A. Vavassori

525 TENOFOVIR MONOTHERAPY FOR NAÏVE PATIENTS WITH CHRONIC HEPATITIS B: A MULTICENTER EUROPEAN STUDY IN CLINICAL PRACTICE IN 302 PATIENTS FOLLOWED FOR 30 MONTHS

Pinzello8, Alessia M. Giorgini9, Massimo Zuin9, Andrea Salmi10, Paolo Del Poggio11, Francesca De Filippi12, Savino Bruno12, Luisa Pasulo13, Stefano Fagiuoli13, Marco Andreoletti14, Agostino Colli14, Francesco Fumagalli Maldini15, Maria Milanese15, Alberto Eraldo Colombo16, Giorgio Bellati16, Elena Angeli17, Carlo Magni17, Guido A. Gubertini17, Giuliano Rizzardini17, Massimo Fasano18, Teresa Santantonio19, Natalia M. Terreni20, Giancarlo Spinzi20, Floriana Facchetti1, Federica Invernizzi1, Massimo Colombo1 Tenofovir monotherapy for naive patients with chronic hepatitis B: a multicenter European study in clinical practice in 302 patients followed for 30 months

522 MAINTAINED VIRAL SUPPRESSION AND EXCELLENT SAFETY PROFILE OF ENTECAVIR MONOTHERAPY IN 418 NUC-NAÏVE PATIENTS WITH CHRONIC HEPATITIS B: A 4-YEAR FIELD PRACTICE, MULTICENTER STUDY

Angela Testa7, Pasquale Narciso7, Giorgio Antonucci7, Maria Vinci8, Giovambattista Pinzello8, Erika Fatta9, Silvia Fargion9, Paolo Del Poggio10, Barbara Coco11, Maurizia R. Brunetto11, Marco Andreoletti12, Agostino Colli12, Massimo Fasano14, Teresa Santantonio13, Guido Colloredo15, Luisa Pasulo16, Stefano Fagiuoli16, Alberto Eraldo Colombo17, Giorgio Bellati17, Francesco Fumagalli Maldini18, Maria Milanese18, Massimo Pozzi19, Natalia M. Terreni20, Giancarlo Spinzi20, Michela Quagliuolo21, Mauro Borzio21, Giovanna Lunghi22, Massimo Colombo1 Maintained viral suppression and excellent safety profile of entecavir monotherapy in 418 NUCnaive patients with chronic hepatitis B : a 4-year field practice, multicenter study

The Use of Ultrasonography, Transient Elastography, APRI and FIB-4 to Measure Liver Steatosis and Fibrosis in HIV-Positive Patients Not Co- Infected with Hepatitis Viruses with Hypertransaminasemia of Unknown Etiology on HAART

Background: HIV positive patients may be affected by hypertransaminasemia notwithstanding they are not co- infected with HCV and HBV. Aims: To understand the causes of this abnormality and what correlates are in terms of ultrasonic transient elastography (UTE) and ultrasonography (U) features and fibrosis scores. Methods: HIV positive patients with hypertransaminasemia have been studied. They underwent UTE and U. Non-invasive fibrosis scores (APRI and FIB-4) were calculated. Moreover, they underwent immunological and virological tests to exclude known causes of liver damage (including alcohol abuse). Results: Among 24 patients, 3 presented a progressive fibrosis at UTE. 3/3 with progressive fibrosis and further 14 patients among the entire sample had steatosis at U. Using non-invasive fibrosis scores, no patients had significant fibrosis, while 5 patients had mild fibrosis. 14 patients had hepatomegaly independently from steatosis. One patient has progressive fibrosis at UTE and mild fibrosis at both APRI and FIB-4, while 2 patients had fibrosis only at UTE, 2 only at APRI and 1 at both APRI and FIB-4, but not at UTE. Alcoholaemia was negative in all patients, confirming anamnestic information. No other causes of liver disease were found. Conclusions: In this series, more than 50% of patients had steatosis at U. Discordance between the non-invasive methods to estimate liver fibrosis were found. Further prospective studies are necessary to assess concordance between these methods and liver biopsy and assess the prognostic value of UTE, APRI and FIB-4 for liver complications in HIV mono- infected patients so as to improve diagnostic algorithms.

Litiasi biliare e renale in paziente con coinfezione HIV e HCV genotipo 4 in corso di terapia con daclatasvir/sofosbuvir + ribavirina e atazanavir/ritonavir + abacavir/lamivudina: caso clinico

New Direct-acting Antiviral Agents (DAA)-based anti-HCV therapies currently provide extraordinary opportunities to cure patients. Drug-drug interactions are however a real challenge during treatment. In particular, in HIV-infected patients in cART, DAA choice is limited by such interactions, which can result both in reduced efficacy and toxicity. We report the case of a HIV-infected patient on cART with atazanavir/ritonavir/abacavir/lamivudine, who presented kidney and biliary lithiasis, the latter treated with endoscopic retrograde cholangiopancreatography and endoscopic biliary sphincterotomy, after beginning anti-HCV treatment with daclatasvir/sofosbuvir/ribavirin. Hyperbilirubinemia with or without jaundice is a well known side effect of atazanavir, because of its inhibition of uridine diphosphate-glucuronosyl transferase. We speculate that in this case hyperbilirubinemia worsening was due to atazanavir/ribavirin co-administration. However, pharmacokinetic data are lacking about atazanavir/daclatasvir concomitant administration in real life setting.

T-8 Entecavir monotherapy in 418 NUC-naive patients with chronic hepatitis B from field practice: high efficacy and favorable safety profile over 3 years of treatment

direct anti-hepatitis B agents; however, prevalence and clinical impact of this adverse event are poorly appreciated. Material and Methods: 124 patients (78% males, 58 yr, 60% cirrhosis, 14% with 2(OH)-vitamin D deficiency, 90% under tenofovir±lamivudine treatment for 15 months) underwent two dual energy X-ray absorptiometry (DXA) of the lumbar spine (LS) and femoral neck (FN) performed at least 12 months a part. A T score of less than -2.5 and a T score between -1 and -2.5 identified osteoporosis and osteopenia, respectively (WHO criteria). All patients lacked concomitant medication affecting bone metabolism or osteoporosi in the first DXA scan. Results: During a median interval of 15 months (12-50) between DXA scan, 13 (26%) of 50 (40%) patients with normal BMD at the first DXA scan progressed to osteopenia (3 at LS, 7 at FN and 3 at both LS and FN) but none to osteoporosis. Among the 74 (60%) patients with osteopenia at the first DXA scan, 5 (7%) progressed to osteoporosis (2 at LS, 2 at FN and 1 at both LS and FN). Overall, 77% of the patients had stable BMD, 8% improved and 15% worsened. Median LS and FN T scores remained stable between DXA scans (-0.70 vs -0.80; -1.10 vs -1.10, p=ns). Age, gender, BMI, cirrhosis, nucleotide treatment, duration of antiviral therapy, immunosuppression and vitamin D status were not associated with worsening of BMD. In conclusion, in patients with chronic hepatitis B under nucleos(t)ide therapy, BMD worsened in a minority of patients only.

Liver fibrosis: concordance analysis between APRI and FIB-4 scores, evolution and predictors in a cohort of HIV patients without HCV and HBV infection

7‐11 November 2010, Tenth International Congress on Drug Therapy in HIV Infection, Glasgow, UK