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157. Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.

Author

Foster, G. R., Afdhal, N., Roberts, S. K., Bräu, N., Gane, E. J., Pianko, S., Lawitz, E., Thompson, A., Shiftman, M. L., Cooper, C., Towner, W. J., Conway, B., Ruane, P., Bourlière, M., Asselah, T., Berg, T., Zeuzem, S., Rosenberg, W., Agarwal, K., and Stedman, C. A. M.

Abstract

Background: In phase 2 trials, treatment with the combination of the nucleotide polymerase inhibitor sofosbuvir and the NS5A inhibitor velpatasvir resulted in high rates of sustained virologic response in patients chronically infected with hepatitis C virus (HCV) genotype 2 or 3.Methods: We conducted two randomized, phase 3, open-label studies involving patients who had received previous treatment for HCV genotype 2 or 3 and those who had not received such treatment, including patients with compensated cirrhosis. In one trial, patients with HCV genotype 2 were randomly assigned in a 1:1 ratio to receive sofosbuvir-velpatasvir, in a once-daily, fixed-dose combination tablet (134 patients), or sofosbuvir plus weight-based ribavirin (132 patients) for 12 weeks. In a second trial, patients with HCV genotype 3 were randomly assigned in a 1:1 ratio to receive sofosbuvir-velpatasvir for 12 weeks (277 patients) or sofosbuvir-ribavirin for 24 weeks (275 patients). The primary end point for the two trials was a sustained virologic response at 12 weeks after the end of therapy.Results: Among patients with HCV genotype 2, the rate of sustained virologic response in the sofosbuvir-velpatasvir group was 99% (95% confidence interval [CI], 96 to 100), which was superior to the rate of 94% (95% CI, 88 to 97) in the sofosbuvir-ribavirin group (P=0.02). Among patients with HCV genotype 3, the rate of sustained virologic response in the sofosbuvir-velpatasvir group was 95% (95% CI, 92 to 98), which was superior to the rate of 80% (95% CI, 75 to 85) in the sofosbuvir-ribavirin group (P<0.001). The most common adverse events in the two studies were fatigue, headache, nausea, and insomnia.Conclusions: Among patients with HCV genotype 2 or 3 with or without previous treatment, including those with compensated cirrhosis, 12 weeks of treatment with sofosbuvir-velpatasvir resulted in rates of sustained virologic response that were superior to those with standard treatment with sofosbuvir-ribavirin. (Funded by Gilead Sciences; ASTRAL-2 ClinicalTrials.gov number, NCT02220998; and ASTRAL-3, NCT02201953.). [ABSTRACT FROM AUTHOR]

Published
2015
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158. 1162 RIBAVIRIN DOSE MODIFICATION IN TREATMENT-NAIVE AND PREVIOUSLY TREATED PATIENTS WHO RECEIVED TELAPREVIR COMBINATION TREATMENT: NO IMPACT ON SUSTAINED VIROLOGIC RESPONSE IN PHASE 3 STUDIES

Author

Sulkowski, M.S., primary, Roberts, S., additional, Afdhal, N., additional, Andreone, P., additional, Diago, M., additional, Pol, S., additional, Poordad, F., additional, Zeuzem, S., additional, Bengtsson, L., additional, Luo, D., additional, Witek, J., additional, and Adda, N., additional

Published
2012
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160. 60 RESULTS OF ENABLE 2, A PHASE 3, MULTICENTER STUDY OF ELTROMBOPAG AND PEGINTERFERON ALFA-2B TREATMENT IN PATIENTS WITH HEPATITIS C AND THROMBOCYTOPENIA

Author

Dusheiko, G., primary, Afdhal, N., additional, Giannini, E.G., additional, Chen, P.J., additional, Han, K.-H., additional, Rodriguez-Torres, M., additional, Rugina, S., additional, Lawitz, E., additional, Streinu-Cercel, A., additional, Shiffman, M.L., additional, Poordad, F., additional, Kamel, Y. Mostafa, additional, Brainsky, A., additional, Geib, J., additional, Vasey, S.Y., additional, Patwardhan, R., additional, Campbell, F., additional, and Theodore, D., additional

Published
2012
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164. The safety and efficacy of oral docosahexaenoic acid supplementation for the treatment of primary sclerosing cholangitis - a pilot study

