A 45-year-old man with chronic hepatitis C genotype 1b is started on direct-acting antiviral therapy with sofosbuvir-ledipasvir for 12 weeks. The primary efficacy endpoint at 12 weeks post-treatment completion is:
- A HCV RNA reduction of >2 log10 at week 4 (rapid virological response)
- B Sustained virological response at 12 weeks (SVR12) — undetectable HCV RNA ✓
- C Normalisation of serum ALT and AST levels
- D Loss of HCV core antigen from serum
Explanation
SVR12 (undetectable HCV RNA 12 weeks after completing antiviral therapy) is the primary virological cure endpoint for hepatitis C treatment, equivalent to a biological cure in >99% of cases. SVR reduces hepatic fibrosis progression, liver-related mortality, and extra-hepatic manifestations. Normalisation of transaminases may accompany SVR but is not the primary efficacy endpoint.
Reference: Harrison's Principles of Internal Medicine, 21st ed.
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