDs should still be considered experimental. http://links.lww.com/MOP/A62.

The initial management of multiple myeloma in the era of novel agents: 2021 and beyond.

The initial management of multiple myeloma in the era of novel agents: 2021 and beyond.

Pleural Drainage Strategy After IPC Placement: A Focused Clinical Review.

The first indwelling pleural catheter (IPC) received Federal Drug Administration approval in 1997, nearly 40 years after John Chambers first described instillation of talc into the pleural space for palliation of malignant pleural effusions. Since then IPCs have revolutionized the management of malignant pleural effusions, providing an effective means of controlling dyspnea in the end stages of life without the pain and prolonged hospital stays long associated with chemical sclerosing agents. While palliation of symptoms is the primary purpose of IPCs, development of pleurodesis in the outpatient setting is often an important secondary goal. Historically, decisions regarding IPC drainage frequency have been largely arbitrary and only recently has the evidence started to emerge regarding the effects of specific drainage strategies on both symptom control and pleurodesis development. This focused clinical review explores the current literature regarding IPC drainage strategies as well as novel methods designed to improve the efficacy of IPCs in a thorough and systematic manner. In addition, this review provides an in-depth analysis and synthesis of the data focusing on key considerations needed to develop patient-centered and cost-effective strategies for the use of IPCs in malignancy.

Eptinezumab: A calcitonin gene-related peptide monoclonal antibody infusion for migraine prevention.

This article seeks to analyze the clinical trials concerning the newly approved eptinezumab to assess its efficacy, safety, and application to current clinical practice. The Institute of Health US National Library of Medicine Clinical Trials, PubMed, and Cochrane Library databases were searched for relevant abstracts, journal articles, and other published sources. Search terms included eptinezumab, Vyepti®, and ALD403. Relevant English-language articles were evaluated and included in the narrative. Two randomized controlled trials compared quarterly infusions of eptinezumab 100 mg, eptinezumab 300 mg, and placebo in chronic and episodic migraine sufferers. In episodic migraine, eptinezumab resulted in a reduction of approximately 4 monthly migraine days, which was significant compared to placebo. In chronic migraine, eptinezumab reduced monthly migraine days by approximately 8 days, also significant compared to placebo. More patients who received eptinezumab experienced at least 75% reduction in monthly migraine days compared to placebo, resulting in a number needed to treat as low as 6, depending on the study population and the dose. The preventive impact was noticed day one post-infusion. The most common treatment-emergent adverse events were nausea and fatigue, and there was a low incidence of hypersensitivity or study withdrawal. Eptinezumab is the fourth Calcitonin Gene-related Peptide monoclonal antibody to receive Federal Drug Administration approval. Its delivery as a quarterly infusion sets it apart from the other agents in this class. As an infusion, eptinezumab has a quick onset of action that may prove especially beneficial to those with severe or refractory episodic or chronic migraines, despite the perceived increased direct and indirect cost of an infusion.

The adoption of immune checkpoint inhibitors and patterns of care at the end of life.

12027 Background: As immune checkpoint inhibitors (ICIs) have transformed the care of patients with cancer, it is unclear whether treatment at end of life (EOL) has changed. Because aggressive therapy at EOL is associated with increased costs and patient distress, we explored the association between the FDA approvals of ICIs and treatment patterns at EOL. Methods: We conducted a retrospective, observational study using patient-level data from the Flatiron health EHR-derived de-identified database. Patients had advanced melanoma, non-small cell lung cancer (NSCLC) (cancer types with an ICI indication) or microsatellite stable (MSS) colon cancer (a cancer type without an ICI indication) and died between 2013 and 2017. We calculated annual proportions of decedents who received systemic cancer therapy in the final 30 days of life and used logistic regression to model the association between the post-ICI Federal Drug Administration (FDA) approval time period and use of systemic therapy at EOL, adjusting for patient characteristics. We also assessed the use of chemotherapy or targeted/biologic therapies at EOL, before and after FDA approval of ICIs using Pearson Chi Square test. Results: There was an increase in use of EOL systemic cancer therapy in the post-ICI approval period for both melanoma (33.9% to 43.2%, p-value &lt; 0.001) and NSCLC (37.4% to 40.3%, p-value &lt; 0.001). In contrast, the control group of decedents with MSS colon cancer demonstrated no significant increase in use of systemic therapy at EOL. After controlling for patient characteristics, there was a significantly higher odds of receiving systemic treatment at EOL in the post-ICI time period compared to the pre-ICI time period in melanoma (OR 1.42, 95% CI 1.09-1.86, p-value &lt; 0.001) and NSCLC (OR 1.13, 95% CI 1.06-1.20, p value &lt; 0.001), with no significant difference in receipt of systemic therapy in patients with MSS colon cancer. After FDA approval of ICIs, patients with NSCLC and melanoma had a decrease in the use of chemotherapy, with a concomitant increase in use of ICIs at EOL. Decedents with MSS colon cancer did not have a statistically significant change in use of chemotherapy or targeted/biologic therapies during the study period. Conclusions: The adoption of ICIs was associated with a substantive increase in the use of systemic therapy at EOL in melanoma, and a smaller yet significant increase in NSCLC.

