Which patients need antiviral treatment? Is antiviral treatment required for HBsAg and HBV DNA positive hepatitis B virus infected patients? The answer is no, in actual clinical practice, depending on the patient’s condition, some patients do need antiviral therapy, while some patients do not need antiviral therapy at all, the following indications for antiviral therapy are summarized as follows.
A, the general indications for antiviral therapy for patients with chronic hepatitis B include.
1, HBeAg positive, HBV DNA ≥ 105 copies/m l (equivalent to 2000 IU/mL); HBeAg negative, HBV DNA ≥ 104 copies/m l (equivalent to 2000 IU/mL); at the same time, ALT should be ≥ 2 × ULN (normal value); if treated with interferon, ALT should be ≤ 10 × ULN (normal value), total serum bilirubin should be <2×ULN (normal value).
2, for patients with ALT <2×ULN (normal value), liver puncture histological pathology should be: liver histology showing Knodell HAI ≥4, or inflammatory necrosis ≥G2, or fibrosis ≥S2.
3. Antiviral therapy should also be considered for those who are persistently HBV DNA positive and do not meet the above treatment criteria, but have one of the following conditions.
① For ALT greater than the upper limit of normal and age > 40 years, antiviral therapy should also be considered.
② For those with persistently normal ALT but older (>40 years old), close follow-up and preferably liver biopsy should be performed; if liver histology shows Knodell HAI ≥4, or inflammatory necrosis ≥G2, or fibrosis ≥S2, antiviral therapy should be actively administered.
(iii) For those with evidence of disease progression (e.g., enlarged spleen) on dynamic observation, patients should first be advised to undergo liver histology and be given antiviral therapy if necessary.
Elevated ALT due to drugs, alcohol or other factors should be ruled out before starting antiviral therapy, as well as temporary normalization of ALT after application of enzyme-lowering drugs. In some special diseases such as cirrhosis or taking biphenyl structure derivatives, the AST level can be higher than ALT, and the AST level can be used as the main indicator at this time.
II. Indications for antiviral therapy in compensated hepatitis B cirrhosis
The indications for treatment for HBeAg positive people are HBV DNA ≥104 copies/mL and HBeAg negative people are HBV DNA ≥103 copies/mL, regardless of normal or elevated ALT. The goal of treatment is to delay or reduce the occurrence of hepatic failure and hepatocellular carcinoma (HCC), and because of the long duration of treatment, nucleoside (acid) analogs with a low incidence of drug resistance are preferred, and the criteria for discontinuation are unclear.
Interferon should be used with great caution because of its potential to cause complications such as liver failure. If considered necessary, it is advisable to start with a small dose and gradually increase to the intended therapeutic dose according to the patient’s tolerance.
Patients with hepatitis B cirrhosis in the decompensated stage
As long as HBV DNA is detected, regardless of whether ALT or AST is elevated, it is recommended to apply antiviral therapy with nucleoside (acid) analogues promptly based on informed consent to improve liver function and delay or reduce the need for liver transplantation. Because of the need for long-term treatment, nucleoside (acid) analogs with a low incidence of drug resistance should be used, and should not be discontinued at will. Meanwhile, interferon therapy can lead to liver failure, so it is contraindicated for patients with decompensated cirrhosis.
IV. Antiviral therapy for patients with chronic hepatitis B under special circumstances
1, after the standard ordinary interferon alpha or pegylated interferon alpha treatment does not respond to patients with chronic hepatitis B, if there are indications for treatment can be selected nucleoside (acid) analogues and then treatment.
2. For patients with primary non-response after standardized treatment with nucleoside (acid) analogues, i.e., a decrease in serum HBV DNA of <2 log10 at least 6 months of treatment, the treatment regimen should be changed to continue treatment.
V. Patients treated with chemotherapy and immunosuppressive agents
①For patients treated with chemotherapy and immunosuppressive agents for other diseases, HBsAg should be routinely screened; if HBsAg positive, lamivudine or other nucleoside (acid) analogues should be started 1 week before treatment even if HBV DNA is negative and ALT is normal.
② For HBsAg-negative and anti-HBc-positive patients, HBV DNA and HBsAg should be closely monitored when long-term or high-dose immunosuppressive or cytotoxic drug therapy is given, and antiviral therapy should be added promptly if there is a positive shift.
Treatment of patients with HBV/HCV co-infection
For such patients, we should first determine what kind of virus is predominant, and then decide how to treat. If the patient’s HBV DNA is ≥ 104 copies/mL and HCV RNA is not detected, the HBV infection should be treated first. Those with high HBV DNA levels and detectable HCV RNA should be treated with standard doses of pegylated interferon and ribavirin for 3 months first, and then add treatment with lamivudine or entecavir or adefovir if HBV DNA is nonresponsive or elevated.
VII. About antiviral therapy for pediatric patients
The indications, efficacy and safety of generic IFN-α therapy for children aged 12 years or older (weight ≥ 35 kg) with chronic hepatitis B are similar to those for adults, with doses of 3-6 MU/m2 and a maximum dose of no more than 10 MU/m2 . On the basis of informed consent, treatment with lamivudine or adefovir may also be administered at the same dose and duration of therapy as in adults.