scholarly journals 103. Persistence on F/TDF for HIV Pre-exposure Prophylaxis: Insights from Real-world Evidence

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S181-S181
Author(s):  
Li Tao ◽  
Valentina Shvachko ◽  
Robertino Mera ◽  
Moupali Das ◽  
Christoph Carter ◽  
...  
Keyword(s):  
Renal Dysfunction ◽  
Real World ◽  
Bone Fracture ◽  
Clinical Characteristics ◽  
Hazard Ratios ◽  
Real World Evidence ◽  
Younger Age ◽  
History Of ◽  
Exposure Prophylaxis ◽  
Over Time

Abstract Background Background: Daily F/TDF is highly effective for HIV pre-exposure prophylaxis (PrEP). Prior studies have found that women and people of younger age have lower adherence and lower persistence on PrEP, yet real-world evidence describing persistence associated with other clinical characteristics and the patterns of persistence is limited. Methods Methods: We identified 313,526 HIV-1 negative individuals in the United States who initiated F/TDF for PrEP between January 1, 2012 and December 31, 2019 from a de-identified prescription claims database. PrEP users were defined as non-persistent if a gap in prescription fills >30 days was detected. We used survival analyses to estimate the persistence rate by year of PrEP initiation, and Cox regressions adjusting for multiple demographic and clinical characteristics to determine hazard ratios and corresponding 95% confidence interval of non-persistence for PrEP. Results Results: Among the 313,526 PrEP users with a median age at PrEP initiation of 35 years of age (interquartile range, IQR, 26−43), 88% were men (median days of persistence = 118, IQR 30−316 days) and 12% were women (median 30 days, IQR 30−92 days). PrEP persistence at 30, 60 and 90 days increased over time, reaching the highest levels in 2019 (Figure). In a multivariate analysis, younger age, female sex, and non-white race were associated with higher risk of non-persistence (Table). We also observed associations of a 5% lower rate of non-persistence if PrEP was prescribed by internal medicine or infectious disease physicians than by family medicine physicians, and a 13% lower rate of non-persistence associated prescriptions ordered from mail-order pharmacies than prescriptions of retail pharmacies. Finally, history of bone fracture or renal dysfunction prior to PrEP initiation were associated with a 13% and 9% higher rate of non-persistence, respectively. Figure. F/TDF for PrEP persistence rates over time. Table. Hazard ratios and corresponding 95% confidence intervals of non-persistence on F/TDF PrEP since initiation, 2012–2019 Conclusion This study demonstrates that persistence on F/TDF for PrEP has improved over time, and identifies several characteristics associated with non-persistence, including age, sex, race/ethnicity, prescriber specialty, type of pharmacy, and history of bone fracture or renal dysfunction. These findings can help to inform interventions aimed at improving PrEP persistence in people at risk of HIV. Disclosures Li Tao, MD, PhD, Gilead Sciences Inc (Employee) Valentina Shvachko, n/a, Gilead Sciences Inc (Employee) Robertino Mera, MD, PhD, Gilead Sciences Inc (Employee) Moupali Das, MD, MPH, Gilead Sciences Inc (Employee) Christoph Carter, MD, PhD, Gilead Sciences Inc (Employee) David Magnuson, PharmD, Gilead Sciences Inc (Employee)

scholarly journals 855. Persistence on F/TAF versus F/TDF for HIV Pre-Exposure Prophylaxis: A Real-World Evidence Analysis in the United States

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S518-S519
Author(s):  
Li Tao ◽  
Valentina Shvachko ◽  
Moupali Das ◽  
Christoph C Carter ◽  
Jared Baeten ◽  
...  
Keyword(s):  
United States ◽  
Real World ◽  
The United States ◽  
Odds Ratios ◽  
Preexposure Prophylaxis ◽  
Hazard Ratios ◽  
Real World Evidence ◽  
The Us ◽  
Evidence Analysis ◽  
Exposure Prophylaxis

