İnjektabl ilaç, Johnson & Johnson’ın Edurant ismiyle piyasaya sürülen rilpivirin ve ViiV Healthcare’in araştırma aşamasındaki kabotegravir moleküllerinin kombinasyonundan oluşuyor. Faz IIb aşamasındaki araştırmada 309 HIV hastasına viral baskılanma sağlanana kadar standard üç ilaçlı tedavi verildi. Ardından araştırmacılar grubu üçe böldüler ve bazı hastaların günlük ilaçlarına devam ettiler. Diğerlerine ise aylık veya sekiz haftada bir rilpivirin ve kabotegravir kombinasyonu injekte ettiler. 96 hafta sonunda viral baskılanma oranları 8 haftalık grupta %95, dört haftalık hastalarda %94 ve günde üç hap alanlarda %91 olmak üzere çalışmanın üç grubunda da tutarlı bulundu. Sonuçların daha geniş bir faz III araştırmasında ele alınması planlanıyor. İnjeksiyonun 2020 itibariyle piyasaya sürülmesi hedefleniyor.
J&J and ViiV’s long-acting HIV treatment stacks up to daily pills in Phase II
November 3, 2015 | By Damian Garde
A new semimonthly treatment from Johnson & Johnson ($JNJ) and ViiV Healthcare tamped down HIV as well as daily therapy in a midstage trial, promising a more convenient option for patients.
The injected therapy combines J&J’s rilpivirine, marketed as Edurant, with ViiV’s investigational cabotegravir. In a Phase IIb trial, the partners recruited 309 HIV patients and gave them standard three-drug therapy until they achieved viral suppression. From there, investigators split the group in three, keeping some patients on daily pills and giving others either monthly or every-8-weeks injections of rilpivirine and cabotegravir.
After 96 weeks, the rates of viral suppression were consistent across all three arms of the study, J&J and ViiV said, with 95% for the 8-week group, 94% for the four-week patients and 91% for those on three pills a day.
The plan now is to amplify those results in a larger Phase III study, the partners said, with the goal of launching the combo injection by 2020.
Last year ViiV, an HIV-focused company majority owned by GlaxoSmithKline ($GSK), made J&J its first partner since getting off the ground in 2009 as the pair teamed up on a single-tablet combination of rilpivirine and ViiV’s Tivicay. That drug, which would compete with Gilead Sciences’ ($GILD) Atripla, is now in Phase III development.
ViiV has been among the few recent bright spots for GSK, which co-owns the company with Pfizer ($PFE) and Shionogi. GSK briefly considered an IPO for its stake in ViiV but abandoned the idea amid long-running struggles for its legacy businesses, making the steady growth of HIV revenue all the more vital.