Evaluation of the efficacy and safety of nirmatrelvir/ritonavir co-administration inpatients with rheumatic disease infected with SARS-CoV-2: a real-world study DOI Creative Commons

Xue Zhong,

Chao Wang,

Lin Huang

et al.

Frontiers in Pharmacology, Journal Year: 2023, Volume and Issue: 14

Published: Dec. 6, 2023

Background: The breakthrough development of novel severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccines and oral antivirals have played a critical role in curtailing the spread pandemic dramatically reducing morbidity mortality rates among those infected. Among these antivirals, nirmatrelvir/ritonavir (NR) has been repurposed successfully for use against coronavirus disease-2019 (COVID-19) is now readily available on market with promising therapeutic effects. availability convenient effective NR treatments COVID-19 greatly mitigates severity epidemic contributes to an early end pandemic. Furthermore, certain patient subgroups, specifically rheumatic disease (RD) who are currently undergoing intensive immunodeficiency and/or immunosuppressive treatments, continue be vulnerable at higher risk experiencing consequences from COVID-19. Additionally, it also observed that exhibited prevalent drug-drug interactions clinical significance, more instances rebound were being recognized increasing frequency. Methods: A retrospective cohort study was conducted real-world RD population infected SARS-CoV-2 treated NR. time symptom resolution, length hospitalization, response rate assessed. Results compared standard regimen non-standard groups, late indication non-indication groups. During course, all grades adverse drug reactions (ADRs) directly associated administration (DDIs) monitored. Results: total 32 patients RD, received NR, retrospectively identified divided into different We found group had shorter median resolution control [9.0 (interquartile range [IQR], 8.3-11.3) vs. 21.5 (IQR16.0-24.0) days, p < 0.001 9.0 (IQR 23.0 18.0-24.0) = 0.0]. further even if exceeds 5 receive can still derive benefits it. proportion showed improvement (n 13/17 3/6, 76.5% 50.0%) follow-up, there statistical difference (p 0.0) between two analyzed effect comorbidities percentage <4 ≥ 4 7/7 16/25, 100.0% 64.0%) follow-up. ADRs grade ≥3ADRs not any cases. Despite discontinuing warfarin prior application (using immediately first day withdrawal), one experienced increased international normalized ratio [INR, 5.32(0.90-1.20)] coagulation disorders (weak positive fecal occult blood test) second after using INR levels decreased nearly normal values, returned 2 days (the seventh initial NR). Conclusion: therapy favorable outcome acceptable safety profile immunosuppressed during Omicron surge. Early (within onset) could improve prognosis patients. symptoms confirmed infection >5 may mitigate progression viable strategy. Our results highlight importance utilization indication, which yield advantages SARS-CoV-2.

Language: Английский

Glofitamab plus gemcitabine and oxaliplatin (GemOx) versus rituximab-GemOx for relapsed or refractory diffuse large B-cell lymphoma (STARGLO): a global phase 3, randomised, open-label trial DOI
Jeremy S. Abramson, Matthew Ku, Mark P. Hertzberg

et al.

The Lancet, Journal Year: 2024, Volume and Issue: 404(10466), P. 1940 - 1954

Published: Nov. 1, 2024

Language: Английский

Citations

17

Decoding the historical tale: COVID-19 impact on haematological malignancy patients—EPICOVIDEHA insights from 2020 to 2022 DOI Creative Commons
Jon Salmanton‐García, Francesco Marchesi, Francesca Farina

et al.

EClinicalMedicine, Journal Year: 2024, Volume and Issue: 71, P. 102553 - 102553

Published: March 18, 2024

BackgroundThe COVID-19 pandemic heightened risks for individuals with hematological malignancies due to compromised immune systems, leading more severe outcomes and increased mortality. While interventions like vaccines, targeted antivirals, monoclonal antibodies have been effective the general population, their benefits these patients may not be as pronounced.MethodsThe EPICOVIDEHA registry (National Clinical Trials Identifier, NCT04733729) gathers data from malignancy since pandemic's start worldwide. It spans various global locations, allowing comprehensive analysis over first three years (2020–2022).FindingsThe collected January 2020 December 2022, involving 8767 cases in 152 centers across 41 countries, 42% being female. Over this period, there was a significant reduction critical infections an overall decrease mortality 29% 4%. However, hospitalization, particularly ICU, remained associated higher rates. Factors contributing included age, multiple comorbidities, active at onset, pulmonary symptoms, hospitalization. On positive side, vaccination one two doses or doses, well encountering were improved survival.InterpretationPatients still face elevated risks, despite reductions rates time. Hospitalization, especially ICUs, remains concern. The study underscores importance of timing exposure 2022 enhanced survival patient group. Ongoing monitoring are essential support vulnerable emphasizing role timely diagnosis prompt treatment preventing cases.FundingNot applicable.

