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Cardiovascular adverse events during treatment with darunavir-based regimens in an Italian observational study

Authors Antinori A, Rusconi S, Gianotti N, Bini T, Mancusi D, Termini R

Received 20 July 2018

Accepted for publication 2 April 2019

Published 14 May 2019 Volume 2019:13 Pages 1667—1685


Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 2

Editor who approved publication: Prof. Dr. Cristiana Tanase

A Antinori,1 S Rusconi,2 N Gianotti,3 T Bini,4 D Mancusi,5 R Termini5

1HIV/AIDS Department, National Institute for Infectious Diseases “Lazzaro Spallanzani” IRCCS, Rome, Italy; 2Infectious Diseases Unit, DIBIC Luigi Sacco, University of Milan, Milan, Italy; 3Infectious Diseases, San Raffaele Scientific Institute, Milan, Italy; 4Clinic of Infectious Diseases, ASST “Santi Paolo e Carlo” Hospital, Milan, Italy; 5Medical Affairs Department, Infectious Diseases, Janssen-Cilag SpA, Cologno Monzese (MI), Italy

Background: The protease inhibitor (PI) darunavir (DRV) has proven to be highly effective and well tolerated for HIV treatment. The DAD (Data collection on Adverse Effects of Anti-HIV Drugs) cohort showed an increased 5-year cumulative cardiovascular (CV) risk in patients given various PIs, including DRV, whereas two other recent studies found no association between DRV and CV diseases.
Methods: We performed a post-hoc analysis of CV adverse events (CVAEs) in an Italian cohort, the TMC114-HIV4042 observational study, where 875 patients treated with ritonavir-boosted DRV-based regimens were followed for a total of 1,566 patient-years.
Results: We observed 23 CVAEs of any type, including 17 [12 (95%CI, 7–19) per 1,000 patient-years] primary; 14 [10 (95%CI, 5–17) per 1,000 patient-years] were primary Framingham-type general CVAEs, close to what expected according to the Framingham algorithm based on traditional risk factors. Age and systolic blood pressure (SBP) at the time of study enrolment were the only relevant (p<0.01) independent predictors of CVAEs in all models; patients with any CVAE were on average 10 years older and had an SBP 14 mmHg higher than patients without CVAEs. When controlling for age and SBP, the association with other traditional factors, including serum lipids, and with HIV-specific factors was not statistically significant (p>0.05). Models that also adjusted for previous ARV exposure showed no statistically significant association between any-type CVAEs and either DRV doses, 1,200 or 800 mg/daily (as also suggested by propensity score stratification), or previous DRV exposure duration.
Conclusion: We found no evidence of a relationship between DRV use and increased CV risk.

Keywords: HIV infection, darunavir, cardiovascular risk, observational study

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