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FDA Approves Oral & Sub-Q Regimen for HIV – Sunlenca

The FDA recently approved a new antiviral therapy regimen, Sunlenca (lenacapavir) from Gilead Sciences, indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations. Sunlenca is given in combination with other antiretroviral(s). 

Sunlenca is the first of a new class of drugs called capsid inhibitors. Sunlenca blocks the HIV-1 virus’ protein shell (the capsid)interrupting multiple essential steps of the viral lifecycle. 

As noted, Sunlenca is supplied as both an oral and subcutaneous injectable regimen. It comes with two induction schedule options (see below). Startup doses and then followed by maintenance injections every six months.

Recommended dosage:

Initiation with one of two options followed by once every 6-months maintenance dosing.

• Initiation Option 1

   Day 1                927 mg by subcutaneous injection (2 x 1.5 mL injections)

600 mg orally (2 x 300 mg tablets)

   Day 2                600 mg orally (2 x 300 mg tablets)

• Initiation Option 2

   Day 1                600 mg orally (2 x 300 mg tablets)

   Day 2                600 mg orally (2 x 300 mg tablets) 

   Day 8                300 mg orally (1 x 300 mg tablet)

   Day 15              927 mg by subcutaneous injection (2 x 1.5 mL injections)

• Maintenance

927 mg by subcutaneous injection (2 x 1.5 mL injections) every 6

months (26 weeks) from the date of the last injection +/-2 weeks.

Gilead confirmed that Sunlenca injection and tablets are expected to cost $42,250 in the first year of therapy and $39,000 annually after that (maintenance injections only).

Gilead did not provide detail on how Sunlenca would be distributed. Given its benign safety profile, it could be expected that the therapy regimen (oral and sub-q injectable) will be provided by specialty pharmacy in limited distribution. Compliance and persistence are central to therapy success.

CLICK HERE to access prescribing information


FDA Approves Sunlenca – New HIV Drug for Adults with Limited Treatment Options

December 22, 2022 The U.S. Food and Drug Administration approved Sunlenca (lenacapavir), a new type of antiretroviral medication for adult patients living with human immunodeficiency virus type 1 (HIV-1), whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations. After the starting dose is completed, Sunlenca is administered…………………

CLICK HERE to access the full FDA press release

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