scholarly journals NCOG-33. HEMATOLOGIC PREDICTORS OF OUTCOMES IN GLIOBLASTOMA TREATED WITH SURGERY AND CHEMORADIATION

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii136-ii136
Author(s):  
Nicholas Damico ◽  
Theresa Elder ◽  
Michael Kharouta ◽  
Anthony Sloan ◽  
Amber Kerstetter-Fogle ◽  
...  
Keyword(s):  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Regression ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Continuous Variables ◽  
Surgical Biopsy ◽  
Platelet Counts ◽  
Cell Counts ◽  
Time Point

Abstract BACKGROUND There are conflicting reports regarding the prognostic value of platelet and other blood counts in glioblastoma. However, few series have looked at all hematologic parameters simultaneously. METHODS We performed a retrospective chart review of patients diagnosed with supratentorial glioblastoma from 2014-2019 who started conventional chemoradiation following initial surgical biopsy and/or resection. Hematologic parameters were collected at baseline, in the preoperative and postoperative periods and at the initiation and completion of chemoradiation. This included platelet counts, hemoglobin levels, white blood cell counts (WBC), neutrophil and lymphocyte counts with neutrophil:lymphocyte (NLR) and platelet:lymphocyte ratios (PLR) calculated at each time point. Cox regression was performed to assess the association between each hematologic parameter and both overall survival (OS) and progression free survival (PFS). A multivariate Cox proportional hazards model adjusted for all hematologic parameters, age, sex, race and KPS was generated for each time point. All hematologic parameters were modeled as continuous variables. RESULTS A total of 58 patients met inclusion criteria. 18 were female and 40 male. The median age was 59.5 (range 43-82). Median follow up for all patients was 15.3 months. A total of 52 patients completed radiation therapy and 18 completed 6 cycles of adjuvant chemotherapy. Hemoglobin and neutrophil counts at the conclusion of chemoradiation were associated with OS and PFS on univariate and multivariate analyses. The HR for OS were 0.74 (95% CI 0.5807-0.9313) and 1.28 (1.143-1.441) respectively. The HR for PFS were 0.70 (0.5531-0.8881) and 1.16 (1.05-1.271) respectively. Postoperative lymphocyte and platelet counts at initiation of chemoradiation were both associated with OS with unadjusted HR of 3.2 (1.037-9.960) and HR of 0.99 (0.9898-0.9999) respectively, which remained significant on multivariate analysis. However, neither were associated with PFS. CONCLUSION Several hematologic parameters are associated with glioblastoma outcomes in these initial analyses. Further analyses with additional patients are ongoing.

Relationship between biomarkers and everolimus efficacy in the phase III RECORD-1 trial of patients with metastatic renal cell carcinoma (mRCC).

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 352-352
Author(s):  
Stephane Oudard ◽  
Bernard J. Escudier ◽  
John A. Thompson ◽  
Viktor Grünwald ◽  
Cristina Masini ◽  
...  
Keyword(s):  
Plasma Levels ◽  
Time Course ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Day Treatment ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Phase Iii ◽  
Continuous Variables ◽  
Baseline Levels

