scholarly journals Efficacy of remdesivir-containing therapy in hospitalized COVID-19 patients: a prospective clinical experience

Author(s):  
Alessandro Russo ◽  
Erica Binetti ◽  
Cristian Borrazzo ◽  
Elio Gentilini Cacciola ◽  
Luigi Battistini ◽  
...  

Objectives: remdesivir is currently approved for the treatment of COVID-19. The recommendation for using remdesivir in COVID-19 was based on the in vitro and in vivo activity of this drug against SARS-CoV-2. Methods: this was a prospective, observational study conducted on a large population of patients hospitalized for COVID-19. The primary endpoint of the study was to evaluate the impact of remdesivir-containing therapy on 30-day mortality; secondary endpoint was the impact of remdesivir-containing therapy on the need of high flow oxygen therapy (HFNC) or non-invasive ventilation (NIV) or mechanical ventilation. Data were analyzed after propensity score matching. Results: 407 patients with SARS-CoV-2 pneumonia were consecutively enrolled. Out of these, 294 (72.2%) and 113 (27.8%) were respectively treated or not with remdesivir. Overall, 61 (14.9%) patients were treated during hospitalization with non-invasive or mechanical ventilation, while a 30-day mortality was observed in 21 (5.2%) patients. Cox regression analysis, after propensity score matching, showed that therapies, including remdesivir-containing therapy, were not statistically associated with 30-day survival or mortality, while need of HFNC/NIV (HR 17.921, CI95% 0.954-336.73, p=0.044) and mechanical ventilation (HR 3.9, CI95% 5.36-16.2, p=0.003) resulted independently associated with 30-day mortality. Finally, therapies including or not remdesivir were not independently associated with lower or higher risk of HFNC/NIV or mechanical ventilation. Conclusions: this real-life experience about the remdesivir use in hospitalized patients with COVID-19 was not associated with significant increase in rates of survival or reduced use of HFNC/NIV or mechanical ventilation, compared to patients treated with other therapies not including remdesivir.

2021 ◽  
Vol 10 (17) ◽  
pp. 3784
Author(s):  
Alessandro Russo ◽  
Erica Binetti ◽  
Cristian Borrazzo ◽  
Elio Gentilini Cacciola ◽  
Luigi Battistini ◽  
...  

Objectives: Remdesivir is currently approved for the treatment of COVID-19. The recommendation for using remdesivir in patients with COVID-19 was based on the in vitro and in vivo activity of this drug against SARS-CoV-2. Methods: This was a prospective observational study conducted on a population of patients hospitalized for COVID-19. The primary endpoint of this study was the impact of remdesivir-containing therapy on 30-day mortality; the secondary endpoint was the impact of remdesivir-containing therapy on the need for high-flow oxygen therapy (HFNC), non-invasive ventilation (NIV), or mechanical ventilation. The data were analyzed after propensity score matching. Results: A total of 407 patients with SARS-CoV-2 pneumonia were consecutively enrolled. Out of these, 294 (72.2%) were treated with remdesivir and 113 (27.8%) were not. Overall, 61 patients (14.9%) were treated during hospitalization with HFNC, NIV, or mechanical ventilation, while 30-day mortality was observed in 21 patients (5.2%). Univariate analysis of patients treated with remdesivir or not showed no differences in 30-day mortality (4% vs. 6%, p = 0.411) in the two study groups. Cox regression analysis, after propensity score matching, showed that therapies, including remdesivir-containing therapy, were not statistically associated with 30-day survival or mortality. The Kaplan–Meier curves of 30-day survival in patients treated with remdesivir or not before (p = 0.24) and after (p = 0.88) propensity score matching showed no differences between the two study groups. Finally, patients treated with remdesivir or not showed the same need for HFNC/NIV or mechanical ventilation. Conclusions: This real-life experience of remdesivir use in hospitalized patients with COVID-19 was not associated with significant increases in rates of survival or reduced use of HFNC/NIV or mechanical ventilation compared with patients treated with other therapies not including remdesivir.


