Preventing HBV Infection
Indications for HBV Vaccination:
- Patients without chronic HBV infection and without immunity to HBV (anti-HBs <10 mIU/mL) (AII)
- Patients with isolated anti-HBc (BII). Recommend one standard dose of HBV vaccine followed by anti-HBs at 1-2 months. If the titer is >100 mIU/mL, no further vaccination is needed, but if the titer is <100 mIU/mL, a complete series of HBV vaccine should be completed followed by anti-HBs testing (BII).
- Early vaccination is recommended before CD4 count falls below 350 cells/mm3 (AII), as low CD4 count at time of vaccination has been associated with poor response to the vaccine.
- However, in a patient with low baseline CD4 cell count, vaccination should not be deferred until CD4 reaches >350 cells/mm3, as some patients with CD4 <200 cells/mm3 do respond to vaccination (AII).
For Vaccine Non-Responders:
- HBV vaccine IM (Engerix-B® 20 mcg/mL or Recombivax HB® 10 mcg/mL) at 0, 1, and 6 months (AII); or
- HBV vaccine IM (Engerix-B® 40 mcg/mL or Recombivax HB® 20 mcg/mL) at 0, 1, 2, and 6 months (BI); or
- Combined HAV and HBV vaccine (Twinrix®) 1 mL IM as a 3-dose series (at 0, 1, and 6 months) or as a 4-dose series (at days 0, 7, 21 to 30, and 12 months) (AII); or
- Vaccine conjugated to CpG (Heplisav-B®) IM at 0 and 1 months (CIII) – a 2-dose series can only be used when both doses given are Heplisav-B®.
- Anti-HBs should be obtained 1 to 2 months after completion of the vaccine series. Patients with anti-HBs <10 mIU/mL will be considered as vaccine non-responders (BIII).
Alternative Vaccine Dose and Duration for Vaccine Non-Responders:
- Revaccinate with a second vaccine series (BIII).
- For patients with low CD4 count at the time of first vaccination series, some experts might delay revaccination until after a sustained increase in CD4 count with ART (CIII).
- Double dose, 4-dose series - HBV vaccine IM (Engerix-B® 40 mcg/mL or Recombivax HB® 20 mcg/mL at 0, 1, 2, and 6 months (BI).
Treating HBV Infection
Indication for Therapy:
Preferred Therapy (CrCl ≥60 mL/min)
- All patients with HIV/HBV coinfection, regardless of CD4 count and HBV DNA level (AII). Therapy should be selected to treat both HIV and HBV infections (AIII).
Preferred Therapy (CrCl 30–59 mL/min)
- The ART regimen must include 2 drugs active against HBV, preferably with [TDF 300 mg + (FTC 200 mg or 3TC 300 mg)] or [TAF (10 or 25 mg)a + FTC 200 mg] PO once daily (AIII).
Preferred Therapy (CrCl <30 mL/min)
- The ART regimen must include 2 drugs active against HBV, preferably with TAF (10 or 25 mg)a + FTC 200 mg PO once daily (AIII).
Duration of Therapy
- A fully suppressive ART regimen without tenofovir should be used, with the addition of renally dosed entecavir to the regimen or
- ART with renally dose-adjusted TDF and FTC can be used (BIII) when recovery of renal function is unlikely (see Table 7 for dosing recommendation for TDF and FTC or 3TC for patients with renal impairment). Guidance for TAF use in persons with CrCl <30 is not yet established.
- Patients on treatment for HBV and HIV should receive therapy indefinitely (CIII).
If the Patient Refuses ART:
- Anti-HBV therapy is indicated for all those who meet criteria for treatment according to the AASLD 2018 guidelines.
- Peg-IFN-alfa 2a 180 mcg SQ once weekly for 48 weeks (CIII), or
- Peg-IFN- alfa 2b 1.5 mcg/kg SQ once weekly for 48 weeks (CIII)
- Directly acting HBV drugs (such as 3TC, FTC, TAF, TDV, entecavir, adefovir, and telbivudine) must not be given in the absence of a fully suppressive ART regimen to avoid selection of drug resistant HIV (AII).
- Hepatitis A vaccination is recommended for all HAV antibody-negative patients who have chronic liver disease, are men who have sex with men, or who are injection drug users (AIII).
- Antibody responses to HAV should be assessed 1 month after completion of vaccination series. If HAV Ab IgG is negative, patients should be revaccinated when the CD4 count is >200 cells/mm3 (BIII).
- As patients with HBV/HCV/HIV coinfection appear to have accelerated liver fibrosis progression, high risk of HCC, and increased mortality, treatment for both HBV and HCV infection should be initiated, if feasible.
- As HBV reactivation can occur during treatment for HCV with directly active agents (DAAs) in the absence of HBV-active drugs, all patients with HIV/HBV coinfection who will be treated for HCV should be on HBV-active ART at the time of HCV treatment initiation (AIII).
- When changing ART regimens, it is crucial to continue agents with anti-HBV activity (BIII).
- If anti-HBV therapy must be discontinued, serum transaminase levels should be monitored every 6 weeks for 3 months, then every 3 to 6 months thereafter.
- If a hepatic flare occurs after drug discontinuation, HBV therapy should be re-instituted, as it can be potentially lifesaving (AIII).
- If immunosuppressive therapy is given, HBV reactivation can occur. For patients who are HBsAg positive, treatment for HBV should be administered (AII). Patients with isolated anti-HBc can either be monitored or be given prophylaxis to prevent reactivation depending on the degree of immunosuppression and whether HBV DNA is detectable (AII).