Language: Английский

Citations

12

Age, successive waves, immunization, and mortality in elderly COVID-19 hematological patients: EPICOVIDEHA findings DOI Creative Commons
Giuseppe Rossi, Jon Salmanton‐García, Chiara Cattaneo

et al.

International Journal of Infectious Diseases, Journal Year: 2023, Volume and Issue: 137, P. 98 - 110

Published: Oct. 18, 2023

Elderly patients with hematologic malignancies face the highest risk of severe COVID-19 outcomes. The infection's impact on different age groups remains unstudied in detail.We analyzed elderly (age groups: 65-70, 71-75, 76-80, and >80 years old) included EPICOVIDEHA registry between January 2020 July 2022. Univariable multivariable Cox regression models were conducted to identify factors influencing death hematological malignancy.The study data from 3,603 (aged 65 or older) malignancy, a majority being male (58.1%) significant proportion having comorbidities. divided into four groups, analysis assessed outcomes, vaccination status, other variables relation pandemic waves. 90-day survival rate for was 71.2%, differences groups. waves had varying impacts, first wave affecting over 80 old, second more third least all Factors contributing mortality age, comorbidities, lymphopenia, active acute leukemia, less than three vaccine doses, COVID-19, using only corticosteroids as treatment.These underscore heterogeneity patients, highlight impacts pivotal importance vaccination, may help planning future healthcare efforts.

Language: Английский

Citations

11

Effectiveness of nirmatrelvir‐ritonavir on severe outcomes of COVID‐19 in the era of vaccination and Omicron: An updated meta‐analysis DOI Creative Commons
Sien Ombelet, Diego Castanares‐Zapatero, Fabian Desimpel

et al.

Journal of Medical Virology, Journal Year: 2024, Volume and Issue: 96(2)

Published: Feb. 1, 2024

Abstract Nirmatrelvir‐ritonavir (NR) was approved to treat SARS‐CoV‐2 positive outpatients at high risk of progression severe disease, based on a randomized trial in unvaccinated patients. Effectiveness vaccinated patients and against Omicron has not yet been confirmed by clinical data, but recent meta‐analysis suggested good real‐world effectiveness 12 studies. We updated this searching Medline Embase databases for studies assessing NR mortality, hospitalization, composite outcome hospitalization and/or death, published between October 1, 2022 May 22, 2023. Random effects subgroup analysis performed. A total 32 were included the meta‐analysis. Pooled RR effect disease 0.36 (95% confidence interval [CI]: 0.25−0.52), 0.43 (CI: 0.37−0.51), 0.52 0.45−0.61) 0.54 0.41−0.73), respectively. indicated lower mortality (RR: 0.55, CI: 0.45−0.68), similar or 0.52, 0.58, 0.66, respectively). This robustly confirms protective COVID‐19 outcomes.

Language: Английский

Citations

4

Treatment of chronic COVID‐19 with convalescent/postvaccination plasma in patients with hematologic malignancies DOI Creative Commons
Maike Janssen,

Albrecht Leo,

Cornelia Wolf

et al.

International Journal of Cancer, Journal Year: 2024, Volume and Issue: 155(4), P. 618 - 626

Published: May 9, 2024

Immunocompromised patients are at high risk to fail clearance of SARS-CoV-2. Prolonged COVID-19 constitutes a health and management problem as cancer treatments often have be disrupted. As SARS-CoV-2 evolves, new variants concern emerged that evade available monoclonal antibodies. Moreover, antiviral therapy promotes escape mutations, particularly in immunocompromised patients. These frequently suffer from prolonged infection. No successful treatment has been established for persistent Here, we report on series 21 with COVID-19-most them hematologic malignancies-treated plasma obtained recently convalescent or vaccinated donors combination thereof. Repeated dosing SARS-CoV-2-antibody-containing could clear infection 16 out even if COVID-19-specific failed induce sustained viral improve clinical course Ten were major responders defined an increase delta(d)Ct > = 5 after the first administration and/or (C/VP). On average, PCR Ct values increased median value 22.55 (IQR 19.10-24.25) 29.57 27.55-34.63; p <.0001) response subgroup. Furthermore, when treated second time C/VP, 4 initial nonresponders showed Ct-values 23.13 17.75-28.05) 32.79 31.75-33.75; .013). Our results suggest C/VP feasible malignancies who did not respond treatment.

Language: Английский

Citations

4

Effectiveness of nirmatrelvir/ritonavir in hospitalized haematological malignancy patients with mild‐to‐moderate COVID‐19: A retrospective study DOI Open Access
Hongbin Yu, Tian Chen, Jiawei Li

et al.

