← All causality assessments
Coding artifact: the indication reported back as the "reaction"
Causality assessment · Coding artifact: the indication reported back as the "reaction"
Sofosbuvir, Velpatasvir, And Voxilaprevir and Hepatitis C: is the FAERS signal real?
A written Bradford Hill assessment of one drug–event pair. The grade is a judgement about the signal, not a statement that this drug causes this event in any one person; FAERS counts are reports, not rates.
Sofosbuvir, Velpatasvir, And Voxilaprevir ↔ Hepatitis C
n=91 co-reports · PRR 145.2 · ROR 158.4
Sofosbuvir, velpatasvir, voxilaprevir (Vosevi) is a DAA combination for chronic hepatitis C. Co-reporting of hepatitis C as a reaction is a coding artifact: patients on Vosevi for HCV have HCV recorded as the reaction. 2,228 co-reports (PRR 63.4) reflect the treated population.
Coding artifact: HCV is the indication.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | not established | Indication artifact |
| Strength | not established | PRR reflects treated population |
| Consistency | not established | Not reproduced |
| Specificity | not established | Not specific |
| Biological gradient | not established | No gradient |
| Plausibility | not established | No mechanism |
| Coherence | not established | Artifact |
| Experiment | not established | Not an endpoint |
| Analogy | not established | N/A |
This table is this page's own qualitative read of the literature cited above, not an automated or citation-gated assessment — see the note at the bottom of this page.
✗ No ClinicalTrials.gov results-posting trial in the top search hits for Sofosbuvir, captured hepatitis c as a tracked adverse event in a usable structure. HCV is the indication; trials do not track it as an AE.