Granted Patent
B2
US 12,290,509 · App. 18/467,858 · Granted May 6, 2025
Treatment of hepatitis delta virus infection
Inventors:
David A. Cory (Palo Alto, CA); Ingrid Choong (Palo Alto, CA); Jeffrey S. Glenn (Palo Alto, CA)
Assignee:
EIT Pharma, Inc.
View Patent ↗
Loading inventors, assignments & file history…
Abstract
Methods of reducing hepatitis delta virus (HDV) viral loads in a patient are provided. In some embodiments, the method comprises treating the patient with lonafarnib-ritonavir co-therapy. In some embodiments, the method further comprises treating the patient with an interferon.
Claims (20)
1. A method of treating a human patient having a hepatitis delta virus (HDV) infection, the method comprising administering to the patient a therapeutically effective dose of lonafarnib and a therapeutically effective dose of ritonavir.
2. The method of claim 1 , wherein lonafarnib and ritonavir are administered in a single unit dose form.
3. The method of claim 1 , wherein lonafarnib and ritonavir are administered as separate unit dose forms.
4. The method of claim 1 , further comprising administering interferon alpha or interferon lambda to the patient.
5. The method of claim 1 , wherein lonafarnib is administered at a total daily dose in a range of 50 mg to 150 mg.
6. The method of claim 1 , wherein at least one of lonafarnib or ritonavir is administered orally.
7. The method of claim 1 , wherein lonafarnib and ritonavir are administered for at least 2 weeks, at least 2 months, at least 3 months, at least 4 months, at least 5 months, at least 6 months, or at least 1 year.
8. A method of inducing immune reactivation in a human patient having a hepatitis delta virus (HDV) infection, the method comprising administering to the patient a therapeutically effective does of lonafarnib and a therapeutically effective dose of ritonavir for at least a period of time until immune reactivation is observed in the patient.
9. The method of claim 8 , where in the patient also has a hepatitis B virus (HBV) infection.
10. The method of claim 8 , wherein the immune reactivation comprises an aminotransferase (ALT) flare.
11. The method of claim 8 , wherein lonafarnib is administered at a first dose for a first treatment period and at a second dose for a second treatment period subsequent to the first treatment period.
12. The method of claim 11 , wherein the first dose is greater than the second dose.
13. The method of claim 11 , wherein the first dose is less than the second dose.
14. The method of claim 11 , wherein the first dose and the second dose are the same.
15. The method of claim 11 , wherein the first treatment period and the second treatment period are different lengths of time.
16. A method of treating a subject having a hepatitis delta virus (HDV) infection, the method comprising administering to the subject lonafarnib and ritonavir in amounts that result in a serum lonafarnib concentration in the subject greater than 2,000 ng/mL, or greater than 4,000 ng/mL, or in a range from 3,500 ng/mL to 7,500 ng/mL.
17. The method of claim 16 , wherein the serum lonafarnib concentration is measured after 4 weeks of treatment.
18. The method of claim 16 , wherein the administering of lonafarnib and ritonavir is ceased when HDV viral load is undetectable in the subject.
19. The method of claim 18 , wherein the administering of lonafarnib and ritonavir is resumed when the HDV viral load is detectable again in the subject.
20. The method of claim 16 , wherein HDV viral load is undetectable in the subject for at least one month.
Assignments (3)
CHANGE OF NAME
Recorded Dec 19, 2025
From: EIGER INNOTHERAPEUTICS, INC.
To: EIT PHARMA, INC.
Reel/Frame 073970/0913 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Sep 30, 2024
From: EIGER BIOPHARMACEUTICALS, INC.
To: EIGER INNOTHERAPEUTICS, INC.
Reel/Frame 068746/0913 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Sep 15, 2023
From: CORY, DAVID A.; CHOONG, INGRID; GLENN, JEFFREY S.
To: EIGER BIOPHARMACEUTICALS, INC.
Reel/Frame 064917/0390 →
Continuity (13)
Continuation In Part
PCTUS2015028933
· May 1, 2015
Provisional Application
62151349
· Apr 22, 2015
Provisional Application
62073413
· Oct 31, 2014
Provisional Application
62044766
· Sep 2, 2014
Provisional Application
61987315
· May 1, 2014
Provisional Application
62321623
· Apr 12, 2016
Provisional Application
62297740
· Feb 19, 2016
Provisional Application
62251026
· Nov 4, 2015
References Cited (307)
US 4695623A
· Stabinsky
· 1987
[cited by applicant]
US 4897471A
· Stabinsky
· 1990
[cited by applicant]
US 5382657A
· Karasiewicz et al.
· 1995
[cited by applicant]
US 5424286A
· Eng
· 1995
[cited by applicant]
US 5541206A
· Kempf et al.
· 1996
[cited by applicant]
US 5648497A
· Kempf et al.
· 1997
[cited by applicant]
US 5951974A
· Gilbert et al.
· 1999
[cited by applicant]
US 5981709A
· Greenwald et al.
· 1999
[cited by applicant]
US 6169096B1
· Venet et al.
· 2001
[cited by applicant]
US 6365600B1
· End et al.
· 2002
[cited by applicant]
US 6420387B1
· Venet et al.
· 2002
[cited by applicant]
US 6469021B1
· Truesdale et al.
· 2002
[cited by applicant]
US 6573291B2
· Gronberg et al.
· 2003
[cited by applicant]
US 6627223B2
· Percel et al.
· 2003
[cited by applicant]
US 6734194B2
· End et al.
· 2004
[cited by applicant]
US 6743805B2
· End et al.
· 2004
[cited by applicant]
US 6838467B2
· End
· 2005
[cited by applicant]
US 6903074B1
· Morgan et al.
· 2005
[cited by applicant]
US 6927040B2
· Sheppard et al.
· 2005
[cited by applicant]
US 7038032B2
· Sheppard et al.
· 2006
[cited by applicant]
US 7135170B2
· Klucher et al.
· 2006
[cited by applicant]
US 7148459B2
· Williford et al.
· 2006
[cited by applicant]
US 7157559B2
· Brady et al.
· 2007
[cited by applicant]
US 7183416B2
· Chemburkar et al.
· 2007
[cited by applicant]
US 7253183B2
· End et al.
