Cabotegravir injection, combined with long-acting rilpivirine injection, helps to treat HIV-1 infection in adults. Credit: RAJ CREATIONZS / Shutterstock.com.

China’s National Medical Products Administration (NMPA) has approved ViiV Healthcare’s Vocabria (cabotegravir injection) used along with the Janssen Pharmaceutical Companies of Johnson & Johnson’s Rekambys (rilpivirine long-acting injection) to treat human immunodeficiency virus type-1 (HIV-1) infection.

Cabotegravir injections and tablets received approval in China in July 2023, before the recent marketing authorisation of the long-acting injection.

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Cabotegravir injection, combined with rilpivirine injection, is indicated to treat HIV-1 infection in adults who have successfully controlled the virus and maintain a stable antiretroviral regimen.

The patients should have no history of viral resistance or virological failures with non-nucleoside reverse transcriptase inhibitor and integrase inhibitor agents.

Vocabria, in combination with rilpivirine tablets, has been approved for use as an optional oral lead-in before starting injections or as an oral therapy for individuals who may miss planned injection doses.

The Chinese approval is based on data from three pivotal studies, FLAIR (first long-acting injectable regimen), ATLAS (antiretroviral therapy as long-acting suppression) and the Phase IIIb ATLAS-2M study.

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More than 1,200 subjects from 16 countries took part in these studies.

ATLAS and FLAIR showed the safety and efficacy of cabotegravir and rilpivirine against standard-of-care oral regimens.

The ATLAS-2M trial revealed that dosing once every two months had comparable efficacy to once a month.

ViiV Healthcare CEO Deborah Waterhouse stated: “The approval of cabotegravir injection and rilpivirine long-acting injection marks a step forward in helping to change the treatment experience for some people living with HIV in China who may have challenges with daily HIV therapies.”

In February 2022, GSK announced the settlement of a patent dispute between ViiV Healthcare and Gilead Sciences.