I. Which chronic hepatitis B patients need antiviral therapy
Recommendation 1. A mandatory thorough evaluation of the patient and counseling to guide indications for treatment must be performed before antiviral therapy is administered.
Recommendation 2. Patients with viral replication but persistently normal or slightly elevated serum ALT levels should not be treated with antiviral therapy unless they have severe liver fibrosis or cirrhosis. These patients need to be followed closely and monitored for HCC every 3 to 6 months.
Recommendation 3. Evaluation for liver fibrosis is recommended for patients with viremia along with ALT at high normal levels or slightly elevated and older than 40 years of age, except in patients who already have evidence of clinically diagnosed cirrhosis.
Recommendation 4: Antiviral therapy should be considered in patients with chronic HBV infection with ALT > 2 ULN and HBV DNA > 20 000 IU/ml (105 copies/ml) in HBeAg-positive patients and HBV DNA > 2 000 IU/ml (104 copies/ml) in HBeAg-negative patients. The presence of severe liver fibrosis or cirrhosis should be considered for antiviral therapy, regardless of the high ALT level. If significant liver failure is imminent or has occurred, antiviral therapy should be initiated as soon as possible. In addition to the above, observation for 3 to 6 months is recommended to ensure the necessity of treatment.
Recommendation 5. Patients with primary treatment can be treated with conventional interferon 5-10 MU 3 times a week [IB], or PegIFNα-2a 180 μg or 1-1.5 μg/Kg once a week; or nucleoside analogues (entecavir 0.5 mg once a day; or tenofovir 300 mg once a day; or adefovir 10 mg once a day; or telbivudine 600 mg once daily; or lamivudine 100 mg once daily. (Entecavir and tenofovir are the preferred recommended options). Thymidine alfa 1.6 mg twice weekly is also an option.
II. How should chronic hepatitis B patients on antiviral therapy be managed
Recommended recommendation 1: ALT, HBeAg or HBV DNA should be monitored at least once every 3 months during antiviral therapy. renal function should also be monitored if tenofovir or adefovir is used. Muscle strength should be monitored for diminished muscle strength when treated with telbivudine. During the application of interferon therapy, monitoring of complete blood count and other adverse drug reactions must be mandatory.
Recommendation 2: After completion of antiviral therapy, ALT and HBV DNA should be monitored monthly for the first 3 months to detect early relapse, and every 3 months thereafter. If asymptomatic, monitor every 3 months (for patients with cirrhosis) to 6 months (for patients who have developed a response) thereafter. In non-responders, further monitoring of HBV markers should be performed to identify delayed response and to re-treat when indicated.
Recommendation 3. For conventional interferon, the current recommended regimen is 4-6 months for HBeAg-positive patients and at least 1 year for HBeAg-negative patients. For PegIFN, the recommended duration of therapy is 12 months. For Thymosin α1, the recommended duration of therapy is 6 months for both HBeAg-positive patients and HBeAg-negative patients.
Recommendation 4. For oral antiviral drugs, in HBeAg-positive patients, discontinuation may be considered when HBeAg serologic conversion with undetectable HBV DNA has been confirmed for at least 12 months. In HBeAg-negative patients, if HBsAg remains positive it is not clear how long treatment should be continued, but if HBVDNA is not detected at 3 different time points at least 2 years after treatment and at least 6 months apart, discontinuation of treatment may be considered. In patients with good compliance who have failed primary therapy at 3 months of treatment initiation or who have unsatisfactory viral control at month 6, treatment with lamivudine, telbivudine or adefovir can be switched to a stronger or additional drug without cross-resistance.
