DUBLIN–(BUSINESS WIRE)–The “Disease Analysis: HIV Pre-Exposure Prophylaxis (HIV PrEP)” report has been added to ResearchAndMarkets.com’s providing.
Since its preliminary US and EU approvals for HIV pre-exposure prophylaxis (PrEP) in 2012 and 2016, respectively, Truvada’s PrEP-specific gross sales have steadily risen to blockbuster ranges, with estimated 2019 PrEP gross sales of $2,279m within the US and 5 main European markets.
Truvada’s robust efficiency has been pushed by its standing as the one accredited remedy for PrEP till Descovy’s US approval in October 2019, the favorable suggestions for its use in US CDC and WHO pointers, and reimbursement by the healthcare methods of 4 of the 5 main European markets in both nationwide or pilot packages.
Nonetheless, PrEP stays underutilized because of poor consciousness and lack of/restricted reimbursement in some European international locations, although uptake is growing because of latest favorable reimbursement choices in Germany, Spain, England, Wales, and Northern Eire, in addition to Gilead’s advertising efforts.
The US has the best price of uptake (estimated at 22.6% of at-risk people in 2020) and generates the vast majority of world PrEP revenues, although the October 2020 launch of generic variations of Truvada has triggered a steep decline within the drug’s gross sales. Inside the EU and UK, Truvada is the one accredited agent for PrEP however generates minimal gross sales because of generic competitors since July 2017. PrEP uptake can be estimated to be a lot decrease within the 5 main European markets (5.3% in 2020), due partially to a historic lack of reimbursement in some international locations and continued lack of reimbursement in Italy.
As a way to defend PrEP revenues from generic variations of Truvada, since October 2019 Gilead has been selling swapping to Descovy, which has displayed non-inferior efficacy and marginal enhancements in bone and renal security.
Regardless of the COVID-19 pandemic lowering interplay between physicians and their sufferers, Gilead has efficiently transformed roughly half of sufferers to Descovy (46% market share versus 54% for Truvada as of the tip of Q3 2020), due largely to Descovy being priced at parity to Truvada. Nonetheless, in October 2020, Teva launched the primary generic model of Truvada, which is able to severely restrict additional swapping to Descovy as widespread use of Descovy in sufferers with no pre-existing renal or bone threat components is unlikely to be deemed as value efficient in comparison with lower-cost generic Truvada.
Descovy does have a possible progress alternative within the deliberate HIV Girls’s Prevention Research, which is predicted to start in mid-2021 and can help its US approval in adolescents and grownup girls (the FDA refused to approve Descovy for girls as the only pivotal DISCOVER trial solely included males who’ve intercourse with males [MSM] and transgender girls).
Nonetheless, if trial timelines are similar to the DISCOVER trial, supplementary approval to be used in girls is unlikely to happen till late 2024, leaving Descovy little time to capitalize on the brand new indication earlier than its anticipated patent expiry in June 2025. It additionally appears possible that Gilead will shift its PrEP improvement focus to its six-monthly subcutaneously administered lenacapavir, which might be extra aggressive towards longer-acting pipeline rivals and was added to the HIV Girls’s Prevention Research in December 2020.
There are at present six brokers in medical improvement for pharmacological PrEP, comprising 5 antiretrovirals and a single broadly neutralizing antibody. All the pipeline brokers purpose to supply much less frequent dosing schedules as a way to handle the difficulty of suboptimal adherence to once-daily Truvada/Descovy, which may end up in impaired effectiveness in real-world observe. Notable threats to Truvada/Descovy embody ViiV Healthcare’s Vocabria, which is dosed intramuscularly each two months (eight weeks) and has already demonstrated superior efficacy in comparison with Truvada within the HPTN 083 (cisgender males and transgender girls) and HPTN 084 (cisgender girls) trials.
Vocabria’s bimonthly administration might be very enticing to sufferers who battle to stick to each day tablets, although its injectable nature and requirement for doctor administration will deter some sufferers, that means Descovy will nonetheless be capable to keep some market share following Vocabria’s anticipated US launch in late 2021/early 2022. Merck & Co’s oral once-monthly islatravir is one other main risk, as a once-monthly choice ought to vastly enhance adherence whereas avoiding the necessity for doctor administration, although no in-human proof-of-concept efficacy knowledge are at present accessible for islatravir within the PrEP setting.
The general chance of approval of a Part I antiviral asset is 13.1%, and the typical likelihood a drug advances from Part III is 68.3%. Antiviral property, on common, take 8.5 years from Part I to approval, which is barely lower than the typical of 9.0 years for the general infectious illness area.
Key Subjects Lined:
KEY REGULATORY EVENTS
- First PrEP In China: Gilead Faces Altering Market For Truvada
PROBABILITY OF SUCCESS
CLINICAL TRIAL LANDSCAPE
DRUG ASSESSMENT MODEL
- Uptake of PrEP is predicted to proceed following constructive European reimbursement choices lately, along with the launches of extra choices with extra handy dosing
- Dominance of generic Truvada has restricted progress of the European market, however Vocabria’s potential to enhance adherence and effectiveness will drive progress
- Vocabria is predicted to grow to be the top-selling remedy by means of 2026
- Descovy will fail to completely protect Gilead’s US PrEP revenues due to competitors from Vocabria, islatravir, and generic Truvada
- Oral once-monthly islatravir is predicted to grow to be the brand new commonplace of care from 2025 if improved adherence interprets into superior effectiveness in comparison with Truvada/Descovy
RECENT EVENTS AND ANALYST OPINION
- Vocabria for HIV Prevention (November 9, 2020)
- Vocabria for HIV Prevention (Could 18, 2020)
- Descovy for HIV Prevention (August 7, 2019)
- Descovy for HIV Prevention (August 5, 2019)
KEY UPCOMING EVENTS
- Higher consciousness and entry to PrEP
- Longer-acting brokers with much less frequent dosing regimens, significantly in girls
For extra details about this report go to https://www.researchandmarkets.com/r/9z0e9k