· 2007
[cited by applicant]
US 7364752B1
· Fort et al.
· 2008
[cited by applicant]
US 7511027B2
· Casey et al.
· 2009
[cited by applicant]
US 7595174B2
· Brady et al.
· 2009
[cited by applicant]
US 7759092B2
· Zamost et al.
· 2010
[cited by applicant]
US 7968315B2
· Zamost et al.
· 2011
[cited by applicant]
US 8211670B2
· Zamost et al.
· 2012
[cited by applicant]
US 8268781B2
· Gotthardt et al.
· 2012
[cited by applicant]
US 8293726B2
· Habib
· 2012
[cited by applicant]
US 8759027B2
· Zamost et al.
· 2014
[cited by applicant]
US 8980245B2
· Ho
· 2015
[cited by applicant]
US 9096556B2
· Reddy et al.
· 2015
[cited by applicant]
US 9616108B2
· Stoffers et al.
· 2017
[cited by applicant]
US 9821031B2
· Stoffers et al.
· 2017
[cited by applicant]
US 20020123461A1
· Drucker et al.
· 2002
[cited by applicant]
US 20030096014A1
· Sherman
· 2003
[cited by applicant]
US 20030114471A1
· Venet et al.
· 2003
[cited by applicant]
US 20030181355A1
· Glenn
· 2003
[cited by applicant]
US 20040092443A1
· Fridkin et al.
· 2004
[cited by applicant]
US 20060111398A1
· Fourie
· 2006
[cited by applicant]
US 20070287664A1
· Ralston, II et al.
· 2007
[cited by applicant]
US 20080021078A1
· Tidmarsh et al.
· 2008
[cited by applicant]
US 20100029554A1
· Ghosh et al.
· 2010
[cited by applicant]
US 20110105557A1
· End
· 2011
[cited by applicant]
US 20110313009A1
· Tidmarsh et al.
· 2011
[cited by applicant]
US 20180338993A1
· Cory et al.
· 2018
[cited by applicant]
CN 107530338
· 2018
[cited by applicant]
CN 106535895
· 2020
[cited by applicant]
EP 3226973
· 2017
[cited by applicant]
EP 3285768
· 2018
[cited by applicant]
EP 3137078
· 2019
[cited by applicant]
JP 2002533435
· 2002
[cited by applicant]
JP 2004501153
· 2004
[cited by applicant]
JP 2004510762
· 2004
[cited by applicant]
JP 2009530382
· 2009
[cited by applicant]
JP 2012111775
· 2012
[cited by applicant]
JP 2012524753
· 2012
[cited by applicant]
JP 2014509630
· 2014
[cited by applicant]
JP 2014523878
· 2014
[cited by applicant]
JP 2014530874
· 2014
[cited by applicant]
JP 2017514911
· 2017
[cited by applicant]
JP 2017536403
· 2017
[cited by applicant]
JP 6490800
· 2019
[cited by applicant]
KR 19990028407
· 1999
[cited by applicant]
KR 1020170005827
· 2017
[cited by applicant]
KR 1020170138540
· 2017
[cited by applicant]
WO 9701349
· 1997
[cited by applicant]
WO 9723478
· 1997
[cited by applicant]
WO 9731641
· 1997
[cited by applicant]
WO 0039082
· 2000
[cited by applicant]
WO 02081649
· 2002
[cited by applicant]
WO 2005097165
· 2005
[cited by applicant]
WO 2005117864
· 2005
[cited by applicant]
WO 2007012033
· 2007
[cited by applicant]
WO 2007013944
· 2007
[cited by applicant]
WO 2007041713
· 2007
[cited by applicant]
WO 2008085982
· 2008
[cited by applicant]
WO 2008137692
· 2008
[cited by applicant]
WO 2009042960
· 2009
[cited by applicant]
WO 2011088126
· 2011
[cited by applicant]
WO 2012131061
· 2012
[cited by applicant]
WO 2012164575
· 2012
[cited by applicant]
WO 2012174220
· 2012
[cited by applicant]
WO 2013024494
· 2013
[cited by applicant]
WO 2013034927
· 2013
[cited by applicant]
WO 2013059638
· 2013
[cited by applicant]
WO 2013116720
· 2013
[cited by applicant]
WO 2014071231
· 2014
[cited by applicant]
WO 2015079009
· 2015
[cited by applicant]
WO 2015168648
· 2015
[cited by applicant]
WO 2016090107
· 2016
[cited by applicant]
WO 2016172342
· 2016
[cited by applicant]
WO 2016191394
· 2016
[cited by applicant]
WO 2016191395
· 2016
[cited by applicant]
WO 2017079009
· 2017
[cited by applicant]
WO 2018094404
· 2018
[cited by applicant]
WO 2020041778
· 2020
[cited by applicant]
“Aasld Abstacts”, Hepatology, vol. 60, No. 4, Oct. 2014, pp. 308A-309A.
[cited by applicant]
“Lonafarnib with Ritonavir in HDV (LOWR-2) (LOWR-2)”, History of Changes for Study: NCT02430194, Available Online at: https://clinicaltrials.gov/ct2/history/NCT02430194?V _ 1=View#StudyPageTop, Apr. 25, 2015, 7 pages.
[cited by applicant]
“Treatment of Chronic Delta Hepatitis with Lonafarnib and Ritonavir”, History of Changes for Study: NCT02511431, Available Online at:https://www.clinicaltrials.gov/ct2/history/NCT02511431? V _2=View#StudyPageTop, Aug. 1…
[cited by applicant]
Adachi et al., “The Forkhead Transcription Factor FoxO1 Regulates Proliferation and Transdifferentiation of Hepatic Stellate Cells”, Gastroenterology, vol. 132, No. 4, Apr. 2007, pp. 1434-1446.
[cited by applicant]
Amiel et al., “Glucose Concentrations of Less Than 3.0 mmol/L (54 Mg/dL) Should be Reported in Clinical Trials: A Joint Position Statement of the American Diabetes Association and the European Association for the Study …
[cited by applicant]
Guo et al., “Therapeutic Strategies and New Intervention Points in Chronic Hepatitis Delta Virus Infection”, Int. J. Mol. Sci. vol. 16, Aug. 18, 2015, pp. 19537-19552.