2020 ◽  
Author(s):  
Chih-Wen Lin ◽  
Yaw-Sen Chen ◽  
Gin-Ho Lo ◽  
Yao-Chun Hsu ◽  
Chia-Chang Hsu ◽  
...  

Abstract Background: Patients with Barcelona Clinic Liver Cancer (BCLC) stage B hepatocellular carcinoma (HCC) are recommended to undergo transcatheter arterial chemoembolization (TACE). However, TACE in combination with radiofrequency ablation (RFA) is not inferior to surgical resection (SR), and the benefits of surgical resection (SR) for BCLC stage B HCC remain unclear. Hence, this study aims to compare the impact of SR, TACE+RFA, and TACE on analyzing overall survival (OS) in BCLC stage B HCC. Methods: Overall, 428 HCC patients were included in BCLC stage B, and their clinical data and OS were recorded. OS was analyzed by the Kaplan-Meier method and Cox regression analysis. Results: One hundred forty (32.7%) patients received SR, 231 (53.9%) received TACE+RFA, and 57 (13.3%) received TACE. The OS was significantly higher in the SR group than that in the TACE+RFA group [hazard ratio (HR): 1.78; 95% confidence incidence (CI): 1.15-2.75, p=0.009]. The OS was significantly higher in the SR group than that in the TACE group (HR: 3.17; 95% CI: 2.31-4.36, p<0.0001). Moreover, the OS was significantly higher in the TACE+RFA group than that in the TACE group (HR: 1.82; 95% CI: 1.21-2.74, p=0.004). The cumulative OS rates at 1, 3 and 5 years in the SR, TACE+RFA, and TACE groups were 89.2%, 69.4% and 61.2%, 86.0%, 57.9% and 38.2%, and 69.5%, 37.0% and 15.2%, respectively. After propensity score matching, the SR group still had a higher OS than those of the TACE+RFA and TACE groups. The TACE+RFA group had a higher OS than that of the TACE group. Conclusion: The SR group had higher OS than the TACE+RFA and TACE groups in BCLC stage B HCC. Furthermore, the TACE+RFA group had higher OS than the TACE group.


2020 ◽  
Author(s):  
Gang Wang ◽  
Ling Wen Wang ◽  
Jie Hai Jin ◽  
min Hong Dong ◽  
wei Wei Chen ◽  
...  

Abstract Background: To evaluate the impact of primary tumor radiotherapy on survival in patients with unresectable metastatic rectal or rectosigmoid cancer. Methods: Form September 2008 to September 2017, 350 patients with unresectable metastatic rectal or rectosigmoid cancer were retrospectively reviewed in our center. All patients received at least 4 cycles of chemotherapy, and were divided into two groups according to with primary tumor radiotherapy or without. 163 patients received primary tumor radiotherapy, and the median radiation dose was 56.69Gy(50.4-60). Survival curves were estimated from the Kaplan–Meier procedure to roughly compare survival among two groups. Subsequently, 18-month survival was used as the outcome variable for this study. This study mainly evaluated the impact of primary tumor radiotherapy on survival of these patients through a series of multivariate Cox regression analyses after propensity score matching (PSM). Results: The median follow-up time was 21 months. All 350 patients received a median of 7 cycles of chemotherapy (range 4-12), 163 (46.67%) patients received primary tumor radiotherapy for local symptoms. The Kaplan–Meier survival curves showed a significant overall survival (OS) advantage for primary tumor radiotherapy group to without radiotherapy (20.07 vs 17.33 months; P=0.002). In this study, multivariate Cox regression analysis after adjusted covariates, multivariate Cox regression analysis after PSM, and inverse probability of treatment weighting (IPTW) analysis and propensity score (PS)-adjusted model analysis consistently showed that primary tumor radiotherapy could effectively reduce the risk of death for these patients at 18 months (HR: 0.62, 95% CI 0.40-0.98; HR:0.79, 95% CI:0.93-1.45; HR: 0.70, 95% CI 0.55-0.99 and HR: 0.74, 95% CI:0.59-0.94). Conclusion: Compared with patients with stage IV rectal or rectosigmoid cancer who did not receive primary tumor radiotherapy, received primary tumor radiotherapy reduced the risk of death in these patients. The radical doses(59.4Gy/ 33 fractions or 60Gy/ 30 fractions) of radiation for primary tumors might be considered for unresectable metastatic rectal or rectosigmoid cancer, not just for relieve symptoms. Keywords: Stage IV Rectal cancer, primary tumor radiotherapy, propensity score matching.


