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Efficacy of sofosbuvir and simeprevir-based regimens for 304 HCV treatment-experienced patients in a real-life setting; data from the TRIO network [Meeting Abstract]
Bacon, Bruce R; Dieterich, Douglas; Flamm, Steven L; Kowdley, Kris V; Lawitz, Eric; Milligan, Scott; Younossi, Zobair; Tsai, Naoky
ISI:000344483803024
ISSN: 1527-3350
CID: 2729022
Evaluation of sofosbuvir and simeprevir-based regimens in the TRIO network: academic and community treatment of a real-world, heterogeneous population [Meeting Abstract]
Dieterich, Douglas; Bacon, Bruce R; Flamm, Steven L; Kowdley, Kris V; Milligan, Scott; Tsai, Naoky; Younossi, Zobair; Lawitz, Eric
ISI:000344483800047
ISSN: 1527-3350
CID: 2729012
Evaluation of efficacy of sofosbuvir and simeprevir-based regimens in a real-life population of 345 HCV patients with cirrhosis; data from the TRIO network [Meeting Abstract]
Flamm, Steven L; Bacon, Bruce R; Dieterich, Douglas; Kowdley, Kris V; Lawitz, Eric; Milligan, Scott; Tsai, Naoky; Younossi, Zobair
ISI:000344483803032
ISSN: 1527-3350
CID: 2729032
Similar Adjusted Svr12 Rates for HIV Co-Infected and HCV Mono-Infected Patients and No Dose or Population (Treatment-Naive/Relapser) Effect: Pooled Analysis of Faldaprevir Phase III Trials [Meeting Abstract]
Dieterich, Douglas T; Ferenci, Peter; Jacobson, Ira M; Negro, Francesco; Puoti, Massimo; Rockstroh, Juergen K; Manns, Michael P; Arasteh, Keikawus; Oliveira, Celia; Dufour, Jean-Francois; Zehnter, Elmar; Leen, Clifford; Bhagani, Sanjay; Stern, Jerry O; Quinson, Anne-Marie; Scherer, Joseph; Manero, Montserrat; Jensen, Donald M
ISI:000371236404395
ISSN: 1528-0012
CID: 2571222
Comparisons of Populations in Faldaprevir Phase III Studies Based on Pegylated Interferon alpha-2A and Ribavirin-Predicted Responsiveness and Impact on Achieving Svr12 [Meeting Abstract]
Ferenci, Peter; Jensen, Donald M; Dieterich, Douglas T; Jacobson, Ira M; Romero-Gomez, Manuel; Foster, Graham; Asselah, Tarik; Cooper, Curtis; Tural, Cristina; Streinu-Cercel, Adrian; Ryder, Stephen D; Puoti, Massimo; Tam, Edward; Calleja, Jose Luis; Nunez, Marina; Quinson, Anne-Marie; Boecher, Wulf; Voss, Florian; Scherer, Joseph
ISI:000371236404657
ISSN: 1528-0012
CID: 2571272
Faldaprevir Efficacy in HCV Genotype-1-Infected Patients in Four Phase III Trials: Analysis by Ns3 Baseline Polymorphisms, Genotype-1 Subtype and Genotype-1A Clades [Meeting Abstract]
Berger, Kristi; Sarrazin, Christoph; Jacobson, Ira M; Jensen, Donald M; Ferenci, Peter; Dieterich, Douglas T; Stern, Jerry O; Quinson, Anne-Marie; Scherer, Joseph; Kukolj, George
ISI:000371236404615
ISSN: 1528-0012
CID: 2571242
Effect of HCV Genotype-1 Subtype on Response to Faldaprevir Plus Pegylated Interferon alpha-2A and Ribavirin in Treatment-Naive Patients: Pooled Data From Phase III Trials [Meeting Abstract]
Jacobson, Ira M; Jensen, Donald M; Dieterich, Douglas T; Sarrazin, Christoph; Foster, Graham; Yoshida, Eric M; Nelson, Mark; Ingiliz, Patrick; Soriano, Vicente; Cooper, Curtis; Stern, Jerry O; Quinson, Anne-Marie; Kukolj, George; Scherer, Joseph; Drulak, Murray; Gallivan, John-Paul; Schobelock, Michael; Ferenci, Peter
ISI:000371236404651
ISSN: 1528-0012
CID: 2571262
MELD score and antibiotics use are predictors of length of stay in patients hospitalized with hepatic encephalopathy
Martel-Laferriere, Valerie; Homberger, Caitlin; Bichoupan, Kian; Dieterich, Douglas T
BACKGROUND: Hepatic encephalopathy (HE) represents a significant burden to the healthcare system. The aim of this study was to determine factors influencing the hospital length of stay among patients hospitalized with HE. METHODS: A data warehouse query was performed to identify 316 patients with a first hospitalization during which HE occurred, between April 2010 and February 2012. Baseline and hospitalization characteristics were collected with IRB approval. A negative binomial multivariable model was used to control for potential confounders on the length of hospitalization. RESULTS: Median age was 59 years, and 60.4% of admitted patients were male. The median MELD score was 22 (IQR: 17-28). Median length of stay was 8 days (IQR: 3.25-14.25). After controlling for MELD score, female gender (2.2 days; p = 0.04), being initially admitted for a reason other than HE (liver-related: 7.6 days; p < 0.01 and non liver-related 10.7 days; p < 0.01) and receiving antibiotics other than rifaximin (10.5 days; p < 0.01) were associated with longer length of stay whereas hepatitis C (-3.1 days; p < 0.01) was associated with a shorter length of stay. CONCLUSIONS: MELD score, gender, use of antibiotics other than rifaximin, reason for admission and hepatitis C are predictors readily available in clinic that can help identify patients at risk for longer length of stay.
