Joint analysis of time-varying effect of vaccine and antiviral drug for preventing severe complications and mortality
Scientific Reports,
Год журнала:
2025,
Номер
15(1)
Опубликована: Фев. 15, 2025
This
study
investigated
the
time-varying
effects
of
vaccines
and
oral
antiviral
drugs
in
preventing
severe
COVID-19
complications
mortality
Hong
Kong.
Utilizing
data
from
hospitalized
patients
diagnosed
with
SARS-CoV-2
between
March
15,
2022,
November
30,
employed
Andersen-Gill
model
time-dependent
explanatory
variables
to
address
immortal
time
bias.
Results
demonstrate
that
both
antivirals
offered
protection,
showing
significant
waning
after
fourth
dose.
Oral
were
most
effective
if
administered
within
five
days
diagnosis.
Understanding
these
temporal
is
crucial
for
optimizing
intervention
strategies
improving
clinical
outcomes.
The
also
underscores
importance
considering
pharmacodynamics
vaccination
schedules
combating
COVID-19.
Язык: Английский
Evaluating the Introduction of COVID-19 Oral Antivirals Through a Test and Treat Programme: Implementation Research in Four African Countries
Опубликована: Янв. 1, 2025
Introduction:
Access
to
oral
antivirals
like
nirmatrelvir/ritonavir
treat
COVID-19
remains
largely
unavailable
across
Africa.
Ghana,
Malawi,
Rwanda
and
Zambia,
all
members
of
the
COVID
Treatment
QuickStart
Consortium,
leveraged
existing
infrastructure
rapidly
commence
test-and-treat
programs.
We
describe
individual-level
impact
within
cascade
care.Methods:
A
retrospective
cohort
study
was
conducted
in
36
facilities
four
countries
that
captured
data
on
SARS-CoV-2
positive
individuals
who
were
screened
for
treatment.
criteria
included
being
high-risk
severe
disease
progression,
presenting
five
days
symptom
onset,
having
mild-to-moderate
severity;
treatment
eligibility
ultimately
determined
by
trained
healthcare
workers.Findings:
From
1,941
participants,
50·2%
eligible
while
65·2%
prescribed
nirmatrelvir/ritonavir.
Among
those
prescribed,
1,265
(73·2%)
received
follow-up,
among
whom
99·4%
confirmed
initiation
97·6%
completed
five-day
course.
Two
serious
adverse
events
reported,
but
neither
attributed
nirmatrelvir/ritonavir.Interpretations:
These
are
first
suggest
antiviral
can
be
quickly,
efficiently
safely
deployed
lower-
middle-income
countries,
parallel
with
implementation
research.
Programs
integrated
their
response
into
health
service
infrastructure,
allowing
decentralization
demonstrating
introducing
newly
developed
diagnostics
government
systems
is
feasible
lower-resourced
settings
during
emergencies.
Equitable
timely
access
treatments
crucial
combat
emerging
global
threats
achieve
equity.Funding:
Open
Society
Foundations,
Conrad
N.
Hilton
Foundation,
Pfizer
funded
had
no
role
research.Declaration
Interest:
Christian
Ramers
served
Advisory
Board
consulting
fees
he
has
also
or
honoraria
from
Gilead
Sciences,
Viiv,
AbbVie.
All
other
authors
declare
competing
interests.Ethical
Approval:
This
approved
Duke
University
Institutional
Review
(Pro00111388),
Ghana
Health
Services
Ethics
Committee
(017/11/22),
National
Sciences
Research
Committee,
Malawi
(#23/03/4025),
(105/RNEC/2023),
ERES
Converge
(Zambia)
(23-Jan-023).
Язык: Английский
Impact of differences between interim and post-interim analysis populations on outcomes of a group sequential trial: Example of the MOVe-OUT study
Clinical Trials,
Год журнала:
2025,
Номер
unknown
Опубликована: Март 2, 2025
Pre-specified
interim
analyses
allow
for
more
timely
evaluation
of
efficacy
or
futility,
potentially
accelerating
decision-making
on
an
investigational
intervention.
In
such
analysis,
the
randomized,
double-blind
MOVe-OUT
trial
demonstrated
superiority
molnupiravir
over
placebo
outpatient
treatment
COVID-19
in
high-risk
patients.
full
analysis
population,
point
estimate
difference
primary
endpoint
was
notably
lower
than
at
analysis.
We
conducted
a
comprehensive
assessment
to
investigate
this
unexpected
effect
size,
with
goal
informing
future
clinical
research
evaluating
treatments
rapidly
evolving
infectious
diseases.
The
modified
intention-to-treat
population
divided
into
cohort
(i.e.
all
participants
included
analysis;
prospectively
defined)
and
post-interim
remaining
participants;
retrospectively
defined).
Baseline
characteristics
(including
many
well-established
prognostic
factors
disease
progression),
outcomes,
virologic
outcomes
were
evaluated.
impact
changes
baseline
time
explored
using
logistic
regression
modeling
simulations.
well-balanced
between
arms
overall.
