SUNLENCA

What it is

SUNLENCA contains lenacapavir sodium equivalent to 463.5 mg per 1.5 mL as a solution for injection, and 300 mg per tablet as a film-coated tablet. It is available as a solution for injection and as film-coated tablets. Lenacapavir is a novel, first-in-class HIV-1 capsid inhibitor. Lenacapavir is a multistage, selective inhibitor of HIV-1 capsid function that directly binds to the interface between capsid protein subunits and inhibits HIV-1 replication by interfering with multiple essential steps of the viral lifecycle, including capsid-mediated nuclear uptake of HIV-1 proviral DNA, virus assembly, and capsid core formation.

Approved indications

— Treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen, in combination with other antiretrovirals.

Dosing overview

The recommended SUNLENCA treatment regimen in adults consists of an initiation dosing period (oral tablets and subcutaneous injections) and once every 6-months maintenance dosing (subcutaneous injections). On treatment Days 1 and 2, the recommended dose is 600 mg per day taken orally; on Day 8, the recommended dose is 300 mg taken orally; then on Day 15, the recommended dose is 927 mg administered by subcutaneous injection. The recommended maintenance dose is 927 mg of SUNLENCA administered by subcutaneous injection once every 6 months (26 weeks) from the date of the last injection (±2 weeks). SUNLENCA oral tablets may be taken with or without food. No dose adjustment of SUNLENCA is required for elderly patients. No dose adjustment of SUNLENCA is required in patients with mild, moderate, or severe renal impairment (CrCl ≥15 mL/min). No dose adjustment of SUNLENCA is required in patients with mild or moderate hepatic impairment (Child-Pugh Class A or B).

Key safety warnings

If SUNLENCA is discontinued, to minimise the risk of developing viral resistance it is essential to adopt an alternative, fully suppressive antiretroviral regimen where possible, no later than 28 weeks after the final injection of SUNLENCA. If SUNLENCA is discontinued, residual concentrations of lenacapavir may remain in the systemic circulation of patients for prolonged periods and may affect the exposures of other medicinal products (such as sensitive CYP3A substrates) that are initiated within 9 months after the last subcutaneous dose of SUNLENCA. In patients with HIV treated with combination antiretroviral therapy, immune reconstitution syndrome has been reported; in patients with severe immune deficiency at the time of initiation of antiretroviral therapy, an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions or aggravation of symptoms, typically within the first few weeks or months of initiation, with relevant examples including cytomegalovirus retinitis, generalised and/or focal mycobacterial infections and Pneumocystis jirovecii pneumonia. Improper administration (intradermal injection) has been associated with serious injection site reactions, including necrosis and ulcer; SUNLENCA must be administered subcutaneously. Patients should be advised that SUNLENCA or any other antiretroviral therapy does not cure HIV infection and that they may still develop opportunistic infections and other complications of HIV infection, and should remain under close clinical observation by physicians experienced in the treatment of patients with HIV associated diseases.

Contraindications

Co-administration with strong inducers of CYP3A, P-gp, and UGT1A1, such as rifampicin, carbamazepine, phenytoin, or St. John's wort is contraindicated.

PBS listing

SUNLENCA was recommended for PBS listing in November 2023 for treatment of multidrug resistant HIV in combination with optimised background regimen, with cost-effectiveness achieved through price reduction and a risk sharing arrangement to manage risk of leakage.

Regulatory history

SUNLENCA lenacapavir 300 mg film-coated tablet and 463.5 mg/1.5 mL solution for injection were first registered on the ARTG on 27 March 2023. The TGA approved SUNLENCA on 23 March 2023 for the treatment of adults with multidrug-resistant HIV-1 infection. The PBAC initially did not recommend SUNLENCA in November 2022. The PBAC recommended listing in November 2023, noting cost-effectiveness with price reduction.