Abstract Background Persistence to preexposure prophylaxis (PrEP) is an important determinant of its efficacy, but evidence on real-world persistence is lacking. This study assesses adherence to F/TDF and F/TAF for PrEP both in terms of discontinuation and re-initiation patterns. Methods We identified HIV-negative individuals in the United States who initiated F/TDF or F/TAF for PrEP between October 2019 and December 2020 from a de-identified prescription claims database; users taking generic F/TDF were excluded. Non-persistence was defined as a prescription fill gap of >30 days; discontinuation included switch from F/TDF to F/TAF or F/TAF to F/TDF. We used survival analyses to estimate persistence, Cox regressions to compare the hazard ratios (HR) of discontinuation, and logistic regression to compare the odds ratios of re-initiation after discontinuation. Results Among F/TAF users (N=82,402) median age at PrEP initiation was 35 years (interquartile range [IQR] 28−47) and median PrEP persistence was 4 months (IQR 1.8-8.9), compared to 31 years (IQR 25−40) and 2 months (IQR 1.0-3.8) for F/TDF users (N=48,501). PrEP persistence at 60 and 90 days was higher among F/TAF users than F/TDF users (Figure). F/TDF users were 2.5 times more likely to discontinue than F/TAF users, with more marked differences in older users than that in younger users (p for interaction between discontinuation and age group < 0.01, Table). We also observed a higher rate of discontinuation of F/TDF versus F/TAF if PrEP was prescribed by internal medicine or infectious disease physicians than by family medicine physicians (data not shown). After discontinuation, F/TAF users were 1.7 times more likely than F/TDF users to re-initiate PrEP; the association was not different by age. Persistence rates of F/TAF and F/TDF for PrEP by time of PrEP initiation Hazard ratios (HR) and corresponding 95% confidence intervals (CI) of non-persistence and odds ratios (OR) of re-initiation after discontinuation for users of F/TAF and F/TDF for PrEP in the US, Oct 2019 – Dec 2020 Conclusion In this real-world analysis, the F/TAF for PrEP regimen was associated with higher persistence and re-initiation than F/TDF for PrEP. These findings underscore the dynamic nature of PrEP utilization in the real-world and the importance of interventions aimed at improving PrEP persistence and re-initiation in people who would benefit from PrEP. Disclosures Li Tao, MD, PhD, Gilead Sciences Inc (Employee, Shareholder) Valentina Shvachko, MS, Gilead Sciences Inc (Employee, Shareholder) Moupali Das, MD, Gilead Sciences Inc. (Employee, Shareholder) Christoph C. Carter, MD, Gilead Sciences Inc. (Employee, Shareholder) Jared Baeten, MD, PHD, Gilead Sciences Inc. (Employee, Shareholder) David Magnuson, PharmD, Gilead Sciences Inc (Employee, Shareholder)

Comprehensive real-world evidence research in stage III and IV melanoma: Evaluation of a cohort of patients treated at a Portuguese institution.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18774-e18774
Author(s):  
Ivo Julião ◽  
Jose Luis Cunha ◽  
Patricia Redondo ◽  
Jessica Rodrigues ◽  
Tiago Figueiredo ◽  
...  
Keyword(s):  
Real World ◽  
Clinical Characteristics ◽  
Index Date ◽  
Systemic Treatment ◽  
Stage Iv ◽  
Stage Iii ◽  
Line Treatment ◽  
Adequate Treatment ◽  
Real World Evidence

