CHMP recommends novel long-acting HIV treatment
The positive opinion means HIV patients could overcome challenges of taking daily oral regimens, says ViiV Healthcare's Chief Medical Officer.
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The positive opinion means HIV patients could overcome challenges of taking daily oral regimens, says ViiV Healthcare's Chief Medical Officer.
The authorised formulations are a tablet and a long-acting injection used for preventing sexually transmitted HIV-1 infection (pre-exposure prophylaxis (PrEP).
The Cabenuva (cabotegravir + rilpivirine) injectable regime could benefit individuals with HIV who have challenges adhering to treatment, Phase III interim analysis suggests.
The first long-acting injectable PrEP option proven superior to daily oral FTC/TDF in reducing HIV acquisition, has been approved in the European Union (EU).
The first fixed dose combination (FDC) formulation containing dolutegravir that is suitable for certain paediatric HIV patients globally, has been deemed safe and effective by US researchers.
Sublicence agreements signed by the Medicines Patent Pool (MPP) and three generic manufacturers could enable millions to access a long-acting HIV medicine.
The world‘s first international trial into second-line HIV therapy has shown two simplified treatments are at least as effective as standard of care.
Under a new agreement, licenced manufacturers will be able to supply generic versions of ViiV’s long-acting cabotegravir HIV pre-exposure prophylaxis (PrEP) medication to developing nations.
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US FDA approves Cabenuva (cabotegravir, rilpivirine) based on results from the ATLAS-2M Phase IIIb trial which showed every-two-month dosing was non-inferior to once-monthly dosing.
NICE has published draft guidance recommending cabotegravir, the first long-acting injectable treatment for HIV-1 infection in adults.
Dovato demonstrated non-inferior efficacy compared to TAF-based regimens in virologically suppressed adults with HIV-1 in Phase III study.