Expert consensus on antiviral therapy for special patients with chronic hepatitis B (II)

  6 Pediatric patients Recommendation 7: The indications and course of treatment for pediatric patients can be referred to adult patients, but due to the young age of pediatric patients and fewer drugs available for treatment, the indications for treatment should be strict. For children aged 2 to 11 years, antiviral therapy with IFN-α, ETV, TDF or LAM can be applied with adequate communication with parents and informed consent (C1). When resistant variants occur in patients over 12 years of age with LAM, combination of ADV may be considered for treatment (C1).  7 Pregnant patients Recommendation 8: For women of childbearing age, antiviral therapy should be completed before pregnancy if possible; patients with unintended pregnancy during antiviral therapy with IFN need to terminate pregnancy, and patients with unintended pregnancy during antiviral therapy with LAM, LdT or TDF can continue antiviral therapy with the original regimen with adequate communication with the patient. Patients on antiviral therapy with ADV and ETV may be considered for switching to LAM, LdT or TDF to continue antiviral therapy (B1).  Recommendation 9: High viral load (HBV DNA > 6
log10 copies/ml) in pregnant women with LAM, LdT or TDF for mother-to-child transmission blockade (B1). NAs treatment can be discontinued at 6 months after delivery if the patient is still immunotolerant at the end of pregnancy (B1).  Recommendation 10: There is no evidence of adverse effects of NAs therapy on sperm as well as the fetus. For male patients on antiviral therapy with NAs, fertility can be considered with adequate communication with the patient (C2).  8 Combined HCV/HIV infection Recommendation 11: Combined HCV infection should be determined before deciding how to treat. If the patient has HBV DNA ≥ 104 copies/ml and HCV
RNA is undetectable, then HBV infection should be treated first (B1). For those with high HBV DNA levels and detectable HCV RNA, treatment with standard dose Peg-IFN combined with ribavirin should be started for 3 months, and if HBV
DNA is non-responsive or elevated, treatment with NAs should be added (B1).  Recommendation 12: People with co-infection with HIV who are not on HAART or do not require HAART in the near future (CD4 >
500/ml), anti-HBV therapy with a drug without anti-HIV activity, such as Peg-IFN-α or ADV (B1), should be selected. Patients who are receiving effective HARRT therapy can then combine anti-HBV drugs in their HAART regimen, either TDF combined with LAM regimen or TDF combined with FTC regimen (C1).  9 Patients with combined renal disease Recommendation 13: Patients with HBV-AG who have detectable HBV
DNA, NAs antiviral therapy (C1) should be considered; however, there is no unanimous opinion on drug selection, duration and discontinuation indications. For anti-HBV therapy in patients with combined renal insufficiency, the dosing interval and/or dose should be adjusted according to the patient’s creatinine clearance and dialysis status.  10 Patients treated with immunosuppressive or cytotoxic drugs Recommendation 14: When HBsAg-positive patients are treated with immunosuppressive or cytotoxic drugs, even if the HBV
DNA is below the lower limit of detection and ALT is normal, the prophylactic treatment with NAs should be started 2 to 4 weeks before treatment, and the prophylactic drug should be chosen from drugs with rapid HBV DNA inhibition, such as ETV or TDF (B1).  Recommendation 15: For HBsAg-negative, anti-HBc-positive patients, if strong immunosuppressive or cytotoxic drugs (such as anti-CD20, anti-TNF or high-dose glucocorticoids) are needed, it is recommended to give NAs prophylaxis; otherwise, patients can be closely monitored for HBV
DNA and HBsAg, and promptly add antiviral therapy if positive (C1).  Recommendation 16: After the cessation of chemotherapy or immunosuppressive therapy, the time of NAs discontinuation should be decided according to the patient’s condition (B1).  11 Patients with ALT ≤ 2 times the upper limit of normal Recommendation 17: Patients with high HBV DNA load and ALT of (1 to 2)× ULN and patients with normal ALT and age > 30 years should be treated with hepatic therapy.
Patients with normal ALT and age > 30 years should undergo liver tissue biopsy (B1). If liver histology shows Knodell HAI ≥ 4, or inflammatory necrosis ≥ G2, or fibrosis ≥
S2, antiviral therapy should be given aggressively (A1).