scholarly journals 853. Real-World Persistency of Patients Receiving Tenofovir-Based Pre-Exposure Prophylaxis for the Prevention of HIV Infection in the US

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S516-S517
Author(s):  
Alan Oglesby ◽  
Guillaume Germain ◽  
Francois Laliberte ◽  
Staci Bush ◽  
Heidi Swygard ◽  
...  
Keyword(s):  
Hiv Infection ◽  
Real World ◽  
Patient Characteristics ◽  
Baseline Period ◽  
Hiv Diagnosis ◽  
Analysis Group ◽  
Populations At Risk ◽  
Proportion Of Days Covered ◽  
Exposure Prophylaxis

Abstract Background Once-daily oral tenofovir-based combinations as pre-exposure prophylaxis (PrEP) have shown to be an effective biomedical HIV prevention strategy for populations at-risk of acquiring HIV-1. However, low adherence can lead to poor effectiveness. This study described the characteristics of commercially-insured US PrEP users. Methods This retrospective study used IQVIA™ PharMetrics Plus data (1/1/2015–3/31/2020) to identify adults newly initiated (index date) on emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or emtricitabine/tenofovir alafenamide (FTC/TAF) as daily PrEP. Users had ≥6 months of continuous enrollment pre-index (baseline); those diagnosed with HIV or with antiretroviral therapy (ART) use during baseline were excluded. User characteristics were described during the baseline period. For FTC/TDF users, proportion of days covered (PDC), persistence, treatment breaks, and switching were described during the follow-up period, which spanned from index to the earliest of disenrollment or end of data. Non-persistence was defined as a >90-day gap from last day of supply, with re-initiation after this gap indicating treatment break. For PDC and persistence, follow-up was censored at HIV infection, defined by both multi-class ART initiation and HIV diagnosis. Results In total 24,232 FTC/TDF and 1,187 FTC/TAF users were identified. Overall, mean age was 35.1 years and 94.5% were male (Table 1). Mean [median] length of follow-up was longer for FTC/TDF (504 [390] days) than FTC/TDF users (77 [70] days). On average, FTC/TDF users had 9.0 dispensings with 38.3 days of supply per dispensing over follow-up; 11.1% had ≥1 treatment break (mean length, 249 days). Among those initiated on FTC/TDF, 10.8% switched to FTC/TAF. The mean PDC for FTC/TDF users at 6 and 12 months was 0.74 and 0.67, respectively, corresponding to 63.7% and 57.9% of patients with PDC ≥0.70 (Figure 1). Persistence to FTC/TDF at 6 and 12 months was 70.2% and 57.4%, respectively (Figure 2). Table 1. Baseline Demographics and Clinical Characteristics of PrEP Users by Regimen Figure 1. Proportion of Days Covered of FTC/TDF Users Figure 2. Kaplan-Meier Persistence Rates of FTC/TDF Users Conclusion Patient characteristics of PrEP users are broadly similar between regimens, though switching from FTC/TDF to FTC/TAF is common. FTC/TDF users had lower real-world PDC and persistence than in recent clinical trials (DISCOVER and HPTN 083). Disclosures Alan Oglesby, MPH, GlaxoSmithKline (GSK) (Employee, Shareholder) Guillaume Germain, MSc, ViiV Healthcare (Other Financial or Material Support, I am an employee of Groupe d’analyse, Ltée, a consulting company that provided paid consulting services to ViiV Healthcare for the conduct of the present study.) Francois Laliberte, MA, Viiv (Research Grant or Support) Staci Bush, NP, GlaxoSmithKline (GSK) (Employee, Shareholder) Heidi Swygard, MD, ViiV Healthcare (Employee) Sean MacKnight, MScPH, Analysis Group (Employee) Annalise Hilts, BA, Analysis Group, Inc. (Employee) Mei Sheng Duh, MPH, ScD, ViiV Healthcare (Grant/Research Support)

scholarly journals Early use of erenumab in US real-world practice

2021 ◽  
Vol 4 ◽  
pp. 251581632110204
Author(s):  
Alina Bogdanov ◽  
Victoria Chia ◽  
Mark Bensink ◽  
Robert Urman ◽  
Lauren Fischer ◽  
...  
Keyword(s):  
Real World ◽  
The United States ◽  
Baseline Period ◽  
Calcitonin Gene ◽  
Proportion Of Days Covered ◽  
Early Use ◽  
High Adherence ◽  
The Mean ◽  
Anxiety Depression

