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Frontiers of Medicine

ISSN 2095-0217

ISSN 2095-0225(Online)

CN 11-5983/R

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Front. Med.    2024, Vol. 18 Issue (1) : 169-179    https://doi.org/10.1007/s11684-023-1011-0
A pilot study on Paxlovid therapy for hemodialysis patients with severe acute respiratory syndrome coronavirus 2 infections
Xu Hao1, Zhiyao Bao2,3, Ranran Dai2,3, Xiaojing Wu1, Xin Li1, Muyin Zhang1, Hao Li1, Lili Xu1, Panpan Qiao1, Xuefei Liu2,3, Weiting Hu2,3, Ze Zhang2,3, Jie Fang4, Min Zhou2,3(), Weiming Wang1(), Jieming Qu2,3()
1. Department of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China
2. Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China
3. Institute of Respiratory Diseases, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China
4. Department of Pharmacy, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China
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Abstract

We aimed to investigate the safety and efficacy of nirmatrelvir/ritonavir (Paxlovid) therapy for hemodialysis-dependent patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Thirteen hemodialysis patients infected with the Omicron variant of SARS-CoV-2 from April 3 to May 30, 2022, were recruited. Laboratory parameters and chest CT (computed tomography) imaging were analyzed. The treatment group included six patients who received 150 mg/100 mg of Paxlovid orally once daily for 5 days, whereas the control group included seven patients who received basic treatment. No serious adverse reactions or safety events were recorded. Four control patients progressed to moderate disease, and none in the treatment group showed progression of chest CT findings (P < 0.05). Paxlovid therapy tended toward early viral clearance and low viral load on Day 8. Moreover, 83.3% of the patients in the treatment group and 57.1% of the patients in the control group turned negative within 22 days. In the Paxlovid treatment group, we found significantly increased levels of lymphocytes (P=0.03) and eosinophils (P=0.02) and decreased levels of D-dimer on Day 8 compared with those on Day 1. Paxlovid therapy showed a potential therapeutic effect with good tolerance in hemodialysis patients. The optimal dose and effectiveness evaluation must be further investigated in a largeer cohort.
Keywords Paxlovid      hemodialysis      SARS-CoV-2      viral load      chest CT scan     
Corresponding Author(s): Min Zhou,Weiming Wang,Jieming Qu   
About author:

Li Liu and Yanqing Liu contributed equally to this work.
Just Accepted Date: 13 October 2023   Online First Date: 17 November 2023    Issue Date: 22 April 2024
 Cite this article:   
Xu Hao,Zhiyao Bao,Ranran Dai, et al. A pilot study on Paxlovid therapy for hemodialysis patients with severe acute respiratory syndrome coronavirus 2 infections[J]. Front. Med., 2024, 18(1): 169-179.
 URL:  
https://academic.hep.com.cn/fmd/EN/10.1007/s11684-023-1011-0
https://academic.hep.com.cn/fmd/EN/Y2024/V18/I1/169
Fig.1  Flowchart of the cohort selection.
Treatment group n = 6 Control group n = 7 P value
Age (year) 65.5 ± 14.9 73.1 ± 8.3 0.39
Female (%) 5 (83.3) 1 (14.3) 0.05
Hemodialysis vintage (year) 4.9 ± 3.7 2.9 ± 1.7 0.27
Hypertension, n (%) 4 (66.7) 8 (100) 0.32
Diabetes, n (%) 2 (33.3) 4 (50) 0.94
BMI (kg/m2) 22.6 ± 1 21.6 ± 1.6 0.34
HGB (g/L) 98.8 ± 15 113.3 ± 15 0.17
WBC (×109/L) 5.1 ± 0.9 5.1 ± 1.7 0.93
LYMP (×109/L) 1 ± 0.2 0.9 ± 0.7 0.28
EOS (×109/L) 0.08 ± 0.03 0.11 ± 0.06 0.71
PCT (ng/mL) 0.4 ± 0.1 0.9 ± 0.5 0.06
CRP (mg/L) 22.2 ± 21.4 15.7 ± 13.9 0.2
eGFR (mL/min/1.73 m2) 3.4 (2.5–4.9) 5.7 (3.8–7.6) 0.06
UA (μmol/L) 466 (377–735) 491 (322–588) 0.74
Alb (g/L) 38.4 ± 4.9 39.5 ± 2.4 0.99
ALT (IU/L) 23.3 ± 2.7 14.9 ± 9.3 0.02
AST (IU/L) 19.7 ± 4.9 16.4 ± 8.5 0.28
D-dimer 0.5 ± 0.2 0.5 ± 0.7 0.14
Initial RT-PCR tests
ORF 21.3 ± 3.3 20.7 ± 3 0.57
N 19.4 ± 3.9 19.2 ± 3.6 0.89
Tab.1  Baseline clinical characteristics of the patients
Patient no. Sex Age (year) Hemodialysis vintage (year) Days of Paxlovid therapy from the symptom onset Clinical classification Principal symptoms Comorbidity Other treatments
Corticosteroids Antibiotics γ-Globulin
T1 F 72 4 2 Mild Cough, shortness of breath Hypertension None None Yes
T2 F 82 2.5 2 Mild Fever Hypertension, diabetes None None None
T3 F 77 3 1 Mild Cough Hypertension, diabetes, asthma None None Yes
T4 M 61 2 3 Mild Cough, diarrhea Hypertension None None None
T5 F 65 13 2 Mild Cough Hypertension None Yes None
T6 F 36 5 3 Mild Cough Poliomyelitis None None None
C1 M 67 2 / Mild Cough Hypertension None Yes Yes
C2 F 72 3.5 / Mild Cough, sputum production Hypertension, diabetes None None None
C3 M 61 7 / Mild Fever Hypertension None None None
C4 M 73 2 / Mild Fever Hypertension None None None
C5 M 82 1 / Mild Cough Hypertension, diabetes None None None
C6 M 78 2 / Mild Cough, fever Hypertension, diabetes, coronary heart disease None Yes Yes
C7 M 65 2 / Mild Cough, sputum production Hypertension, diabetes, atrial fibrillation None None None
Tab.2  Clinical information of the enrolled patients
Treatment group n = 6 Control group n = 7 P value
Days until PCR turns negative 18 ± 2.6 18.9 ± 2.5 0.82
HGB (g/L) 94.4 ± 16.7 106.7 ± 8.5 0.19
WBC (×109/L) 7.9 ± 3.5 6.5 ± 1.7 0.98
LYMP (×109/L) 1.2 ± 0.5 1.1 ± 0.5 0.74
EOS (×109/L) 0.26 ± 0.07 0.26 ± 0.9 0.96
CRP (mg/L) 24.6 ± 11.3 10.7 ± 1.9 0.06
PCT (ng/mL) 1.7 ± 1.2 0.4 ± 0.3 0.27
eGFR (mL/min/1.73 m2) 6.2 (3.4–7.5) 8.3 (4.9–7.5) 0.32
UA (μmol/L) 320.3 (246.2–463) 400.6 (321.1–494.7) 0.32
Alb (g/L) 36.4 ± 3.9 35.4 ± 4.2 0.78
ALT (IU/L) 13.6 ± 5.3 15 ± 14 0.45
AST (IU/L) 12.8 ± 5.2 14.1 ± 10.7 0.75
D-dimer 0.5 ± 0.2 0.4 ± 0.3 0.43
Tab.3  Clinical parameters of the patients when PCR turns negative
Fig.2  Dynamic changes in the laboratory parameters in all patients on the 1st day of admission and the day of obtaining negative PCR test results. Each line represents one patient. (A) The WBC level did not obviously change from the 1st day of admission to the day of obtaining a negative PCR result, except in one treatment patient with other viral infections. (B) The lymphocyte level had an increasing trend in the treatment and control groups. (C) The ALT level had a decreasing trend in the treatment and control groups, except in one control patient. (D) The D-dimer level had a decreasing trend in the treatment group and an increasing trend in the control group. WBC, white blood cell count; ACT, alanine aminotransferase.
Fig.3  Days to negative SARS-CoV-2 PCR results in the treatment and control patients and the dynamic changes in SARS-CoV-2 PCR tests. (A) Distribution of the percentage of patients who obtained a negative PCR test within 8, 15, 22, and 28 days in the treatment and control groups. The results showed that the PCR tests of 33% of the patients in the treatment group and 29% of the patients in the control group turned negative within 15 days; 50% of the patients in the treatment group and 29% of the patients in the control group turned negative within 22 days. (B) In the viral shedding time analysis, the median time of the two groups was 17.5 days vs. 22 days (treatment group vs. control group). Dynamic changes in the CT values of the ORF (C) and N (D) genes in the treatment and control patients. The CT values of the treatment patients on D8 were higher than those of the control patients.
Fig.4  Dynamic changes in the laboratory parameters in the treatment and control patients on D1 and D8. (A) In the treatment group, the leucocyte levels were higher on D8 than those on D1. (B) The lymphocyte levels in the treatment group increased significantly on D8 compared with those on D1 (P < 0.05). (C) The neutrophil levels in the treatment group increased on D8 compared with those on D1 without significance. (D) The eosinophil levels in the treatment group increased significantly on D8 compared with those on D1. (E) D-dimer level had a decreasing trend in the treatment group and an increasing trend in the control group. (F) No obvious changes in the CRP level were found between D1 and D8 in the two groups.
Fig.5  Chest CT images of the patients in the treatment group (T1, A–C; T4, D–F) and control group (C5, G–I; C6, J–L). T1, a 72-year-old female patient (A–C), and T4, a 61-year-old male patient (D–F), were mild. No obvious changes were observed in the CT images on admission (A, D), D8 (B, E), or D15 (C, F) after the first dose of Paxlovid. C5, an 82-year-old male patient (G–I), was mildly symptomatic. No obvious changes were observed in the CT images on admission (G), and patchy ground-glass opacities were observed in the middle lobe of the right lung on D8 (H). These opacities were absorbed on D15 (I). C6, a 78-year-old male patient (J–L), was mildly symptomatic. No obvious changes were observed in the CT images on admission (J), and patchy ground-glass opacities were observed in the inferior lobes of the bilateral lungs on D8 (K). These opacities still existed on D15 (L).
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