Results from the BEYOND trial show positive clinical outcomes and patient experiences.
One-year results from a real-world study of Cabenuva (cabotegravir/rilpivirine) presented at the International AIDS Society’s AIDS 2024 meeting in Munich, Germany, showed that switching to the injectable HIV medication improved patients’ outlook and kept the viral loads low.
Cabenuva, approved bythe FDA in 2021, is delivered as a pair of intramuscular shots — one of cabotegravir and the other, rilpivirine — usually every two months. A healthcare professional delivers the shots. Long-acting injectable formulations are coming on strong as an alternative to daily pills for HIV treatment for several reasons. The shots are more convenient, increase adherence and are just as, if not more, effective than the daily pills, partly due to adherence improving.
The BEYOND trial, which is sponsored by the ViiV Healthcare, the maker of Cabenuva, is a two-year study of the utilization, outcomes and experience of people living with HIV after they started treatment with Cabenuva. It is being conducted at 30 sites in the U.S. A total of 308 people living with HIV were enrolled in the study. At the sixth-month mark, 36 had dropped out. A year out, 245 remained on treatment.
Cindy Garris, M.S., senior director of U.S. health outcomes at ViiV Healthcare, presented findings from the BEYOND trial that showed that 181 (97%) of the 187 of the people who started the study with viral load at less than 50 copies per milliliter (c/mL) were still at that level after year of treatment. All 13 of the people who started the trial at 50 c/mL or higher who were still receiving treatment had viral loads of less than 50 c/mL. There was one case of confirmed “virological failure,” defined as defined as two consecutive viral load measurements of 200 or more c/mL or one such measurement followed by discontinuation of Cabenuva.
The results from the real-world trial were similar to those seen in the phase 3 trials of Cabenuva, according to Garris and her colleagues.
William Valenti, M.D., co-founder and staff physician at Trillium Health and a professor of clinical medicine at the University of Rochester, presented the findings from BEYOND that measured people’s experiences and outlook. At the start of study, just under half (49%) of participants reported sometimes, often,or always hiding their oral medication out fear of showing their HIV status. After a year of being treated with Cabenuva, that proportion had fallen to 15%, and two-thirds of the respondents indicated that they never were concerned about revealing their HIV stauts . After a year of Cabenuva, the vast majority (97%) of the participants indicated that they preferred Cabenuva and less than 1% preferred daily pills.
The responses to the surveys showed that one side benefit of seeing a healthcare professional to get the shots was greater opportunity to discuss HIV treatment and other issues with a healthcare provider on a regular basis.
Today, the clade 2b outbreak has reached alarming proportions, with over 94,000 confirmed cases reported across 117 countries, including significant numbers in the U.S. and Brazil, and up to 103 deaths. The virus has been found to affect younger men who have sex with men, who are linked to high rates of HIV co-infection.
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