Background: Erenumab, a monoclonal antibody (mAb) developed to block the calcitonin gene-related peptide (CGRP) receptor, is approved for the prevention of migraine in adults. This retrospective observational study sought to describe early real-world use of erenumab. Methods: This study used the Practice Fusion ambulatory Electronic Health Record database, which represents approximately 6% of ambulatory care among primary care and specialist practices in the United States. Among migraine patients initiating erenumab, demographics, migraine type, comorbidities, and prior treatments were assessed during the 12-month baseline period. Treatment patterns including changes in acute and preventive medications, switches to other CGRP mAbs (fremanezumab and galcanezumab), and for erenumab, changes in dose and adherence were examined among patients with 6 months of follow-up. Results: Of 3,336 patients identified (85.9% female; mean age = 49.1 years), approximately 40% had documentation of chronic migraine. Common comorbidities included non-migraine headache, anxiety, depression, and hypertension. Most patients (76.3%) initiated on the 70 mg dose of erenumab. Among 1,638 patients included in the treatment pattern analysis, 53.1% used acute medications and 55.7% used other non-specific preventive migraine medications during follow-up, reductions of 9.8% and 10.2%, respectively, over the same period of time before index. Switching to fremanezumab and galcanezumab were observed in 12.2% and 13.8% of patients, respectively. The mean proportion of days covered by erenumab at 6 months was 79%. Dosage of erenumab increased (from 70 mg to 140 mg) in 13.0% and decreased (from 140 mg to 70 mg) in 24.9% of patients. Conclusion: This early real-world study showed high adherence among erenumab users. This combined with observed reductions in previously used acute and preventive medications are suggestive of erenumab’s benefit.

scholarly journals Real-World Outcomes of Ivacaftor Treatment in People with Cystic Fibrosis: A Systematic Review

2021 ◽  
Vol 10 (7) ◽  
pp. 1527
Author(s):  
Jamie Duckers ◽  
Beth Lesher ◽  
Teja Thorat ◽  
Eleanor Lucas ◽  
Lisa J. McGarry ◽  
...  
Keyword(s):  
Systematic Review ◽  
Cystic Fibrosis ◽  
Real World ◽  
Safety Profile ◽  
Clinical Trial Data ◽  
Patient Characteristics ◽  
Healthcare Resource Utilization ◽  
Patient Reported ◽  
Clinical Benefits

Cystic fibrosis (CF) is a rare, progressive, multi-organ genetic disease. Ivacaftor, a small-molecule CF transmembrane conductance regulator modulator, was the first medication to treat the underlying cause of CF. Since its approval, real-world clinical experience on the use of ivacaftor has been documented in large registries and smaller studies. Here, we systematically review data from real-world observational studies of ivacaftor treatment in people with CF (pwCF). Searches of MEDLINE and Embase identified 368 publications reporting real-world studies that enrolled six or more pwCF treated with ivacaftor published between January 2012 and September 2019. Overall, 75 publications providing data from 57 unique studies met inclusion criteria and were reviewed. Studies reporting within-group change for pwCF treated with ivacaftor consistently showed improvements in lung function, nutritional parameters, and patient-reported respiratory and sino-nasal symptoms. Benefits were evident as early as 1 month following ivacaftor initiation and were sustained over long-term follow-up. Decreases in pulmonary exacerbations, Pseudomonas aeruginosa prevalence, and healthcare resource utilization also were reported for up to 66 months following ivacaftor initiation. In studies comparing ivacaftor treatment to modulator untreated comparator groups, clinical benefits similarly were reported as were decreases in mortality, organ-transplantation, and CF-related complications. The safety profile of ivacaftor observed in these real-world studies was consistent with the well-established safety profile based on clinical trial data. Our systematic review of real-world studies shows ivacaftor treatment in pwCF results in highly consistent and sustained clinical benefit in both pulmonary and non-pulmonary outcomes across various geographies, study designs, patient characteristics, and follow-up durations, confirming and expanding upon evidence from clinical trials.

