GSK's HIV franchise could reach £7B in 2026, analyst says, as real-world data start backing long-acting Cabenuva

GSK is banking on long-acting cabotegravir for growth in its HIV department. At least one team of analysts believes the company has the winning formula, and real-world evidence has started backing the case.

GSK’s entire HIV business could reach about 7 billion pounds sterling in sales by 2026, and the cabotegravir franchise—which currently includes Cabenuva treatment and Apretude for PrEP—could reach peak sales of around 3 billion pounds in 2030, ODDO BHF analysts estimated in a Friday note.

The ODDO team confirmed their forecast after speaking with HIV expert Christine Katlama in France. The takeaway? Long-acting HIV treatments are a “real game-changer for patients as they enable a significant improvement in quality of life and better treatment observance,” the team wrote. GSK’s cabotegravir is leading the space with no real competitor in the near future, the ODDO analysts said.

Last year, GSK’s HIV drugs brought in 4.8 billion pounds in global sales. The British pharma itself has projected that cabotegravir-based therapies could reach over 2 billion pounds at peak.

The only notable competitor in sight in the long-acting space is Gilead Sciences’ lenacapavir. The capsid inhibitor can be given every six months, whereas the dosing interval for cabotegravir is currently two months at the longest. However, lenacapavir, like cabotegravir, must be paired with another antiretroviral drug, and Gilead right now doesn’t have a long-acting partner.

Lenacapavir was originally paired with Merck & Co.’s potentially long-acting islatravir. But a recent clinical setback has forced Merck to revisit the proper dosing strength of the drug with a new phase 3 program launched in September.

Still, changing the HIV treatment paradigm from daily pills to an injection given once every two months won't be an easy feat. Meanwhile, questions are circling about Cabenuva’s antiviral strength and whether its dosing schedule is convenient enough to change patient behaviors. 

Real-world data by GSK’s HIV-focused ViiV Healthcare and academics have started to offer more answers to those questions, and so far the evidence is in support of cabotegravir.

At IDWeek 2022, researchers presented an analysis of electronic health records from a database called Observational Pharmaco-Epidemiology Research and Analysis (OPERA). The data showed that in a group of U.S. patients who had viral loads below 200 copies/mL after their first Cabenuva injection, 99% of patients remained virologically suppressed after a median follow-up of 3.4 months.

In patients who had over 200 copies/mL at first prescription, with a median viral load of 16,400 copies/mL, 91% of them achieved virologic suppression, defined as having fewer than 200 copies/mL.

While the data only followed patients for a very short time, the observations suggest that Cabenuva is effective among virologically suppressed individuals, the researchers concluded.

Cabenuva won U.S. approval in January 2021. The fact that real-world studies already exist “shows how much enthusiasm there is around Cabenuva,” Kimberly Smith, M.D., ViiV’s head of R&D, said in an interview with Fierce Pharma.

Despite strong data from Cabenuva’s clinical trials, market watchers still wanted to know if the experience would play out in the same way in the real world. So far, the data are “showing the same thing that we saw in our pivotal studies, that people are doing well, they’re tolerant, and they’re happy,” Smith said.

HIV doctors are used to prescribing pills but not injections. In a separate observational study of healthcare professionals across 24 U.S. sites, 79% of doctors reported they were “extremely” or “very” positive about administering Cabenuva, according to results shared at IDWeek 2022. About 87% of responders said injection visits take less than 45 minutes, including waiting time. Altogether 75% of responders estimated that at least a quarter of their existing patients are eligible for Cabenuva.