CHMP recommends novel long-acting HIV treatment

The Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for a marketing authorisation to approve the first complete long-acting regimen to treat HIV.

The regimen comprises of Vocabria (cabotegravir long-acting injections) in combination with Johnson & Johnson Innovative Medicine’s Rekambys (rilpivirine long-acting injections), as a treatment of HIV-1 infection in virologically suppressed adolescents aged 12 years and over who weigh at least 35 kg.

This expanded indication provides a novel treatment option that significantly reduces dosing frequency, from 365 days to six days per year.

“[The] positive CHMP opinion is an important step towards bringing the first long-acting injectable regimen to adolescents living with HIV. Long-acting regimens have potential to provide effective HIV therapy and help address the challenges many people face taking daily oral regimens,” Dr Harmony Garges, MPH, Chief Medical Officer at ViiV Healthcare (majority owned by GSK) commented.

Data supporting the CHMP’s decision

Week 24 data from the ongoing Phase I/II study MOCHA study (IMPAACT 2017, Study 208580) of cabotegravir and rilpivirine long-acting supported the positive opinion from the EMA’s committee.

The findings, based on evaluation of 144 adolescents, showed that 96.5 percent of participants remained virologically suppressed at week 24, GSK noted.

ViiV Healthcare stated that marketing authorisation for this expanded indication from the European Commission (EC) is expected in the coming months.

Demonstrating superior efficacy in HIV treatment

In early 2024, interim results from the Phase III LATITUDE (Long-Acting Therapy to Improve Treatment Success in Daily Life) study reported “superiority of long-acting therapy [injectable antiretroviral treatment (ART) Cabenuva (cabotegravir + rilpivirine)], compared to daily oral therapy in individuals who have difficulty taking pills for HIV every day is a remarkable outcome,” Dr Kimberly Smith, MPH, Head of R&D at ViiV Healthcare commented following the data release. “The LATITUDE study shows cabotegravir and rilpivirine injectable treatment can help them keep their virus suppressed… Optimising therapy for all people living with HIV, including those with adherence challenges, is critical to the effort to end the HIV epidemic.”