Kidney Week

Abstract: FR-PO011

Antiviral Effects of Voclosporin on SARS-CoV-2 in Immunocompromised Kidney Patients

Session Information

• COVID-19: AKI Outcomes, Biomarkers, Treatments, Case Reports
  November 04, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
  Abstract Time: 10:00 AM - 12:00 PM

Category: Coronavirus (COVID-19)

• 000 Coronavirus (COVID-19)

Authors

• Arends, Eline Jana, Leids Universitair Medisch Centrum, Leiden, Zuid-Holland, Netherlands

Eline Jana Arends,

• Meziyerh, Soufian, Leids Universitair Medisch Centrum, Leiden, Zuid-Holland, Netherlands

Soufian Meziyerh,

• Moes, Dirk jan, Leids Universitair Medisch Centrum, Leiden, Zuid-Holland, Netherlands

Dirk jan Moes,

• Kamerling, Sylvia, Leids Universitair Medisch Centrum, Leiden, Zuid-Holland, Netherlands

Sylvia Kamerling,

• Van der kooij, Sandra W., Leids Universitair Medisch Centrum, Leiden, Zuid-Holland, Netherlands

Sandra W. Van der kooij,

• Ogando, Natacha S., Leids Universitair Medisch Centrum, Leiden, Zuid-Holland, Netherlands

Natacha S. Ogando,

• Snijder, Eric J., Leids Universitair Medisch Centrum, Leiden, Zuid-Holland, Netherlands

Eric J. Snijder,

• Van Hemert, Martijn J., Leids Universitair Medisch Centrum, Leiden, Zuid-Holland, Netherlands

Martijn J. Van Hemert,

• Visser, Leo G., Leids Universitair Medisch Centrum, Leiden, Zuid-Holland, Netherlands

Leo G. Visser,

• Feltkamp, Mariet, Leids Universitair Medisch Centrum, Leiden, Zuid-Holland, Netherlands

Mariet Feltkamp,

• Rabelink, Ton J., Leids Universitair Medisch Centrum, Leiden, Zuid-Holland, Netherlands

Ton J. Rabelink,

• van Kooten, Cees, Leids Universitair Medisch Centrum, Leiden, Zuid-Holland, Netherlands

Cees van Kooten,

• De Vries, Aiko P.J., Leids Universitair Medisch Centrum, Leiden, Zuid-Holland, Netherlands

Aiko P.J. De Vries,

• Teng, Yoe Kie Onno, Leids Universitair Medisch Centrum, Leiden, Zuid-Holland, Netherlands

Yoe Kie Onno Teng,

Group or Team Name

• on behalf of all the VOCOVID investigators

Background

Immunocompromised patients, including Kidney Transplant Recipients (KTRs) and lupus nephritis (LN) patients, are at increased risk for prolonged SARS-CoV-2 infection and developing COVID-19-related complications. Recently, we reported that voclosporin, a novel calcineurin inhibitor (CNI), demonstrated in vitro a more potent inhibitory effect on SARS-CoV-2 replication than other CNIs (tacrolimus and ciclosporin). Additionally the AURORA-2 study, where 216 LN patients were treated with voclosporin or placebo on top of standard of care, SARS-CoV-2 infection was detected in 12/100 placebo-treated patients (12%) compared to 7/116 voclosporin treated patients (6%) and more patients died due to COVID-19 in the placebo arm versus voclosporin arm (3% vs 0%). In this proof-of-concept study we assessed whether voclosporin demonstrated an added antiviral benefit in SARS-CoV-2 positive immunocompromised patients.

Methods

We performed a prospective, randomised, open-label, single-center, exploratory, proof of concept study in 20 KTRs with mild to moderate symptoms from a COVID-19 infection comparing time to viral clearance of SARS-CoV-2 between patients on standard immunosuppressive therapy with tacrolimus versus voclosporin (the VOCOVID study).

Results

In the VOCOVID study no difference in time to viral clearance or time to clinical recovery was found between both treatment arms. Pharmacokinetic analysis demonstrated that adequate trough levels of voclosporin were reached from day 4-8 after randomization. Looking at specific timepoint in a post-hoc analysis, indeed a significantly better viral clearance of SARS-CoV-2 was observed in voclosporin treated patients at day 4-8. No safety concerns were raised.

Conclusion

The present study provides evidence that voclosporin has a favorable benefit-risk profile for immunocompromised kidney disease patients who contract a SARS-CoV-2 infection while requiring the continuation of their immunosuppressants.

Funding

• Commercial Support –