Background: Real-world data are critical to demonstrate the reproducibility of evidence and the external generalizability of randomized clinical trials. Palbociclib is an oral small-molecule inhibitor of cyclin-dependent kinases 4/6 that has been shown to improve progression-free survival when combined with letrozole or fulvestrant in phase 3 clinical trials.  Objective: To evaluate real-world outcomes in patients with metastatic breast cancer who received palbociclib in combination with endocrine therapy in routine clinical practice.  Methods: In this retrospective observational multicentre study, data were evaluated for all women with metastatic breast cancer who were treated with palbociclib from April 2017 to September 2019. Treatment response was assessed through progression-free survival according to the Response Evaluation Criteria in Solid Tumors, version 1.1.  Results: Fifty-three patients were included in the study, with median age 57 years (range 31–87 years). For all patients treated with palbociclib, median progression-free survival by the end of the study period was 14.4 months (95% confidence interval [CI] 6.2–22.2 months). Twenty-three women who received palbociclib as a first-line treatment did not experience progression-free survival; for these patients, the median treatment duration was 12.1 months (95% CI 1.4–28.0 months). For the 23 patients who received palbociclib as second-line therapy for metastatic breast cancer, median progression-free survival was 13.3 months (95% CI 4.1–22.4 months). Among the 7 women who received palbociclib as third-line therapy, median progression-free survival was 6.0 months (95% CI 0.9–11.1 months). The most common adverse events were hematologic, with grade 3 or 4 neutropenia occurring in 20 (38%) of the 53 patients.  Conclusions: This study provides data from a real-world setting that match the results of previous studies in terms of effectiveness (i.e., progression-free survival) when palbociclib plus endocrine therapy was used as second- or third-line treatment. Palbociclib had appropriate tolerability and a profile of easily manageable adverse effects, with none of the patients suspending their treatment because of toxic effects.  RÉSUMÉ  Contexte : Les données du monde réel sont essentielles pour démontrer la reproductibilité des éléments probants et la « généralisabilité » externe des essais cliniques randomisés. Il a été démontré qu’en association avec le létrozole ou le fulvestrant dans les essais cliniques de phase 3, le palbociclib (un inhibiteur oral à petite molécule des kinases dépendantes des cyclines 4/6) améliorait la survie sans progression.  Objectif : Évaluer les résultats réels des patientes atteintes d’un cancer du sein métastatique qui ont reçu du palbociclib en association avec un traitement endocrinien dans le cadre d’une pratique clinique de routine.  Méthodes : Dans cette étude observationnelle rétrospective multicentrique, les données ont été évaluées pour toutes les femmes atteintes d’un cancer du sein métastatique et qui ont été traitées avec du palbociclib d’avril 2017 à septembre 2019. La réponse au traitement a été évaluée par la survie sans progression au moyen des critères RECIST d’évaluation de la réponse des tumeurs solides, version 1.1.  Résultats : Cinquante-trois patientes (âge médian : 57 ans; extrêmes 31- 87 ans) ont été incluses dans l’étude. Pour toutes les patientes traitées avec le palbociclib, la survie moyenne sans progression à la fin de la période d’étude était de 14,4 mois (intervalle de confiance à 95 % [IC] 6,2-22,2 mois). Vingt-trois femmes ayant reçu du palbociclib en guise de traitement de première ligne n’ont pas connu de survie sans progression; pour ces patientes, la durée moyenne du traitement était de 12,1 mois (IC à 95 % 1,4-28 mois). Pour les 23 patientes ayant reçu le palbociclib en guise de traitement de deuxième ligne pour le cancer du sein métastatique, la survie moyenne sans progression était de 13,3 mois (IC à 95 % 4,1-22,4 mois). Parmi les 7 femmes ayant reçu le palbociclib en guise de traitement de troisième ligne, la survie moyenne sans progression était de 6,0 mois (IC à 95 % 0,9-11,1 mois). Les effets indésirables les plus fréquents étaient d’ordre hématologique, avec une neutropénie de grade 3 ou 4 survenant chez 20 (38 %) des 53 patientes.  Conclusions : Cette étude fournit des données provenant d’un contexte réel. Elles correspondent aux résultats d’études précédentes en termes d’efficacité (c’est-à-dire « survie sans progression ») lorsque le palbociclib, associé à un traitement endocrinien, était utilisé comme traitement de deuxième ou de troisième ligne. Le seuil de tolérance du palbociclib est approprié et son profil d’effets indésirables est facilement gérable : aucune des patientes n’a en effet suspendu son traitement en raison d’effets toxiques.

