Infectious Disease Special Edition - Summer 2021

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Cabenuva: A Novel Long-Acting Injectable HIV Treatment BY SARAH M. MICHIENZI, PHARMD, BCPS, AAHIVP, AND RACHEL KAUTZ, PHARMD CANDIDATE 2022

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abenuva is the first FDA-approved long-acting (LA) injectable regimen for patients with HIV infection.1 Cabenuva (ViiV Healthcare) consists of cabotegravir (CAB), an integrase strand transfer inhibitor (INSTI), and rilpivirine (RPV), a non-nucleoside reverse transcriptase inhibitor (NNRTI) approved to replace antiretroviral therapy (ART) in patients with HIV-RNA less than 50 copies/mL who have been on a stable ART with no history of treatment failure or suspected resistance to CAB or RPV. The approval of CAB/RPV was an important milestone in the treatment of HIV. This article provides an overview of CAB/RPV and 2 key studies leading to its approval.

About CAB/RPV1 CAB/RPV consists of an oral leadin, followed by the initial injection, which are continued monthly. The oral lead-in includes a Vocabria (CAB, ViiV

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Healthcare) 30-mg tablet once daily and an Edurant (RPV, Janssen) 25-mg tablet once daily for at least 28 days. Both medications should be taken with food. The purpose of the oral lead-in is to assess the patients’ tolerability to the regimen before the LA form is injected. If tolerated after 1 month, on the last day of oral lead-in therapy, the patient can receive the initial 600-mg CAB and 900-mg RPV injections. These are 2 separate 3-mL intramuscular (IM) injections that should be administered on opposite gluteal sites or at least 2 cm apart on the same gluteal site. The continuation injections are administered the same way but consist of a 400-mg (2-mL) CAB injection and a 600-mg (2-mL) RPV injection. Before administering the injections, the vials should be removed from the refrigerator and left for 15 minutes to allow the medication to come to room temperature. CAB/RPV can remain in the carton at room temperature for

up to 6 hours. After 6 hours at room temperature, the medication should be discarded. Both medications are suspensions that need to be shaken vigorously before being drawn into a syringe. Once drawn into the syringe, the medication should be administered immediately but can remain in the syringes for up to 2 hours. CAB/ RPV should only be administered by a health care professional. The continuation injections are to be administered monthly. For the monthly visits, the patient may receive their injections up to 7 days before or after their scheduled monthly target date. If this window is missed, and the time since the last injection was less than 2 months prior, the patient should resume the 400-mg CAB injection and 600-mg RPV injection as soon as possible. If it has been more than 2 months since their last injections, they need to reinitiate the regimen with the 600mg CAB injection and 900-mg RPV


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