HCV Can Be Cured illustration of the Hep C virus inside a right-facing arrowConnect your patients to cure by making a prompt, quality referral to a treatment provider or by treating chronic Hep C in your practice.

Cure, or sustained virologic response (SVR12), is defined as undetectable levels of HCV in the blood at 12 weeks after completion of therapy.1,2

Treating Hep C in your practice.

If you have made the decision to treat Hep C, consider these steps to guide treatment. By treating Hep C patients, you are ensuring that they receive follow-up care and potential cure.1

Throughout the treatment process, there are several tests to ensure patient safety, assess treatment response, and monitor patient adherence.

Treatment considerations for Hep C.

Consider the following when deciding whether to treat or refer a patient to a Hep C specialist1:

Clinical factors1

  • Advanced liver disease
  • Certain medical or psychiatric comorbidities
  • Complicated treatment history

Nonclinical factors1

  • Distance to treatment provider and patient’s access to transportation
  • Patient’s willingness to see a different provider
  • Wait time to secure an appointment
AASLD/IDSA AND ASAM RECOMMEND TREATMENT FOR ALL PATIENTS WITH CHRONIC HEP C INFECTION.1,3,a

aPer AASLD/IDSA guidance, treatment is not recommended for those with short life expectancies that cannot be remediated by treating Hep C, by transplantation, or by other directed therapy. Patients with short life expectancies owing to liver disease should be managed in consultation with an expert.1

HCV = hepatitis C virus

AASLD/IDSA = American Association for the Study of Liver Diseases/Infectious Diseases Society of America

ASAM = American Society of Addiction Medicine

1Pre-treatment assessments.

The results of these recommended baseline tests and evaluations will help you determine which therapies your patient can be prescribed.

Recommended assessments before starting therapy1,b
Order a quantitative HCV RNA (viral load) testWhy it's important
Screen for other potential viral infections (eg, HBV and HIV-1 coinfection)Why it's important
Assess for potential drug-drug interactions with concomitant medicationsWhy it's important
Evaluate comorbiditiesWhy it's important
Conduct staging for hepatic fibrosisWhy it's important
Conduct Hep C genotype and subtype testingWhy it's important
Recommended tests before starting therapy1,b
Conduct a complete blood count (CBC)Why it's important
Determine the international normalized ratio (INR)Why it's important
Order a hepatic function panel: albumin, total bilirubin, direct bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP)Why it's important
Assess the estimated glomerular filtration rate (eGFR)Why it's important
Order population sequencing or deep sequencing
Dependent on therapy choice
Why it's important

HBV = hepatitis B virus

HBsAg = surface antigen of HBV

anti-HBs = hepatitis B surface antibody

anti-HBc = hepatitis B core antibody

bBased on AASLD/IDSA guidance.

Accurate fibrosis staging is critical.

Baseline fibrosis assessment is an important step for developing a Hep C treatment plan. The results of fibrosis tests can determine if your patient is eligible for specific treatment options and if additional measures for the management of cirrhosis are needed.1

AASLD/IDSA RECOMMENDS THAT ALL PERSONS WITH HEP C INFECTION BE EVALUATED FOR ADVANCED FIBROSIS USING LIVER BIOPSY, IMAGING, AND/OR NONINVASIVE MARKERS.1

Liver biopsy limitations.

Liver biopsy is the diagnostic standard, but sampling error and observer variability limit test performance, particularly when inadequate sampling occurs.1

Noninvasive tests to stage the degree of fibrosis in patients with chronic Hep C infection include1:

  • Direct serum biomarkers (components of the extracellular matrix produced by activated hepatic stellate cells)
  • Vibration-controlled transient liver elastography
  • Indirect serum biomarkers (routine tests) (eg, fibrosis-4 [FIB-4], or AST-to- platelet ratio index [APRI])

For your consideration

  • No single method is recognized to have high accuracy alone, and each test must be interpreted carefully1
  • The most efficient approach to fibrosis combines direct biomarkers and vibration-controlled transient liver elastography1
  • If the above tests are unavailable, as an alternative, the APRI or FIB‌-4 can prove helpful—although neither is sensitive enough to rule out substantial fibrosis‌1
HCV Can Be Cured illustration depicting progression of liver damage from Hep C occurring over time, from stage F0/F1 (no or mild fibrosis) to stage F4 (cirrhosis)

Treating Hep C patients with cirrhosisIndividuals with clinical evidence of cirrhosis do not require additional staging; however, additional measures such as hepatocellular carcinoma (HCC) screening may be needed.1 Evidence of cirrhosis can be determined by history, blood tests, and physical symptoms such as fatigue, jaundice, and ascites.1

2On-treatment monitoring.

Once pretreatment assessments are completed, select the appropriate therapy and help patients with access.

Select a treatment regimen.

  • Consider treatments based on your patient’s pretreatment labs and medical history1
  • Evaluate possible treatments based on efficacy, tolerability and toxicity profiles, and dosing schedule1

Special populations provide specific guidance for patients in special populations, such as those with HIV/Hep C coinfection, decompensated cirrhosis, posttransplant Hep C infection, and severe renal impairment or end-stage renal disease.1

Help your patients obtain treatment coverage.