e18774 Background: Malignant melanoma (MM) is one of the most aggressive skin cancers and its incidence has been increasing worldwide. Deep understanding of patient characteristics and the course of the disease, specially through the evaluation of real-world evidence, is extremely relevant for an adequate treatment approach and better outcomes. This study aims to comprehensively evaluate demographic and clinical characteristics and also treatment outcomes of patients with stage III and IV MM, treated at a Portuguese institution. Methods: Retrospective cohort study of patients with de novo MM stage III/IV or that evolved from earlier MM stages, between 2015 and 2017 (considered the index date). Patients were followed until 12/31/2019. Demographic, clinical and treatment characteristics were evaluated. Survival was assessed, from the index date, using the Kaplan Meier method and log-rank test to compare groups. Results: We included 215 patients with a median age of 66 years (20-96) and 50.2% (n = 108) were male. At index date, 63.7% (n = 137) were stage III. From those, 41.6% (n = 57) progressed to stage IV during follow-up. At diagnosis, the majority of patients had ulceration (53.3%; n = 119), normal LDH ( < 248 U/L; 56.3%; n = 121) and from 110 patients tested for BRAF, 45.4% (n = 50) had a mutation. In earlier stages, 41.8% (n = 81) performed sentinel LN only and from those 61.7% (n = 50) had latter metastatic disease. Complete LND was performed in 49% (n = 95) and 58.9% (n = 56) had a distant relapse. Brain metastasis were diagnosed in 28.4% (n = 61) of the patients, and 50.8% (n = 31) were not eligible for any treatment due to poor clinical status. Systemic treatment was performed in 70 patients with advanced disease. In 1st line, 34 (48.6%) patients underwent anti-PD-1, 28 (40.0%) BRAF/MEKi, 5 (7.1%) BRAFi and 3 (4.3%) chemotherapy. A 2nd line treatment was performed in 21 (30.0%) patients and 2 (9.5%) underwent 3rd line treatment. With a median follow-up of 29 months OS for all patients at 24 months was 54.9% (95% CI; 48.6-62.0): 69.3% (95% CI; 62.0-77.5) for stage III patients and 29.5% (95% CI; 20.9-41.6) for stage IV patients. OS was worst for known risk factors (ulceration, mitotic rate and LDH). OS at 24 months for patients under systemic treatment was 37.4% (95% CI; 26.9-52.0), with no differences between immunotherapy and targeted therapy. Finally, 22 patients were submitted to limb perfusion with an OS of 58.1% (95% CI; 41.2-81.9) at 24 months and a median PFS of 7.4 months (95% CI; 3.9-11.3). Conclusions: Analysis of real-world data is a solid tool in the evaluation, development and improvement of treatment strategies. Demographic and clinical characteristics are comparable to those of other studied cohorts. Longer follow-up of this population and the inclusion of new patients submitted to contemporary approaches will allow improving knowledge and care for melanoma patients in Portugal.

Ontology Versioning Driven by Instance Evolution in the τOWL Framework

2021 ◽  
Author(s):  
Zouhaier Brahmia ◽  
Fabio Grandi ◽  
Abir Zekri ◽  
Rafik Bouaziz
Keyword(s):  
Semantic Web ◽  
Real World ◽  
Ontology Construction ◽  
Web Based ◽  
The Real ◽  
Initial Design ◽  
Design Time ◽  
Schema Versioning ◽  
History Of ◽  
Over Time

Like other components of Semantic Web-based applications, ontologies are evolving over time to reflect changes in the real world. Several of these applications require keeping a full-fledged history of ontology changes so that both ontology instance versions and their corresponding ontology schema versions are maintained. Updates to an ontology instance could be non-conservative that is leading to a new ontology instance version no longer conforming to the current ontology schema version. If, for some reasons, a non-conservative update has to be executed, in spite of its consequence, it requires the production of a new ontology schema version to which the new ontology instance version is conformant so that the new ontology version produced by the update is globally consistent. In this paper, we first propose an approach that supports ontology schema changes which are triggered by non-conservative updates to ontology instances and, thus, gives rise to an ontology schema versioning driven by instance updates. Note that in an engineering perspective, such an approach can be used as an incremental ontology construction method driven by the modification of instance data, whose exact structure may not be completely known at the initial design time. After that, we apply our proposal to the already established [Formula: see text]OWL (Temporal OWL 2) framework, which allows defining and evolving temporal OWL 2 ontologies in an environment that supports temporal versioning of both ontology instances and ontology schemas, by extending it to also support the management of non-conservative updates to ontology instance versions. Last, we show the feasibility of our approach by dealing with its implementation within a new release of the [Formula: see text] OWL-Manager tool.

