HIV Specialist - June 2021 - 7

GLOBAL HIV PRE-EXPOSURE PROPHYLAXIS DISEASE ANALYSIS REPORT 2021
Uptake of PrEP is Expected to Continue
Following Positive European Reimbursement Decisions
A
NEW REPORT, the " Disease
Analysis: HIV Pre-Exposure
Prophylaxis (HIV PrEP) " report
looks at the potential uptick in global use
of HIV pre-exposure prophylaxis (PrEP).
Since its initial U.S. and E.U. approvals
in 2012 and 2016, respectively, Truvada's
PrEP-specific sales have steadily risen to
blockbuster levels in the U.S. and five major
European markets.
Truvada's strong performance has been
driven by its status as the only approved
therapy for PrEP until Descovy's U.S.
approval in October 2019, the favorable
recommendations for its use in U.S. Centers for
Disease Control (CDC) and WHO guidelines,
and reimbursement by the healthcare systems
of four of the five major European markets in
either national or pilot programs.
However, PrEP remains underutilized
due to poor awareness and lack of/limited
reimbursement in some European countries,
though uptake is increasing due to recent
favorable reimbursement decisions in
Germany, Spain, England, Wales, and Northern
Ireland, as well as Gilead's marketing efforts.
The U.S. has the highest rate of uptake
(estimated at 22.6% of at-risk individuals
in 2020) and generates the majority of
global PrEP revenues, though the October
2020 launch of generic versions of Truvada
has triggered a steep decline in the drug's
sales. Within the E.U. and U.K., Truvada
is the only approved agent for PrEP but
generates minimal sales due to generic
competition since July 2017. PrEP uptake is
also estimated to be much lower in the five
major European markets (5.3% in 2020), due
partially to a historical lack of reimbursement
in some countries and continued lack of
SHUTTERSTOCK/ BLACKATOR
reimbursement in Italy.
In order to protect PrEP revenues from
generic versions of Truvada, since October
2019 Gilead has been promoting swapping
to Descovy, which has displayed non-inferior
efficacy and marginal improvements in bone
and renal safety.
Despite the COVID-19 pandemic reducing
interaction between physicians and their
patients, Gilead has successfully converted
approximately half of patients to Descovy
(46% market share versus 54% for Truvada
as of the end of Q3 2020), due largely to
Descovy being priced at parity to Truvada.
However, in October 2020, Teva launched the
first generic version of Truvada, which will
severely limit further swapping to Descovy
as widespread use of Descovy in patients
with no pre-existing renal or bone risk factors
is unlikely to be deemed as cost effective
compared to lower-cost generic Truvada.
Descovy does have a potential growth
opportunity in the planned HIV Women's
Prevention Study, which is expected to begin
in mid-2021 and will support its US approval
in adolescents and adult women (the FDA
refused to approve Descovy for women as
the sole pivotal DISCOVER trial only included
men who have sex with men [MSM] and
transgender women).
However, if trial timelines are comparable
to the DISCOVER trial, supplementary approval
for use in women is unlikely to occur until late
2024, leaving Descovy little time to capitalize
on the new indication before its anticipated
patent expiry in June 2025. It also seems likely
that Gilead will shift its PrEP development
focus to its six-monthly subcutaneously
administered lenacapavir, which would be
more competitive against longer-acting
pipeline rivals and was added to the HIV
Women's Prevention Study in December 2020.
There are currently six agents in clinical
development for pharmacological PrEP,
comprising five antiretrovirals and a single
broadly neutralizing antibody. All of the
pipeline agents aim to offer less frequent
dosing schedules in order to address the
issue of suboptimal adherence to oncedaily
Truvada/Descovy, which can result in
impaired effectiveness in real-world practice.
Notable threats to Truvada/Descovy include
ViiV Healthcare's Vocabria, which is dosed
intramuscularly every two months (eight
weeks) and has already demonstrated superior
efficacy compared to Truvada in the HPTN
083 (cisgender men and transgender women)
and HPTN 084 (cisgender women) trials.
Vocabria's bimonthly administration
could be very attractive to patients who
struggle to adhere to daily pills, though
its injectable nature and requirement for
physician administration will deter some
patients, meaning Descovy will still be able
to maintain some market share following
Vocabria's anticipated U.S. launch in late
2021/early 2022. Merck & Co's oral oncemonthly
islatravir is another major threat, as a
once-monthly option should greatly improve
adherence while avoiding the need for
physician administration, though no in-human
proof-of-concept efficacy data are currently
available for islatravir in the PrEP setting.
The overall likelihood of approval of a Phase
I antiviral asset is 13.1 percent, and the average
probability a drug advances from Phase III is
68.3 percent. Antiviral assets, on average, take
8.5 years from Phase I to approval, which is
slightly less than the average of 9.0 years for
the overall infectious disease space.
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HIV Specialist - June 2021

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