Simplified HCV Treatment* for Treatment-Naive Patients Without Cirrhosis

Who Is NOT Eligible

Patients who have any of the following characteristics:

  • Prior hepatitis C treatment
  • Cirrhosis
  • Prior liver transplant
  • HIV or HBsAg positive
  • End-stage renal disease (ie, eGFR <30 mL/min/m2)
  • Currently pregnant
 

Who Is Eligible for Simplified Treatment

Patients with chronic hepatitis C who do not have cirrhosis and have not previously received hepatitis C treatment

 
Pretreatment Assessment*
  • Cirrhosis assessment: Liver biopsy is not required. The cutoffs of the following tests suggest cirrhosis. If any test suggests cirrhosis, treat the patient as having cirrhosis. 
    • FIB-4 >3.25
    • APRI >2.0
    • Platelet count <150,000/mm3
    • Fibroscan stiffness >12.5 kPa
  • Medication reconciliationRecord current medications, including over-the-counter drugs and herbal/dietary supplements.
  • Potential drug-drug interaction assessmentDrug-drug interactions can be assessed using the AASLD/IDSA guidance or the University of Liverpool drug interaction checker.
  • Education: Educate the patient about proper administration of medications, adherence, avoidance of alcohol, and prevention of reinfection.
  • Pretreatment laboratory testing:
    • Within 6 months of initiating treatment:
      • Complete blood count (CBC)
      • Hepatic function panel (ie, albumin, total protein, total and direct bilirubin, alanine aminotransferase [ALT], aspartate aminotransferase [AST], and alkaline phosphatase levels)
      • Calculated glomerular filtration rate (eGFR)
    • Anytime prior to starting antiviral therapy:
      • Quantitative HCV RNA (HCV viral load)
      • HIV antigen/antibody test
      • Hepatitis B surface antigen (HBsAg)
    • Before initiating antiviral therapy:
      • Serum pregnancy testing and counseling about pregnancy risks of HCV medication should be offered to women of childbearing age.
Recommended Regimens*
  • Glecaprevir (300 mg) / pibrentasvir (120 mg) to be taken with food for a duration of 8 weeks
  • Sofosbuvir (400 mg) / velpatasvir (100 mg) for a duration of 12 weeks
On-Treatment Monitoring
  • Inform patients taking diabetes medication of the potential for symptomatic hypoglycemia. Monitoring for hypoglycemia is recommended.
  • Inform patients taking warfarin of the potential for changes in their anticoagulation status. Monitoring INR for subtherapeutic anticoagulation is recommended.
  • No laboratory monitoring is required for other patients.
  • An in-person or telehealth visit may be scheduled, if needed, for patient support, assessment of symptoms, and/or new medications.
Post-Treatment Assessment of Cure (SVR)
  • Monitoring patients taking diabetes medication for hypoglycemia is recommended.
  • Monitoring INR for patients taking warfarin is recommended. 
  • Assessment of quantitative HCV RNA and hepatic function panel are recommended 12 weeks or later following completion of therapy to confirm HCV RNA is undetectable (virologic cure) and transaminase normalization.
  • Assessment for other causes of liver disease is recommended for patients with elevated transaminase levels after achieving SVR.
Follow-Up After Achieving Virologic Cure (SVR)
  • No liver-related follow-up is recommended for noncirrhotic patients who achieve SVR.
  • Patients with ongoing risk for HCV infection (eg, intravenous drug use or MSM engaging in unprotected sex ) should be counseled about risk reduction, and tested for HCV RNA annually and whenever they develop elevated ALT, AST, or bilirubin.
Follow-Up for Patients Who Do Not Achieve a Virologic Cure
  • Assessment for disease progression every 6 to 12 months with a hepatic function panel, CBC, and international normalized ratio (INR) is recommended.
  • Patients in whom initial HCV treatment fails to achieve cure (SVR) can be retreated, often successfully. Consult the AASLD/IDSA guidance for recommendations regarding the evaluation of patients for retreatment and selection of an appropriate HCV antiviral regimen.

*More detailed descriptions of the patient evaluation process and antivirals used for HCV treatment, including the treatment of patients with cirrhosis, can be found here.

Last update: 
November 6, 2019
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