China Approves First Complete Long-Acting Injectable Regimen for HIV-1: Cabotegravir (Vocabria®) and Rilpivirine (Rekambis®)

On October 26, GSK announced that ViiV Healthcare (hereinafter referred to as "ViiV"), its HIV drug development joint venture, received approval from the China National Medical Products Administration (NMPA) for the combined use of its product Vocabria® (generic name: cabotegravir injection) with Janssen Pharmaceuticals, Inc., a subsidiary of Johnson & Johnson, product Rekambys® (generic name: rilpivirine injection), for the treatment of HIV-1 infected individuals who have achieved virologic suppression. Cabotegravir tablets were also approved for use in combination with rilpivirine tablets, serving as optional oral lead-in therapy prior to initiating injectable treatment or as an oral treatment regimen for those unable to adhere to scheduled injections. The European Medicines Agency (EMA) noted in its official press release on October 16, 2020, that this is the first long-acting injectable HIV treatment regimen, replacing daily oral medication and allowing for administration once every month or every two months. It is also the first complete long-acting (up to every two months) HIV-1 injectable treatment regimen approved by the China National Medical Products Administration.

In 2022, approximately 29.8 million people living with HIV worldwide were receiving antiretroviral therapy (ART)². After more than 40 years of human efforts, HIV infection is no longer an incurable disease. By the end of 2022, China reported 1.223 million people living with HIV/AIDS³, maintaining an overall low prevalence level.

Long-acting HIV-1 treatment regimens can improve medication adherence among people living with HIV, help control the infection and reduce transmission, and contribute to the goal of "ending AIDS as a public health threat by 2030." At the same time, they provide new treatment options for people living with HIV to meet evolving therapeutic needs.

The approval was based on data from three pivotal studies: the Phase III ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) studies, as well as the Phase IIIb ATLAS-2M study, which collectively enrolled more than 1,200 participants from 16 countries. The ATLAS and FLAIR studies demonstrated the efficacy and tolerability of the combination regimen of cabotegravir and rilpivirine compared to standard oral therapy, while the ATLAS-2M study showed that long-acting treatment administered every two months was as effective as treatment administered monthly10,11,12. In the ATLAS study, 92.5% of participants receiving long-acting therapy and 95.5% of those receiving oral therapy maintained virologic suppression at week 48 (adjusted difference: -0.3%; 95% confidence interval [CI], -6.7%-0.7%), meeting the non-inferiority criteria10. In the FLAIR study, 93.6% of participants receiving long-acting therapy and 93.3% of those receiving oral therapy maintained virologic suppression at week 48 (adjusted difference: 0.4%; 95% CI, -3.7%-4.5%), meeting the non-inferiority criteria13. In the ATLAS-2M study, after 48 weeks of treatment, cabotegravir and rilpivirine administered every 8 weeks was non-inferior to administration every 4 weeks (adjusted difference: 0.8%, 95% CI: -0.6%, 2.2%)13.

About Cabotegravir

Cabotegravir, developed by ViiV Healthcare, is an integrase strand transfer inhibitor (INSTI) for use in adult HIV-1 patients who have achieved virologic suppression after receiving stable antiretroviral therapy. It has been approved as a long-acting agent for use in combination with injectable rilpivirine.

INSTIs inhibit HIV replication by preventing viral DNA from integrating with the genetic material of human immune cells (T cells). This step is crucial in the HIV replication cycle and is also the reason why HIV becomes a chronic condition.

Cabotegravir Injection and Cabotegravir Sodium Tablets have been officially approved by the China National Medical Products Administration on July 11, 2023, for use in combination with Rilpivirine Injection and Rilpivirine Tablets to treat HIV-1 infected individuals who have achieved virologic suppression.

About Rilpivirine Tablets and Rilpivirine Injection

Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that works by interfering with the reverse transcriptase enzyme, which can prevent viral replication. Rilpivirine tablets are approved for use in combination with other antiretroviral drugs for the treatment of HIV-1 in antiretroviral treatment-naïve patients aged 12 years and older, weighing no less than 35 kg, and with a viral load ≤100,000 HIV RNA copies/ml.

Rilpivirine Injection is a long-acting injectable solution for intramuscular injection, developed by Janssen Sciences Ireland Unlimited Company. Rilpivirine Injection was approved for marketing in China on October 18, 2023.

Editor: Mu Mian

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