- GlaxoSmithKline, through its majority-owned subsidiary, ViiV Healthcare, is now cleared to sell a long-acting, injectable HIV medicine, providing the U.K. company with a potentially valuable tool as its competes against market-leading drugs from Gilead.
- On Thursday, the Food and Drug Administration approved the medicine, which now has the brand name Cabenuva, as a replacement treatment for certain adults whose HIV infections are in check from other therapies. Cabenuva is given once a month, and is a combination of a GSK drug called cabotegravir and the active ingredient in Johnson & Johnson's Edurant.
- Drugmakers like GSK and Gilead are trying to develop HIV therapies that are safer and more convenient than older, multiple-pill-a-day regimens. Gilead's highly effective, once-daily pill Biktarvy, for example, has been on the market just a few years, but is already the world's top-selling HIV drug. Though GSK lags behind its rival, Thursday's approval does hand the company the first and only complete, long-acting treatment for HIV.
New drugs, while invaluable weapons in the fight against HIV, have not resolved many of the larger problems related to patient care.
Accessing treatment can be difficult due to a mixture of drug costs, insurance coverage, stigma and a limited awareness of the disease. The barriers are also especially high for Black and Latino patients, two groups disproportionately affected by HIV. Because of these issues, the Centers for Disease Control and Prevention has detailed how only about a third of people living with HIV keep their virus under control through treatment.
For those who are receiving treatment, adherence can be a challenge. Two decades ago, HIV patients had to take fistfuls of pills to keep their infections in check. Today, a single daily pill can be just as effective. But keeping up with that schedule isn't easy for everyone, which is where GSK and ViiV hope to make a difference with a drug like Cabenuva.
"For years, many of our clients have struggled to manage their health while working to stabilize key aspects of their lives," said Brett Andrews, CEO of PRC, a San Francisco-based nonprofit that offers financial support and healthcare services to people affected by HIV.
"Cabenuva will provide some people living with HIV greater freedom to pursue vocational, educational and other opportunities, like travel, without the need for daily oral medication management," Andrews added, in a Jan. 21 statement from GSK.
Cabenuva could also provide a revenue boost for GSK, which has struggled to compete against Gilead. Over the first nine months of 2020, Gilead recorded $12.7 billion in sales from its HIV drugs, reflecting a 7% increase year over year. During the same period, GSK had HIV drug sales of 3.6 billion pounds, or roughly $4.9 billion, an increase of just 1% year over year.
Looking to close the gap with Gilead, GSK has been working to develop drugs with fewer so-called active ingredients — which, in theory, should make them more tolerable to patients. The company has specifically focused on two-drug regimens, and has already gotten a couple of them approved by the FDA. Juluca, a mixture of rilpivirine and a drug called dolutegravir, was cleared for the U.S. market in late 2017, while Dovato, which pairs dolutegravir with lamivudine, arrived in the spring of 2019.
Despite the approvals, GSK's two-drug strategy has yet to pan out. Juluca and Dovato sales over the first nine months of last year were both in the range of 200 million to 400 million pounds, well below GSK's top-selling HIV medication Triumeq, a three-drug product which brought in 1.7 billion pounds during the period.
Gilead, meanwhile, has five blockbuster HIV medications in its arsenal. Biktarvy, which is also a three-drug product, earned $5.2 billion across the first three quarters of 2020.
GSK had hit a snag with Cabenuva a little over a year ago, when the FDA rejected it because of manufacturing concerns unrelated to the drug's safety. Thursday's approval signals the manufacturing issue is resolved. Now, however, GSK's challenge is getting patients and doctors on board.