A year after offering his patients the first long-acting injectable HIV treatment, Jonathan Angel, MD, director of the infectious diseases division at the University of Ottawa, Ontario, Canada reported that 15 of the 21 patients who started treatment were on regimen still take it, everyone with virus suppression. Those not cited mentioned a combination of discomfort, injection site pain, and “injection fatigue”.
These are just a few things HIV providers learn when they start what Chloe Orkin, MD, professor of HIV medicine at Queen Mary University of London, UK, called a paradigm shift to long-acting treatment that is not just soon Syringes could include rings, implants, and microarray patches.
“It’s a paradigm shift, and we are at the very beginning of that paradigm shift,” Orkin said during the discussion session at the European AIDS Clinical Society’s (EACS) 2021 annual meeting. “We have to change our model and it is a challenge.”
In the US, the US Food and Drug Administration approved the first long-acting solution for injection, a combination of cabotegravir and rilpivirine (CAB / RIL; Cabenuva, ViiV Healthcare) in January 2021. However, it has been approved in Canada since March 2020 and has been available at Angel’s Clinic since November 2020. It is also available in Canada every other month. Injected into the buttocks, the shot found not inferior to standard daily oral treatment in many studies, including ATLAS, ATLAS-2M – which tested the approach every two months – and FLAIR studies.
Angels Clinic was involved in all three of these studies, so his clinic has 5 years of experience preparing for the change in workflow and the new approach the recordings require.
Of the 21 people Angel treated, 11 were White Canadians, nine were Black African and one was Indigenous Canadians, with women making up a third of the participants. The mean age was 51 years and all patients had undetectable viral loads prior to starting therapy. (Studies of the drug’s effectiveness in people who have difficulty taking daily pills are ongoing.)
Most of these 21 patients had undetectable viral loads for more than 5 years, but some were only undetectable for 6 months before the injections started. Her immune system was also healthy, with a median CD4 count of 618 cells / µl. As in the clinical trials, none of the participants experienced any failure of antiretroviral treatment. Since public health insurers in Canada are not yet required to approve the shots, Angels patients who receive Cabenuva also have private health insurance. Up to 90% of people in Canada are covered by statutory health insurance for drugs; Hence, the inclusion is not yet widespread.
Twenty patients switched from integrase inhibitor regimens and one received non-nucleoside reverse transcriptase inhibitor-based therapy prior to initiating treatment with Cabenuva.
And while the drug was not approved for syringe insertion this way, two patients asked – and Angel agreed – that they start injecting without first taking pills daily for a month to check safety.
“This is my conclusion from these data: the oral training period is not required,” Angel said in his presentation at the meeting. “It can offer some comfort to either a doctor or a patient, but it doesn’t seem medically necessary.”
This approach isn’t without data to back it up. Research presented at HIV Glasgow 2020 showed that people who switched from dolutegravir / abacavir / lamivudine daily orally directly to the injections did so without any problems.
At the last visit to the clinic, 15 out of 21 received the syringes. None had failed treatment and all were still virally suppressed. Four participants left the studies and one other opted to return to the daily pills, citing a level of what Angel called “injection fatigue”.
“Just as we use the term ‘pill fatigue’ to refer to patients who are tired of taking pills, patients get tired of coming in for their monthly visits and injections,” he said. They find the drive to the clinic for the intramuscular injections “inconvenient,” he said.
Unlike the United States, where Cabenuva is only approved for monthly injections, Health Canada has already approved injections every two months, which Angel said could reduce the chance of injection fatigue.
Angel’s presentation drew comments, questions, and excitement from the crowd. Annemarie Wensing, Dr. do not swallow pills or in other scenarios.
“These are not hypothetical conversations,” said Angel. “I’m having these conversations with patients now – temporary use, they travel for 3 months and come back, can they switch from injectable to oral to injectable?
For now, he said, the answer is, “We’ll find out.”
Meanwhile, another big question arises when it comes to injections, said Marta Vasylyev, MD, of Lviv Regional AIDS Center in Ukraine: When will they be available to the people who could benefit the most – people in an environment of limited use Resources, people, who have had a hard time remembering how to take their pills every day?
At the moment, Angel replied, injections are still only a treatment for those who are already doing well during HIV treatment: those with already suppressed viral loads, who are good at taking pills every day and who are treated in well-equipped clinics.
“There are huge obstacles to overcome if this is ever to be available [in resource-limited settings], and many more obstacles than any oral therapy, “he said.” Not much has been discussed here about the need for cold chain requirements from pharmacies both centrally and locally. [or] the requirements for additional nursing or medical personnel to administer the drug. So you are providing for a very resource intensive therapy that is now quite restrictive [as to] who will access it. “
Angel serves on the boards of ViiV Healthcare and Gilead Sciences and has conducted contract research for ViiV Healthcare, Gilead and Merck. Orkin has received research grants, consultancy fees, travel sponsorship, and speaker fees from ViiV, Merck, and GlaxoSmithKline. Vasylyev did not report any relevant financial relationships.
Annual meeting 2021 of the European AIDS Clinical Society (EACS). Parallel Session ACT NOW. Presented on October 29, 2021.
Heather Boerner is a science writer based in Pittsburgh, Pennsylvania. In 2014 her book Positively Negative: Love, Pregnancy, and Science’s Surprising Victory Over HIV was published.
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