Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Exposed and HIV-Infected Children
The information in the brief version is excerpted directly from the full-text guidelines. The brief version is a compilation of the tables and boxed recommendations.
Hepatitis B Virus
Last Updated: November 6, 2013; Last Reviewed: November 6, 2013
|Rating of Recommendations: A = Strong; B = Moderate; C = Optional
Rating of Evidence: I = One or more randomized trials in children† with clinical outcomes and/or validated endpoints; I* = One or more randomized trials in adults with clinical outcomes and/or validated laboratory endpoints with accompanying data in children† from one or more well-designed, nonrandomized trials or observational cohort studies with long-term clinical outcomes; II = One or more well-designed, nonrandomized trials or observational cohort studies in children† with long-term outcomes; II* = One or more well-designed, nonrandomized trials or observational studies in adults with long-term clinical outcomes with accompanying data in children† from one or more similar nonrandomized trials or cohort studies with clinical outcome data; III = Expert opinion
†Studies that include children or children/adolescents, but not studies limited to post-pubertal adolescents
|Indication||First Choice||Alternative||Comments/Special Issues|
||Hepatitis B immunoglobulin following exposure
||See Figure 1 for detailed vaccine recommendations.
Primary Prophylaxis Indicated for:
||Hepatitis A Vaccine||N/A||Secondary Prophylaxis Indicated for:
|Treatment||Treatment of Only HBV Required (Child Does Not Require cART):
Treatment of Both HIV And HBV Required (Child Not Already Receiving 3TC or FTC)
||Indications for Treatment Include:
Choice of HBV treatment options for HIV/HBV-co-infected children depends upon whether concurrent HIV treatment is warranted.
3TC and FTC have similar activity (and have cross-resistance) and should not be given together. FTC is not FDA-approved for treatment of HBV.
TDF is approved for use in treatment of HIV infection in children aged ≥2 years but it is not approved for treatment of HBV infection in children aged <12 years. It should only be used for HBV in HIV/HBV-infected children as part of a cART regimen.
Adefovir is approved for use in children aged ≥12 years.
ETV is not approved for use in children younger than age 16 years, but is under study in HIV-uninfected children for treatment of chronic hepatitis B. Can be considered for older HIV-infected children who can receive adult dosage. It should only be used for HBV in HIV/HBV-infected children who also receive an HIV-suppressive cART regimen.
IRIS may be manifested by dramatic increase in transaminases as CD4 cell counts rise within the first 6 to 12 weeks of cART. It may be difficult to distinguish between drug-induced hepatotoxicity and other causes of hepatitis and IRIS.
In children receiving TDF and 3TC or FTC, clinical and laboratory exacerbations of hepatitis (flare) may occur if the drug is discontinued; thus, once anti-HIV/HBV therapy has begun, it should be continued unless contraindicated or until the child has been treated for >6 months after HBeAg seroconversion and can be closely monitored on discontinuation.
If anti-HBV therapy is discontinued and a flare occurs, reinstitution of therapy is recommended because a flare can be life threatening.
Telbivudine has been approved for use in people aged ≥16 years with HBV; there are no data on safety or efficacy in children aged <16 years; a pharmacokinetic study is under way in HIV-uninfected children.
|Key to Acronyms: 3TC = lamivudine; cART = combined antiretroviral therapy; CD4 = CD4 T lymphocyte; FTC = emtricitabine; HBeAg = hepatitis B antigen; HBV = hepatitis B virus; IFN-α = interferon alfa; IRIS = immune reconstitution inflammatory syndrome; SQ = subcutaneous; TDF = tenofovir disoproxil fumarate