The European Commission has granted marketing authorization for Vocabria (cabotegravir long-acting injections) in combination with Rekambys (rilpivirine long-acting injections) for the treatment of HIV-1 infection in adolescents aged 12 years and older, weighing at least 35 kg, who are virologically suppressed. This approval marks a significant advancement in HIV treatment, offering a long-acting injectable option that reduces the burden of daily oral medication. The decision is based on data from the MOCHA study, highlighting the efficacy and patient preference for this novel regimen.
Addressing Treatment Challenges in Adolescents
Adolescents living with HIV often face challenges with treatment adherence and viral suppression compared to older age groups. As of 2023, an estimated 1.55 million people aged 10 to 19 were living with HIV worldwide. The once-daily pill regimens can be difficult for some adolescents to adhere to consistently, leading to suboptimal treatment outcomes. The long-acting injectable combination of cabotegravir and rilpivirine aims to address these challenges by reducing the frequency of dosing and potentially mitigating stigma associated with daily pill taking.
Clinical Evidence from the MOCHA Study
The marketing authorization is supported by data from the MOCHA study (IMPAACT 2017, Study 208580), a Phase I/II multicenter, open-label, non-comparative study. The study evaluated the safety, tolerability, and pharmacokinetics of cabotegravir and rilpivirine long-acting in 144 adolescents. Week 24 data showed that 96.5% of participants (139 of 144) remained virologically suppressed, defined as plasma HIV-1 RNA value <50 c/mL. Importantly, no new safety concerns were identified in this adolescent population.
Patient Preference and Quality of Life
In addition to virologic efficacy, the MOCHA study also assessed patient preference. An overwhelming 99% of participants (139/141) stated they preferred the injectable long-acting medicines over daily oral regimens. The main reasons cited were convenience and reduced pill burden, with participants specifically noting a decrease in adherence-related stress and increased privacy.
Expert Commentary
Harmony P. Garges, MD, Chief Medical Officer at ViiV Healthcare, emphasized the importance of this approval, stating, "This authorisation for Vocabria + Rekambys is an important milestone for adolescents living with HIV across Europe who may prefer a long-acting HIV treatment that could address challenges with taking daily oral regimens and could better suit their individual needs."
Vocabria and Rekambys: Mechanism of Action
Vocabria contains cabotegravir, an integrase strand transfer inhibitor (INSTI), which works by preventing the HIV virus from inserting its genetic material into human immune cells, thus blocking viral replication. Rekambys contains rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI), which inhibits the reverse transcriptase enzyme, an essential component for HIV replication. The combination of these two drugs with different mechanisms of action provides a complete regimen for maintaining viral suppression in individuals with HIV-1 infection.
Implications for HIV Treatment
The approval of Vocabria + Rekambys offers a valuable alternative to daily oral antiretroviral therapy for adolescents with HIV-1. By reducing the dosing frequency to as few as six injections per year, this long-acting regimen has the potential to improve adherence, reduce stigma, and enhance the overall quality of life for young people living with HIV.
