Summary: Monitoring Patients Who Are Starting HCV Treatment, Are on Treatment, or Have Completed Therapy

Pretreatment and On-Treatment Monitoring

Recommended Assessments Prior to Starting Antiviral Therapy

RECOMMENDED RATING

Staging of hepatic fibrosis is essential prior to HCV treatment (see Testing and Linkage to Care and 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 about 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 (ie, albumin, total and direct bilirubin, alanine aminotransferase [ALT], aspartate aminotransferase [AST], and alkaline phosphatase levels)
  • Calculated glomerular filtration rate (eGFR)
The following laboratory tests are recommended at any time prior to starting antiviral therapy:
  • HCV genotype and subtype
  • Quantitative HCV RNA (HCV viral load)
I, C

Patients scheduled to receive an HCV NS3 protease inhibitor (ie, paritaprevir, simeprevir, grazoprevir, voxilaprevir, glecaprevir) should be assessed for a history of decompensated liver disease and for liver disease severity using the Child-Turcotte-Pugh (CTP) score (see third-party calculator).

  • Patients with current or prior history of decompensated liver disease or with a current CTP score ≥7 should not receive treatment with regimens that contain NS3 protease inhibitors due to increased blood levels 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.
I, A
All patients initiating HCV direct-acting antiviral (DAA) therapy should be assessed for HBV coinfection with HBsAg testing, and for evidence of prior infection with anti-HBs and anti-HBc testing. IIa, 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. IIb, B

 

Recommended Monitoring During Antiviral Therapy

RECOMMENDED RATING
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. I, B

Creatinine level, calculated glomerular filtration rate (eGFR), and a hepatic function panel are recommended after 4 weeks of treatment and as clinically indicated.
 

More frequent assessment for drug-related adverse effects (eg, CBC for patients receiving ribavirin) is recommended as clinically indicated.
 

Patients receiving elbasvir/grazoprevir should be monitored with a hepatic function panel at 8 weeks (and again at 12 weeks if receiving 16 weeks of treatment).

I, B

A 10-fold increase in alanine aminotransferase (ALT) activity at any time during treatment should prompt discontinuation of therapy.
 

An increase in ALT <10-fold that is accompanied by any weakness, nausea, vomiting, jaundice, or significantly increased bilirubin, alkaline phosphatase, or international normalized ratio (INR) should also prompt discontinuation of therapy.
 

Asymptomatic increases in ALT <10-fold should be closely monitored with repeat testing at 2-week intervals. If levels remain persistently elevated, consideration should be given to discontinuation of therapy.

I, B

Quantitative HCV viral load testing is recommended after 4 weeks of therapy and 12 weeks after completion of therapy.

Antiviral drug therapy should not be interrupted or discontinued if HCV RNA levels are not performed or available during treatment.

I, B

Quantitative HCV viral load testing can be considered at the end of treatment and 24 weeks or longer following the completion of therapy.

I, B
For HBsAg-positive patients who are not already on HBV suppressive therapy, the following are recommended:
  • For patients whose HBV DNA level meets AASLD criteria for treatment, antiviral therapy for HBV should be initiated.
  • For patients whose baseline HBV DNA level does not meet criteria for treatment, one of two approaches may be taken:
    • Initiate prophylactic antiviral therapy for those with low or undetectable HBV DNA levels. If this course is elected, pending further data, prophylaxis should be continued until 12 weeks after completion of DAA therapy.
    • Monitor HBV DNA levels during and immediately after DAA therapy for HCV. Antiviral treatment for HBV should be given in the event of a rise in HBV DNA >10-fold above baseline or to >1000 IU/mL in those with a previously undetectable or unquantifiable HBV DNA level.
IIa, B

 

Recommendations for Discontinuation of Treatment Because of Lack of Efficacy

RECOMMENDED RATING
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 >10-fold (>1 log10 IU/mL) on repeat testing at week 6 (or thereafter), discontinuation of HCV treatment is recommended. III, C
The significance of a positive HCV-RNA test result at week 4 that remains positive but lower at week 6 is unknown. No recommendation to stop therapy or extend therapy can be provided at this time. III, C

 

 

Recommended Monitoring for Pregnancy-Related Issues Prior to and During Antiviral Therapy That Includes Ribavirin

RECOMMENDED RATING
Women of childbearing age should be counseled not to become pregnant while receiving a ribavirin-containing antiviral regimen, and for at least 6 months after stopping the regimen. I, C
Male partners of women of childbearing age should be cautioned to prevent pregnancy while they are receiving a ribavirin-containing antiviral regimen, and for up to 6 months after stopping the regimen. I, C
Serum pregnancy testing is recommended for women of childbearing age prior to beginning treatment with a regimen that includes ribavirin. I, C
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. I, 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. I, C

 

Post-Treatment Follow-Up for Patients in Whom Treatment Failed

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

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

 

The Following Monitoring Is Not Recommended During or After Therapy

NOT RECOMMENDED RATING
Monitoring for HCV drug resistance-associated substitutions during or after therapy is not recommended. IIb, C

 

Post-Treatment Follow-Up for Patients Who Achieved a Sustained Virologic Response

Recommended Follow-Up for Patients Who Achieved a Sustained Virologic Response (SVR)

RECOMMENDED RATING
For patients who do not have advanced fibrosis (ie, those with Metavir stage F0, F1, or F2), recommended follow-up is the same as if they were never infected with HCV. I, 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 test rather than an HCV-antibody test is recommended to assess for HCV recurrence or reinfection. I, 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 SVR. I, C
A baseline endoscopy is recommended to screen for varices if cirrhosisa is present. Patients in whom varices are found should be treated and followed as indicated. I, C
Assessment of other causes of liver disease is recommended for patients who develop persistently abnormal liver tests after achieving SVR. I, C
a For decompensated cirrhosis, please refer to the appropriate section.

 

Monitoring for HCV During Chemotherapy and Immunosuppression

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

 

Last update: 
May 24, 2018
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