ABSTRACT
BACKGROUND: The cytomegalovirus (CMV) donor-positive/recipient-positive (D+/R+) population is the largest proportion of renal transplant recipients (RTR). Guidelines for prevention of CMV in the intermediate-risk D+/R+ population include prophylaxis with valganciclovir (VGCV) 900 mg/day for 3 months. This study is the first head-to-head analysis, to our knowledge, comparing the efficacy and safety CMV prophylaxis of VGCV 450 vs 900 mg/day for 3 months in D+/R+ RTR. METHODS: A multicenter, retrospective analysis evaluated 478 adult RTR between January 2008 and October 2011. Study participants received VGCV 450 mg/day (Group 1; n=398) or 900 mg/day (Group 2; n=89)×3 months for CMV prophylaxis. All VGCV was adjusted for renal function. All groups included in this study received study-approved induction and maintenance immunosuppression regimens. The primary endpoint was incidence of CMV disease at 12 months. RESULTS: The rates of graft loss, patient survival, T-cell and/or antibody-mediated rejection, hematological adverse events, opportunistic infections, and early VGCV discontinuation were evaluated. Patient demographics were comparable, but had significant differences in ethnicity and donor type between the groups. CONCLUSION: The occurrence of CMV disease at 12 months was similar between the groups (3.5% vs 3.4%; P=1.000). Log-rank test found no statistically significant difference in the time to development of CMV between the 2 groups (P=.939).
Subject(s)
Antibiotic Prophylaxis/methods , Antiviral Agents/therapeutic use , Cytomegalovirus Infections/prevention & control , Cytomegalovirus/isolation & purification , Ganciclovir/analogs & derivatives , Kidney Transplantation/adverse effects , Adult , Allografts/virology , Antiviral Agents/administration & dosage , Antiviral Agents/adverse effects , Cytomegalovirus Infections/blood , Cytomegalovirus Infections/epidemiology , Cytomegalovirus Infections/virology , Female , Follow-Up Studies , Ganciclovir/administration & dosage , Ganciclovir/adverse effects , Ganciclovir/therapeutic use , Graft Rejection/epidemiology , Graft Rejection/immunology , Humans , Immunosuppression Therapy/methods , Incidence , Male , Middle Aged , Opportunistic Infections/epidemiology , Practice Guidelines as Topic , Retrospective Studies , Serologic Tests , Transplant Recipients , Treatment Outcome , ValganciclovirABSTRACT
Drug-induced liver disease accounts for about 50% of acute or subacute liver failure in the United States. United Network of Organ Sharing (UNOS) data suggest 8%-20% of liver transplantation in this country per year is for fulminant liver failure due to drugs. Even though the most common medication implicated in acute liver injury is acetaminophen (75%), there are numerous other drugs that are responsible for acute and chronic liver injury. A variety of antifungal medications are known to cause a wide range of liver injury from a mild hepatocellular-cholestatic injury pattern to acute/subacute liver failure. Terbinafine is one of the antifungals that have been associated with such liver injuries. We report a case of terbinafine-induced severe liver failure requiring liver transplantation.