Background Chronic hepatitis C treatment has changed with the direct-acting antivirals (DAAs) for the hepatitis C virus (HCV) with high levels of safety and effectiveness. Available data from clinical trials reveal that baseline factors at the beginning of treatment can influence treatment results: viral genotype, baseline viral load, degree of fibrosis and previous treatments. Purpose To assess the influence of different variables on the effectiveness of Sofosbuvir(SOF)/Ledipasvir(LDV) in HCVpatients. Material and methods Retrospective-observational study. Study period: April 2015-February 2016. Inclusion-criteria: Patients with HCV infection treated with SOF/LDV,12 weeks. Exclusion-criteria: Patients with no data. Outcomes collected: Demographics: age/sex. Clinical data: basal-viral-load (VL), sustained-virological-response at week 12 (SVR12), defined as HCV-RNA titres lower than 15I U/mL 12 weeks after end of treatment. METAVIR-score: F0-F4. Liver-transplant, HCV-genotype (G), HIV-coinfection, previous treatments for HCV. Logistic regressions were used to identify independent clinical and demographic predictors of treatment failure. Analyses were performed by SPSS.v17. All associations were tested at a significance level of 0.05. Results 124 patients were included (65.6% men); mean age, 56.67±10.07 years. Naive (60.7%), 25.4% HIV-coinfected; 14.8% liver-transplant patients; genotypes: 9.68% G1; 23.38% G1a; 37.10% G1b; 12.90% G3; 16.94% G4. 63.9% patients had VL>800 000 UI/ml. Adherence to DDAs: 100%. Fibrosisdegree: 6.6% F1, 26.2% F2, 33.6% F3 and 33.6% F4.Global SVR12 was 91.67% and all patients with HCV G1a, G1b, G4 achieved SVR12. Only one pre-treated-non-cirrhotic HCV G1 patients relapsed. The lowest SVR12 were obtained for G3 (43.75%) (7/16). None of the variables analyzed significantly influenced on SVR12, except G(p=0.001). Most of relapses occurred in G3. Conclusion Variables analyzed didn´t influence on SVR12 matching the results of Kouris et al. 2018. However, we observed G influenced on SVR12 . It has been observed LDV is less active against G3 in-vitro (Gane et al. 2015).

on the documentation available at the point-of-care ('Hospital list'), which in turn got validated via NEHR data ('NEHR list'), with the final step being a patient interview, formulating the final medication list ('BPMH list'). Primary outcome metrics were the frequency and types of medication discrepancies derived from the comparison of the aforementioned lists, including the former SoC. ResultsThe study included 100 patients (52% female, average age=62 years). 231 discrepancies were found between the NEHR list and the Hospital list (median=2; IQR=4), 64% of the patients being affected. The most common discrepancy was drug omission (65%) and incorrect daily dose (26%). There was an inconsistency between the BPMH list and the SoC in 90% of the patients (median=3; IQR=3), the most common errors being drug omission (41%) and incorrect daily dose (31%). Conclusion and RelevanceBased on these results, the NEHR can contribute to the compilation of a more prudent BPMH due to its more comprehensive data content. This methodology may, in turn, facilitate the prevention of multiple medication-related errors. These outcomes also underline the legitimacy of pharmacists' access to such national systems.

Background and Importance Boosting generics is an indispensable approach in conducting cost-saving management in healthcare systems. In fact, generics can provide similar effectiveness and safety to originators but with lower costs and can increase market competition.

syndrome and multiorgan failure occurred. Respiratory support and ionotropic agents were started in the intensive care unit. The diagnostic suspicion of atypical incomplete KD, non-coronary involvement, was confirmed and treatment was switched to intravenous immunoglobulin 2 g/kg/ day, acetylsalicylic acid 30 mg/kg/day and methylprednisolone infusion until the day of discharge. On illness day 10, laboratory blood tests showed progressive reduction in inflammation markers and rapid normalisation of liver enzymes (lipase 1824, amylase 502, declining leucocytes 8.57, Hb 12, negative CRP). Because of the uncertainty about the cause, anti-S-specific IgG antibodies to SARS-CoV-2 were measured. Serology testing for SARS-Cov-2 revealed IgG antibody concentrations. On day 12 of the illness, she was discharged. Conclusion and relevance It is known that SARS-CoV-2 infection can activate uncontrolled inflammation. Cases are being informally reported among paediatricians, and recently patients with severe forms have been reported, emphasising the apparent rise in the number of children presenting with a multisystem inflammatory state requiring intensive care. The connection between viral infections and KD, the analogies between the two conditions, open new perspectives with regard to aetiopathogenesis.