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Background and Importance The Spanish Medicines and Health Products Agency (AEMPS) has developed criteria to adapt the prescription of sotrovimab1, due to the pandemic situation and the limited drug stock. Aim and Objectives To describe the patients' population on treatment with sotrovimab and to assess the adequacy of this prescription according to the criteria established by the AEMPS. Material and Methods Retrospective observational study analysing all sotrovimab prescriptions in patients with SARS-CoV-2 infection from 01/25/2022 to 08/31/2022. Demographic variables and data required by the AEMPS for sotrovimab prescription were collected: Omicron variant infection, SARS-CoV-2 vaccination status, serology [anti-S antibody< 260 BAU (binding antibody units)/mL]. Also, patients had to belong to one of the following groups: * Group 1: Immunocompromised, regardless of vaccination status. * Group 2: >80 years unvaccinated. * Group 3: >65 years (regardless of vaccination status) and >=1 risk factor for progression. Prescriptions for sotrovimab were collected and analysed to determine whether they met the criteria and whether they were accepted. Data collected from electronic medical records and processed using Excel2019. Results Fifty patients were included, 62% male;median age 69 years (IQR=60-76). 100% had the Omicron variant. Vaccination status: 84% complete, 6% incomplete and 10% unvaccinated. Serology: 96% (<260 BAU/mL) and 4% (>260 BAU/ ml). 92% belonged to group 1 (39% solid organ transplantation, 29% active myelotoxic chemotherapy, 13% non-cytotoxic onco-haematological treatments with neutropenia/lymphopenia, 13% treatment with biological immunomodulators, 2% Down's syndrome, 2% haematopoietic stem cell transplantation or CAR-T, 2% HIV infection (with <=200 cells/mL). Two per cent belonged to group 2. The remaining patients (6%) did not belong to any group. Ten per cent of the applications did not meet the criteria: four of them were not accepted (patients did not belong to any risk group);one was accepted, although it was a well-controlled HIV. Conclusion and Relevance The main profile of patients treated with sotrovimab is men with solid organ transplantation, vaccinated and with negative immunity to SARS-CoV-2. Although the appropriateness of the prescription is high, it is necessary to continue protocolising the use of this drug to ensure its rational use.
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Background and Importance On March 28th 2022, nirmatrelvir/ ritonavir was marketed in Spain. The Spanish Agency for Medicines and Medical Devices (AEMPS) established criteria to prioritise its administration in patients at high risk of progression to severe COVID. Data regarding the effectiveness and safety of nirmatrelvir in preventing severe coronavirus disease outcomes are limited. Aim and Objectives To assess the effectiveness and safety of nirmatrelvir/ritonavir in patients at high risk for severe COVID-19. Material and Methods Prospective descriptive study from April to August 2022 of patients treated with nirmatrelvir/ritonavir. Sociodemographic variables, vaccination status, hospital admission, high risk factors for progression and concomitant treatment were recorded. Readmissions were recorded within 30 days of the end of antiviral treatment. Results 53 patients were included with a mean age of 64 years, 51% women and 49% men. 57% were vaccinated with 3 doses, 17% with 2 doses, 9% with 4 doses, 6% with 1 dose and 11% were not vaccinated. 34% (18/53) were hospitalised at the time of initiation of treatment. The most prevalent high-risk criteria were: 24% active treatment with myelotoxic chemotherapy, 21% treatment in the previous 6 months with anti-CD20 drugs, 14% over 80 years vaccinated with some risk factor for progression, 7% patients with onco-haematological treatment and 7% in treatment in the previous 3 months with inhibitors of the proteinkinase. 3 treatments were performed off-label for persistent covid. The mean number of days from the onset of symptoms to the start of treatment was 1.6 days. 23% of patients required dose adjustment due to renal impairment. 53% required adjustment of chronic treatment for interactions, mainly with metamizole, statins, fentanyl and diazepam. 2 patients received remdesivir and sotrovimab, 2 remdesivir and another two sotrovimab. 4 (7%) patients were readmitted within 30 days after the end of treatment with nirmatrelvir ritonavir, 1 of them with persistent covid. One patient stopped treatment for hives. Conclusion and Relevance Nirmatrelvir ritonavir has been shown to be a safe and effective drug in high-risk patients of progression to severe covid.
