New Beginnings: Sunlenca

Despite significant advances in the scientific understanding of human immunodeficiency virus (HIV) in recent years, there is still an unmet need for those living with the virus. Particularly those individuals who have already tried several therapies and are unable to maintain virologic suppression due to resistance, intolerance, and/or safety considerations. This is an area Gilead Sciences has identified and is looking to address with its new HIV-1 therapy, Sunlenca (lenacapavir).

After receiving FDA approval on Dec. 22, 2022, following priority review, fast-track, and breakthrough therapy designations, Sunlenca is the first of a new class of drugs called capsid inhibitors. The treatment works by blocking the HIV-1 virus’ protein shell (the capsid), interfering with multiple essential steps of the viral lifecycle. Being designed to inhibit HIV at multiple stages of its lifecycle, the therapy is unique in that most antiretrovirals act on just one stage of viral replication.

Sunlenca tablets are approved for pharmacologic loading of the medication followed by Sunlenca injection initiation, which is then repeated every six months. It is the only HIV treatment option administered twice yearly.

“[Sunlenca’s] unique mode of action, picomolar potency, and long half-life, permitting dosing just once every six months after initiation, represents a monumental breakthrough for adults with multi-drug resistant HIV who are heavily treatment experienced,” says Jared Baeten, vice president, HIV clinical development, Gilead.

Sunlenca’s FDA approval is supported by data from the Phase II/III CAPELLA trial, which evaluated lenacapavir in combination with an optimized background regimen in adults with multi-drug resistant HIV-1 who have already tried several therapies.

Gilead began the development of lenacapavir, the active agent in Sunlenca, 16 years ago. Scientists designed and screened nearly 4,000 compounds, leading to its innovation.

“Once identified, our team worked with incredible speed and focus to bring Sunlenca to patients with only 3.5 years between filing the IND and its first new drug application,” Baeten tells Pharmaceutical Executive^®.

Gilead has priced Sunlenca to enable access for people with multi-drug resistant HIV with high unmet needs. In the US, during the initial year of therapy, the wholesale acquisition cost (WAC) for Sunlenca injections and tablets is $42,250 per year. The WAC in the maintenance years is $39,000 per year.

“At Gilead, we believe that everyone living with HIV should have access to the latest treatment innovations and be able to make informed decisions with their healthcare providers,” says Brian Plummer, senior director, global public affairs, HIV, Gilead. “The clinical profile of Sunlenca, including its lack of known cross-resistance to other antiretrovirals, offers adults with multi-drug resistant HIV a renewed chance to achieve virologic suppression, while potentially reducing the economic impact from health cost resource utilization.”

Gilead has long worked with payers and providers to enable more equitable access to HIV treatment and that continues with Sunlenca. The Gilead Advancing Access® program assists individuals prescribed Sunlenca with understanding their coverage. It also assists in educating them on financial support options available to them. Additional offerings of the program include:

• Access to program specialists for coverage questions.
• A patient assistance program, which can provide medication at no cost to eligible individuals who don’t have insurance.
• A Sunlenca co-pay coupon program, which is available for eligible commercially-insured individuals who need help paying for their out-of-pocket medicine costs.

Looking forward, there are still many plans for lenacapavir in terms of research. The agent is involved in multiple ongoing and planned clinical studies in Gilead’s prevention and treatment research program. The PURPOSE Phase III clinical trials are studying lenacapavir for the prevention of vaginal (PURPOSE 1) and rectal (PURPOSE 2) acquisition of HIV.

“We believe it is possible to end the HIV epidemic for everyone, everywhere. Long-acting options for HIV treatment and prevention will be the next wave of innovation that could help address the differentiated needs and preferences of the diverse range of individuals and communities affected by the epidemic,” says Baeten. “These diverse, unmet needs propel our research teams at Gilead, and it is paramount this work is supported by the most rigorous clinical science.”