ViiV Healthcare’s fostemsavir receives marketing authorisation in the EU

Fostemsavir (brand name Rukobia) has this week received marketing authorisation in the EU following a US approval in July 2020. This means that the first-in-class treatment is now an option for thousands of treatment experienced people living with HIV.

The new compound is an attachment inhibitor, which acts by attaching itself to glycoproteins on the virus and preventing it from attaching and entering the person’s CD4+ cells. There are no known resistances for this class of treatment, which makes it a viable option for people living with HIV and multi-drug resistance.

The marketing authorisation was supported by data from the Phase 3 BRIGHTE study conducted with 371 heavily treatment experienced people living with HIV and multi-drug resistance. The study took part in two arms.

Randomised: 272 participants took either fostemsavir or a placebo alongside their existing ‘background’ therapy for eight days, then after that received open-label fostemsavir alongside their background therapy.

Non-randomised: 99 participants how had no fully active therapy in their system were given fostemsavir under compassionate use.

By week 96 an undetectable viral load <40 copies/mL was achieved in 60% of the randomised arm, and 37% in the non-randomised compassionate use arm. Both arms saw an increase in CD4+ cell counts.

The most common drug-related adverse events reported in the non-randomised arm were fatigue (5%), nausea (6%), and diarrhoea (6%).

The most common drug-related adverse events reported in the randomised arm were nausea (10%), diarrhoea (4%), headache (4%) and immune reconstitution inflammatory syndrome (2%).

The recommended dose of fostemsavir is 600mg twice daily.

Professor Carlo Federico Perno, Director, Microbiology and Diagnostic Immunology, Pediatric Hospital Bambino Gesu', Rome said:

“We’ve seen significantly improved HIV treatments becoming available over the past few decades, making HIV a manageable life-long condition. However, for some people who are living with multidrug-resistant HIV, there is an urgent need for new treatment options.

In clinical trials, fostemsavir, in combination with other antiretroviral therapies, demonstrated sustained rates of virologic suppression and clinically meaningful CD4+ T-cell recovery offering us a long-awaited new option for this specific HIV community.”