ViiV Healthcare, which is majority-owned by GSK, has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of cabotegravir long-acting injectable for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1.
The regulatory submission is supported by data from two international phase 2b/3 multicentre randomised, double-blind, active controlled studies, HPTN 083 and HPTN 084.
The studies demonstrated that cabotegravir long-acting for PrEP was superior to daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), with clinical trial participants experiencing a 69% lower rate of HIV acquisition compared to FTC/TDF tablets in HPTN 083, and a 90% lower rate of HIV acquisition compared to FTC/TDF tablets in HPTN 084.
PrEP is an effective treatment for an at-risk HIV-negative person to reduce their risk of infection, but until recently, the treatment was only available as a daily-dose pill. Cabotegravir is the first non-pill option, offering up to two months of protection from a single intramuscular injection.
Kimberly Smith, head of research and development at ViiV Healthcare, said: “With approximately 100,000 people in Europe newly diagnosed with HIV each year, this submission is an important step forward in offering expanded options for HIV prevention.
“Long-acting prevention options, if used appropriately and at scale, could have the potential to transform the shape of the HIV epidemic and we look forward to continuing to work with community groups, governments and regulatory authorities to make this option available for those who need it.”
Cabotegravir long-acting for PrEP is currently approved in the US, Australia and Zimbabwe as Apretude.
The company recently presented positive results from a phase 3b study which showed the combination of cabotegravir with Janssen’s – a pharmaceutical arm of Johnson & Johnson – Rekambys (rilpivirine long-acting injectable suspension) was successfully implemented across a range of European healthcare settings and demonstrated high clinical effectiveness and a low rate of viral failure throughout the duration of the trial.
At 12 months, primary findings from the CARISEL study demonstrated that despite most European clinics having no prior long-acting cabotegravir and rilpivirine experience, there was high acceptability, appropriateness, and feasibility among clinic staff towards its implementation as well as the long-acting regimen itself.
“As healthcare providers and clinics look for real world evidence on the successful implementation of this innovative treatment, the findings of CARISEL provide continued and strong evidence for its applicability across diverse healthcare settings,” said Berend van Welzen, CARISEL investigator, UMC Utrecht.