National Centre in HIV Epidemiology and Clinical Research, University of New South Wales, Sydney, Australia.
AIDS. 2011 Sep 10;25(14):1727-35. doi: 10.1097/QAD.0b013e328349bbf3.
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).
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.
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).
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.
通过使用乙型肝炎病毒（HBV）活性与非 HBV 活性抗逆转录病毒治疗（ART），在 PHIDISA II 研究中检查 HIV 和 HBV 相关结果在 HIV/HBV 合并感染参与者中的作用。
PHIDISA II 是一项在 HIV 感染成年人中进行的 ART 治疗的随机研究，采用齐多夫定加去羟肌苷，或拉米夫定加司他夫定，在 2x2 因子设计中。通过随机化，HIV/HBV 合并感染的参与者接受 HBV 活性或非 HBV 活性 ART。检查了以下感兴趣的结果：免疫恢复和 HIV RNA 抑制；肝发作；HBV DNA 抑制；和死亡率。
在 1771 名参与者中的 106 名（6%）存在 HIV/HBV 合并感染。与 HIV 单感染参与者相比，HIV/HBV 合并感染的参与者更可能是男性，并且具有更高的基线丙氨酸氨基转移酶、更低的白蛋白和更低的血小板。所有组的中位 CD4 细胞增加和 HIV RNA 抑制相似。在合并感染组中观察到 9.4%的肝发作，而在单感染组中观察到 0.02%的肝发作。在第 48 周时，只有接受拉米夫定治疗的患者中有 33%观察到 HBV DNA 抑制（<55 IU/ml），而未接受 HBV 活性药物治疗的患者中有 13%（P=0.13）。在随访期间，合并感染（17%）参与者的死亡率明显高于单感染（11%）参与者（P=0.04）。
总之，在 PHIDISA II 中，在 HIV/HBV 参与者中使用含拉米夫定的 ART 治疗除了 ART 本身之外几乎没有额外的益处，并且未能影响该组的更高死亡率。这些数据为最近的指南提供了有力支持，该指南主张在开始 ART 时，所有 HIV-HBV 合并感染个体均使用替诺福韦。
