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1026A AASLD ABSTRACTS HEPATOLOGY, October, 2015 1676 Noninvasive markers of liver fibrosis remain stable in the majority of hepatitis B virus and human immunodeficiency virus co-infected patients undergoing tenofovir-containing antiretroviral therapy Anders Boyd 1 , Karine Lacombe 1,2 , Pierre-Marie Girard 1,2 , Caroline Lascoux-combe 3 , Patrick Miailhes 4 , Hayette Rougier 2 , Lawrence Serfaty 2 ; 1 Inserm UMR_S1136, Paris, France; 2 Hôpital Saint-Antoine, Paris, France; 3 Hôpital Saint-Louis, Paris, France; 4 Hôpital Croix-Rousse, Lyon, France Long-term tenofovir (TDF) use has been associated with significant regression of liver fibrosis during hepatitis B virus (HBV) monoinfection. However, there are few data in TDF-treated patients infected with both HBV and the human immunodeficiency virus (HIV), in whom HIV-associated immunosuppression could affect liver repair. In this prospective study, 168 HIV-HBV co-infected patients enrolled in the French HIV-HBV cohort were included if they initiated TDF-containing antiretroviral therapy and had liver fibrosis measurements at baseline and ≥1 during treatment. Patients with hepatitis C of D virus were not included. Fibrosis was assessed at baseline and every 6-12 months and ≥F3 fibrosis determined from two noninvasive measures: biochemical score (≥0.59, FibroTest®) and/or transient elastography (≥7.6kPa, FibroScan). Determinants for fibrosis regression or progression were evaluated using Cox proportional hazards regression. Patients were predominately male (86.3%) with a median age of 41 years (IQR=36-48). At baseline, HBV- DNA was detectable in 134 (80.2%) patients with a median HBV-DNA viral load of 5.02 IU/mL (IQR=2.95-7.15) and 104 (61.9%) had HBeAg-positive serology. After a median follow-up of 59.3 months (IQR=36.1-92.7), 140 (83.3%) patients were able to maintain or achieve undetectable HBV-DNA viral loads. Among patients with F3-F4 baseline liver fibrosis, 24/53 (45.3%) remained at the same level of fibrosis during treatment and 29/53 (54.7%) regressed to F0-F1-F2 fibrosis after a median 16.9 months (IQR=8.6-32.8). Of the latter group, 10/29 (34.5%) maintained F0-F1-F2 fibrosis until the end of follow-up. Liver fibrosis regression was significantly associated with CD4+ cell count ≥500/mm 3 (HR=2.09, 95%CI=1.13- 3.88) in multivariable analysis. Among patients with F0-F1-F2 baseline liver fibrosis, 70/115 (60.9%) remained at the same level of fibrosis and 45/115 (39.1%) progressed to F3-F4 fibrosis after a median 29.0 months (IQR=18.0-47.4). Of the latter group, 28/45 (59.6%) maintained F3-F4 fibrosis. Liver fibrosis progression was significantly associated with higher age (HR/year=1.10, 95%CI=1.06-1.14), alanine aminotransferase >2X ULN (HR=2.10-9.28), and tended to be associated with an AIDS-defining event (HR=1.79, 0.98-3.27) in multivariable analysis. In conclusion, liver fibrosis levels are stable for the majority of HIV-HBV co-infected patients undergoing TDF-containing ART, despite extensive control of HBV replication. Immunosuppression plays a strong role in reducing fibrosis levels, supporting the need for earlier ART-initiation in this patient population. Disclosures: Lawrence Serfaty - Advisory Committees or Review Panels: MSD, Janssen, Roche, Gilead, BMS, Abbvie; Speaking and Teaching: Aptalis The following authors have nothing to disclose: Anders Boyd, Karine Lacombe, Pierre-Marie Girard, Caroline Lascoux-combe, Patrick Miailhes, Hayette Rougier 1677 Factors associated with decreases in estimated glomular filtration rates for patients co-infected with hepatitis B virus and human immunodeficiency virus undergoing tenofovir-containing antiretroviral therapy Anders Boyd 1 , Karine Lacombe 2,1 , Patrick Miailhes 3 , Caroline Lascoux-combe 4 , Hayette Rougier 2 , Julie Bottero 2,1 , Pierre-Marie Girard 2,1 ; 1 Inserm UMR_S1136, Paris, France; 2 Hôpital Saint-Antoine, Paris, France; 3 Hospices Civils de Lyon, Lyon, France; 4 Hôpital Saint-Louis, Paris, France Renal