352 Background: Compared with placebo, everolimus provided significant improvement in median PFS in the RECORD-1 study of VEGFr-TKI-refractory mRCC. To investigate the role of angiogenesis pathway molecules as potential biomarkers of everolimus efficacy in RECORD-1, plasma levels of sVEGFR-2, VEGF-A, and bFGF were estimated. Methods: In addition to best supportive care, patients received everolimus 10 mg/day (n = 277) or placebo (n = 139). Placebo patients who progressed were offered everolimus. Predose blood samples were collected on day 1 of the first four 28-day treatment cycles. Plasma levels of sVEGFR-2, VEGF-A, and bFGF were assessed by ELISA. Effect of treatment over time on each biomarker was assessed by a mixed effects model. Hazard ratios (HR) for prognostic effects were obtained using log baseline biomarker values as continuous variables in a stratified Cox proportional hazards model. Results: Plasma levels of sVEGFR-2, VEGF-A, and bFGF were available for 45%, 45%, and 39% of everolimus patients and 50%, 50%, and 45% of placebo patients. Patients with biomarker data had baseline characteristics similar to those of the overall population. Mean baseline levels (pg/mL) of sVEGFR-2, VEGF-A, and bFGF were similar for everolimus (8945, 245, and 8, respectively) and placebo (8985, 253, and 13, respectively). Everolimus significantly improved median PFS over placebo irrespective of baseline levels of the analyzed biomarkers (p < 0.001), indicating they are not predictive of everolimus efficacy. Prolonged PFS in the biomarker population was associated with lower VEGF-A baseline level (HR, 1.27; 95% CI, 1.03-1.57; p = 0.028), suggesting VEGF-A may be prognostic for mRCC. Compared with placebo, everolimus significantly reduced bFGF (p = 0.0095) and sVEGFR-2 (p< 0.001) levels over the time course of the study; no effect on VEGF-A levels was observed. Conclusions: Everolimus significantly improved PFS compared with placebo, regardless of baseline biomarker levels. Lower VEGF-A levels may be a potential prognostic factor for longer PFS. Everolimus treatment significantly downregulated plasma levels of bFGF and sVEGFR-2 from baseline. Clinical trial information: NCT00410124.

scholarly journals 508. Title Favipiravir for the Treatment of Coronavirus Disease 2019; A Propensity Score Matched Cohort Study

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S356-S356
Author(s):  
Rand A Alattar ◽  
Shiema A Ahmed ◽  
Tasneem Abdallah ◽  
Rashid Kazman ◽  
Aseelah N Qadmour ◽  
...  
Keyword(s):  
Clinical Improvement ◽  
Propensity Scores ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Regression ◽  
Supplemental Oxygen ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Ordinal Scale ◽  
All Cause Mortality

Abstract Background We investigated clinical outcomes of favipiravir in patients with COVID-19 pneumonia. Methods Patients who between 23 May 2020 and 18 July 2020 received ≥24 hours of favipiravir were assigned to the favipiravir group, while those who did not formed the non-favipiravir group. The primary outcome was 28-day clinical improvement, defined as two-category improvement from baseline on an 8-point ordinal scale. Propensity scores (PS) for favipiravir therapy were used for 1:1 matching. Cox regression was used to examine associations with the primary endpoint. Results The unmatched cohort included 1,493 patients, of which 51.7% were in the favipiravir group, and 48.3% were not receiving supplemental oxygen at baseline (table 1). Favipiravir was started within a median of 5 days from symptoms onset. Significant baseline differences between the two unmatched groups existed, but not between the PSmatched groups (N = 774) (table 1). After PS-matching, there were no significant differences between the two groups in the proportion with 28-day clinical improvement (93.3% versus 92.8%, P 0.780), or 28-day all-cause mortality (2.1% versus 3.1%, P 0.360) (Table 2). Favipiravir was associated with more viral clearance by day 28 (79.8% versus 64.1%, P &lt; 0.001) (table 2). In the adjusted Cox proportional hazards model, favipiravir therapy was not associated 28-day clinical improvement (adjusted hazard ratio 0.978, 95% confidence interval 0.862 –1.109, P 0.726) (Table 3). Conclusion Favipiravir therapy for COVID-19 pneumonia is well tolerated but is not associated with an increased likelihood of clinical improvement or reduced all-cause mortality by 28 days. Disclosures All Authors: No reported disclosures

Stem-like markers in the circulating tumor cells assessment in ovarian cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e17542-e17542
Author(s):  
Snezhanna Gening ◽  
Tatyana Abakumova ◽  
Inna Antoneeva ◽  
Tatyana Gening
Keyword(s):  
Ovarian Cancer ◽  
Tumor Cells ◽  
Circulating Tumor Cells ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Regression ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Ca 125 ◽  
Blood Samples