2020 ◽  
Author(s):  
Chih-Wen Lin ◽  
Yaw-Sen Chen ◽  
Gin-Ho Lo ◽  
Yao-Chun Hsu ◽  
Chia-Chang Hsu ◽  
...  

Abstract Background: Patients with Barcelona Clinic Liver Cancer (BCLC) stage B hepatocellular carcinoma (HCC) are recommended to undergo transcatheter arterial chemoembolization (TACE). However, TACE in combination with radiofrequency ablation (RFA) is not inferior to surgical resection (SR), and the benefits of surgical resection (SR) for BCLC stage B HCC remain unclear. Hence, this study aims to compare the impact of SR, TACE+RFA, and TACE on analyzing overall survival (OS) in BCLC stage B HCC.Methods: Overall, 428 HCC patients were included in BCLC stage B, and their clinical data and OS were recorded. OS was analyzed by the Kaplan-Meier method and Cox regression analysis. Results: One hundred forty (32.7%) patients received SR, 231 (53.9%) received TACE+RFA, and 57 (13.3%) received TACE. The OS was significantly higher in the SR group than that in the TACE+RFA group [hazard ratio (HR): 1.78; 95% confidence incidence (CI): 1.15-2.75, p=0.009]. The OS was significantly higher in the SR group than that in the TACE group (HR: 3.17; 95% CI: 2.31-4.36, p<0.0001). Moreover, the OS was significantly higher in the TACE+RFA group than that in the TACE group (HR: 1.82; 95% CI: 1.21-2.74, p=0.004). The cumulative OS rates at 1, 3 and 5 years in the SR, TACE+RFA, and TACE groups were 89.2%, 69.4% and 61.2%, 86.0%, 57.9% and 38.2%, and 69.5%, 37.0% and 15.2%, respectively. After propensity score matching, the SR group still had a higher OS than those of the TACE+RFA and TACE groups. The TACE+RFA group had a higher OS than that of the TACE group. Conclusion: The SR group had higher OS than the TACE+RFA and TACE groups in BCLC stage B HCC. Furthermore, the TACE+RFA group had higher OS than the TACE group.


2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Wei Peng ◽  
Chuan Li ◽  
Xiaoyun Zhang ◽  
Tianfu Wen ◽  
Zheyu Chen

Abstract Background Thrombocytopenia was reported both detrimental and advantageous to hepatocellular carcinoma (HCC). However, there is little evidence showing clearly the clinical value of preoperative thrombocytopenia on the surgical outcome of patients with small HCC. This retrospective study aimed at elucidating the correlation between preoperative thrombocytopenia and surgical outcome of small HCC patients within Milan criteria treated with liver resection. Methods Data of hepatitis B virus (HBV)-related small HCC patients were retrospectively analyzed, and we performed the propensity score matching (PSM) analysis to overcome the imbalance of clinicopathological features. Patients enrolled were subsequently categorized into two groups according to preoperative platelet counts: thrombocytopenia group and non-thrombocytopenia group. Survival outcomes of the patients in both groups were described with the Kaplan-Meier method, and the difference was compared with a log-rank test. Cox regression analysis was applied to identify the risk factors of surgical outcome. Results After PSM, the estimated 1-, 3-, and 5-year overall survival (OS) rates for small HCC patients in the thrombocytopenia group were 94.5%, 77.0%, and 57.6%, and 95.0%, 79.6%, and 68.0%, respectively, for small HCC patients in the non-thrombocytopenia group (P = 0.042). And the 1-, 3-, and 5-year estimated recurrence-free survival (RFS) rates for small HCC patients in the thrombocytopenia group were 70.4%, 51.0%, and 42.1%, and 83.8%, 63.7%, and 46.7%, respectively, for small HCC patients in the non-thrombocytopenia group (P = 0.035). Multivariate analysis indicated preoperative thrombocytopenia was a significant prognosticator of poor RFS (hazard ratio (HR) = 1.388, 95% confidence interval (CI) 1.028~1.874, P = 0.033). Conclusion Preoperative thrombocytopenia had an undesirable impact on the recurrence of small HCC patients treated with liver resection.


