GSK's Long-Acting HIV PrEP Drug Cabotegravir Injection Launched in China

Today (January 10) afternoon, GSK announced its long-acting HIV pre-exposure prophylaxis drugCabotegravir Injection Officially Launched, for those at risk of infectionAdults and adolescents (body weight ≥35kg) for HIV-1 pre-exposure prophylaxis (PrEP)To reduce the risk of sexually transmitted HIV-1 infection, combine with safe sexual behavior measures for better HIV-1 PrEP effectiveness.

▍About Cabotegravir

In May 2024, Cabotegravir Sodium Tablets and Cabotegravir Injection were approved by the China National Medical Products Administration. The approval was based on two international Phase IIb/III multicenter, randomized, double-blind, active-controlled studies (HPTN 083 and HPTN 084), which aimed to evaluate the safety and efficacy of long-acting Cabotegravir Injection for pre-exposure prophylaxis (PrEP) of HIV-1 in HIV-negative men who have sex with men, transgender women, and cisgender women.

HPTN 083 (participants from a diverse gender population) study results showed that, compared to the daily oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC) regimen, participants receiving long-acting injectable CabotegravirThe risk of HIV infection was reduced by 68%.。HPTN 084 (subjects were young women) study results showed that, compared with the TDF/FTC oral tablet group, the long-acting injectable group had a lower incidence of HIVRisk of infection reduced by 91%。

▍The Field of HIV Pre-Exposure Prophylaxis is Heating Up

And just a week ago, Gilead Sciences filed for a new Class 5.1 drugLenapevir Sodium Tablets and Lenapevir Sodium InjectionThe listing application has just been approved by the National Medical Products Administration (NMPA).

Lenapevir has also shown significant efficacy in pre-exposure prophylaxis for HIV. In the Phase 3 clinical trial PURPOSE 1 (participants were young women) published by Gilead Sciences, data indicates that lenapevir demonstrates effectiveness in preventing HIV among women.100% EffectivenessThe results of the second Phase 3 clinical trial, PURPOSE 2 (conducted in a diverse gender population), published in November, showed that among participants receiving lenapavir injections, up to99.9% Not Infected with HIV。

But currently in China, lenapavir is only approved for use in combination with other antiretroviral drugs to treat patients who cannot achieve virological suppression with their current regimen.Adult patients with multidrug-resistant type 1 human immunodeficiency virus (HIV-1) infection.

Cabotegravir is currently the only long-acting injectable drug approved in China for pre-exposure prophylaxis of HIV, and its indication was approved earlier than that of lenacapavir.

But the cabotegravir HIV pre-exposure prophylaxis regimen requiresInject at least 6 times per yearUsers will receive an initial injection of 600mg (3ml) per month for the first two months, followed by a maintenance injection of 600mg (3ml) every two months. In contrast, Lenapavir requires only two subcutaneous injections per year, reducing the frequency of medication and improving patient compliance.

▍Cabotegravir Still Undergoing Upgrades

At the 2024 Conference on Retroviruses and Opportunistic Infections (CROI 2024), GSK presented Phase I clinical trial data for the cabotegravir ultra-long-acting (CAB-ULA) injectable.

The research data published this time show that the long-acting injectable agent Cabotegravir can still maintain a stable plasma concentration with a dosing interval of at least four months, thereby maintaining effective suppression of HIV.This means that cabotegravir may be upgraded from 6 injections per year to 3 injections per year.

At that time, the track of long-acting HIV drugs may become even more heated.

Editor of this article: Liang Jiachen