GSK's Long-Acting HIV Therapy Cabotegravir Approved in China for PrEP, Reducing Infection Risk by Up to 91%

May 14, 2024 10:58 CST Updated 10:58

GSK

Pharmaceutical R&D Manufacturer

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On May 13, GSK announced that its HIV drug research joint venture ViiV HealthcareCabotegravir Sodium TabletsAndCabotegravir InjectionRecently, it has been approved by China's NMPA at the same time,For pre-exposure prophylaxis (PrEP) of HIV-1 in adults and adolescents (weight ≥35kg) at risk of infection, to reduce the risk of sexually transmitted HIV-1., combined with safe sexual behavior measures to achieve better HIV-1 PrEP outcomes.This is a therapy that prevents HIV infection without the need for daily medication.In a Phase 2b/3 clinical study, compared with the control group, the cabotegravir long-acting injection group91% reduction in HIV infection risk。

Screenshot source: 123RF

Pre-exposure prophylaxis (PrEP) is an effective biological prevention method for preventing HIV infection through the use of antiviral drugs.Cabotegravir Long-Acting Injection is aIntegrase Strand Transfer Inhibitors (INSTI) suppress HIV replication by preventing viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is crucial in the HIV replication cycle and is also the reason HIV becomes a chronic condition.。Cabotegravir Injection and Cabotegravir Sodium TabletsPreviouslyAs of July 2023Officially obtained in ChinaNMPAApproval, UnitedCabotegravir Injection and Rilpivirine Tablets for Use in HIV-1 Infected Individuals Who Have Achieved Virologic Suppression.

According to the introduction in the GSK press release,Cabotegravir Long-Acting Regimen Requires Only a Minimum of 6 Injections Per Year for HIV Pre-Exposure ProphylaxisUsers 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. Prior to the first injection, users may choose to take oral tablets of cabotegravir sodium for approximately one month (at least 28 days) to assess drug tolerability.

The approval in China this time is based on two international Phase 2b/3 multicenter, randomized, double-blind, active-controlled studies (HPTN 083 and HPTN 084), which aimed to evaluateLong-Acting Injectable Cabotegravir for HIV Pre-Exposure Prophylaxis in HIV-1 Negative Men Who Have Sex with Men, Transgender Women, and Cisgender Womensafety and efficacy. Among them, the HPTN 083 study was conducted among 4,566 HIV-1 negative men who have sex with men and transgender women who have sex with men at high risk; the HPTN 084 study targeted 3,224 cisgender women at high risk of HIV infection. The studies evaluated daily oralTenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC)Safety and Efficacy of Tablets vs. Long-Acting Injectable Cabotegravir Every 8 Weeks for HIV Prevention. The study assessed user tolerance to cabotegravir through an oral lead-in period prior to intramuscular injection.

The results of the HPTN 083 study showed that, compared with the control group regimen,Participants who received the long-acting injectable cabotegravir had a 68% lower risk of HIV infection.(12 vs 39; annual incidence rate: 0.37% vs 1.22%). The results of the HPTN 084 study showed that, compared with the control group,The Risk of HIV Infection in the Long-Acting Injection Group Was Reduced by 91%(3 vs 36; annual incidence rate: 0.15% vs 1.85%).

References:

[1] Long-acting pre-exposure prophylaxis drugs for HIV, cabotegravir sodium tablets and cabotegravir injection, officially approved in China. Retrieved May 13, 2024, from https://mp.weixin.qq.com/s/uBRI8fPX8CvZ2FdZkSGm8Q

[2] Vocabria® and Rekambys® Approved in China for Use as a Long-Acting Injectable Treatment Regimen for HIV-1. Retrieved Oct 27, 2023, from https://mp.weixin.qq.com/s/gNvcw51ubLXDyYVuiESfcQ

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