Linked Life Data

18697216

Source:http://linkedlifedata.com/resource/pubmed/id/18697216

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
4
pubmed:dateCreated
2008-10-2
pubmed:databankReference
pubmed:abstractText
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 in 46% in arm 1, 92% in arm 2, and 91% in arm 3 (P = 0.013, intent-to-treat analysis). HBV-resistant changes were detected in two subjects, both in arm 1. Hepatitis B e antigen (HBeAg) loss was observed in 33% of HBeAg-positive subjects, and 8% experienced hepatitis B surface antigen loss. Hepatic flare was observed in 25% of subjects. CONCLUSION: LAM monotherapy resulted in a greater proportion of subjects with HBV DNA >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.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Oct
pubmed:issn
1527-3350
pubmed:author
pubmed:issnType
Electronic
pubmed:volume
48
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
1062-9
pubmed:meshHeading
pubmed-meshheading:18697216-Adenine, pubmed-meshheading:18697216-Adult, pubmed-meshheading:18697216-Anti-HIV Agents, pubmed-meshheading:18697216-Antiretroviral Therapy, Highly Active, pubmed-meshheading:18697216-Benzoxazines, pubmed-meshheading:18697216-DNA, Viral, pubmed-meshheading:18697216-Dose-Response Relationship, Drug, pubmed-meshheading:18697216-Drug Therapy, Combination, pubmed-meshheading:18697216-Female, pubmed-meshheading:18697216-HIV Infections, pubmed-meshheading:18697216-Hepatitis B, pubmed-meshheading:18697216-Hepatitis B virus, pubmed-meshheading:18697216-Humans, pubmed-meshheading:18697216-Lamivudine, pubmed-meshheading:18697216-Male, pubmed-meshheading:18697216-Middle Aged, pubmed-meshheading:18697216-Phosphonic Acids, pubmed-meshheading:18697216-Prospective Studies, pubmed-meshheading:18697216-Thailand, pubmed-meshheading:18697216-Treatment Outcome, pubmed-meshheading:18697216-Zidovudine
pubmed:year
2008
pubmed:articleTitle
A randomized trial of combination hepatitis B therapy in HIV/HBV coinfected antiretroviral naïve individuals in Thailand.
pubmed:affiliation
Viral Hepatitis Program, National Centre in HIV Epidemiology and Clinical Research, University of New South Wales, Darlinghurst, Sydney, NSW, Australia. gmatthews@nchecr.unsw.edu.au
pubmed:publicationType
Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't