GSK plc (LON/NYSE: GSK) announced that ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced that the European Commission has authorised Apretude (cabotegravir long-acting (LA) injectable and tablets) for HIV prevention. Cabotegravir is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in high-risk adults and adolescents (at least 12 years of age), weighing at least 35 kg.
· Given as few as six times per year, cabotegravir has demonstrated superior efficacy to a daily oral PrEP option (FTC/TDF tablets) in reducing the risk of HIV acquisition in clinical trials.[1],[2],[3],[4]
· With approximately 100,000 people newly diagnosed with HIV each year in Europe,[5] expanding HIV prevention options is crucial in reducing HIV transmission.
Cabotegravir LA injectable and tablets for PrEP is the first and only HIV prevention option approved in the European Union (EU) that reduces the number of doses needed for effective HIV prevention from 365 daily pills to as few as six injections per year. Cabotegravir LA injectable and tablets for PrEP has demonstrated superior efficacy to daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in reducing the risk of HIV acquisition in clinical trials, giving people in the EU more options for PrEP.1,2,3,4
Deborah Waterhouse, CEO at ViiV Healthcare, said: “This authorisation marks a pivotal milestone for people across the EU who could benefit from an innovative, long-acting HIV prevention option that may better suit their personal preferences. Long-acting PrEP, alongside other HIV prevention strategies, plays an important role in helping to address some of the challenges that people may have with oral PrEP options”.
This approval is supported by data from two international phase IIb/III multicentre, randomised, double-blind, active controlled studies, HPTN 083 and HPTN 084, which evaluated the safety and efficacy of cabotegravir LA for PrEP in HIV-negative men who have sex with men (MSM), transgender women and cisgender women who were at increased risk of sexually acquired HIV. The studies demonstrated that cabotegravir LA for PrEP was superior to daily oral FTC/TDF tablets, with clinical trial participants given cabotegravir LA for PrEP experiencing a 69% lower rate of HIV acquisition compared to FTC/TDF tablets in HPTN 083 (12 vs 39; annual incidence: 0.37% vs 1.22%; HR 0.31 [CI: 0.16, 0.58]), and a 90% lower rate of HIV acquisition compared to FTC/TDF tablets in HPTN 084 (3 vs 36; annual incidence: 0.15% vs 1.85%; HR 0.10 [CI: 0.04, 0.27]).1,2,3,4
Cabotegravir LA for PrEP is approved for use in the US, Australia, South Africa, as well as other countries as Apretude. Submission to other regulatory agencies is on-going.
[1] Landovitz RJ, Donnell D, Clement ME, et al. Cabotegravir for HIV Prevention in Cisgender Men and Transgender Women. The New England Journal of Medicine 2021;385:595-608. DOI: 10.1056/NEJMoa2101016
[2] Delaney-Moretlwe S, Hughes J, Bock P, et al. Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial. The Lancet 2022;399(10337):1779-1789. DOI: 10.1016/S0140-6736(22)00538-4
[3] Clinical Trials.gov – Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC), For Pre-Exposure Prophylaxis in HIV-Uninfected Cisgender Men and Transgender Women Who Have Sex With Men. Available at
https://clinicaltrials.gov/ct2/show/NCT02720094. Last accessed August 2023.
[4] Clinical Trials.gov – Evaluating the Safety and Efficacy of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women. Available at https://clinicaltrials.gov/ct2/show/NCT03164564. Last accessed August 2023.
[5] ECDC/World Health Organisation (2021) HIV/AIDS surveillance in Europe. Available at https://www.ecdc.europa.eu/sites/default/files/documents/2021-Annual_HIV_Report_0.pdf. Last accessed March 2023. Last accessed August 2023.
ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK and Pfizer dedicated to delivering advances in treatment and care for people living with HIV and for people who could benefit from HIV prevention options.
