BELGIUM — In a groundbreaking development, global pharmaceutical giant GSK has made a significant stride in the fight against HIV.
Its majority-owned subsidiary, ViiV Healthcare, has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for “cabotegravir” long-acting (LA) injectable and tablets, aimed at HIV prevention.
Celebrating the progress made in HIV treatment and prevention services in Europe, GSK, a prominent FTSE 100 company, notes a consistent decline in new HIV cases.
However, despite these efforts, around 100,000 new HIV diagnoses are still reported each year, necessitating further advancements in prevention options.
Cabotegravir LA is poised to revolutionize HIV prevention by offering a groundbreaking option for individuals at risk of HIV acquisition.
Administered as infrequently as six times per year, this new approach provides a promising alternative to daily oral medications.
The positive opinion from the EMA is founded on robust data from two international multicentre, randomized, double-blind, active-controlled studies.
These studies meticulously evaluated the safety and efficacy of cabotegravir LA for Pre-Exposure Prophylaxis (PrEP) in high-risk individuals, including HIV-negative men who have sex with men, transgender women, and cisgender women.
The results of these studies are truly remarkable, as cabotegravir LA for PrEP has shown superiority over daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF).
In one study, participants receiving cabotegravir LA experienced a staggering 69% lower rate of HIV acquisition compared to those on FTC/TDF tablets.
In another study, cabotegravir LA exhibited an astounding 90% lower rate of HIV acquisition in comparison to FTC/TDF tablets.
Already approved for use in the United States, Australia, Zimbabwe, South Africa, Malawi, Botswana, and Brazil under the name Apretude, cabotegravir LA for PrEP is a trailblazing solution.
Submissions to other regulatory agencies are currently underway, signaling a global movement to combat HIV.
ViiV Healthcare’s head of research and development, Kimberly Smith, underscored the critical importance of expanding prevention options to bring an end to the HIV epidemic.
She highlighted the potential of long-acting options to overcome challenges such as inconsistent adherence to daily pills and the stigma associated with oral PrEP use, offering hope to those who could benefit from PrEP.
With their eyes set on pushing the boundaries of science, ViiV Healthcare remains at the forefront of developing solutions to address the most pressing unmet needs in HIV prevention.
Dr. Smith expressed hope that people in Europe would soon gain access to this groundbreaking prevention option, empowering them with greater choice and a brighter future free from HIV.
In the quest for even more innovative HIV treatments, GSK has also developed Cabenuva (cabotegravir and rilpivirine), the world’s first full long-acting HIV regimen.
Although administered once every two months by a healthcare professional, industry experts are exploring the potential of an ultralong-acting, self-administered therapy that could attract greater interest.
GSK’s groundbreaking journey toward ultralong-acting HIV treatment is made possible through Halozyme’s Enhanze drug delivery technology, converting infused antibody therapies into convenient under-the-skin injections.
Meanwhile, Gilead Sciences has also made strides in long-acting HIV treatments, with European approval for lenacapavir (Sunlenca), a capsid inhibitor administered every six months.
Gilead continues to search for the ideal long-acting combo partner for lenacapavir, exploring options like a long-acting version of bictegravir and a combination of two bNAbs.
The field of HIV antiretroviral therapies has predominantly relied on daily small-molecule drugs. However, the promise of broadly neutralizing antibodies (bNAbs) as longer-term options offers hope for a revolutionary shift in HIV treatment.
Among these hopeful developments is N6LS, a promising drug that GSK acquired through a licensing deal with the National Institutes of Health in 2019.
This innovative drug targets the gp120 protein on the HIV envelope, effectively blocking the virus from binding to CD4 on T cells and thwarting viral entry.
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