Human cytomegalovirus and transplantation: drug development and regulatory issues
Cytomegalovirus (CMV) infection is highly prevalent worldwide and can cause serious disease among immunocompromised individuals, including persons with HIV and transplant recipients on immunosuppressive therapies. It can also result in congenital cytomegalovirus when women are infected during pregna...
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| Format: | Article |
| Language: | English |
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Elsevier
2016-07-01
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| Series: | Journal of Virus Eradication |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S205566402030457X |
| _version_ | 1818848774953369600 |
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| author | Megan McIntosh Benjamin Hauschild Veronica Miller |
| author_facet | Megan McIntosh Benjamin Hauschild Veronica Miller |
| author_sort | Megan McIntosh |
| collection | DOAJ |
| description | Cytomegalovirus (CMV) infection is highly prevalent worldwide and can cause serious disease among immunocompromised individuals, including persons with HIV and transplant recipients on immunosuppressive therapies. It can also result in congenital cytomegalovirus when women are infected during pregnancy. Treatment and prevention of CMV in solid organ and haematopoietic stem cell transplant recipients is accomplished in one of three ways: (1) prophylactic therapy to prevent CMV viraemia; (2) pre-emptive therapy for those with low levels of replicating virus; and (3) treatment for established disease. Despite the high prevalence of CMV, there are few available approved drug therapies, and those that are available are hampered by toxicity and less-than-optimal efficacy. New therapies are being developed and tested; however, inconsistency in standardisation of virus levels and questions about potential endpoints in clinical trials present regulatory hurdles that must be addressed. This review covers the current state of CMV therapy, drugs currently under investigation, and clinical trial issues and questions that are in need of resolution. |
| first_indexed | 2024-12-19T06:22:42Z |
| format | Article |
| id | doaj.art-d8815bc90b144d43979938276a6f92d4 |
| institution | Directory Open Access Journal |
| issn | 2055-6640 |
| language | English |
| last_indexed | 2024-12-19T06:22:42Z |
| publishDate | 2016-07-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Journal of Virus Eradication |
| spelling | doaj.art-d8815bc90b144d43979938276a6f92d42022-12-21T20:32:39ZengElsevierJournal of Virus Eradication2055-66402016-07-0123143148Human cytomegalovirus and transplantation: drug development and regulatory issuesMegan McIntosh0Benjamin Hauschild1Veronica Miller2Forum for Collaborative HIV Research, University of California Berkeley, School of Public Health, Washington DC, USAForum for Collaborative HIV Research, University of California Berkeley, School of Public Health, Washington DC, USACorresponding author: Veronica Miller, Forum for Collaborative HIV Research, 1608 Rhode Island Avenue NW, Suite 212, Washington DC, 20036, USA; Forum for Collaborative HIV Research, University of California Berkeley, School of Public Health, Washington DC, USACytomegalovirus (CMV) infection is highly prevalent worldwide and can cause serious disease among immunocompromised individuals, including persons with HIV and transplant recipients on immunosuppressive therapies. It can also result in congenital cytomegalovirus when women are infected during pregnancy. Treatment and prevention of CMV in solid organ and haematopoietic stem cell transplant recipients is accomplished in one of three ways: (1) prophylactic therapy to prevent CMV viraemia; (2) pre-emptive therapy for those with low levels of replicating virus; and (3) treatment for established disease. Despite the high prevalence of CMV, there are few available approved drug therapies, and those that are available are hampered by toxicity and less-than-optimal efficacy. New therapies are being developed and tested; however, inconsistency in standardisation of virus levels and questions about potential endpoints in clinical trials present regulatory hurdles that must be addressed. This review covers the current state of CMV therapy, drugs currently under investigation, and clinical trial issues and questions that are in need of resolution.http://www.sciencedirect.com/science/article/pii/S205566402030457XCytomegalovirusCMVregulatory sciencedrug development |
| spellingShingle | Megan McIntosh Benjamin Hauschild Veronica Miller Human cytomegalovirus and transplantation: drug development and regulatory issues Journal of Virus Eradication Cytomegalovirus CMV regulatory science drug development |
| title | Human cytomegalovirus and transplantation: drug development and regulatory issues |
| title_full | Human cytomegalovirus and transplantation: drug development and regulatory issues |
| title_fullStr | Human cytomegalovirus and transplantation: drug development and regulatory issues |
| title_full_unstemmed | Human cytomegalovirus and transplantation: drug development and regulatory issues |
| title_short | Human cytomegalovirus and transplantation: drug development and regulatory issues |
| title_sort | human cytomegalovirus and transplantation drug development and regulatory issues |
| topic | Cytomegalovirus CMV regulatory science drug development |
| url | http://www.sciencedirect.com/science/article/pii/S205566402030457X |
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