Wednesday, March 29, 2017

Care of Patients Who Have Achieved a Sustained Virologic Response (SVR) Following Antiviral Therapy for Chronic Hepatitis C Infection

AGA Institute releases practice update for managing patients cured of HCV infection
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.
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Updated
May 2017
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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

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Gastroenterology
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AGA Institute Clinical Practice Update: Care of Patients Who Have Achieved a Sustained Virologic Response (SVR) Following Antiviral Therapy for Chronic Hepatitis C Infection
Ira M. Jacobson M.D., Joseph K. Lim, M.D., and Michael W. Fried, M.D.

ACCEPTED MANUSCRIPT
DOI: http://dx.doi.org/10.1053/j.gastro.2017.03.018

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Abstract
Chronic hepatitis C virus (HCV) infection is well-recognized as a common blood borne infection with global public health impact, affecting 3 to 5 million persons in the U.S. and over 170 million persons worldwide. Chronic HCV infection is associated with significant morbidity and mortality due to complications of liver cirrhosis and hepatocellular carcinoma (HCC). Current therapies with all-oral directly acting antiviral agents (DAAs) are associated with high rates of sustained virologic response (SVR), generally exceeding 90%. SVR is associated with a reduced risk of liver cirrhosis, hepatic decompensation, need for liver transplantation, and both liver-related and all-cause mortality. However, a subset of patients who achieve SVR will remain at long-term risk for progression to cirrhosis, liver failure, HCC, and liver-related mortality. 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. In this clinical practice update, available evidence and expert opinion are used to generate best practice recommendations on the care of patients with chronic HCV who have achieved SVR.

Index
Assessment of HCV RNA after SVR12 has been attained
With the initiation of trials of DAA regimens, initially in combination with interferon and later
without it, the attainment of SVR 12 weeks after completion of treatment replaced SVR24 as
the primary endpoint, defined as undetectable HCV RNA on a highly sensitive PCR assay (lower
limit of detection <12 IU/mL).  This transition was based upon the rarity of relapse after follow
up week 12, and it helped move the field ahead by shortening the intervals between successive
trials in development programs (22). It has become apparent that late relapse beyond this time
point is no more common, and perhaps less so, than it was after interferon-based therapy

Ongoing surveillance for hepatocellular carcinoma after SVR
Is HCC risk after SVR exclusive to patients with advanced fibrosis and cirrhosis?
Can HCC surveillance ever be discontinued?
How should screening for, and management of, varices be affected by SVR?
Should patients be routinely monitored for regression of advanced fibrosis or
cirrhosis?

Recurrent HCC After SVR
Reinfection
Lifestyle Measures
Conclusions
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