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Background and Importance Nirmatrelvir/ritonavir (PAXLOVID) is a recently approved drug to prevent progression in high-risk COVID-19-infected patients. Aim and Objectives To evaluate prescribing and dispensing of PAXLOVID and the proportion of patients with hospitalisation or death from any cause at 28 day. Material and Methods Descriptive, retrospective, observational study carried out between May and August 2022 in a secondlevel hospital. All patients with PAXLOVID prescription were selected. Sources of information were: electronic medical records and the prescription programme. The Variables analysed were: sex, age, risk factors, indications, interactions, dispensation (yes/no) and final treatment received. Risk factors were evaluated with our country's drug regulatory agency (DRA) recommendations to assesed the indication. Efficacy was assessed by the proportion of patients admitted to hospital and 28-day mortality. Results PAXLOVID was prescribed to 34 patients, 14 (41.2%) were women. The median age was 76.3 years old [RIQ 25.4]. Main indications for PAXLOVID were: to be undergoing treatment with myelotoxic chemotherapy (32.3%), corticosteroids or other immunosuppressants (29.4%);being over 80 years of age and presenting specific Risk factors (14.7%) and primary immunodeficiency (5.8%). 21 patients (61.8%) had some relevant interaction with their usual medication. The most frequent interactions were with statins (23.5%), analgesics (20.6%), oral anticoagulants (12%), antiarrhythmics (8.8%), antiplatelet drugs (5.8%), antidepressants (5.8%) and antidiarrhoeals (5.8%). After Validation by the Pharmacy Service, 11 patients (32.4%) did not receive PAXLOVID, 5 because they did not meet DRA criteria, 2 because their glomerular filtration rate was less than 30 ml/min and 4 because they had incompatible interactions. 4 patients finally received 3 days-remdesivir. Among patients who received PAXLOVID, 82.26% received full doses, with 4 patients (11.76%) requiring adjustment for renal impairment. 3 patients (13%) were hospitalised in the first month, none died. Conclusion and Relevance The main indications for which PAXLOVID was prescribed were patients undergoing chemotherapy and/or immunosuppressive treatments. Interactions with PAXLOVID were frequent and in some cases limited treatment. Validation by Pharmacy Service prevented a considerable number of patients from receiving PAXLOVID when it was no-indicated or when they had insurmountable interactions, also allowed patients to receive the dose adjusted for renal impairment. PAXLOVID was effective in avoiding hospital admission and mortality in the majority of patients.
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Category: Prostate Background to the audit: On top of conventional chemotherapy and hormonal manipulation, radium 223 treatment, which is given over six cycles, has been shown to improve symptoms and survival for castration-resistant metastatic prostate cancer in a previous alpharadin in symptomatic prostate cancer (ALSYMPCA) study. Standard: Inclusion and exclusion criteria were set out as per the original study. Indicator: The indication of this audit is to compare the safety and efficacy of our Mid and South Essex patients who received radium 223 treatment since the implementation of treatment in our trust in January 2018. Target: All the patients who received radium 223 treatment between January 2018 and November 2021 were included. Methodology: It was a retrospective cohort study. Results of first audit round: Our audit had fewer patients (n=36) compared with the original study (n=614). It demonstrated comparable inclusion and exclusion criteria for the treatment. However, we had lower overall survival of 13.5 months for the patients who completed six cycles of radium 223 compared with 14.9 months in the ALSYMPCA study. Being a single-centre audit, having older patients with poorer performance status, less bisphosphonate use and the global COVID pandemic during the time of our audit could have affected the survival outcome. However, when we compared our results with another UK study done in Mount Vernon and Lister Hospitals, they had comparable overall survival (13.1 months) for patients who completed all six doses of radium 223. First action plan: To continue current practice of careful patient selection for radium 223 treatment. To encourage use of bisphosphonate to help improve bony pain. References: 1. Parker C, Nilsson S, Heinrich D et al. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med 2013;369(3): 213-223. 2. Dadhania S, Alonzi R, Douglas S et al. Single-centre experience of use of radium 223 with clinical outcomes based on number of cycles and bone marrow toxicity. Anticancer Res 2018;38(9): 5423-5427. 3. Saad F, Sternberg CN, Mulders PF, Niepel D, Tombal BF. The role of bisphosphonates or denosumab in light of the availability of new therapies for prostate cancer. Cancer Treat Rev 2018;68: 25-37. Copyright © 2022
