HAART Containing Tenofovir (Viread) plus Emtricitabine (Emtriva) is Effective for HIV-HBV Coinfected Patients

Several recent studies have added to the evidence that structured interruption of antiretroviral therapy can lead to detrimental outcomes for people with HIV. The disadvantages of treatment interruption may be even more pronounced among HIV positive individuals with hepatitis B virus (HBV) coinfection, since some drugs used to treat HIV are also active against HBV, including 3TC (lamivudine; Epivir), emtricitabine (Emtriva), and tenofovir (Viread). 

Emtricitabine and tenofovir are the 2 drugs in the Truvada fixed-dose combination pill and - along with efavirenz (Sustiva) - are components of the Atripla combination pill. Discontinuation of these drugs may not only lead to loss of HBV suppression, but can also trigger hepatitis "flares" characterized by elevated transaminases (the liver enzymes ALT and AST).

In the January 2, 2008 issue of AIDS, researchers reported data from an analysis of 16 HIV-HBV coinfected (but HCV negative) Thai patients in the STACCATO trial (out of a total 362 Thai participants).

Patients taking HAART regimens containing emtricitabine/tenofovir were randomly assigned to receive continuous therapy or to undergo CD4 cell count-guided interruptions. Those in the treatment interruption arm stopped antiretroviral therapy when their CD4 count was greater than 350 cells/mm3, and restarted when the count fell below this level.

Liver enzyme levels and HBV viral load were measured at weeks 4, 8, 12, and then every 12 weeks through the end of the trial. A complete hepatitis B serology was performed when emtricitabine/tenofovir was initiated and again at week 48. The median follow-up period was 69 weeks (range 48-96).

Individuals undergoing treatment interruption who experienced ALT/AST levels 5 or more times the upper limit or normal (ULN) or bilirubin more than 2.5 times ULN immediately restarted emtricitabine/tenofovir-containing HAART.


• HBV replication was suppressed below the level of detection in 15 of 16 coinfected patients.

• Overall, patients in the treatment interruption arm had worse control of HBV and higher transaminase levels.

• After treatment interruption, HBV DNA increased by a median 2.52 logs (range 0.49-4.70).

• Transaminase levels and HBV viral load increased during treatment interruption in 5 of 6 patients (mostly asymptomatic).

• 1 individual experienced a severe hepatitis flare.

• All respond completely when emtricitabine/tenofovir-containing HAART was restarted.

• 1 patient in the continuous therapy arm became HB "e" antigen (HBeAg) negative and developed HBe antibodies.

• 1 person on continuous therapy lost hepatitis B surface antigen (HBsAg) but did not develop HBs antibodies.

• Conversion to HBe antibody positivity occurred only in the continuous treatment arm.

In conclusion, the authors wrote, "Tenofovir/emtricitabine-containing antiretroviral therapy is highly effective in controlling chronic HIV-HBV coinfection but treatment should not be interrupted."

HIV-NAT, Thai Red Cross AIDS Research Center, Bangkok, Thailand; Outpatient Clinic of Internal Medicine and Division of Infectious Diseases, University Hospital, Basel, Switzerland; National Centre in HIV Epidemiology and Clinical Research, University of New South Wales, Sydney, Australia; Khon Kaen University, Khon Kaen, Thailand; Bamrasnaradura Institute, Nonthaburi, Thailand; Sanpatong Hospital, Chiang Mai, Thailand; Division des Maladies Infectieuses, Geneva University Hospital, Geneva, Switzerland.



R Nuesch, J Ananworanich, P Srasuebkul, and others. Interruptions of tenofovir/emtricitabine-based antiretroviral therapy in patients with HIV/hepatitis B virus co-infection. AIDS 22(1): 152-154. January 2, 2008.