A monthly two-drug injection developed by the GSK spinoff ViiV Healthcare has been approved for the treatment of HIV in Canada, which could replace the need for daily antiretroviral pills.
The treatment — branded as Cabenuva and developed in collaboration with Janssen — was approved by Health Canada to suppress HIV in adults with stable and low levels of the virus in their blood.
Normally, adults with stable and low levels of HIV must take daily antiretroviral pills for the rest of their lives to suppress the virus, a regimen that can be difficult to maintain. This treatment, which contains ViiV Healthcare’s antiretroviral drug cabotegravir and Janssen’s approved drug rilpivirine in a slow-release formulation, is designed to replace the daily regimen with monthly injections and improve patient compliance.
“Today’s approval marks a monumental step in the treatment of HIV,” stated Deborah Waterhouse, CEO of ViiV Healthcare.
At the same time, cabotegravir was approved by Health Canada as an oral drug. This, combined with oral rilpivirine, is designed to act as a short-acting ‘lead-in’ to Cabenuva injections to make sure that the treatment is safe for the patient. In addition, the two drugs can be taken orally if the patient misses one of their monthly injections.
The approval of the long-acting injection was based on two phase III trials, where the treatment was as good at suppressing HIV as daily antiretrovirals.
ViiV Healthcare now aims to gain market approval for the same treatment in other parts of the world, such as the EMA and the FDA, which rejected the treatment in December 2019 due to manufacturing concerns.
Additionally, ViiV Healthcare is testing the treatment as a two-monthly injection, which was shown to be as good as monthly injections in a phase III trial in August 2019.
This treatment is able to suppress the HIV virus for longer than current antiretroviral drugs, but cannot get rid of the virus permanently. There are many efforts to achieve an HIV cure by killing HIV-infected immune cells.
For example, the Spanish company AELIX Therapeutics is developing a therapeutic vaccine for HIV and the UK company Immunocore is working with the Bill and Melinda Gates Foundation to develop an immunotherapy to functionally cure the disease.
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