FDA Approves Fostemsavir for Heavily Pretreated Patients With HIV


Fostemsavir (Rukobia, ViiV Healthcare) is indicated for use in heavily treatment-experienced adults with multidrug resistant HIV-1 infection.


Officials with the FDA approved ViiV Healthcare’s fostemsavir (Rukobia), 600 mg extended-release tablets, for the treatment of HIV-1 in combination with other antiretroviral (ARV) therapies in heavily treatment-experienced (HTE) adults with multidrug resistant infection, according to a press release.

HTE individuals with HIV have very few options available to them due to resistance, tolerability, or safety considerations, leaving them at risk of progressing to AIDS and death. HTE adults account for approximately 6% of adults living with HIV who are on treatment, according to ViiV.

In the phase 3 BRIGHTE study, the safety and efficacy of fostemsavir was evaluated in combination with optimized background therapy (OBT) in 371 HTE adults living with multidrug-resistant HIV, many of whom had advanced disease at the start of the study. Patients were enrolled in either a randomized or nonrandomized cohort. Randomized patients received either blinded fostemsavir 600 mg twice daily or placebo in addition to their current failing regimen for 8 days of functional monotherapy. Beyond day 8, randomized patients received open-label fostemsavir 600 mg twice daily plus an investigator-selected OBT. In the nonrandomized cohort, patients were treated with open-label fostemsavir 600 mg twice daily plus OBT from day 1 onward. The use of an investigational drug as a component of an OBT was permitted in this cohort.

According to the data, 60% of individuals who received fostemsavir in addition to an investigator-selected OBT achieved undetectable HIV viral load and clinically meaningful improvements to CD4+ T-cell count through week 96. Seven percent of patients discontinued treatment with fostemsavir due to an adverse event (AE). The most common AEs observed in ≥5% of randomized and nonrandomized patients were nausea, fatigue, and diarrhea.

“As the novel HIV attachment inhibitor, fostemsavir targets the first step of the viral lifecycle offering a new mechanism of action to treat people living HIV,” Jacob P. Lalezari, MD, chief executive officer and director of Quest Clinical Research, said in a statement. “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.”


ViiV Healthcare announces US FDA approval for Rukobia (fostemsavir), a first-in-class treatment for HIV in adults with few treatment options available. News Release. ViiV Healthcare; July 2, 2020. Accessed July 3, 2020. https://viivhealthcare.com/en-gb/media/press-releases/2020/july/viiv-healthcare-announces-us-fda-approval-for-rukobia/

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