ViiV’s Rukobia cleared in EU as rescue HIV therapy

The European Commission has given a green light to the use of ViiV Healthcare’s Rukobia as a treatment for people with HIV that has developed resistance to other antiretroviral therapy (ART). 

The first-in-class HIV attachment inhibitor is cleared for use as an add-on therapy to other ARTs in adults “for whom it is otherwise not possible to construct a suppressive antiviral regimen,” according to ViiV, which is majority-owned by GlaxoSmithKline.

Rukobia (fostemsavir) was approved for the same indication by the FDA last year, providing a rescue therapy option for older HIV patients who may have been on ART for decades.

When the HIV epidemic started in the 1980s, patients could only expect to live for one to two years from diagnosis, but increasingly effective combination ART regimens mean people with HIV can now expect to have a near-normal life expectancy.

For the early recipients of combination ART, however, emerging resistance can mean that regimens start to lose their effectiveness, forcing a switch to other drugs, and eventually they may run out of options.

Rukobia works by targeting the first step of the HIV lifecycle and doesn’t have cross-resistance with other currently licensed antiretroviral classes, re-establishing virus control in patients who are at risk of disease progression and death.

In the phase 3 BRIGHTE study fostemsavir was significantly better than placebo when added on to current therapy at reducing viral load in this hard-to-treat patient population.

Almost two thirds of patients who took ViiV’s drug on top of their usual therapy achieved undetectable HIV viral load and clinically significant improvements to CD4+ T-cell counts, with the benefit extending for at least 96 weeks.

“There have been great strides forward in the treatment of HIV over the last few decades, however, there still remains a small subset of people living with multi-drug resistant HIV who are at risk of having their disease progress,” said ViiV’s chief executive Deborah Waterhouse.

As a rescue therapy sales of Rukobia aren’t expected to be huge – some analysts think it could peak at around $400 million a year – but its importance to people living with HIV is undoubted and it adds to a portfolio at ViiV that is facing increased competition from arch-rival Gilead.

Rukobia made £11 million (around $15 million) since its launch in the US last year, a drop in the ocean of the £4.9 billion brought in by ViiV’s biggest brands like Triumeq (dolutegravir/abacavir/lamivudine) and Tivicay (dolutegravir).

ViiV also picked up an FDA approval last month  for its Johnson & Johnson-partnered injectable HIV therapy Cabenuva (cabotegravir/rilpivirine), a long-acting HIV treatment that keeps the virus at bay with a monthly depot injection instead of daily tablets.