Author

Martin, C. R., primary, Blanco, P. G., additional, Keach, J. C., additional, Petz, J. L., additional, Zaman, M. M., additional, Bhaskar, K. R., additional, Cluette-Brown, J. E., additional, Gautam, S., additional, Sheth, S., additional, Afdhal, N. H., additional, Lindor, K. D., additional, and Freedman, S. D., additional

Published
2011
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166. 127 PHOSPHODIESTERASE POLYMORPHISMS MAY BE ASSOCIATED WITH BASELINE THYROID STIMULATING HORMONE (TSH) AND PEGINTERFERON TREATMENT INDUCED HYPOTHYROIDISM IN PATIENTS WITH CHRONIC HEPATITIS C

Author

Clark, P.J., primary, Thompson, A.J., additional, Zhu, M., additional, Ge, D., additional, Shianna, K., additional, Tillmann, H.L., additional, Patel, K., additional, Urban, T., additional, Singh, A., additional, Sulkowski, M., additional, Afdhal, N., additional, Jacobson, I., additional, Esteban, R., additional, Poordad, F., additional, Lawitz, E., additional, McCone, J., additional, Shiffman, M.L., additional, Galler, G., additional, Lee, W.M., additional, Reindollar, R., additional, King, J., additional, Kwo, P., additional, Ghalib, R., additional, Freilich, B., additional, Nyberg, L., additional, Noviello, S., additional, Bopari, N., additional, Koury, K., additional, Pedicone, L.D., additional, Brass, C., additional, Albrecht, J.K., additional, Goldstein, D., additional, McHutchison, J.G., additional, and Muir, A.J., additional

Published
2011
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167. 1372 ONCE DAILY PSI-7977 PLUS PEG-IFN/RBV IN HCV GT1: 98% RAPID VIROLOGIC RESPONSE, COMPLETE EARLY VIROLOGIC RESPONSE: THE PROTON STUDY

Author

Nelson, D.R., primary, Lalezari, J., additional, Lawitz, E., additional, Hassanein, T., additional, Kowdley, K., additional, Poordad, F., additional, Sheikh, A., additional, Afdhal, N., additional, Bernstein, D., additional, Dejesus, E., additional, Freilich, B., additional, Dieterich, D., additional, Jacobson, I., additional, Jensen, D., additional, Abrams, G.A., additional, Darling, J., additional, Rodriguez-Torres, M., additional, Reddy, R., additional, Sulkowski, M., additional, Bzowej, N., additional, Demicco, M., additional, Strohecker, J., additional, Hyland, R., additional, Mader, M., additional, Albanis, E., additional, Symonds, W.T., additional, and Berrey, M.M., additional

Published
2011
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169. 1185 ELTROMBOPAG IN CHRONIC LIVER DISEASE PATIENTS WITH THROMBOCYTOPENIA UNDERGOING AN ELECTIVE INVASIVE PROCEDURE: RESULTS FROM ELEVATE, A RANDOMISED CLINICAL TRIAL

Author

Afdhal, N., primary, Giannini, E., additional, Tayyab, G.N., additional, Mohsin, A., additional, Lee, J.W., additional, Andriulli, A., additional, Jeffers, L., additional, McHutchison, J., additional, Campbell, F., additional, Blackman, N., additional, Hyde, D., additional, Brainsky, A., additional, and Theodore, D., additional

Published
2010
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170. 1166 THE PREDICTIVE VALUE OF IL28B GENE POLYMORPHISM FOR RESPONSE TO PEGINTERFERON AND RIBAVIRIN IS ENHANCED BY QUANTITATION OF IP-10 IN PRETREATMENT SERUM

Author

Fried, M.W., primary, Aerssens, J., additional, Thompson, A., additional, Darling, J., additional, McHutchison, J.G., additional, Howell, C., additional, Afdhal, N., additional, Bollekens, J., additional, DeWit, M., additional, Scholliers, A., additional, Shianna, K., additional, Goldstein, D., additional, and Fanning, G., additional

Published
2010
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172. 2015 GENOME WIDE ANALYSIS OF PATIENTS FROM THE IDEAL STUDY IDENTIFIES A CAUSAL ROLE FOR ITPA GENETIC VARIATION IN RIBAVIRIN-INDUCED HEMOLYTIC ANEMIA

