Hepatitis C Treatment With Generic Sofosbuvir‐Based Regimens in Patients Undergoing Hemodialysis
Bibliographic record
Abstract
OBJECTIVES: To assess the efficacy and safety of locally manufactured generic sofosbuvir-based direct-acting antivirals in the treatment of Hepatitis C virus (HCV) infected patients on maintenance hemodialysis. PATIENTS AND METHODS: We have conducted a retrospective multicenter study including patients on maintenance hemodialysis, treated with sofosbuvir-based regimens between 01/01/2017 and 09/30/2021. Patients were treated for 12 or 24 weeks, with sofosbuvir 400 mg + ledipasvir 90 mg 3 times/week, or sofosbuvir 3 times/week + daclatasvir 60 mg/d, or sofosbuvir + daclatasvir in coformulation, 3 times/week. Sustained virological response was defined as a negative HCV RNA test 12 weeks after treatment. The occurrence of serious adverse events during treatment defines intolerance to treatment. Statistical analysis was performed using SPSS software (version 25). RESULTS: A total of 120 patients were treated; the mean age was 50 ± 14.17 years [18-78], 50% were men. Twenty-two patients (n = 22; 18.3%) were previously treated with pegylated Interferon. Genotype 1 was predominant (n = 68; 82%). Most of the patients (n = 53; 44.2%) had no significant fibrosis, and 24 (20%) had cirrhosis. The SVR rate was 93.3% (CI 95% [88.8; 97.8]) (n = 112), the serious adverse events rate was 10.8% (CI 95% [0.054-0.166]) (n = 13), including 2 deaths unrelated to direct-acting antivirals. Early treatment discontinuation occurred in 5.8% (n = 7), and a relapse in 0.8% (n = 1). On multivariate analysis, risk factors for serious adverse events included advanced liver fibrosis, thrombocytopenia, hypoalbuminemia, high bilirubin level, and pre-treatment status. CONCLUSION: Locally manufactured generic sofosbuvir-based regimens are safe and effective in maintenance hemodialysis patients. However, they should be closely monitored to manage comorbidities and complications during treatment.
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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 | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
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".