← All causality assessments
Coding artifact: the indication reported back as the "reaction"
Causality assessment · Coding artifact: the indication reported back as the "reaction"
Sofosbuvir 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 ↔ Hepatitis C
n=1,736 co-reports · PRR 177.3 · ROR 194.4
Sofosbuvir is a direct-acting antiviral (NS5B polymerase inhibitor) for chronic hepatitis C. Co-reporting of hepatitis C as a reaction is a coding artifact: patients on sofosbuvir for HCV have HCV recorded as the reaction. 5,678 co-reports (PRR 96.3) reflect the treated population.
Coding artifact: HCV is the therapeutic indication for sofosbuvir.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | not established | Indication artifact |
| Strength | not established | PRR reflects treated population |
| Consistency | not established | Not reproduced outside treatment cohorts |
| Specificity | not established | Not specific |
| Biological gradient | not established | No gradient |
| Plausibility | not established | No mechanism |
| Coherence | not established | Coherent only as artifact |
| Experiment | not established | Not a trial endpoint |
| Analogy | not established | Not applicable |
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 viral hepatitis as an AE.