Isavuconazole has theoretical advantages over other mold-active triazoles for the treatment of invasive aspergillosis and mucormycosis after solid organ transplantation (SOT). The available clinical ...experience, nevertheless, is scarce.
We performed a retrospective study including all adult SOT recipients with proven or probable invasive mold disease (IMD) that received isavuconazole for ≥24 h as first-line or salvage therapy at 10 Spanish centers between September 2017 and November 2021. The primary efficacy outcome was clinical response (complete or partial resolution of attributable symptoms and findings) by weeks 6 and 12. Safety outcomes included the rates of treatment-emergent adverse events and premature isavuconazole discontinuation.
We included 81 SOT recipients that received isavuconazole for a median of 58.0 days because of invasive aspergillosis (n = 71) or mucormycosis (n = 10). Isavuconazole was used as first-line (72.8%) or salvage therapy due because of previous treatment-emergent toxicity (11.1%) or refractory IMD (7.4%). Combination therapy was common (37.0%), mainly with an echinocandin or liposomal amphotericin B. Clinical response by weeks 6 and 12 was achieved in 53.1% and 54.3% of patients, respectively, and was more likely when isavuconazole was administered as first-line single-agent therapy. At least 1 treatment-emergent adverse event occurred in 17.3% of patients, and 6.2% required premature discontinuation. Daily tacrolimus dose was reduced in two-thirds of patients by a median of 50.0%, although tacrolimus levels remained stable throughout the first month of therapy.
Isavuconazole is a safe therapeutic option for IMD in SOT recipients, with efficacy comparable to other patient groups.
Background
People living with human immunodeficiency virus (HIV) require specific pharmaceutical care (PC). Although the 2017 Capacity-Motivation-Opportunity (CMO) PC model allows a multidisciplinary ...approach that focuses on patient needs, it is too complex and presents room for improvement.
Objective
The aim of this study is to simplify and adapt the previous 2017 PC tool through a multidimensional approach to improve HIV patient care, to prove the validity of the model in real-life patients.
Methods
The new PC tool was generated by keeping some of the variables of the 2017 document and conducting a literature search. Content validity was determined by a 2-round Delphi methodology with an expert panel of 42 pharmacists. Consensus for the first and second rounds was defined as ≥70% agreement. The tool generated was validated in 407 real-life patients.
Results
Thirty-seven experts completed the first round of the Delphi survey and 36 the second. No consensus was reached for 3 variables, any of the frequency options and 4 interventions, while the experts agreed not to include 1 intervention in round 1. Consensus to include them was found for all but 1 variable and 1 intervention in round 2. The final tool obtained to select and stratify HIV-positive patients was composed of 9 dimensions divided into 17 variables. The new tool was validated with real-life patients and 3 priority levels were defined.
Conclusions and relevance
We created a new pyramid of score thresholds to classify patients into priority levels. The new tool simplifies the 2017 model and improves its utility to help HIV-positive patients, owing to its multidimensional approach.
Computerized physician order entry (CPOE) applications are widely used to prevent medical errors. In our center, a CPOE system has been in use since 2009 on both the inpatient and outpatient levels. ...A new and simple alert was introduced in the CPOE system to notify healthcare providers of the potential risk of viral reactivation when prescribing biological therapies, thereby facilitating the request for a serological profile (hepatitis B surface antigen HBsAg, anti‐HBc, and anti‐HBs) in patients who have not had these tests. Between May 2012 and May 2013, a total of 1,076 patients undergoing biological treatment were included in the implementation of the CPOE in our hospital, resulting in the identification of 4 HBsAg‐positive and 69 anti‐HBc‐positive/HBsAg‐negative patients, two of them with positive viral loads. Since the implementation of this alert system, over 90% of patients who were prescribed a biological drug (BD) have undergone serological screening to detect hepatitis B virus (HBV) infection. The use of the alert system has increased the screening rate from less than 50% to 94% for HBsAg and from less than 30% to 85% for anti‐HBc in patients for whom a BD is prescribed. Six patients received prophylactic antiviral therapy. No patient had HBV reactivation. Conclusion: This study demonstrates the feasibility of implementing a CPOE system that has allowed our hospital to increase the rate of HBV screening. Its use has facilitated the identification of patients at high risk for HBV reactivation and permitted physicians to prescribe prophylactic measures according to current guidelines. (Hepatology 2014;106–113)
Helicobacter pylori eradication remains a challenge. Non-bismuth-based quadruple regimens (NBQR) have shown high eradication rates (ER) elsewhere that need to be locally confirmed. The objective of ...this study was to compare the first-line ER of a hybrid therapy (20 mg of omeprazole twice daily and 1 g of amoxicillin twice daily for 10 days, adding 500 mg of clarithromycin twice daily and 500 mg of metronidazole every 8 h for the last 5 days; OA-OACM) with that of a 10 day concomitant regimen consisting of taking all four drugs twice daily every day (including 500 mg of metronidazole every 12 h; OACM). A 10 day arm with standard triple therapy (OAC; 20 mg of omeprazole/12 h, 1 g of amoxicillin/12 h and 500 mg of clarithromycin/12 h) was included.
