Clinical Effectiveness and Safety of Remdesivir in Hemodialysis Patients with COVID-19.
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ABSTRACT:
SUBMITTER: Lim JH
PROVIDER: S-EPMC9462925 | biostudies-literature | 2022 Nov
REPOSITORIES: biostudies-literature
Publications
Clinical Effectiveness and Safety of Remdesivir in Hemodialysis Patients with COVID-19.
Lim Jeong-Hoon JH Park Sang Don SD Jeon Yena Y Chung Yu Kyung YK Kwon Jae Wan JW Jeon You Hyun YH Jung Hee-Yeon HY Park Sun-Hee SH Kim Chan-Duck CD Kim Yong-Lim YL Kwon Ki Tae KT Choi Ji-Young JY Cho Jang-Hee JH
Kidney international reports 20220910 11
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Project description:BackgroundThere are scarce data regarding the use of remdesivir in patients with severe acute respiratory distress syndrome coronavirus 2 (SARS-CoV-2) and end-stage renal disease as US Food and Drug Administration cautions against its use in patients with an estimated glomerular filtration rate <30 ml/min/1.73m2 unless the potential benefits outweigh the potential risks. We studied the compassionate use and safety profile of remdesivir in patients with end-stage renal disease and moderate to severe SARS-CoV-2 infection.MethodsWe conducted an observational prospective study in 48 dialysis-dependent patients with SARS-CoV-2 infection who received remdesivir as part of institutional treatment protocol. During the treatment period, 100 mg of remdesivir was given 4 hours before hemodialysis sessions. Liver function tests, inflammatory markers such as serum C-reactive protein, serum ferritin and lactate dehydrogenase levels, and oxygen requirement before and after remdesivir treatment were compared.ResultsThere were no events of significant liver function test alterations with the administration of 2 to 6 doses of remdesivir. A significant decline in serum C-reactive protein level (P < 0.001) was noted. More than two thirds (68.57%) of patients showed an improvement in oxygen requirement. Early administration of remdesivir within 48 hours of hospital admission shortened the duration of hospitalization by a mean of 5.5 days (P = 0.001).ConclusionRemdesivir was well tolerated and found safe in our study. If initiated within 48 hours of hospitalization, it reduces recovery time. Assessing the mortality benefits of remdesivir in these patients requires a randomized controlled trial with a larger population.
| S-EPMC7746511 | biostudies-literature
Project description:Remdesivir was the first antiviral approved for treating COVID-19. We investigated its patterns of use, effectiveness and safety in clinical practice in Greece. This is a retrospective observational study of hospitalized adults who received remdesivir for COVID-19 in September 2020-February 2021. The main endpoints were the time to recovery (hospital discharge within 30 days from admission) and safety. The "early" (remdesivir initiation within 24 h since hospitalization) and "deferred" (remdesivir initiation later on) groups were compared. One thousand and four patients (60.6% male, mean age 61 years, 74.3% with severe disease, 70.9% with ≥1 comorbidities) were included, and 75.9% of them were on a 5-day regimen, and 86.8% were in the early group. Among those with a baseline mild/moderate disease, the median (95% CI) time to recovery was 8 (7-9) and 12 (11-14) days for the early and deferred groups, respectively (p < 0.001). The corresponding estimates for those with a severe disease were 10 (9-10) and 13 (11-15) days, respectively (p = 0.028). After remdesivir initiation, increased serum transaminases and an acute kidney injury were observed in 6.9% and 2.1%, respectively. Nine (0.9%) patients discontinued the treatment due to adverse events. The effectiveness of remdesivir was increased when it was taken within 24 h since admission regardless of the disease severity. Remdesivir's safety profile is similar to that described in clinical trials and other real-world cohorts.
| S-EPMC10459397 | biostudies-literature
Project description:AimsRemdesivir is 1 of the repurposed drugs under investigation to treat patients with COVID-19. Clinicians and decision-makers need a summary of the most recent evidence. This scoping review maps the evidence on the efficacy, effectiveness and safety of remdesivir for patients with COVID-19, up to 14 September 2020.MethodsOur scoping review searched Pubmed, Embase (Ovid), Scopus and 17 primary trial registries for empirical publications or active registered clinical trials for data on the efficacy, effectiveness, or safety of remdesivir for COVID-19 or SARS-CoV-2. We conducted a narrative synthesis of the included publications.ResultsSeventeen empirical studies and 23 clinical trial registrations (n = 40) accumulated 46 508 participants. We found 4 published randomized-controlled trials accumulating 2293 patients. Two trials reported shorter median recovery time and better clinical status among patients who received remdesivir compared with the control groups. Observational studies report an association between remdesivir treatment and decreased mortality, as well as increased survival. The most common adverse reaction was hepatic impairment, although the trials reported a similar proportion of adverse events in the intervention and control groups.ConclusionRemdesivir might shorten the time to clinical improvement among hospitalized adults with severe COVID-19. Trial data report a similar proportion of adverse events in treated and control groups. The results of the 23 registered active trials, including more than 30 000 participants, will shed light on the efficacy and safety of the antiviral. The findings of the remaining clinical trials expected to report results in 2020 will allow a quantitative synthesis of available evidence.