Real-world evidence of cancer immunotherapy (CIT) combination treatment in first-line (1L) extensive-stage small cell lung cancer (ES-SCLC).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 8561-8561
Author(s):  
Eric S. Nadler ◽  
Anupama Vasudevan ◽  
Kalatu Davies ◽  
Yunfei Wang ◽  
Ann Johnson ◽  
...  
Keyword(s):  
Brain Metastases ◽  
Real World ◽  
Performance Status ◽  
Descriptive Analysis ◽  
Patient Characteristics ◽  
Treatment Patterns ◽  
Combination Regimen ◽  
Duration Of Treatment ◽  
The Real

8561 Background: Atezolizumab plus chemotherapy was the first CIT combination regimen approved for 1L treatment of ES-SCLC in 2019. This study investigated patient characteristics and treatment patterns for patients with ES-SCLC receiving this regimen in the real-world community oncology setting. Methods: This was a retrospective study including adult patients diagnosed with ES-SCLC between 01-Oct-2018 (after IMpower 133 publication in NEJM Sep-2018) and 31-Dec-2019, with follow-up through 31-March-2020 using The US Oncology Network electronic health records data. Descriptive analyses of patient characteristics and treatment patterns were conducted, with Kaplan-Meier (K-M) methods used to assess time to treatment discontinuation (TTD) and time to next treatment/death (TTNT). Results: Of the 408 patients included in this study, 267 (71.4%) received atezo+carboplatin+etoposide (Atezo+Chemo), 80 (21.4%) received carboplatin+etoposide (Chemo only) and the rest received other regimens. The Atezo+Chemo patients in the real-world cohort compared with the IMpower 133 trial (n = 201) were older (median age 68 vs. 64 years) and included fewer males (45% vs. 64%), fewer white race (73% vs. 81%), more patients with brain metastases at baseline (23% vs. 9%), and more patients with worse ECOG (2/3) performance-status score (24% vs. 0%). The median follow-up, TTD, and TTNT in months (mo) for the real-world cohort are presented in the table alongside the best comparable measures reported for the trial. Conclusions: Most patients in this real-world ES-SCLC cohort received the Atezo+Chemo regimen in the 1L setting. While the follow-up was much shorter and patients had worse baseline characteristics (age, brain metastases, ECOG) in the real-world setting compared to the IMpower 133 trial, the real-world median TTD in this descriptive analysis was found to be in line with the median duration of treatment in the trial. Further research with longer follow-up comparing the real-world effectiveness of the CIT and chemo regimens is needed.[Table: see text]

scholarly journals 992. Rethinking the 28-day HIV nPEP Dispensing Practice: A Pediatric ID Clinic Analysis

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S524-S525
Author(s):  
David Zhang ◽  
Julia Rosebush ◽  
Palak Bhagat ◽  
Allison Nelson ◽  
Veena Ramaiah ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Wholesale Price ◽  
Cost Savings ◽  
Patient Characteristics ◽  
Post Exposure Prophylaxis ◽  
Exposure Prophylaxis ◽  
The Cost ◽  
The University ◽  
Lost To Follow Up