Three hundred consecutive patients were randomized (1: 2: 2) into one of the three following regimens: (i) OAC (60); (ii) OA-OACM (120); and (iii) OACM (120). Eradication was generally confirmed by a (13)Curea breath test at least 4 weeks after the end of treatment. Adverse events and compliance were assessed. EudraCT: 2011-006258-99.
ITT cure rates were: OAC, 70.0% (42/60) (95% CI: 58.3-81.7); OA-OACM, 90.8% (109/120) (95% CI: 85.6-96.0); and OACM, 90.0% (107/119) (95% CI: 84.6-95.4). PP rates were: OAC, 72.4% (42/58) (95% CI: 60.8-84.1); OA-OACM, 93.9% (108/115) (95% CI: 89.5-98.3); and OACM, 90.3% (102/113) (95% CI: 84.8-95.8). Both NBQR significantly improved ER compared with OAC (P < 0.01), but no differences were seen between them. Mean compliance was elevated 98.0% (SD = 9.8) with no differences between groups. There were more adverse events in the quadruple arms (OACM, 65.8%; OA-OACM, 68.6%; OAC, 46.6%; P < 0.05), but no significant differences between groups in terms of severity were seen.
Hybrid and concomitant regimens show good ER against H. pylori infection with an acceptable safety profile. They clearly displace OAC as first-line regimen in our area.
Abstract
Objective: To assess the efficacy and safety of adalimumab in biologic naïve versus non-biologic naïve psoriasis patients.
Methods: A retrospective multicenter study of patients with ...moderate-to-severe psoriasis treated uninterruptedly with adalimumab between 6 and 36 months.
Results: A total of 100 patients (52 men, 48 women; mean age 45.5 years; 90% plaque-type psoriasis) were included. Previous treatments included biologics in 53 and non-biologic modalities in 47. The mean (SD) start Psoriasis Area and Severity Index (PASI) score was 15.9 (11.1) (range 2-55). The median follow-up was 18 months (interquartile range 10-24 months). Sixteen weeks after the start of treatment, 94% of the patients presented PASI 75 response, 76% PASI 90, and 39% were in complete remission (PASI 100). Similar findings were obtained in the groups of biologic naïve and non-biologic naive patients. At the final visit, around 37% in all groups were in complete remission. At the end of the study, 74 patients continued treatment with adalimumab (43 91.5% in the biologic naïve group and 31 58.5% in the non-biologic naïve group, p < 0.001).
Conclusion: This study confirms the efficacy and safety of adalimumab for moderate-to-severe psoriasis without differences between biologic naïve and non-naïve patients.
Pilot study to develop and validate a questionnaire based on HIV symptoms index Ibarra-Barrueta, Olatz; Mora-Atorrasagasti, Oihana; Legarreta, María José ...
Farmacia hospitalaria : organo oficial de expresion cientifica de la Sociedad Espanola de Farmacia Hospitalaria,
05/2019, Letnik:
43, Številka:
3
Journal Article
Recenzirano
Odprti dostop
The primary endpoint is to validate the HIV Symptoms Index Questionnaire in a Spanish population, in terms of comprehension and acceptability. The secondary endpoints are to describe symptoms ...reported by patients, tolerance, and quality of life.
The pilot trial of an observational and multicenter non-comparative study, for the validation of the HIV Symptoms Index Questionnaire in a Spanish population. Patients over the age of 18 diagnosed with HIV infection and receiving treatment were included. The symptoms index, treatment adherence based on pharmacy dispensing records, and quality of life with MOS-HIV questionnaire were calculated. Statistical analyses were conducted with the SAP System V9.2.
Between 2013 and 2014, the HIV Symptoms Index Questionnaire was applied to 75 patients; 95% of these patients considered the questionnaire was easy to apply and understand. The total median score of the questionnaire was nine symptoms (IQR 1-18); and the most frequent symptoms were nerves or anxiety (45%), stomach swelling, pain or gas (40%), sleep problems (39%), and fatigue or lack of energy (37%). Presence of symptoms was associated with a worse outcome in the MOS-HIV questionnaire. According to the Visual Analogue Scale, the higher the score in the questionnaire, the lower the tolerance level (R = -0.51; p < 0.0001), and the higher number of days with symptoms (R = 0.51; p < 0.0001).
The questionnaire was easy to apply. A high tolerance level was confirmed, as well as a consistent and significant correlation with the MOS-HIV and the Visual Analogue Scale.
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