Table 1.
Characteristics and Outcomes of BK Virus Nephropathy Cases
| Patient No. | Age (y)/Sex | Disease | Donor | GVHD Onset | HC Onset | Scr Doublinga | Time and Means of Diagnosis | Maximum BK Viremiab | Treatment | HD Start | Time and Cause of Death |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1c | 58/M | Lymphoma | MUD | On d 290 | No HC | On d 522 | Biopsy on d 555 | 2.3 × 107 copies/mL on d 565 | Brincidofovir orally, 100 mg, 2×/wk, started on d 572 (94 doses)d | No HD | On d 914 (GVHD, bacterial sepsis) |
| 2 | 64/M | Multiple myeloma | MRD | No GVHD | On d 61 (grade 3) | On d 311 | Autopsy on d 342 | 1.1 × 105 copies/mL on d 317 | Brincidofovir orally, 100 mg, 2×/wk, started on d 281 (9 doses)e | No HD | On d 342 (bacterial sepsis, hemolytic anemia, CMV encephalitis) |
| 3 | 7/M | AML | MMUD | On d 107 | No HC | On d 368 | Nephrectomy on d 326 | Not available | None | No HD | On d 439 (GVHD) |
| 4 | 27/M | Lymphoma | MMUD | No GVHD | On d 61 | On d 72 | Autopsy on d 122 | 1.3 × 104 copies/mL on d 107 | IV cidofovir, 0.5 mg/kg (×2) | On d 97 | On d 122 (bacterial pneumonia) |
| 5 | 59/F | AML | MMUD | On d 53 | On d 53 (grade 4) | On d 222 | Biopsy on d 270 | 2.2 × 106 copies/mL on d 258 | IV cidofovir, 5 mg/kg (×5), then 1 mg/kg (×2); intravesicular cidofovir, ciprofloxacin, leflunomide | On d 273 | On d 291 (bacterial pneumonia) |
Note: Day equals the number of days since stem cell infusion.
Abbreviations: AML, acute myelogenous lymphoma; CMV, cytomegalovirus; MRD, matched related donor; MMUD, mismatched unrelated donor; MUD, matched unrelated donor; GVHD, graft-versus-host disease; HC, hemorrhagic cystitis; HD, hemodialysis; IV, intravenous; Scr, serum creatinine.
Relative to baseline concentration.
Quantitation of BK viremia was determined by a commercial polymerase chain reaction assay performed at Focus Diagnostics or Viracor-IBT Laboratories.
The subject of this case report; was treated with brincidofovir for BK virus nephropathy. Kidney biopsy was performed at an outside institution.
Patient 1 received 54 doses of brincidofovir on CMX001-350 study and 40 doses under emergency investigational drug (EIND) application provisions.
Patient 2 was treated with brincidofovir for CMV encephalitis.