[cited by applicant]
Heidrich, B., et al. “Treatment options for hepatitis delta virus infections”, Curr Infect Dis Rep, vol. 15, No. 1, Feb. 2013, pp. 31-38, DOI:10.1007/s11908-012-0307-z.
[cited by applicant]
“Amidation-Definition of Amidation by the Free Dictionary”, The Free Dictionary, Available Online at: https://www.thefreedictionary.com/Amidation, Accessed from Internet on Dec. 24, 2019, pp. 1-3.
[cited by applicant]
Hepatology, vol. 60, Supplement 1, Special Issue: The 65th Annual Meeting of the Am. Ass'n for the Study of Liver Diseases, Abstracts (Oct. 2014), pp. 308A-309A.
[cited by applicant]
Alexopoulos et al., “Design and Synthesis of Novel Biologically Active Thrombin Receptor Non-Peptide Mimetics Based on the Pharmacophoric Cluster Phe/Arg/NH2 of the Ser42-Phe-Leu-Leu-Arg46 Motif Sequence: Platelet Aggre…
[cited by applicant]
Andreasen et al., “Secretion of Glucagon-Like Peptide-1 and Reactive Hypoglycemia After Partial Gastrectomy”, Digestion, vol. 55, No. 4, 1994, pp. 221-228.
[cited by applicant]
Andronati et al., “Peptidomimetics—Antagonists of the Fibrinogen Receptors: Molecular Design, Structures, Properties and Therapeutic Applications”, Current Medicinal Chemistry, vol. 11, No. 9, May 2004, pp. 1183-1211.
[cited by applicant]
Ashkenazi et al., “Immunoadhesins”, International Reviews of Immunology, vol. 10, 1993, pp. 219-227.
[cited by applicant]
Bantle et al., “Hyperinsulinemic Hypoglycemia Developing Late After Gastric Bypass”, Obesity Surgery, vol. 17, No. 5, May 2007, pp. 592-594.
[cited by applicant]
Botros et al., “Effect of Carbohydrate Restriction in Patients with Hyperinsulinemic Hypoglycemia After Roux-En-Y Gastric Bypass”, Obesity Surgery, vol. 24, No. 11, Nov. 2014, pp. 1850-1855.
[cited by applicant]
Breslin et al., “Non-Peptide Alphavbeta3 Antagonists. Part 6: Design and Synthesis of Alphavbeta3 Antagonists Containing a Pyridone or Pyrazinone Central Scaffold”, Bioorganic & Medicinal Chemistry Letters, vol. 13, No.…
[cited by applicant]
Buchwald et al., “Long-Term, Continuous Intravenous Heparin Administration by an Implantable Infusion Pump in Ambulatory Patients with Recurrent Venous Thrombosis”, Surgery, vol. 88, No. 4, Oct. 1980, pp. 507-516.
[cited by applicant]
Calabria et al., “GLP-1 Receptor Antagonist Exendin-(9-39) Elevates Fasting Blood Glucose Levels In Congenital Hyperinsulinism Owing to Inactivating Mutations in the ATP-Sensitive K+ Channel”, Diabetes, vol. 61, No. 10,…
[cited by applicant]
Calabria et al., “Postoperative Surveillance and Detection of Postprandial Hypoglycemia After Fundoplasty in Children”, The Journal of Pediatrics, vol. 159, No. 4, Oct. 2011, pp. 597-601.
[cited by applicant]
Calabria et al., “Postprandial Hypoglycemia in Children After Gastric Surgery: Clinical Characterization and Pathophysiology”, Hormone Research in Paediatrics, vol. 85, No. 2, Jan. 1, 2016, pp. 140-146.
[cited by applicant]
Cancelas et al., “Resistance of Succinic Acid Dimethyl Ester Insulinotropic Action to Exendin (9-39) Amide”, Hormone and Metabolic Research, vol. 34, No. 1, Jan. 1, 2002, pp. 13-15.
[cited by applicant]
Cancelas et al., “Suppression by Exendin(9-39)Amide of Glucagon-Like Peptide-1 Insulinotropic Action in Rats Infused with Dimethyl Ester of Succinic Acid”, Endocrine, vol. 15, No. 3, Aug. 2001, pp. 283-285.
[cited by applicant]
Caudy et al., “Fragile X-Related Protein and VIG Associate with the RNA Interference Machinery”, Genes & Development, vol. 16, No. 19, Oct. 1, 2002, pp. 2491-2496.
[cited by applicant]
Cheon et al., “High-Affinity Binding Sites for Related Fibroblast Growth Factor Ligands Reside Within Different Receptor Immunoglobulin-Like Domains”, Proceedings of the National Academy of Science, vol. 91, No. 3, Feb.…
[cited by applicant]
Coryell , “Depressive Disorders”, Merck Manuals, Available Online at: https://www.merckmanuals.com/professional/psychiatric-disorders/mood-disorders/depressivedisorders, Accessed from Internet on Oct. 1, 2019, pp. 1-10.
[cited by applicant]
Cosgrove et al., “BPDZ 154 Activates Adenosine 5′-Triphosphate-Sensitive Potassium Channels: In Vitro Studies Using Rodent Insulin-Secreting Cells and Islets Isolated from Patients with Hyperinsulinism”, The Journal of …
[cited by applicant]
Craig et al., “Critical Role for GLP-1 in Symptomatic Post-Bariatric Hypoglycaemia”, Diabetologia, vol. 60, No. 3, Mar. 2017, pp. 531-540.
[cited by applicant]
Craig et al., “Efficacy and Pharmacokinetics of Subcutaneous Exendin (9-39) in Patients with Post-Bariatric Hypoglycaemia”, Diabetes, Obesity and Metabolism, vol. 20, No. 2, Feb. 2018, pp. 352-361.
[cited by applicant]
Davidson et al., “Exenatide”, Nature Reviews Drug Discovery, vol. 4, Sep. 2005, pp. 713-714.
