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Abstrak :
Penelitian mengenai pengaruh remdesivir terhadap perubahan nilai cycle threshold (Ct) atau viral load masih sedikit, memiliki hasil yang berbeda-beda, dan belum pernah dilakukan pada subjek dari Indonesia. Penelitian ini bertujuan untuk mengevaluasi pengaruh remdesivir terhadap perubahan nilai Ct dan keamanannya pada pasien COVID-19 derajat berat. Penelitian dilakukan secara retrospektif dengan desain kohort studi. Subjek penelitian terdiri dari kelompok remdesivir (n=80) dan non remdesivir (n=80). Pengamatan yang dilakukan adalah perubahan nilai Ct sebelum dan sesudah penggunaan antivirus pada gen ORF1ab, E, dan N, kebutuhan oksigenasi, mortalitas, kejadian yang tidak dikehendaki (KTD) dan analisis kausalitas KTD dengan Algoritma Naranjo. Hasil yang ditemukan menunjukkan remdesivir mempengaruhi peningkatan nilai Ct pada pasien COVID-19 derajat berat daripada kelompok non remdesivir, dengan peningkatan pada gen ORF1ab adalah 97,5% vs 83,8% (p=0,005), peningkatan pada gen E adalah 95% vs 81,2% (p=0,013), dan peningkatan gen N adalah 97,5% vs 82,5% (p=0,003). Hasil analisis multivariat, remdesivir mempengaruhi peningkatan gen ORF1ab 7,6 kali (95% CI: 1,600-36,449), gen E 5,1 kali (95% CI: 1,528-17,071), dan gen N 8,9 kali (95% CI: 1,864-42,265). Kebutuhan oksigenasi dan mortalitas kelompok remdesivir menunjukkan persentase yang lebih rendah daripada kelompok non remdesivir (15% vs 22,5%; p=0,311; dan 63,8% vs 70%; p=0,502). KTD lebih banyak terjadi pada kelompok remdesivir daripada kelompok non remdesivir (58,8%, vs 53,8%; p=0,633). Kejadian yang signifikan dan memiliki proporsi yang tinggi pada kelompok remdesivir adalah peningkatan ALT (p=0,037). Hasil penelitian ini dapat disimpulkan bahwa remdesivir mempengaruhi peningkatan nilai Ct, namun menunjukkan terjadinya gangguan fungsi hati yang bermanifestasi pada peningkatan nilai ALT. ......Studies on the effect of remdesivir on changes in the cycle threshold (Ct) values or viral load are still limited with varied results, even have never been conducted on subjects from Indonesia. This study aims to evaluate the effect of remdesivir on changes in Ct values and its safety in severe COVID-19 patients. The study was conducted retrospectively with a study cohort design. Research subjects consisted of remdesivir group (n=80) and non-remdesivir group (n=80). Observations focused on changes in the Ct values before and after antiviral use in the ORF1ab, E, and, N genes, oxygenation requirements, mortality, adverse events (AE), and AE causality analysis using the Naranjo Algorithm. The results showed that remdesivir affected the increase in Ct values in severe COVID-19 patients than the non-remdesivir group, with an increase in the ORF1ab gene was 97.5% vs. 83.8% (p = 0.005), an increase in the E gene was 95% vs 81.2% (p = 0.013), and an increase in the N gene was 97.5% vs 82.5% (p=0.003). The results of multivariate analysis showed that remdesivir increased the ORF1ab gene 7.6 times (95% CI: 1.600-36.449), the E gene 5.1 times (95% CI: 1.528-17.071), and the N gene 8.9 times (95% CI: 1.864-42.265). Oxygenation requirements and mortality in the remdesivir group showed lower percentages than the non-remdesivir group (15% vs 22.5%; p=0.311; and 63.8% vs 70%; p=0.502). AE in the remdesivir group was higher than in the non-remdesivir group (58.8%, vs. 53.8%; p=0.633). A significant event and a high proportion in the remdesivir group was an increase in ALT (p=0.037). The results of this study can be concluded that remdesivir affects the increase in Ct values, but shows the occurrence of impaired liver function which manifests in the increase in ALT values.