However,
between-
within-arm
differences
known
(e.g.
comorbidities,
SARS-CoV-2
viral
load,
anti-SARS-CoV-2
antibody
status)
observed
cohorts.
For
individual
factors,
these
generally
minor
otherwise
not
notable;
as
progressed,
however,
shifts
combination
increasingly
favored
arm
across
most
evaluated
cohort.
Model-based
simulations
confirmed
that
reduction
size
could
be
accounted
by
longitudinal
trends
toward
lower-risk
study
among
participants.
Infectivity
load
data
molnupiravir's
antiviral
activity
consistent
both
cohorts,
which
heavily
dominated
different
clades
(reflecting
rapid
evolution).
cumulative
randomly
occurring
within
time,
rather
reduced
against
variants,
likely
impacted
outcomes.
Our
results
have
broader
implications
group
sequential
trials
seeking
evaluate
emerging
pathogens.
During
dynamic
epidemic
pandemic
conditions,
adaptive
should
designed
interpreted
especially
carefully,
considering
they
will
enroll
large
overrun
even
small
multiple
variables
can
disproportionately
prespecified
timepoints.
Shifts
may
introduce
additional
variability
difficult
disentangle
from
temporal
epidemiology
evolutionary
causative
pathogen)
management.(ClinicalTrials.gov:
NCT04575597.).
Язык: Английский
Cost-Effectiveness Analysis of Molnupiravir Versus Best Supportive Care for the Treatment of Outpatient COVID-19 in High-Risk Older Adults in Japan
PharmacoEconomics - Open,
Год журнала:
2025,
Номер
unknown
Опубликована: Апрель 23, 2025
This
analysis
aimed
to
evaluate
the
cost
effectiveness
of
molnupiravir
versus
best
supportive
care
for
treatment
older
adult
patients
(aged
≥
65
years)
in
Japan
with
mild
moderate
COVID-19
who
are
at
risk
disease
progression
leading
hospitalization,
predominantly
using
input
data
derived
from
Omicron
era
SARS-CoV2
pandemic.
A
decision-analytic
model
was
developed,
comprising
a
decision-tree
acute
phase
(30
days),
followed
by
lifetime
Markov
model.
Inputs
used
parametrize
were
database
study
conducted
and
published
systematic
literature
review
real-world
studies,
ad-hoc
searches
other
research
(for
progression,
cost,
utility
estimates).
modelled
death
averted
due
hospitalization
as
an
indirect
effect
(through
preventing
hospitalization).
Costs
expressed
2022
Japanese
yen
(¥;
JPY),
perspective
payers
(the
base
case)
or
society
(in
scenario
analysis).
QALYs
discounted
2%
per
year.
Cost
primarily
compared
willingness-to-pay
(WTP)
threshold
¥5,000,000
quality-adjusted
life
year
(QALY)
gained.
Treatment
is
associated
QALY
gain
0.018
incremental
¥81,472
over
effective
(with
cost-effectiveness
ratio
[ICER]
¥4,638,477)
based
on
predefined
WTP
Molnupiravir
leads
reduction
proportion
die
(0.09%
vs
0.29%
care).
also
lower
costs
hospitalizations
(¥22,527
¥27,472).
In
deterministic
sensitivity
analysis,
top
five
most
sensitive
parameters
baseline
rate,
mortality
benefit
molnupiravir,
rate
general
ward,
discount
intensive
unit.
probabilistic
gained,
had
80%
probability
being
care.
cost-effective
option
outpatients
(age
symptomatic
Japan,
relative
Язык: Английский
Scientometric analysis of COVID-19: A basis for developing a general theory of pandemic from scholarly communications perspective
Опубликована: Июль 1, 2024
This
study
conducted
a
scientometric
analysis
of
the
COVID-19
pandemic
with
aim
providing
foundation
for
developing
general
theory
pandemics
from
scholarly
communications
perspective.
To
achieve
this,
sought
to
answer
single
question:
How
do
knowledge,
innovation,
and
environment
relate
one
another
during
pandemic?
Carayannis
Campbell
(2010)
posed
similar
question
different
perspective,
this
builds
on
that
by
attempting
provide
framework
in
case
occurs.
understand
publication
behavior
scholars
over
five-year
period
2019
2024,
authors
analyzed
data
extracted
Scopus
between
August
18
28,
2023.
The
search
strategy
used
was
“COVID-19
OR
Coronavirus
Coronaviruses
SARS-CoV-2
2019-nCoV.”
yielded
511,920
results,
which
17,487
were
study.
It
found
many
countries
around
globe
formed
six
clusters.
As
result,
researchers
these
continued
produce
significant
research
outputs,
leading
high
number
citations
enhancing
their
position
within
communications.
An
interesting
finding
revealed
new
relevant
topics,
prompting
link
findings
quintuple
helix
theory.
recommended
using
empirical
theoretical
models
develop
theories
can
further
define
pandemics.
Язык: Английский