Monitoring Box. Summary of the Recommendations for Monitoring Patients Who Are Starting HCV Treatment, Are On Treatment, Or Have Completed Therapy

Summary of the Recommendations for Monitoring Patients Who Are Starting HCV Treatment, Are on Treatment, or Have Completed Therapy

 

Recommended Assessments Prior to Starting Antiviral Therapy

  • Staging of hepatic fibrosis is essential prior to HCV treatment (see Testing and Linkage to Careand see When and in Whom to Treat).
  • Assessment of potential drug-drug interactions with concomitant medications is recommended prior to starting antiviral therapy.
    • Patients should also be educated on the proper administration of medications (eg, dose, frequency of medicines, food effect, missed doses, adverse effects, etc), the crucial importance of adherence, and the necessity for close supervision and blood tests during and after treatment.

The following laboratory tests are recommended within 12 weeks prior to starting antiviral therapy:

  • Complete blood count (CBC); international normalized ratio (INR)
  • Hepatic function panel (albumin, total and direct bilirubin, alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase levels)
  • Calculated glomerular filtration rate (GFR)
  • Thyroid-stimulating hormone (TSH) if IFN is used

The following laboratory testing is recommended at any time prior to starting antiviral therapy:

  • HCV genotype and subtype
  • Quantitative HCV RNA (HCV viral load)

Rating for all statements above: Class I, Level C

 

  • Patients scheduled to receive an HCV NS3 protease inhibitor (paritaprevir, simeprevir, grazoprevir) should be assessed for a history of decompensated liver disease and for severity of liver disease using CTP score. Patients with current or prior history of decompensated liver disease or with a current CTP score of 7 or greater should NOT receive treatment with regimens that contain NS3 protease inhibitors due to increased area under the curve (AUC) and/or lack of safety data. Similarly, patients with a CTP score of 5 or 6, who cannot be closely monitored for laboratory or clinical symptoms during treatment, should not receive treatment with a regimen that contains paritaprevir/ritonavir.
    Rating: Class I, Level A
  • All patients initiating HCV DAA therapy should be assessed for HBV coinfection with HBsAg, anti-HBs, and anti-HBc.
    Rating: Class IIa, Level B
  • Testing for the presence of resistance-associated substitutions (RASs) prior to starting treatment should be performed as recommended in the Initial Treatment and the Retreatment Sections.
    Rating: Class IIb, Level B

     

Recommended Monitoring During Antiviral Therapy

  • Clinic visits or telephone contact are recommended as clinically indicated during treatment to ensure medication adherence and to monitor for adverse events and potential drug-drug interactions with newly prescribed medications.
  • Complete blood count (CBC), creatinine level, calculated glomerular filtration rate (GFR), and hepatic function panel are recommended after 4 weeks of treatment and as clinically indicated. Thyroid-stimulating hormone (TSH) is recommended every 12 weeks for patients receiving IFN. More frequent assessment for drug-related toxic effects (eg, CBC for patients receiving ribavirin) is recommended as clinically indicated. Patients receiving elbasvir/grazoprevir should be monitored with hepatic function panel at 8 weeks (and again at 12 weeks if receiving 16 weeks of treatment).
  • A 10-fold increase in alanine aminotransferase (ALT) activity at week 4 should prompt discontinuation of therapy. Any increase in ALT of less than 10-fold at week 4 and accompanied by any weakness, nausea, vomiting, jaundice, or significantly increased bilirubin, alkaline phosphatase, or international normalized ratio, should also prompt discontinuation of therapy. Asymptomatic increases in ALT of less than 10-fold elevated at week 4 should be closely monitored and repeated at week 6 and week 8. If levels remain persistently elevated, consideration should be given to discontinuation of therapy.

Rating: Class I, Level B

  • Quantitative HCV viral load testing is recommended after 4 weeks of therapy and at 12 weeks following completion of therapy. Antiviral drug therapy should NOT be interrupted or discontinued if HCV RNA levels are not performed or available during treatment.
  • Quantitative HCV viral load testing can be considered at the end of treatment and 24 weeks or longer following the completion of therapy.

Rating: Class I, Level B

 

 

  • Patients with compensated cirrhosis who are receiving paritaprevir/ritonavir-based regimens should be assessed for clinical signs of decompensated liver disease (eg, ascites, encephalopathy) and for biochemical evidence of liver injury with a hepatic function panel at week 2 and week 4 of treatment, and as needed during the remainder of treatment. Paritaprevir/ritonavir-based regimens should be discontinued if patients develop ascites or encephalopathy or a significant increase in direct bilirubin or ALT or AST.
    Rating: Class I, Level A
  • For HBsAg+ patients who are not already on HBV suppressive therapy, monitoring of HBV DNA levels during and immediately after DAA therapy for HCV is recommended and antiviral treatment for HBV should be given if treatment criteria for HBV are met.
    Rating: Class IIa, Level B

 

For decompensated cirrhosis, please refer to the appropriate section.

