Real-world effectiveness of Yindan Jiedu granules-based treatment on patients infected with the SARS-CoV-2 Omicron variants BA.2 combined with high-risk factors: A cohort study

Abstract

Background: Our previous studies have shown that Yindan Jiedu granules (YDJDG) can effectively treat coronavirus disease 2019 (COVID-19); however, the high infectivity and the immune escape potential of the Omicron variant BA.2 make it more difficult to control, and patients with high-risk factors prone to progress rapidly.Purpose: To evaluate YDJDG’s efficacy in treating patients with the Omicron variant BA.2 with high-risk factors and compared it with that of Paxlovid.Methods: A total of 257 patients who fulfilled the inclusion criteria were allocated to the YDJDG (115 cases), Paxlovid (115 cases), and control (27 cases) groups. A Cox regression model was used to analyze the independent factors affecting the shedding time of nucleic acid in 14 days. Propensity score matching (PSM) was used to match the characteristics of individuals in the three groups, while the Kaplan-Meier method was used to compare the shedding proportion of nucleic acids.Results: Cox analysis showed that the vaccine booster (p = 0.006), YDJDG treatment (p = 0.020), and Paxlovid treatment (p < 0.0001) were independent predictors of nucleic acid shedding at 14 days. The median recovery time was 11.49 days in the YDJDG group, 10.21 days in the Paxlovid group, and 13.93 days in the control group. After PSM (3:1), the results showed that the nucleic acid shedding time of the YDJDG group (n = 53) was 2.47 days shorter than that of the control group (n = 21) (p = 0.0076), while the Paxlovid group (n = 44) had a 4.34 days shorter than that of the control group (n = 17) (p < 0.0001). After PSM (1:1), YDJDG and Paxlovid (76 pairs) were also analyzed. In the YDJDG group, nucleic acid shedding time was 1.43 days longer than that observed in the Paxlovid group (p = 0.020). At 10 and 14 days, the Paxlovid group showed a significant difference in the nucleic acid shedding proportion compared with the control group (p = 0.036, p = 0.0015). A significant difference was also observed between the YDJDG and control groups (p = 0.040) at 14 days.Conclusion: As a safe and convenient oral drug, YDJDG can be used as an alternative to antiviral therapy for such patients.

Real-world effectiveness of molnupiravir, azvudine and paxlovid against mortality and viral clearance among hospitalized patients with COVID-19 infection during the omicron wave in China: a retrospective cohort study

“…Although existing evidence shows that the clinical symptoms caused by the Omicron variant and its sub variants have been signi cantly reduced compared to before, patients with more than one high-risk factor are still prone to disease progression. 3,13 Therefore, it is meaningful to pay attention to the treatment choice for such patients. In this retrospective real-world cohort study of hospitalized patients with COVID-19, initiation treatment with paxlovid (nirmatrelvir/ritonavir) or azvudine was associated with signi cantly lower risk of 28-day allcause mortality, compared with not having been administered either antiviral.…”

“…3 Therefore, when paxlovid is combined with highly dependent drugs on CYP3A metabolic clearance or CYP3A strong inducers, drug interactions are likely occur, resulting in many patients having to suspend or replace drugs for underlying diseases. 3,4 In addition, paxlovid is not recommended for patients with severe liver insu ciency (Child-Pugh grade C) and severe renal insu ciency (eGFR<30 ml/min). Molnupiravir's largest trial to date is MOVe-OUT, a placebo-controlled phase 3 trial in unvaccinated, non-hospitalized patients who are at high risk of adverse events due to COVID-19.…”

“…Ritonavir is a strong mechanism-based CYP3A inhibitor that increases the blood concentration of nirmatrervir and enhances its therapeutic effect. 3 Therefore, when paxlovid is combined with highly dependent drugs on CYP3A metabolic clearance or CYP3A strong inducers, drug interactions are likely occur, resulting in many patients having to suspend or replace drugs for underlying diseases. 3,4 In addition, paxlovid is not recommended for patients with severe liver insu ciency (Child-Pugh grade C) and severe renal insu ciency (eGFR<30 ml/min).…”