The Committee deems that the clinical benefit of PREVYMIS (letermovir) is substantial in the prophylaxis of CMV disease in CMV-seronegative adults who have received a kidney transplant from a CMV-seropositive donor [D+/R-].
Clinical Added Value
minor
Considering:
the partially met medical need in CMV-seronegative adults who have received a kidney transplant from a CMV-seropositive donor [D+/R-] in the context of prophylaxis of CMV disease;
the demonstrated non-inferiority of letermovir compared to valganciclovir in terms of the proportion of patients with CMV disease at week 52 post-transplant (primary endpoint) in whom the donor is CMV-seropositive [D+/R-]: 10.4% (30/289) versus 11.8% (35/297), i.e. an adjusted difference = -1.4% (95% CI = [-6.5; 3.8]);
a relatively favourable safety profile due to a lower risk of leukopenia and neutropenia (risk factors for infection with CMV and other pathogens) compared to valganciclovir;
a genetic resistance barrier of letermovir that appears to be convincing (low resistance rate) and an absence of cross-resistance with other anti-CMV antiviral agents, in particular DNA polymerase inhibitors, leaving open the possibility of considering the use of other antiviral agents at a later stage without the risk of therapeutic failure;
but:
the lack of demonstration of a superiority of letermovir compared to valganciclovir in terms of the proportion of patients with CMV disease at week 52 post-transplant in whom the donor is CMV-seropositive [D+/R-];
the lack of demonstration of an improvement in the time to onset of CMV disease with letermovir compared to valganciclovir, after follow-up for 52 weeks post kidney transplant;
the Committee deems that PREVYMIS (letermovir) provides a minor clinical added value (CAV IV) in the care pathway for theprophylaxis of CMV disease in CMV-seronegative adults who have received a kidney transplant from a CMV-seropotive donor [D+/R-].
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