[cited by applicant]
De Leon , “Effect of Exendin-(9-39) on Glycemic Control in Subjects with Congenital Hyperinsulinism”, Available Online at: https://www.clinicaltrials.gov/ct2/show/NCT00571324, Accessed from Internet on Nov. 21, 2019, 28…
[cited by applicant]
De Leon et al., “Exendin-(9-39) Corrects Fasting Hypoglycemia in SUR-1 Mice by Lowering cAMP in Pancreatic Beta-Cells and Inhibiting Insulin Secretion”, Journal of Biological Chemistry, vol. 283, No. 38, Sep. 19, 2008, …
[cited by applicant]
De Leon et al., “Role of Endogenous Glucagon-Like Peptide-1 in Islet Regeneration After Partial Pancreatectomy”, Diabetes, vol. 52, No. 2, Feb. 2003, pp. 365-371.
[cited by applicant]
Deary et al., “Partitioning the Symptoms of Hypoglycaemia Using Multi-Sample Confirmatory Factor Analysis”, Diabetologia, vol. 36, No. 8, Aug. 1993, pp. 771-777.
[cited by applicant]
Drucker , “Biologic Actions and Therapeutic Potential of the Proglucagon-Derived Peptides”, Nature Clinical Practice Endocrinology & Metabolism, vol. 1, No. 1, Nov. 2005, pp. 22-31.
[cited by applicant]
Dunne et al., “Hyperinsulinism in Infancy: From Basic Science to Clinical Disease”, Physiological Reviews, vol. 84, No. 1, Jan. 2004, pp. 239-275.
[cited by applicant]
Edwards et al., “Glucagon-Like Peptide 1 has a Physiological Role in the Control of Postprandial Glucose in Humans: Studies with the Antagonist Exendin 9-39”, Diabetes, vol. 48, No. 1, Jan. 1999, pp. 86-93.
[cited by applicant]
Edwards et al., “Subcutaneous Glucagon-Like Peptide-1 (7-36) Amide is Insulinotropic and Can Cause Hypoglycaemia in Fasted Healthy Subjects”, Clinical Science, vol. 95, No. 6, Dec. 1998, pp. 719-724.
[cited by applicant]
Eisenberg et al., “ASMBS Position Statement on Postprandial Hyperinsulinemic Hypoglycemia After Bariatric Surgery”, Surgery for Obesity and Related Diseases, vol. 13, No. 3, Mar. 2017, 26 pages.
[cited by applicant]
Eliasson et al., “SUR1 Regulates PKA-Independent cAMP-Induced Granule Priming in Mouse Pancreatic B-Cells”, The Journal of General Physiology, vol. 121, No. 3, Mar. 2003, pp. 181-197.
[cited by applicant]
Eng et al., “Isolation and Characterization of Exendin-4, an Exendin-3 Analogue, from Heloderma Suspectum Venom: Further Evidence for an Exendin Receptor on Dispersed Acini from Guinea Pig Pancreas”, The Journal of Biol…
[cited by applicant]
Evan et al., “Isolation of Monoclonal Antibodies Specific for Human c-myc Proto-Oncogene Product”, Molecular and Cellular Biology, vol. 5, No. 12, Dec. 1985, pp. 3610-3616.
[cited by applicant]
Field et al., “Purification of a RAS-Responsive Adenylyl Cyclase Complex from
[cited by applicant]
Fournet et al., “Unbalanced Expression of 11p15 Imprinted Genes in Focal Forms of Congenital Hyperinsulinism”, The American Journal of Pathology, vol. 158, No. 6, Jun. 2001, pp. 2177-2184.
[cited by applicant]
Franco et al., “A Review of Studies Comparing Three Laparoscopic Procedures in Bariatric Surgery: Sleeve Gastrectomy, Roux-En-Y Gastric Bypass and Adjustable Gastric Banding”, Obesity Surgery, vol. 21, No. 9, Sep. 2011,…
[cited by applicant]
Gebhard et al., “Postprandial GLP-1, Norepinephrine, and Reactive Hypoglycemia in Dumping Syndrome”, Digestive Diseases and Sciences, vol. 46, No. 9, Sep. 2001, pp. 1915-1923.
[cited by applicant]
Goldfine et al., “Patients with Neuroglycopenia After Gastric Bypass Surgery have Exaggerated Incretin and Insulin Secretory Responses to a Mixed Meal”, The Journal of Clinical Endocrinology & Metabolism, vol. 92, No. 1…
[cited by applicant]
Goodson , “Dental Application”, Chapter 6, In Medical Applications of Controlled Release, vol. 2, 1984, pp. 115-138.
[cited by applicant]
Gough , “Liraglutide: From Clinical Trials to Clinical Practice”, Diabetes, Obesity and Metabolism, vol. 14, No. 2, Apr. 2012, pp. 33-40.
[cited by applicant]
Heber et al., “Endocrine and Nutritional Management of the Post-bariatric Surgery Patient: An Endocrine Society Clinical Practice Guideline”, The Journal of Clinical Endocrinology and Metabolism, vol. 95, No. 11, Nov. 2…
[cited by applicant]
Heidaran et al., “Beta PDGFR-IgG Chimera Demonstrates that Human Beta PDGFR Ig-Like Domains 1 to 3 are Sufficient for High Affinity PDGF BB Binding”, The FASEB Journal, vol. 9, No. 1, Jan. 1995, pp. 140-145.
[cited by applicant]
Hepburn et al., “Symptoms of Acute Insulin-Induced Hypoglycaemia in Humans with and Without IDDM”, Diabetes Care, vol. 14, No. 11, Nov. 1991, pp. 949-957.
[cited by applicant]
Hofeldt , “Reactive Hypoglycemia”, Endocrinology and Metabolism Clinics of North America, vol. 18, No. 1, Mar. 1989, pp. 185-201.
[cited by applicant]
Hopp et al., “A Short Polypeptide Marker Sequence Useful for Recombinant Protein Identification and Purification”, Bio/Technology, vol. 6, No. 10, Oct. 1988, pp. 1204-1210.
[cited by applicant]
Hussain et al., “Medications Used in the Treatment of Hypoglycemia Due to Congenital Hyperinsulinism of Infancy (HI)”, Pediatric Endocrinology Reviews, vol. 2, No. 1, Nov. 2004, pp. 163-167.
[cited by applicant]
Kapoor et al., “Advances in the Diagnosis and Management of Hyperinsulinemic Hypoglycemia”, Nature Clinical Practice Endocrinology & Metabolism, vol. 5, No. 2, Feb. 2009, pp. 101-112.
