Fostemsavir approved in the EU (Rukobia): NICE deferred in the UK

Simon Collins, HIV i-Base

On 11 December 2020, ViiV Healthcare announced approval of fostemsavir in the EU. [1]

Technically, this positive opinion still requires formal approval but this usually follows within two months.

Fostemsavir is the first gp120 attachment inhibitor and was developed as a treatment for people with multi-drug resistance to other HIV classes.

Submission to the EU was made in December 2019 based on results from an international phase 3 BRIGHTE study in in 371 participants, 99 of who used open-label fostemsavir.

Given extensive drug resistance at baseline, fostemsavir was still associated with achieving undetectable viral load in roughly 40 – 60% of participants at week 96.

Notably, mean increase in CD4 counts was 205 cells/mm³ with 56% of participants increasing from < 50 to >200 cells/mm³.

Fostemsavir is marketed by ViiV Healthcare under the trade name Rukabia.

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Fostemsavir had a long development history and it is important that ViiV Healthcare followed this through to approval after acquiring the compound from BMS in 2015.

Currently, the demand for drugs to use in multidrug resistance in the UK is too limited for a full NICE evaluation. Access however, will be available based on NHS recommendations from specialist HIV commissioning.

The significant increase in CD4 count, might deserve further researcher, including in cases of discordant responses to ART, where viral load is suppressed but CD4 count remains low, especially if this continues to present a risk for opportunistic infections.

Cases of urgent need should contact ViiV directly until this access is in place.

Similar commissioning arrangements are also being organised for access to ibalizumab which was also recently approved.

For people with a history of multidrug resistance and detectable viral load on current ART, using both fostemsavir and ibalizumab together might provide life-saving holding treatment until the next pipeline drugs.

Even though each drug is likely to be priced close to £100,000 per year, they would only need to be used during a window period until the next drug approvals.

Reference

1. ViiV Healthcare. ViiV Healthcare announces positive CHMP opinion for Rukobia (fostemsavir), a first-in-class attachment inhibitor for the treatment of adults with multidrug-resistant HIV with few treatment options available. (11 December 2020).
   https://viivhealthcare.com/en-gb/media/press-releases/2020/december/viiv-healthcare-announces-positive-chmp-opinion-for-rukobia
2. ViiV Healthcare. Prescribing and patient information.
   https://viivhealthcare.com/en-gb/our-medicines/rukobia (website)
   https://viivhealthcare.com/content/dam/cf-viiv/viiv-healthcare/en_GB/files/Final_Rukobia_Prescribing_Information_NDA_212950.pdf (PDF)

This article was first posted on 15 December 2020.