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Hepatitis C Infection for Primary Care Providers

Tin, Kevin; Eiei Soe; Park, James; Tobias, Hillel
ISSN: 1040-2497
CID: 2464172

Simeprevir plus sofosbuvir in patients with chronic hepatitis C virus genotype 1 infection and cirrhosis: A Phase 3 study (OPTIMIST-2)

Lawitz, Eric; Matusow, Gary; DeJesus, Edwin; Yoshida, Eric M; Felizarta, Franco; Ghalib, Reem; Godofsky, Eliot; Herring, Robert W; Poleynard, Gary; Sheikh, Aasim; Tobias, Hillel; Kugelmas, Marcelo; Kalmeijer, Ronald; Peeters, Monika; Lenz, Oliver; Fevery, Bart; De La Rosa, Guy; Scott, Jane; Sinha, Rekha; Witek, James
Hepatitis C virus (HCV)-infected patients with cirrhosis are historically a difficult-to-treat population and are at risk of hepatic decompensation. In the Phase 2 COSMOS study that evaluated simeprevir (HCV NS3/4A protease inhibitor)+sofosbuvir (HCV nucleotide-analog NS5B polymerase inhibitor)+/-ribavirin for 12 or 24 weeks in HCV genotype (GT)1-infected patients, high rates of sustained virologic response 12 weeks after planned end of treatment (SVR12) were achieved, including in patients with cirrhosis (METAVIR score F4). This Phase 3, open-label, single-arm study (OPTIMIST-2 [NCT02114151]) evaluated the efficacy and safety of 12 weeks of simeprevir+sofosbuvir in HCV GT1-infected treatment-naive or treatment-experienced patients with cirrhosis. Patients (aged 18-70 years) with chronic HCV GT1 infection and documented presence of cirrhosis received oral simeprevir 150 mg once daily (QD)+sofosbuvir 400 mg QD for 12 weeks. The primary efficacy endpoint of the study was the proportion of patients achieving SVR12 versus a composite historical control (HC; SVR12 rate of 70%). Safety and patient-reported outcomes were assessed. Overall, 103 patients received treatment. SVR12 with simeprevir+sofosbuvir (83% [95% confidence interval 76-91%]) met the primary objective of superiority versus the HC (70%). SVR12 rates for treatment-naive and treatment-experienced patients were 88% (44/50) and 79% (42/53), respectively. Adverse events (AEs) occurred in 72 (70%) patients, with most (64%) being Grade 1 or 2. Serious AEs (none considered related to study treatment) occurred in 5 (5%) patients and 3 (3%) patients discontinued all study treatment due to AEs. Patient-reported outcomes improved from baseline to follow-up Week 12. CONCLUSION: Simeprevir+sofosbuvir for 12 weeks achieved superiority in SVR12 rates versus the HC in treatment-naive and treatment-experienced HCV GT1-infected patients with cirrhosis and was generally safe and well tolerated
PMID: 26704148
ISSN: 1527-3350
CID: 2042092

A Sustained Viral Response Achieved with Sofosbuvir/Ledipasvir May Increase the Incidence of Acute Cellular Rejection Post Liver Transplantation [Meeting Abstract]

Bortecen, K; Layman, R; Gelb, B; Winnick, A; Morgan, G; Tobias, H; Teperman, L
ISSN: 1600-6143
CID: 2386272

Left-to-left TIPS [Meeting Abstract]

