Impact of lamivudine on HIV and hepatitis B virus-related outcomes in HIV/hepatitis B virus individuals in a randomized clinical trial of antiretroviral therapy in southern Africa

Matthews, Gail V., Manzini, Prince, Hu, Zonghui, Khabo, Paul, Maja, Patrick, Matchaba, Gugu, Sangweni, Phumele, Metcalf, Julie, Pool, Nicholaas, Orsega, Susan and Emery, Sean (2011) Impact of lamivudine on HIV and hepatitis B virus-related outcomes in HIV/hepatitis B virus individuals in a randomized clinical trial of antiretroviral therapy in southern Africa. AIDS, 25 14: 1727-1735. doi:10.1097/QAD.0b013e328349bbf3


Author Matthews, Gail V.
Manzini, Prince
Hu, Zonghui
Khabo, Paul
Maja, Patrick
Matchaba, Gugu
Sangweni, Phumele
Metcalf, Julie
Pool, Nicholaas
Orsega, Susan
Emery, Sean
Title Impact of lamivudine on HIV and hepatitis B virus-related outcomes in HIV/hepatitis B virus individuals in a randomized clinical trial of antiretroviral therapy in southern Africa
Journal name AIDS   Check publisher's open access policy
ISSN 0269-9370
1473-5571
Publication date 2011-09-10
Sub-type Article (original research)
DOI 10.1097/QAD.0b013e328349bbf3
Open Access Status Not yet assessed
Volume 25
Issue 14
Start page 1727
End page 1735
Total pages 9
Place of publication Philadelphia, PA, United States
Publisher Lippincott Williams & Wilkins
Language eng
Formatted abstract
Objective: To examine HIV and hepatitis B virus (HBV)-related outcomes in HIV/HBV-coinfected participants in the PHIDISA II study by use of HBV-active vs. non-HBV-active antiretroviral therapy (ART).

Design and Methods: PHIDISA II was a randomized study of ART therapy in HIV-infected adults employing zidovudine along with didanosine, or lamivudine along with stavudine in a factorial 2x2 design. HIV/HBV-coinfected participants by randomization received HBV-active or non-HBV-active ART. The following outcomes of interest were examined: immunological recovery and HIV RNA suppression; hepatic flare; HBV DNA suppression; and mortality.

Results: HIV/HBV coinfection was present in 106 of 1771 (6%) of participants. Participants with HIV/HBV coinfection were more likely to be men, and have higher baseline alanine aminotransferase, lower albumin, and lower platelets than those with HIV monoinfection. Median CD4 + cell gain and HIV RNA suppression was similar across all groups. Hepatic flare was observed in 9.4% of coinfected and 0.02% monoinfected participants. HBV DNA suppression (<55IU/ml) at week 48 was observed in only 33% of those on lamivudine vs. 13% in those on no HBV-active drugs (P=0.13). Mortality over follow-up was significantly greater in coinfected (17%) than monoinfected (11%) participants (P=0.04).

Conclusion: In summary, the use of lamivudine-containing ART in HIV/HBV participants in PHIDISA II resulted in little additional benefit over that of ART itself and failed to impact on the greater mortality in this group. These data provide strong support for recent guidelines advocating the use of tenofovir in all HIV-HBV-coinfected individuals initiating ART.
Keyword Hepatitis B
HIV
Lamivudine
Mortality
Randomized controlled trial
South Africa
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Medicine Publications
 
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Citation counts: TR Web of Science Citation Count  Cited 22 times in Thomson Reuters Web of Science Article | Citations
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