Prioritization of high-cost new drugs for HCV: making sustainability ethical

Hepatitis C virus (HCV) infection is a major health problem worldwide. Chronic HCV infection may in the long run cause cirrhosis, hepatic decompensation and hepatocellular carcinoma, with an ultimate disease burden of at least 350,000 deaths per year worldwide. The new generation of highly effective direct acting antivirals (DAA) to treat HCV infection brings major promises to infected patients in terms of exceedingly high rates of sustained virological response (SVR) but also of tolerability, allowing even the sickest patients to be treated. Even in the face of the excellent safety and efficacy and wide theoretical applicability of these regimens, their introduction is currently facing cost and access issues denying their use to many patients in need. Health systems in all countries are facing a huge problem of distributive justice, since while they should guarantee individual rights, among which the right to health in its broader sense, therefore not limited to healing, but extended to quality of life, they must also grant equal access to the healthcare resources and keep the distribution system sustainable. In the face of a disease with a relatively unpredictable course, where many but not of all chronically infected will eventually die of liver disease, selective allocation of this costly resource is debatable. In most countries the favorite solution has been a stratification of patients for prioritization of treatment, which means allowing Interferon-free DAA treatment only in patients with advanced fibrosis or cirrhosis, while keeping on hold persons with lesser stages of liver disease. In this report, we will perform an ethical assessment addressing the issues linked to access to new therapies, prioritization and eligibility criteria, analyzing the meaning of the term “distributive justice” and the different approaches that can guide us (individualistic libertarianism, social utilitarianism and egalitarianism) on this specific matter. Even if over time the price of new DAA will be reduced through competition and eventual patent expiration, the phenomenon of high drug costs will go on in the next decades and we need adequate tools to face the problems of distributive justice that come with it

Correction to: Use of low-molecular weight heparin, transfusion and mortality in COVID-19 patients not requiring ventilation (Journal of Thrombosis and Thrombolysis, (2021), 52, 3, (772-778), 10.1007/s11239-021-02429-z)

none63In the original version of the article, the group was mentioned incorrectly. The correct name is "CSS COVID-19 Group". Also, in the Table 4 the p for ICU access and CKD were 0.024 (instead of 0.24) and 0.006 (instead of 0.06). These have been corrected with this erratum.noneGrandone E.; Tiscia G.; Pesavento R.; De Laurenzo A.; Ceccato D.; Sartori M.T.; Mirabella L.; Cinnella G.; Mastroianno M.; Dalfino L.; Colaizzo D.; Vettor R.; Intrieri M.; Ostuni A.; Margaglione M.; Alboini P.E.; Antonioni A.; Aucella F.; Bochicchio G.B.; Carbonelli C.; Carella M.; Castori M.; Centonze A.; Ciliberti G.; Copetti M.; Corritore M.; De Cosmo S.; D'Aloiso L.; D'Errico M.M.; de Matthaeis A.; Del Gaudio A.; Di Giorgio A.; Giambra V.; Greco A.; Florio L.; Fontana A.; Inchingolo V.; Inglese M.; Labonia M.; La Marca A.; Latiano T.; Leone M.; Maiello E.; Mangia A.; Marciano C.; Massa V.; Massafra S.; Orciulo G.; Palladino N.; Perna R.; Piscitelli P.; Piemontese M.; Prencipe M.A.; Raggi P.; Rodriquenz M.G.; Russo R.; Sancarlo D.; Simeone A.; Trischitta V.; Zarrelli M.; Vaira P.; Vergara D.; Vescovi A.Grandone, E.; Tiscia, G.; Pesavento, R.; De Laurenzo, A.; Ceccato, D.; Sartori, M. T.; Mirabella, L.; Cinnella, G.; Mastroianno, M.; Dalfino, L.; Colaizzo, D.; Vettor, R.; Intrieri, M.; Ostuni, A.; Margaglione, M.; Alboini, P. E.; Antonioni, A.; Aucella, F.; Bochicchio, G. B.; Carbonelli, C.; Carella, M.; Castori, M.; Centonze, A.; Ciliberti, G.; Copetti, M.; Corritore, M.; De Cosmo, S.; D'Aloiso, L.; D'Errico, M. M.; de Matthaeis, A.; Del Gaudio, A.; Di Giorgio, A.; Giambra, V.; Greco, A.; Florio, L.; Fontana, A.; Inchingolo, V.; Inglese, M.; Labonia, M.; La Marca, A.; Latiano, T.; Leone, M.; Maiello, E.; Mangia, A.; Marciano, C.; Massa, V.; Massafra, S.; Orciulo, G.; Palladino, N.; Perna, R.; Piscitelli, P.; Piemontese, M.; Prencipe, M. A.; Raggi, P.; Rodriquenz, M. G.; Russo, R.; Sancarlo, D.; Simeone, A.; Trischitta, V.; Zarrelli, M.; Vaira, P.; Vergara, D.; Vescovi, A

