ABSTRACT
Background. Cabotegravir + Rilpivirine Long Acting (CAB+RPV LA) every 2 months is a recommended regimen in European and US treatment guidelines for PLWH with virological suppression and no known resistance to CAB or RPV. CARISEL, an implementation study, is the first study where all participants switched from standard oral therapy to 2 monthly CAB+RPV. Key clinical and implementation secondary endpoints are reported. Methods. This single arm study enrolled virologically-suppressed PLWH to receive CAB+RPV LA 2-monthly at 18 clinics in 5 EU countries, conducted from Sept 2020-Feb 2022. Clinics with no prior experience with CAB+RPV LA were preferentially selected. Sites were randomized to standard implementation (Arm-S) or enhanced implementation (Arm-E) which included additional implementation strategies. Proportion of participants with plasma HIV-1 RNA >=50c/mL and < 50c/mL at Month 12 (FDA Snapshot algorithm, ITT-E) were reported. Adverse events, COVID-related events, clinic visit length, and safety were analyzed by implementation arm. Results. 72% of clinics (13/18) had no experience with CAB+RPV LA at study start. 430 enrolled and treated participants were included with 25% female, 18% black, and a mean baseline age of 44 yrs (30% > 50 years). At Month 12, 87% of participants maintained virologic suppression in each implementation arm (Table 1) and 1 participant (1/430;0.23%) in Arm-E experienced confirmed virologic failure. Grade 1-2 AEs were reported in Arm-E:99% vs Arm-S: 97%;Grade 3-4 drug-related AEs reported in Arm-E: 4%, Arm-S: 8%. ISRs were reported in 86% of participants;98% were mild or moderate, median duration of 3 days and a low proportion of participants discontinued treatment due to ISR (6%). Total time in clinic decreased more in Arm-E than Arm-S;visit length varied by country (Table 2). COVID was diagnosed in 16% of participants. COVID-19 related protocol deviations reported in 3% of participants. There were no discontinuations and no snapshot failures due to COVID-19. Conclusion. Regardless of implementation arm, CAB+RPV LA was a highly effective and well tolerated, consistent with clinical outcomes in the Phase 3 clinical program. Clinic visit lengths varied by country and decreased over time. COVID-19 did not lead to treatment disruption or study discontinuation. (Table Presented).
ABSTRACT
Background: The SARS-CoV-2 pandemic has had an unprecedented impact on healthcare systems, and cancer patients were amongst the most vulnerable. CONTACT is a national multidisciplinary study assessing the impact of the SARS-CoV-2 pandemic upon diagnostic and treatment pathways among patients with pancreatic ductal adenocarcinoma (PDAC). Method(s): A novel, mixed prospective and retrospective design, with retrospective case identification of both cohorts, and trainee-performed data collection. The treatment of consecutive patients with newly diagnosed PDAC from a pre-COVID cohort (07/01/ 2019-03/03/2019) were compared to a cohort diagnosed during the first wave of SARS-CoV-2 in the UK ('COVID' cohort, 16/03/2020-10/05/ 2020), with 12-month follow-up. Result(s): Among 984 patients (pre-COVID: N=483, COVID: N=501), across 96 hospitals, the COVID cohort were less likely to receive staging investigations other than CT scan (148/501, 29.5% vs 180/486, 37.2%;p=0.01). Among patients treated with curative intent, there was a reduction in the proportion of patients recommended surgery (42/77, 54.5% vs 72/94, 76.6%, p=0.001) and increase in the proportion recommended neoadjuvant therapy (35/77, 45.5% vs 22/94, 23.4%, p=0.002). Among patients within a non-curative pathway, fewer patients were recommended (201/424, 47.4% vs 223/389, 57.3%, p=0.004) or received palliative therapy (87/424, 20.5% vs 103/389, 26.5%, p=0.045). Ultimately, fewer patients in the COVID cohort underwent resection surgery (29/501, 6.4% vs 45/483, 9.3%, OR 0.64, 95%CI: 0.37- 0.97, p=0.036), whilst more patients received no treatment whatsoever (347/ 501, 69.3% vs 286/483, 59.2% p=0.009). There was no difference in median survival between the COVID and pre-COVID cohorts, (105 days, IQR: 86-124 vs 130 days, IQR: 108-157, p=0.093). Conclusion(s): The CONTACT study confirms alarming reduction in the staging and treatment provided to patients with PDAC diagnosed during the SARS-CoV-2 pandemic. Restoration of cancer services to pre-pandemic standards must be urgently addressed.
