Evidence map›Paper›PMID 22405335›Full record

ArticleAIDS research and therapy2012

Assessment of HBV flare in a randomized clinical trial in HIV/HBV coinfected subjects initiating HBV-active antiretroviral therapy in Thailand.

Anchalee Avihingsanon, Gail V Matthews, Sharon R Lewin, Pip Marks, Jose Sasadeusz, David A Cooper, Scott Bowden, Stephen Locarnini, Greg J Dore, Kiat Ruxrungtham

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in AIDS research and therapy, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00192595 (Virological and Clinical Anti-HBV Efficacy of Tenofovir in Antiretroviral naïve Patients With HIV/HBV Co-infection), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
1.6field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00192595 phase4completednot on this map

Virological and Clinical Anti-HBV Efficacy of Tenofovir in Antiretroviral naïve Patients With HIV/HBV Co-infection

TypeinterventionalSponsorKirby InstituteRan2004 to 2007Enrolled36ConditionsHIV Infection, Hepatitis B CoinfectionArmsTenofovir, Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV)
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 31 citations in OpenAlex.

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  11. HIV and co-infections.Immunological reviews · 2013
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 2 countries.

Anchalee Avihingsanon *HIV-NAT Thai Red Cross AIDS Research Centre, Bangkok, Thailand.
Gail V Matthews *The Kirby Institute for infection and immunity in society, University of New South Wales, Sydney, Australia.
Sharon R LewinInfectious Diseases Unit, The Alfred Hospital, Melbourne, Australia.
Pip MarksThe Kirby Institute for infection and immunity in society, University of New South Wales, Sydney, Australia.
Jose SasadeuszInfectious Diseases Unit, The Alfred Hospital, Melbourne, Australia.
David A CooperThe Kirby Institute for infection and immunity in society, University of New South Wales, Sydney, Australia.
Scott BowdenVictorian Infectious Diseases Reference Laboratory, Melbourne, Australia.
Stephen LocarniniVictorian Infectious Diseases Reference Laboratory, Melbourne, Australia.
Greg J DoreThe Kirby Institute for infection and immunity in society, University of New South Wales, Sydney, Australia.
Kiat RuxrungthamHIV-NAT Thai Red Cross AIDS Research Centre, Bangkok, Thailand.
UNSW Sydney · AUHIV Netherlands Australia Thailand Research Collaboration · THThe Alfred Hospital · AUVictorian Infectious Diseases Reference Laboratory · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHepatic Flare (HF) after initiation of highly active antiretroviral therapy (HAART) in HIV-HBV coinfected individuals is well recognized but prospective data on predictors and subsequent outcome are limited.

methodsThe Tenofovir in HIV-HBV coinfection study was a randomized clinical trial of HBV-active HAART including lamivudine and/or tenofovir in antiretroviral naïve HIV-HBV individuals in Thailand.

resultsEarly HF (EHF) was defined as ALT > 5 × ULN during the first 12 weeks. EHF was observed in 8 (22%) of individuals at a median of 56 days. 6/8 EHF cases were asymptomatic and resolved with HAART continuation, however one subject with underlying cirrhosis died following rapid hepatic decompensation. EHF was significantly associated with higher baseline ALT (79 IU/L vs 36 IU/L non-EHF, p = 0.008) and HBV DNA (9.9 log10 c/ml vs 8.4 log10 c/ml non EHF, p = 0.009), and subsequent serological change. HBeAg loss occurred in 75% of EHF cases versus 22% in non-EHF (p = 0.04), and HBsAg loss in 25% of EHF cases versus 4% of non-EHF (p = 0.053).

conclusionEHF after HBV active HAART initiation was frequently observed in this population. Timing of EHF, association with elevated ALT and HBV DNA and high rate of seroconversion are all consistent with immune restoration as the likely underlying process. CLINICAL TRIAL NUMBER: NCT00192595.

Identifiers

PMID22405335
PMCPMC3324378
OpenAlexW2155352363

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.