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December 03, 2020
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Patients satisfied with long-acting injectable ART at 2 years

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Patients with HIV on long-acting cabotegravir plus rilpivirine reported improved treatment satisfaction compared with daily ART at 96 weeks, according to results from the phase 3 FLAIR study.

Patients also reported a high level of and improved acceptability of certain adverse reactions after initiation of therapy, Vasiliki Chounta, MSc, director at ViiV Healthcare in Brentford, United Kingdom, said during a virtual presentation at IDWeek.

The phase 3, multicenter, open-label, randomized clinical study showed that cabotegravir (ViiV Healthcare) plus rilpivirine (Janssen Pharmaceuticals) administered via intramuscular injection every 4 weeks was noninferior to current daily oral maintenance HIV treatment based on the primary endpoint of the proportion of patients with plasma HIV-1 RNA of 50 copies/mL or greater.

For this analysis, Chounta and colleagues explored patient-reported measures of interest based on qualitative reviews with patients in the phase 2b study, market research and literature reviews.

Results showed that the acceptability of injection site reactions after the first injection with long-acting cabotegravir/rilpivirine was high at 5 weeks and significantly improved over time, with the majority of patients rating pain and local reactions as totally or very acceptable on the Perception of Injection Questionnaire.

Treatment acceptance, as measured by the Chronic Treatment Acceptance Questionnaire, also numerically improved from baseline across all measured timepoints up to week 96 for patients in the long-acting cabotegravir/rilpivirine group vs. the daily oral therapy group. This change, however, was not statistically significant, which was due in part to the very high acceptance rates observed at baseline among study patients.

There were also statistically significant improvements in satisfaction with HIV treatment, as measured by the HIV Treatment Satisfaction Questionnaire, with long-acting cabotegravir/rilpivirine vs. daily oral therapy at 96 weeks.

“In conclusion, cabotegravir/rilpivirine long-acting provided high levels of treatment satisfaction and acceptance for up to 2 years among study participants. [The study] also demonstrated significant improvements from baseline in treatment satisfaction for long-acting compared to daily oral therapies at week 96 as well as significant improvements in acceptability of injection site reactions over time,” Chounta said. “These data, alongside efficacy and safety results, highlight the therapeutic potential of cabotegravir/rilpivirine long-acting as well as the added value this regimen brings to people living with HIV.”