[cited by applicant]
Kellogg et al., “Postgastric Bypass Hyperinsulinemic Hypoglycemia Syndrome: Characterization and Response to a Modified Diet”, Surgery for Obesity and Related Diseases, vol. 4, No. 4, Jul.-Aug. 2008, pp. 492-499.
[cited by applicant]
Kenny , “When Hypoglycemia is Not Obvious: Diagnosing and Treating Under-Recognized and Undisclosed Hypoglycemia”, Primary Care Diabetes, vol. 8, No. 1, Apr. 2014, pp. 3-11.
[cited by applicant]
Kim et al., “Glucose-Stimulated Insulin Secretion in Gastric Bypass Patients with Hypoglycemic Syndrome: No Evidence for Inappropriate Pancreatic Beta-Cell Function”, Obesity Surgery, vol. 20, No. 8, Aug. 2010, pp. 1110…
[cited by applicant]
Koh et al., “Neonatal Hypoglycaemia—The Controversy Regarding Definition”, Archives of Disease in Childhood, vol. 63, No. 11, Nov. 1988, pp. 1386-1388.
[cited by applicant]
Kulkarni et al., “Use of Exendin (9-39) Amide to Define the in-Vivo and in-Vitro Roles of GLP-1 (7-36) Amide in the Regulation of Insulin Secretion”, Regulatory Peptides, vol. 57, No. 2, May 1995, p. 201.
[cited by applicant]
Laferrere et al., “Effect of Weight Loss by Gastric Bypass Surgery Versus Hypocaloric Diet on Glucose and Incretin Levels in Patients with Type 2 Diabetes”, The Journal of Clinical Endocrinology & Metabolism, vol. 93, N…
[cited by applicant]
Langa et al., “The Diagnosis and Management of Mild Cognitive Impairment: A Clinical Review”, JAMA, vol. 312, No. 23, Dec. 17, 2014, pp. 2551-2561.
[cited by applicant]
Langer , “New Methods of Drug Delivery”, Science, New Series, vol. 249, No. 4976, Sep. 28, 1990, pp. 1527-1533.
[cited by applicant]
Larochelle et al., “Specific Receptor Detection by a Functional Keratinocyte Growth Factor-Immunoglobulin Chimera”, The Journal of Cell Biology, vol. 129, No. 2, Apr. 15, 1995, pp. 357-366.
[cited by applicant]
Larraufie et al., “Important Role of the GLP-1 Axis for Glucose Homeostasis After Bariatric Surgery”, Cell Reports, vol. 26, No. 6, Feb. 5, 2019, 23 pages.
[cited by applicant]
Lev-Ran et al., “The Diagnosis of Postprandial Hypoglycemia”, Diabetes, vol. 30, No. 12, Dec. 1981, pp. 996-999.
[cited by applicant]
Lutz-Freyermuth et al., “Quantitative Determination that One of Two Potential RNA-Binding Domains of the a Protein Component of the U1 Small Nuclear Ribonucleoprotein Complex Binds with High Affinity to Stem—Loop II of …
[cited by applicant]
Mandal, “Defining Hypoglycemia”, News Medical: Life Sciences, Available Online at: https://www.news-medical.net/health/Defining-Hypoglycemia.aspx, Accessed from Internet on Nov. 20, 2019, 3 pages.
[cited by applicant]
Manning et al., “GLP-1: A Mediator of the Beneficial Metabolic Effects of Bariatric Surgery?”, Physiology, vol. 30, No. 1, Jan. 5, 2015, pp. 1-28.
[cited by applicant]
Martin et al., “GAP Domains Responsible for Ras P21-Dependent Inhibition of Muscarinic Atrial K+ Channel Currents”, Science, vol. 255, No. 5041, Jan. 10, 1992, pp. 192-194.
[cited by applicant]
McLaughlin et al., “Reversible Hyperinsulinemic Hypoglycemia After Gastric Bypass: A Consequence of Altered Nutrient Delivery”, The Journal of Clinical Endocrinology and Metabolism, vol. 95, No. 4, Apr. 2010, pp. 1851-1…
[cited by applicant]
Mechanick et al., “Clinical Practice Guidelines for the Perioperative Nutritional, Metabolic, and Nonsurgical Support of the Bariatric Surgery Patient—2013 Update: Cosponsored by American Association of Clinical Endocri…
[cited by applicant]
Meier et al., “Comment to: Patti ME, McMahon G, Mun EC et al. (2005) Severe Hypoglycaemia Post-Gastric Bypass Requiring Partial Pancreatectomy: Evidence for Inappropriate Insulin Secretion and Pancreatic Islet Hyperplas…
[cited by applicant]
Meijeren et al., “Evaluation of Carbohydrate Restriction as Primary Treatment for Post-Gastric Bypass Hypoglycemia”, Surgery for Obesity and Related Diseases, vol. 13, No. 3, Mar. 2017, pp. 404-410.
[cited by applicant]
Miholic et al., “Emptying of the Gastric Substitute, Glucagon-Like Peptide-1 (GLP-1), and Reactive Hypoglycemia After Total Gastrectomy”, Digestive Diseases and Sciences, vol. 36, No. 10, Oct. 1991, pp. 1361-1370.
[cited by applicant]
Moize et al., “Nutritional Pyramid for Post-Gastric Bypass Patients”, Obesity Surgery, vol. 20, No. 8, Apr. 18, 2010, pp. 1133-1141.
[cited by applicant]
Montrose-Rafizadeh et al., “High Potency Antagonists of the Pancreatic Glucagon-Like Peptide-1 Receptor”, The Journal of Biological Chemistry, vol. 272, No. 34, Aug. 22, 1997, pp. 21201-21206.
[cited by applicant]
Myers , “Why Does Blood Pressure Drop After a Meal?”, Available Online at: https://www.livestrong.com/article/483876-why-does-blood-pressure-drop-after-a-meal/, Accessed from Internet on Nov. 21, 2019, 2 pages.
[cited by applicant]
Nabel , “Cardiovascular Disease”, The New England Journal of Medicine, vol. 349, No. 6, Jul. 3, 2003, pp. 60-72.
