20 Mar Maintenance of HIV-1 Suppression Using Long-Acting Cabotegravir and Rilpivirine
MedicalResearch.com Interview with:
Susan Swindells MBBS
Professor, Infectious Diseases
Department of Internal Medicine
University of Nebraska Medical Center
MedicalResearch.com: What is the background for this study?
Response: The background for this study is the development of long-acting injectable formulations of two antiretroviral agents: cabotegravir and rilpivirine. These were previously tested in a Phase 2 study, and the current study (called ATLAS) reports findings from Phase 3 in which HIV-infected patients on antiretroviral therapy were switched to monthly injections.
The partner study, (FLAIR), is published in the same addition of the journal, and reports results from patients that were new to antiretroviral therapy, and took oral medications as a lead-in to achieve viral suppression before switching to similar monthly injections. Both studies included randomization to continuing oral antiretroviral therapy.
MedicalResearch.com: What are the main findings?
Response: The findings from both studies were that virologic suppression rates on the monthly injections were noninferior to continuing oral therapy. A few patients developed virologic resistance with mutations (three in each study), and serious adverse events were rare.
Overall, the injections were tolerated well despite a fairly high incidence of injection site reactions. These were generally mild and self-limiting. Participants on the injectable arms reported much higher levels of satisfaction with the treatment than those continuing oral therapy.
MedicalResearch.com: What should readers take away from your report?
Response: Readers should take away the message that these studies pave the way to an exciting new alternative method of receiving antiretroviral therapy. Lifelong, daily oral therapy can be challenging for some patients, and they may welcome an alternative. Getting medications by monthly injection frees them from having to remember to take tablets every day, and importantly, from having to be reminded that they have HIV infection.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Recommendations for future research are centered around the fact that both of these studies included patients with well-controlled HIV disease, and all of the participants adhered closely to the study procedures. In real life, patients who have difficulty with adherence to medications may also benefit from this approach, but that remains to be tested. Importantly, this alternative method of antiretroviral therapy delivery has not been tested in in children, or in pregnant women.
MedicalResearch.com: Is there anything else you would like to add?
Response: This new method may be attractive to patients and providers in resource limited settings, but the cost of the intervention has yet to be determined. Also, the rilpivirine component requires cold chain, which may be a barrier to delivery and distribution in any countries.
My only disclosure is receipt of research grants to my institution for the conduct of the studies.
Long-Acting Cabotegravir and Rilpivirine for Maintenance of HIV-1 Suppression
Susan Swindells, M.B., B.S., Jaime-Federico Andrade-Villanueva, M.D., Gary J. Richmond, M.D., Giuliano Rizzardini, M.D., Axel Baumgarten, M.D., Mar Masiá, M.D., Gulam Latiff, M.D., Vadim Pokrovsky, M.D., Fritz Bredeek, M.D., Graham Smith, M.D., Pedro Cahn, M.D., Yeon-Sook Kim, M.D., Ph.D., et al.
March 19, 2020 N Engl J Med 2020; 382:1112-1123
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