J Korean Med Sci.  2023 Feb;38(8):e59. 10.3346/jkms.2023.38.e59.

Short-Term Effectiveness of Oral Nirmatrelvir/Ritonavir Against the SARS-CoV-2 Omicron Variant and Culture-Positive Viral Shedding

• Lee E
• Park S
• Choi JP
• Kim MK
• Yang E
• Ham SY
• Lee S
• Lee B
• Yang JS
• Park BK
• Kim DS
• Lee SY
• Lee JY
• Jang HC
• Jeon J
• Park SW

• KMID: 2539632
• DOI: http://doi.org/10.3346/jkms.2023.38.e59

Abstract

Background
Information on the effectiveness of nirmatrelvir/ritonavir against the omicron is limited. The clinical response and viral kinetics to therapy in the real world need to be evaluated.
Methods
Mild to moderate coronavirus disease 2019 (COVID-19) patients with risk factors for severe illness were prospectively enrolled as a treatment group with nirmatrelvir/ritonavir therapy versus a control group with supportive care. Serial viral load and culture from the upper respiratory tract were evaluated for seven days, and clinical responses and adverse reactions were evaluated for 28 days.
Results
A total of 51 patients were analyzed including 40 in the treatment group and 11 in the control group. Faster symptom resolution during hospitalization (P= 0.048) was observed in the treatment group. Only minor adverse reactions were reported in 27.5% of patients. The viral load on Day 7 was lower in the treatment group (P = 0.002). The viral culture showed a positivity of 67.6% (25/37) vs. 100% (6/6) on Day 1, 0% (0/37) vs. 16.7 (1/6) on Day 5, and 0% (0/16) vs. 50.0% (2/4) on Day 7 in the treatment and control groups, respectively.
Conclusions
Nirmatrelvir/ritonavir against the omicron was safe and resulted in negative viral culture conversion after Day 5 of treatment with better symptomatic resolution.

Keyword

Viral Load; Culture; Omicron; COVID-19; Nirmatrelvir/Ritonavir

Figure

• 

  Fig. 1 Study design. The subjects were recruited and allocated into treatment and control groups in four hospitals from February to April 2022.COVID-19 = coronavirus disease 2019.

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  Fig. 2 Distribution of SARS-CoV-2 viral load in the treatment and control groups. (A) SARS-CoV-2 E gene, (B) SARS-CoV-2 ORF1ab gene. The number of patients who had nasopharyngeal swabs by day after the start of treatment in the treatment and control groups is indicated respectively. The cyclic threshold value for SARS-CoV-2 on each day was statistically compared between the treatment and the control groups.SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2.aThe differences between the mean values of viral RNA copies of the treatment group samples and the control group samples.bStatistical significance of the viral RNA copies measured from the treatment group samples, compared with those measured from the control group samples at each designated day after treatment.

• 

  Fig. 3 Distribution of SARS-CoV-2 viral load of fully vaccinated patients in the treatment and control groups. (A) SARS-CoV-2 E gene, (B) SARS-CoV-2 ORF1ab gene.SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2.aThe differences between the mean values of viral RNA copies of the treatment group samples and the control group samples.bStatistical significance of the viral RNA copies measured from the treatment group samples, compared with those measured from the control group samples at each designated day after treatment.

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