People in the United States have had access to GlaxoSmithKline’s long-acting HIV treatment for nearly a year. Now the game-changing therapy will be available to people in England and Wales.
With a sign-off from the National Institute for Health and Care Excellence, HIV patients will be able to switch from daily oral drugs to injections every two months following an initiation phase.
Developed by ViiV Healthcare, GSK’s HIV company with partners Pfizer and Shionogi, Cabenuva scored FDA approval in January in combination with Johnson & Johnson’s Edurant. A month earlier, it won approval in the European Union, where it is known commercially as Vocabria.
Cabenuva nabbed approvals after a phase 3 study showed that a once-a-month injectable regimen performed comparable to daily antiretroviral pills. A subsequent trial showed that a two-month formulation worked as well as shots once a month.
“We are committed to listening to people living with HIV to understand their priorities for treatment options and to push boundaries to develop therapies that meet their needs,” Nneka Nwokolo, ViiV’s senior global medical director, said in a statement.
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To support the case for its medicine, ViiV points to a recent survey which showed that 60% of those with HIV fear that their condition will be exposed without their consent, with 45% saying they have been forced to disclose their HIV status because they were observed taking their daily medication.
“We still have a long way to go in educating around HIV, but today’s announcement demonstrates how far we’ve come since the 1980s epidemic,” Garry Brough of Positively UK said in a statement. “Having to take tablets every day can be physically, emotionally and socially burdensome for some people. This decision reflects the rightful need for people living with HIV to have the freedom to manage their HIV in a way that works best for them, helping them to live their life to the full.”
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GSK also is developing Cabenuva as a preventative treatment. In September, the drug scored FDA priority review designation, setting it up for a decision in January.
With an approval, the drug could challenge Gilead’s market-leading drugs in the PrEP category. Previously, investigators halted a Cabenuva study when the drug showed superior efficacy to Gilead’s daily pill Truvada.