(P11) Longitudinal trends in self-reported side effects and prescribed 3rd agent in ART
LarsE Eriksson1,2,3 Åsa Mellgren4, Maria Reinius2, Pernilla Albinsson1, Gaetano Marrone5,6, Veronica Svedhem1,5
1) Department of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden 2) Department of Learning, Informatics, Management and Ethics, Karolinska Institutet, Stockholm, Sweden 3) School of Health Sciences, City, University of London, United Kingdom 4) Clinic of Infectious Disease, Södra Älvsborg Hospital, Borås Sweden 5) Unit of Infectious Diseases, Department of Medicine Huddinge, Karolinska Institutet, Stockholm, Sweden. 6) Global Health - Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden
Background. Adverse events (AE) are reported for all ART in different proportions. However, data from clinical trials may not be representative and generalizable to the entire population people living with HIV (PLWH) due to e.g. variations in sociodemographic characteristics. Observational studies including both patients reported outcome measures (PROMs) and patient related experience measures (PREMs) will add the patient’s` perspective and there by a more holistic approach. The aim of this study was to investigate the associations between AEs measured as PROM and PREM, prescribed ART, epidemiological data and biomarkers, using both qualitative and longitudinal quantitative methods to further evaluate the Health Questionnaire (HQ) as a tool to follow trends over time on patients reports of side effects of ART.
Method: The National quality assurance registry has an annual self-reported nine-item HQ. We analyzed 9,476 HQs from 4,186 PLWH together with their prescribed ART and relevant biomarkers collected 2011–2017. Data were analyzed by descriptive statistics, mixed logistic regression and Pearson correlation coefficient. Fifteen of the PLWH were also interviewed in a qualitative sub-study.
Results: The cross-sectional analysis of the annual HQ data showed that the frequency of reported side effects decreased from 32% 2011 to 15% 2017. During the same period, a shift in ART prescription from efavirenz to dolutegravir took place. The correlation coefficient between percentage per year of patients given efavirenz and patients reporting side effect was 0.94 (p0.0016) and the correlation between percentage per year of patients given dolutegravir and patients reporting side effect was -0.83 (p0.02)(Fig 1). In the qualitative interviews, participants presented a wide array thoughts of the concept “side effect of antiretroviral treatment”, where most described side effects as when medication affected the body in a harmful way. While some said that a bodily reaction was a side effect first when your doctor had confirmed it, others said that all events happening during medication, both physical and psychological, where side effects.
Conclusions: It is well known that patients report AE on placebo and the qualitative part of this study gives a deeper understanding of all phenomena patients may add to the concept of side effects on ART. Despite this fact, we found a strong positive correlation between reported side effects in the HQ and the sharp decline in use of efavirenz. This further supports the feasibility of the HC as a tool, both for longitudinal follow up on trends in PROMs and basis for evaluating QoL when revisit HealthCare.
Fig 1 Trend analysis between percentage per year of patients given efavirenz or dolutegravir, respectively, and patients reporting side effects