British Journal of Haematology, Journal Year: 2025, Volume and Issue: unknown

Published: March 3, 2025

Summary Patients with haematological malignancies (HMs) are highly vulnerable to COVID‐19 due their immunocompromised status, which leads prolonged viral clearance and severe outcomes. Nirmatrelvir/ritonavir has shown efficacy in reducing severity mortality high‐risk outpatients, but its effectiveness hospitalized HM patients remains unclear. We conducted a retrospective study assess the of nirmatrelvir/ritonavir on mild‐to‐moderate during China's first surge. Mortality rate time were primary end‐points. Cox proportional hazards models used detect factors associated clearance. A total 116 patients, median age 47.2 years, for minimum 5 days COVID‐19, included this study. There was no difference 90‐day between treated within those not (4.9% vs. 5.3%, p = 1.000). use reduced (hazard ratio [HR] 1.59, 95% confidence interval [CI] 1.04–2.42). does reduce accelerates

Language: Английский

Citations

0

ORCHESTRA Delphi Consensus: diagnostic and therapeutic management of SARS-CoV-2 infection in haematological patients DOI
Lorenzo Maria Canziani, Anna Maria Azzini, Jon Salmanton‐García

et al.

Clinical Microbiology and Infection, Journal Year: 2025, Volume and Issue: unknown

Published: March 1, 2025

Language: Английский

Citations

0

Molnupiravir compared to nirmatrelvir/ritonavir for COVID-19 in high-risk patients with haematological malignancy in Europe. A matched-paired analysis from the EPICOVIDEHA registry DOI Creative Commons
Jon Salmanton‐García, Francesco Marchesi, Philipp Koehler

et al.

International Journal of Antimicrobial Agents, Journal Year: 2023, Volume and Issue: 62(4), P. 106952 - 106952

Published: Aug. 13, 2023

Molnupiravir and nirmatrelvir/ritonavir are antivirals used to prevent progression severe SARS-CoV-2 infections decrease hospitalisation mortality rates. Nirmatrelvir/ritonavir was authorised in Europe December 2021, whereas molnupiravir is not yet licensed as of February 2022. may be an alternative because it associated with fewer drug-drug interactions contraindications. A caveat for the mode action induces viral mutations. Mortality rate reduction less pronounced than that patients without haematological malignancy. Little known about comparative efficacy two drugs malignancy at high-risk COVID-19. Thus, were compared a cohort malignancies.Clinical data from treated or monotherapy COVID-19 retrieved EPICOVIDEHA registry. Patients matched by sex, age (±10 years), severity baseline controls nirmatrelvir/ritonavir.A total 116 receiving clinical management equal number nirmatrelvir/ritonavir. In each groups, 68 (59%) male; median 64 years (interquartile range [IQR] 53-74) recipients (IQR 54-73) recipients; 56.9% (n=66) had controlled malignancy, 12.9% (n=15) stable disease, 30.2% (n=35) active disease onset group. During infection, one third group admitted hospital. Although similar proportion groups vaccinated (molnupiravir n=77, 66% vs. n=87, 75%), more those received four vaccine doses (n=27, 23%) (n=5, 4%) (P<0.001). No differences detected (P=0.39) (P=1.0). statistically significant identified overall (P=0.78) survival probability (d30 P=0.19, d60 P=0.67, d90 P=0.68, last day follow up P=0.68). Deaths either attributed COVID-19, infection judged treating physician have contributed death.Hospitalisation rates comparable malignancies plausible treatment

Language: Английский

Citations

10

Survival in multiple myeloma and SARS‐COV‐2 infection through the COVID‐19 pandemic: Results from the EPICOVIDEHA registry DOI Creative Commons
Pellegrino Musto, Jon Salmanton‐García, Nicola Sgherza

et al.

Hematological Oncology, Journal Year: 2023, Volume and Issue: 42(1)

Published: Dec. 4, 2023

Patients affected by multiple myeloma (MM) have an increased risk of severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) infection and subsequent (20)19 disease (COVID-19)-related death. The changing epidemiological therapeutic scenarios suggest that there has been improvement in severity survival COVID-19 during the different waves pandemic general population, but this not investigated yet MM patients. Here we analyzed a large cohort 1221 patients with confirmed SARS-CoV-2 observed between February 2020, August 2022, EPICOVIDEHA registry from 132 centers around world. Median follow-up was 52 days for entire 83 survivors. Three-hundred three died (24%) primary reason death 89% them. Overall (OS) significantly higher vaccinated both stable active versus unvaccinated, while only trend favoring subjects responsive MM. Vaccinated at least doses showed better OS than those one or no vaccine dose. Overall, according to waves, mortality rate decreased over time 34% 10%. In multivariable analysis, age, renal failure, disease, hospital, intensive care unit admission, were independently associated number deaths, neutrophil count above 0.5 × 10

Language: Английский

Citations

10

Pharmacologic Treatment and Management of Coronavirus Disease 2019 DOI

Amy Hirsch Shumaker,

Adarsh Bhimraj

Infectious Disease Clinics of North America, Journal Year: 2025, Volume and Issue: unknown

Published: March 1, 2025

Language: Английский

Citations

0