Cabotegravir/rilpivirine

Cabotegravir/rilpivirine, sold under the brand name Cabenuva, is a co-packaged medication for the treatment of HIV/AIDS.[2][3][4] It contains cabotegravir and rilpivirine.[2][4]

Cabotegravir/rilpivirine
Combination of
CabotegravirIntegrase strand transfer inhibitor (INSTI)
RilpivirineNon-nucleoside reverse transcriptase inhibitor (NNRTI)
Clinical data
Trade namesCabenuva
License data
Routes of
administration		Intramuscular
ATC code
  • None
Legal status
Legal status
Identifiers
KEGG

The most common adverse reactions include injection site reactions, fever (pyrexia), fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness and rash.[2]

This is the first FDA-approved injectable, complete regimen for HIV-infected adults that is administered once a month.[2][3] It is also approved for use in Canada and the European Union.[5]

Medical uses

Cabotegravir/rilpivirine is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace a current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure.[2] In tbe European Union, it is intended for maintenance treatment of adults who have undetectable HIV levels in the blood (viral load less than 50 copies/mL) with their current ARV treatment, and when the virus has not developed resistance to non-nucleoside reverse transcriptase inhibitors (NNRTIs) and integrase strand transfer inhibitors.[6]

History

The safety and efficacy of cabotegravir/rilpivirine were established through two randomized, open-label, controlled clinical trials in 1,182 HIV-infected adults who were virologically suppressed (HIV-1 RNA less than 50 copies/milliliter) before initiation of treatment with cabotegravir/rilpivirine.[2][3] Participants in both trials continued to show virologic suppression at the conclusion of each study, and no clinically relevant change from baseline in CD4+ cell counts was observed.[2]

The U.S. Food and Drug Administration (FDA) granted the approval of Cabenuva to ViiV Healthcare.[2]

On 15 October 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Rekambys, intended for the treatment of human immunodeficiency virus type-1(HIV-1) infection in combination with cabotegravir injection.[7] Rekambys was approved for medical use in the European Union in December 2020.[8]

The EMA has recommended the granting of marketing authorizations for two new antiretroviral (ARV) medicines, Rekambys (rilpivirine) and Vocabria injection (cabotegravir), to be used together for the treatment of people with human immunodeficiency virus type 1 (HIV-1) infection.[6] The two medicines are the first antiretrovirals that come in a long-acting injectable formulation.[6] This means that instead of daily pills, people receive intramuscular injections monthly or every two months.[6]

The combination of Rekambys and Vocabria injection is intended for maintenance treatment of adults who have undetectable HIV levels in the blood (viral load less than 50 copies/ml) with their current antiretroviral treatment, and when the virus has not developed resistance to certain class of anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs) and integrase strand transfer inhibitors (INIs).[8][6]

References
  1. "Cabenuva Product information". Health Canada. Retrieved 22 January 2021.
  2. "FDA Approves First Extended-Release, Injectable Drug Regimen for Adults Living with HIV". U.S. Food and Drug Administration (FDA) (Press release). 21 January 2021. Retrieved 21 January 2021. This article incorporates text from this source, which is in the public domain.
  3. "Cabenuva and Vocabria approved for HIV infection". U.S. Food and Drug Administration (FDA). 27 January 2021. Retrieved 27 January 2021. This article incorporates text from this source, which is in the public domain.
  4. "ViiV Healthcare announces FDA approval of Cabenuva (cabotegravir, rilpivirine), the first and only complete long-acting regimen for HIV treatment". ViiV Healthcare. 21 January 2021. Retrieved 21 January 2021 – via Business Wire.
  5. "Janssen Announces European Commission Authorisation of the First Complete Long-Acting Injectable HIV Treatment in Europe". Business Wire. Retrieved 22 January 2021.
  6. "First long-acting injectable antiretroviral therapy for HIV recommended approval". European Medicines Agency (EMA) (Press release). 16 October 2020. Retrieved 16 October 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  7. "Rekambys: Pending EC decision". European Medicines Agency (EMA). 16 October 2020. Retrieved 16 October 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  8. "Rekambys EPAR". European Medicines Agency (EMA). 13 October 2020. Retrieved 4 January 2021.
  • "Cabotegravir". Drug Information Portal. U.S. National Library of Medicine.
  • "Rilpivirine". Drug Information Portal. U.S. National Library of Medicine.
  • Clinical trial number NCT02938520 for "Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants" at ClinicalTrials.gov
  • Clinical trial number NCT02951052 for "Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults" at ClinicalTrials.gov
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