When to Check SVR After Completing Epclusa
Check HCV RNA at 12 weeks after completing Epclusa treatment to confirm sustained virologic response (SVR12), with routine confirmation recommended again at 48 weeks post-treatment. 1
Primary SVR Assessment Timeline
SVR12 is the standard endpoint: Measure HCV RNA at 12 weeks after completing direct-acting antiviral (DAA) therapy using a sensitive assay with a lower limit of detection <50 IU/mL (ideally ≤25 IU/mL). 1, 2
Undetectable HCV RNA at 12 weeks post-treatment confirms SVR and is considered tantamount to virologic cure, with less than 1% of patients relapsing after achieving SVR12 with modern DAA regimens. 1, 2
Additional Follow-Up Testing
Routine confirmation at 48 weeks post-treatment is recommended to ensure durability of response, though late relapse beyond SVR12 is extremely rare (<1%). 1, 2
Testing at 24 weeks post-treatment should be considered on an individual patient basis, particularly if there are concerns about adherence or other risk factors. 1
Routine testing beyond 48 weeks is not supported by available evidence unless the patient has ongoing risk factors for reinfection (people who inject drugs, men who have sex with men with ongoing high-risk behavior). 1, 2
Risk-Based Ongoing Surveillance
Annual HCV RNA testing is indicated for patients with persistent reinfection risk, including active injection drug use or ongoing high-risk sexual behavior. 2
For patients without ongoing risk factors and no cirrhosis, once SVR is confirmed at 12 weeks (and optionally at 48 weeks), they can be considered cured and discharged from HCV-specific follow-up. 2
Special Considerations for Cirrhotic Patients
Cirrhotic patients require indefinite hepatocellular carcinoma (HCC) surveillance with liver imaging (ultrasound ± alpha-fetoprotein) every 6 months, regardless of achieving SVR. 1, 2
Endoscopic surveillance for esophageal varices should continue at 2-3 year intervals in patients with cirrhosis who achieve SVR. 1, 2
HCV RNA surveillance alone is insufficient for cirrhotic patients—they need comprehensive monitoring for complications of cirrhosis even after viral cure. 2
Important Clinical Caveats
Do not use anti-HCV antibody testing to assess cure: Antibodies persist indefinitely regardless of cure status; only HCV RNA testing (qualitative or quantitative PCR) can distinguish active infection from resolved infection. 2
The transition from SVR24 to SVR12 as the primary endpoint occurred with DAA trials because relapse after 12 weeks is exceedingly rare—preliminary data showed 0 of 1850 patients relapsed between weeks 12 and 24 in ledipasvir/sofosbuvir studies. 1
SVR12 is nearly identical to SVR24 in predicting long-term cure, which is why SVR12 has become the accepted standard for treatment efficacy assessment. 1