PMCID:4287486
PMID: 25326084
ISSN: 1471-230x
CID: 1310492
Pegylated-IFNalpha2a for HIV/hepatitis C virus coinfected patients: out with the old, in with the new
Bichoupan, Kian; Dieterich, Douglas T
INTRODUCTION: Liver disease is a major burden in patients co-infected with HIV and hepatitis C virus (HCV). From the time of its approval, pegylated-IFNalpha-2a (pegIFN-alpha2a) has played a major role in treatment of HCV in HIV/HCV co-infection. AREAS COVERED: This article briefly summarizes the epidemiology of HCV/HIV co-infection, the pharmacokinetic, and pharmacodynamic properties of pegIFN-alpha2a. Results from clinical trials investigating therapies containing pegIFN-alpha2a for HIV/HCV co-infected patients will be discussed with a focus on efficacy and safety. EXPERT OPINION: PegIFN-alpha2a has improved rates of sustained virologic response for co-infected patients. In combination with direct-acting antivirals (DAA), the disparity between mono- and co-infected patients is beginning to disappear. For the first time, IFN-free regimens are available in clinical practice. It is unlikely that pegIFN-alpha2a will continue to be a critical component in treatments for HCV in the general co-infected population.
PMID: 25104426
ISSN: 1471-2598
CID: 1141372
Costs of Telaprevir-based Triple Therapy for Hepatitis C: $189,000 per Sustained Virologic Response
Bichoupan, Kian; Martel-Laferriere, Valerie; Sachs, David; Ng, Michel; Schonfeld, Emily A; Pappas, Alexis; Crismale, James; Stivala, Alicia; Khaitova, Viktoriya; Gardenier, Donald; Linderman, Michael; Perumalswami, Ponni V; Schiano, Thomas D; Odin, Joseph A; Liu, Lawrence; Moskowitz, Alan J; Dieterich, Douglas T; Branch, Andrea D
Introduction: In registration trials, triple therapy with telaprevir (TVR), pegylated-interferon (IFN), and ribavirin (RBV) achieved sustained virological response (SVR) rates between 64-75%, but the clinical effectiveness and economic burdens of this treatment in real-world practice remain to be determined. Methods: Records of 147 patients who initiated TVR-based triple therapy at the Mount Sinai Medical Center (5/2011-12/2011) were reviewed. Direct medical costs for pre-treatment, on-treatment, and post-treatment care were calculated using data from Medicare reimbursement databases, RED Book, and Healthcare Cost and Utilization Project database. Costs are presented in 2012 US dollars. SVR (undetectable HCV RNA 24 weeks after the end-of-treatment) was determined on an intention-to-treat basis. Cost-per-SVR was calculated by dividing the median cost by the SVR rate. Results: Median age of the 147 patients was 56 years [interquartile range (IQR) = 51 - 61], 68% were male, 19% were black, 11% had HIV/HCV co-infection, 36% had advanced fibrosis/cirrhosis (FIB-4 scores >/= 3.25), 44% achieved an SVR. The total cost of care was $11.56 million. Median cost of care was $83,721 per patient (IQR=$66,652- $98,102). The median cost-per-SVR was $189,338 (IQR=$150,735 - $221,860). Total costs were TVR (61%), IFN (24%), RBV (4%), adverse event management (8%), professional fees (2%), and laboratory tests (1%). Conclusions: TVR and IFN accounted for 85% of costs. Pharmaceutical prices and the low (44%) SVR rate, in this real-world study, were major contributors to the high cost-per-SVR. (Hepatology 2014;).
PMCID:4190678
PMID: 25065814
ISSN: 0270-9139
CID: 1089682