2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Bo Yu ◽  
Victor Perez Gutierrez ◽  
Alex Carlos ◽  
Gregory Hoge ◽  
Anjana Pillai ◽  
...  

Abstract Background Hospitalized patients with COVID-19 demonstrate a higher risk of developing thromboembolism. Anticoagulation (AC) has been proposed for high-risk patients, even without confirmed thromboembolism. However, benefits and risks of AC are not well assessed due to insufficient clinical data. We performed a retrospective analysis of outcomes from AC in a large population of COVID-19 patients. Methods We retrospectively reviewed 1189 patients hospitalized for COVID-19 between March 5 and May 15, 2020, with primary outcomes of mortality, invasive mechanical ventilation, and major bleeding. Patients who received therapeutic AC for known indications were excluded. Propensity score matching of baseline characteristics and admission parameters was performed to minimize bias between cohorts. Results The analysis cohort included 973 patients. Forty-four patients who received therapeutic AC for confirmed thromboembolic events and atrial fibrillation were excluded. After propensity score matching, 133 patients received empiric therapeutic AC while 215 received low dose prophylactic AC. Overall, there was no difference in the rate of invasive mechanical ventilation (73.7% versus 65.6%, p = 0.133) or mortality (60.2% versus 60.9%, p = 0.885). However, among patients requiring invasive mechanical ventilation, empiric therapeutic AC was an independent predictor of lower mortality (hazard ratio [HR] 0.476, 95% confidence interval [CI] 0.345–0.657, p < 0.001) with longer median survival (14 days vs 8 days, p < 0.001), but these associations were not observed in the overall cohort (p = 0.063). Additionally, no significant difference in mortality was found between patients receiving empiric therapeutic AC versus prophylactic AC in various subgroups with different D-dimer level cutoffs. Patients who received therapeutic AC showed a higher incidence of major bleeding (13.8% vs 3.9%, p < 0.001). Furthermore, patients with a HAS-BLED score of ≥2 had a higher risk of mortality (HR 1.482, 95% CI 1.110–1.980, p = 0.008), while those with a score of ≥3 had a higher risk of major bleeding (Odds ratio: 1.883, CI: 1.114–3.729, p = 0.016). Conclusion Empiric use of therapeutic AC conferred survival benefit to patients requiring invasive mechanical ventilation, but did not show benefit in non-critically ill patients hospitalized for COVID-19. Careful bleeding risk estimation should be pursued before considering escalation of AC intensity.


2021 ◽  
Author(s):  
Pei-Min Hsieh ◽  
Hung-Yu Lin ◽  
Chao-Ming Hung ◽  
Gin-Ho Lo ◽  
I-Cheng Lu ◽  
...  