Author

Thompson, A.J., primary, Fellay, J., additional, Ge, D., additional, Urban, T., additional, Shianna, K., additional, Sulkowski, M., additional, Muir, A., additional, Afdhal, N., additional, Jacobson, I., additional, Esteban, R., additional, Poordad, F., additional, Lawitz, E., additional, Mc Cone, J., additional, Shiffman, M., additional, Galler, G., additional, Lee, W., additional, Reindollar, R., additional, King, J., additional, Kwo, P., additional, Ghalib, R., additional, Freilich, B., additional, Nyberg, L., additional, Patel, K., additional, Tillmann, H., additional, Noviello, S., additional, Bopari, N., additional, Koury, K., additional, Pedicone, L., additional, Brass, C., additional, Albrecht, J.K., additional, Goldstein, D., additional, and Mc Hutchison, J.G., additional

Published
2010
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173. 126 HEMOGLOBIN DECLINE IS ASSOCIATED WITH SVR AMONG HCV GENOTYPE 1-INFECTED PERSONS TREATED WITH PEGINTERFERON (PEG)/RIBAVIRIN (RBV): ANALYSIS FROM THE IDEAL STUDY

Author

Sulkowski, M., primary, Shiffman, M., additional, Afdhal, N., additional, Reddy, R., additional, McCone, J., additional, Lee, W., additional, Herrine, S., additional, Harrison, S., additional, Deng, W., additional, Brass, C., additional, Koury, K., additional, Noviello, S., additional, Albrecht, J., additional, and McHutchison, J., additional

Published
2009
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174. 1044 TELAPREVIR IN HEPATITIS C GENOTYPE-1-INFECTED PATIENTS WITH PRIOR NON-RESPONSE, VIRAL BREAKTHROUGH OR RELAPSE TO PEGINTERFERON- ALFA-2A/B AND RIBAVIRIN THERAPY: SVR RESULTS OF THE PROVE3 STUDY

Author

Manns, M., primary, Muir, A., additional, Adda, N., additional, Jacobson, I., additional, Afdhal, N., additional, Heathcote, J., additional, Zeuzem, S., additional, Reesink, H., additional, Terrault, N., additional, Bsharat, M., additional, George, S., additional, McHutchison, J., additional, and Di Bisceglie, A., additional

Published
2009
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178. [6] VALOPICITABINE (NM283), ALONE OR WITH PEG-INTERFERON, COMPARED TO PEG INTERFERON/RIBAVIRIN (PEGIFN/RBV) RETREATMENT IN PATIENTS WITH HCV-1 INFECTION AND PRIOR NON-RESPONSE TO PEGIFN/RBV: ONE-YEAR RESULTS

Author

Afdhal, N., primary, O'Brien, C., additional, Godofsky, E., additional, Rodriguez-Torres, M., additional, Pappas, S.C., additional, Lawitz, E., additional, Pockros, P., additional, Sulkowski, M., additional, Jacobson, I., additional, Chao, G., additional, Knox, S., additional, Pietropaolo, K., additional, and Brown, N.A., additional

Published
2007
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179. 39 Valopicitabine (NM283), alone or with peginterferon, compared to peg interferon/ribavirin (pegifn/RBV) re-treatment in hepatitis patients with prior non-response to PEGIFN/RBV: Week 24 results

Author

Afdhal, N., primary, O Brien, C., additional, Godofsky, E., additional, Rodriguez-Torres, M., additional, Pappas, S.C., additional, Pockros, P., additional, Lawitz, E., additional, Bzowej, N., additional, Rustgi, V., additional, Sulkowski, M., additional, Sherman, K., additional, Jacobson, I., additional, Chao, G., additional, Knox, S., additional, Pietropaolo, K., additional, and Brown, N., additional

Published
2006
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186. Royal Academy of Medicine in Ireland — Section of Medicine Proceedings of Registrar’s Prize Meeting, Wednesday 4th May, 1988

Author

McCormack, P. M. E., Cotter, T., O’Malley, K., Foley, D. P., Dunne, P., O’Brien, M., Crowe, J. P., O’Callaghan, T., Lennon, J., O’Brien, T., Soden, Muriel, Bresnihan, B., Duggan, J., Patchett, S., Enright, H., Afdhal, N., O’Connell, L., O’Donoghue, D. P., Tobin, A., Clarke, R., Graham, I., O’Morain, C., Keating, J., Burke, P., McDonald, G., Monson, J., Stephens, R., Corrigan, O., and Keeling, P. W. N.

