ArticleHIV medicine2025
Therapeutic failure reported with HIV long-acting injectables: An analysis of the FDA Adverse Event Reporting System from 2021 to 2024.
Article in HIV medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07620652 (Retrospective/Prospective Pilot Study to Evaluate Efficacy and Safety of Switching to BIC/FTC/TAF in PWH With a Previous Virological Failure Under CAB/RPV LAI), which is not on this map. Cited by 7 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Retrospective/Prospective Pilot Study to Evaluate Efficacy and Safety of Switching to BIC/FTC/TAF in PWH With a Previous Virological Failure Under CAB/RPV LAI
Who cites it
7 citing papers in PubMed.
- What Do People with HIV Want to Know About Long-Acting Injectable Cabotegravir/Rilpivirine?AIDS and behavior · 2026Article
- Post-marketing safety signals, therapeutic failure, and product-use issues reported with injectable Cabenuva: A FAERS disproportionality analysis.Journal of public health research · 2026Article
- The Epidemiology of HIV-1 Resistance to Two-Drug Regimens in Multicenter Cohort From Poland-A Cross-Sectional Study.Health science reports · 2026Article
- Alternative Administration of Antiretroviral Therapy in People with HIV Unable to Swallow: A Scoping Review.HIV/AIDS (Auckland, N.Z.) · 2026Review
- Effectiveness and predictors of treatment discontinuation of long-acting cabotegravir/rilpivirine in virologically suppressed people with HIV: real-life data from the Icona Cohort.The Journal of antimicrobial chemotherapy · 2025Article
- Tixagevimab/cilgavimab or placebo for COVID-19 in ACTIV-2: Safety, pharmacokinetics and neutralizing and anti-drug antibodies.iScience · 2025Article
- Therapeutic failure reported with HIV long-acting injectables: An analysis of the FDA Adverse Event Reporting System from 2021 to 2024.HIV medicine · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesWe examined adverse event (AE) reports relating to cabotegravir/rilpivirine (CAB/RPV) in the US FDA Adverse Event Reporting System (FAERS), focusing on therapeutic failure (TF) and non-therapeutic failure (NTF) outcomes.
methodsFAERS is a database of AE and medication error reports from post-marketing surveillance. The study was granted exempt approval by the Binghamton University Institutional Review Board. We queried reports for CAB/RPV in the FAERS system from 1 January 2021 to 31 March 2024. TFs were defined as involving any of the following terms: viral load increased, virological failure, pathogen resistance, blood HIV RNA increased, treatment failure, drug ineffective, viral mutation identified, viraemia, and therapy non-responder. The top 20 most common AEs were also identified. Means, standard deviations, and percentages were used to characterize the sample.
resultsThe study cohort consisted of 2605 reports. The reported sex of the study cohort was 50% male (n = 1295), 19% female (n = 505), and 31% unspecified (n = 805), with a mean ± standard deviation (SD) age of 46.9 ± 12.4 years (n = 378). The top three most reported AEs were TFs, product dose omissions, and injection site pain, with 377 (14.5%), 354 (13.6%), and 331 (12.7%) cases, respectively. The mean ± SD weight of people with a report of TF versus NTF was 101.8 ± 33.4 kg and 87.7 ± 26.7 kg, respectively (p = 0.0175).
conclusionOur findings suggest that healthcare professionals should have a heightened awareness of potential challenges with CAB/RPV administration, including TFs and dose omissions in real-world settings.
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