CROI 2015 Program and Abstracts

Abstract Listing

Oral Abstracts

Conclusions: The kinetics of viral decline in patients of the Synergy trial was remarkably slow in regard of the very rapid cure of HCV. This suggests that HCV RNA is not a reliable marker for predicting outcome of treatment containing SOF+LDV. Additional mechanisms of action that are not reflected in the observed viral load, such as production of non- infectious virus, may explain the high cure rates. 149 Real-World Pharmaceutical Costs in the Simeprevir/Sofosbuvir Era: $164,485 per SVR4 Kian Bichoupan 1 ; NeetaTandon 2 ; RachanaYalamanchili 1 ; Neal M. Patel 1 ; Sweta Chekuri 1 ; Alyson Harty 1 ;Thomas Schiano 1 ; PonniV. Perumalswami 1 ; Douglas Dieterich 1 ; Andrea D. Branch 1 1 Mount Sinai School of Medicine, New York, NY, US; 2 Janssen Scientific Affairs, Titusville, NJ, US Background: Pharmaceutical costs-per-sustained virologic response (SVR4) were determined for patients treated with simeprevir (SMV) and sofosbuvir (SOF) at a large metropolitan medical center. Methods: The SVR4 rate was calculated for 103 genotype 1 HCV-infected patients who started on SMV- SOF-containing regimens between 12/2013-6/2014. Advanced fibrosis/ cirrhosis was defined as a FIB-4 score ≥ 3.25. Costs were based on Red Book Wholesale Acquisition Costs and the number of days on treatment: SMV=$790/d, SOF =$1,000/d, and RBV=$8.58/d. The rate of relapse between 4 and 12 weeks after the end of treatment (EOT) was determined for 41 patients with the necessary follow up data. Episodes of hepatic decompensation and other serious adverse events (SAEs) were noted. Results: The median age of the 103 patients was 60 years (interquartile range [IQR] = 54-65 years), 14% had HIV/HCV co-infection, 13%were black, 74%were male, 46% had a score ≥ 3.25; 74% had genotype 1a HCV, 25%were naïve to treatment, 28% previously failed therapy with an HCV protease inhibitor. Median baseline laboratory values were as follows: platelet count = 154 x103/ m L (IQR: 111-194 x103/ m L), albumin = 4.1 g/dL (IQR: 3.8-4.4 g/dL), total bilirubin = 0.7 mg/dL (IQR: 0.5 – 1.0 mg/dL), median log HCV viral load = 6.25 IU/ mL (IQR: 5.90 – 6.72 IU/mL). The treatment completion rate for the entire group was 98%, see Table. Overall, 93 (90%) achieved SVR4: SMV/SOF/RBV 77/85 (91%), SMV/SOF 16/18 (89%). Three (2.9%) patients experienced hepatic decompensation/SAE. The SVR4 rates for mono-infected and HIV/HCV patients were 89% and 100% (p=0.35), respectively. The overall mean pharmaceutical cost-per-SVR4 was $164,485. Among 41 patients with the necessary follow up, three (7%) relapsed between week-4 and week-12 post EOT. Cost per SVR by Regimen Conclusions: In the SMV/SOF era, 98% of patients completed the planned regimen in real world clinical practice. The SVR4 rate was 90% and the mean pharmaceutical cost- per-SVR4 was $164,485. Treatment was highly effective in patients with HIV/HCV co-infection. Rates of decompensation/SAE were < 3%. Surveillance beyond SVR4 is needed to determine the final SVR rate. Seven percent of patients with follow up data relapsed between 4 and 12 weeks EOT. 150 Impact of Deferring HCV Treatment on Liver-Related Events in HIV+ Patients Cindy Zahnd 1 ; Luisa P. Salazar-Vizcaya 1 ; Jean-François Dufour 2 ; Beat Müllhaupt 3 ; GillesWandeler 1 ; Roger Kouyos 3 ; Barbara Bertisch 1 ; Andri Rauch 2 ; Olivia Keiser 1 The Swiss HIV and Hepatitis C Cohort Studies 1 Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland; 2 University Hospital Bern, Bern, Switzerland; 3 University Hospital Zurich, Zurich, Switzerland Background: Successful treatment of HCV infections substantially reduces the risk of liver-related complications. However, cost considerations and the availability of better treatment options in the future often leads to the deferral of treatment of HCV infection in patients with limited liver fibrosis. In this study, we modelled the impact of different treatment strategies on liver fibrosis progression among HIV-infected patients with incident HCV infection. Methods: We developed an individual-based model of liver disease progression. We parameterized it with observed data on incident HCV infections among men who have sex with men from the Swiss HIV Cohort Study (SHCS) and with published data. We simulated patients from HCV infection through stages of liver disease: from fibrosis grade F0 to F4, decompensated cirrhosis, hepatocellular carcinoma and death. Liver disease progression was affected by age at HCV infection and alcohol consumption. Patients also progressed through the care cascade: they could be diagnosed, treated and succeed or fail treatment. We assumed treatment efficacy with Interferon (IFN)-free regimen was 90%. Successfully treated patients had a residual liver fibrosis progression of 0.1 times the rate of patients with detectable HCV. We compared liver-related events and duration of infectiousness (ie. detectable viral load) between the following strategies: treatment of all patients one month after diagnosis, one year after diagnosis or as they reach F2, F3 or F4. Results: Delaying treatment until 1 year after diagnosis or until F2, F3 or F4 led to 14, 43, 142 and 418 additional cases of liver-related deaths per 1000 HCV infections as compared with treating all patients one month after diagnosis. The average time people were infectious increased from 5 years with early (one month after diagnosis) to 21 years with late (F4) treatment ( Figure ).

Oral Abstracts

SHCS is our base scenario and is given here for reference, it depicts current practise in the SHCS. HCC: Hepatocellular Carcinoma

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CROI 2015