ViiV’s injectable HIV PrEP drug Apretude gets EU okay

People in the EU who need access to pre-exposure prophylaxis (PrEP) for HIV could soon have a new option with fewer doses after the European Commission approved ViiV Healthcare’s Apretude.

The long-acting injectable drug, which can be given as few as six times per year, is an alternative to daily oral PrEP with Gilead Sciences’ Truvada (emtricitabine/tenofovir disoproxil fumarate) and Descovy (emtricitabine/tenofovir alafenamide), approved in the EU in 2016 and 2021, respectively.

With approximately 100,000 people newly diagnosed with HIV each year in Europe, expanding HIV prevention options is crucial in reducing HIV transmission, according to ViiV’s majority owner, GSK.

Apretude (cabotegravir) has been cleared for use in combination with safer sex practices to reduce the risk of HIV infection in high-risk adults and adolescents (at least 12 years of age), weighing at least 35 kg.

PrEP – used to protect at-risk people such as an HIV-negative individual with an HIV-positive partner – requires high levels of adherence to be effective, and ViiV maintains that the infrequent dosing required with Apretude can make it easier for patients to stay protected.

For some people, compliance with regular dosing can be challenging, particularly if there are confounding issues such as substance use disorders, depression, poverty and efforts to conceal medication from family and friends.

“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,” said ViiV’s chief executive Deborah Waterhouse.

“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,” she added.

Apretude has been approved in the US since the end of 2021 and made £41 million in sales in full-year 2022 – all from the US market – rising to £36 million in the first six months of 2023.

It still has a long way to go to challenge Gilead’s PrEP franchise, however, which has raked in billions of dollars since Truvada first reached the market for PrEP in 2012.

It is thought that around two-thirds of Truvada’s peak sales of $3 billion came from PrEP, with the remainder from its use as a treatment for HIV infection, before sales started to fall as generics entered the market. Descovy has been growing to compensate, however – thanks to an improved safety profile – and reached $1.7 billion last year.

Another company looking at entering the PrEP market is MSD – known as Merck & Co in the US – which has been investigating monthly oral and yearly implantable formulations of islatravir for this use. The oral formulation was discontinued last year after a safety signal emerged in clinical trials.