The landscape of HIV treatment continues to evolve, and a significant milestone has just been reached with the FDA’s approval of Rukobia (fostemsavir), a novel therapy from ViiV Healthcare. Reported by Pharmaphorum, this approval marks an important advancement for a growing segment of people with HIV: those who have survived decades with the virus and now face dwindling treatment options due to drug resistance.
When HIV first emerged over 30 years ago, life expectancy after diagnosis was dishearteningly short. Thanks to the development of combination antiretroviral therapy (ART), people living with HIV today can expect to live nearly as long as those without the virus. However, long-term survivors, many now over the age of 55, are encountering a new challenge: the gradual loss of efficacy in the ART regimens they’ve relied on for years.
By 2018, more than a third of all HIV-positive individuals in the US, around 400,000 people, were over 55. Among them, a significant subset has been treated so extensively that their virus has developed resistance to multiple ART classes, leaving them vulnerable to disease progression.
Rukobia offers hope for these heavily pre-treated adults. Backed by results from the phase 3 BRIGHTE study, the drug was shown to significantly reduce HIV viral load when added to existing therapy in patients with extensive treatment histories and resistant virus. Unlike other HIV drugs, Rukobia is a first-in-class attachment inhibitor that targets the gp120 protein on the virus’s surface, preventing it from binding to and entering human cells. Its unique mechanism means it remains effective even when other ART drugs no longer work, as there is no cross-resistance with established classes.
ViiV Healthcare, majority-owned by GlaxoSmithKline, estimates that approximately 6% of US adults with HIV could benefit from Rukobia. While this represents a relatively small patient pool, it is an essential one, as these individuals face the greatest risk of progressing to AIDS.
Analyst projections for Rukobia’s commercial impact are modest, around $400 million in annual sales, especially when compared to ViiV’s other recent launches like Juluca and Dovato or Gilead Sciences’ blockbuster Biktarvy, which posted $1.7 billion in sales in just one quarter. Still, Rukobia’s approval expands ViiV’s arsenal as the company competes with Gilead, the current leader in the HIV market.
This approval also comes at a time when ViiV is recovering from a setback: the FDA’s rejection of its once-monthly injectable Cabenuva due to manufacturing issues. With Rukobia, ViiV demonstrates its ongoing commitment to innovation, particularly for patients with the fewest remaining options.
Rukobia’s introduction is more than just another drug approval—it is a testament to the progress in HIV care, ensuring that even those who have lived through every stage of the epidemic can continue to hope for effective treatment.
