Omicron driving spike in new Covid-19 cases in Bangladesh
recently and expected to rise in coming days according to health officials.
The Covid-19 positivity rate in Bangladesh has reached the
highest-ever 33.37% in last week.
The health authorities recorded 15,440 new infections after
testing 46,268 samples across the country. The latest figure took the country's
Covid case tally to 17, 62,771, according to the data provided by the
Directorate General of Health Services (DGHS).
The U.S. Food and Drug Administration (FDA) issued
an emergency use authorization (EUA) for nirmatrelvir tablets and
ritonavir tablets (co-packaged for oral use) for the treatment of
mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric
patients (12 years of age and older weighing at least 40 kilograms) with
positive results of direct SARS-CoV-2 testing, and who are at high risk for
progression to severe COVID-19, including hospitalization or death.
FDA’s authorization provides a new tool to combat COVID-19 at
a crucial time in the pandemic as Omicron variants emerge.
In a randomized, double-blind, placebo-controlled clinical trial, Nirmatrelvir and Ritonavir significantly reduced the proportion of people with COVID-19 related hospitalization or death from any cause by 88% compared to placebo.
Nirmatrelvir and
Ritonavir Effective against Omicron variant?
Multiple studies conducted by Pfizer demonstrating that the in
vitro efficacy of nirmatrelvir, the active main protease (Mpro)
inhibitor of nirmatrelvir and ritonavir tablets, is maintained against the
SARS-CoV-2 variant Omicron.
In the first of these in vitro studies, nirmatrelvir
was tested against the Mpro – an enzyme that the coronavirus needs
to replicate – from several SARS-CoV-2 variants of concern (VoCs), including
Omicron, in a biochemical assay. The results showed in all cases that
nirmatrelvir was a potent inhibitor of its target. Nirmatrelvir’s Ki – a
measure of its ability to bind to an enzyme – was approximately 1 nanomolar
(nM) (or Ki fold change <1) for both the Omicron and the original Washington
variant in this assay, indicating its continued ability to prevent in vitro
viral replication.
In a second in vitro study conducted, nirmatrelvir was
tested against several SARS-CoV-2 VoCs, including Omicron, in an antiviral,
cell-based assay. Reduction in viral load was measured through polymerase chain
reaction (PCR) analysis, a test designed to detect the virus. Nirmatrelvir’s drug
potency showing a concentration that is effective in producing 50% of the
maximal response – was 16 nM for the Omicron variant, compared to 38 nM for the
USA-WA1/2020 variant, reaffirming its robust in vitro antiviral
activity.
Background:
Efficacy in Subjects at High Risk of Progressing to Severe
COVID-19 Illness.
Methods:
The primary data supporting this EUA for Nirmatrelvir plus Ritonavir are from
EPIC-HR, a Phase 2/3, randomized, double-blind, placebo-controlled clinical
trial studying Nirmatrelvir and Ritonavir for the treatment of non-hospitalized
symptomatic adults with a laboratory confirmed diagnosis of SARS-CoV-2
infection.
A total of 2,246 subjects were randomized to receive either Nirmatrelvir
plus Ritonavir or placebo. Eligible subjects were 18 years of 26 age and older
with at least 1 of the following risk factors for progression to severe
disease: diabetes, overweight (BMI >25), chronic lung disease (including
asthma), chronic kidney disease, current smoker, immunosuppressive disease or
immunosuppressive treatment, cardiovascular disease, hypertension, sickle cell
disease, neurodevelopmental disorders, active cancer, medically-related
technological dependence, or were 60 years of age and older regardless of
comorbidities. Subjects with COVID-19 symptom onset of ≤5 days were included in
the study. Subjects were randomized to receive nirmatrelvir/ritonavir 300
mg/100 mg or placebo orally every 12 hours for 5 days.
All patients had not received a COVID-19 vaccine and had not
been previously infected with COVID-19. The main outcome measured in the trial was
the proportion of people who were hospitalized due to COVID-19 or died due to
any cause during 28 days of follow-up.
Results:
In this analysis, 1,039 patients had received Nirmatrelvir
and Ritonavir, and 1,046 patients had received placebo and among these
patients, 0.8% who received Nirmatrelvir and Ritonavir were hospitalized or
died during 28 days of follow-up compared to 6% of the patients who received
placebo.
Conclusions:
For the primary endpoint, the relative risk reduction in the
analysis population for Nirmatrelvir and Ritonavir compared to placebo was 88%.
Nirmatrelvir and Ritonavir significantly reduced
the proportion of people with COVID-19 related hospitalization or death from
any cause by 88% compared to placebo among patients treated within five days of
symptom onset and who did not receive COVID-19 therapeutic monoclonal antibody
treatment.
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