Amy E Greer1, San-San Ou, Ethan Wilson, Estelle Piwowar-Manning, Michael S Forman, Marybeth McCauley, Theresa Gamble, Cholticha Ruangyuttikarn, Mina C Hosseinipour, Nagalingeswaran Kumarasamy, Mulinda Nyirenda, Beatriz Grinsztejn, Jose Henrique Pilotto, Natthapol Kosashunhanan, Marineide Gonçalves de Melo, Joseph Makhema, Victor Akelo, Ravindre Panchia, Sharlaa Badal-Faesen, Ying Q Chen, Myron S Cohen, Susan H Eshleman, Chloe L Thio, Alexandra Valsamakis. 1. *Department of Pathology, Johns Hopkins Hospital, Baltimore, MD;†Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA;‡Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD;§FHI 360, Washington, DC;‖FHI 360, Durham, NC;¶Research Institute for Health Sciences, Chiang Mai University, Chaing Mai, Thailand;#University of North Carolina at Chapel Hill, Chapel Hill, NC;**UNC Project-Malawi, Institute for Global Health and Infectious Diseases, Lilongwe, Malawi;††YRGCARE Medical Centre, VHS, Chennai, India;‡‡College of Medicine-Johns Hopkins Project, Blantyre, Malawi;§§Instituto Nacional de Infectologia Evandro Chagas-INI-Fiocruz, Rio de Janeiro, Brazil;‖‖Hospital Geral de Nova Iguacu and Laboratorio de AIDS e Imunologia Molecular-IOC/Fiocruz, Rio de Janeiro, Brazil;¶¶Hospital Nossa Senhora da Conceição, Porto Alegre RS, Brazil;##Botswana Harvard AIDS Institute, Gaborone, Botswana;***Kenya Medical Research Institute, Kisumu, Kenya;†††Center for Disease Control, Kisumu, Kenya;‡‡‡University of the Witwatersrand, Perinatal HIV Research Unit, Soweto HPTN CRS, Soweto, South Africa;§§§University of Witwatersrand, Johannesburg, South Africa;‖‖‖Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC; and¶¶¶Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.
Abstract
OBJECTIVE: Data comparing hepatitis B virus (HBV) infection in HIV-infected [HIV(+)], and HIV-uninfected [HIV(-)] individuals recruited into the same study are limited. HBV infection status and chronic hepatitis B (cHB) were characterized in a multinational clinical trial: HIV Prevention Trials Network (HPTN 052). METHOD:HBV infection status at enrollment was compared between HIV(+) (N = 1241) and HIV(-) (N = 1232) from 7 HBV-endemic countries. Hepatitis B e antigen and plasma HBV DNA were determined in cHB. Median CD4, median plasma HIV RNA, and prevalence of transaminase elevation were compared in HIV(+) with and without cHB. Significance was assessed with χ, Fisher exact, and median tests. RESULTS: Among all participants, 33.6% had HBV exposure without cHB (8.9% isolated HBV core antibody, "HBcAb"; 24.7% HBcAb and anti-HB surface antibody positive, "recovered"), 4.3% had cHB, 8.9% were vaccinated, and 53.5% were uninfected. Data were similar among HIV(+) and HIV(-) except for isolated HBcAb, which was more prevalent in HIV(+) than HIV(-) [10.1% vs. 7.7%, P = 0.046]. Median HBV DNA trended higher in HIV(+) than in HIV(-). In HIV(+) with cHB versus those without cHB, transaminase elevations were more prevalent (alanine aminotransferase ≤ grade 2, 12% vs. 5.2%, P = 0.037; aspartate aminotransferase ≤ grade 2, 26% vs. 6.0%, P < 0.001), CD4 trended lower, and HIV RNA was similar. CONCLUSIONS:HBV infection status did not differ by HIV infection status. HIV co-infection was associated with isolated HBcAb and a trend of increased HBV DNA. In HIV, cHB was associated with mild transaminase elevations and a trend toward lower CD4.
RCT Entities:
OBJECTIVE: Data comparing hepatitis B virus (HBV) infection in HIV-infected [HIV(+)], and HIV-uninfected [HIV(-)] individuals recruited into the same study are limited. HBV infection status and chronic hepatitis B (cHB) were characterized in a multinational clinical trial: HIV Prevention Trials Network (HPTN 052). METHOD:HBV infection status at enrollment was compared between HIV(+) (N = 1241) and HIV(-) (N = 1232) from 7 HBV-endemic countries. Hepatitis B e antigen and plasma HBV DNA were determined in cHB. Median CD4, median plasma HIV RNA, and prevalence of transaminase elevation were compared in HIV(+) with and without cHB. Significance was assessed with χ, Fisher exact, and median tests. RESULTS: Among all participants, 33.6% had HBV exposure without cHB (8.9% isolated HBV core antibody, "HBcAb"; 24.7% HBcAb and anti-HB surface antibody positive, "recovered"), 4.3% had cHB, 8.9% were vaccinated, and 53.5% were uninfected. Data were similar among HIV(+) and HIV(-) except for isolated HBcAb, which was more prevalent in HIV(+) than HIV(-) [10.1% vs. 7.7%, P = 0.046]. Median HBV DNA trended higher in HIV(+) than in HIV(-). In HIV(+) with cHB versus those without cHB, transaminase elevations were more prevalent (alanine aminotransferase ≤ grade 2, 12% vs. 5.2%, P = 0.037; aspartate aminotransferase ≤ grade 2, 26% vs. 6.0%, P < 0.001), CD4 trended lower, and HIV RNA was similar. CONCLUSIONS:HBV infection status did not differ by HIV infection status. HIV co-infection was associated with isolated HBcAb and a trend of increased HBV DNA. In HIV, cHB was associated with mild transaminase elevations and a trend toward lower CD4.
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