scholarly journals Short-Lasting Headaches in Children

Cephalalgia ◽  
2006 ◽  
Vol 26 (10) ◽  
pp. 1220-1224 ◽  
Author(s):  
JP Vieira ◽  
AB Salgueiro ◽  
M Alfaro
Keyword(s):  
Family History ◽  
Clinical Characteristics ◽  
Paroxysmal Hemicrania ◽  
Primary Headaches ◽  
Secondary Headache ◽  
Younger Age ◽  
Associated Symptoms ◽  
History Of ◽  
Stabbing Headache ◽  
Idiopathic Stabbing Headache

Short-lasting headaches have been studied infrequently in children and it is not known if the main categories of primary headaches of this type in adults are applicable to children. We report our experience with a group of 20 children with a brief headache. Two patients had a secondary headache. One patient had a headache with some clinical characteristics of paroxysmal hemicrania. The remaining 17 had a very brief headache. They were in many aspects comparable to others from previous studies on idiopathic stabbing headache in children: no associated symptoms, no other associated headache, frequent family history of migraine. They differed, however, in the younger age of the patients and the more frequent extratrigeminal location of the pain. Extratrigeminal ice-pick pain may be a variant of idiopathic stabbing headache, more prevalent in young children.

scholarly journals Real World Evidence: welcome to reality!

2020 ◽  
Vol 23 (1) ◽  
pp. 75
Author(s):  
Pintaudi, B.
Keyword(s):  
Real World ◽  
Randomized Clinical Trials ◽  
Relevant Information ◽  
Administrative Databases ◽  
Real World Data ◽  
World Data ◽  
Real World Evidence ◽  
History Of ◽  
The Times ◽  
Concrete Face

Real World Data (RWD) constitute a set of information sources on which the very current line of research of Real World Evidence (RWE) is based. RWE studies are based on data from observational studies, administrative databases, population or disease registers, insurance registers, electronic medical records, population health surveys and, more recently, social media and data from mobile devices and apps. While Randomized Clinical Trials (RCTs) answer the question “Can it work?” “Is it safe?” RWDs are more interested in answering the question “Does it work?”. We therefore move from a question of “efficacy / safety” to one of “effectiveness”. RWE studies allow to evaluate the safety of a treatment in a longer period than that of the RCTs, verify its quality and cost effectiveness, allow us to trace the natural history of a disease conditioned or not by a treatment, give us relevant information on compliance and on adherence to treatments and allow us to identify service models and patient preferences. Given the exciting perspective that the “real” vision of things outlines, AMD has decided to keep up with the times by forming a Group of work on “Real World Evidence”. The activities that the RWE Working Group is already promoting and carrying out are: 1) support for the publication of clinical cases; 2) support for the drafting of research protocols; 3) analysis of the Annals database. Addressing Real World Evidence in the widest possible way by collaborating with interested AMD Members, aligning with the need to give a concrete face to things, represents the vision of this Group. “Welcome to reality”! KEY WORD Real World Data, Real World Evidence, effectiveness.

scholarly journals Heart Failure After Myocardial Infarction - A Population-Based Study

Circulation ◽  
2001 ◽  
Vol 103 (suppl_1) ◽  
pp. 1359-1359
Author(s):  
Jens P Hellermann ◽  
Steven J Jacobsen ◽  
Barbara P Yawn ◽  
Susan Weston ◽  
Margaret M Redfield ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Heart Failure ◽  
Clinical Characteristics ◽  
Reperfusion Therapy ◽  
Population Based ◽  
Proportional Hazard ◽  
Population Based Study ◽  
History Of ◽  
The Impact ◽  
Over Time

