Efficacy
The efficacy of Valcyte has been demonstrated in a pivotal clinical study containing 2 phases2:
- A 4-week randomized controlled trial comparing the efficacy of Valcyte with IV ganciclovir for induction treatment of CMV retinitis
- An ongoing extension phase in which all subjects received Valcyte as maintenance treatment
In the three-week induction phase, 160 patients with AIDS and newly diagnosed CMV retinitis were randomized (on a 1:1 ratio) to receive either oral Valcyte (900 mg twice daily) or IV ganciclovir (5 mg/kg twice daily) In the one-week maintenance phase, the patients received Valcyte 900 mg once daily or IV ganciclovir 5 mk/kg once daily, respectively2
The primary endpoint was the progression of retinitis during the first four weeks of therapy as determined by treatment-masked assessment of retinal photographs.
Efficacy results: The proportion of patients with progression of CMV retinitis was the same in both treatment groups2
Status of CMV Retinitis Progression at Week 4
| Valcyte n=80 |
IV Ganciclovir n=80 |
|
| Patient progressors | 7 | 7 |
| Patient nonprogressors | 64 | 63 |
| Unevaluable patients | 2 | 3 |
Safety
Information
Reference:
2Martin DF, Sierra-Madero J, Walmsley S, et al, for the Valganciclovir Study Group. A controlled trial of valganciclovir as induction therapy for cytomegalovirus retinitis. N Engl J Med. 2002;346:1119-1126.