[cited by applicant]
Naz et al., “Novel Human Prostate-Specific cDNA: Molecular Cloning, Expression, and Immunobiology of the Recombinant Protein”, Biochemical and Biophysical Research Communications, vol. 297, No. 5, Oct. 11, 2002, pp. 107…
[cited by applicant]
Ng et al., “Acarbose Treatment of Postprandial Hypoglycemia in Children After Nissen Fundoplication”, The Journal of Pediatrics, vol. 139, No. 6, Dec. 1, 2001, pp. 877-879.
[cited by applicant]
Nielsen , “Peptide Nucleic Acids as Therapeutic Agents”, Current Opinion In Structural Biology, vol. 9, No. 3, Jun. 1999, pp. 353-357.
[cited by applicant]
Paborsky et al., “Mammalian Cell Transient Expression of Tissue Factor for the Production of Antigen”, Protein Engineering, Design and Selection, vol. 3, No. 6, May 1, 1990, pp. 547-553.
[cited by applicant]
Palladino et al., “Hyperinsulinism in Infancy and Childhood: When an Insulin Level is Not Always Enough”, Clinical Chemistry, vol. 54, No. 2, Feb. 2008, pp. 256-263.
[cited by applicant]
Palladino et al., “Increased Glucagon-Like Peptide-1 Secretion and Postprandial Hypoglycemia in Children After Nissen Fundoplication”, The Journal of Clinical Endocrinology and Metabolism, vol. 94, No. 1, Jan. 2009, pp.…
[cited by applicant]
Patti et al., “Hypoglycemia After Gastric Bypass: The Dark Side of GLP-1”, Gastroenterology, vol. 146, No. 3, Mar. 2014, pp. 1-4.
[cited by applicant]
Patti et al., “Severe Hypoglycemia Postgastric Bypass Requiring Partial Pancreatectomy: Evidence for Inappropriate Insulin Secretion and Pancreatic Islet Hyperplasia”, Diabetologia, vol. 48, No. 11, Nov. 2005, pp. 2236-…
[cited by applicant]
Pramanick et al., “Excipient Selection In Parenteral Formulation Development”, Pharma Times, vol. 45, No. 3, Mar. 2013, pp. 65-77.
[cited by applicant]
Salehi et al., “Blockade of Glucagon-Like Peptide 1 Receptor Corrects Postprandial Hypoglycemia After Gastric Bypass”, Gastroenterology, vol. 146, No. 3, Mar. 1, 2014, pp. 669-680.
[cited by applicant]
Salehi et al., “Gastric Bypass Surgery Enhances Glucagon-Like Peptide 1-Stimulated Postprandial Insulin Secretion in Humans”, Diabetes, vol. 60, No. 9, Sep. 1, 2011, pp. 2308-2314.
[cited by applicant]
Saudek et al., “A Preliminary Trial of the Programmable Implantable Medication System for Insulin Delivery”, The New England Journal of Medicine, vol. 321, No. 9, Aug. 31, 1989, pp. 574-579.
[cited by applicant]
Schirra et al., “Endogenous Glucagon-Like Peptide 1 Controls Endocrine Pancreatic Secretion and Antro-Pyloro-Duodenal Motility in Humans”, Gut, vol. 55, No. 2, Feb. 2006, pp. 243-251.
[cited by applicant]
Schirra et al., “Exendin(9-39)Amide is an Antagonist of Glucagon-Like Peptide-1(7-36)Amide in Humans”, The Journal of Clinical Investigation, vol. 101, No. 7, Apr. 1, 1998, pp. 1421-1430.
[cited by applicant]
Scroochi et al., “Glucose Intolerance but Normal Satiety in Mice with a Null Mutation in the Glucagon-Like Peptide 1 Receptor Gene”, Nature Medicine, vol. 2, No. 11, Nov. 1, 1996, pp. 1254-1258.
[cited by applicant]
Seaquist et al., “Hypoglycemia and Diabetes: A Report of a Workgroup of the American Diabetes Association and the Endocrine Society”, Diabetes Care, vol. 36, No. 5, May 2013, pp. 1384-1395.
[cited by applicant]
Sefton , “Implantable Pumps”, Critical Reviews in Biomedical Engineering, vol. 14, No. 3, Jan. 1, 1987, pp. 201-240.
[cited by applicant]
Seghers et al., “Sur1 Knockout Mice, A Model for KATP Channel-Independent Regulation of Insulin Secretion”, The Journal of Biological Chemistry, vol. 275, No. 13, Mar. 31, 2000, pp. 9270-9277.
[cited by applicant]
Service et al., “Hyperinsulinemic Hypoglycemia with Nesidioblastosis After Gastric-Bypass Surgery”, The New England Journal of Medicine, vol. 353, No. 3, Jul. 21, 2005, pp. 249-254.
[cited by applicant]
Service et al., “Mean Amplitude of Glycemic Excursions, a Measure of Diabetic Instability”, Diabetes, vol. 19, No. 9, Sep. 1970, pp. 644-655.
[cited by applicant]
Skinner et al., “Use of the Glu-Glu-Phe C-Terminal Epitope for Rapid Purification of the Catalytic Domain of Normal and Mutant Ras GTPase-Activating Proteins”, The Journal of Biological Chemistry, vol. 266, No. 22, Aug.…
[cited by applicant]
Song et al., “NMR for the Design of Functional Mimetics of Protein-Protein Interactions: One Key is in the Building of Bridges”, Biochemistry and Cell Biology, vol. 76, Nos. 2-3, 1998, pp. 177-188.
[cited by applicant]
Stanley , “Editorial: Advances in Diagnosis and Treatment of Hyperinsulinism in Infants and Children”, The Journal of Clinical Endocrinology & Metabolism, vol. 87, No. 11, Nov. 2002, pp. 4857-4859.
[cited by applicant]
Suhl et al., “Medical Nutrition Therapy for Post-Bariatric Hypoglycemia: Practical Insights”, Surgery for Obesity and Related Diseases, vol. 13, No. 5, May 2017, pp. 888-896.
[cited by applicant]
Tack et al., “Pathophysiology, Diagnosis and Management of Postoperative Dumping Syndrome”, Nature Reviews Gastroenterology & Hepatology, vol. 6, No. 10, Sep. 1, 2009, pp. 583-590.