Early Real-World Experience with EndoAnchors by Indication

The Heli-FX EndoAnchor (EA) system is a transmural aortic fixation device with Federal Drug Administration (FDA) approval for treatment of endoleaks, endograft migration, or high-risk seal zones. Published data are primarily from industry-sponsored registries highlighting safety and efficacy. Our objective is to evaluate real-world outcomes of EA usage after FDA approval across a variety of stent grafts and indications at a single institution. We retrospectively reviewed our prospectively maintained aneurysm database for patients undergoing endovascular aortic repair (EVAR) with Heli-FX EAs. Technical success was defined as successful EA deployment, while procedural success was defined as absence of endoleak on completion aortogram. Cohorts were divided by indication and outcomes assessed via review of clinical and radiographic data. From 2016 to 2018, 37 patients underwent EA fixation. We divided the cohort by indication: Group A (prior EVAR with endoleak), B (intraoperative type 1A endoleak), C (high-risk seal zone), and D (thoracic EVAR). In Group A (n=11), all endoleaks were type 1A and a mean of 10 EAs were deployed with 100% technical and 45.4% procedural success. Two perioperative reinterventions were performed (translumbar coil embolization and proximal graft extension with bilateral renal artery stents). At a mean 10.6months of follow-up, 45.4% of patients had persistent endoleaks, with 100% aortic-related survival. In Group B (n=10), a mean of 8.7 EAs were used with 100% technical and procedural success. One immediate adverse event occurred (right iliac dissection from wire manipulation, treated with a covered stent). At 13.6-month mean follow-up, there was significant sac regression (mean 9.75mm) with no type 1A endoleaks. In Group C (n=10), a mean of 9.5 EAs were deployed with 100% technical and procedural success. At 11.2-month mean follow-up, there were no residual endoleaks and significant sac regression (mean 3.4mm). Overall survival was 100%. In Group D (n=6), a mean of 8.3 EAs were used with 83.3% technical and 66.6% procedural success. One immediate adverse event occurred, in which an EA embolized to the left renal artery. At 9.4-month mean follow-up, overall survival was 83.3% with a mean 2.2-mm increase in sac diameter. Early experience suggests that EAs effectively treat intraoperative type 1A endoleaks and high-risk seal zones, with significant sac regression and no proximal endoleaks on follow-up. In patients treated for prior EVAR with postoperative type 1A endoleaks, fewer than half resolved after EA attempted repair. Further experience and longer term follow-up will be necessary to determine which patients most benefit from postoperative EA fixation.

Beyond the Present Constraints That Prevent a Wide Spread of Tissue Engineering and Regenerative Medicine Approaches.

Despite the success of tissue engineered medical products (TEMPs) in preclinical translational research, very few have had success in the clinical market place. This gap, referred to as the “valley of death” is due to the large number of ventures that failed to attract or retain investor funding, promotion, and clinical acceptance of their products. This loss can be attributed to a focus on a bench to bedside flow of ideas and technology, which does not account for the multitude of adoption, commercial, and regulatory constraints. The implementation of an alternative bedside to bench and back again approach permits investigators to focus on a specific unmet clinical need, defining crucial translation related questions early in the research process. Investigators often fail to accurately identify critical clinical adoption criteria due to their focus on improved patient outcomes. Other adoption criteria (such as price, time, ethical concerns, and place in the workflow) can cause a product to fail despite improved patient outcomes. By applying simplified business principles such as the build-measure-learn loop and the business model canvas to early-stage research projects, investigators can narrow in on appropriate research topics and define design constraints. Additionally, 86% of all clinical trials fail to result in Federal Drug Administration approval, resulting in significant economic burdens. On the reverse side, approval through the European Medical Agency is widely considered to be more direct but has its challenges. The Committee for Advanced Therapies within the European Medical Agency has received 22 market authorization applications for advanced therapy medicinal products, of which only 10 received authorization. A thorough understanding of the various regulatory pathways permits investigators to plan for future regulatory obstacles and potentially increase their chances of success. By utilizing a bedside to bench and back again approach, investigators can improve the odds that their research will have a meaningful clinical impact.