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Background: Research on the impact of COVID-19 on different patient populations has been of great value for the optimization of patient care since the start of the SARS-CoV-2 pandemic. Earlier, we reported the interim analysis of the immediate outcomes in patients (pts) with hematologic (hem) disease and COVID-19. Long-term results of the CHRONOS19 registry are now available. Methods: CHRONOS19 is an observational prospective cohort study among adult pts ((≥18 years) with hem diseases (malignant or non-malignant) and laboratory-confirmed or suspected (based on clinical symptoms and/or CT) COVID-19 in Russia. Data from 15 centers all over the country were collected on a web-based platform in a de-identified manner at 30, 90, and 180 days after COVID-19 was diagnosed. The primary endpoint was 30-day all-cause mortality. Secondary outcomes included COVID-19 complications, rate of ICU admission and mechanical ventilation, outcomes of hem disease in SARS-CoV-2 infected pts, overall survival, and risk factors for disease severity and mortality. Results: As of July 30, 2021, 666 pts were enrolled (females / males [n (%)]: 317 (48%) / 349 (52%);median [range] age: 56 [18-90] years. Disease types (malignant/non-malignant [n (%)]): 618 (93%) / 48 (7%), including AML 115 (17%), MM 113 (17%), NHL 106 (16%), CML / CMPD 92 (14%), ALL 52 (8%), CLL 50 (8%), MDS 25 (4%), HCL 23 (3%), HL 21 (3%), AA 16 (2%), APL 11 (2%), others 42 (6%);among them induction phase / remission / relapse or refractory / NA in 237 (35%) / 231 (35%) / 152 (23%) / 46 (7%) pts. Concomitant conditions were reported in 385 (58%) pts: cardiovascular 254 (66%), diabetes 76 (20%), obesity 57 (15%), pulmonary 41 (11%), chronic renal 44 (11%) or hepatic 33 (9%) disease, other 90 (23%). At a median follow-up of 7,5(1-19) months, 618 pts were evaluable for the primary outcome. Thirty-day all-cause mortality was 16% (100 pts died). Death due to COVID-19 complications occurred in 82 pts, 14 pts died due to progression of hem disease. Overall, 217 (33%) pts had severe disease, COVID-19 complications were detected in 458 (70%) pts, the most common were pneumonia in 425 (93%) pts, respiratory failure in 252 (55%) pts, multiple organ failure in 56 (12%) pts, cytokine storm in 52 (11%) pts, ARDS in 47 (10%) pts, and sepsis in 44 (10%) pts. The rate of ICU admission was 23% (145 pts) with high mortality in this group of pts (77%), 111 (17%) pts required mechanical ventilation, among them only 5 (4.5%) pts survived. Treatment of hem disease was changed, interrupted, or discontinued in 395 (60%) pts with a median delay of 4 weeks. At 30 days, the rate of relapse / progression of hem disease was 5% / 8% (24 / 40 of 517 evaluable pts). At the longer follow-up (90 and 180 days), relapse / progression occurred in another 9 / 23 pts. At the data cutoff, the median overall survival was not reached. Antibody detection was performed in 253 pts: 211 (84%) pts had IgG to SARS-CoV-2. In a univariate analysis, older age (> 60 years), myelotoxic agranulocytosis, transfusion dependence, diabetes among comorbidities, ARDS and other complications, except CRS, ICU and mechanical ventilation (Fig. 1) were associated with higher risks of mortality (p<0.05). The final results of the CHRONOS19 study will be presented. Conclusions: Patients with hem disease and COVID-19 have higher mortality than a general population with SARS-CoV-2 infection, predominantly due to COVID-19 complications. The longer-term follow-up did not reveal any concerns in terms of hem disease outcomes. [Formula presented] Disclosures: Vorobyev: Janssen, Roche, Sanofi, Takeda, Biocad, Abbvie: Other: Advisory Boards, Speakers Bureau;Astellas, Novartis, AstraZeneca: Speakers Bureau. Chelysheva: Pharmstandart: Speakers Bureau;Pfizer: Speakers Bureau;Bristol Myers Squibb: Speakers Bureau;Novartis Pharma: Speakers Bureau.