[cited by applicant]
Tan et al., “Repeat Subcutaneous Dosing of Exendin 9-39 Reduces Hyperinsulinemic Hypoglycemia and Neuroglycopenic Symptoms in Patients with Post-Bariatric Hypoglycemia”, Diabetes, vol. 66, No. 1, Jun. 9-13, 2017, 1 page.
[cited by applicant]
Thanthan et al., “Glucagon-Like Peptide-1 Inhibits Insulinotropic Effects of Oxyntomodulin and Glucagon in Cattle”, Domestic Animal Endocrinology, vol. 42, No. 3, Apr. 2012, pp. 155-164.
[cited by applicant]
Todd et al., “A Tumor that Secretes Glucagon-Like Peptide-1 and Somatostatin in a Patient with Reactive Hypoglycemia and Diabetes”, The Lancet, vol. 361, No. 9353, Jan. 18, 2003, pp. 228-230.
[cited by applicant]
Toft-Nielsen et al., “Determinants of the Effectiveness of Glucagon-Like Peptide-1 in Type 2 Diabetes”, The Journal of Clinical Endocrinology & Metabolism, vol. 86, No. 8, Aug. 1, 2001, pp. 3853-3860.
[cited by applicant]
Toft-Nielsen et al., “Exaggerated Secretion of Glucagon-Like Peptide-1 (GLP-1) Could Cause Reactive Hypoglycaemia”, Diabetologia, vol. 41, No. 10, Oct. 1998, pp. 1180-1186.
[cited by applicant]
Traina et al., “Primer on Pramlintide, an Amylin Analog”, The Diabetes Educator, vol. 37, No. 3, May-Jun. 2011, pp. 426-431.
[cited by applicant]
Vilsboll et al., “No Reactive Hypoglycaemia in Type 2 Diabetic Patients After Subcutaneous Administration of GLP-1 and Intravenous Glucose”, Diabetic Medicine, vol. 18, No. 2, Feb. 2001, pp. 144-149.
[cited by applicant]
Vogt et al., “A Non-Peptide Mimetic of Ras-CAAX: Selective Inhibition of Farnesyltransferase and Ras Processing”, The Journal of Biological Chemistry, vol. 270, No. 2, Jan. 13, 1995, pp. 660-664.
[cited by applicant]
Webb et al., “Growth Restriction and Exendin 4 Promote Endocrine Expression in Cultured Islet Cells Derived from Patients with Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI)”, Endocrine Research, vol. 31, No…
[cited by applicant]
Williard et al., “Small Molecule Allosteric Modulation of the Glucagon-like Peptide-1 Receptor Enhances the Insulinotropic Effect of Oxyntomodulin”, Molecular Pharmacology, vol. 82, No. 6, Dec. 2012, pp. 1066-1073.
[cited by applicant]
Gastroenterology, Annual Abstract Supplement, vol. 142, Issue 4, Supplement 2, (2007), p. A765.
[cited by applicant]
“History of Changes for Study: NCT02430194 Lonafarnib With Ritonavir in Hdv (LOWR-2) (LOWR-2)”, submitted Apr. 25, 2015, available at clinicaltrials.gov/ct2/history/NCT02511431?V_2=View#StudyPageTop, 7 pages.
[cited by applicant]
“History of Changes for Study: NCT02511431 Treatment of Chronic Delta Hepatitis With Lonafarnib and Ritonavir”, submitted Aug. 11, 2015, available at clinicaltrials.gov/ct2/history/NCT02430194?v_1=View#StudyPageTop, 11 …
[cited by applicant]
Abbas, Z., et al., “Management of Hepatitis Delta: Need for Novel Therapeutic Options”, World Journal of Gastroenterology, vol. 21, No. 32. Aug. 28, 2015, p. 9461-9465, DOI:10.3748/wjg.v21.i32.9461.
[cited by applicant]
Andric, N. “Remote consultation referral system: An effective way to treat homeless and marginalized patients with chronic hepatitis C in primary care”, Hepatitis-Viral. Journal of Gastroenterology and Hepatology, vol. …
[cited by applicant]
Bedossa, P., et al., “Intraobserver and Interobserver Variations in Liver Biopsy Interpretation in Patients with Chronic Hepatitis C”, Hepatology, vol. 20, Issue 1, Jul. 1994, p. 15-20, DOI:https://doi.org/10.1002/hep.1…
[cited by applicant]
Bergmeyer, H.U., et al. “Approved recommendation (1985) on IFCC methods for the measurement of catalytic concentration of enzymes”, J. Clin. Chem. Clin. Biochem., vol. 24, No. 7, Jan. 1986, p. 481-495.
[cited by applicant]
Blanchet, M., et al., “Use of FDA approved therapeutics with hNTCP metabolic inhibitory properties to impair the HDV lifecycle”, Antiviral Research, Elsevier Masson, vol. 106, year 2014, p. 111-115, DOI:http://dx.doi.or…
[cited by applicant]
Bordier, B.B., et al. “A prenylation inhibitor prevents production of infectious hepatitis delta virus particles”, J. Virol., vol. 76, Issue 20, Oct. 2002, p. 10465-10472, DOI:10.1128/jvi.76.20.10465-10472.2002.
[cited by applicant]
Bordier, B.B., et al., “In vivo antiviral efficacy of prenylation inhibitors against hepatitis delta virus”, The Journal of Clinical Investigation, vol. 112, No. 3, Aug. 1, 2003, p. 407-414, DOI:10.1172/JCI200317704.
[cited by applicant]
Brunt, E., “Grading and staging the histopathological lesions of chronic hepatitis: The Knodell histology activity index and beyond” Hepatology, vol. 31, Issue 1, Dec. 30, 2003, p. 241-246, DOI:https://doi.org/10.1002/h…
[cited by applicant]
Canini, L., et al., “Understanding hepatitis delta virus dynamics and antiviral efficacy of the prenylation inhibitor lonafarnib”, AASLD Abstracts, Hepatology, vol. 60, No. 4, Oct. 2014, p. 317A-321A.
[cited by applicant]
Chiba, H., “Interaction with drug metabolism”, Japanese Journal of Clinical Pharmacology and Therapeutics, vol. 31, No. 3, May 2000, pp. n527-n528.
