• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Valcyte (valganciclovir HCl tablets) Dear Healthcare Professional Letter Sep 2003

The following is the text of a letter from Roche Pharmaceuticals. Contact the company for a copy of any referenced enclosures.


 

VALCYTET (valganciclovir HCl tablets)
NDC 0004-0038-22

Roche Laboratories, Inc.
340 Kingsland Street
Nutley, NJ 07110-1199

September 30, 2003

Dear Healthcare Professional:

We are pleased to announce that Valcyte is now indicated for the prevention of cytomegalovirus (CMV) disease in kidney, heart, and kidney-pancreas transplant patients at high risk for CMV disease (Donor CMV seropositive/Recipient CMV seronegative [(D+/R-)]). Valcyte is not indicated for use in liver transplant patients. The safety and efficacy of Valcyte for the prevention of CMV disease in other solid organ transplant patients such as lung transplant patients have not been established. A newly updated package insert is included for your reference.

We recently completed a double-blind, double-dummy active comparator study (known as PV16000) in 364 heart, liver, kidney, and kidney-pancreas transplant patients at high ­risk for CMV disease (D+/R-). PV 16000 was designed to be a non-inferiority study that measured overall CMV disease: Patients were randomized in a 2:1 fashion to either Valcyte tablets 900 mg once daily or Cytovene ® (ganciclovir capsules) 1 g three times daily. Doses of Valcyte and ganciclovir were adjusted for renal function. Study drug was started by day 10 and continued through day 100 post-transplant.

In the study, CMV disease was defined as the occurrence of either CMV syndrome or tissue invasive CMV. CMV syndrome was defined as the presence of CMV in blood by a positive CMV DNA PCR along with fever (greater than or equal to 38° C on two occasions at least 24 hours apart), and one or more of the following: malaise, leukopenia, atypical lymphocytosis, thrombocytopenia, elevated hepatic enzymes. Tissue invasive CMV was defined as the presence of localized CMV infection (CMV inclusion cells or in situ detection of CMV antigen or DNA in a biopsy or other appropriate specimen) along with relevant symptoms or signs of organ dysfunction.

Clinical Outcome

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 arm (12.1%, N=239) and the oral ganciclovir arm (15.2%, N=125). While there was no difference between the Valcyte and ganciclovir arms in the overall rate of CMV disease, organ-specific subgroup analyses revealed important information.

Kidney, Kidney-Pancreas, and Heart Transplant

In the kidney, kidney-pancreas, and heart transplant sub-populations, Valcyte was determined to be effective in the prevention of CMV disease. For organ-specific data, please see the table below.

Liver Transplant

In the liver transplant sub-population, there was a higher incidence of overall CMV disease in the Valcyte arm vs. the ganciclovir arm (19% vs. 12%). In addition, further analyses revealed a significant increase in the number of patients with tissue-invasive CMV in the Valcyte arm vs. the ganciclovir arm (14% vs. 3%). Based on these results, Valcyte was not approved for the prevention of CMV disease in liver transplant recipients.

Percentage of Patients with CMV Disease and Tissue-Invasive CMV Disease by
Organ Type: Endpoint Committee, 6 Month ITT Analysis*

 
CMV Disease 1
Tissue-Invasive
CMV Disease
CMV Syndrome
Organ
VGCV
(N=239)
GCV
(N=125)
VGCV
(N=239)
GCV
(N=125)
VGCV
(N=239)
GCV
(N=125)
Liver (n=177)
19%
(22/118)
12%
(7/59)
14%
(16/118)
3%
(2/59)
5%
(6/118)
9%
(5/59)
Kidney (n=120)
6%
(5/81)
23%
(9/39)
1%
(1/81)
5%
(2/39)
5%
(4/81)
18%
(7/39)
Heart (n=56)
6%
(2/35)
10%
(2/21)
0%
(0/35)
5%
(1/21)
6%
(2/35)
5%
(1/21)
Kidney / Pancreas n=11
0%
(0/5)
17%
(1/6)
0%
(0/5)
17%
(1/6)
0%
(0/5)
0%
(0/6)

* Please see Valcyte complete prescribing information (enclosed)
GCV = oral ganciclovir; VGCV = Valcyte

1 Number of Patients with CMV Disease = Number of Patients with Tissue-Invasive CMV Disease + Number of Patients with CMV Syndrome.

 

If you have any questions or need additional information please contact the Roche Professional Product Information Department at 1-800-526-6367, Monday through Friday 8:00 AM - 6:00 PM EST. Please see the VALCYTE complete product information enclosed.

Sincerely,

W. Robert Lange, MD, MPH
Medical Director