Letermovir treatment for refractory or resistant cytomegalovirus infection or disease or with concurrent organ dysfunction: A phase 2 open label study
Bibliographic record
Abstract
Introduction: Refractory or resistant cytomegalovirus (CMV) infection and disease pose a significant challenge in immunocompromised patients, including solid organ transplant (SOT) and allogeneic hematopoietic cell transplant (allo-HCT) recipients. This study aimed to evaluate letermovir as a treatment for patients with CMV infection or disease. Methods: We performed an open-label, phase II non-randomized clinical trial. Adult and paediatric (≥12 years of age) patients who had undergone an SOT or allo-HCT and who required antiviral treatment for refractory or resistant CMV or who had CMV with concurrent organ dysfunction were eligible. Patients received letermovir treatment daily for up to 12 weeks with an optional additional 12 weeks of therapy for secondary prophylaxis if clinically indicated. The primary objectives were to evaluate the safety and efficacy of letermovir treatment based upon virological and clinical responses. Results: Ten patients were enrolled in the study, and seven patients completed the study treatment and follow-up period. The overall virological response (defined as a complete virological response at the end of the study period) rate was 60% in the study population. The study drug was well tolerated, as only two patients experienced study drug-related toxicity and only one grade 3 toxicity (elevated ALT) was observed. Letermovir was not associated with acute kidney injury, hepatotoxicity, cardiac arrhythmias, or bone marrow suppression. Conclusion: In this limited sample, letermovir for CMV treatment was safe and well tolerated. Further research is needed to determine if letermovir can be used for the treatment of refractory or resistant CMV infection or disease.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".