CROI 2016 Abstract eBook
Abstract Listing
Poster Abstracts
584 Directly Acting Agents Against HCV Results From the German Hepatitis C Cohort (GECCO)
Stefan Christensen 1 ; Stefan Mauss 2 ; Dietrich Hueppe 3 ;Thomas Lutz 4 ; Knud Schewe 5 ; Jürgen K. Rockstroh 6 ; Axel Baumgarten 7 ; Karl Georg Simon 8 ; Heiner Busch 1 ; Patrick Ingiliz 7 1 Cntr for Interdisciplinary Med, Muenster, Germany; 2 Cntr for HIV and Hepatogastroenterology, Duesseldorf, Germany; 3 Practice for Gastroenterology Herne, Herne, Germany; 4 Infektiologikum, Frankfurt/Main, Frankfurt, Germany; 5 ICH Hamburg, Hamburg, Germany; 6 Medizinische Univsklinik, Bonn, Germany; 7 Med Cntr for Infectious Diseases, Berlin, Germany; 8 Practice for Gastroenterology Leverkusen, Leverkusen, Germany Background: Since 2014, several directly acting agents (DAA) have been approved for therapy of chronic hepatitis C virus (HCV) infection in Europe. Henceforward, interferon– free regimens have become standard-of-care in Germany. Recently shortening therapy to 8 weeks was introduced for sofosbuvir (SOF) and ledipasvir (LDV). Here, we report data from the German hepatitis C cohort (GECCO). Methods: The GECCO cohort is a multicenter cohort from 8 sites in Germany. All patients starting on the following DAAs were included in the analysis: SOF/pegylated interferon (PegIFN)/ribavirin (RBV); SOF/RBV; SOF/simeprevir (SMV); SOF/daclatasvir (DCV) +/- RBV; SOF/ledipasvir (LDV) +/-RBV; paritaprevir/ritonavir)/ombitasvir/dasabuvir (3D)+/-RBV. A particular interest was given to patients treated for 8 weeks with SOF/LDV. All GECCO patients are part of the German hepatitis C registry. Results: Up to now, 1157 patients were included into the cohort, 65%were male, and the mean age was 53 years. 282 (24.4%) were HIV-HCV coinfected with a median CD4 cell count of 608/mm 3 (IQR 403-765). The HCV genotype (GT) distribution was as follows: 841 (73%) GT 1, 49 (4.4%) GT 2, 188 (16%) GT 3, 74 (6.3%) GT4. The SVR12 (ITT) rates were: GT1: 89%, GT2: 87%, GT3: 81%, GT4: 79%, but only 6% of failures were related to relapse. HIVHCV-coinfected patients responded as well as HCV monoinfected patients (83% vs 81%, p=ns). In patients with genotype 1 and 4, SVR12 rates were significantly lower in patients with liver cirrhosis than without cirrhosis (75% vs 89%, p=0.02). 3 hepatic decompensations and 3 deaths occurred. 3 reinfections after SVR were documented within the observational period. 132 (127 GT 1 and 5 GT 4) patients were treated with SOF/LDV for 8 weeks: 19% of the patients had been unsuccessfully treated before, mainly with dual therapy consisting of pegylated interferon and ribavirin. 17%were HIV coinfected. Post-treatment week 12 has been reached by 92 patients so far, only 2 patients relapsed (SVR =98%). Conclusions: DAA-based treatments are highly effective in real-life in HCV-mono- and HIV-HCV-coinfected patients. Relapse occurs only in 6%, and more often in patients with liver cirrhosis. All DAA combinations were generally well tolerated. In particular SOF/LDV for 8 weeks seems highly effective in selected patients in this population. 585 High HCV Cure Rates for Drug Users TreatedWith DAAs at an Urban Primary Care Clinic Brianna Norton ; Julia Fleming; Meredith Steinman; KimYu; Joseph Deluca; Chinazo O. Cunningham; Alain Litwin Montefiore Med Cntr, Bronx, NY, USA
