The American Gastroenterological Association (AGA) Institute released a practice update on managing patients with chronic hepatitis C virus (HCV) infection who have attained a sustained virologic response (SVR) after antiviral treatment. The clinical practice update was published in Gastroenterology.
Direct-acting antiviral (DAA) regimens for chronic HCV infection achieve high rates of SVR and have replaced interferon (IFN) in many countries. The current definition of SVR is undetectability of HCV RNA at 12 weeks after treatment (SVR12). Patients who achieve an SVR have a less than 1% risk of relapse and are considered cured.
Patients cured of HCV may experience reductions in the risk for death and hepatocellular carcinoma (HCC), as well as regression of liver changes including fibrosis or cirrhosis, but may still have higher rates of HCV-related complications than the general population. Patients who have already developed liver damage at the time of achieving SVR may be particularly at risk for future complications.
“With the marked increase in number of patients who achieve SVR with present DAA regimens for hepatitis C, there is a need to promote a broad-based understanding among clinicians regarding which patients can be discharged from further HCV-related care, the criteria that define a need for ongoing management, and the elements and duration of that management,” wrote the authors of the clinical practice update.
The clinical practice update offers best practice advice on monitoring HCV RNA after an SVR, HCC surveillance, and screening for and management of varices based on the available evidence. It also discusses reinfection risk and lifestyle interventions.
Once SVR12 (SVR for 12 weeks or longer) has been confirmed, HCV RNA levels should be obtained at 48 weeks or beyond to monitor for late virologic relapse. Whether or not HCV RNA should be checked at 24 weeks after treatment or intermittently after 48 weeks should be based on the patient’s individual risk for reinfection.
Patients with fibrosis or liver cirrhosis classified as stage 3 or higher should be monitored for HCC using liver imaging, with or without serum α-feto-protein (AFP), twice a year. Whether or not HCC screening can eventually be discontinued in this patient population is unclear, and for that reason the guideline authors recommend indefinite HCC screening. On the other hand, patients with less severe liver fibrosis (stage 0 to 2) do not need to undergo HCC surveillance.
The authors also recommend initial endoscopic screening for esophagogastric varices in all patients with liver cirrhosis, even patients who have attained an SVR. Patients with cirrhosis who exhibit no or small varices on initial testing should undergo repeat endoscopy 2 to 3 years after achieving an SVR.
Patients who have attained virologic cure should also be educated on risk factors for liver injury, such as alcohol use, in order to prevent worsening of liver fibrosis.
“Most of the published evidence and experience about long-term outcomes after SVR are derived from studies of IFN-based therapy. It is appropriate at present to formulate recommendations based on that experience, but we expect and encourage large long-term studies of outcomes after IFN-free DAA therapy, which will further refine our concepts of appropriate management and, like the guidelines governing antiviral treatment itself, should lead to dynamic reassessment of the best practices for management of patients post-SVR in the years ahead,” the authors wrote.
The researchers report financial relationships with AbbVie, Bristol-Myers Squibb, Gilead, Intercept, Janssen, Merck, Trek, and TARGET PharmaSolutions.
Jacobson IM, Lim JK, Fried MW. American Gastroenterological Association Institute clinical practice update-expert review: care of patients who have achieved a sustained virologic response after antiviral therapy for chronic hepatitis C infection. [published online March 23, 2017]. Gastroenterology. doi:10.1053/j.gastro.2017.03.018