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LIVTENCITY▼® (maribavir) efficacy data
LIVTENCITY (maribavir) is indicated for the treatment of cytomegalovirus (CMV) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet in adult patients who have undergone a haematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT).1
Consideration should be given to official guidance on the appropriate use of antiviral agents.1
In the pivotal Phase 3 trial, LIVTENCITY delivered double the viraemia clearance (55.7%) compared to investigator-assigned therapy (IAT) (23.9%) – primary endpoint2
In the pivotal Phase 3 trial, LIVTENCITY delivered almost double the viraemia clearance at Study Week 8 maintained through Week 16 (18.7%) compared to IAT (10.3%) – key secondary endpoint2
Confirmed viraemia clearance* of refractory CMV in all transplants (HSCT and SOT) at Study Week 82
Confirmed CMV viraemia clearance and symptom control* in all transplants (HSCT and SOT) at the end of Study Week 8, maintained through Study Week 162
*Plasma CMV DNA <137 IU/mL in 2 consecutive tests ≥5 days apart.2
†CMV infection symptom control was defined as resolution or improvement of tissue-invasive disease or CMV syndrome for symptomatic patients at baseline, or no new symptoms for patients who were asymptomatic at baseline.2
LIVTENCITY – positive safety profile in post-transplant refractory CMV (with or without resistance)
- In the SOLSTICE trial, the most reported treatment-related adverse event was dysgeusia that typically resolved during or after treatment (35.9% [84/234] receiving LIVTENCITY vs 0.9% [1/116] receiving investigator-initiated therapy)3
- Transplant recipients treated with LIVTENCITY experienced less treatment-related neutropenia vs those receiving valganciclovir/ganciclovir (1.7% receiving LIVTENCITY vs 25% receiving valganciclovir/ganciclovir)2
- Transplant patients treated with LIVTENCITY experienced less treatment-related acute kidney injury vs those receiving foscarnet (1.7% receiving LIVTENCITY vs 19.1% receiving foscarnet)2
In subgroup analyses of the pivotal Phase 3 trial, viraemia clearance was observed in SOT recipients<sup>2-5</sup>
Confirmed viraemia clearance in a subgroup analysis of SOT recipients with refractory CMV at Study Week 8*2,4
Confirmed CMV viraemia clearance and symptom control at the end of Study Week 8, maintained through Study Week 16 in a subgroup analysis of SOT recipients with refractory CMV3
*Limitations: This study was not powered to detect differences between treatments in this patient subgroup.2
SOLSTICE primary endpoint: subgroup analysis of efficacy by organ type
In a subgroup analysis of heart transplant recipients with refractory CMV receiving LIVTENCITY (6/14; vs 11.1% [1/9] on IAT)4
95% Cl: 30.7% (-1.72–63.2)
In a subgroup analysis of lung transplant recipients with refractory CMV receiving LIVTENCITY (19/40; vs 13.6% [3/22] on IAT)4
95% Cl: 38.2% (16.9–59.5)
In a subgroup analysis of kidney transplant recipients with refractory CMV receiving LIVTENCITY (44/74; vs 34.4% [11/32] on IAT)4
95% Cl: 26.7% (7.5–45.9)
In a subgroup analysis of liver transplant recipients with refractory CMV receiving LIVTENCITY vs 0/1 on IAT5
Note: this subgroup analysis has been calculated from low patient numbers and the two treatment groups are not equally matched; therefore, it is insufficient to show a difference in treatment effect.
In subgroup analyses of the pivotal Phase 3 trial, viraemia clearance was observed in HSCT recipients<sup>2,6</sup>
Confirmed viraemia clearance in a subgroup analysis (randomised population) of HSCT recipients with refractory CMV at Study Week 8*2
Confirmed CMV viraemia clearance and symptom control† at the end of Study Week 8, maintained through Study Week 16 in a subgroup analysis (randomised population) of HSCT recipients with refractory CMV6
*Limitations: This study was not powered to detect differences between treatments in this patient subgroup.2
†CMV infection symptom control was defined as resolution or improvement of tissue-invasive disease or CMV syndrome for symptomatic patients at baseline, or no new symptoms for patients who were asymptomatic at baseline.2
SOLSTICE trial: rescue arm<sup>2</sup>
Summary of HSCT and SOT recipients randomised to IAT meeting criteria for entry into LIVTENCITY rescue arm*7
HSCT and SOT recipients in rescue arm achieving confirmed CMV viraemia clearance**7
*All patients who entered the LIVTENCITY rescue arm had demonstrated persistence of CMV viraemia despite treatment with IAT for at least 3 weeks. All patients entered the rescue arm between study Weeks 3–7, except for 1 patient who entered between Weeks 7–8.7
†Whole blood or plasma CMV DNA levels were measured by local or central specialty laboratory qPCR assay.7
‡Patient had to meet 2 criteria: (i) whole blood or plasma CMV DNA had decreased <1 log10 from baseline as measured by local or speciality laboratory qPCR assay, and (ii) the presenting tissue-invasive CMV disease for symptomatic patients had not improved/worsened, or patient was asymptomatic at baseline and developed tissue-invasive disease.7
§At least 50% increase from baseline value, attributed to treatment toxicity (e.g. cidofovir, foscarnet).7 #When on treatment with cidofovir or foscarnet.7
¶Absolute neutrophil count <500/mm3 when on treatment with valganciclovir/ganciclovir.7
**Included all patients who entered the rescue arm and received any dose of LIVTENCITY as rescue therapy.7
Confirmed viraemia clearance = plasma CMV DNA < lower limit of quantification (i.e. <137 IU/mL) in 2 consecutive tests ≥5 days apart.2
IAT = one or a combination of ganciclovir, valganciclovir, foscarnet, or cidofovir.2
Refractory CMV = failure to achieve >1 log10 decrease in CMV DNA level in whole blood or plasma after a 14-day or longer treatment period with intravenous (IV) ganciclovir/oral valganciclovir; IV foscarnet, or IV cidofovir.2
Cl = confidence interval; CMV = cytomegalovirus; HSCT = haematopoietic stem cell transplant; IAT = investigator-assigned therapy; qPCR = quantitative polymerase chain reaction; SOT = solid organ transplant.
References:
- LIVTENCITY UK Summaries of Product Characteristics [GB & NI].
- Avery RK, et al. Clin Infect Dis. 2022;75(4):690–701.
- Data on File for Maribavir for SOT recipients. EXA/GB/MARI/0029.
- Avery RK, et al. Am J Transplant. 2021;21(suppl. 3).
- Data on File for Maribavir for 100% CMV clearance in LT patients. EXA/GB/MARI/0030.
- Data on File for Maribavir for HCT recipients. EXA/GB/MARI/0028.
- Pereira M, et al. Efficacy and safety of Maribavir as a rescue treatment for investigator assigned therapy in transplant recipients with refractory or resistant cytomegalovirus infections in the SOLSTICE study: phase 3 trial results. In: The 2021 IDWeek Virtual Conference; 2021. Oral Abstract 21.