Published
1988
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193. Introduction: thrombocytopenia in chronic liver disease – treatment implications and novel approaches.

Author

AFDHAL, N. H. and ESTEBAN, R.

Subjects
*THROMBOCYTOPENIA, *LIVER diseases, *BLOOD coagulation disorders, *BLOOD platelet transfusion, *NEUTROPENIA
Abstract

Background Thrombocytopenia is a common hematologic toxicity among patients with chronic liver disease. Aim To give a brief overview of thrombocytopenia and its effects on patients with chronic liver disease. Results Thrombocytopenia is generally mild to moderate in severity and can thus be managed relatively easily. Severe thrombocytopenia (platelet count <50,000 /μL), however, may present significant challenges to patient management. Thrombocytopenia can increase the risk of bleeding associated with invasive or surgical procedures. Therefore, while perhaps less widely appreciated than the impact of anemia or neutropenia, effective prevention and management of thrombocytopenia is also critical for patients with liver disease. Conclusions This supplement to Alimentary Pharmacology & Therapeutics provides a comprehensive review of the significance of thrombocytopenia in patients with chronic liver disease, its pathophysiology and relationship to coagulation disorders, impact on clinical care and resource utilization, and novel therapies that may be able to supplant platelet transfusions. [ABSTRACT FROM AUTHOR]

Published
2007
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194. Clot lysis by gastric juice: an in vitro study.

Author

Patchett, S E, Enright, H, Afdhal, N, O'Connell, W, and O'Donoghue, D P

Abstract

Gastric juice from patients with peptic ulcer disease and from patients with no upper gastrointestinal abnormality was studied in order to assess its effect on a formed fibrin clot. In both groups of patients gastric juice caused a marked increase in fibrinolysis as evidenced by a shortening of the euglobulin clot lysis time. This plasmin mediated fibrinolytic activity was found to be heat labile and only present in an acid environment. Addition of tranexamic acid or sucralfate to gastric juice almost completely reversed this effect, whereas pepstatin was only partially effective. It is probable that acid dependent proteases other than pepsin are responsible for the marked fibrinolysis. The ulcer healing agent sucralfate might be useful in those patients at risk of bleeding or rebleeding from active peptic ulcer disease. [ABSTRACT FROM PUBLISHER]

Published
1989

195. Immunohistochemical Cal9-9 in primary colonic polyps and polyps synchronous with colorectal cancer.

Author

Afdhal, N H, Long, A, Tobbia, I, Cullen, A, and O'Donoghue, D P

Abstract

A prospective study was undertaken to examine the immunohistochemical expression of tumor antigen Cal9-9 in 56 colorectal cancers and 95 colonic adenomas, divided into 65 primary polyps and 30 polyps synchronous with colorectal cancer. Seventy five per cent of tumours were positive for Cal9-9. Antigen was expressed more frequently in advanced Duke's C and D and poorly differentiated colorectal cancer. Overall 51% of adenomas were positive for Cal9-9. Antigen expression correlated significantly with increasing size (p less than 0.001), synchronicity with colorectal cancer (p less than 0.001), severe dysplasia (p less than 0.001) and villous typing (p less than 0.003). Discriminate analysis using the first three variables correctly classified 79% of positive and 89% of negative Cal9-9 results. The similar frequency of antigen expression seen in colorectal cancers and their synchronous adenoma suggests a field change in the tumour bearing colon. Adenomas positive for Cal9-9 may have a greater malignant potential for carcinomatous change. [ABSTRACT FROM PUBLISHER]

Published
1987
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196. Atomic Force Microscopy Reveals Aggregation of Gastric Mucin at Low pH

Author

Hong, Z., Chasan, B., Bansil, R., Turner, B. S., Bhaskar, K. R., and Afdhal, N. H.