Wu, S; Deipolyi, A; Farquharson, S; Park, J; Sigal, S; Tobias, H; Teperman, L; Charles, H
Learning Objectives: 1. Describe anatomic and physiologic aspects of creating left hepatic vein (LHV) to left portal vein (LPV) transjugular intrahepatic portosystemic shunts (TIPS). 2. Illustrate through a series of 15 cases the technical aspects unique to left-sided TIPS. 3. Understand outcomes of left-to-left TIPS creation for refractory ascites and variceal bleeding, compared with right and middle hepatic vein and right portal vein TIPS Background: TIPS creation is a primary treatment for complications of portal hypertension. Classically, the shunt is created between the right hepatic and right portal veins, owing to the relatively larger size of the right hepatic lobe that would theoretically increase safety and the potential for accessing one of multiple portal venous branches. LHV to LPV TIPS is much less frequently done, though preliminary studies have suggested possibly increased safety. In addition, there may be specific indications for left to left TIPS, most of which are anatomic in nature Clinical Findings/Procedure Details: Fifteen patients underwent successful LHV to LPV TIPS creation at a single institution from 11/2011 to 12/2014. Through a series of examples, the anatomy of left-to-left TIPS creation will be reviewed: left-sided TIPS tend to be shorter and less angulated compared with right-sided TIPS. Given the shorter trajectory, use of a pediatric needle for access may be considered. Patient outcomes regarding control of ascites and bleeding will be reviewed. Only 2 of 15 patients (13%) required a revision with angioplasty or further stent placement over 6 months. All of the patients were alive at 1 month post-TIPS. Conclusions: Left hepatic to left portal vein TIPS creation is safe and provides comparable outcomes compared with right-sided TIPS. Future controlled trials in centers frequently performing TIPS creation could clarify which approach is optimal. However, familiarity with the technical aspects of left-sided TIPS creation is essential as many patients have anatomy unfavorable for right-sided TIPS
ISSN: 1051-0443
CID: 2093852

Current Challenges and the Management of Chronic Hepatitis C in Mainland China

Duan, Zhongping; Jia, Ji-Dong; Hou, Jinlin; Lou, Lillian; Tobias, Hillel; Xu, Xiao Yuan; Wei, Lai; Zhuang, Hui; Pan, Calvin Q
Despite decreasing prevalence, new cases of hepatitis C in China are increasing recently with growing percentage of patients who are with advanced disease, aging, or not eligible for interferon-based treatments. Hepatitis C infection represents a serious public health burden. This review was based on expert's consensus during a medical forum on hepatitis sponsored by the Beijing Wu Jie-Ping Medical Foundation. The literature searches were conducted in PubMed and critical publications in Chinese journals. Data on hepatitis C prevalence, risk factors, viral or host features, and treatment modalities were extracted and reviewed. Recent large-scale surveys reported reducing prevalence of hepatitis C to approximately 0.4% in China, partly because of regulation changes to safer medical practices and illegalizing commercial blood donations. Patient demographics evolved from being dominated by former paid blood donors to include intravenous drug users and others. Although hepatitis C genotype 1 is the most common, other genotypes are emerging in prevalence. The current standard of care is interferon-based without direct acting antivirals. However, many patients failed therapy because of high treatment costs, substantial needs to manage side effects, difficulties with treatment monitoring in the rural areas, and growing populations of elderly and cirrhotic patients. The lack of high efficacy therapies with good safety profile and low disease awareness in China resulted in increasing public burden of advanced hepatitis C disease. Despite significant reduction of hepatitis C prevalence, iatrogenic, nosocomial, and community transmissions are still significant. In addition to promoting disease awareness, interferon-free regimens are needed to reduce the public health burden.This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivitives 3.0 License, where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially.
PMID: 24921215
ISSN: 0192-0790
CID: 1033772

Diagnostic feasibility of procalcitonin in recipients of liver, kidney and hematopoietic stem cell transplantation [Meeting Abstract]

Teperman, J; Torres, J; Dubrovskaya, Y; Tobias, H; Press, R; Teperman, L; Safdar, A
Objectives: Accurate diagnosis of infections in transplant recipients remains a daunting task. To address the diagnoses dilemma, we assessed feasibility of procalcitonin (PCT), a recently approved biomarker in patients at a major University Medical Center in New York. Methods: All data was retrieved retrospectively after approval from Institutional Review Board. Transplant recipients were compared with general medicine patients, and patients with hematologic neoplasia and those being cared for in medical and surgical intensive care units between April 2012 and February 2013. Chi-square and Mann Whitney U test were used for statistical analysis. PCT (ng/ml) and other values are given as median [range]. Results: Among 342 patients studied, transplant recipients (n=26) were younger (60 vs. 69 years; p<0.01), had fewer cardiovascular diseases (19.2% vs. 44.3%; P<0.05), whereas diabetes was more common compared with other patients (53.8% vs. 21.8%; P<0.05). APACHE II scores was not different in either group (15 vs. 17; p=0.06). Similarly, there were no differences for corticosteroid use, chemotherapy and surgeries (P>0.05). PCT values were higher in transplant recipients with bacteremia, Gram-negative infections, and pneumonia (Table 1). There were no significant differences in PCT values among recipients of SOT vs. HSCT (1.62 [0.05-197] vs. 0.28 [0.05-13.1], respectively; P=0.3) during early (<1 month) or later transplant period (1.9 [0.05-13.10] vs. 1.15 [0.015-197], respectively; P=0.8). Conclusions: PCT appears as a promising diagnostic tool for transplant recipients with bacteremia, Gram-negative infections and pneumonia. Further validation studies are underway. TABLE 1. Comparison of PCT in transplant and other patients. (Table Presented)
ISSN: 1600-6143
CID: 3006782