Use of low-molecular weight heparin, transfusion and mortality in COVID-19 patients not requiring ventilation

It is still debated whether prophylactic doses of low-molecular- weight heparin (LMWH) are always effective in preventing Venous Thromboembolism (VTE) and mortality in COVID-19. Furthermore, there is paucity of data for those patients not requiring ventilation. We explored mortality and the safety/efficacy profile of LMWH in a cohort of Italian patients with COVID-19 who did not undergo ventilation. From the initial cohort of 422 patients, 264 were enrolled. Most (n = 156, 87.7%) received standard LMWH prophylaxis during hospitalization, with no significant difference between medical wards and Intensive Care Unit (ICU). Major or not major but clinically relevant hemorrhages were recorded in 13 (4.9%) patients: twelve in those taking prophylactic LMWH and one in a patient taking oral anticoagulants (p: n.s.). Thirty-nine patients (14.8%) with median age 75 years. were transfused. Hemoglobin (Hb) at admission was significantly lower in transfused patients and Hb at admission inversely correlated with the number of red blood cells units transfused (p < 0.001). In-hospital mortality occurred in 76 (28.8%) patients, 46 (24.3%) of whom admitted to medical wards. Furthermore, Hb levels at admittance were significantly lower in fatalities (g/dl 12.3; IQR 2.4 vs. 13.3; IQR 2.8; Mann–Whitney U-test; p = 0.001). After the exclusion of patients treated by LMWH intermediate or therapeutic doses (n = 32), the logistic regression showed that prophylaxis significantly and independently reduced mortality (OR 0.31, 95% CI 0.13–0.85). Present data show that COVID-19 patients who do not require ventilation benefit from prophylactic doses of LMWH

N-3 fatty acids in patients with multiple cardiovascular risk factors

BACKGROUND: Trials have shown a beneficial effect of n-3 polyunsaturated fatty acids in patients with a previous myocardial infarction or heart failure. We evaluated the potential benefit of such therapy in patients with multiple cardiovascular risk factors or atherosclerotic vascular disease who had not had a myocardial infarction. METHODS: In this double-blind, placebo-controlled clinical trial, we enrolled a cohort of patients who were followed by a network of 860 general practitioners in Italy. Eligible patients were men and women with multiple cardiovascular risk factors or atherosclerotic vascular disease but not myocardial infarction. Patients were randomly assigned to n-3 fatty acids (1 g daily) or placebo (olive oil). The initially specified primary end point was the cumulative rate of death, nonfatal myocardial infarction, and nonfatal stroke. At 1 year, after the event rate was found to be lower than anticipated, the primary end point was revised as time to death from cardiovascular causes or admission to the hospital for cardiovascular causes. RESULTS: Of the 12,513 patients enrolled, 6244 were randomly assigned to n-3 fatty acids and 6269 to placebo. With a median of 5 years of follow-up, the primary end point occurred in 1478 of 12,505 patients included in the analysis (11.8%), of whom 733 of 6239 (11.7%) had received n-3 fatty acids and 745 of 6266 (11.9%) had received placebo (adjusted hazard ratio with n-3 fatty acids, 0.97; 95% confidence interval, 0.88 to 1.08; P=0.58). The same null results were observed for all the secondary end points. CONCLUSIONS: In a large general-practice cohort of patients with multiple cardiovascular risk factors, daily treatment with n-3 fatty acids did not reduce cardiovascular mortality and morbidity. Copyright © 2013 Massachusetts Medical Society