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Causality: well established
Causality assessment · Causality: well established
Nevirapine and Hepatotoxicity: 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.
Nevirapine ↔ Hepatotoxicity
n=170 co-reports · PRR 18.1 · ROR 18.4
Nevirapine carries a boxed warning for severe, sometimes fatal hepatotoxicity, especially in the first weeks of therapy and in patients with higher CD4 counts; 170 co-reports give PRR 18.1. The label requires a lead-in dose and frequent liver monitoring early on.
Regulatory basis: nevirapine (Viramune) prescribing information — boxed warning for hepatotoxicity; lead-in dosing and liver monitoring.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | First 18 weeks of therapy |
| Strength | met | PRR 18.1 with 170 co-reports |
| Consistency | met | Reproduced across cohorts |
| Specificity | met | Higher in defined risk groups |
| Biological gradient | not established | Not simply dose-related |
| Plausibility | met | Plausible immune-mediated injury |
| Coherence | met | Fits nevirapine hypersensitivity |
| Experiment | n/a | Too rare and severe for trial capture |
| Analogy | met | Analogous to other antiretroviral hepatotoxins |
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.
✓ Trial evidence found — HIV Protease Inhibitors for the Prevention of Malaria in Ugandan Children (NCT00978068)
| Adverse event | Group 1 (n=84) · Group 2 (n=86) | |
|---|---|---|
| Stevens-Johnson Syndrome | 0/84 | 1/86 |
Post-marketing signal terms appear in this trial's posted adverse-event tables; per-arm counts shown as affected/at-risk. View on ClinicalTrials.gov →