After overcoming vial issue, Gilead wins FDA approval for long-acting HIV injectable Sunlenca

Four decades after the start of the HIV epidemic, patients whose virus has become resistant to multiple therapies have a new treatment option.

Gilead Sciences' Sunlenca is now cleared to be used in adults whose HIV-1 infection is multi-drug resistant due to high levels of prior treatment. The drug is targeted at the many HIV-infected individuals who cannot achieve viral suppression—even with the range of treatments available.

Viral suppression occurs when the virus is reduced to undetectable levels, which makes people unable to spread the virus, Jared Baeten, M.D., Ph.D., Gilead’s vice president of clinical development, explained in an interview with Fierce Pharma.

This patient population makes up around 2% of adults living with HIV. While the number might seem small, the California-based company nevertheless saw a need that wasn't being met by current medications.

“That's why we developed lenacapivir, though that patient segment is quite small,” Baeton said.

Sunlenca has other appealing points that make it stand out from other HIV drugs. For one, it’s a long-lasting treatment given every six months. Most HIV treatments require daily pills, but GSK also has a new long-acting injection in Cabenuva. That drug is given monthly or every other month.

The FDA based its approval on Gilead's phase 2/3 Capella trial, which showed the drug elicits "high rates of virologic suppression" in patients with multi-drug resistant HIV, Gilead previously said.

The approval is just “the beginning of the rest of this journey to figure out longer-acting treatment options and prevention options for wider groups,” Baeten said.

Earlier this year, the drug escaped a clinical hold after the FDA cited concern with the drug and the vials it was stored in. Previously, the FDA rejected Gilead's approval application for the therapy.

Sunlenca scored its first global approval in Europe back in August. It’s also being tested as a single agent as an HIV PrEP option in the phase 3 PURPOSE 2 trial.