IDDF2019-ABS-0134 Sofosbuvir/velpatasvir is effective and safe in patients with concomitant proton pump inhibitor use in clinical studies
Bibliographic record
Abstract
Background Prior to the availability of Phase 1 drug interaction data, concomitant proton pump inhibitor (PPI) use was prohibited in clinical trials of sofosbuvir/velpatasvir (SOF/VEL). Later clinical studies allowed for the use of up to 20 mg omeprazole or equivalent dosing. This analysis evaluated the efficacy and safety of patients with and without compensated cirrhosis who received SOF/VEL for 12 weeks and reported concomitant use of a PPI. Methods This was a retrospective analysis from 12 Phase 2 and Phase 3 clinical studies in which patients of all genotypes with and without compensated cirrhosis received 12 weeks of SOF/VEL and reported concomitant use of a PPI. Efficacy was assessed by SVR12 and relapse rates and safety was assessed by treatment-emergent adverse events (AEs). Results 87 patients reported concomitant use of a PPI. The mean age (range) was 57 years (26–78), 79% were male and 75% white; 56% of patients were infected with genotype 3 and 29% with genotype 1; 37% of patients had compensated cirrhosis and 39% were treatment experienced. The most common PPI was omeprazole reported by 68% of patients. The SVR12 rate was 97% (84 of 87 patients). Of the 3 patients who did not achieve SVR12, 2 patients relapsed (relapse rate 2%) and one patient with a history of diabetes discontinued SOF/VEL after 7 days of dosing due to hyperglycemia. No other patient had an AE which led to discontinuation or interruption of SOF/VEL. 78% of patients had an AE, most of which were mild, and 11% had a serious AE. These efficacy and safety are comparable to patients enrolled in the same studies who received SOF/VEL for 12 weeks without concomitant use of a PPI (SVR12 rate 97% [2445 of 2517 patients]; relapse rate 2% [40 of 2488 patients]). Conclusions In Phase 2 and Phase 3 clinical studies, the single-tablet regimen of SOF/VEL for 12 weeks was effective and safe in patients with concomitant PPI use. These data support the use of SOF/VEL according to labeled recommendations with respect to co-administration of PPIs and other acid reducing agents.
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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 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| 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".