Long-acting HIV regimen a ‘game changer’ preferred by most patients
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SEATTLE — Long-acting cabotegravir plus rilpivirine administered every 2 months was noninferior to daily oral HIV medication and was preferred by most participants in a phase 3b randomized trial, according to data presented here.
“The treatment needs of people living with HIV are changing, with ample evidence on patient preference suggesting some people living with HIV can experience challenges with taking daily oral treatment for HIV,” Harmony P. Garges, MD, MPH, chief medical officer for ViiV Healthcare, which markets the FDA-approved long-acting Cabenuva, said in a press release.
Moti Ramgopal, MD, founder of Midway Immunology and Research Center and Midway Specialty Care in Fort Pierce, Florida, told Healio that the challenges include fears about disclosure, forgetting their daily tablets, or the need for daily tablets being a constant reminder of their HIV. “It's important to offer patients options that can address these fears,” Ramgopal said.
Ramgopal and colleagues conducted SOLAR, a phase 3b study that compared injections of cabotegravir and rilpivirine (CAB+RPV LA) given every 2 months with daily oral bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The study included 670 participants who were taking BIC/FTC/TAF — 447 who switched to long-acting injections of CAB+RPV LA, most of whom received an oral lead-in, and 223 who remained on the daily oral medication.
Overall, the study found that in addition to CAB+RPV LA achieving the primary endpoint of noninferior virologic efficacy vs. daily oral BIC/FTC/TAF, 90% of participants who switched to CAB+RPV LA and who completed a survey (n = 425) preferred the long-acting regimen. The top five reasons were not having to worry about remembering to take HIV medication every day, the convenience of only needing injections every 2 months, not having to carry HIV medication around, not having to think about their HIV status daily and not worrying about others seeing or finding their HIV treatment pills.
Additional data from the study showed that CAB+RPV LA and BIC/FTC/TAF were both well tolerated by patients and that adverse events (AEs) and serious adverse events were comparable between arms — although the researchers did find that drug-related AEs were more frequent among participants receiving CAB+RPV LA vs. BIC/FTC/TAF (20% vs. < 1%).
The most commonly reported drug-related AEs in the CAB+RPV LA arm were pyrexia (3%), headache (2%), fatigue (2%) and diarrhea (2%), whereas participants receiving BIC/FTC/TAF most commonly reported weight gain (< 1%) and abnormal hepatic function (< 1%).
During a press conference at the Conference on Retroviruses and Opportunistic Infections, Ramgopal said he thinks this treatment option is a “game changer.”
“Just the fact that they can forget about that treatment for 2 months, come in for the next strategy — even though there are still challenges — my patients are telling me it's a game changer,” he said.
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Ramgopal MN, et al. Abstract 191. Presented at: Conference on Retroviruses and Opportunistic Infections; Feb. 19-22, 2023; Seattle.
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