e17542 Background: Circulating tumor cells (CTCs) are a potential source of dissemination and relapse in ovarian cancer (OC). Stem cell properties can provide a survival advantage for CTCs. The clinical significance of stem-like CTCs in OC remains to be studied. We aimed to assess the quantities of the stem, epithelial, mesenchymal CTCs and their relationships with the clinical parameters in the OC. Methods: Peripheral blood samples (7.5 ml) were obtained from patients with primary epithelial OC before treatment. CTCs were isolated by flow cytometry (Cytoflex S (Beckman Coulter, USA)) using antibodies to CD45 (BioLegend, USA); CD44 (BioLegend, USA), CD133 (Miltenyi biotec, Germany), ALDH (Stemcell, Canada) to detect the stem markers; EpCAM (BioLegend, USA), cytokeratins 8, 18 (Abcam plc., UK), vimentin (BioLegend, USA) for epithelial and mesenchymal markers. Blood samples from patients with benign ovarian tumors served as a control. Informed voluntary consent was obtained from all the women. Statistical processing included Mann-Whitney U-test, linear regression, Cox proportional hazards model for progression-free survival (PFS) (Statistica 13.0 (TIBCO, USA)). Results: The study included 30 patients, median age 64 (34-76) years. 15 patients had a FIGO stage IV, 12 - stage III, 1 – stage II and 1 – stage I. The content of CTCs populations is presented in the table. The CTCs counts did not differ depending on age, platelet count, and stage 3 or 4. The amount of CD45-CK+Vim- was higher in the presence of ascites (p = 0.035). We found a regression relationship between the serum CA-125 and the number of CD45-CD44+CD133+ (R2= 0.220, p = 0.016); the leukocyte count in blood and CD45-CD44+ALDHhigh (R2= 0.234, p = 0.017); the number of CD45-Vim+ and CD45-CD44+CD133+ALDH+ (R2= 0.305, p = 0.014); CD45-CK-Vim+ and CD45-EpCAM+CK+ (R2= 0.717, p < 0.001). The Cox regression model for PFS included the number of CD45-CD44+CD133+ALDH+ (HR 1.51 95% CI 1.01-2.24 p = 0.043) and the cytoreductive surgery performance (HR 0.09 95% CI 0.01-0.89 p = 0.039) during the first line of treatment. Conclusions: Various populations of circulating tumor cells coexist in ovarian cancer patients. The use of a combination of stem markers in the CTCs detection can increase their prognostic value in OC. This work was supported by the RFBR grant No. 19-315-90011.[Table: see text]

Genetic and nongenetic factors for contralateral progression of unilateral moyamoya disease: the first report from the SUPRA Japan Study Group

2021 ◽  
pp. 1-10
Author(s):  
Yohei Mineharu ◽  
Yasushi Takagi ◽  
Akio Koizumi ◽  
Takaaki Morimoto ◽  
Takeshi Funaki ◽  
...  
Keyword(s):  
Risk Factors ◽  
Moyamoya Disease ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Regression ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Multicenter Cohort Study ◽  
Cox Regression Analysis ◽  
Unilateral Moyamoya Disease

OBJECTIVE Although many studies have analyzed risk factors for contralateral progression in unilateral moyamoya disease, they have not been fully elucidated. The aim of this study was to examine whether genetic factors as well as nongenetic factors are involved in the contralateral progression. METHODS The authors performed a multicenter cohort study in which 93 cases with unilateral moyamoya disease were retrospectively reviewed. The demographic features, RNF213 R4810K mutation, lifestyle factors such as smoking and drinking, past medical history, and angiographic findings were analyzed. A Cox proportional hazards model was used to find risk factors for contralateral progression. RESULTS Contralateral progression was observed in 24.7% of cases during a mean follow-up period of 72.2 months. Clinical characteristics were not significantly different between 63 patients with the R4810K mutation and those without it. Cox regression analysis showed that the R4810K mutation (hazard ratio [HR] 4.64, p = 0.044), childhood onset (HR 7.21, p < 0.001), male sex (HR 2.85, p = 0.023), and daily alcohol drinking (HR 4.25, p = 0.034) were independent risk factors for contralateral progression. CONCLUSIONS These results indicate that both genetic and nongenetic factors are associated with contralateral progression of unilateral moyamoya disease. The findings would serve to help us better understand the pathophysiology of moyamoya disease and to manage patients more appropriately.