Essential Pharmacotherapies for Bipolar Disorder

The evidence basis for treatment of bipolar disorder, both for adults and children, is fairly varied and while Federal Drug Administration (FDA) approval provides one marker of evidence, many psychotropic medications are used for off-label indications. Primary care providers are increasingly at the forefront of initiating treatment for patients with mental health disorders. The purpose of this review is to discuss the current state of evidence for medications treating bipolar disorder, highlighting the evidence, exploring contraindications, side effects, and monitoring requirements for each of the major agents available. Currently, there are three major classes of medication to treat bipolar disorder: lithium, anti-seizure drugs, and a growing range of second-generation antipsychotics. The guiding principle in initiation of treatment is to target treatment to the primary phase of illness while balancing side effect profiles with patient characteristics and comorbidities. While FDA approval of medications for the treatment of bipolar disorder is somewhat limited for both children and adults, in practice, a wider range of medications have shown to be useful. Increasing second-generation antipsychotic medications can be used as first-line agents for both bipolar mania and bipolar depression.

Advances in immunotherapy for melanoma.

In recent years, the introduction and Federal Drug Administration approval of immune checkpoint inhibitor antibodies has dramatically improved the clinical outcomes for patients with advanced melanoma. These antagonist monoclonal antibodies are capable of unleashing dormant or exhausted antitumor immunity, which has led to durable complete and partial responses in a large number of patients. Ipilimumab targets the cytotoxic T lymphocyte-associated protein 4 (CTLA-4) receptor. Nivolumab and pembrolizumab target programmed cell death protein 1 (PD-1) receptors and have proven to be superior to ipilimumab alone. The combination of ipilimumab and nivolumab has yielded higher response rates, greater tumor shrinkage, and longer progression-free survival than either monotherapy alone. As other promising immunotherapies for melanoma proceed through clinical trials, future goals include defining the role of immune checkpoint inhibitors as adjuvant therapy, identifying optimal combination strategies, and developing reliable predictive biomarkers to guide treatment selection for individual patients.

General Approach to the Care of the Child With Pulmonary Hypertension

Pulmonary hypertension (PH) is a complex pulmonary vascular disease of multiple etiologies, characterized by inappropriate elevation of pulmonary vascular pressure and resistance that can present at any age, including during childhood. The pharmacologic care of patients with PH has seen tremendous advances in the past 20 years, improving survival and overall quality of life for patients of all ages, although mortality remains high.1 While the care of children with PH involves the same PH-specific medicines used for adults, PH-specific drugs are employed off-label due to a lack of Federal Drug Administration approval, which adds to the complexity of administration.2 Furthermore, in addition to pharmacologic therapy, multiple other factors are involved in the care of the pediatric PH patient that require careful consideration, such as differences relating to growth and developmental stages and according to PH etiology. This review will discuss some of the highly relevant pediatric-related issues outside of traditional pharmacologic factors, with a focus on the importance of a collaborative approach to care, genetic testing, and palliative care.

Obstacles to Studying Emerging Technologies.

Laparoscopic radiofrequency ablation of uterine leiomyomas with a new Federal Drug Administration (FDA)-approved device, a device that delivers radiofrequency energy, is a novel procedure that aims to meet patient and physician demand for effective, minimally invasive leiomyoma treatment. However, as a new procedure, the durability of symptom relief, the safety in widespread use, and ultimately the comparative effectiveness of radiofrequency ablation of leiomyomas need further study. In June 2013, the University of California Fibroid Network, a collaboration of the five University of California Departments of Obstetrics and Gynecology, launched the Uterine Leiomyoma Treatment with Radiofrequency Ablation Study, an investigator-initiated early postmarket approval clinical trial of radiofrequency ablation of leiomyomas. In this commentary, we provide a review of the FDA approval process for medical devices using the device that delivers radiofrequency energy as a case study and describe significant limitations of this process that may adversely affect clinical care. We show how the deficiencies in the FDA process have challenged our ability to conduct independent early postmarket research evaluating the safety and long-term effectiveness of this novel technology. Our experience validates the Institute of Medicine's recommendation that advancements in surgical technology introducing new treatments without long-term effectiveness data, comparative study, or both should emerge onto the market under research conditions. Until the FDA requires more rigorous study of novel devices, we suggest ways of working together as a community of gynecologic surgeons to evaluate promising new technologies in early postmarket studies, putting research before widespread adoption of surgical innovation.