Abstract

Mammalian gastric mucin, at high concentration, is known to form a gel at low pH, behavior essential to the protection of the stomach from auto-digestion. Atomic force microscopy (AFM) measurements of dilute solutions of porcine gastric mucin in an aqueous environment in the pH range 6−2 provide a direct visualization of extended fiberlike molecules at pH 6 that aggregate at pH 4 and below forming well-defined clusters at pH 2. The clusters consist of 10 or less molecules. AFM images of mucin at high concentration at pH 2 reveal clusters similar to those seen in the dilute solutions at low pH. We also imaged human gastric mucus revealing a network having a “pearl necklace” structure. The “pearls” are similar in size to the clusters found in the purified porcine gastric mucin gels. AFM images of deglycosylated mucin reveal that the deglycosylated portions of the molecule re-fold into compact, globular structures suggesting that the oligosaccharide chains are important in maintaining the extended conformation of mucin. However, the oligosaccharides do not appear to be directly involved in the aggregation at low pH, as clusters of similar size are observed at pH 2 in both native and deglycosylated mucin.

Published
2005

197. Viscoelastic Properties and Dynamics of Porcine Gastric Mucin

Author

Celli, J., Gregor, B., Turner, B., Afdhal, N. H., Bansil, R., and Erramilli, S.

Abstract

Gastric mucin is a glycoprotein known to undergo a pH-dependent sol−gel transition that is crucial to the protective function of the gastric mucus layer in mammalian stomachs. We present microscope-based dynamic light scattering data on porcine gastric mucin at pH 6 (solution) and pH 2 (gel) with and without the presence of tracer particles. The data provide a measurement of the microscale viscosity and the shear elastic modulus as well as an estimate of the mesh size of the gel formed at pH 2. We observe that the microscale viscosity in the gel is about 100-fold lower than its macroscopic viscosity, suggesting that large pores open up in the gel reducing frictional effects. The data presented here help to characterize physiologically relevant viscoelastic properties of an important biological macromolecule and may also serve to shed light on diffusive motion of small particles in the complex heterogeneous environment of a polymer gel network.

Published
2005

198. Interaction of Mucin with Cholesterol Enriched Vesicles:  Role of Mucin Structural Domains

Author

Afdhal, N. H., Cao, X., Bansil, R., Hong, Z., Thompson, C., Brown, B., and Wolf, D.

Abstract

We utilized fluorescence recovery after photobleaching (FRAP) and fluorescence correlation spectroscopy (FCS) to examine the role of gallbladder mucin (GBM) in promoting the aggregation and/or fusion of cholesterol enriched vesicles. By fluorescent labeling either the vesicle or the mucin, we could examine the change in vesicle size as well as changes in mucin's diffusion constant. Both FRAP and FCS show that GBM has a profound effect in inducing vesicles to aggregate/fuse, particularly after overnight incubation. GBM mucin domains (either protease digested or reduced GBM) are not as effective as native GBM. Intact GBM alone was able to shorten crystal appearance time and increase the number of crystals nucleated by polarized optical microscopy. In summary, our findings would suggest that both glycosylated and nonglycosylated domains of GBM are involved in early aggregation of cholesterol enriched vesicles but that this effect is reversible in the absence of nonglycosylated domains.

Published
2004

199. An assessment of digital image analysis to measure fibrosis in liver biopsy specimens of patients with chronic hepatitis C.

Author

O'Brien, M J, Keating, N M, Elderiny, S, Cerda, S, Keaveny, A P, Afdhal, N H, and Nunes, D P

Abstract

The aim was to assess the validity of a digitally computed fibrosis ratio as a measure of fibrosis stage in liver biopsy specimens. We scored 230 liver biopsy specimens from patients with chronic hepatitis C for fibrosis using modified Knodell criteria; fibrosis ratios were computed from digital images that encompassed the complete trichrome-stained section of each case. Although an overall correlation between fibrosis ratio and ordinal score was present, subset analysis showed that this correlation existed only among biopsy specimens with high scores (3-6, early bridging fibrosis to established cirrhosis). There was no correlation or difference between category means found among biopsy specimens with low scores (0-3, normal to early bridging fibrosis). Furthermore, concordance by both estimates in direction of fibrosis change among serial liver biopsy specimens was found in only 11 (30%) of 37 pairs compared. The findings suggest that a qualitative assessment of the computerized fibrosis pattern is necessary for the interpretation of computerized fibrosis ratio measurements, particularly in patients with early stage fibrosis.

Published
2000
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