Commission Authorizes ViiV Healthcare’s Long-Acting Injectable Regimen for HIV Treatment

Published: 04 Feb 2025

Author: Precedence Research

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The European Commission approved ViiV-Health's long-acting injectable treatment for HIV-1 infection, a major boost in the anticontagion approach to HIV attestation. The said injections consist of Vocabria (cabotegravir) and Rekambys (rilpivirine), a product of Johnson & Johnson. The combination treatment is for HIV-1-infected adolescents 12 years and older, weighing at least 35 kg, who are virologically suppressed. Vocabria is an integrase strand transfer inhibitor (INSTI) that inhibits viral replication. Rekambys is used together with cabotegravir to ensure effective virus suppression; it is a non-nucleoside reverse-transcriptase inhibitor (NNRTI). This regimen does not require an oral lead-in, streamlining the treatment.

Regulatory Journey and Previous Approvals 

In December 2020, the European Medicines Agency (EMA) approved the injection of cabotegravir plus rilpivirine long-acting regimen, namely, Vocabria+Rekambys in virologically suppressed adults with HIV-1. This newest authorization further extends treatment access to adolescents and offers an alternative route of administration that is more suitable for adolescents' own needs and preferences. "This is a major milestone for adolescents living with HIV throughout Europe who may prefer a long-acting HIV treatment that could address many challenges associated with daily oral regimens and better suit their individual needs", said ViiV Healthcare Chief Medical Officer Dr. Harmony Garges. The most considerable advantage of this regimen is that it offers flexibility in the circle of treatment frequency. Instead of 365 daily pills per year, patients under this treatment can receive anywhere between 6 and more injectable treatments in a given calendar year, thus improving adherence rates and decreasing the stigma and stress typically associated with daily oral HIV medications. The EC approval is supported by data from MOCHA, a currently ongoing multicenter and open-label noncomparative Phase 1/2 study assessing safety, tolerability, and pharmacokinetics of the cabotegravir and rilpivirine long-acting regimen in 144 adolescents from age 12 years and older weighing at least 35 kg. Long-acting injectable treatments offer a good perspective for addressing problems relating to adherence to daily schedules, stigma reduction, and quality of life in HIV care.

Future Implications

ViiV Healthcare's injectable HIV treatment, Vocabria + Rekambys, has been approved by the European Commission to treat HIV. This approval could be a template for any future long-term and ongoing research efforts focused on injectable regimens to deal with adherence issues across many subject groups. Should the attempted study succeed, the Vocabria + Rekambys history could make way for further research into other modalities for chronic and infectious diseases. However, the long-awaited international rollout of long-acting HIV therapies has, for the most part, begun for low- and middle-income countries where the HIV burden remains significantly high. The approval generates hopes for better treatment adherence among adolescents living with HIV, societal acceptance to overcome stigmas, and an improved quality of life.