From the Guidelines
The 12-week waiting period after completing Epclusa (sofosbuvir/velpatasvir) treatment for hepatitis C is the standard timeframe to check for sustained virologic response (SVR) because it allows sufficient time for viral clearance and confirms that the virus has not rebounded after treatment cessation, with a cure rate of over 99% certainty, as supported by the most recent and highest quality study 1. The SVR is tested at this point because it represents the most reliable indicator of cure. When a patient achieves SVR12 (undetectable HCV RNA 12 weeks after treatment completion), they are considered cured. This timeframe has been established through clinical trials showing that viral relapse, if it occurs, typically happens within the first 12 weeks after treatment. Some key points to consider include:
- The test involves a simple blood draw to measure HCV RNA levels, and no special preparation is needed.
- Patients should continue regular follow-up with their healthcare provider even after achieving SVR, especially if they have cirrhosis or other liver complications.
- The 12-week mark represents the optimal balance between providing timely confirmation of cure while ensuring the result is definitive, as stated in the EASL recommendations on treatment of hepatitis C 1.
- Clinical trials have shown high SVR12 rates with sofosbuvir and velpatasvir treatment, including a 98% SVR12 rate in patients with HCV genotype 1 infection and a 99% SVR12 rate in patients with HCV genotype 2 infection 1.
- The American Gastroenterological Association also supports the use of SVR12 as a reliable indicator of cure, with fewer than 1% of patients relapsing after SVR 1.
From the Research
Rationale for Waiting 12 Weeks After Hepatitis C Treatment
- The primary reason for waiting 12 weeks after hepatitis C treatment with Epclusa to check for Sustained Virological Response (SVR) is based on the high concordance of SVR12 with SVR24, as demonstrated in several studies 2, 3.
- SVR12 has been shown to be a reliable predictor of SVR24, with high positive and negative predictive values, indicating that the virus is unlikely to recur after 12 weeks 2.
- The use of SVR12 as a primary endpoint in clinical trials has been supported by studies demonstrating its high concordance with SVR24, allowing for earlier assessment of treatment efficacy 2, 3.
- In patients treated with sofosbuvir-velpatasvir, SVR12 rates have been consistently high, ranging from 95% to 100%, depending on the patient population and genotype 4, 5, 6.
- The 12-week follow-up period is also supported by the fact that most relapses occur within the first 12 weeks after treatment, and the risk of relapse decreases significantly after this period 2, 3.