GSK’s ViiV to lean on long-acting HIV portfolio ahead of dolutegravir patent expiration

GSK’s ViiV Healthcare is eyeing 2026 and 2027 for potential longer-acting versions of its respective HIV injectables for prevention and treatment, executives said on a media call Wednesday.

The effort is part of GSK’s plan to bounce back from a key patent expiration in April 2028 for dolutegravir, its blockbuster oral integrase inhibitor. It launched in 2013 as Tivicay and is now a key component of GSK’s two-drug HIV treatments: Dovato and Juluca.

To compensate for that loss of exclusivity, ViiV will lean heavily on its long-acting portfolio that features injectables Apretude and Cabenuva — and that CEO Deborah Waterhouse describes as the “future of HIV care.”

Kimberly Smith

“Patients and providers … are telling us not only that they’re having a great experience with long-acting regimens, but that they want more,” ViiV’s head of R&D Kimberly Smith said on the call.

ViiV touts its cabotegravir injection Apretude as the first long-acting injectable for HIV pre-exposure prophylaxis, and the company scored a label expansion last year allowing the drug to be administered every two months. By 2026, ViiV hopes to extend the dosing interval to every four months, and by 2027, the company aims to do the same for its long-acting injectable treatment Cabenuva.

Waterhouse hopes to further extend the interval for both products to twice-yearly dosing by the end of the decade. Cabenuva competes with Gilead’s lenacapavir, which was approved in December as a twice-yearly treatment option branded as Sunlenca.

ViiV also has its sights set on a long-acting self-administered regimen by the end of the decade, although it has not yet selected a lead candidate.

“We have several products in our portfolio that we’re evaluating as potential options for self-administration,” Smith said. “You need to have the right medicine, the right volume and you also need to have the right device that works well for patients to be able to deliver.”

The team plans to select a regimen to move forward for self-administration in 2024 and it expects to start registrational studies in 2026. By that time, Waterhouse predicts ViiV’s long-acting portfolio will generate roughly one-third of its overall revenue. Apretude and Cabenuva generated £381 million in sales in 2022.

ViiV’s dolutegravir products accounted for a majority of sales in 2022, earning more than £5.1 billion, or $6.2 billion. While the drug’s core patents expire in 2028 in the US and 2029 in Europe, ViiV holds additional formulation patents around Dovato and Juluca, according to Waterhouse.

The Joint United Nations Programme on HIV and AIDS set a goal back in 2019 to end the HIV epidemic by 2030, though the World Health Organization reported last year that infection rates are not falling rapidly enough to meet that target.

“The outcomes for people living with HIV have changed exponentially during our lifetime,” Waterhouse said. “Unfortunately, we have not made significant progress in tackling HIV stigma, which still remains pervasive.”

In the US, it is estimated that only half of people living with HIV are virally suppressed, Smith said.

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