Abstract Background In July 2017, The University of Chicago Comer Children’s Hospital Emergency Department (ED) transitioned from a 5-day to a 28-day HIV nPEP (non-occupational post-exposure prophylaxis) dispensation model in an effort to increase adherence. Anecdotal reports of patients lost to follow-up after ED discharge called into question the utility and cost-effectiveness of this practice. We analyzed HIV nPEP follow-up rates in our clinic, explored reasons for nonadherence, and performed basic cost-savings analyses to inform potential changes to our dispensation model. Methods A retrospective review of both electronic health and pharmacy records was conducted for patients prescribed 28-days of HIV nPEP in the ED and scheduled for outpatient follow-up in Pediatric ID clinic from July 2017-June 2019. Clinic provider documentation of nPEP adherence and reasons for nonadherence were examined. Patients were given an initial dose of nPEP regimen in the ED and provided all subsequent doses to complete at home. Using average wholesale price (AWP), we calculated the total cost of each regimen and potential savings if a shorter duration of HIV nPEP supply was dispensed. Results 50 patients received a 28-day supply of HIV nPEP. Please refer to Table 1 regarding baseline patient characteristics. Of these, only 19 (38%) patients had documented outpatient follow-up after nPEP initiation. Median time to follow-up was 6 days (IQR: 3.0-9.0 days). Of the 19 patients with follow-up, 3 admitted to medication non-adherence. Although side effects were elicited in a total of 9 patients (18%), only 1 cited medication intolerance as the reason for discontinuing their nPEP. Given the relatively short time to follow-up, a potential savings of $1720-2211/patient could be achieved if a 10-14 day supply was dispensed. Conclusion Outpatient follow-up after 28-day HIV nPEP dispensation in our ED was < 40%, calling into question the cost-effectiveness of this dispensation model. While our current practice alleviates nPEP interruption due to potential insurance issues and pick-up delays, follow-up and adherence are not assured. The significant cost-savings with a shorter supply at the outset may encourage more robust follow-up and adherence. Disclosures All Authors: No reported disclosures

Is Adherence to the American College of Chest Physicians Recommended Anticoagulation Treatment Duration Associated with Different Outcomes Among Patients with Venous Thromboembolism?

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 1126-1126 ◽  
Author(s):  
Alex C. Spyropoulos ◽  
Ron Preblick ◽  
Jackie Kwong ◽  
Melissa Lingohr-Smith ◽  
Jay Lin
Keyword(s):  
Venous Thromboembolism ◽  
Treatment Duration ◽  
Bleeding Risk ◽  
Patient Characteristics ◽  
Baseline Period ◽  
Employment Equity ◽  
Minimum Duration ◽  
Study Population ◽  
Equity Ownership

