Purpose
In pre-clinical studies we have demonstrated the ability of light-based therapies
- UVC and photodynamic therapy (PDT) during EVLP to inactivate HCV in donor lungs.
In a step-wise application of this technology to clinical transplantation, we designed
a clinical trial to evaluate to effects of UVC treatment using NAT+ HCV donor lungs
followed by transplantation.
Methods
Twenty patients receiving NAT+ HCV lungs were included in the study. In the control group, lungs were subjected to 5-6h of EVLP whereas in UVC group, lungs were subjected perfusate irradiation with UVC (254 nm, 31mW/cm²) followed by
transplantation.
Results
11 patients received lungs subjected to EVLP alone, and 9 patients received lungs
subjected to EVLP+UVC. Donor viral loads were similar between the 2 groups (3585000
IU/ml vs. 3480000 IU/mL, p=0.56). During EVLP, lung function was stable and similar
between the 2 groups. 19/20 patients developed viremia. Perfusate and tissue levels
of HCV by PCR during EVLP were not significantly affected by UVC treatment (Fig.1A), however, the UVC group showed a marked delay in developing viremia post-transplantation
(Fig 1B). Median day 7 viral loads were 4390 vs. 168 IU/ml; p=0.27 in control vs. UVC group
respectively. The proportion of patients with viral loads less than 3-log copies at
day 7 was 2/11 (18%) in control vs. 5/8 (62.5%) in UVC group; p=0.07. Survival post
lung transplantation is 100% in both groups with a mean follow up of 162 (14-385)
days.
Conclusion
This is the first clinical trial evaluating a therapeutic intervention during EVLP.
As in our pre-clinical studies, UVC does not alter virus quantities measured by PCR
(virus fragments) during EVLP, however it does appear to confer impairment in virus
infectivity. The combination of UVC therapy with an ultra-short course of direct anti-virus
agents may provide the ability to prevent transmission altogether, allowing expansion
of transplantation using HCV+ organs.
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Article info
Identification
Copyright
© 2019 Published by Elsevier Inc.
