A randomized trial of combination hepatitis B therapy in HIV/HBV coinfected antiretroviral naïve individuals in Thailand

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Hepatology. 2008 Aug 11. [Epub ahead of print]

A randomized trial of combination hepatitis B therapy in HIV/HBV coinfected

antiretroviral naïve individuals in Thailand.

s GV, Avihingsanon A, Lewin SR, Amin J, Rerknimitr R, Petcharapirat P,

Marks P, Sasadeusz J, DA, Bowden S, Locarnini S, Ruxrungtham K, Dore GJ.

National Centre in HIV Epidemiology and Clinical Research, University of New

South Wales, Sydney, Australia.

Coinfection with human immunodeficiency virus (HIV) and hepatitis B virus (HBV)

is associated with considerable liver disease morbidity and mortality. Emerging

HIV epidemics in areas of high HBV endemicity such as Asia are expanding the

population with HIV/HBV coinfection. Limited randomized trial data exist to

support current guidelines for HBV combination therapy in HIV/HBV coinfection.

The objective of this prospective randomized clinical trial was to compare the

strategy of HBV monotherapy with lamivudine (LAM) or tenofovir disoproxil

fumarate (TDF) versus HBV combination therapy with LAM/TDF in

antiretroviral-naïve HIV/HBV-coinfected subjects in Thailand. Thirty-six

HIV/HBV-coinfected subjects initiating highly active antiretroviral therapy

(HAART) were randomized to either LAM (arm 1), TDF (arm 2), or LAM/TDF (arm 3)

as HBV-active drugs within HAART. At week 48, time-weighted area under the curve

analysis revealed that the median HBV DNA reduction from baseline was 4.07

log(10) c/mL in arm 1, 4.57 log(10) c/mL in arm 2, and 4.73 log(10) c/mL in arm

3 (P = 0.70). HBV DNA suppressed to 3 log(10) c/mL at week 48 and in early

resistance development. This study confirms current treatment guidelines that

recommend a TDF-based regimen as the treatment of choice for HIV/HBV

coinfection, but does not demonstrate any advantage of HBV combination therapy

in this short-term setting. (HEPATOLOGY 2008.).

PMID: 18697216 [PubMed - as supplied by publisher]

[Guest guest]

Hepatology. 2008 Aug 11. [Epub ahead of print]

A randomized trial of combination hepatitis B therapy in HIV/HBV coinfected

antiretroviral naïve individuals in Thailand.

s GV, Avihingsanon A, Lewin SR, Amin J, Rerknimitr R, Petcharapirat P,

Marks P, Sasadeusz J, DA, Bowden S, Locarnini S, Ruxrungtham K, Dore GJ.

National Centre in HIV Epidemiology and Clinical Research, University of New

South Wales, Sydney, Australia.

Coinfection with human immunodeficiency virus (HIV) and hepatitis B virus (HBV)

is associated with considerable liver disease morbidity and mortality. Emerging

HIV epidemics in areas of high HBV endemicity such as Asia are expanding the

population with HIV/HBV coinfection. Limited randomized trial data exist to

support current guidelines for HBV combination therapy in HIV/HBV coinfection.

The objective of this prospective randomized clinical trial was to compare the

strategy of HBV monotherapy with lamivudine (LAM) or tenofovir disoproxil

fumarate (TDF) versus HBV combination therapy with LAM/TDF in

antiretroviral-naïve HIV/HBV-coinfected subjects in Thailand. Thirty-six

HIV/HBV-coinfected subjects initiating highly active antiretroviral therapy

(HAART) were randomized to either LAM (arm 1), TDF (arm 2), or LAM/TDF (arm 3)

as HBV-active drugs within HAART. At week 48, time-weighted area under the curve

analysis revealed that the median HBV DNA reduction from baseline was 4.07

log(10) c/mL in arm 1, 4.57 log(10) c/mL in arm 2, and 4.73 log(10) c/mL in arm

3 (P = 0.70). HBV DNA suppressed to 3 log(10) c/mL at week 48 and in early

resistance development. This study confirms current treatment guidelines that

recommend a TDF-based regimen as the treatment of choice for HIV/HBV

coinfection, but does not demonstrate any advantage of HBV combination therapy

in this short-term setting. (HEPATOLOGY 2008.).

PMID: 18697216 [PubMed - as supplied by publisher]