Background: New direct-acting antivirals promise high cure rates for the majority of patients with chronic HCV; however, it is unknown whether high cure rates will be obtained in clinical practice, particularly among persons who use drugs (PWUDs). We investigated the effectiveness of onsite treatment with care coordination for patients that access primary care at an urban federally qualified health center (FQHC), and we explored differences in HCV cure rates for PWUD versus non-PWUD. Methods: Onsite HCV treatment occurred once weekly by an HCV specialist at an FQHC in the Bronx, NY. An HCV care coordinator, funded by the NYC Department of Health’s Check Hep C Program, was responsible for patient scheduling, reminder calls, health education, and obtaining prior authorizations. We identified 114 patients with an HCV evaluation from January 2014- February 2015, and reviewed medical records for patients who initiated HCV treatment. Patients were categorized as PWUD if they were receiving opioid agonist therapy (OAT) or noted to have active drug use in the medical chart or urine toxicology. Chi-square testing was performed to determine differences in HCV cure between PWUD and non-PWUD. Results: 114 patients were evaluated for HCV and 67 (59%) initiated HCV treatment during the study time frame. Treatment patients were mostly male (64%), Latino or African American (82%), with a median age of 60. 21%were HCV treatment experienced, 22%were HIV/HCV co-infected, and 24% had cirrhosis. Over half of the patients were PWUD (52%). 28 patients were on OAT (15 on methadone, 13 on buprenorphine) and 24 patients were actively using drugs during HCV care. The majority of the patients were genotype 1 (93%) and all were treated with sofosbuvir-based regimens. The overall HCV cure rate was 94% (63/67), and there were no differences in cure rates for PWUD (94%, 33/35) versus non-PWUD (94%, 30/32, p=0.5). Conclusions: Suboptimal HCV treatment of PWUD contributes to growing HCV-related morbidity and mortality, and maintains a continued reservoir for HCV infection. Among PWUD who received care coordinator assisted sofosbuvir-based therapy at an urban FQHC, HCV cure rates were high, and no different than for non-PWUD. On-site treatment with care coordination may help to mitigate barriers to specialty care and improve HCV cure rates for PWUD. Similar treatment models should be replicated and tested throughout the 1200 FQHCs in the United States, settings that are known to serve high numbers of PWUD.
Poster Abstracts
586 Impact of Liver Stiffness on Response to DAA-Based HCV Therapy In Cirrhotic Patients
Karin Neukam 1 ; Antonio Rivero-Juárez 2 ; Luis E Morano-Amado 3 ; Rafael Granados 4 ; Antonio Collado 5 ; Dolores Merino 6 ; Mª José Blanco Rodríguez 7 ; Sergio Reus-Bañuls 8 ; Juan A. Pineda 9 ; for the Grupo de Estudio de HepatitisVírica, Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica: GEHEP-SEIMC; Grupo de Estudio de HepatitisVírica, Sociedad Andaluza de Enfermedades Infecciosas y Microbiología Clínica: HEPAVIR; RIS-HEP07 1 Valme Univ Hosp, Seville, Spain; 2 IMIBIC, Córdoba, Spain; 3 Hosp Universitario Alvaro Cunqueiro, Vigo, Spain; 4 Hosp Universitario de Gran Canaria Doctor Negrín, Las Palmas, Spain; 5 Hosp Universitario Torrecárdenas, Almería, Spain; 6 Complejo Hospario de Huelva, Huelva, Spain; 7 Hosp Jerez de la Frontera (AGS Norte de Cádiz), Jerez de la Frontera, Spain; 8 Hosp General Universitario de Alicante, Alicante, Spain; 9 Hosp Universitario de Valme, Sevilla, Spain Background: Specific clinical trials or substudies within clinical trials in cirrhotic patients are commonly conducted, including patients with a liver stiffness (LS) above a specific threshold (usually above 12.5-14 kPa). However, the median levels of LS differ considerably between studies. In addition, rates of sustained virologic response (SVR) according to the level of LS are scarcely analyzed in trials including cirrhotic subjects, in spite of the fact that LS might have an impact on the likelihood of SVR within this subset. Therefore, the aim of this study was to evaluate the impact of the grade of liver stiffness on SVR to DAA-based therapy in patients with cirrhosis in real-life practice.
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CROI 2016
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