III. Remedies for nucleoside resistance in patients with chronic hepatitis B
Recommendation 1. For patients who develop resistance during lamivudine treatment, adefovir can be added to continued lamivudine application; tenofovir can also be chosen instead. Switching to entecavir 1 mg/d is not recommended. for patients who develop resistance during adefovir therapy, add lamivudine, telbivudine or entecavir or switch to tenofovir. For patients who develop resistance during entecavir therapy, add tenofovir or adefovir. For patients who fail or develop resistance during treatment with lamivudine or telbivudine in combination with adefovir, a switch to entecavir plus tenofovir is recommended. For those who develop drug resistance during lamivudine treatment can also be switched to interferon or other nucleoside analogues.
Four, chronic hepatitis B women of childbearing age should be how antiviral treatment
For women of childbearing age who are not yet pregnant, interferon-based therapy is preferred and pregnancy is not advisable during interferon therapy. Those who are pregnant and need treatment can be treated with pregnancy grade B oral medication.
Recommendation 2. In order to prevent mother-to-child transmission, pregnant women with HBVDNA > 2×106 IU/mL can be treated with tenofovir in late pregnancy, and tenofovir can also be one of the options.
V. Antiviral therapy for chronic hepatitis B co-infection with HIV
Recommendation: Antiretroviral agents, including tenofovir and emtricitabine/lamivudine, are the primary treatment modality for most patients with HIV co-infection with HBV. If CD4 > 500 cells/mm3 and antiretroviral therapy is not currently required, treatment with adefovir or PegIFNα may be an option.
VI. Antiviral therapy for chronic hepatitis B combined with HCV or HDV infection
Recommendation: In patients with concurrent HCV or HDV infection, attention should be paid to identifying which virus causes the predominant liver damage, and treatment should be given according to the treatment plan (III).
Antiviral treatment for chronic hepatitis B liver failure
Recommendation: For patients with obvious or imminent hepatic decompensation and initial treatment, use entecavir or tenofovir. However, for patients on initial oral antivirals, treatment with telbivudine, lamivudine or adefovir may also be indicated. Renal function and lactate must be monitored for this group, especially for patients with MELD scores above 20.
VIII. Antiviral therapy for HBV-infected patients with liver cancer
Recommendation: Patients with HBVDNA higher than 2000 IU/ml should be treated with nucleoside analogues for antiviral therapy before and after hepatocellular carcinoma treatment, just as chronic hepatitis B patients who have not developed hepatocellular carcinoma are treated. Patients with hepatocellular carcinoma should start antiviral treatment with nucleoside analogues before receiving arterial chemoembolization therapy.
IX. Management of HBV-infected patients receiving immunosuppressive therapy or chemotherapy
Recommendations 1. Before receiving immunosuppressive therapy or chemotherapy, patients should be screened for HBsAg (IVA). If the patient is HBsAg positive, oral nucleoside analog therapy can be started if there is clinical indication. Alternatively, prophylactic treatment with lamivudine may be initiated before the start of immunosuppressive therapy or chemotherapy and continued until at least 6 months after the end of immunosuppressive therapy or chemotherapy. Entecavir and tenofovir may also be used for prophylactic treatment.
Recommendation 2: Patients preparing for anti-CD20 drug therapy need to be screened for anti-HBc and closely monitored for HBVDNA levels if positive.
X. Antiviral therapy for HBV infection-related liver failure and post-liver transplantation
Recommendations 1. Patients with HBV infection-associated liver failure with detectable HBVDNA should all be given nucleoside (acid) analogue therapy. Lamivudine combined with low-dose HBIG (week 1, 400-800 U, intramuscularly, once daily; given long-term thereafter, 400-800 U, once monthly) is safe and effective in preventing HBV reinfection in allografts. Lamivudine combined with adefovir or entecavir may be considered for prophylaxis.
Recommendation 2: Prophylaxis with adefovir instead of HBIG at least 1 year after liver transplantation is safe and cost-effective. For patients considered “low risk”, lamivudine alone may also be considered in the later post-transplant period.
Recommendation 3: Long-term prophylaxis with lamivudine or HBIG is indicated in patients who have not been infected with HBV and who receive a liver from an anti-HBc-positive donor.
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