 

Recommendations for Discontinuation of Treatment Because of Lack of Efficacy

  • If HCV RNA is detectable at week 4 of treatment, repeat quantitative HCV RNA viral load testing is recommended after 2 additional weeks of treatment (treatment week 6). If quantitative HCV viral load has increased by greater than 10-fold (>1 log10 IU/mL) on repeat testing at week 6 (or thereafter), then discontinuation of HCV treatment is recommended.
  • The significance of a positive HCV RNA test result at week 4 that remains positive, but lower, at week 6 or week 8 is unknown. No recommendation to stop therapy or extend therapy can be provided at this time.

Rating: Class III, Level C

 

Recommended Monitoring for Pregnancy-related Issues Prior to and During Antiviral Therapy that Includes Ribavirin

  • Women of childbearing age should be counseled not to become pregnant while receiving ribavirin-containing antiviral regimens, and for up to 6 months after stopping.
  • Male partners of women of childbearing age should be cautioned to prevent pregnancy while they are receiving ribavirin-containing antiviral regimens, and for up to 6 months after stopping.

Rating: Class I, Level C

  • Serum pregnancy testing is recommended for women of childbearing age prior to beginning treatment with a regimen that includes ribavirin.
  • Since the safety of DAA regimens that do not include ribavirin has not been established during pregnancy, counseling and serum pregnancy testing should be offered to women of childbearing age before beginning HCV treatment.

Rating: Class I, Level C

  • Assessment of contraceptive use and of possible pregnancy is recommended at appropriate intervals during (and for 6 months after) ribavirin treatment for women of childbearing potential, and for female partners of men who receive ribavirin treatment.
    Rating: Class I, Level C 

Recommended Monitoring for Patients in Whom Treatment Failed to Achieve a Sustained Virologic Response

  • Disease progression assessment every 6 months to 12 months with a hepatic function panel, complete blood count (CBC), and international normalized ratio (INR) is recommended.
    Rating: Class I, Level C
  • Screening for hepatocellular carcinoma with ultrasound examination every 6 months is recommended for patients with advanced fibrosis (ie, Metavir stage F3 or F4).
    Rating: Class I, Level C
  • Endoscopic screening for esophageal varices is recommended if cirrhosis is present.
    Rating: Class I, Level A
  • Evaluation for retreatment is recommended as effective alternative treatments become available.
    Rating: Class I, Level C

 

For decompensated cirrhosis, please refer to the appropriate section.

 

Recommended Follow-up for Patients Who Achieve a Sustained Virologic Response (SVR).

  • For patients who do not have advanced fibrosis (ie, those with Metavir stage F0-F2), recommended follow-up is the same as if they were never infected with HCV.
    Rating: Class I, Level B
  • Assessment for HCV recurrence or reinfection is recommended only if the patient has ongoing risk for HCV infection or otherwise unexplained hepatic dysfunction develops. In such cases, a quantitative HCV RNA assay rather than an anti-HCV serology test is recommended to test for HCV recurrence or reinfection.
    Rating: Class I, Level A
  • Surveillance for hepatocellular carcinoma with twice-yearly ultrasound examination is recommended for patients with advanced fibrosis (ie, Metavir stage F3 or F4) who achieve an SVR.
    Rating: Class I, Level C
  • A baseline endoscopy is recommended to screen for varices if cirrhosis is present. Patients in whom varices are found should be treated and followed up as indicated.
    Rating: Class I, Level C
  • Assessment of other causes of liver disease is recommended for patients who develop persistently abnormal liver tests after achieving an SVR.
    Rating: Class I, Level C

 

For decompensated cirrhosis, please refer to the appropriate section.

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The following monitoring is Not Recommended during or after therapy.

  • Monitoring for HCV drug resistance-associated substituions during or after therapy is Not Recommended.
    Rating: Class IIb, Level C

Monitoring for HCV During Chemotherapy and Immunosuppression

  • Prospective monitoring for HCV recurrence among patients who achieved a sustained virologic response and who are receiving immunosuppressive treatment (eg, systemic corticosteroids, antimetabolites, chemotherapy, etc) is NOT routinely recommended.
    Rating: Class III, Level C

Changes made April 12, 2017.

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