Abstract 15644: Proinflammatory Diet Independently Predicts Shorter Event-free Survival in Patients With Heart Failure

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Junghee Kang ◽  
Debra K Moser ◽  
Martha J Biddle ◽  
Terry A Lennie
Keyword(s):  
Heart Failure ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Regression ◽  
Enzyme Inhibitor ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Event Free Survival ◽  
Free Survival ◽  
Phone Calls

Introduction: Inflammation is a common biological process accompanying chronic conditions, such as heart failure (HF) that can be moderated by diet. The association between foods thought to promote inflammation and event-free survival in patients with HF has not been investigated. Hypothesis: The inflammatory potential of individuals’ diets, measured using the dietary inflammatory index (DII), will be associated with event-free survival in patients with HF. Methods: The DII scores were calculated from 4-day food diaries recorded at baseline by 213 patients with HF (age 61±12years, 35% female, 43% NYHA III/IV). Patients were followed for a median of 365 days by monthly phone calls, medical record review, and death records to determine time to all cause-hospitalization or death. The DII scores were dichotomized using median value for the Cox regression model. Hierarchical multivariate Cox proportional hazards model was used to determine whether DII scores predicted event-free survival after controlling for age, gender, body mass index, prescribed angiotensin-converting-enzyme inhibitor, beta-blocker, cholesterol lowering agent, antiinflammatory agent, N-terminal pro B-type natriuretic peptide, comorbidity, depressive symptoms, and the New York Heart Association functional classification. Results: The DII scores independently predicted event-free survival in the model constant ( p = 0.012). Higher DII scores were associated with more than double the risk of an event compared to lower DII scores (HR: 2.28, 95% Confidence Interval =1.21-4.36). Conclusions: Greater intake of foods considered to promote inflammation was associated with shorter event-free survival in patients with HF. These results provide further evidence of the importance of diet to HF outcomes.

scholarly journals Simulation Extrapolation Method for Cox Regression Model with a Mixture of Berkson and Classical Errors in the Covariates using Calibration Data

2019 ◽  
Vol 15 (2) ◽  
Author(s):  
Jean de Dieu Tapsoba ◽  
Edward C. Chao ◽  
Ching-Yun Wang
Keyword(s):  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Regression ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Classical Type ◽  
Calibration Data ◽  
Finite Sample ◽  
Cox Regression Analysis ◽  
Simulation Extrapolation

Abstract Many biomedical or epidemiological studies often aim to assess the association between the time to an event of interest and some covariates under the Cox proportional hazards model. However, a problem is that the covariate data routinely involve measurement error, which may be of classical type, Berkson type or a combination of both types. The issue of Cox regression with error-prone covariates has been well-discussed in the statistical literature, which has focused mainly on classical error so far. This paper considers Cox regression analysis when some covariates are possibly contaminated with a mixture of Berkson and classical errors. We propose a simulation extrapolation-based method to address this problem when two replicates of the mismeasured covariates are available along with calibration data for some subjects in a subsample only. The proposed method places no assumption on the mixture percentage. Its finite-sample performance is assessed through a simulation study. It is applied to the analysis of data from an AIDS clinical trial study.

scholarly journals Unplanned Reoperation After Trapeziometacarpal Arthroplasty: Rate, Reasons, and Risk Factors

Hand ◽  
2016 ◽  
Vol 12 (5) ◽  
pp. 446-452 ◽  
Author(s):  
Suzanne C. Wilkens ◽  
Zichao Xue ◽  
Jos J. Mellema ◽  
David Ring ◽  
Neal Chen
Keyword(s):  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Regression ◽  
Persistent Pain ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Cox Regression Analysis ◽  
Factors Associated ◽  
Hazards Model ◽  
Kaplan Meier