Abstract Introduction: Venous thromboembolism (VTE) represents a major clinical and economic burden. The American College of Chest Physicians (ACCP) Guideline 9th Edition on the treatment of VTE recommends a minimum duration of anticoagulation (AC) therapy depending on patient risk profiles. The objectives of this study were to evaluate the clinical and economic outcomes associated with adherence to the AC treatment duration recommendation among VTE patients in the real world setting. Methods: Adult patients (≥18 years of age) with at least 1 inpatient diagnosis or 2 outpatient diagnoses on two different dates of deep vein thrombosis (DVT) and/or pulmonary embolism (PE), based on ICD-9-CM codes, were identified from the IMS Pharmetrics Plus database during 1/1/2009 through 3/31/2013. The first VTE diagnosis was defined as the index event. Study patients were required to have continuous insurance coverage during the 12 months before (baseline) and after (follow-up) the index event and no prior VTE diagnosis in the baseline period. They were also required to have received at least one outpatient anticoagulant treatment within 30 days of the initial VTE diagnosis with a minimum medication days of supply of 30 days. ACCP recommend that patients with provoked VTE or unprovoked VTE and high bleeding risks receive AC treatment for at least 3 months and that patients with unprovoked VTE and low or moderate bleeding risks or patients with cancer receive AC treatment for at least 6 months. Patient records in the database including ICD-9-CM codes and RIETE bleeding risk scores were used to group patients into 2 cohorts, one comprised of patients who received AC treatment for a duration as recommended by the ACCP (adherent group, AD) and the other comprised of patients who received AC treatment for a duration less than that recommended by the ACCP (non-adherent group, non-AD). Patient demographics and clinical characteristic were evaluated during the baseline period. Healthcare resource utilization, including hospital admissions, outpatient medical services, and prescription drug usage, were measured during the baseline and follow-up periods. VTE recurrence, defined as hospitalization or ER visit with a VTE diagnosis code, was also measured during the follow-up period. Multivariate regression analysis was utilized to compare clinical and economic outcomes of study cohorts while controlling for key patient characteristics. Results: The study population included 81,827 patients with a mean age (standard deviation) of 55.3 (13.8) years. For the index VTE event, 61% had DVT only, 26% had PE only, and 13% had DVT/PE. Of the study population, the minimum ACCP recommended AC treatment durations were 3 and 6 months for 27% (n=22,157) and 73% (n=59,670) of patients, respectively. Among all patients, 74% (n=60,550) received AC therapy for the ACCP recommended duration. The proportion of patients with VTE risks, including recent hospitalization (17% vs. 9%, p<0.001), recent surgery (9% vs. 6%, p<0.001), index diagnosis of PE only (28% vs. 20%, p<0.001), and index diagnosis of DVT/PE (15% vs. 8%, p<0.001) was greater in the AD cohort than in the non-AD cohort. Furthermore, mean Charlson Comorbidity Index score (1.67 vs. 1.59, p<0.001) and RIETE bleeding risk score (RIETE ≥1: 66% vs. 55%, p<0.001) were higher for the AD cohort compared to the non-AD cohort. The most prevalent anticoagulants used for treatment were warfarin (89% vs. 96%, p<0.001) and low molecular weight heparin (58% vs. 59%, p<0.01). After controlling for key patient characteristics, risks for all-cause hospitalization (Odds ratio (OR): 0.80, confidence interval (CI): 0.77-0.83, p<0.001) and VTE recurrence (OR=0.91, CI: 0.86-0.95, p<0.001) were lower among VTE patients in the AD cohort vs. the non-AD cohort, as were differences in all-cause total healthcare payments (-$3,416, p<0.001) and VTE-related healthcare payments (-$2,139, p<0.001) during the follow-up period. Conclusions: Approximately a quarter of the study population with VTE did not receive treatment with AC therapy for the minimum duration as recommended by the ACCP guideline. Patients who did not receive outpatient AC therapy for the recommended duration had more VTE recurrences, utilized more inpatient services, and had higher healthcare costs than patients who received AC therapy for the ACCP recommended duration. Disclosures Spyropoulos: Daiichi Sankyo, Inc.: Consultancy. Preblick:Daiichi Sankyo, Inc.: Employment, Equity Ownership. Kwong:Daiichi Sankyo, Inc.: Employment, Equity Ownership. Lingohr-Smith:Chimerix, Inc.: Consultancy; Bristol-Myers Squibb: Consultancy; Daiichi Sankyo, Inc: Consultancy; Novosys Health: Employment. Lin:Chimerix, Inc.: Consultancy; Daiichi Sankyo, Inc: Consultancy; Bristol-Myers Squibb: Consultancy; Novosys Health: Employment.

Comparison of Survival Rates, Healthcare Resource Use and Costs of Elderly Patients with Chronic Myeloid Leukemia Receiving Dasatinib or Nilotinib As Second-Line Therapy

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 2618-2618
Author(s):  
B. Douglas Smith ◽  
Jun Liu ◽  
Dominick Latremouille-Viau ◽  
Zhou Zhou ◽  
Annie Guerin ◽  
...  
Keyword(s):  
Research Funding ◽  
Index Date ◽  
Survival Rates ◽  
Baseline Period ◽  
Harvard University ◽  
Second Line ◽  
Second Line Therapy ◽  
Analysis Group ◽  
Line Therapy