Abstract Background: The benefits of surgical resection (SR) for various Barcelona Clinic Liver Cancer (BCLC) stages of hepatocellular carcinoma (HCC) remain unclear. We investigated the risk factors of overall survival (OS) and survival benefits of SR over nonsurgical treatments in patients with HCC of various BCLC stages.Methods: Overall, 2316 HCC patients were included, and their clinicopathological data and OS were recorded. OS was analyzed by the Kaplan-Meier method and Cox regression analysis. Propensity score matching (PSM) analysis was performed.Results: In total, 66 (2.8%), 865 (37.4%), 575 (24.8%) and 870 (35.0%) patients had BCLC stage 0, A, B, and C disease, respectively. Furthermore, 1302 (56.2%) of all patients, and 37 (56.9%), 472 (54.6%), 313 (54.4%) and 480 (59.3%) of patients with BCLC stage 0, A, B, and C disease, respectively, died. The median follow-up duration time was 20 (range 0-96) months for the total cohort and was subdivided into 52 (8-96), 32 (1-96), 19 (0-84), and 12 (0-79) months for BCLC stages 0, A, B, and C cohorts, respectively. The risk factors for OS were 1) SR and cirrhosis; 2) SR, cirrhosis, and Child-Pugh (C-P) class; 3) SR, hepatitis B virus (HBV) infection, and C-P class; and 4) SR, HBV infection, and C-P class for the BCLC stage 0, A, B, and C cohorts, respectively. Compared to non-SR treatment, SR resulted in significantly higher survival rates in all cohorts. The 5-year OS rates for SR vs non-SR were 44.0% vs 28.7%, 72.2% vs 42.6%, 42.6% vs 36.2, 44.6% vs 23.5%, and 41.4% vs 15.3% (all p-values<0.05) in the total and BCLC stage 0, A, B, and C cohorts, respectively. After PSM, SR resulted in significantly higher survival rates compared to non-SR treatment in various BCLC stages.Conclusion: SR conferred significant survival benefits to patients with HCC of various BCLC stages and should be considered a recommended treatment for select HCC patients, especially patients with BCLC stage B and C disease.


2021 ◽  
Vol 30 (4) ◽  
pp. e71-e79
Author(s):  
Michael A. Liu ◽  
Brianna R. Bakow ◽  
Tzu-Chun Hsu ◽  
Jia-Yu Chen ◽  
Ke-Ying Su ◽  
...  

Background Few population-based studies assess the impact of cancer on sepsis incidence and mortality. Objectives To evaluate epidemiological trends of sepsis in patients with cancer. Methods This retrospective cohort study included adults (≥20 years old) identified using sepsis-indicator International Classification of Diseases codes from the Nationwide Inpatient Sample database (2006-2014). A generalized linear model was used to trend incidence and mortality. Outcomes in patients with cancer and patients without cancer were compared using propensity score matching. Cox regression modeling was used to calculate hazard ratios for mortality rates. Results The study included 13 996 374 patients, 13.6% of whom had cancer. Gram-positive infections were most common, but the incidence of gram-negative infections increased at a greater rate. Compared with patients without cancer, those with cancer had significantly higher rates of lower respiratory tract (35.0% vs 31.6%), intra-abdominal (5.5% vs 4.6%), fungal (4.8% vs 2.9%), and anaerobic (1.2% vs 0.9%) infections. Sepsis incidence increased at a higher rate in patients with cancer than in those without cancer, but hospital mortality rates improved equally in both groups. After propensity score matching, hospital mortality was higher in patients with cancer than in those without cancer (hazard ratio, 1.25; 95% CI, 1.24-1.26). Of patients with sepsis and cancer, those with lung cancer had the lowest survival (hazard ratio, 1.65) compared with those with breast cancer, who had the highest survival. Conclusions Cancer patients are at high risk for sepsis and associated mortality. Research is needed to guide sepsis monitoring and prevention in patients with cancer.


2021 ◽  
Author(s):  
Bo Yu ◽  
Victor Perez Gutierrez ◽  
Alex Carlos ◽  
Gregory Hoge ◽  
Anjana Pillai ◽  
...  

