GSK agrees deal to develop longer-acting HIV drugs

GlaxoSmithKline has agreed a deal to develop ultra-long acting HIV drugs administered as little as four times a year that could revolutionise treatment of the virus.

ViiV Healthcare — an HIV specialist that is majority-owned by GSK and backed by Pfizer and Japanese pharma group Shionogi — will develop a Shionogi molecule as a long-acting HIV treatment with dosing intervals of three months or more.

It will pay Shionogi £20m for the molecule, a further £15m when clinical development milestones are met, plus royalties on net sales. Shionogi will make capped contributions to the development.

The molecule will not be available for clinical trials before 2023, but ViiV executives said in an interview they were hopeful about its future given preliminary signs of high resistance to mutations in HIV and its long duration in the body. Kimberly Smith, head of R&D at ViiV, said successful development of the molecule, called S-365598, could eventually lead to twice-yearly treatment for HIV.

“What we heard [from patients is] the less frequent the dosing, the better,” Smith said, adding the company aimed to “make HIV treatment a lesser part of people’s lives”.

ViiV already has a long-acting treatment on the market in the US and Europe called Cabenuva, which is administered once every one or two months.

Currently, the vast majority of people with HIV take a daily combination of drugs orally that are well-tolerated and effective. The combination inhibits viral replication, lowering the presence of the virus in the blood to undetectable levels and enabling patients to live normal and healthy lives with relatively little need for medical intervention. A byproduct of effective treatment is that people living with HIV who have undetectable viral loads cannot pass it on.

More long-acting drugs can reduce the compliance problems that can go with remembering to take drugs every day and thereby limiting the chances of developing resistance.

ViiV is not the only one in this field. Merck and Gilead Sciences, for example, are working together to develop long-acting HIV treatments.

The prices of HIV drugs have been contentious, with companies accused of overcharging. Andy Hill, a senior visiting research fellow in pharmacology at Liverpool University, said long-acting treatment could transform HIV care.

“However we already have excellent oral treatments taken once daily, used by over 20m people worldwide,” he said. “The new long acting treatments need to show significant benefits and be as cheap as the current options.”

Deborah Waterhouse, ViiV chief executive, said the company uses a combination of high-volume, lower-price deals and royalty-free licences to ensure good global access.

Separately on Tuesday, Viiv said one of the components of Cabenuva, cabotegravir, has received priority-review designation from the US Food and Drug Administration for HIV prevention, with a target approval date of late January 2022.

Last year, trials showed the drug was superior at preventing HIV compared with the current standard of care, Gilead’s Truvada.