Abstract Introduction: Dasatinib and nilotinib are two second-generation tyrosine kinase inhibitors (TKIs) that are well established as treatment options for patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase resistant or intolerant to imatinib and the treatment guidelines do not differentiate based on patient age. Importantly, elderly patients (≥65 years old) account for about half of CML patients; yet there are little data reported focusing on outcomes in this distinct group of patients, often with multiple medical problems and different socio-economic profiles when compared to younger patients. This study aimed to compare survival rates, healthcare resource utilization (HRU), and medical service costs between elderly CML patients receiving dasatinib versus nilotinib as second-line therapy after imatinib. Methods: Patients aged ≥65 years with ≥2 CML diagnoses who received imatinib as first-line therapy followed by nilotinib or dasatinib as second-line therapy were identified using the Medicare Research Identifiable Files (RIF) from 2006 to 2012. Selected patients were continuously enrolled in the Part A (i.e., institutional claims), Part B (i.e., non-institutional claims), and Part D (i.e., drug events) for ≥6 months before and ≥1 month after the second-line TKI therapy initiation date (i.e., index date). Patients enrolled in a clinical trial, those with a stem-cell transplant, or receiving chemotherapy (except hydroxyurea) during the 6 months before the index date (i.e., baseline period) were excluded from the study. Based on the second-line TKI, patients were classified as nilotinib users or dasatinib users. Survival rates were estimated using Kaplan Meir analyses and compared between nilotinib and dasatinib users using Cox proportional-hazards models. HRU and healthcare costs (USD 2013; payer’s perspective) were observed from the index date up to the end of follow-up. Because the length of follow-up varied across patients, HRU and costs were reported per-patient-per-month (PPPM). Incidence rate ratios (IRR) were estimated using Poisson regression models and monthly cost differences were estimated using general linear models with a log link and a gamma distribution or two-part models. Multivariate regression analyses were used to adjust for potential confounding factors measured during the baseline period or at the index date. Results: After applying the sample selection criteria, 659 patients using a second-line TKI therapy were selected; 280 were nilotinib users and 379 were dasatinib users. On average, patients had a follow-up of 24 months (median=22 months) after the index date. The mean age was 76 years and most patients were female (62%). Nilotinib and dasatinib users were generally similar in terms of gender, region of residence, prior imatinib treatment duration, CML complexity, and comorbidity profile. However, nilotinib users were slightly older than dasatinib users; a greater proportion of nilotinib users were 80+ years old at the index date (35% of nilotinib users vs. 27% of dasatinib users; p=.039). In addition, the proportion of patients with cardiovascular disease (40% of nilotinib users vs. 31% of dasatinib users; p=0.015) or congestive heart failure (23% of nilotinib users vs. 14% of dasatinib users; p=0.002) during the baseline period was higher in nilotinib users when compared to dasatinib users. Despite these differences, the median survival time was >4.9 years for nilotinib users and 4.0 years for dasatinib users (log rank test p=.032). After adjusting for potential confounding factors, nilotinib users had a mortality risk that was 38% lower than that of dasatinib users (p=.006) and, nilotinib users had 21% fewer inpatient admissions, 17% fewer inpatient days, 31% fewer emergency room visits, and 12% fewer outpatient visits when compared to dasatinib users (PPPM; all p≤.001). The adjusted monthly medical cost was $378 lower in nilotinib users when compared to dasatinib users (PPPM; p=.045). Conclusion: This retrospective study of elderly Medicare beneficiaries with CML receiving second-line therapy with dasatinib or nilotinib suggested that those receiving nilotinib had longer survival, lower HRU, and lower medical costs than those receiving dasatinib. Further health outcome researches and longer term studies focusing on elderly CML are needed to better define the best practice patterns. Disclosures Liu: Jun Liu is an employee of Harvard University which has received research funding from Analysis Group, Inc.: Employment. Latremouille-Viau:Dominick Latremouille-Viau is an employee of Analysis Group, Inc. which has received consulting fees from Novartis Pharmaceuticals Corporation: Employment. Zhou:Zhou Zhou is an employee of Analysis Group, Inc. which has received consulting fees from Novartis Pharmaceuticals Corporation: Employment. Guerin:Annie Guerin is an employee of Analysis Group, Inc. which has received consulting fees from Novartis Pharmaceuticals Corporation: Employment. Fernandez:Daniel Fernandez is an employee of Harvard University which has received research funding from Analysis Group, Inc.: Employment. Yi:Dingdong Yi is an employee of Harvard University which has received research funding from Analysis Group, Inc.: Employment. Wang:Xufei Wang is an employee of Harvard University which has received research funding from Analysis Group, Inc.: Employment. Wu:Eric Q. Wu is an employee of Analysis Group, Inc. which has received consulting fees from Novartis Pharmaceuticals Corporation: Employment. Mhatre:Novartis Pharmaceuticals Corporation: Employment. Keir:Novartis: Employment, Equity Ownership. Chen:Novartis: stock options Other; Novartis Pharmaceuticals Corporation: Employment.