ABSTRACT
Introduction: The use of continuous glucose monitors (CGM) and insulin pumps (PUMP) have been associated with improved outcomes in type 1 diabetes (T1D) care. Therefore, disengaging from these devices represents a risk for worsening health outcomes. Objective(s): We sought to evaluate the effect of the COVID-19 pandemic on device disengagement rates by race and ethnicity. Method(s): This retrospective cohort study Pre-COVID-19 [n = 15,838] + peri-COVID-19 ([n = 14,799]) used EMR data from 15 sites (i.e., 3 adult and 12 pediatric diabetes centers) within the T1D Exchange Quality Improvement Collaborative. We identified individuals using at least one Advanced Diabetes Technology (ADT [PUMP or CGM]) at their most recent visit. Individuals who continued to use that technology for at least two subsequent visits were classified as engaged. Those who reported not using ADT in two subsequent visits were classified as disengaged. Result(s): Comparing pre-COVID-19 (January 2017-March 2020) to peri-COVID-19 (April 2020-2021) time periods, we observed increases in disengagement among non-Hispanic White (NHW;42% to 45%, p = 0.03) and Hispanic (12% to 19%, p < 0.001) individuals. We found no difference among NH Black (NHB;61% to 62%, p = 0.7) individuals. Conclusion(s): The pandemic has presented self-care challenges for individuals with T1D, including continued use of ADT. NHB individuals exhibited the highest disengagement rates overall, while NHW/Hispanic individuals experienced significant pandemic-related increases in disengagement. Future research should evaluate the relative impact of intrinsic (i.e., patient-level) versus extrinsic (i.e., family-, environment-, and system-level) factors associated with race-/ethnicity- based differences in rate of disengagement.
ABSTRACT
Background: Several studies have been published on a rare side effect of severe venous thrombosis at unusual sites and thrombocytopenia after vaccination against SARS-CoV- 2, referred to as vaccine-induced immune thrombocytopenia and thrombosis (VITT). Aim(s): To identify new cases of acute splanchnic vein thrombosis (SVT) or Budd-Chiari Syndrome (BCS) who presented following SARS-CoV- 2 vaccination in the Vascular Liver Disease Group (VALDIG) network, and to evaluate the incidence of VITT. Method(s): We conducted a prospective international cohort study between May 1st, 2021 and January 10th, 2022, on consecutive patients with acute SVT or BCS who presented within 6 weeks following any type or dose of SARS-CoV- 2 vaccination. Anonymous data were collected including baseline characteristics, risk factors, treatment and survival. Cases were identified as definite VITT, probable VITT or possible VITT or unlikely VITT as defined by Pavord et al (NEJM 2021). Result(s): 25 patients with acute (N = 24) or recurrent (N = 1) SVT or BCS were collected from 14 centers in 4 countries (after ChAdOx1 nCoV-19 N = 11, BNT162b2 N = 9, Ad26.COV2.S N = 1, mRNA-1273 N = 1). Median time after vaccination to symptoms was 10 days (2-40). Median age was 52.5 years (21-66), 52% were female. Three patients (12%) fulfilled criteria for definite VITT, 6 (24%) for probable VITT, 2 (8%) for possible VITT, 14 (56%) for unlikely VITT. Thrombosis was located in the portal vein (N = 20), hepatic vein(s) (N = 9), mesenteric vein (N = 18) or splenic vein (N = 9). Concomitant extra-abdominal thrombosis was seen in 5 patients (20%). Patients were treated with LMWH (60%), DOACs (24%) or VKA (40%). Six (2/3 with definite VITT) received IVIG. Thrombophilia was found in 5 patients and 3 had a myeloproliferative neoplasm. Conclusion(s): 25 cases of acute SVT or BCS following SARS-CoV- 2 vaccination were identified. Although definite VITT was rare (12%), no underlying disorder was identified in the majority of patients, contrary to 'typical' cases of SVT and BCS.
ABSTRACT
Background: Patients with end stage renal failure are not only at high risk of developing Coronavirus disease 2019 (COVID-19) but there are reports of disproportionately severe impact on dialysis patients, with reported short-term mortality of 20% or higher. The aim of this study was to assess the impact of COVID-19 in patients on peritoneal dialysis (PD). Method(s): We conducted a retrospective observational study across four hospitals in West Midlands in United Kingdom. We identified a total of 50 patients on PD, 18 years and over, with a positive SARS-COV-2 swab from 1st of January 2020 to 31st of December 2020. Data was analysed using IBM SPSS software. We looked at mortality (7 days, 28 days, 3 months), intensive therapy unit (ITU) admission, ventilation requirement, peritonitis and conversion to haemodialysis. Result(s): The mean age was 63 years, with higher prevalence in men (66%). 54% were of white ethnicity (46% of Black, Asian and minority ethnic groups). 10 out of the 50 patients (20%) had died within 7 days, 17 (34%) had died within 28 days and 19 (38%) were not alive at 3 months. 3 patients (6%) required ITU admission. 4 patients (8%) received non-invasive ventilation, but none required mechanical ventilation. 4 patients (8%) were converted to haemodialysis. 8 patients (16%) had peritonitis. Conclusion(s): We found a high risk of short-term mortality in our PD patients who acquired COVID-19 infection. However, more studies are required to establish any causal link between COVID-19 infection in PD patients and high short-term mortality.