GSK's Complete Long-Acting HIV Therapy Cabotegravir Submitted for Approval in China, Reducing Annual Dosing Days from 365 to 12

Source: PharmaCube Info

Author: Shi Bei

On November 25, the CDE website showed that the National Medical Products Administration (NMPA) has accepted the marketing application for GSK/ViiV Healthcare's HIV (Human Immunodeficiency Virus) drug cabotegravir injection and cabotegravir sodium tablets. This therapy is expected to become the first complete long-acting HIV treatment available in China, reducing the number of days patients need to take medication from 365 days to just 12 days.

Cabotegravir (brand name: Vocabria) is an HIV integrase strand transfer inhibitor (INSTI) that has been successively approved in the European Union and the United States. Its injectable form, when used in combination with rilpivirine injection, is administered once a month as an alternative to existing antiretroviral (ARV) regimens. It is intended for use in patients with type 1 HIV infection who are in a stable stage of virological suppression (HIV-1 RNA <50 copies/mL), have no history of treatment failure, and have no known or suspected resistance to either cabotegravir or rilpivirine.

Before starting the combined therapy, patients need to undergo approximately one month of treatment with Cabotegravir tablets and Rilpivirine tablets to assess their tolerance to Cabotegravir and Rilpivirine.

Instructions for Use

Results from the pivotal Phase III ATLAS and FLAIR studies, conducted in 1,100 participants across 16 countries globally, showed that monthly intramuscular injections in the buttocks maintained viral suppression over a 48-week treatment period equivalent to daily oral triple therapy (two nucleoside reverse transcriptase inhibitors (NRTIs) combined with an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or protease inhibitor (PI)). Ninety percent of the participants in the clinical studies reported a preference for the once-monthly injection regimen compared to their previous daily oral therapy.

Note: The original text has been abridged.