BOOM – GUIDELINES FOR PREVENTION AND TREATMENT OF CHRONIC HERVEN B
1. QUICK SUMMARY OF HIGHLIGHTS RECOMMENDATIONS ON TREATMENT, PREVENTION AND TRACKING
Patients are assessed for risk of disease progression to determine when to initiate treatment based on factors such as HBV DNA levels, ALT levels, severity of liver damage, as well as age and family history. and co-morbidities. The kinetic change is more significant than the one-time assessment
• Recommendation 6: Chronic hepatitis B patients with HBV DNA (+) => antiviral therapy is indicated if ALT elevation is persistent (>ULN) and other causes of ALT elevation are excluded. Possible causes of elevated ALT include: infection, medication, alcoholic hepatitis, nonalcoholic steatohepatitis, autoimmune, systemic disease affecting the liver, and at the same time in cases where ALT levels are temporarily normal. drug-induced (B1)
• Recommendation 7: Patients with compensated cirrhosis => antiviral therapy will be indicated if HBV DNA is positive, regardless of ALT level and HBeAg status.
Patients with decompensated cirrhosis => antiviral therapy is indicated if HBsAg (+), even undetectable HBV DNA (A1)
• Recommendation 8: Patients with HBV DNA (+) and normal ALT are at high risk for disease progression and antiviral therapy is indicated if any of the following criteria are present (1) liver biopsy with hepatitis and/or cirrhosis (≥G2, ≥S2). (2) Prolonged normal ALT (tested every 3 months x 12 months) but family history of cirrhosis or liver cirrhosis and > 30 years of age). (3) Persistently normal ALT, no family history of cirrhosis or liver cirrhosis but >30 years of age and noninvasive testing or liver biopsy showing hepatitis or minor fibrosis. (4) extrahepatic symptoms associated with HBV such as glomerulonephritis, vasculitis, peripheral neuropathy….(B1)
• Recommendation 9: HBeAg (+) chronic hepatitis B patients are treated with entecavir, TDF, TAF. If after 1 year HBV DNA level (-), ALT normal, HBeAg seroconversion => continue treatment for at least 3 years (monitoring every 6 months). Discontinue treatment if HBV DNA remains (-), ALT is normal, and HBsAg is lost. Prolonged treatment may reduce the risk of recurrence (A1)
• Recommendation 11: HBeAg (-) chronic hepatitis B patients are treated with entecavir, TDF, TAF => therapy discontinuation is considered if HBsAg disappears and HBV DNA (-). (A1)
• Recommendation 13: In chronic hepatitis B patients with compensated cirrhosis => long-term treatment with ETV, TDF, or TAF, or peg-lFN-α is recommended. Side effects of peg-lFN-α are closely monitored (A1)
• Recommendation 14: Chronic hepatitis B patients with decompensated cirrhosis => long-term treatment with ETV and TDF is recommended. TAF as an alternative if necessary (C1)
• Recommendation 15: chronic hepatitis B patients are treated with ETV, TDF or TAF, after 48 weeks if HBV DNA level >2×10^3 IU/ml => change treatment regimen and assess drug adherence, if patients using ETV will be switched to TDF or TAF, if using TDF or TAF will switch to ETV alone or in combination with ETV. (C2). Peg-IFN-α therapy to be used in combination (B1)
Chronic hepatitis B patients with cirrhosis are treated with ETV, TDF or TAF, after 24 weeks if HBV DNA level >2×10^3 IU/ml => change treatment regimen and assess compliance status If the patient is taking ETV, they will be switched to TDF or TAF, if using TDF or TAF will be switched to ETV alone or in combination with ETV. (C2).
• Recommendation 16: All patients undergoing chemotherapy or immunosuppressive therapy will be screened for HBsAg and anti-HBc (A1). Patients with HBsAg (+) => antiretroviral therapy will be started 1 week before or when the patient receives chemotherapy or immunosuppressive therapy (A1). And ETV, TDF or TAF is used (B1).
