Page 150 - HIV/AIDS Guidelines

coinfected patients. Therefore, 3TC or FTC should be used in combination with other anti-HBV drugs
(AII). 10
• Immune reconstitution after initiation of treatment for HIV and/or HBV can be associated with elevation
in transaminases, possibly because HBV is primarily an immune-mediated disease. 11
• Some ARV agents can cause increases in transaminase levels. The rate and magnitude of these increases
are higher with HBV coinfection. 12-13 The etiology and consequences of these changes in liver function
tests are unclear because continuation of ART may be accompanied by resolution of the changes.
Nevertheless, some experts suspend the implicated agent(s) when the serum alanine transferase (ALT)
level is increased to 5–10 times the upper limit of normal. However, in HIV/HBV-coinfected persons,
increases in transaminase levels can herald hepatitis B e antigen (HBeAg) seroconversion due to immune
reconstitution, so the cause of the elevations should be investigated prior to the decision to discontinue
medications. In persons with transaminase increases, HBeAg seroconversion should be evaluated by
testing for HBeAg and anti-HBe as well as HBV DNA levels.

Recommendations for HBV/HIV-Coinfected Patients

• All patients with chronic HBV should be advised to abstain from alcohol, assessed for immunity to
hepatitis A virus (HAV) infection (anti-HAV antibody total) and vaccinated if nonimmune, advised on
methods to prevent HBV transmission (methods that do not differ from those to prevent HIV
transmission), and evaluated for the severity of HBV infection as outlined in the Guidelines for
Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents. 14
• Prior to intiation of ART, all persons who test positive for HBsAg should be tested for HBV DNA using a
quantitative assay to determine the level of HBV replication (AIII). Persons with chronic HBV infection
already receiving ART active against HBV should undergo quantitative HBV DNA testing every 6–12
months to determine the effectiveness of therapy in suppressing HBV replication. The goal of HBV
therapy with NRTIs is to prevent liver disease complications by sustained suppression of HBV
replication to the lowest achievable level.
• If not yet on therapy and HBV or HIV treatment is needed: In persons without HIV infection, the
recommended anti-HBV drugs for the treatment of persons naive to HBV therapy are TDF and
entecavir. 15-16 In HIV-infected patients, however, only TDF can be considered part of the ARV regimen;
entecavir has weak anti-HIV activity and must not be considered part of an ARV regimen. In addition,
only TDF is fully active for the treatment of persons with known or suspected 3TC-resistant HBV
infection. To avoid selection of HBV-resistant variants, when possible, these agents should not be used as
the only agent with anti-HBV activity in an ARV regimen (AIII).

Preferred regimen. The combination of TDF + FTC or TDF + 3TC should be used as the NRTI backbone of
a fully suppressive ARV regimen and for the treatment of HBV infection (AII). 17-19

Alternative regimens. If TDF cannot safely be used, entecavir should be used in addition to a fully
suppressive ARV regimen (AII); importantly, entecavir should not be considered to be a part of the ARV
20
regimen (BII). Due to a partially overlapping HBV-resistance pathway, it is not known if the combination
of entectavir + 3TC or FTC will provide additional virologic or clinical benefit compared with entecavir
alone. In persons with known or suspected 3TC-resistant HBV infection, the entecavir dose should be
increased from 0.5 mg/day to 1 mg/day. However, entecavir resistance may emerge rapidly in patients with
3TC-resistant HBV infection. Therefore, entecavir should be used with caution in such patients with frequent
monitoring (~ every 3 months) of the HBV DNA level to detect viral breakthrough. 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; 17, 21-22 however, data on these regimens in persons with
HIV/HBV coinfection are limited (BII). Due to safety concerns, peginterferon alfa should not be used in

Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents J-2

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