NAPLEX Question of the Week: New HIV Dosage Form

The FDA recently approved a new dosage form for HIV management. Are you ready for the challenge?

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A 47 year old African American female living with HIV arrives for her regular appointment with her outpatient infectious diseases pharmacist. She has been on Biktarvy for nearly 2 years and has tolerated it well. Her CD4 count is 400 cells/mm3 and her viral load is undetectable. Recently she discovered that the FDA has approved Cabenuva which may be given once monthly and would like to know more about potentially transitioning. Which of the following are true regarding Cabenuva therapy? Select all that apply.

A. Cabenuva contains a non-nucleoside reverse transcriptase inhibitor and an integrase strand transfer inhibitor

B. If not tolerated, alternative fully suppressive antiretroviral therapy should be provided within 3 months of discontinuing Cabenuva therapy.

C. This patient, if transitioning to Cabenuva, should discontinue Biktarvy therapy within one week of initiating Cabenuva therapy.

D. Patients experiencing new depressive symptoms should be evaluated as Cabenuva has been associated with depressive disorders

E. Patients may be given Cabenuva therapy up to 7 days before or after the due date of their regularly scheduled monthly injection.

Answers with rationale:

The correct answers are A, D, and E.

Cabenuva was recently FDA-approved for treatment of HIV-1 infection in adults to replace current antiretroviral regimen in those who are on a stable regimen, have no history of treatment failure, are virologically suppressed, and have no known or suspected resistance to either cabotegravir (integrase strand inhibitor) or rilpivirine (non-nucleoside reverse transcriptase inhibitor) which are the two components (answer A is correct). Answer B is incorrect as antiretroviral therapy should be initiated within one month of discontinuing Cabenuva therapy, despite data showing that residual concentrations of Cabenuva may persist for a year or more in the systemic circulation. Answer C is incorrect as all patients starting Cabenuva therapy should have a trial of at least one month of oral cabotegravir and rilpivirine to assess tolerability with the first injection starting on last day or oral therapy. Answers D and E are correct as written. In addition, Cabenuva consists of 2 separate injections once monthly that should be given via intramuscular gluteal injection only, with the two injections given on opposite sides or at least 2 cm apart. Once drawn up for injection, Cabenuva must be administered within 2 hours.

Until next week!

Dr. B

Christopher M. Bland

Clinical Associate Professor, University of Georgia College of Pharmacy