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Prophylaxis with valganciclovir plus mycophenolate
This combination prophylaxis regimen suppresses cytomegalovirus (CMV) replication while simultaneously reducing T-cell mediated rejection through dual immunosuppressive and antiviral mechanisms.
This combination prophylaxis regimen suppresses cytomegalovirus (CMV) replication while simultaneously reducing T-cell mediated rejection through dual immunosuppressive and antiviral mechanisms. Used for CMV prophylaxis and rejection prevention in solid organ transplant recipients.
At a glance
| Generic name | Prophylaxis with valganciclovir plus mycophenolate |
|---|---|
| Sponsor | University of Bologna |
| Drug class | Combination antiviral and immunosuppressant |
| Target | CMV DNA polymerase (valganciclovir); IMPDH type II (mycophenolate) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Transplantation |
| Phase | Phase 3 |
Mechanism of action
Valganciclovir is a nucleoside analog that inhibits CMV DNA polymerase, preventing viral replication in transplant recipients. Mycophenolate is an inosine monophosphate dehydrogenase (IMPDH) inhibitor that selectively suppresses T and B lymphocyte proliferation. Together, they provide both CMV prophylaxis and immunosuppression to prevent graft rejection in transplant patients.
Approved indications
- CMV prophylaxis and rejection prevention in solid organ transplant recipients
Common side effects
- Neutropenia
- Anemia
- Gastrointestinal disturbances
- Renal impairment
- Infection (non-CMV)
Key clinical trials
- Valganciclovir Prophylaxis Versus Preemptive Therapy for Cytomegalovirus in Living Donor Kidney Transplant Recipients (PHASE4)
- Use of Tacrolimus and MTOR Inhibitors With Anticipatory Therapy vs. Tacrolimus and Mycophenolic Acid With Universal Prophylaxis in Renal Recipients at High Risk of Posttransplant Cytomegalovirus. (PHASE4)
- Donor-Alloantigen-Reactive Regulatory T Cell (darTregs) in Liver Transplantation (PHASE1)
- Steroid-Free Versus Steroid-Based Immunosuppression in Pediatric Renal (Kidney) Transplantation (PHASE1, PHASE2)
- Prevention of Transplant Atherosclerosis With Everolimus and Anti-cytomegalovirus Therapy (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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