Cobas(R) HCV Gt for Use on the Cobas(R) 4800 System: A Highly Accurate HCV Genotyping Test

POSTER PRESENTATIONS overall genotype accuracy of Abbott Real Time HCV GT Assay II compared to sequencing was 98.6% (342/347). One of 377 samples yielded mixed genotype results and 29 samples yielded indeterminate results. Subtype accuracy on genotype 1a and 1b samples was 100% (143/143). The subtype was not identified for one genotype 1a and five genotype 1b samples. The overall genotype accuracy of Versant HCV Genotype 2.0 Assay compared to sequencing was 100% (364/364). Eight of 377 samples yielded mixed genotype results and five samples yielded HCV negative results. Subtype accuracy on genotype 1a and 1b samples was 100% (141/141). The subtype was not identified on four genotype 1a and three genotype 1b samples. The percent agreement for identification of HCV genotypes 1 to 6 was 99.7% (333/334) between cobas ® HCV GT and Abbott Real Time HCV GT Assay II and 99.7% (338/339) between cobas ® HCV GT and Versant HCV Genotype 2.0 Assay. Conclusions: cobas ® HCV GT for use on the cobas ® 4800 System is a highly accurate, fully automated, real-time PCR, HCV genotyping assay with excellent genotyping and subtyping accuracy compared to sequencing, for genotypes 1 to 6 and subtypes 1a and 1b.

Conclusions: Tubular and/or glomerular involvement are quite frequent in HCV cirrhotic patients. The occurrence of eGFR < 90 mL/ min/1.73 m2 allows to recognize patients with chronic renal involvement and should prompt to monitor renal function more closely. FRI-165 COBAS(R) HCV GT FOR USE ON THE COBAS(R) 4800 SYSTEM: A HIGHLY ACCURATE HCV GENOTYPING TEST S.A. Herman1, E. Perez1, E.G. Marins2, T. Schneider3, A. Berger4, C. Sarrazin4. 1Development; 2Medical Affairs, Roche Molecular Systems, Inc., Pleasanton, United States; 3Development, Roche Diagnostics International AG, Rotkreuz, Switzerland; 4J. W. Goethe University Hospital, Frankfurt, Germany E-mail: [email protected] Background and Aims: Identification of Hepatitis C Virus (HCV) genotypes 1 to 6 and subtypes 1a and 1b from individuals with chronic HCV infection is essential to select the most appropriate therapeutic regimen. This study evaluated the accuracy of cobas ® HCV GT for use on the cobas® 4800 System compared to nucleic acid sequencing, and the correlation of cobas ® HCV GT with two CEmarked in vitro diagnostic assays. Methods: 379 HCV positive plasma and serum specimens with HCV viral loads ≥1,000 International Units/mL were tested with cobas ® HCV GT, Abbott Real Time HCV GT Assay II and Versant HCV Genotype 2.0 Assay. Results were compared to the genotype determined by nucleic acid sequencing in the 5′ untranslated region (5′ UTR) and the NS5b gene. Samples with HCV negative, indeterminate or mixed genotype results were excluded from the calculations of percent agreement. Results: The overall genotype accuracy of cobas ® HCV GT compared to nucleic acid sequencing was 99.7% (352/353). Six of 379 samples yielded mixed genotype results and 20 samples yielded indeterminate results (HCV detected but no genotype identified). Subtype accuracy on genotype 1a and 1b samples was 100% (148/ 148). The subtype was not identified for one genotype 1b sample. The S612

FRI-166 LONG-TERM FOLLOW-UP OF PATIENTS WITH CHRONIC HCV INFECTION FOLLOWING TREATMENT WITH DIRECT ACTING ANTIVIRAL REGIMENS: MAINTENANCE OF SVR, PERSISTENCE OF RESISTANCE MUTATIONS AND CLINICAL OUTCOMES E.J. Lawitz1, P. Ruane2, C. Stedman3, G. Foster4, R.H. Hyland5, S. Coogan6, S. Moody7, H. Dvory-Sobol8, S.J. Knox5, D.M. Brainard5, A. Abergel9, K. Agarwal10, Z. Younes11, C. Schwabe12. 1Texas Liver Institute, University of Texas Health Science Center, San Antonio, TX; 2 Ruane Medical and Liver Health Institute, Los Angeles, CA, United States; 3Christchurch Hospital, Christchurch, New Zealand; 4Blizard Institute, Queen Mary University of London, London, United Kingdom; 5 Clinical Research, Gilead Sciences, Inc.; 6Clinical Operations, Gilead Sciences Inc., Foster City, CA; 7Pharpoint Research, Inc., Durham, NC; 8 Clinical Virology, Gilead Sciences, Inc., Foster City, CA, United States; 9 Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France; 10King’s College Hospital, London, United Kingdom; 11Gastro One, Germantown, TN, United States; 12Auckland Clinical Studies, Auckland, New Zealand E-mail: [email protected] Background and Aims: Significant advances in the treatment of chronic hepatitis C have been made with the introduction of direct acting antiviral (DAA) regimens. While sustained virologic response (SVR) rates may now be achieved in the majority of patients, data describing long term virologic and clinical outcomes with these regimens are needed. Methods: We report interim data from two 3-year registry studies capturing long-term outcomes in patients with chronic hepatitis C treated with DAAs. Subjects are enrolled into the two registries according to SVR status; SVR versus non-SVR (Sequence registry). We determined the durability of SVR, relapse rates and reinfection rates. The persistence of resistance associated variants (RAV) in treatment failures is followed. Liver disease progression is assessed by periodic clinical and laboratory evaluations. Results: 5433 patients enrolled in the SVR registry with a median (range) follow-up of 71 (0-156) weeks. 536 patients enrolled in the Sequence registry with a median (range) of follow-up of 44 (0–159) weeks. Demographic and disease characteristics are described below. In the SVR registry, at the time of data analysis 99.7% (5414/5433) of patients have maintained SVR with 0.3% (19/5433) having emergent virus (6 relapses, 8 new infections, 5 to be confirmed). Viral emergence occurred by Week 96 in all patients. In the Sequence registry, of 89 patients who received an NS5A inhibitor and had baseline sequencing data 91.0% (81/89) had NS5A RAVs at Week 96. HCC was reported in 0.3% (16/5433) and 0.9% (5/536) of patients in the SVR and Sequence registries through Week 96 respectively. There

Journal of Hepatology 2016 vol. 64 | S425–S630