• Recommendation 17: Patients wishing to become pregnant while on treatment for chronic hepatitis B or patients with indications for antiviral therapy during pregnancy => TDF is used (B1)
• Recommendation 19: if HBV DNA level >200,000 UI/ml during 2nd and 3rd trimesters of pregnancy => counsel patients at risk of transmission and initiate antiretroviral therapy with TDF or LdT from week 24-28 of pregnancy (A1) . Pregnant women in the immune tolerant stage will be stopped antiretroviral immediately after delivery or 1-3 months after treatment. Breastfeeding is not a contraindication to the use of TDF (C2). Liver function tests, HBV DNA are checked every 3-6 months after stopping the drug => if the patient develops hepatitis flare, antiviral treatment should be started immediately (A2)
• Recommendation 20: Patients with chronic HBV infection with chronic kidney disease, impaired renal function or on renal replacement therapy => ETV and TAF are the first choice, LdT is the alternative. ADV and TDF are not recommended (B1).
• Recommendation 21: In patients with co-existing chronic hepatitis B and C, when DAA therapy is used to treat HCV => NA therapy (ETV, TDF, or TAF) is initiated to prevent hepatitis B reactivation if HBsAg (+) and will be discontinued after 12 weeks of DAA therapy (B2).
Patients with chronic HBV infection with HBsAg (-) and anti-HBc (+) are at risk of HBV reactivation => during treatment with DAA monitor HBV DNA and HBsAg every month, if HBsAg (+) => start NA therapy (ETV, TDF, or TAF)
• Recommendation 24: In patients with acute, subacute, acute/chronic HBV infection or chronic liver failure, NA therapy (ETV, TDF, or TAF) is recommended if HBsAg (+) (A1). Prognosis is good if HBV DNA decreases by 2 lg IU/mL over 2-4 weeks.
• Recommendation 25: chronic HBV infection with HCC => NA therapy (ETV, TDF, or TAF) is recommended if HBsAg (+) (A1).
HCC patients with HBsAg (+) but HBV DNA (-) are still at risk for HBV reactivation when undergoing hepatectomy, TACE, radiation therapy, or chemotherapy.
• Recommendation 26: In patients with chronic HBV infection undergoing liver transplantation, NA therapy (ETV, TDF, or TAF) is recommended if HBsAg (+) (A1).
2. Criteria for diagnosis of cirrhosis due to chronic hepatitis B: diagnosis includes a combination of criteria (i)+(ii) or (i)+(iii) below:
i. Patients with HBsAg (+) or HBsAg (-), anti-HBc (+) and a history of clear chronic hepatitis B (HBsAg (+) > 6 months) and other causes were excluded.
ii. Liver biopsy suggests cirrhosis
iii. Patients with ≥2/5 of the following criteria and non-cirrhotic portal causes were excluded: (1) Imaging showing signs of cirrhosis and/or portal hypertension, (2) endoscopic findings of varicose veins Esophageal vasculature, (3) elastography suggestive of cirrhosis, (4) serum albumin test decreased (<35g/l) and/or prolonged PT (>3 s compared with control), (5) decreased platelets <100,000//mm3
• Clinically, cirrhosis is divided into compensated and decompensated based on the presence or absence of serious complications such as ascites, ruptured esophageal varices, and hepatic encephalopathy. Most of the compensated cirrhosis is child A. Decompensated cirrhosis is mostly child B and child C.
3. Efficacy and safety of antiretroviral drugs (NAs .)
• Entecavir (ETV): efficacious and safe for long-term use, improved histology in patients with cirrhosis, significantly reduced cirrhosis- and HCC-related complications, and reduced overall mortality and mortality due to cirrhosis. liver. 5-year resistance rate #1.2% in new antiretroviral users, increasing to 51% in lamivudine-resistant (LAM) patients
• Tenofovir alafenamide fumarate (TAF): in a phase III study 581 HBeAg (+) chronic hepatitis B patients treated with Tenofovir alafenamide fumarate tablets (TAF). After 96 weeks of HBV DNA treatment <29 IU/mL in 73% of patients, ALT returned to normal # 75% of patients. HBeAg seroconversion #18% and HBsAg loss #1%. Meanwhile 285 chronic hepatitis B patients with HBeAg (-) after 96 weeks HBV DNA <29 IU/mL in 90%, ALT levels to # 81% and HBsAg loss <1%.
• Common side effects of TAF treatment include: headache (12%), nausea (6%) and fatigue (6%). After 96 weeks of treatment in the TAF group of patients, there was a significantly lower decrease in bone density compared with Tenofovir disoproxil fumarate (TDF) in the hip and spine, and there was also a significantly less decrease in renal function compared with TDF.
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Source: BS. Huynh Trung