| S-EPMC7753529 | biostudies-literature
Project description:Background: This study aimed to determine the real-world safety and effectiveness of remdesivir in hospitalized adult COVID-19 patients with moderate-to-critical disease in Indonesia. Methods: A multicenter, retrospective cohort study was conducted at four COVID-19 referral hospitals in Jakarta. A total of 587 patients were included, of whom 243 received remdesivir within 72 h of admission. The safety endpoints were the proportions of patients with any adverse event (AE), any grade 3 AE, and AE of each system organ class. The effectiveness endpoints were ICU admission >24 h from baseline, live discharge and mortality at day 14, live discharge and mortality at day 28, and virologic conversion. Patients who received remdesivir within 72 h of admission were considered the treatment group, and those who did not were the control group. Multivariate adjustments were performed using a modified Poisson regression. Results: The study found no significant differences in safety endpoints between the two groups. However, the effectiveness endpoints showed that remdesivir was associated with a decreased risk of ICU admission >24 h from baseline (RR 0.71, 95% CI 0.52-0.96), an increased probability of live discharge at day 14 (RR 1.37, 95% CI 1.08-1.74), and an increased probability of live discharge at day 28 (RR 1.28, 95% CI 1.05-1.57). The rate of virologic conversion was not significantly different between the two groups. Conclusion: The study concludes that remdesivir is safe and effective in the treatment of moderate-to-critical COVID-19 in a real-world setting in Indonesia.
| S-EPMC10347402 | biostudies-literature
Project description:ObjectivesThis study aimed to estimate the cost-effectiveness of remdesivir, the first novel therapeutic to receive Emergency Use Authorization for the treatment of hospitalized patients with COVID-19, and identify key drivers of value to guide future pricing and reimbursement efforts.MethodsA Markov model evaluated the cost-effectiveness of remdesivir in patients hospitalized with COVID-19 from a US healthcare sector perspective. A lifetime time horizon captured potential long-term costs and outcomes. Model outcomes included discounted total costs, life-years, and quality-adjusted life-years (QALYs). Remdesivir was modeled as an addition to standard of care and compared with standard of care alone, including dexamethasone for patients requiring respiratory support. COVID-19 hospitalizations were assumed to be reimbursed through a single payment based on the respiratory support received alongside a remdesivir carveout payment in the base case. Sensitivity and scenario analyses identified key drivers.ResultsAt a unit price of $520 per vial and assuming no survival benefit with remdesivir, the incremental cost-effectiveness was $298 200/QALY for patients with moderate to severe COVID-19 and $1 847 000/QALY for patients with mild COVID-19. Although current data do not support a survival benefit, if one was assumed, the cost-effectiveness estimate was $50 100/QALY for the moderate to severe population and $103 400/QALY for the mild population. Another key driver included the hospitalization payment structure (per diem vs bundled payment).ConclusionsWith the current evidence available, remdesivir's price is too high to align with its expected health gains for hospitalized patients with COVID-19. Results from this study provide a rationale for iterative health technology assessment.
| S-EPMC8856900 | biostudies-literature
Project description:BackgroundsRemdesivir (RDV) is an antiviral agent approved for the treatment of coronavirus disease 2019 (COVID-19); however, is not recommended for patients with renal impairment. Due to limitations associated with prospective clinical trials, real-world data on the safety and efficacy of RDV in patients with renal impairment are necessary.MethodsPropensity score-matched (PSM) retrospective analysis was conducted between March 2020 and September 2022 in COVID-19 patients with an eGFR < 30 mL/min in four Korean hospitals. The RDV treatment group was matched to the untreated control group. The safety and clinical outcomes in patients who received RDV were analyzed.ResultsA total of 564 patients were enrolled; 229 patients received RDV either for treatment or prophylaxis. On day 5, no difference in nephrotoxicity was observed between the two groups, and liver enzyme levels were within the normal range. In multivariate analysis for new dialysis, RDV treatment was not a risk factor for new dialysis. Among the 564 patients, 417 were indicated for a 5-day course of RDV treatment and 211 patients were treated with RDV. After PSM, no differences in the clinical outcomes were observed between the two groups.ConclusionRDV use in COVID-19 patients with renal impairment did not result in significant nephrotoxicity or hepatotoxicity.
