The First Extended-Release HIV Injectable Formulation, CABENUVA (Cabotegravir and Rilpivirine), approved by U.S. Food and Drug Administration.
By Dwi Prasetyaning Rahmawati
A new hope arose for patients undergoing chronic treatment of Human Immunodeficiency Virus (HIV) infection. By the 21st of January 2021, the United States Food and Drug Administration (FDA) has approved the drug, Cabenuva for the treatment of HIV. This regimen will enable patients to simplify their once-daily oral intake medication into monthly intramuscular injections, which can facilitate patient satisfaction and adherence as well.
First found around the late 19th century, HIV infection, which can develop to Acquired Immune Deficiency Syndrome (AIDS), has claimed countless lives. Until 2019, it is reported that around 690,000 people died of HIV related illness worldwide (WHO, 2020). It was in 1987, when the first HIV/AIDS treatment, Azidothymidine (AZT), or known as Zidovudine, a class of Nucleoside Reverse Transcriptase Inhibitors (NRTIs), was approved by U.S. FDA. Constantly developed, today the current antiretroviral treatment of HIV is the use of Fixed-Dose Combination (FDC) and a once-daily regimen to make it less burdensome for patients. However, according to research, the rate of adherence in patients taking daily ARV for HIV is still around 60% (Beer and Skarbinski, 2015). Thus, the approval of Cabenuva is in line with the expectation to improve patients’ adherence.
Cabenuva contains the combination of Cabotegavir and Rilpivirine. While the first one is in the class of Integrase Strand-transfer inhibitors (INSTIs), Rilpivirine is the second generation of Nonnucleoside Reverse-Transcriptase Inhibitors (NNRTIs), that both works to inhibit HIV replication. Mixed in an injectable intramuscular formulation, Cabenuva performs an extended-release ability. This regimen is purposed for patients with HIV type 1 infection, where the level of viral level is suppressed (HIV-1 RNA less than 50 copies/milliliter) and the immunological function is improved.
Furthermore, Cabenuva can only be administered to patients with no history of treatment failure and with no known or suspected resistance to either Cabotegravir or Rilpivirine. Therefore, prior to taking this injectable long last formulation, patients need to take oral Cabotegavir and Rilpivirine medication for one month, to ensure the medications are well-tolerated before switching to the extended-release injectable form (FDA, 2021).
Although Cabenuva might be able to improve patients’ adherence, a Randomized Control Trial (RCT) research has proven that this injectable long-acting form is non-inferior to standard oral therapy for maintaining HIV-1 suppression (Swindels, et al., 2020). Frequently, the most common adverse effect included injection site reaction, followed by other less common side effects such as fever (pyrexia), fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash.
Overall, it is concluded that the approval of Cabenuva will carry the expectation to improve the medication success rate of patients with HIV-1 from the adherence perspective. As a healthcare stakeholder, pharmacists have a vital role in supporting patients with HIV by ensuring the proper and effective use of antiretroviral medication, as well as monitoring the safety and efficacy of the regimens.
References
U.S. Food And Drug Administration (January 21,2021)https://www.fda.gov/news-events/press-announcements/fda-approves-first-extended-release-injectable-drug-regimen-adults-living-hiv
National Institute of Allergy and Infectious Disease (November 26, 2018) https://www.niaid.nih.gov/diseases-conditions/antiretroviral-drug-development#:~:text=In%20March%201987%2C%20AZT%20became,reverse%20transcriptase%20inhibitors%2C%20or%20NRTIs.
Beer, Linda., Skarbinski, Jacek (2014). Adherence to Antiretroviral Therapy Among HIV-Infected Adults in The United States. AIDS Educ Prev. 2014 Dec; 26(6): 521–537. https://dx.doi.org/10.1521%2Faeap.2014.26.6.521
Swindells, et al (2020). Long-Acting Cabotegravir and Rilpivirine for Maintenance of HIV-1 Suppression. N Engl J Med 2020; 382:1112–1123 https://dx.doi.org/10.1056/NEJMoa1904398