Abstrak :
Latar belakang: Infeksi SARS-CoV-2 menyebabkan disregulasi sistem imun sehingga memperberat klinis pasien. Penilaian CT dan parameter inflamasi pejamu (neutrofil, limfosit, CRP dan feritin) saat admisi diharapkan membantu klinisi memberi tatalaksana efektif bagi pasien berisiko perburukan. Tujuan: Mengetahui pengaruh nilai CT dan parameter inflamasi pejamu saat admisi terhadap derajat penyakit COVID-19 dalam 14 hari sejak onset gejala. Metode: Studi kohort retrospektif dengan menelusuri rekam medis pasien COVID-19 berusia >18 tahun yang dirawat di RSCM dan RS Medistra pada Juni 2020-Februari 2021. Dilakukan analisis bivariat antara nilai CT, neutrofil, limfosit, CRP, feritin saat admisi dengan keparahan COVID-19, dilanjutkan analisis ROC untuk mendapatkan titik potong optimal. Setelahnya, dilakukan analisis multivariat dan membuat model klinis terbaik menilai kemungkinan keparahan COVID-19. Hasil: Dari 336 subjek didapatkan COVID-19 berat-kritis sejumlah 75,3%. Tidak terdapat hubungan antara nilai CT rendah-sedang dan CT rendah-tinggi terhadap keparahan COVID-19 dengan nilai p masing-masing 0129 dan 0,913, sementara itu terdapat hubungan signifikan antara neutrofil, limfosit, CRP dan feritin terhadap keparahan COVID-19 dengan masing-masing nilai p<0,001. Dari analisis ROC, didapat titik potong optimal neutrofil (>71,5%), limfosit (<18,5%), CRP (>17,2 mg/dL), feritin (270 ng/mL) terhadap terjadinya COVID-19 berat-kritis dalam 14 hari sejak onset gejala. Hasil analisis multivariat menujukkan faktor yang mempengaruhi COVID-19 berat-kritis antara lain neutrofil (aRR 1,850 [IK 95% 1,482-2,311]), limfosit (aRR 1,877 [IK 95% 1,501 – 2,348]), CRP (aRR 2,068 [IK 95% 1,593 – 2,685]), dan feritin (aRR 1,841 [IK 95% 1,438 – 2,357]). Model klinis kombinasi neutrofil, limfosit, CPR dan feritin terhadap COVID-19 berat-kritis memiliki nilai AUC 0,933 (IK 95% 0,902 – 0,963). Kesimpulan: nilai CT tidak mempengaruhi COVID-19 tidak berat dan berat-kritis. Neutrofil, limfosit, CRP, dan feritin saat admisi mempengaruhi terjadinya COVID-19 tidak berat dan berat-kritis Kombinasi neutrofil, limfosit, CRP dan feritin merupakan model klinis terbaik menilai kemungkinan keparahan COVID-19 dalam 14 hari sejak onset gejala. ......Background: SARS-CoV-2 infection leads to immune dysregulation and hyperinflammation, thus potentially exacerbating clinical outcomes. Assessing CT value and host inflammatory parameters such as neutrophils, lymphocytes, CRP, and feritin upon admission may assist clinicians in providing effective management, especially for patient at risk of severe-critical condition. Objective: To analyze the effect of CT values and host inflammatory parameters upon admission on the severity of COVID-19 within 14 days of symptom onset. Methods: A retrospective cohort study tracing COVID-19 patient’s medical records aged >18 years admitted to RSUPN Ciptomangunkusumo and RS Medistra from June 2020 to February 2021. Bivariate analysis was conducted between CT values, neutrophils, lymphocytes, CRP, feritin on admission with COVID-19 severity, then ROC analysis to determine the optimal cut off points. Multivariate analysis was performed to control confounding factors. The best clinical model was analyzed for severe-critical outcome within 14 days of symptom onset. Results: Out of 336 subjects, 75,3% had severe-critical COVID-19. There was no association between low-moderate CT value and low-high CT value with COVID-19 severity, with p value 0,129 and 0,913 respectively. However, there was significant association between neutrophils, lymphocytes, CRP, and feritins with COVID-19 severity, each with p<0.001. ROC analysis determined optimal cut off for neutrophils (>71.5%), lymphocytes (<18.5%), CRP (>17.2 mg/dL), and feritin (270 ng/mL) for the occurrence of severe-critical COVDI-19 within 14 days symptom onset. Multivariate analysis revealed factors influencing severe-critical COVID-19 including neutrophils (aRR 1.850 [95% CI 1.482-2.311]), lymphocytes (aRR 1.877 [95% CI 1.501 – 2.348]), CRP (aRR 2.068 [95% CI 1.593 – 2.685]), and feritin (aRR 1.841 [95% CI 1.438 – 2.357]). Combination of neutrophil, lymphocytes, CRP, and feritin was the best clinical model for severe-critical COVID-19 with AUC value 0.933 (95% CI 0.902 – 0.963). Conclusion: Neutrophils, lymphocytes, CRP, and feritin value upon admission effect COVID-19 severity within 14 days of symptom onset