HBV related complications in HIV positive patients during HAART therapy Irina Magdalena Dumitru*, E. Dumitru*, S. Rugina*, Roxana Carmen Cernat**, Simona Diaconu** *Ovidius University, Faculty of Medicine, ** Clinical Infectious Diseases Hospital, Constanta, ROMANIA Abstract no. WEPDB204

Background The natural history of HBV is known to be complicated by HIV coinfection, with a higher rate of chronic hepatitis, greater levels of HBV replication and lower incidences of spontaneous loss of HBeAg or HBsAg. We evaluated the long term evolution of liver disease among HIV/HBV coinfected patients receiving HAART. Methods Prospective, observational cohort study of 72 patients with HIV/HBV coinfection, without signs of liver disease in the begining of the study period. Prospective, observational cohort study of 72 patients with HIV/HBV coinfection, without signs of liver disease in the begining of the study period. The patients were treated with HAART, during a period of five years. The patients were treated with HAART, during a period of five years. Clinical and biological data were collected every 3 months, immunological and virological data every six months, ultrasound every year. Clinical and biological data were collected every 3 months, immunological and virological data every six months, ultrasound every year. In the last year we performed Fibroscan in every patient. In the last year we performed Fibroscan in every patient. Determination of HBV drug resistance was performed in cases with detectable serum HBV-DNA level (HBV-DNA < 55 UI/mL). Determination of HBV drug resistance was performed in cases with detectable serum HBV-DNA level (HBV-DNA < 55 UI/mL).

Patients characteristics All patients [No. (%)] N = 72 % Gender [No. (%)] Male Male Female Female Exposure group [No. (%)] Homosexual Homosexual IDU IDU Heterosexual Heterosexual Hepatitis B status [No. (%)] Ag HBe Negative Ag HBe Negative Ag HBe Positive Ag HBe Positive Hepatitis D status [No. (%)] 00 Hepatitis C status [No. (%)] Negative Negative Positive Positive Antiretroviral naïve [No. (%)] 00 HAART regimen [No. (%)] RTV-boosted PI RTV-boosted PI NNRTI NNRTI Mean age [years (IQR)] 28.5 (19.6 – 38.4) Mean CD4 cell count [cells/μl (IQR)] HIV-RNA < 50 copies/ml ( ) 100

Results After five years of follow-up, advanced liver disease was diagnosed in 8/72 patients: 5 liver cirrhosis 2 hepatocellular carcinoma 1 fulminant hepatitis All these patients had: high level of serum HBV-DNA lamivudine resistance (M204V, M204I, L180M, L180I) undetectable serum level of HIV Five of these patients died The rest of 64 patients had no signs of active liver disease: normal or less than 2 x ULN level of ALT, F0-F1 according to Fibroscan In these patients, serum HBV-DNA was detectable in another 14 cases Lamivudine resistance was founded in 10 cases Detectable HBV-DNA

Conclusion In HIV/HBV coinfected patients treated with HAART, LAM resistance is less frequent (25%) than in immunocompetent patients (higher than 60%*), but when occurred, was associated with: In HIV/HBV coinfected patients treated with HAART, LAM resistance is less frequent (25%) than in immunocompetent patients (higher than 60%*), but when occurred, was associated with: an accelerated course of liver disease an accelerated course of liver disease faster progression to cirrhosis faster progression to cirrhosis liver insufficiency liver insufficiency HCC HCC Appropriate monitoring of chronic viral hepatitis B in HIV positive patients include the recognition of LAM resistence in every case of detectable HBV-DNA level. Appropriate monitoring of chronic viral hepatitis B in HIV positive patients include the recognition of LAM resistence in every case of detectable HBV-DNA level. * Fischer KP et al. Drug Resist Updat. 2001, Pallier C et al. J Virol 2006