Long-term use of darunavir/ritonavir-containing regimens in daily practice in Belgium: retrospective observational cohort data of 1701 HIV-patients

Abstract

Background Once daily (QD) ritonavir or cobicistat-boosted darunavir (DRV/b), in combination with other antiretrovirals (ARVs), is recommended as a first-line option for human immunodeficiency virus-infected patients in European and USA guidelines. The objective of this study was to analyse the outcomes of DRV/r QD-based antiretroviral therapy (ART) regimens in real-life settings.

Methods This is an observational, non-interventional, non-comparative, retrospective, multicentre cohort study. Data were collected from the databases of eight Belgian AIDS Reference Centres. All patients who received at least one dose of DRV/r QD, regardless of background ARV regimen, with a minimum follow-up of 6 months were included.

Results Data from 1701 subjects were collected. Most were male (66.5%) with a mean age of 42.9 years, 33.1% were treatment-naïve and 66.9% were ART experienced. During a median follow-up of 2.45 years (95% CI: 1.50–3.34), the probability to remain on treatment was 87% for the first year, 79% for the second year. DRV/r was well tolerated with few discontinuations due to adverse events (6.9%) or virological failure (0.8%). Among the 1138 treatment-experienced patients, 111 (9.8%) patients received DRV/r QD monotherapy.

Conclusions This retrospective cohort analysis confirms the long-term effectiveness and good tolerability of DRV/r QD in a real-life setting. No unexpected adverse events were reported.

Keywords:

• Belgium
• HAART (highly active antiretroviral therapy)
• HIV (human immunodeficiency virus)
• darunavir
• once-daily

Acknowledgements

The authors thank the participating centres, Business & Decision for the data collection and T.O.M. Life Science Consulting for medical writing services. Furthermore, the authors thank Suzy Van Sanden and Gert Loriers from Janssen for their contribution. The study was funded by Janssen-Cilag NV, Belgium. These data were presented at the HIV Drug Therapy congress 2016 in Glasgow (Posters #131 and #137) and during the national BREACH congress in Belgium (Nov 2016).