Combination therapy with macitentan and phosphodiesterase type-5 inhibitor (PDE5i) in pulmonary arterial hypertension (PAH): real-world data from OPUS and OrPHeUS

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
V McLaughlin ◽  
R Channick ◽  
N.H Kim ◽  
M Flynn ◽  
S Leroy ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Real World ◽  
Patient Characteristics ◽  
Functional Class ◽  
Funding Source ◽  
Real World Data ◽  
World Data ◽  
Start Date ◽  
Phosphodiesterase Type 5 Inhibitor

Abstract Introduction Guidelines for the management of PAH recommend combination therapy for most patients, yet real-world data on treatment patterns in PAH are limited. Purpose To describe the characteristics, safety and clinical outcomes of PAH patients newly treated with double combination therapy with macitentan and PDE5i in the OPsumit® USers (OPUS) Registry and the OPsumit® Historical USers cohort study (OrPHeUS) combined dataset. Methods OPUS is a prospective, US, multicentre, observational drug registry (NCT02126943) ongoing since April 2014. OrPHeUS was a retrospective, US, multicentre chart review (NCT03197688); Oct 2013–Mar 2017. This cohort included patients initiating combination therapy with macitentan and a PDE5i (in any order) ≤60 days apart. Baseline was defined as the start date of the second therapy (i.e., start of combination therapy). Patient characteristics at baseline, changes in 6-minute walk distance (6MWD) and WHO functional class (FC) from baseline to follow-up, safety and outcomes are described. Results Of the 4428 OPUS/OrPHeUS PAH patients initiating macitentan, 2490 received this in combination with a PDE5i; of these patients, 740 (29.7%) initiated macitentan and a PDE5i concurrently (≤60 days apart). Data on disease duration was recorded in 729 patients at baseline; of these, 588 (80.7%) patients were incident (≤6 months since diagnosis) and 141 (19.3%) were prevalent (&gt;6 months since diagnosis); median time from diagnosis to start of combination therapy of was 1.4 (Q1=0.6, Q3=3.6) months. At baseline, median age was 60 (Q1=49, Q3=70) years and 73.6% of patients were female. Mean baseline 6MWD was 264.5 (SD=119.8) m, recorded in 240 (32.4%) patients. WHO FC was recorded at baseline for 347 (46.9%) patients; 263 (75.8%) were in FC III/IV. Median combination therapy exposure was 10.2 (Q1=3.4, Q3=21.8) months, with 58.8% of patients ongoing at data cut. Changes from baseline to follow up in FC and 6MWD are shown in the figure. There was ≥1 adverse event (AE) reported in 455 (61.5%) patients and ≥1 hepatic AE (HAE) in 76 (10.3%) patients. In total, 232 (31.4%) patients discontinued macitentan; 122 (16.5%) due to AEs, 4 (0.5%) due to HAEs, 98 (13.2%) not due to an AE/HAE, and 8 (1.1%) for unknown reasons. Of the 305 patients who discontinued combination therapy, 137 (18.5%) discontinued macitentan only, 73 (9.9%) discontinued PDE5i only, and 95 (12.8%) discontinued both drugs at the same time. Kaplan-Meier estimates (95% CI) showed that 60.7% (56.4, 64.8) of patients were free from hospitalisation and 88.7% (85.7, 91.1) were alive at 12 months. Conclusions In this real-world setting, less than one third of patients treated with macitentan received initial oral combination therapy, despite current expert consensus favouring such therapeutic approaches. Patients initiating macitentan+PDE5i ≤60 days apart had improved 6MWD and WHO FC from baseline to follow-up. Funding Acknowledgement Type of funding source: Other. Main funding source(s): Actelion Pharmaceuticals Ltd

scholarly journals Primary results of the Spanish Cryoballoon Ablation Registry: acute and long-term outcomes of the RECABA study

