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HBV: Treat vs Monitor
HBV Infection: When to Treat vs When to Monitor?

Released: February 21, 2023

Expiration: February 20, 2025

Tram T. Tran
Tram T. Tran, MD
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One of the most complex issues in managing patients infected with HBV is determining when to treat vs when to monitor the infection. For example, what would you recommend for an HBeAg-positive middle-aged woman with HBV DNA < 20,000 IU/mL, ALT ≥ 2 x ULN, but no cirrhosis?

Like many patients with HBV infection, she may be asymptomatic, be reluctant to take long-term medications that do not immediately affect how she feels, have concerns about adverse events, or be at risk for nonadherence.

In Clinical Care Option’s decision support tool for first-line HBV therapy, most experts recommend monitoring without treatment for a patient like this. In this commentary, I’ll explore why.

Criteria for Treating vs Monitoring HBV Infection
Decisions on when to treat vs observe a patient with HBV infection should be based on evidence of disease activity. If there is clear evidence of disease activity—defined as both viral replication and liver inflammation/injury—then treatment is indicated.

Threshold 1: Viral replication. Oral antiviral medications target the viral replication cycle, and quantifying HBV DNA levels can determine whether viral replication is occurring.

The treatment threshold for HBV DNA levels ranges between 2000 and 20,000 IU/mL, depending on which HBV guidelines you are using. If HBV DNA is undetectable, then monitoring may be more appropriate except in special populations, as I discuss below.

Threshold 2: Liver inflammation or injury. Guidelines vary on treatment thresholds for ALT levels; some set a threshold of any abnormal ALT level whereas others set a threshold of 2 x ULN (where normal is defined as 19 IU/mL for women and 30 IU/mL for men).

However, normal ALT levels do not rule out liver injury, so it is important to also look for evidence of previous long-term liver injury. For example, looking for thrombocytopenia, which is associated with hepatic fibrosis, and liver stiffness, as measured by transient elastography, can help determine whether a patient has liver injury and meets this second criterion for treatment.

When Not to Use These Criteria
In some special populations, viral replication and liver inflammation/injury may not be used as criteria for treatment.

For example, in patients with a strong family history of hepatocellular carcinoma, clinicians may recommend treatment at any detectable level of HBV DNA, regardless of ALT levels or evidence of liver inflammation/injury.

As another example, in immunosuppressed patients with HBV infection, prophylactic therapy would be indicated to prevent HBV reactivation, regardless of the presence of active disease.

Case Scenario Revisited: Monitoring
Returning to our patient in the case scenario above, we can now apply these 2 criteria to determine whether to recommend treatment vs monitoring for her HBV infection. Her HBV DNA levels are < 20,000 IU/mL—below the threshold set by the American Association for the Study of Liver Diseases guidelines for HBeAg-positive patients—so she does not meet the first criterion.

Although she meets the second criterion because her ALT levels are ≥ 2 x ULN, she must meet both criteria to be recommended for therapy. Therefore, most experts recommended monitoring without treatment for this patient.

This monitoring should include HBV DNA levels at least every 3-6 months. HBV DNA levels often fluctuate, and treatment may be warranted if this patient’s HBV DNA levels were to rise near the 20,000 IU/mL threshold.

A very important clinical point is that all patients who are HBsAg positive need surveillance for hepatocellular carcinoma every 6 months, regardless of their HBV DNA or ALT levels. This means that even if you choose to monitor a patient with HBV infection, you should still regularly see and monitor them for cancer. This also provides more opportunities for you to determine whether their HBV infection is becoming more active.

Your Thoughts
How do you approach determining when to treat vs monitor a patient with HBV infection? Have you integrated these criteria into your practice? Please contribute your experiences and insight in the comments box below.

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In your practice, what would you recommend for an HBeAg-positive, middle-aged woman with HBV infection, HBV DNA < 20,000 IU/mL, ALT ≥ 2 x ULN, and no cirrhosis?
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