FDA Approves IM Injectable for HIV PrEP – Apretude

We are catching up on the wave of FDA approvals that happen in the waning hours of the year.

The FDA approved Apretude (cabotegravir), from Viiv, for use in at-risk adults and adolescents for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV.

Apretude is an extended-release injectable suspension as a gluteal intramuscular injection only . It is first administered as two initiation injections one month apart, and then every two months thereafter (total of 6 doses in year 1). Patients can start treatment with Apretude or take oral cabotegravir (Vocabria) for four weeks to assess how well they tolerate the drug.

Uptake has increased measurably since the introduction of Truvada, an oral medication also indicated for PrEP. However, compliance with the daily oral regimen has not been exemplary. It is believed that a periodic injection of Apretude will increase compliance rates.

Apretude includes a boxed warning to not use the drug unless a negative HIV test is confirmed. It must only be prescribed to individuals confirmed to be HIV-negative immediately prior to starting the drug and before each injection to reduce the risk of developing drug resistance. It appears that this testing requirement will mean that patients will be seeing a healthcare professional for the testing and injection.

Apretude has a list price of $3,700 per dose (or $22,200 per year, for six doses). By comparison, Truvada (brand) is priced at $21,000 per year. However, Truvada is also now available as a generic priced at a very low cost of $500 annually with a coupon.

Apretude is expected to ship to wholesalers and specialty distributors in early 2022.

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