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4927 Oral Antiviral Therapy and Monoclonal Antibody for the Treatment of COVID-19 Infection in Outpatients Receiving Anti-Cancer Treatment for Hematological Malignancies: A Multicenter Prospective Study Exploring Efficacy, Safety and Predictors of COVID-19 Lung Failure

Program: Oral and Poster Abstracts
Session: 905. Outcomes Research—Lymphoid Malignancies: Poster III
Hematology Disease Topics & Pathways:
Research, Clinical Research, real-world evidence
Monday, December 12, 2022, 6:00 PM-8:00 PM

Carla Minoia, MD, PhD1*, Davide Bavaro, MD2*, Giacomo Loseto, MD3*, Crescenza Pasciolla, MD4*, Lucia Diella5*, Carmen Pelligrino, MD2*, Valentina Totaro, MD5*, Vito Spada, MD6*, Michele Camporeale, MD5*, Immacolata Attolico, MD7*, Tommasina Perrone8*, Felice Clemente, MSc3*, Francesco di Gennaro, MD PhD2*, Pellegrino Musto, MD9,10, Attilio Guarini, MD11* and Annalisa Saracino6*

1Hematology and Cell Therapy, Istituto Tumori "Giovanni Paolo II" I.R.C.C.S. Ospedale Oncologico, Bari, Italy
2Clinic of Infectious Diseases, Department of Biomedical Sciences and Human Oncology,, University of Bari "Aldo Moro", Bari, Italy
3Hematology Unit, IRCCS Istituto Tumori 'Giovanni Paolo II', Bari, Italy
4Hematology Unit - Istituto Tumori Bari "Giovanni Paolo" IRCCS, Bari, Italy
5Clinic of Infectious Diseases, Department of Biomedical Sciences and Human Oncology, University of Bari "Aldo Moro", Bari, Italy
6Clinic of Infectious Diseases, Department of Biomedical Sciences and Human Oncology, University of Bari "Aldo Moro", Bari, Italy, University of Bari "Aldo Moro", Bari, Italy
7Hematology Unit, University of Bari, Bari, Italy
8Hematology Unit, University of Bari "Aldo Moro", Bari, Italy
9Department of Emergency and Organ Transplantation, “Aldo Moro” University School of Medicine, Bari, Italy
10Hematology and Bone Marrow Transplantation Unit - AOUC Policlinico, Department of Emergency and Organ Transplantation, “Aldo Moro” University, Bari, Italy
11Hematology and Cell Therapy Unit, IRCCS Istituto Tumori 'Giovanni Paolo II', Bari, Italy

Background: Serious complications during SARS-CoV2 infection were reported in onco-haematological patients; in addition, COVID-19 can also indirectly force the interruption or delay of cancer treatment. Early administration of oral antivirals [molnupiravir (MOL) and nirmatrelvir/ritonavir (NIR/r)] or monoclonal antibody (Sotrovimab) may reduce hospitalization and death risk. However, data in hematological patients are lacking.

Methods: Outpatients diagnosed with onco-hematologic malignancy presenting COVID-19 were treated with oral antivirals. Hospitalization and lung failure rate, overall mortality, and safety were analyzed.

Results: Overall, 83 outpatients were prospectively enrolled in the study [median (q1-q3) age of 61 (48 - 72) years; males in 52% of cases]. All subjects were affected by B.1.1.529 (omicron) SARS-CoV2 variant. Notably, 75 (90%) were fully vaccinated against SARS-CoV2.

A total of 33 (40%) was affected by HL/NHL, 21 (25%) by AML/MDS, 14 (17%) by CLL, 15 (18%) by other malignancies, including 4 ALL, 9 MM, and 2 CML.

At the time of COVID-19, 11 (13%) were hematopoietic-stem-cell transplant recipients, 19 (23%) were treated with anti-CD20, 7 (8%) were under chronic steroid therapy.

After multidisciplinary evaluation, 44 (53%) and 39 (47%) were treated with NIR/r and MOL, respectively; in addition, 14 (17%) patients underwent a combination therapy with Sotrovimab. Median (q1-q3) time from diagnosis of COVID-19 to therapy was of 1 (1-2) days. No grade 3-4 adverse events related to antiviral or Sotrovimab were reported.

Overall, 7 (8%) patients were hospitalized for COVID-19 despite therapy. By performing a univariate and multivariate logistic regression, predictors of hospitalization were: recent administration of anti-CD20 (aOR=13.03, 95%CI=1.86-91.3), chronic steroid therapy (aOR=21.37, 95%CI=1.86-244), incomplete/lack of vaccination (aOR=16.07, 95%CI=1.45-177).

Interestingly, the subgroup of patients affected by HL/NHL and CLL presented a longer viral shedding, if compared with AML/MDS and other malignancies groups (14 vs 14 vs 8 vs 8 days respectively, p=.031); similarly, persisting COVID-19 symptoms (>21 days) was significantly more frequent in HL/NHL group vs others (18% vs 0% in other groups, p=.020).

Conclusions: The early administration of oral antivirals may be safe in onco-hematologic outpatients and could reduce the risk of hospitalization and death due to SARS-COV2 infection. Nevertheless, some groups of patients are still at higher risk and need further attention.

Disclosures: No relevant conflicts of interest to declare.

*signifies non-member of ASH