toxicity remains one of the more common tolerance issues encountered during prolonged treatment with tenofovir (TDF). Although determinants for renal impairment during TDF have been well established among patients infected with hepatitis B virus (HBV) or human immunodeficiency virus (HIV), little is known how these specific factors influence renal function in HIV-HBV co-infected patients. In this prospective study, 175 HIV-HBV co-infected patients enrolled in the French HIV-HBV cohort were included if they initiated TDF-containing antiretroviral therapy (ART) and had creatinine levels available at baseline and ≥1 during treatment. Patients with hepatitis C or D virus were not included. Estimated glomular filtration rates (eGRF) were calculated using the CKD-EPI equation from creatinine values obtained at baseline and every 6-12 months. Mixed-effect linear regression models were used to evaluate differences in eGRF changes from baseline (ΔeGFR) between certain risk-factors. Determinants towards impaired renal function (90 (p=0.002), males (p=0.04), an AIDS-defining illness (p=0.03), shorter duration of ART at baseline (p=0.01), concomitant therapy with a protease inhibitor (p=0.005), and baseline liver cirrhosis (p=0.03). Among patients with normal baseline renal function, 51/114 (44.7%) maintained eGFR levels >90 mL/min/1.73m 2 , while 63/114 (55.3%) developed either mild (60-89 mL/min/1.73m 2 , n=59) or moderate (30-59 mL/min/1.73m 2 , n=4) renal impairment after 15.0 months (IQR=7.1-35.8). In multivariable analysis, higher age (HR/year=1.05, 95%CI=1.01-1.10) and AIDS-defining illness (HR=1.68, 95%CI=1.05-2.69) were associated with developing renal impairment, whereas undetectable HBV-DNA was significantly protective (HR=0.41, 95%CI=0.23-0.76). In conclusion, liver fibrosis and AIDS-defining illnesses negatively and independently affect renal function in HIV-HBV co-infected patients undergoing long-term TDF. Controlled HBV-infection prevents further progression towards renal impairment, stressing the need for effective therapy in this population. Disclosures: The following authors have nothing to disclose: Anders Boyd, Karine Lacombe, Patrick Miailhes, Caroline Lascoux-combe, Hayette Rougier, Julie Bottero, Pierre-Marie Girard
HEPATOLOGY, VOLUME 62, NUMBER 1 (SUPPL) AASLD ABSTRACTS 1027A 1678 No Detectable Resistance to Tenofovir Disoproxil Fumarate (TDF) when Given Alone or in Combination with Emtricitabine (FTC) in Chronic Hepatitis B (CHB) Patients with Documented Resistance to Lamivudine (LAM): Final 5 Year Results Thomas Berg 2 , Edward J. Gane 3 , Maciej S. Jablkowski 4 , Petr Urbanek 5 , Amoreena C. Corsa 1 , Yang Liu 1 , Kyungpil Kim 1 , John F. Flaherty 1 , Cihan Yurdaydin 6 , Scott Fung 7 , Kathryn M. Kitrinos 1 ; 1 Gilead Sciences, Foster City, CA; 2 University Hospital Leipzig, Leipzig, Germany; 3 New Zealand Liver Transplant Unit, Auckland, New Zealand; 4 Medical University of Lodz, Lodz, Poland; 5 Central Military Hospital Prague, Prague, Czech Republic; 6 Ankara University Medical School, Ankara, Turkey; 7 Toronto General Hospital, Toronto, ON, Canada Aim: To compare amino acid changes within HBV polymerase/reverse transcriptase (pol/RT) after up to 5 years (240 weeks) of treatment with TDF or the combination of FTC and TDF. Methods: Patients enrolled in the study were receiving LAM, harbored LAM resistance mutations in pol/RT (rtM204V/ I±rtL180M) as determined by INNO-LiPA Multi-DR v2/v3, and were randomized 1:1 to receive TDF or FTC/TDF for up to 240 weeks. A subset of enrolled patients received prior CHB treatment in addition to LAM: 13 received entecavir (ETV) and 61 received adefovir (ADV). In addition, a subset of enrolled patients harbored ETV resistance mutations at baseline (TDF = 14, FTC/TDF = 11). Virologic breakthrough (VB) was defined as confirmed HBV DNA >1 log 10 increase from nadir or HBV DNA ≥69 IU/mL after
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1312A AUTHOR INDEX HEPATOLOGY, Octo
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