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San Francisco—The American Association for the Study of Liver Diseases (AASLD) has released comprehensive guidelines for the treatment of chronic hepatitis B (CHB). CHB affects more than 240 million people globally, causing significant morbidity and mortality. It is a significant public and personal health concern.

New Guidelines

The American Association for the Study of Liver Diseases (AASLD) has released a comprehensive document covering the guidelines for the treatment of chronic hepatitis B (CHB). CHB affects more than 240 million people globally, causing significant morbidity and mortality.

This guideline was developed in compliance with the Institute of Medicine standards for trustworthy practice guidelines using the Grading of Recommendation Assessment, Development and Evaluation (GRADE) approach.

Objectives of these new guidelines answer critical questions, including:

1. Should adults with immune active CHB be treated with antiviral therapy to decrease liver-related complications?
   Treatment Intervention: Antiviral therapy
   Comparison: No treatment
   Outcome: Cirrhosis, decompensation, HCC, death, loss of HBsAg
   Recommendations: The AASLD recommends antiviral therapy for adults with immune-active CHB (HBeAg negative or HBeAg positive) to decrease the risk of liver-related complications. The AASLD also recommends Peg-IFN, entecavir, or tenofovir as preferred initial therapy for adults with immune-active CHB.
2. Should adults with immune-tolerant infection be treated with antiviral therapy to decrease liver-related complications?
   Treatment Intervention: Antiviral therapy
   Comparison: No treatment
   Outcome: Cirrhosis, decompensation, HCC, death, loss of HBsAg
   Recommendations: The AASLD recommends against antiviral therapy for adults with immune-tolerant CHB. The AASLD suggests that ALT levels be tested at least every 6 months for adults with immune-tolerant CHB to monitor for potential transition to immune-active or -inactive CHB. The AASLD suggests antiviral therapy in the select group of adults >40 years of age with normal ALT and elevated HBV DNA (≥1,000,000 IU/mL) and liver biopsy showing significant necroinflammation or fibrosis.
3. Should antiviral therapy be discontinued in hepatitis B e antigen (HBeAg)-positive persons who have developed HBeAg seroconversion on therapy?
   Treatment Intervention: Continued antiviral therapy
   Comparison: Stopping antiviral therapy
   Outcome: Cirrhosis, HCC, reactivation, seroreversion, decompensation, loss of HBsAg
   Recommendations: The AASLD suggests that HBeAg-positive adults without cirrhosis with CHB who seroconvert to anti-HBe on therapy discontinue NAs after a period of treatment consolidation. The AASLD suggests indefinite antiviral therapy for HBeAg-positive adults with cirrhosis with CHB who seroconvert to anti-HBe on NA therapy, based on concerns for potential clinical decompensation and death, unless there is a strong competing rationale for treatment discontinuation.
4. Should antiviral therapy be discontinued in persons with HBeAg-negative infection with sustained HBV DNA suppression on therapy?
   Treatment Intervention: Continued antiviral therapy
   Comparison: Stopping antiviral therapy
   Outcome: Reactivation, decompensation, loss of HBsAg
   Recommendations: The AASLD suggests indefinite antiviral therapy for adults with HBeAg-negative immune-active CHB, unless there is a competing rationale for treatment discontinuation.
5. In HBV-monoinfected persons, does entecavir therapy, when compared to tenofovir therapy, have a different impact on renal and bone health?
   Treatment Intervention: Tenofovir
   Comparison: Entecavir
   Outcome: Renal function, hypophosphatemia, bone health
   Recommendations: The AASLD suggests no preference between entecavir and tenofovir regarding potential long-term risks of renal and bone complications.
6. Is there a benefit to adding a second antiviral agent in persons with persistent low levels of viremia while being treated with either tenofovir or entecavir?
   Treatment Intervention: Continue therapy
   Comparison: Change or switch therapy
   Outcome: HBV resistance, clinical flare, decompensation, loss of HBeAg
   Recommendations: The AASLD suggests that persons with persistent low-level viremia (<2,000 IU/mL) on entecavir or tenofovir monotherapy continue monotherapy, regardless of ALT. The AASLD suggests one of two strategies in persons with virological breakthrough on entecavir or tenofovir monotherapy: either switch to another antiviral monotherapy with high barrier to resistance or add a second antiviral drug that lacks cross-resistance.
7. Should persons with compensated cirrhosis and low levels of viremia be treated with antiviral agents?
   Treatment Intervention: Antiviral therapy
   Comparison: No treatment
   Outcome: Decompensation, HCC, death
   Recommendations: The AASLD suggests that adults with compensated cirrhosis and low levels of viremia (<2,000 IU/mL) be treated with antiviral therapy to reduce the risk of decompensation, regardless of ALT level. The AASLD recommends that HBsAg-positive adults with decompensated cirrhosis be treated with antiviral therapy indefinitely regardless of HBV DNA level, HBeAg status, or ALT level to decrease risk of worsening liver-related complications.
8. Should pregnant women who are hepatitis B surface antigen (HBsAg) positive with high viral load receive antiviral treatment in the third trimester to prevent perinatal transmission of HBV?
   Treatment Intervention: Antiviral therapy in third trimester
   Comparison: No treatment
   Outcome: Cirrhosis, decompensation, HCC, death, loss of HBsAg CHB in the infant, maternal safety, fetal/infant safety
   Recommendations: The AASLD suggests antiviral therapy to reduce the risk of perinatal transmission of hepatitis B in HBsAg-positive pregnant women with an HBV DNA level >200,000 IU/mL. The AASLD recommends against the use of antiviral therapy to reduce the risk of perinatal transmission of hepatitis B in the HBsAg-positive pregnant woman with an HBV DNA ≤200,000 IU/mL.
9. Should children with HBeAg-positive CHB be treated with antiviral therapy to decrease liver-related complications?
   Treatment Intervention: Antiviral therapy
   Comparison: No treatment
   Outcome: Cirrhosis, decompensation, HCC, death, HBeAg seroconversion, loss of HBsAg
   Recommendations: The AASLD suggests antiviral therapy in HBeAg-positive children (ages 2 to <18 years) with both elevated ALT and measurable HBV DNA levels, with the goal of achieving sustained HBeAg seroconversion. The AASLD recommends against use of antiviral therapy in HBeAg-positive children (ages 2 to <18 years) with persistently normal ALT, regardless of HBV DNA level.