Azvudine versus Paxlovid for oral treatment of COVID-19 in Chinese patients with pre-existing comorbidities
et al., Journal of Infection,
Retrospective 2,118 hospitalized COVID-19 patients in China, showing improved results with azvudine vs. paxlovid.Confounding by contraindication.
Hoertel et al. find that over 50% of patients that died had a contraindication for the use of Paxlovid Hoertel
. Retrospective studies that do not exclude contraindicated patients may significantly overestimate efficacy. Black box warning.
The FDA notes that "severe, life-threatening, and/or fatal adverse reactions due to drug interactions have been reported in patients treated with paxlovid" FDA
This study includes paxlovid and azvudine
risk of death, 175.0% higher, RR 2.75, p = 0.11, treatment 11 of 228 (4.8%), control 4 of 228 (1.8%), propensity score matching.
risk of mechanical ventilation, 200.0% higher, RR 3.00, p = 0.28, treatment 6 of 228 (2.6%), control 2 of 228 (0.9%), propensity score matching.
risk of ICU admission, no change, RR 1.00, p = 1.00, treatment 1 of 228 (0.4%), control 1 of 228 (0.4%), propensity score matching.
composite outcome, 93.8% higher, RR 1.94, p = 0.03, treatment 31 of 228 (13.6%), control 16 of 228 (7.0%), non-invasive respiratory support, endotracheal intubation, ICU admission, all-cause death, propensity score matching.
respiratory suport, 80.0% higher, RR 1.80, p = 0.07, treatment 27 of 228 (11.8%), control 15 of 228 (6.6%), propensity score matching.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Dian et al., 31 Aug 2023, retrospective, China, peer-reviewed, 5 authors, study period 5 December, 2022 - 31 January, 2023, this trial compares with another treatment - results may be better when compared to placebo.
Abstract: Journal of Infection 87 (2023) e24–e27
Contents lists available at ScienceDirect
Journal of Infection
journal homepage: www.elsevier.com/locate/jinf
Letter to the Editor
Azvudine versus Paxlovid for oral treatment of
COVID-19 in Chinese patients with pre-existing
Chinese guidelines grant the use of Azvudine and Paxlovid in
COVID-19 patients, especially those with pre-existing comorbid
ities.1,2 Recently, Gao Y et al. reported that Paxlovid appears to be
superior to Azvudine in the virus clearance among general COVID-19
patients.3 However, a multicenter randomized controlled study de
monstrated that Paxlovid showed no significant reduction in the risk
of all-cause mortality on day 28 and the duration of virus clearance
in hospitalized adult COVID-19 patients with pre-existing co
morbidities.4 Several studies demonstrated that Azvudine could re
duce the duration of virus clearance and improve the clinical
prognosis in COVID-19 patients including those with pre-existing
comorbidities.5–8 Therefore, concerns arise about the clinical effec
tiveness of Azvudine versus Paxlovid in COVID-19 patients with preexisting comorbidities on admission.
Here, we conducted a single-center, retrospective cohort study
during the outbreak caused by the omicron from December 5,
2022 to January 31, 2023 in Xiangya Hospital of Central South
University. The study included hospitalized patients with preexisting comorbidities and confirmed diagnosis of SARS-CoV-2
infection who received Paxlovid or Azvudine. The patients with
these conditions were excluded: 1) younger than 18 years; 2) re
ceived oxygen support or mechanical ventilation on the date of
the admission; 3) not received any antiviral agents; 4) received
both Azvudine and Paxlovid. The study was approved by the in
stitutional review board of Xiangya Hospital of Central South
University, and all the patients were anonymous and no need for
individual informed consent.
The primary endpoint was a composite disease progression
outcome which was defined as any of the following events: 1) noninvasive respiratory support; 2) initiation of endotracheal intuba
tion; 3) intensive care unit admission; 4) all-cause death. The sec
ondary endpoints were each of these individual disease progression
outcomes. Patients were observed from the date of admission until
discharge, occurrence of outcome event or death, whichever came
first. We used propensity-score models conditional on baseline
characteristics, and the probability of receiving Azvudine was esti
mated in an approach of calliper matching without replacement,
with a calliper width of 0.2. The baseline covariates included age,
sex, time from symptom onset to hospitalization, COVID-19 vacci
nation status, severity of COVID-19 on admission (severe cases were
defined as having respiratory rate ≥30, or oxygen saturation ≤93%, or
PaO2/FiO2 ≤300 mmHg, or lung infiltrates > 50%), and concomitant
treatments initiated at admission (systemic steroid and antibiotics).
The standard mean differences (SMDs) were used to assess the
balance of each baseline covariates between the groups before and
after propensity-score matching which less than 0.1 indicating
covariate was balanced.9 The incidence rates of outcome events were
calculated as the number of outcome events / (sum of person ×
hospital days). Univariate Cox regression model was used to estimate
a hazard ratio (HR) with 95% confidence interval (CI) for each..
is less effective
Please send us corrections, updates, or comments.
c19early involves the extraction of over 100,000 datapoints from
thousands of papers. Community updates
help ensure high accuracy.
Vaccines and treatments are complementary. All practical, effective, and safe
means should be used based on risk/benefit analysis. No treatment, vaccine, or
intervention is 100% available and effective for all current and future
variants. We do not provide medical advice. Before taking any medication,
consult a qualified physician who can provide personalized advice and details
of risks and benefits based on your medical history and situation. FLCCC
provide treatment protocols.