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The advent of all-oral directly acting antiviral agents (DAAs) has led to high rates of sustained virologic response (SVR), generally exceeding 90%, in patients with the hepatitis C virus (HCV).1 Although SVR is associated with positive outcomes, including reduced risk of liver cirrhosis, hepatic decompensation, need for liver transplantation, and liver-related and all-cause mortality, a subset of patients who achieve SVR nevertheless continue to remain at long-term risk for progression to these conditions.
“With the increasingly frequent opportunity to celebrate virologic cure with patients comes the corresponding need to advise them about whether, when, and for how long ongoing care for liver disease is needed,” according to Jacobson et al, authors of a recent clinical practice update on caring for patients with chronic HCV who have achieved SVR.1 “Thus, it is critical to identify the ongoing risks for the individual patient and the measures needed to mitigate those risks.”
The authors caution that “limited evidence is available to guide clinicians on which post-SVR patients should be monitored versus discharged, how to monitor and with which tests, how frequently should monitoring occur, and for how long.” The clinical practice update is intended to provide this guidance.
Achievement of SVR
Best Practice 1
SVR should be confirmed by undetectable HCV RNA at 12 weeks following completion of an all-oral DAA treatment regimen
Best Practice 2
Routine confirmation of SVR at 48 weeks post end of treatment is recommended. Testing for HCV RNA at 24 weeks post treatment should be considered on an individual patient basis.
Best Practice 3
Routine testing for HCV RNA beyond 48 weeks following end of treatment to evaluate for late virologic relapse is not supported by available evidence; periodic testing for HCV RNA is recommended for patients with ongoing risk factors.
The attainment of SVR 12 weeks after treatment completion has now replaced SVR 24 as the primary endpoint. According to the American Association for the Study of Liver Disease/Infectious Disease Society of America (AASLD/IDSA)’s 2016 Guidance document,2 patients do not require another HCV RNA determination after SVR12 and can be dismissed from ongoing follow-up if they had Metavir F0-F2 fibrosis before treatment. However, recent data indicate that late relapse can occur, even in the absence of de novo infection. For this reason, many clinicians prefer to obtain another HCV RNA assay at follow-up week 24 and/or follow-up week 48. “There is no evidence at present that any particular viral genotype or patient type is more prone to this rare phenomenon,” the authors note.
