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Therapeutic efficacy of Valcyte

1. Adult Patients

Maintenance Therapy of CMV Retinitis: No comparative clinical data are available on the efficacy of Valcyte tablets for the maintenance therapy of CMV retinitis because all patients in the CMV retinitis study received open-label Valcyte tablets after Week 4. However, the AUC for ganciclovir is similar following administration of 900 mg Valcyte tablets  once daily and 5 mg per kg intravenous ganciclovir once daily. Although the ganciclovir Cmax is lower following Valcyte tablets administration compared to intravenous ganciclovir, it is higher than the C_max obtained following oral ganciclovir  administration. Therefore, use of Valcyte tablets as maintenance therapy is supported by a plasma concentration-time profile similar to that of two approved products for maintenance therapy of CMV retinitis.

Prevention of CMV Disease in Heart, Kidney, Kidney-Pancreas, or Liver Transplantation: A double blind, double-dummy  active comparator study was conducted in 372 heart, liver, kidney, or kidney-pancreas transplant patients at high risk for  CMV disease (D+/R-). Patients were randomized (2 Valcyte: 1 oral ganciclovir) to receive either Valcyte tablets (900 mg once daily) or oral ganciclovir (1000 mg three times a day) starting within 10 days of transplantation until Day 100  post-transplant. The proportion of patients who developed CMV disease, including CMV syndrome and/or tissue-invasive  disease during the first 6 months post-transplant was similar between the Valcyte tablets arm (12.1%, N=239) and the  oral ganciclovir arm (15.2%, N=125). However, in liver transplant patients, the incidence of tissue-invasive CMV disease  was significantly higher in the Valcyte group compared with the ganciclovir group. These results are summarized in Table 20.

2. Pediatric Patients

Prevention of CMV in Pediatric Heart, Kidney, or Liver Transplantation: Sixty-three children, 4 months to 16 years of age,  who had a solid organ transplant (kidney 33, liver 17, heart 12, and kidney/liver 1) and were at risk for developing CMV disease, were enrolled in an open-label, safety, and pharmacokinetic study of oral Valcyte (Valcyte for oral solution or tablets). Patients received Valcyte once daily within 10 days after transplant until a maximum of 100 days posttransplant. The daily doses of Valcyte were calculated at each study visit based on body surface area and a modified  creatinine clearance.  

Prevention of CMV in Pediatric Kidney Transplantation: Fifty-seven children, 1 to 16 years of age, who had a renal transplant and were at risk for developing CMV disease, were enrolled in an open-label tolerability study of oral Valcyte (Valcyte for oral solution or tablets). Patients received Valcyte once daily within 10 days after transplant until a  maximum of 200 days post-transplant. The daily doses of Valcyte were calculated at each study visit based on body  surface area and a modified creatinine clearance [see Dosage and Administration (2.3)]. No case of CMV syndrome or tissue-invasive CMV disease was reported within the first 12 months post-transplantation.

from FDA,2021.12