Background: Trapeziometacarpal (TMC) arthritis is an expected part of ageing to which most patients adapt well. Patients who do not adapt to TMC arthritis may be offered operative treatment. The factors associated with reoperation after TMC arthroplasty are incompletely understood. The purpose of this study was to determine the rate of, the underlying reasons for, and the factors associated with unplanned reoperation after TMC arthroplasty. Methods: In this retrospective study, we included all adult patients who had TMC arthroplasty for TMC arthritis at 1 of 3 large urban area hospitals between January 2000 and December 2009. Variables were inserted into a multivariable Cox proportional hazards model to determine factors associated with unplanned reoperation, and the Kaplan-Meier curve was used to estimate and describe the probability of unplanned reoperation over time. Results: Among 458 TMC arthroplasties, 19 (4%) had an unplanned reoperation; 16 of 19 (84%) for persistent pain and two-thirds within the first year. The multivariate Cox regression analysis showed that unplanned reoperation was independently associated with younger age, surgeon inexperience, and index procedure type. Conclusions: Surgeons should be aware as well as patients should be informed that as many as 4% are offered or request a second surgery, usually for persistent pain and often within the 1-year window when additional improvement is anticipated.

Genotype-Phenotype Associations in Patients with Severe Congenital Neutropenia.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 502-502
Author(s):  
Philip S. Rosenberg ◽  
Steven Stein ◽  
Elin Rodger ◽  
Audrey Anna Bolyard ◽  
Mary Ann Bonilla ◽  
...  
Keyword(s):  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Statistical Significance ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Severe Congenital Neutropenia ◽  
Congenital Neutropenia ◽  
Causative Gene ◽  
Distinct Subgroup ◽  
Cell Counts

Abstract BACKGROUND: G-CSF therapy has reduced sepsis mortality in patients with severe congenital neutropenia (SCN), revealing a syndromic predisposition to myelodysplastic syndrome and acute myeloid leukemia (MDS/AML). The MDS/AML risk appears to be higher in SCN patients who are less-responsive to therapy; however, the genetic determinants of susceptibility remain to be elucidated. METHODS: We studied 82 North American and Australian patients with SCN on long-term G-CSF enrolled in the Severe Chronic Neutropenia International Registry. These patients had prospective follow-up, sufficient banked DNA for genotyping, and validated clinical data. RESULTS: Fifty-two patients (63%) were positive for germline mutations in neutrophil elastase (ELA2); the remaining 30 patients (37%) had no detectable mutations. Prior to G-CSF therapy, blood cell counts were significantly different between ELA2 positive and negative patients. Compared with ELA2 positive patients, ELA2 negative patients had significantly higher median absolute neutrophil count (ANC) values (158 versus 53 cells/uL, P=0.02), significantly lower monocyte and eosinophil counts (P&lt;0.001), and significantly lower platelet counts (P=0.002). ELA2 negative patients were maintained on significantly lower doses of G-CSF (5.2 versus 9.9 ug/kg/day, P=0.02), consistent with higher baseline ANC values. However, ELA2 negative patients were significantly less responsive to G-CSF therapy. Compared with ELA2 positive patients, on therapy, ELA2 negative patients had significantly smaller median increases in ANC values (1200 versus 2700 cells/uL, P=0.02); the difference remained significant after controlling for individual G-CSF dose (P=0.04). ELA2 negative patients had 5 MDS/AML events in 132 person-years, versus 8 MDS/AML events in 373 person-years among ELA2 positive patients. Using the Cox proportional hazards model, the hazard of MDS/AML was 3.1-fold higher in ELA2 negative patients compared with ELA2 positive patients. This association was of borderline statistical significance (P=0.08). No patient in either group died of sepsis. We found 34 distinct mutations in 52 ELA2 positive patients. The mutation sites were not clustered in the 8 ELA2 positive patients who developed MDS/AML. We found no associations of phenotype or outcome with specific ELA2 mutations; however, the numbers were limited. CONCLUSIONS: SCN patients without mutations in ELA2 constitute a clinically distinct subgroup. ELA2 negative patients are significantly less responsive to G-CSF therapy than ELA2 positive patients, and they may be at substantially higher risk of leukemia. Additional studies are needed to confirm the latter association and identify the causative gene or genes.

scholarly journals Serum Myostatin Predicts the Risk of Hepatocellular Carcinoma in Patients with Alcoholic Cirrhosis: A Multicenter Study

