Monitoring guidance for initial treatment of HCV infection¹

To read the AASLD/IDSA guidelines on monitoring patients who are starting Hepatitis C treatment, are on treatment, or have completed therapy, click here.

Tests available for diagnosis and disease management

HCV tests for screening and diagnostic support

Testing for resistance-associated variants1,m The AASLD/IDSA guidelines recommend testing for the presence of RAVs prior to initiating therapy – NS5a RAVs can impact treatment response in regimens that include an NS5a inhibitor, mainly with genotype 1a and genotype 3 infections – RAV testing should be evaluated and performed on an individual basis as the extent of the impact on treatment response differs based on the combination of antivirals

HCV tests specific for resistance to direct-acting antiviral agents

Guidelines for monitoring response to treatment1,k HCV RNA should be measured after 4 weeks of therapy – Repeat at week 6 if detectable at week 4 – Treatment should be discontinued if viral load increases by >10-fold between weeks 4 and 6 HCV RNA testing should be repeated 12 and 24 weeks after completing treatment to test for sustained viral responsek

HCV tests for monitoring response to treatment

The AASLD/IDSA guidelines for pretreatment assessment recommend: the evaluation of advanced fibrosis (using liver biopsy, imaging, and/or noninvasive markers) for all persons with HCV infection. This will aid in making an appropriate decision regarding HCV treatment strategy and in determining the need for initiating additional measures for the management of cirrhosis (eg, hepatocellular carcinoma screening).1

Additional tests before and during treatment of HCV infection

Note: This guidance is not intended to substitute for the physicians learning, experience and knowledge of their patient, and their determination of how to monitor or treat their patient. Please refer to guidelines HCVGuidelines.org for further information or more detail regarding monitoring of HCV patients.

HBV reactivation can occur in HCV/HBV coinfected patients undergoing HCV DAA therapy. Thus, before initiating treatment with HCV DAAs, the FDA strongly advises that all patients be tested for evidence of current or prior HBV infection by measuring HBsAg and HBcAb.2 To learn more, click on the tests Quest has to offer: HBsAg with reflex confirmation HBcAb total

Once the decision to treat has been made, the HCV genotype is the primary virologic consideration in treatment selection and duration. Learn more by visiting the Hepatitis C: Screening and diagnosis page.

Hepatitis C treatment goals

Therapy for chronic HCV infection is geared toward eradicating viral infection and preventing complications such as hepatocellular carcinoma, cirrhosis, and liver failure.

Newer treatment options for HCV are designed to cause fewer side effects and be significantly more effective in terms of sustained virologic responses (SVRs).¹

Stay informed about the changing Hepatitis C landscape

Watch Laboratory Testing in the Treatment of Hepatitis C: New Drugs, New Tests, New Rules   View all Hepatitis C physician resources Expert Insight on Hepatitis C —Recent Advances in Diagnostics and Therapy   Contact a Quest Diagnostics sales representative Speak Hepatitis C is the #1 cause of liver transplants because of the liver damage it can cause.   Watch our webinar on the evaluation and management of HIV/HCV coinfection

AASLD=American Association for the Study of Liver Diseases; Ab=antibody; ALT=alanine aminotransferase; AST=aspartate aminotransferase; CBC=complete blood count; CDC=Centers for Disease Control and Prevention; DAAs=direct-acting antiviral agents; FDA=Food & Drug Administration; GFR=glomerular filtration rate; HBcAb=Hepatitis B core antibody; HBsAg=Hepatitis B surface antigen; IDSA=Infectious Diseases Society of America; INR=international normalized ratio; PCR=polymerase chain reaction; RAVs=resistance-associated variants; TSH=thyroid-stimulating hormone; USPSTF=U.S. Preventive Services Task Force.

aInitial treatment of HCV infection includes patients with chronic Hepatitis C who have not been previously treated with IFN, PEG-IFN, RBV, or any HCV DAA agent, whether experimental, investigational, or U.S. FDA approved.
^bWithin 12 weeks prior to treatment.
^cOr as clinically indicated.
^dThose receiving EBR/GZR-Zepatier.
^eIf interferon is used.
^fAntiviral drug therapy should NOT be interrupted or discontinued if HCV RNA levels are not performed or available during treatment. ^gWomen and male partners of women of childbearing age should be counseled not to become pregnant while receiving RBV-containing antiviral regimens, and for up to 6 months after stopping. Assessment of contraceptive use and of possible pregnancy is recommended at appropriate intervals during (and for 6 months after) RBV treatment for women of childbearing potential, and for female partners of men who receive RBV treatment.
^hIf HBsAg positive, HBV DNA should be tested prior to DAA therapy. Patients with low or undetectable HBV DNA levels should be monitored at regular intervals (usually not more frequently than every 4 weeks) for HBV reactivation with HBV DNA, and those patients with HBV DNA levels meeting treatment criteria should initiate HBV therapy. Information from hcvguidelines.org
ⁱEvaluation for other coinfections and conditions that may accelerate liver fibrosis.
^jIn patients suspected of Acute Hepatitis.
^kAnd after 6 months of completion of treatment.
^lTest codes may vary by location. Please contact your local laboratory or go to www.QuestDiagnostics.com/TestCenter for more information.
^mAccording to the AASLD and the IDSA.
ⁿReflex testing may be performed at an additional charge.
^oIf Hepatitis C Viral RNA, Quantitative, Real-Time PCR (35645) is positive, Hepatitis C Viral RNA, Genotype, LiPA^® (37811) will be performed at an additional charge. ^pPanel components can be ordered as a group panel or individually. Component test codes include: 7577, 7286, 234, 822, 823.
^q10256(F) for Teterboro.

References: 1. American Association for the Study of Liver Diseases, Infectious Diseases Society of America. Recommendations for testing, managing, and treating hepatitis C. http://hcvguidelines.org/sites/default/files/HCV-Guidance_April_2017_a.pdf . Accessed April 24, 2017. 2. Food & Drug Administration (FDA). FDA approved class labeling revisions regarding the risk of hepatitis B virus reactivation in patients coinfected with hepatitis C virus (HCV) and hepatitis B virus (HBV). https://content.govdelivery.com/accounts/USFDA/bulletins/18741e2. Accessed April 24, 2017.