ViiV Healthcare Submits Prospectus for First Long-Acting HIV Therapy for Adolescents Seeking European Approval

On December 16, GSK announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of ViiV Healthcare's Vocabria (cabotegravir long-acting injectable) in combination with Janssen’s Rekambys (rilpivirine long-acting injectable) for the treatment of HIV-1 infected adolescents aged 12 years and older, weighing at least 35 kg, who are virologically suppressed.

As of 2023, 1.55 million young people aged 10-19 worldwide are living with HIV. Advances in treatment mean that HIV can be a manageable condition, but daily oral regimens have drawbacks, including adherence challenges, daily reminders of HIV status, and the fear and associated stigma of disclosure.

If the extended indication for cabotegravir and rilpivirine is approved, it will mark the first complete long-acting solution for adolescents with HIV.

Harmony P. Garges, M.D., Chief Medical Officer of ViiV Healthcare, said: "The CHMP positive opinion is an important step towards bringing the first long-acting injectable regimen to adolescents living with HIV. Long-acting regimens have the potential to provide effective HIV treatment and help address the challenges posed by daily oral regimens. This progress highlights our ongoing commitment to offering more treatment options for young people and is part of our mission to leave no person living with HIV behind."

Data from Week 24 of the MOCHA study (IMPAACT 2017, Study 208580) also provided positive signals. This is an ongoing Phase I/II multicenter, open-label, non-comparative study investigating the safety, tolerability, and pharmacokinetics of long-acting cabotegravir and rilpivirine. Based on data from 144 adolescents (aged 12 years or older, weighing 35 kg or more), no new safety concerns were identified, and 139 of the 144 participants (96.5%) remained virologically suppressed at Week 24 (plasma HIV-1 RNA <50 c/mL). Additionally, 99% of participants surveyed at Week 24 (139/141) reported a preference for the long-acting injectable regimen over daily oral medication, primarily due to convenience, reduced daily adherence burden, and increased privacy.

Vocabria+Rekambys is expected to receive marketing authorization from the European Commission in the coming months, after being approved by the EMA in December 2020 for the treatment of virologically suppressed adults with HIV-1.

AboutCabotegravir

Vocabria contains the active ingredient Cabotegravir (GSK1265744), developed by ViiV Healthcare. Cabotegravir is a potent integrase strand transfer inhibitor, structurally similar to Dolutegravir. The drug can be administered orally (in tablet form) or via injection (as a long-acting nanosuspension). After injection, Cabotegravir is readily absorbed with a half-life of approximately 40 days, allowing for monthly or bi-monthly dosing.

In November 2021, Vocabria was submitted for marketing approval in China for the first time, reducing the number of treatment days for patients from 365 to 12.