Osteoinduction of Umbilical Cord and Palate Periosteum–Derived Mesenchymal Stem Cells on Poly(Lactic-Co-Glycolic) Acid Nanomicrofibers

The need for tissue-engineered bone to treat complex craniofacial bone defects secondary to congenital anomalies, trauma, and cancer extirpation is sizeable. Traditional strategies for treatment have focused on autologous bone in younger patients and bone substitutes in older patients. However, the capacity for merging new technologies, including the creation of nanofiber and microfiber scaffolds with advances in natal sources of stem cells, is crucial to improving our treatment options. The advantages of using smaller diameter fibers for scaffolding are 2-fold: the similar fiber diameters mimic the in vivo extracellular matrix construct and smaller fibers also provide a dramatically increased surface area for cell-scaffold interactions. In this study, we compare the capacity for a polymer with Federal Drug Administration approval for use in humans, poly(lactic-co-glycolic) acid (PLGA) from Delta polymer, to support osteoinduction of mesenchymal stem cells (MSCs) harvested from the umbilical cord (UC) and palate periosteum (PP). Proliferation of both UC- and PP-derived MSCs was improved on PLGA scaffolds. The PLGA scaffolds promoted UC MSC differentiation (indicated by earlier gene expression and higher calcium deposition), but not in PP-derived MSCs. Umbilical cord-derived MSCs on the PLGA nanomicrofiber scaffolds have potential clinical utility in providing solutions for craniofacial bone defects, with the added benefit of earlier availability.

Are we PREPared? Quality of information available to patients in the UK about PREP on the internet

Professional bodies in the UK (BASHH/BHIVA) do not currently recommended pre‐exposure prophylaxis (PREP) to prevent HIV aquisition for men who have sex with men (MSM) [1]. Conversely, although Federal Drug Administration approval is awaited, the Centers for Disease Control (CDC) have issued clinicians in the USA with interim guidance to facilitate PREP prescriptions [2]. Increasingly patients search the internet for information on HIV treatment, but disparate international policy can lead to confusing patient messages. This study was conducted to systematically assess the quality of internet information available to patients in the UK about PREP. More than 90% of internet searches in the UK are performed using ‘Google.co.uk’ and ‘Bing’ [3]. Using pre‐specified criteria, we reviewed the first 100 hits retrieved from each search engine when the following searches were performed: [“HIV pre‐exposure prophylaxis”]; [“HIV PREP”]; [“HIV PREP guidelines”]; [“HIV PREP guidelines UK”]; [“truvada prophylaxis HIV”]. Of 172 unique websites identified, 124 websites were active at the time of the review (July 2012). 33 websites were links to academic journals including commentaries and clinical trials, not intended to specifically provide patient information; 5 were internet portals directing users to alternative sites and 10 websites contained no information about PREP. Of the remaining 76 websites, 28 were written by medical professionals and 48 were written by journalists, where 7/48 (15%) were individual blogs. 64/76 (84%) contained a definition of PREP; 63/76 (83%) discussed the rationale and 58/76 (76%) reported efficacy data. Advantages and disadvantages of PREP were presented in 56/76 (74%) and 41/76 (54%) of websites respectively. Only 21/76 (28%) of sites referenced existing national guidelines (CDC/BASHH). A minority of sites described the current clinical practice in the UK (7/76, 9%) with an even smaller number presenting the contrast in clinical stance between the CDC and BASHH/BHIVA (3/76, 4%). The use of PREP is evolving, and the internet is an important patient resource. However, current clinical practice in the UK is seldom described in accessible websites. Avoiding ad hoc and unsupervised use of PREP is crucial to prevent future drug resistance and risky sexual behaviour. More should be done to engage at‐risk groups and ensure patients in the UK have access to comprehensive information including the current UK PREP professional guidance.