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HIV/AIDS
Published in Patricia G. Melloy, Viruses and Society, 2023
Like with other antiretroviral drug therapies, long-acting therapies are being tested now too to see if side effects are manageable, if they interact with other drugs, if they can be taken during pregnancy, and how quickly drug resistance develops (Gulick and Flexner 2019). In 2018, an intravaginal ring that can supply a long-acting version of antiretroviral therapy to females was developed (UNAIDS 2021a). A long-acting injectable antiretroviral therapy was approved by the Food and Drug Administration (FDA) in 2021. The injectable therapy, known as CABENUVA, is a combination of cabotegravir, an integrase inhibitor, and rilpivirine, a non-nucleoside reverse transcriptase inhibitor (FDA 2021; Healthcare 2021). Clinical trials yielded promising results for patients who started oral ART and then were switched to the long-acting therapy in the first long-acting injectable regimen (FLAIR) trial, as well as for patients on an oral therapy who switched to the long-acting drug to maintain their suppression of HIV in the antiretroviral therapy as long-acting suppression (ATLAS) trial for either four or eight weeks (Orkin et al. 2020; Swindells et al. 2020; Rizzardini et al. 2020; Gulick and Flexner 2019; Overton et al. 2021; Rial-Crestelo, Pinto-Martínez, and Pulido 2020).
Nanocrystals for controlled delivery: state of the art and approved drug products
Published in Expert Opinion on Drug Delivery, 2022
Rahul S. Kalhapure, Siddhant Palekar, Ketan Patel, Jasmin Monpara
These nanocrystals-based injectable suspensions are available in vials and contain cabotegravir, an anti-HIV drug substance as an active pharmaceutical ingredient. Cabenuva contains cabotegravir extended-release injectable suspension, an HIV integrase strand transfer inhibitor (INSTI), co-packaged with rilpivirine extended-release injectable suspension, an HIV non-nucleoside reverse transcriptase inhibitor (NNRTI). Each mL of the cabotegravir suspension contains 200 mg of Cabotegravir and polyethylene glycol (PEG) 3350 (20 mg/mL) and polysorbate 20 (20 mg/mL). The rilpivirine suspension contains 300 mg/mL rilpivirine stabilized with poloxamer 338 (50 mg/mL) [62]. Apretude is available as a single dose vial (200 mg/mL) and indicated for HIV treatment of at-risk patients or adolescents weighing more than 35 kg for pre-exposure prophylaxis [68].
An evaluation of long-acting cabotegravir + rilpivirine for the treatment of virologically suppressed adults living with HIV
Published in Expert Opinion on Pharmacotherapy, 2022
Hamdi Qazzaz, Christopher Parganas, Theodore James Cory
Cabenuva was approved in the United States on 21 January 2021, for the treatment of HIV-1 in adult patients who are virologically suppressed and on stable antiretroviral regimens [4]. This approval is also for patients who have had no treatment failures and no known resistance to CAB or RPV. Prior to the approval in the United States, Health Canada approved Cabenuva in March 2020 as a monthly injectable for the treatment of HIV-1 infected adults [13,39]. During the same year, the European Medicines Agency (EMA) approved Cabenuva in December 2020 for the treatment of HIV-1 patients who are stable and virologically suppressed [4].