| S-EPMC10759744 | biostudies-literature
Project description:BackgroundReal-world data on safety and clinical outcomes of remdesivir in COVID-19 management is scant. We present findings of data analysis conducted for assessing the safety and clinical outcomes of remdesivir treatment for COVID-19 in India.MethodsThis retrospective analysis used data from an active surveillance programme database of hospitalised patients with COVID-19 who were receiving remdesivir.ResultsOf the 2329 patients included, 67.40% were men. Diabetes (29.69%) and hypertension (20.33%) were the most common comorbidities. At remdesivir initiation, 2272 (97.55%) patients were receiving oxygen therapy. Remdesivir was administered for 5 days in 65.38% of patients. Antibiotics (64.90%) and steroids (47.90%) were the most common concomitant medications. Remdesivir was overall well tolerated, and total 119 adverse events were reported; most common were nausea and vomiting in 45.40% and increased liver enzymes in 14.28% patients. 84% of patients were cured/improved, 6.77% died and 9.16% showed no improvement in their clinical status at data collection. Subgroup analyses showed that the mortality rate was significantly lower in patients < 60 years old than in those > 60 years old. Amongst patients on oxygen therapy, the cure/improvement rate was significantly higher in those receiving standard low-flow oxygen than in those receiving mechanical ventilation, non-invasive ventilation, or high-flow oxygen. Factors that were associated with higher mortality were age > 60 years, cardiac disease, diabetes high flow oxygen, non-invasive ventilation and mechanical ventilation.ConclusionOur analysis showed that remdesivir is well tolerated and has an acceptable safety profile. The clinical outcome of cure/improvement was 84%, with a higher improvement in patients < 60 years old and on standard low-flow oxygen.
| S-EPMC8724590 | biostudies-literature
Project description:ObjectivesThis study analyzed the clinical outcomes of remdesivir treatment in coronavirus disease 2019 (COVID-19) patients in South Korea.MethodsThis retrospective cohort study involved the secondary analysis of epidemiological data. Among patients diagnosed with COVID-19 from July 2, 2020 to March 23, 2021 (12 AM), 4,868 who received oxygen therapy and were released from isolation after receiving remdesivir treatment were assigned to the treatment group, and 6,068 patients who received oxygen therapy but not remdesivir were assigned to the untreated group. The study subjects included children under the age of 19. The general characteristics and severity were compared between the groups. Differences in the time to death and mortality were also compared.ResultsIn the untreated group, the hazard ratio [HR] for mortality was 1.59 among patients aged ≥70 years and 2.32 in patients with severe disease in comparison to the treatment group. In a comparison of survival time among patients with severe disease aged ≥70 years, the HR for mortality before 50 days was 2.09 in the untreated group compared to the treatment group.ConclusionPatients with remdesivir treatment showed better clinical outcomes in this study, but these results should be interpreted with caution since this study was not a fully controlled clinical trial.
