How do you know if hepatitis C is cured

How to Determine if Hepatitis C is Cured

Hepatitis C is considered cured when a patient achieves a sustained virologic response (SVR), defined as undetectable HCV RNA 12 weeks or more after completing treatment.

Definition of Cure

SVR is the primary endpoint used to determine if hepatitis C treatment has been successful:

• SVR12: Undetectable HCV RNA at 12 weeks post-treatment 1
• SVR24: Undetectable HCV RNA at 24 weeks post-treatment 1

Both SVR12 and SVR24 are accepted as evidence of cure, with SVR12 now being the standard in clinical practice due to its high concordance with SVR24.

Testing Protocol to Confirm Cure

Standard Testing Approach:

1. Post-treatment HCV RNA testing:

   • Perform quantitative HCV RNA testing at 12 weeks after completing treatment 1
   • Use a sensitive molecular method with a lower limit of detection <15 IU/ml 1

2. Alternative testing method:

   • HCV core antigen testing can be used as an alternative to HCV RNA testing in settings where RNA testing is unavailable or unaffordable 1
   • In resource-limited settings, a qualitative assay with a lower limit of detection <1,000 IU/ml can be used 1

Interpretation of Results

• Cured: HCV RNA undetectable (<15 IU/ml) at 12 weeks post-treatment
• Not cured/Relapse: Detectable HCV RNA at 12 weeks post-treatment

Reliability of SVR12 as Indicator of Cure

The concordance between SVR12 and SVR24 is extremely high:

• Studies show >99% positive predictive value of SVR12 for SVR24 2
• The negative predictive value is 100%, meaning if a patient doesn't achieve SVR12, they won't achieve SVR24 either 2
• Recent research with modern direct-acting antivirals shows that SVR is durable in >99% of patients 2, 3

Additional Considerations

For Patients with Cirrhosis

• Even after achieving SVR, patients with cirrhosis should continue surveillance for hepatocellular carcinoma (HCC) 1
• SVR significantly reduces but does not eliminate the risk of HCC in cirrhotic patients 1

For Patients at Risk of Reinfection

• Patients with ongoing risk factors (injection drug use, high-risk sexual practices) should be monitored periodically for potential reinfection 1

For Patients with Abnormal Liver Tests After SVR

• If liver enzymes remain elevated after achieving SVR, assessment for other causes of liver disease is recommended 1

Newer Research on Earlier Detection of Cure

Recent research suggests that SVR4 (4 weeks post-treatment) may also be highly predictive of SVR12:

• For patients treated with fixed-dose pangenotypic direct-acting antivirals, SVR4 has a positive predictive value of 99.8% for SVR12 4
• However, current guidelines still recommend testing at 12 weeks post-treatment as the standard approach

What Happens After Cure?

After achieving SVR:

• Liver inflammation typically resolves
• Fibrosis may regress in non-cirrhotic patients
• Risk of liver-related complications decreases significantly
• HCV antibodies usually persist despite viral clearance, but may decline and eventually disappear in some individuals 1

Remember that while HCV antibody tests will typically remain positive after cure, it's the absence of viral RNA that confirms successful treatment.