Page 149 - HIV/AIDS Guidelines

Considerations for Antiretroviral Use in Patients with Coinfections

HIV/Hepatitis B Virus (HBV) Coinfection (Last updated January 10, 2011; last reviewed
January 10, 2011)

Panel’s Recommendations

• Prior to initiation of antiretroviral therapy (ART), all patients who test positive for hepatitis B surface antigen (HBsAg)
should be tested for hepatitis B virus (HBV) DNA using a quantitative assay to determine the level of HBV replication
(AIII).
• Because emtricitabine (FTC), lamivudine (3TC), and tenofovir (TDF) have activity against both HIV and HBV, if HBV
or HIV treatment is needed, ART should be initiated with the combination of TDF + FTC or TDF + 3TC as the
nucleoside reverse transcriptase inhibitor (NRTI) backbone of a fully suppressive antiretroviral (ARV) regimen (AI).

• If HBV treatment is needed and TDF cannot safely be used, the alternative recommended HBV therapy is entecavir in
addition to a fully suppressive ARV regimen (BI). Other HBV treatment regimens include peginterferon alfa monotherapy
or adefovir in combination with 3TC or FTC or telbivudine in addition to a fully suppressive ARV regimen (BII).
• Entecavir has activity against HIV; its use for HBV treatment without ART in patients with dual infection may result in
the selection of the M184V mutation that confers HIV resistance to 3TC and FTC. Therefore, entecavir must be used
in addition to a fully suppressive ARV regimen when used in HIV/HBV-coinfected patients (AII).
• Discontinuation of agents with anti-HBV activity may cause serious hepatocellular damage resulting from
reactivation of HBV; patients should be advised against self-discontinuation and carefully monitored during
interruptions in HBV treatment (AII).

• If ART needs to be modified due to HIV virologic failure and the patient has adequate HBV suppression, the ARV
drugs active against HBV should be continued for HBV treatment in combination with other suitable ARV agents to
achieve HIV suppression (AIII).

Rating of Recommendations: A = Strong; B = Moderate; C = Optional
Rating of Evidence: I = data from randomized controlled trials; II = data from well-designed nonrandomized trials or observational
cohort studies with long-term clinical outcomes; III = expert opinion

Approximately 5%–10% of HIV-infected persons also have chronic HBV infection, defined as testing
positive for HBsAg for more than 6 months. The progression of chronic HBV to cirrhosis, end-stage liver
1
disease, and/or hepatocellular carcinoma is more rapid in HIV-infected persons than in persons with chronic
HBV alone. Conversely, chronic HBV does not substantially alter the progression of HIV infection and does
2
not influence HIV suppression or CD4 cell responses following ART initiation. 3-4 However, several liver-
associated complications that are ascribed to flares in HBV activity, discontinuation of dually active ARVs,
or toxicity of ARVs can affect the treatment of HIV in patients with HBV coinfection. 5-7 These include the
following:

• FTC, 3TC, and TDF are approved ARVs that also have antiviral activity against HBV. Discontinuation of
these drugs may potentially cause serious hepatocellular damage resulting from reactivation of HBV. 8
• Entecavir has activity against HIV; its use for HBV treatment without ART in patients with dual infection
may result in the selection of the M184V mutation that confers HIV resistance to 3TC and FTC.
Therefore, entecavir must be used in addition to a fully suppressive ARV regimen when used in
HIV/HBV-coinfected patients (AII). 9
• 3TC-resistant HBV is observed in approximately 40% of patients after 2 years on 3TC for chronic HBV
and in approximately 90% of patients after 4 years when 3TC is used as the only active drug for HBV in

Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents J-1

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