FDA Approves Gilead’s First-in-Class HIV Drug Sunlenca

The FDA recently approved a new HIV drug for a small patient population desperately in need of treatments. And the twice-yearly medication’s annual price came below the level that respondents to a Zitter Insights poll said they would consider a good value.

On Dec. 22, the FDA approved Gilead Sciences, Inc.’s Sunlenca (lenacapavir) for the treatment, in combination with other antiretroviral(s), of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection who are failing their current antiretroviral regimen due to resistance, intolerance or safety considerations. The agency gave the first-in-class capsid inhibitor priority review, fast track and breakthrough therapy designations.

According to Gilead, about 2% of adults with HIV are heavily treatment experienced. “The availability of new classes of antiretroviral drugs is critical for heavily treatment-experienced people with multi-drug resistant HIV,” said Sorana Segal-Maurer, M.D., director of the Dr. James J. Rahal Jr. Division of Infectious Diseases at NewYork-Presbyterian Queens, professor of clinical medicine at Weill Cornell Medicine and the site principal investigator for Sunlenca’s CAPELLA trial, in a statement.

In that clinical trial, 81% of participants who randomly received lenacapavir and other antiretroviral drugs had an undetectable viral load at week 26. By week 52, 83% had an undetectable viral load.

Two initiation dosing regimens are available: The first is 927 mg subcutaneous injection via two 1.5 mL injections and two 300 mg tablets on day one, two tablets on day two and then a 927 mg injection every six months, while the second is two tablets on days one and two, one tablet on day eight, a 927 mg injection on day 15 and then a 927 mg injection every six months. A health care provider must administer the agent.

Gilead is conducting multiple clinical trials of the drug in HIV pre-exposure prophylaxis (PrEP).

For the Managed Care Biologics and Injectables Index: Q3 2022, from Aug. 26, 2022, to Sept. 30, 2022, Zitter Insights polled 35 commercial payers covering 121.8 million lives and 27 Medicare payers representing 40.2 million lives about their management of HIV. Commercial payers covering almost half of lives said they expect Sunlenca to have a moderate impact on the management of HIV, meaning that other medications may see a change in tiering and/or utilization management criteria. About one-third of 50 physicians who were surveyed during the same time frame said the new agent would have a moderate impact on their treatment of both new and current patients.

Both AIS Health and Zitter Insights are divisions of MMIT.

Commercial payers covering almost half of lives said that with the availability of Sunlenca, there is still high unmet need in treating HIV (see chart).

Payers covering both commercial and Medicare beneficiaries said that an annualized net price in the $60,000 to $70,000 range would be a good value for the new agent. The drug’s wholesale acquisition cost is well below that: The WAC for the first year is $42,250 and then $39,000 in subsequent years.

For more information on the Zitter Insights data, contact Jill Brown Kettler at jbrown@aishealth.com.