| S-EPMC9633264 | biostudies-literature
Project description:Abstract Background Remdesivir (RDV) has been shown to shorten recovery time and was well tolerated in patients with severe COVID-19. Here we report safety of RDV in patients with moderate COVID-19. Methods We conducted an open-label, phase 3 trial (NCT04252664) in hospitalized patients with confirmed SARS-CoV-2 infection, evidence of pulmonary infiltrates, and oxygen saturation >94% on room air. Patients were randomly assigned to receive RDV (5 or 10 days) or standard of care (SOC). RDV was dosed intravenously at 200 mg on day 1, 100 mg daily thereafter. Adverse events (AEs) and laboratory abnormalities were evaluated through the day 11 data cut; safety data through day 28 will be presented at the meeting. Results 584 patients were randomized and treated (5d RDV: n=191; 10d RDV, n=193; SOC: n=200). Baseline characteristics were balanced among groups; median (range) age was 57y (12-95y), 39% were female and 19% Black, 39% had arterial hypertension, 15% hyperlipidemia, 11% asthma. Briefly, across both the 5d and 10d arms, RDV was well tolerated with a similar rate of Grade 3 or 4 AEs and fewer SAEs compared to SOC (Table). AEs more common with RDV vs SOC included nausea, headache, and hypokalemia. Overall, across the 3 arms, incidence of AEs leading to discontinuation and death were low and no clinically relevant changes in laboratory parameters were observed. In addition, median changes in renal and liver function tests from baseline were not statistically significant between the RDV 5d and RDV 10d groups compared to the SOC only group at d14 (Table 1). Table 1. Conclusion RDV given for 5d or 10d was well tolerated in patients with moderate COVID-19. No clinically significant safety signals were observed with RDV vs SOC. Disclosures Gerard J. Criner, MD, Gilead Sciences Inc. (Scientific Research Study Investigator)Regeneron (Scientific Research Study Investigator) Gerard J. Criner, MD, NO DISCLOSURE DATA Mi Young Ahn, MD, Gilead Sciences Inc. (Scientific Research Study Investigator) Gregory Huhn, MD, Gilead Sciences Inc. (Grant/Research Support, Scientific Research Study Investigator)Janssen (Grant/Research Support)Proteus (Grant/Research Support)US National Institutes of Health (Grant/Research Support)Viiv Healthcare (Grant/Research Support) Aruna Subramanian, MD, Gilead Sciences Inc. (Scientific Research Study Investigator) Carlos Lumbreras, MD, Gilead Sciences Inc. (Scientific Research Study Investigator) Stefan Schmiedel, MD, Gilead Sciences Inc. (Scientific Research Study Investigator) Robert H. Hyland, MD, Gilead Sciences Inc. (Employee, Shareholder) Vithika Suri, PhD, Gilead Sciences Inc. (Employee, Shareholder) Huyen Cao, MD, Gilead Sciences Inc. (Employee, Shareholder) Hongyuan Wang, PhD, Gilead Sciences Inc. (Employee, Shareholder) Devi SenGupta, MD, Gilead Sciences Inc. (Employee, Shareholder) Anand Chokkalingam, PhD, Gilead Sciences (Employee) Anu Osinusi, MD, Gilead Sciences (Employee) Diana M. Brainard, MD, Gilead Sciences (Employee) Yao-Shen Chen, MD, Gilead Sciences Inc. (Scientific Research Study Investigator) Yao-Shen Chen, MD, NO DISCLOSURE DATA Huldrych Günthard, MD, Gilead Sciences Inc. (Scientific Research Study Investigator) D Jose Sanz-Moreno, MD, Gilead Sciences Inc. (Scientific Research Study Investigator) Judith A. Aberg, MD, Theratechnology (Consultant) Emanuele Nicastri, MD, Gilead Sciences Inc. (Scientific Research Study Investigator) Owen Tak-Yin Tsang, MD, Gilead Sciences Inc. (Scientific Research Study Investigator) Owen Tak-Yin Tsang, MD, NO DISCLOSURE DATA
| S-EPMC7777368 | biostudies-literature
Project description:BackgroundHemodialysis (HD) patients are more vulnerable to viral epidemics, experiencing higher mortality rates compared to individuals without chronic kidney disease (CKD). This retrospective cohort study sought to demonstrate clinical outcomes and associated factors among coronavirus disease 2019 (COVID-19) confirmed Korean HD patients.MethodsFrom February 2020 to November 2021, the COVID-19 Task Force Team collected clinical data for HD patients with confirmed COVID-19 via a self-report survey of nephrologists. The composite outcome included in-hospital mortality, admission to the intensive care unit (ICU), and use of mechanical ventilation. Risk factors associated with clinical outcomes were analyzed among HD patients and compared to those of individuals without CKD using the COVID-19 database from the Korea Disease Control and Prevention Agency.ResultsA total of 380 HD patients from 206 facilities were diagnosed with COVID-19. Fever (49.5%) and cough (25.7%) were the two most common initial symptoms. The overall in-hospital fatality rate was 22.4% and even higher among ICU admission cases (64.7%). Non-survivors were older, more frequently developed shortness of breath, and were more likely to come from a nursing hospital. Compared to the age- and sex-matched non-CKD population, HD patients showed greater risk of in-hospital mortality (hazard ratio, 2.07; 95% confidence interval, 1.56-2.75; p < 0.001) and composite outcome (hazard ratio, 3.50; 95% confidence interval, 2.56-4.77; p < 0.001).ConclusionHD patients have a greater risk of in-hospital mortality and morbidity from COVID-19. Special attention should be paid to COVID-19 HD patients when they are older or present with symptoms.
| S-EPMC9576454 | biostudies-literature