LIVTENCITY was evaluated using the
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The approval of LIVTENCITY is based on the SOLSTICE Study which assessed the efficacy and safety of LIVTENCITY treatment compared to Investigator Assigned Treatment (IAT) in 350 Hematopoietic Stem Cell Transplant (HSCT) and Solid Organ Transplant (SOT) recipients with CMV infections that were refractory to treatment with ganciclovir, valganciclovir, foscarnet, or cidofovir, including CMV infections with or without confirmed resistance to 1 or more anti-CMV agents.1 Beneficial treatment effect was consistent regardless of transplant type, baseline CMV DNA viral load, genotypic resistance, CMV syndrome at baseline and age.1
"A diagnosis of CMV infection can be particularly unsettling for patients given the complex challenges associated with receiving a life-saving transplant," said
Current antiviral treatment options for post-transplant cytomegalovirus (CMV) infections have unfavorable toxicities, such as neutropenia or nephrotoxicity, that may impact patient care and transplant outcomes.2
LIVTENCITY, is a selective orally bioavailable benzimidazole riboside antiviral drug with a novel mechanism of action against human CMV (HCMV). LIVTENCITY attaches to the UL97 encoded kinase at the adenosine triphosphate (ATP) binding site, abolishing phosphotransferase needed in processes such as DNA replication, encapsidation, and nuclear egress of viral capsids.1
The recommended dose of LIVTENCITY is 400 mg (two 200 mg tablets) twice daily resulting in a daily dose of 800 mg.1 LIVTENCITY is intended for oral use only and can be taken with or without food.1
The primary efficacy endpoint was confirmed CMV viremia clearance (plasma CMV DNA concentration below the lower limit of quantification (
For the primary endpoint, LIVTENCITY was superior to IAT (56% vs. 24%, respectively, p<0.001). For the key secondary endpoint, 19% vs. 10% achieved both CMV viremia clearance and CMV infection symptom control in the LIVTENCITY and IAT group, respectively (p=0.013).1
Most common adverse reactions with LIVTENCITY were: taste disturbance (44.8%), nausea (8.5%), vomiting (7.7%), immunosuppressant drug concentration level increased (6.4%), diarrhea (3.8%), abdominal pain (2.1%), neutropenia (1.7%), acute kidney injury (1.7%), anemia (1.3%), and decreased appetite (1.3%).1
Serious adverse events (SAEs) occurred less frequently in the LIVTENCITY group than in the IAT group (5.1% and 14.7%, respectively).1
No patients in the LIVTENCITY group experienced serious, drug-related neutropenia or febrile neutropenia.1
CMV is a beta herpesvirus that commonly infects humans; serologic evidence of prior infection can be found in 40%-100% of various adult populations.3 CMV typically resides latent and asymptomatic in the body but may reactivate during periods of immunosuppression. Serious disease may occur in individuals with compromised immune systems, which includes patients
In transplant recipients, reactivation of CMV can lead to serious consequences including loss of the transplanted organ and, in extreme cases, can be fatal.10,11 Existing therapies to treat post-transplant CMV infections may demonstrate serious side effects that require dose adjustments or may fail to adequately suppress viral replication.12,13,14,15,16 Additionally, existing therapies may require or prolong hospitalization due to intravenous administration, side effect management and monitoring for adequate hydration.10
References
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1 | LIVTENCITY™ Product Monograph. |
2 | Maffini E, et al. Expert Rev Hematol. 2016;9:585-96; Stevens DR, et al. Transpl Infect Dis. 2015;17:163–73 |
3 | de la Hoz R. Diagnosis and treatment approaches to CMV infections in adult patients. J Clin Virol. 2002;25:S1-S12. |
4 | Azevedo L, Pierrotti L, Abdala E, et al. Cytomegalovirus infection in transplant recipients. Clinics. 2015;70(7):515-523. doi:10.6061/clinics/2015(07)09. |
5 | Razonable RR, Eid AJ. A Viral infections in transplant recipients. Minerva Med. 2009;100(6):23. |
6 | Shannon-Lowe & Emery. The effects of maribavir on the autophosphorylation of ganciclovir resistant mutants of the cytomegalovirus UL97 protein. Herpesviridae 2010, 1:4. |
7 | Styczynski J. |
8 | Azevedo L, Pierrotti L, Abdala E, et al. Cytomegalovirus infection in transplant recipients. Clinics. 2015;70(7):515-523. doi:10.6061/clinics/2015(07)09. |
9 | |
10 | de la Hoz R. Diagnosis and treatment approaches to CMV infections in adult patients. J Clin Virol. 2002;25:S1-S12. |
11 | Kenyon M, Babic A, eds. The European Blood and Marrow Transplantation Textbook for Nurses. |
12 | |
13 | Chemaly RF, Chou S, Einsele H, et al. Definitions of Resistant and Refractory Cytomegalovirus Infection and Disease in Transplant Recipients for Use in Clinical Trials. Clin Infect Dis. 2019;68(8):1420-1426. doi:10.1093/cid/ciy696. |
14 | Razonable RR, Eid AJ. A Viral infections in transplant recipients. Minerva Med. 2009;100(6):23. |
15 | Ljungman et al. Guidelines for the management of cytomegalovirus infection in patients with haematological malignancies and after stem cell transplantation from the 2017 |
16 | Razonable & Humar. Cytomegalovirus in solid organ transplant recipients— Guidelines of the |
* | Refers to acute kidney injury related to foscarnet and neutropenia related to valganciclovir/ganciclovir |
SOURCE
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