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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.
- Source :
-
AIDS (London, England) [AIDS] 2011 Sep 10; Vol. 25 (14), pp. 1727-35. - Publication Year :
- 2011
-
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).<br />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.<br />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 (<55 IU/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).<br />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.
- Subjects :
- AIDS-Related Opportunistic Infections mortality
AIDS-Related Opportunistic Infections physiopathology
Adult
Africa, Southern
Anti-Retroviral Agents administration & dosage
CD4 Lymphocyte Count
Didanosine administration & dosage
Female
Hepatitis B, Chronic mortality
Hepatitis B, Chronic physiopathology
Humans
Kaplan-Meier Estimate
Lamivudine administration & dosage
Male
Stavudine administration & dosage
Treatment Outcome
AIDS-Related Opportunistic Infections drug therapy
Anti-Retroviral Agents pharmacology
Didanosine pharmacology
HIV-1 drug effects
Hepatitis B virus
Hepatitis B, Chronic drug therapy
Lamivudine pharmacology
Stavudine pharmacology
Subjects
Details
- Language :
- English
- ISSN :
- 1473-5571
- Volume :
- 25
- Issue :
- 14
- Database :
- MEDLINE
- Journal :
- AIDS (London, England)
- Publication Type :
- Academic Journal
- Accession number :
- 21716078
- Full Text :
- https://doi.org/10.1097/QAD.0b013e328349bbf3