  • Find and select a specialty pharmacy in your area
  • Discuss the requirements for the pharmacy to process the prescription
    • If prior authorization is needed, all required documentation should be submitted simultaneously with the prescription
    • Hep C therapy is typically shipped directly to the patient
  • Inform your patient about any additional programs and resources

Once treatment has been initiated, monitor your patients:

  • To assess treatment response and safety, including adverse events and potential drug-drug interactions.1
  • At Week 4 and as clinically indicated to assess safety, adherence, and efficacy1:
    • Quantitative HCV RNA test for viral loadc
    • Complete blood count (CBC)
    • Hepatic function panel: albumin, total bilirubin, direct bilirubin, ALT, AST, and ALP
    • Serum creatinine level and calculated eGFR
  • To check for early indicator of nonadherence:
    • The assessment of HCV viral load at week 4 of therapy is useful to determine initial response to therapy and adherence.1
    • In phase 3 clinical trials, almost all patients who did not have cirrhosis had an undetectable HCV RNA level at week 4.1
    • Those with cirrhosis may require more than 4 weeks of treatment before the HCV RNA level is undetectable.1
    • There are no data to support stopping treatment based on detectable HCV RNA at weeks 2, 3, or 4 of treatment, or that detectable HCV RNA at these time points signifies medication nonadherence.1
    • In these cases of potential nonadherence, consider having a discussion with the patient to determine whether the patient understands the dosing schedule and is taking treatment as prescribed.1

cIf HCV RNA is detectable, repeat quantitative HCV RNA testing at Week 6 to determine if discontinuation of treatment is necessary. If the patient’s Hep C viral load has increased by greater than 10-fold (greater than 1 log10 IU/mL) on repeat testing, discontinuation of treatment is recommended.2

As therapy continues.

Monitor your patients to assess treatment safety. Direct-acting antivirals (DAAs) have been shown to be tolerable with low rates of adverse events, especially compared with older therapies.1

AALSD/IDSA recommended tests at Week 4 and as clinically indicated1
Assess creatinine levelWhy it's important
Order a hepatic function panelWhy it's important
Assess eGFRWhy it's important

Please refer to the for additional information and details on managing specific lab levels and/or adverse events.

Management of abnormal ALT.

Assessment of ALT is useful to determine whether Hep C treatment should be discontinued due to liver toxicity.1 However, ALT elevations are typically asymptomatic and resolve with ongoing therapy or completion of therapy.1

  • A 10-fold increase in alanine aminotransferase (ALT) activity at any time during treatment should prompt discontinuation of therapy1
  • 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 therapy1
  • 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 therapy1
3Post-treatment follow-up.

Once treatment has been completed, conduct follow-up tests to determine treatment outcome.

Current interferon-free treatment options has shown cure (SVR12) rates of approximately 95% in clinical studies.1,2,4

Order a quantitative HCV RNA test to assess treatment success:

  • At the end of treatment (optional)
  • 12 weeks after the completion of therapy

How did your patient respond?

The approach used in monitoring a patient after treatment depends on the patient’s response to therapy1:

  • The patient achieved cure
  • The patient completed therapy but failed to achieve cure
  • The patient did not complete therapy, due to inadequate adherence, intolerance, toxicity, or other conditions that led to early discontinuation of treatment, and therefore did not achieve cure

Cure, or sustained virologic response (SVR12), is defined as undetectable levels of HCV in the blood at 12 weeks after completion of therapy.1,2

Cure Achieved

  • Patients with zero to moderate fibrosis (F0–F2) require no special monitoring or follow-up for Hep C treatment or liver care.1
  • Patients with advanced fibrosis (F3) or cirrhosis (F4) should be monitored for HCC with twice-yearly ultrasound. Endoscopy is recommended for patients with cirrhosis to screen for varices.1
  • Patients with ongoing risk for Hep C reinfection, such as those who inject drugs and HIV-infected men who have unprotected sex with men, should be assessed periodically with an HCV RNA test and counseled on prevention. An HCV RNA test is necessary because Hep C patients will always test positive for Hep C antibodies.1
  • Assessment of other causes of liver disease is recommended for patients who develop persistently abnormal liver tests after achieving SVR.1

Cure Not Achieved

  • Monitor Hep C patients for disease progression every 6 to 12 months with a hepatic function panel, CBC, and INR.1
  • For patients with cirrhosis, screening for esophageal varices is recommended. If varices are identified, provide the patient with appropriate management and follow-up.1
  • For patients with advanced fibrosis (F3) or cirrhosis (F4), screen for HCC via ultrasound every 6 months.1
  • Evaluate retreatment as alternative treatments become available.1

Cure does not confer immunity.

Inform patients who achieve cure that they are not immune to Hep C and can become reinfected. If you suspect that a patient has ongoing risk factors, evaluate for reinfection with an HCV RNA test.

Ongoing risk.

Patients who do not achieve SVR risk continued liver injury and Hep C progression and could transmit the virus to others.1 Such patients should be monitored for progressive liver disease and considered for retreatment when effective alternative treatments become available.1

HCC = hepatocellular carcinoma

AASLD/IDSA = American Association for the Study of Liver Diseases/Infectious Diseases Society of America

If a patient cannot be treated.

If for any reason your patient does not qualify for treatment, periodically evaluate disease progression, including reassessment of the degree of fibrosis. If the disease progresses, reconsider treatment options.1