HIV-1 injectable treatment: GSK's ViiV Healthcare gets Chinese nod for Vocabria used in combination with Rekambys

Cabotegravir injection is indicated in combination with rilpivirine long-acting injection for the treatment of human immunodeficiency virus type-1 (HIV-1) infection in adults who are virologically suppressed, on a stable antiretroviral (ARV) regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the non-nucleoside reverse transcriptase inhibitor (NNRTI) and integrase inhibitor (INI) classes. Vocabria (cabotegravir) tablets are approved for use in combination with rilpivirine tablets (trade name Edurant) as an optional oral lead-in before initiating injections or as oral therapy for those who will miss planned injection doses.

By the end of October 2020, there were an estimated 1.045 million people living with HIV in China. Advancements in treatment mean many people living with HIV can now live long and healthy lives, however, some may still struggle with daily oral HIV medication. It may act as a constant reminder of HIV, be a cause of fear that their HIV status will be accidently disclosed or create challenges with adherence.

Deborah Waterhouse, CEO of ViiV Healthcare, said, “At ViiV Healthcare, we are proud to be able to offer innovative solutions that meet the evolving needs of people living with HIV. 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. We look forward to working closely with our partners in China to make this treatment available to those who could benefit from a long-acting regimen, part of our commitment to ensuring no person living with HIV is left behind.”

This approval is based on data from three pivotal trials: the ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) studies, and the phase IIIb ATLAS-2M study, which collectively included more than 1,200 participants from 16 countries. ATLAS and FLAIR demonstrated the efficacy and safety of cabotegravir and rilpivirine compared to standard-of-care oral regimens, while ATLAS-2M showed that once every two month dosing had comparable efficacy to once monthly. In ATLAS, 92.5% of participants receiving long-acting therapy and 95.5% of those receiving oral therapy remained virally suppressed at week 48 (adjusted difference: -0.3%; 95% confidence interval [CI]: -6.7% to 0.7%), meeting the criterion for non-inferiority. In FLAIR, 93.6% of participants receiving long-acting therapy and 93.3% of participants receiving oral therapy remained virally suppressed at week 48 (adjusted difference: 0.4%; 95% CI: −3.7% to 4.5%), meeting the criterion for non-inferiority. In the pooled analysis of ATLAS and FLAIR most long-acting recipients (83%) experienced injection site reactions, which decreased in incidence over time. Injection site reactions led to the withdrawal of 6 (1%) participants. The serious adverse event rate was 4% in each arm. In ATLAS-2M, cabotegravir plus rilpivirine long-acting every eight weeks was non-inferior to dosing every four weeks (adjusted difference: 0.8%; 95% CI: -0.6% to 2.2%) after 48 weeks of treatment. The safety profile was similar between dosing groups, with 844 (81%) of 1,045 participants having adverse events (excluding injection site reactions); no treatment-related deaths occurred.