Abstract
In adults living with HIV, pharmacy refill data are good predictors of virologic failure (VF). The utility of pharmacy refill data for predicting VF in adolescents has not been reported. We evaluated data from 291 adolescents on antiretroviral therapy. The main outcome measure was VF, defined as two consecutive HIV viral load measurements ≥ 400 copies/mL during 24-months of follow-up. Pharmacy refill non-adherence was defined as two consecutive refill adherence measurements < 95% during the same period. Fifty-three (18%) adolescents experienced VF. One hundred twenty-eight (44%) adolescents had refill non-adherence. Refill non-adherence had poor discriminative ability for indicating VF (receiver operating characteristic AUC = 0.60). Sensitivity and specificity for predicting VF was poor (60% (95% CI 46–74%) and 60% (95% CI 53–66%), respectively). The lack of a viable surrogate for VF in adolescents highlights the urgent need for more access to virologic testing and novel methods of monitoring adolescent treatment adherence.
Resumen
En los adultos que viven con el VIH, los datos en la farmacia sobre la renovación de recetas médicas son buenos predictores del fracaso virológico. La utilidad de los datos en la farmacia sobre la renovación de recetas médicas para predecir fracaso virológico en adolescentes no ha sido reportada. Se evaluaron los datos de 291 adolescentes en terapia antirretroviral. La principal medida de resultado fue el fracaso virológico, definida como dos medidas consecutivas de carga viral del VIH ≥ 400 copias/ml durante 24 meses de seguimiento. La no adherencia a la renovación de recetas médicas en la farmacia se definió como dos medidas consecutivas de adherencia a la renovación de recetas médicas < 95% durante el mismo período. Cincuenta y tres (18%) adolescentes tuvieron fracaso virológico. Ciento veintiocho (44%) adolescentes tuvieron no adherencia a la renovación de recetas médicas. El no-adherencia a la renovación de recetas médicas tuvo poca capacidad para indicar fracaso virológico (característica de funcionamiento del receptor AUC = 0.60). La sensibilidad y especificidad para predecir fracaso virológico fue deficiente (60% (95%: 46–74%) y 60% (95% CI 53–66%), respectivamente). La falta de un sustituto viable para el fracaso virológico en los adolescentes resalta la necesidad urgente para más acceso a las pruebas virológicas y métodos novedosos para monitorear la adherencia del tratamiento en los adolescentes.
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Abbreviations
- ART:
-
Anti-retroviral therapy
- AUC:
-
Area under the curve
- HIV:
-
Human immunodeficiency virus
- MEMS:
-
Medical event monitoring system
- ROC:
-
Receiver operating characteristic
- VF:
-
Virologic failure
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Acknowledgements
The study team would like to thank the adolescent study participants and the staff at the Botswana- Baylor Children’s Clinical Centre of Excellence. We would also like to thank Alexandra Montesinos for translating the abstract into Spanish. This work was presented in part by Leah Genn at the Children’s Hospital of Philadelphia Research Institute Summer Scholar Program (CRISSP) 2015 Poster Session.
Funding
The first author’s work on this project was funded through the Children’s Hospital of Philadelphia Research Institute Summer Scholar Program (1R25HD082842-01). Study funding to establish this cohort was obtained from a CDC PEPFAR Public Health Effectiveness grant to the senior author. This work was supported by NIH K23 MH095669 to the senior author. Dr. Gross received support from the Penn Center for AIDS Research (P30 AI 045008). The funders did not play a role in study design, analysis, or the decision to publish this research.
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All procedures were in accordance with the ethical standards of the institutional and national research committees and with the 1964 Helsinki Declaration and its later amendments and comparable ethical standards. The study was approved by the Botswana Health Research Development Committee and Institutional Review Boards at the University of Pennsylvania and Baylor College of Medicine. Written informed consent was obtained from a parent or guardian of each adolescent study participant and assent was obtained for each adolescent participant.
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Genn, L., Chapman, J., Okatch, H. et al. Pharmacy Refill Data are Poor Predictors of Virologic Treatment Outcomes in Adolescents with HIV in Botswana. AIDS Behav 23, 2130–2137 (2019). https://doi.org/10.1007/s10461-018-2325-9
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DOI: https://doi.org/10.1007/s10461-018-2325-9