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Cabenuva Long-Acting New Paradigm in HIV Treatment
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EACS: Long-Acting Injectable Cabotegravir + Rilpivirine. - (11/06/21)
Long-Acting Treatment: Cabotegravir/rilpivirine; Long-Acting Injectable PrEP HPTN 083, 084 - (08/31/21)
CUSTOMIZE: OVERALL RESULTS FROM A HYBRID III IMPLEMENTATION-EFFECTIVENESS STUDY EXAMINING IMPLEMENTATION OF CABOTEGRAVIR AND RILPIVIRINE LONG-ACTING INJECTABLE FOR HIV TREATMENT IN US HEALTHCARE SETTINGS; FINAL PATIENT AND PROVIDER DATA
What this means for clinicians
An important benefit of injectable HIV regimens like the one examined in ATLAS-2M is that people do not have to take daily oral medications, according to Gandhi.
"This is particularly helpful for people who have difficulty remembering to take a daily medication, people who have swallowing difficulties, people who have just had surgery and are not taking oral medications, and people who just don't want to take a medicine every day," he said.
However, the injectable regimens are not without drawbacks, according to Gandhi. They cannot be self-administered and there is potential for resistance if people miss doses.
"People with difficulty adhering with daily oral therapy may benefit from the injections," Gandhi told Healio. "However, another important issue is the fact that, if patients stop taking the injections, they must switch quickly to oral therapy. If not, the injectable drugs leave the body slowly, which may select for drug-resistant HIV, which is more difficult to treat."
https://www.healio.com/news/infectious-disease/20200406/game-changer-three
Jan 22 2022
Long-acting CAB and RPV offers advantages over oral therapy: it is dosed less frequently, avoids the pill fatigue that many people with HIV experience, is subject to fewer drug interactions, and allows for greater confidentiality and privacy (which in turn leads to decreased likelihood of undesired HIV disclosure). As such, patients who face these barriers may be excellent candidates for long-acting CAB and RPV. However, based on evidence to date, they must achieve virologic suppression on their current oral ART regimens before transitioning to long-acting therapy, and this remains a significant impediment for those who might benefit the most [1,5].
Without a cure or an effective vaccine, antiretrovirals remain the cornerstone of HIV treatment and prevention. Although effective and well tolerated [1], the need for high levels of adherence to daily oral regimens remains a barrier to the success of both treatment and prevention. Challenges related to daily oral adherence include pill fatigue, the need for discretion, self-stigma, and other factors [2▪]. Long-acting injectable antiretrovirals have the potential to improve adherence with less frequent dosing, greater confidentiality/privacy, and reduced risk of undesired disclosure. Further, some adverse effects, drug–drug and drug–food interactions may be minimized with injectable routes of administration. Finally, the availability of multiple methods of drug administration can increase the likelihood that one option would be desirable for an individual through changing needs over their lifespan [3].
Although long-acting therapy is viewed by many as an opportunity to overcome some barriers to adherence posed by daily oral therapy, all participants in clinical trials completed thus far were enrolled based upon a history of good adherence, indicated by virologic suppression at the start of long-acting therapy. To address this data gap, the AIDS Clinical Trial Group LATITUDE study (NCT03635788) is currently enrolling participants with prior nonadherence. In the meantime, data from the compassionate use program is promising: 28/35 (80%) patients entered the program with detectable viremia and, at the time of analysis, 16/28 (57%) had achieved virologic suppression with long-acting CAB and RPV [23].
since the long-acting formulations are administered as two separate injections in a Z-track fashion into the gluteus medius, a private space where a patient can comfortably lie down for the injection is ideal. Studies of alternative injection sites, including the vastus lateralis (thigh muscle) are planned [NCT04371380, NCT04484337, and NCT03299049 (substudy)]. A myriad of other implementation factors, including human resource capital to obtain drug, capacity, staffing to support injection monitoring and scheduling, drug product storage (cold-chain storage is required for RPV), inventory management, and cost are current challenges facing widespread posttrial implementation of long-acting CAB and RPV [29]. Approval of the Q8W dosing strategy in the United States and Canada may reduce some of these barriers to implementation.
While participant satisfaction with long-acting ART has been largely positive [2▪,25–28], provider enthusiasm has been more cautious. Concerns include the need for patients to adhere to injection visits for treatment to be successful [26]. Several ongoing studies will evaluate implementation strategies, both within existing clinics and using alternative care sites such as infusion centers and pharmacies, to better understand and address these concerns (NCT03856580, NCT04982445, NCT04863261, NCT04399551, NCT04973254, NCT04001803).
Long-acting CAB and RPV are currently recommended with an OLI to ensure the medications are well tolerated before transition to the long-acting formulations. Given there were no safety signals during the OLI in the clinical trials, direct to injection options are currently being evaluated in ongoing studies, and early data suggest that an ART switch to long-acting therapy is safe and effective when administered without an OLI [24▪].
Week 96 extension results of a Phase 3 study evaluating long-acting cabotegravir with rilpivirine for HIV-1 treatment - (12/29/21)
ViiV Healthcare announces US FDA approval of Apretude (cabotegravir extended-release injectable suspension), the first and only long-acting injectable option for HIV prevention - (12/23/21)
Jan 2021 - ViiV HEALTHCARE ANNOUNCES FDA APPROVAL OF CABENUVA (CABOTEGRAVIR, RILPIVIRINE), THE FIRST AND ONLY COMPLETE LONG-ACTING REGIMEN FOR HIV TREATMENT
FDA Approves Cabenuva and Vocabria for the Treatment of HIV-1 Infection
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