New HIV treatment option for those with multi-drug resistance approved by FDA

ViiV Healthcare’s Rukobia (fostemsavir) has been approved by the US Food and Drug Administration (FDA) as a treatment for HIV in adults with multi-drug resistance or other safety concerns.

Rukobia is a first-in-class treatment, the novel attachment inhibitor, which by attaching the glycoprotein gp120 on the surface of the virus prevents it from attaching to the host immune system cells.

This new one tablet twice daily Rukobia regimen marks a real breakthrough for heavily treatment experienced patients (accounting for approximately 6% of people living with HIV) who, due to multi-drug resistance, are often left on brutal “salvage therapy” using older compounds or left with no options at all.

Approval of Rukobia was supported by data from the phase three BRIGHTE study, which evaluated the safety and efficacy of Rukobia in adults living with multi-drug resistant HIV many of which had advanced disease when entering the study.

In the randomised BRIGHTE study 60% (n=163/272) of those who received Rukobia, in addition to optimised background therapy, achieved an undetectable viral load and meaningful CD4 count by week 96. Of all participants, randomised and non-randomised 7% discontinued treatment due to adverse events.

Deborah Waterhouse, CEO of ViiV Healthcare, said:

“There is a small group of heavily treatment experienced adults living with HIV who are not able to maintain viral suppression with currently available medication and, without effective new options, are at great risk of progressing to AIDS. The approval of Rukobia is a culmination of incredibly complex research, development, and manufacturing efforts to ensure we leave no person living with HIV behind.”

Rukobia was reviewed and approved under the FDA’s’ Fast Track and Breakthrough Therapy Designations’ which are intended to facilitate and expedite the development and review of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition.

Jacob P. Lalezari, M.D., Chief Executive Officer and Director of Quest Clinical Research, said:

“As a novel HIV attachment inhibitor, fostemsavir targets the first step of the viral lifecycle offering a new mechanism of action to treat people living with HIV. In the BRIGHTE study, fostemsavir in combination with other ARVs effectively achieved and maintained long-term viral suppression and demonstrated clinically meaningful rise in CD4+ T-cell count even among heavily immunocompromised patients.

These are exciting advances for the HTE population and an advancement the HIV community has long been waiting for. As an activist as well as researcher, I am very grateful to ViiV Healthcare for their commitment to heavily-treatment experienced people living with HIV.”

Gabriel Maldonado, Founder and CEO, TruEvolution, Inc., said:

“Some members of the HIV community face very challenging treatment journeys and do not respond to available therapies for a variety of reasons. The approval of fostemsavir provides a sense of renewed hope for these adults who have few or no viable treatment options left and have been awaiting alternative medicines to control the virus.”

Fostemsavir is currently under review by the European Medicines Agency and additional submissions to regulatory authorities around the world are planned throughout 2020 and 2021.