European Commission Approves Once Every 6 Month Supplemental HIV-Treatment

Last week, the European Commission (EC) approved use of Gilead Sciences’ investigational medication, lenacapavir (branded as Sunlenca), for use in treatment for people whose HIV is highly treatment resistant. Lenacapvir has been closely watched by advocates because of great anticipation regarding injectable and otherwise long-acting agents (LAAs) and because of its exceptionally long half-life in the body, providing efficacy for about 6 months from just one subcutaneous injection, providing a potential for the longest acting agent to hit the market thus far.

Lenacapavir also stands out as a first-in-class product because it works in a way that no other antiretroviral medication works. Offering a novel mechanism of action, binding the shell (capsid) surrounding viral genetic material that highjacks our own cells in HIV reproduction, capsid inhibitors will work against HIV in multiple areas of the virus’ life cycle. And because this is a tool we’ve never used before, it’s ideal for meeting the treatment needs of people living with highly resistance HIV – the virus doesn’t recognize the medication and has not yet found a way around it. Because HIV is highly adaptable, that lack of resistance may be short-lived once broad reach of the product is made available but excitement remains for a novel product, especially for people who have developed such resistance that options of effective care have diminished to near zero.

Gilead Sciences is awaiting a decision from the United States’ Food and Drug Administration (FDA) on its recently resubmitted “New Drug Application” (NDA), after the agency declined to accept the NDA due to issues with the glass vials used for the injectable form of the medication. The vial issue has since been fixed and research resumed for use of lenacapavir as a supplement to “background” treatment, first-line treatment, and as pre-exposure prophylaxis (PrEP). At the end of July, the FDA provided Gilead with a December 27, 2022 prescription drug user fee date. This is one of the final steps in an initial new drug approval. (Briefly, the Prescription Drug User Fee Act funds a massive portion of the FDA and those medications which pose potential benefit to public health may receive an expedited fee date; HIV advocates historically championed the act as a massive “win” in the early 90’s when introducing this funding scheme sped up their processes to make oncology and HIV medications more readily accessible.)

Patients who may hear about “once every 6-month treatment) should be kindly reminded lenacapavir will serve only as a supplement to other therapies – administering the medication is required to be done by a provider and patients will still need to remain adherent to their existing treatment regimen. HIV medications for treatment need between 2 and 3 different combinations of medications and PrEP only needs 1. As such, there may be a disparity in lenacapavir as PrEP and Sunlenca as treatment in terms of uptake because, while lenacapavir won’t require maintenance of other medications, Sunlenca as treatment will require patients to continue to take the oral medications that are “optimized” with Sunlenca acting almost like a “soft reset” for patients.

Operationalizing will remain an issue, especially for state ADAP Program’s that have not fully implemented access to cabotegravir, in terms of injectable medication management and for arguments that frame investing in successful patient care as something that requires a “cost consideration”. Patient advocates should be well-prepared to defend a desire to see this product come to their patients as those patients so desire it.