Liver Transplantation
Conditions
Keywords
Valganciclovir, Oral Ganciclovir, Liver transplant
Brief summary
Null Hypothesis: There is no significant difference in the incidence of CMV infection when using oral valganciclovir or ganciclovir as prophylactic anti-viral therapy. Alternate Hypothesis: There exists a significant difference in the incidence of CMV infection when oral valganciclovir is used for CMV prophylaxis rather than oral ganciclovir. A formal hypothesis to be tested should be defined.
Detailed description
The objective for this retrospective clinical study is to describe the incidence of CMV infection in orthoptic liver transplant recipients who receive oral valganciclovir or ganciclovir as their CMV prophylactic anti-viral therapy. Endpoints: Primary Endpoint CMV infection will be characterized as viremia, syndrome or disease by the abovementioned methods for up to one year post-transplantation. Secondary Endpoints 1. Patient and allograft survival based on donor/recipient CMV status 2. Incidence of graft rejection and loss associated with CMV infection 3. Time to hepatitis C virus (HCV) occurrence 4. Incidence of HSV, EBV and VZV reactivations 5. Severity of HCV occurrence based on biopsy reports based on the Knodell score 6. Safety and tolerability of oral valganciclovir and ganciclovir
Interventions
DRUGoral Valganciclovir vs oral Ganciclovir
Sponsors
Oregon Health and Science University
Study design
Observational model
DEFINED_POPULATION
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* All liver transplants will be performed at Oregon Health & Science University (OHSU) and the OHSU surgical and medical staff will treat patients.
Exclusion criteria
* Portland Veterans Affairs Medical Center liver transplant recipients * Patients deceased within thirty days of receiving liver allograft * Patients with low risk of acquiring CMV infection: donor-negative and recipient-negative (D-/R-) * Patients undergoing re-transplantation * Lost to follow-up (minimum follow-up is 1 year) * History of CMV infection or disease * Anti-CMV therapy within the past 30 d * Severe, uncontrolled diarrhea or evidence of malabsorption.
Contacts
Primary ContactAli J Olyaei, PharmD
Outcome results
None listed