Cancers ◽  
2020 ◽  
Vol 12 (11) ◽  
pp. 3347
Author(s):  
Ji Hyun Kim ◽  
Seong Hee Kang ◽  
Minjong Lee ◽  
Gi Soo Youn ◽  
Tae Suk Kim ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Multicenter Study ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Characteristic Curve ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Enzyme Linked Immunosorbent Assay ◽  
Platelet Counts ◽  
Hazards Model

Background and Aim: Previous studies reported that serum myostatin is associated with sarcopenia. We aimed to elucidate the association between serum myostatin levels and hepatocellular carcinoma (HCC) development in patients with alcoholic liver cirrhosis (ALC). Methods: This retrospective, multicenter study assessed 1077 Asian ALC patients enrolled from 2007 to 2017. The primary endpoint was the development of HCC within 5 years. Cox proportional hazards model analyses were used to assess the association of serum myostatin levels and HCC development. The time-dependent areas under the receiver operating characteristic curve (AUROC) of serum myostatin for 5-year HCC development were calculated. Serum myostatin levels were measured using an enzyme-linked immunosorbent assay with samples collected on the index date. Results: During a median follow-up of 2.5 years, 5-year cumulative HCC incidence rates were 6.7% in the total population. The median level of serum myostatin was 3.3 ng/mL (interquartile, 2.1–5.2 ng/mL). The AUROC of serum myostatin for 5-year HCC development was 0.78 (95% confidence interval [CI], 0.76–0.81). In Cox proportional hazards model analyses, age, gender, platelet counts, and serum myostatin levels were independent risk factors for HCC development (adjusted hazard ratios [HRs] of age, male gender, platelet counts, and serum myostatin: 1.03, 2.79, 0.996, 1.18, respectively; all p < 0.05). Patients with high myostatin levels had a significantly higher risk of 5-year HCC development than those with low myostatin levels (HR 7.53, p < 0.001). Conclusion: Higher serum myostatin levels were significantly associated with a higher risk of developing HCC in ALC patients, which could identify high-risk patients who need stringent surveillance.

scholarly journals Favipiravir for the Treatment of Coronavirus Disease 2019; a propensity score-matched cohort study

2021 ◽  
Author(s):  
Rand A ALATTAR ◽  
Shiema ABDALLA ◽  
Tasneem AK ABDALLAH ◽  
Rashid KAZMAN ◽  
Aseelah QADMOUR ◽  
...  
Keyword(s):  
Clinical Improvement ◽  
Propensity Scores ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Regression ◽  
Supplemental Oxygen ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Ordinal Scale ◽  
All Cause Mortality

Background We investigated clinical outcomes of favipiravir in patients with COVID-19 pneumonia. Methods Patients who between 23 May 2020 and 18 July 2020 received 24 hours or more of favipiravir were assigned to the favipiravir group, while those who did not formed the non-favipiravir group. The primary outcome was 28-day clinical improvement, defined as two-category improvement from baseline on an 8-point ordinal scale. Propensity scores (PS) for favipiravir therapy were used for 1:1 matching. Cox regression was used to examine associations with the primary endpoint. Results The unmatched cohort included 1,493 patients, of which 51.7% were in the favipiravir group, and 48.3% were not receiving supplemental oxygen at baseline. Favipiravir was started within a median of 5 days from symptoms onset. Significant baseline differences between the two unmatched groups existed, but not between the PS-matched groups (N = 774). After PS-matching, there were no significant differences between the two groups in the proportion with 28-day clinical improvement (93.3% versus 92.8%, P 0.780), or 28-day all-cause mortality (2.1% versus 3.1%, P 0.360). Favipiravir was associated with more viral clearance by day 28 (79.8% versus 64.1%, P <0.001). In the adjusted Cox proportional hazards model, favipiravir therapy was not associated 28-day clinical improvement (adjusted hazard ratio 0.978, 95% confidence interval 0.862 to 1.109, P 0.726). Adverse events were common in both groups, but the 93.9% were Grades 1 to 3. Conclusion Favipiravir therapy for COVID-19 pneumonia is well tolerated but is not associated with an increased likelihood of clinical improvement or reduced all-cause mortality by 28 days.

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