Abstract Background: Hospitalized patients with COVID-19 demonstrate a higher risk of developing thromboembolism. Anticoagulation (AC) has been proposed for high-risk patients, even without confirmed thromboembolism. However, benefits and risks of AC are not well assessed due to insufficient clinical data. We performed a retrospective analysis of outcomes from AC in a large population of COVID-19 patients. Methods: We retrospectively reviewed 1189 patients hospitalized for COVID-19 between March 15 and May 15, 2020, with primary outcomes of mortality, invasive mechanical ventilation, and major bleeding. Patients who received therapeutic AC for known indications were excluded. Propensity score matching of baseline characteristics and admission parameters was performed to minimize bias between cohorts. Results: The analysis cohort included 973 patients. Forty-four patients who received therapeutic AC for confirmed thromboembolic events and atrial fibrillation were excluded. After propensity score matching, 133 patients received empiric therapeutic AC while 215 received low dose prophylactic AC. Overall, there was no difference in the rate of invasive mechanical ventilation (73.7% versus 65.6%, p = 0.133) or mortality (60.2% versus 60.9%, p = 0.885). However, among patients requiring invasive mechanical ventilation, empiric therapeutic AC was an independent predictor of lower mortality (hazard ratio [HR] 0.476, 95% confidence interval [CI] 0.345-0.657, p < 0.001) with longer median survival (14 days vs 8 days, p < 0.001), but these associations were not observed in the overall cohort (p = 0.063). Additionally, no significant difference in mortality was found between patients receiving empiric therapeutic AC versus prophylactic AC in various subgroups with different D-dimer level cutoffs. Patients who received therapeutic AC showed a higher incidence of major bleeding (13.8% vs 3.9%, p < 0.001). Furthermore, patients with a HAS-BLED score of ≥2 had a higher risk of mortality (HR 1.482, 95% CI 1.110-1.980, p = 0.008), while those with a score of ≥3 had a higher risk of major bleeding (Odds ratio: 1.883, CI: 1.114-3.729, p = 0.016). Conclusion: Empiric use of therapeutic AC conferred survival benefit to patients requiring invasive mechanical ventilation, but did not show benefit in non-critically ill patients hospitalized for COVID-19. Careful bleeding risk estimation should be pursued before considering escalation of AC intensity.


2021 ◽  
Author(s):  
Chuang Li ◽  
Xuebo Ding ◽  
Lefeng Wang ◽  
Kuibao Li ◽  
Xinchun Yang ◽  
...  

Abstract Background:There is limited evidence of drug-coated balloon (DCB) only angioplasty in percutaneous treatment of complex de novo ostial coronary lesions. The major objective of our study is to explore the feasibility and test safety of this innovative approach in ostial lesions of left anterior descending artery (LAD). Methods:Patients treated with paclitaxel DCB or second-generation drug-eluting stent (DES) were retrospectively enrolled from two different large centers. The primary endpoints were defined as major adverse cardiovascular events (MACE) composed of cardiovascular death, target lesion revascularization (TLR), target vessel revascularization (TVR), and recurrent myocardial infarction related to target artery occlusion. Cox regression analysis were used to identify risk factors for MACE and propensity score matching is performed to minimize the selection bias.Results:A total of 53 patients were treated with paclitaxel DCB and 336 patients with DES in ostial lesions of LAD were recruited. In accordance with propensity score matching, 49 patients treated with DCB-only coordinated with 49 ones with the strategy of DES. After average follow-up time of 10 months, the rate of MACE trended to lower in DCB-only angioplasty treatment arm and triggered by post-procedure TLR (MACE: 6% vs. 4%, p=0.65; TLR: 2% vs. 4%, p=0.56). Cox regression analysis indicated that not DCB-only angioplasty was considered as an independent risk factor for adverse events after adjustment for cofound risk factors (HR: 1.748, p=0.48).Conclusions:Use of DCB-only approach in treatment of isolated ostial LAD disease could be an innovative and safe strategy without additional risk of aggressive progression of left circumflex artery.


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