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Ángel Ferrero-De-Loma-Osorio ◽  
Rocío Cózar ◽  
Arcadio García-Alberola ◽  
Ermengol Valles ◽  
Alberto Barrera ◽  
...  
Keyword(s):  
Real World ◽  
Standard Of Care ◽  
Patient Characteristics ◽  
Early Recurrence ◽  
Cryoballoon Ablation ◽  
Procedural Time ◽  
Secondary Endpoints ◽  
Procedural Strategy

AbstractCryoablation is safe and effective for the treatment of atrial fibrillation (AF) in controlled clinical trials, but contemporary real-world usage and outcomes are limited. The Report of the Spanish Cryoballoon Ablation Registry (RECABA) was designed to evaluate acute and 12-month outcomes of cryoballoon ablation for the treatment of AF in Spain. Patients from 27 Spanish centers were prospectively enrolled. Patients were treated with cryoballoon ablation and managed according to standard of care protocols at each center. The primary endpoint was ≥ 30 s freedom from AF at 12-month after a 3-month blanking period. Secondary endpoints included a description of patient characteristics, cryoablation procedural strategy and safety, and predictors of efficacy. In total, 1742 patients (71.4% PAF, 68.8% male, mean age 58.02 ± 10.40 years, 76.1% overweight or obese, CHA2DS2-VASc index 1.40 ± 1.28) were enrolled. Patients received 7.2 ± 2.67 cryo-applications. PV potentials could be detected in 61% of the PVs during ablation, with a mean time to block of 52.9 ± 37.02 s. Acute PVI was observed in 97% of PVs with 75.8% isolated with the first cryo-application. Mean procedural time was 113 ± 41 min. Acute complications occurred in 4.4% of the cases. With follow-up in 1628 patients, AF-free survival was 78.5% (PAF: 80.6% vs PersAF 73.3%; p < 0.001). Left atrium enlargement, female sex, non-PAF, and early recurrence were independent predictors of AF recurrence (p < 0.05). RECABA provides detailed insight into current dosing practices and demonstrates cryoablation is safe and effective in real-world use.ClinicalTrials.gov number: NCT02785991.

scholarly journals A Strategy for PrEP Clinicians to Manage Ambiguous HIV Test Results During Follow-up Visits

2018 ◽  
Vol 5 (8) ◽  
Author(s):  
Dawn K Smith ◽  
William M Switzer ◽  
Philip Peters ◽  
Kevin P Delaney ◽  
Timothy C Granade ◽  
...  
Keyword(s):  
Hiv Infection ◽  
Test Results ◽  
Hiv Status ◽  
Management Options ◽  
Hiv Test ◽  
Confirmatory Tests ◽  
Testing Algorithms ◽  
Effective Treatment Regimen ◽  
Exposure Prophylaxis

Abstract Prompt determination of HIV infection status is critical during follow-up visits for patients taking pre-exposure prophylaxis (PrEP) medication. Those who are uninfected can then continue safely taking PrEP, and those few who have acquired HIV infection can initiate an effective treatment regimen. However, a few recent cases have been reported of ambiguous HIV test results using common testing algorithms in PrEP patients. We review published reports of such cases and testing options that can be used to clarify true HIV status in these situations. In addition, we review the benefits and risks of 3 antiretroviral management options in these patients: (1) continue PrEP while conducting additional HIV tests, (2) initiate antiretroviral therapy for presumptive HIV infection while conducting confirmatory tests, or (3) discontinue PrEP to reassess HIV status after a brief antiretroviral-free interval. A clinical consultation resource is also provided.

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