Participants and the health providers knew which treatments have been given.In Trial 2, participants who were previously successfully treated for the infection (who had HIV-1 RNA less than 50 copies/milliliter), were randomized to receive either cabotegravir/rilpivirine (for the first four weeks they received tablets) or to remain on the same therapy for additional 44 weeks. Participants and the health providers knew which treatments have been given.In October 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the granting of a marketing authorization for rilpivirine and cabotegravir, to be used together for the treatment of people with human immunodeficiency virus type 1 (HIV-1) infection. The two medicines are the first antiretrovirals that come in a long-acting injectable formulation. This means that instead of daily pills, people receive intramuscular injections monthly or every two months. Rilpivirine and cabotegravir were approved for medical use in the European Union in December 2020, as two separate medications.In January 2021, the U.S. Food and Drug Administration (FDA) granted the approval of Cabenuva to ViiV Healthcare.The combination was approved for medical use in Australia in February 2021. References
External links
"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