P46 While heart failure (HF), an emerging epidemic, complicates myocardial infarction (MI), little is known on the predictors of HF post-MI, in particular the impact of reperfusion therapy. This population-based study was undertaken to examine the association between clinical characteristics and post-MI HF between 1979 and 1994. Hospitalized incident MIs were validated using enzymes, chest pain, and Minnesota coding of the ECG. Framingham criteria were used to ascertain both in- and outpatient HF. Proportional hazard regression was used to identify predictors of CHF. In the study period, 1657 patients (pts.) (mean age 67.2 ± 13.9 years, 43% women) had an incident MI. History of diabetes, hypertension and prior HF was found in 19%, 54% and 11% of pts respectively. After 5 years, 43% of pts had experienced HF. Factors independently associated with HF were (see table). There was a 2% decline per year in occurrence of HF. Adding reperfusion therapy in the model attenuated the association between year and HF (adjusted RR for reperfusion 0.67, 95% CI 0.53, 0.84, p=0.006; adjusted for year 0.99; 95% CI 0.97, 1.01, p=0.37). Thus, while remaining frequent post-MI CHF has declined over time. Reperfusion therapy accounted for most of the effect of year. Table 1.

scholarly journals Emulating Randomized Clinical Trials with Nonrandomized Real-World Evidence Studies: First Results from the RCT DUPLICATE Initiative

Circulation ◽  
2020 ◽  
Author(s):  
Jessica M. Franklin ◽  
Elisabetta Patorno ◽  
Rishi J. Desai ◽  
Robert J. Glynn ◽  
David Martin ◽  
...  
Keyword(s):  
Real World ◽  
Randomized Clinical Trials ◽  
Cardiovascular Effects ◽  
Primary Analysis ◽  
Clinical Trial Registration ◽  
Use Patterns ◽  
Success Criteria ◽  
Hazard Ratios ◽  
Real World Evidence ◽  
First Results

Background: Regulators are evaluating the use of non-interventional real-world evidence (RWE) studies to assess the effectiveness of medical products. The RCT-DUPLICATE initiative uses a structured process to design RWE studies emulating randomized controlled trials (RCTs) and compare results. Here, we report findings of the first 10 trial emulations, evaluating cardiovascular outcomes of antidiabetic or antiplatelet medications. Methods: We selected 3 active-controlled and 7 placebo-controlled RCTs for replication. Using patient-level claims data from US commercial and Medicare payers, we implemented inclusion/exclusion criteria, selected primary endpoints, and comparator populations to emulate those of each corresponding RCT. Within the trial-mimicking populations, we conducted propensity score matching to control for >120 pre-exposure confounders. All study parameters were prospectively defined and protocols registered before hazard ratios (HRs) and 95% confidence intervals (CIs) were computed. Success criteria for the primary analysis were pre-specified for each replication. Results: Despite attempts to emulate RCT design as closely as possible, differences between the RCT and corresponding RWE study populations remained. The regulatory conclusions were equivalent in 6 of 10. The RWE emulations achieved a HR estimate that was within the 95% CI from the corresponding RCT in 8 of 10 studies. In 9 of 10, either the regulatory or estimate agreement success criteria were fulfilled. The largest differences in effect estimates were found for RCTs where second-generation sulfonylureas were used as a proxy for placebo regarding cardiovascular effects. Nine of 10 replications had a standardized difference between effect estimates of <2, which suggests differences within expected random variation. Conclusions: Agreement between RCT and RWE findings varies depending on which agreement metric is used. Interim findings indicate that selection of active comparator therapies with similar indications and use patterns enhances the validity of RWE. Even in the context of active comparators, concordance between RCT and RWE findings is not guaranteed, partially because trials are not emulated exactly. More trial emulations are needed to understand how often and in what contexts RWE findings match RCTs. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifiers: NCT03936049, NCT04215523, NCT04215536, NCT03936010, NCT03936036, NCT03936062, NCT03936023, NCT03648424, NCT04237935, NCT04237922

scholarly journals Acute Migraine Prescription Patterns Vary by Baseline Cardiovascular Risk and Clinical Characteristics: A Real-World Evidence Study

2020 ◽  
Vol 9 (2) ◽  
pp. 499-509
Author(s):  
Hu Li ◽  
Maurice Vincent ◽  
Xiang Zhang ◽  
Ellen B. Dennehy ◽  
Robert Goodloe ◽  
...  
Keyword(s):  
Cardiovascular Risk ◽  
Real World ◽  
Clinical Characteristics ◽  
Acute Migraine ◽  
Prescription Patterns ◽  
Real World Evidence
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