Initial Experience of Telaprevir for Recurrent Hepatitis C in Post Liver Transplant Patients [Meeting Abstract]

Shin, H. J.; Pereira, A. de Oliveira; Safdar, A.; Tobias, H.; Gelb, B.; Morgan, G.; Diflo, T.; Teperman, L.
ISSN: 1527-6465
CID: 166659

Post Liver Transplant Therapy with Telaprevir for Recurrent Hepatitis C [Meeting Abstract]

Pereira, A. P. de Oliveira; Shin, H. J.; Safdar, A.; Tobias, H.; Gelb, B.; Morgan, G.; Diflo, T.; Winnick, A.; Teperman, L.
ISSN: 1600-6135
CID: 166840

Retreatment of patients nonresponsive to pegylated interferon and ribavirin with daily high-dose consensus interferon

Meyer, Douglas F; Tobias, Hillel; Min, Albert D; Rajendra, Arathi; Zic, Ivanka; Brettholz, Edward; Clain, David J; Klion, Franklin; Bernstein, David; Bodenheimer, Henry C
Background. Current treatment of chronic hepatitis C with pegylated interferon and ribavirin has the ability to eliminate viral infection in about half of the patients treated. Therapeutic options, for those with remaining chronic hepatitis, will remain limited until novel antivirals become available in the future. Consensus interferon is currently available and has demonstrated clinical efficacy with superior invitro antiviral activity, but the maximum tolerated dose is not defined. Methods. We assessed the efficacy of daily high-dose (24 ug) consensus interferon with weight-based (1000-1200 mg daily) ribavirin in HCV genotype 1-infected non-responder patients. Results. Six adverse events were documented in five patients, and the trial was terminated with no subject achieving viral clearance. Conclusions. The occurrence of serious adverse events effectively defined the upper limit of acceptable dose, while also revealing that this dose did not offer enhanced sustained viral clearance.
PMID: 21188197
ISSN: 2090-1364
CID: 903262

A treatment algorithm for the management of chronic hepatitis B virus infection in the United States: 2008 update [Guideline]

Keeffe, Emmet B; Dieterich, Douglas T; Han, Steven-Huy B; Jacobson, Ira M; Martin, Paul; Schiff, Eugene R; Tobias, Hillel
Chronic HBV infection is an important public health problem worldwide and in the United States. A treatment algorithm for the management of this disease, published previously by a panel of U.S. hepatologists, has been revised on the basis of new developments in the understanding of the disorder, the availability of more sensitive molecular diagnostic tests, and the licensure of new therapies. In addition, a better understanding of the advantages and disadvantages of new treatments has led to the development of strategies for reducing the rate of resistance associated with oral agents and optimizing treatment outcomes. This updated algorithm was based primarily on available evidence by using a systematic review of the literature. Where data were lacking, the panel relied on clinical experience and consensus expert opinion. The primary aim of antiviral therapy is durable suppression of serum HBV DNA to low or undetectable levels. Assays can now detect serum HBV DNA at levels as low as 10 IU/mL and should be used to establish a baseline level, monitor response to antiviral therapy, and survey for the development of drug resistance. Interferon alfa-2b, lamivudine, adefovir, entecavir, peginterferon alfa-2a, telbivudine, and tenofovir are approved as initial therapy for chronic hepatitis B and have certain advantages and disadvantages. Although all of these agents can be used in selected patients, the preferred first-line treatment choices are entecavir, peginterferon alfa-2a, and tenofovir. Issues for consideration for therapy include efficacy, safety, rate of resistance, method of administration, and cost
PMID: 18845489
ISSN: 1542-7714
CID: 95018