Randomized Controlled Trials to Define Viral Load Thresholds for Cytomegalovirus Pre-Emptive Therapy
| Autor: | Griffiths, Paul D., Rothwell, Emily, Raza, Mohammed, Wilmore, Stephanie, Doyle, Tomas, Harber, Mark, O’Beirne, James, Mackinnon, Stephen, Jones, Gareth, Thorburn, Douglas, Mattes, Frank, Nebbia, Gaia, Atabani, Sowsan, Smith, Colette, Stanton, Anna, Emery, Vincent C. |
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| Rok vydání: | 2016 |
| Předmět: |
Viral Diseases
Drug Research and Development Physiology Immunology lcsh:Medicine Artificial Gene Amplification and Extension Microbial Genomics Research and Analysis Methods Microbiology Polymerase Chain Reaction Antiviral Therapy Virology Genetics Medicine and Health Sciences Clinical Trials Public and Occupational Health Viremia Molecular Biology Techniques lcsh:Science Molecular Biology Pharmacology Viral Genomics lcsh:R Biology and Life Sciences Computational Biology Correction Genomics Hematology Viral Load Comparative Genomics Vaccination and Immunization Randomized Controlled Trials Body Fluids Infectious Diseases Blood lcsh:Q Preventive Medicine Clinical Medicine Anatomy Viral Transmission and Infection Research Article |
| Zdroj: | PLoS ONE PLoS ONE, Vol 11, Iss 9, p e0163722 (2016) |
| ISSN: | 1932-6203 |
| Popis: | Background To help decide when to start and when to stop pre-emptive therapy for cytomegalovirus infection, we conducted two open-label randomized controlled trials in renal, liver and bone marrow transplant recipients in a single centre where pre-emptive therapy is indicated if viraemia exceeds 3000 genomes/ml (2520 IU/ml) of whole blood. Methods Patients with two consecutive viraemia episodes each below 3000 genomes/ml were randomized to continue monitoring or to immediate treatment (Part A). A separate group of patients with viral load greater than 3000 genomes/ml was randomized to stop pre-emptive therapy when two consecutive levels less than 200 genomes/ml (168 IU/ml) or less than 3000 genomes/ml were obtained (Part B). For both parts, the primary endpoint was the occurrence of a separate episode of viraemia requiring treatment because it was greater than 3000 genomes/ml. Results In Part A, the primary endpoint was not significantly different between the two arms; 18/32 (56%) in the monitor arm had viraemia greater than 3000 genomes/ml compared to 10/27 (37%) in the immediate treatment arm (p = 0.193). However, the time to developing an episode of viraemia greater than 3000 genomes/ml was significantly delayed among those randomized to immediate treatment (p = 0.022). In Part B, the primary endpoint was not significantly different between the two arms; 19/55 (35%) in the less than 200 genomes/ml arm subsequently had viraemia greater than 3000 genomes/ml compared to 23/51 (45%) among those randomized to stop treatment in the less than 3000 genomes/ml arm (p = 0.322). However, the duration of antiviral treatment was significantly shorter (p = 0.0012) in those randomized to stop treatment when viraemia was less than 3000 genomes/ml. Discussion The results illustrate that patients have continuing risks for CMV infection with limited time available for intervention. We see no need to alter current rules for stopping or starting pre-emptive therapy. |
| Databáze: | OpenAIRE |
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