[cited by applicant]
Chudy, M., et al. “Collaborative study to establish a World Health Organization international standard for hepatitis D virus RNA for nucleic acid amplification technique (NAT)-based assays”, World Health Organization, O…
[cited by applicant]
Erba, H.P., et al. “Four different regimens of farnesyltransferase inhibitor tipifarnib in older, untreated acute myeloid leukemia patients: North American Intergroup Phase II study SWOG S0432”, Leukemia Research, vol. …
[cited by applicant]
Erhardt, A., et al., “Treatment of chronic hepatitis delta with pegylated interferon-α2b”, Liver international: official journal of the International Association for the Study of the Liver, vol. 26, No. 7, Sep. 2006, p.…
[cited by applicant]
Etzion, O., et al., “Noninvasive Tests for Detection of Biopsy-proven Cirrhosis in Chronic Hepatitis D Infected Patients are Suboptimal”, American Association for the Study of Liver Diseases (AASLD), The Liver Meeting D…
[cited by applicant]
Ghosal, A., et al., “Identification of Human Liver Cytochrome P450 Enzymes Responsible for The Metabolism of Lonafarnib (Sarasar)”, Drug Metabolism and Disposition, vol. 34, No. 4, Jan. 27, 2006, p. 628-635, DOI:10.1124…
[cited by applicant]
Glenn, J.S., et al. “Identification of a prenylation site in delta virus large antigen” Science, vol. 256, Issue 5061, May 29, 1992, p. 1331-1333, DOI:10.1126/science.1598578.
[cited by applicant]
Glenn, J.S., et al. “Use of a Prenylation Inhibitor as a Novel Antiviral Agent”, Journal of Virology, vol. 72, Issue 11, Nov. 1998, p. 9303-9306, DOI:10.1128/JVI.72.11.9303-9306.1998.
[cited by applicant]
Hanrahan, E.O., et al., “A Phase II Study of Lonafarnib (SCH66336) in Patients With Chemo refractory, Advanced Squamous Cell Carcinoma of the Head and Neck”, American Journal of Clinical Oncology, vol. 32, No. 3, Jun. 2…
[cited by applicant]
Heller, T. et al. “Long-term therapy of chronic delta hepatitis with peginterferon alfa.” Alimentary pharmacology & therapeutics, vol. 40, Issue 1 (2014) p. 93-104. doi:10.1111/apt.12788.
[cited by applicant]
Hill, A., et al. “How much ritonavir is needed to boost protease inhibitors? Systematic review of 17 dose-ranging pharmacokinetic trials”, AIDS, vol. 23, Issue 17, Nov. 13, 2009, p. 2237-2245, DOI:10.1097/QAD.0b013e3283…
[cited by applicant]
Hu, Q. et al., “Highly efficient miniaturized coprecipitation screening (MiCoS) for amorphous solid dispersion formulation development,” International Journal of Pharmaceutics, vol. 450, Issues 1- 2, Jun. 25, 2013, p. 5…
[cited by applicant]
Hull, M.W. et al., “Ritonavir-boosted protease inhibitors in HIV therapy,” Annals of Medicine, vol. 43, Issue 5, 2011, p. 375-388, DOI:10.3109/07853890.2011.572905.
[cited by applicant]
Karatayli, E., et al. “A one step real time PCR method for the quantification of hepatitis delta virus RNA using an external armored RNA standard and intrinsic internal control.”, Journal of Clinical Virology, vol. 60, …
[cited by applicant]
Kodani, M., et al., “One-step real-time PCR assay for detection and quantitation of hepatitis D virus RNA”, Journal of Virological Methods, vol. 193, Issue 2, Nov. 2013, p. 531-535, DOI:10.1016/j.jviromet.2013.07.033.
[cited by applicant]
Koh, C., et al., “Oral prenylation inhibition with Ionafarnib in chronic hepatitis D infection: a proof-of-concept randomized, double-blind, placebo-controlled phase 2A trial”, Lancet Infect Dis, vol. 15, No. 10, Oct. 2…
[cited by applicant]
Koh, C., et al., “Prenylation inhibition with Ionafarnib decreases hepatitis D levels in humans,” Hepatology, ASSLD Abstracts, Abstract No. 1860, vol. 60, No. 4, Oct. 2014, p. 1092A-1093A.
[cited by applicant]
Lau, D.T., et al., “Lamivudine for chronic delta hepatitis”, Hepatology, vol. 30, Issue 2, Aug. 1999, p. 546-549, DOI:https://doi.org/10.1002/hep.510300217.
[cited by applicant]
Li, S., et al., “Effect of hepatitis B virus infection on human P450 3 A4”, Nal Med J. China, vol. 86, No. 38, Oct. 17, 2006, p. 2703-2706.
[cited by applicant]
Liaw, Y.F., “Hepatitis flares and hepatitis B e antigen seroconversion: Implication in anti-hepatitis B virus therapy” Journal of Gastroenterology and Hepatology, vol. 18, Issue 3, Feb. 26, 2003, p. 246-252, DOI:https:/…
[cited by applicant]
Limdi, J.K., et al. “Evaluation of abnormal liver function tests”, Postgraduate Medical Journal, vol. 79, Issue 932, year 2003, p. 307-312, DOI:10.1136/pmj.79.932.307.
[cited by applicant]
List A.F., et al., “Phase I study of continuous oral administration of Ionafarnib (Sarasar) in patients with advanced hematologic malignancies”, Blood, vol. 100, year 2002, p. 789a.
[cited by applicant]
Liu, Y.P., et al. “Rapid and quantitative detection of hepatitis B virus”, World Journal of Gastroenterology, vol. 21, Issue 42, Nov. 14, 2015, p. 11954-11963, DOI:10.3748/wjg.v21.i42.11954.
[cited by applicant]
Lucia, M.B., et al. “HIV-Protease Inhibitors Contribute to P-Glycoprotein Efflux Function Defect in Peripheral Blood Lymphocytes From HIV-Positive Patients Receiving HAART”, JAIDS (Journal of Acquired Immune Deficiency …
[cited by applicant]
Mandorfer, M., et al. “Changes in Hepatic Venous Pressure Gradient Predict Hepatic Decompensation in Patients Who Achieved Sustained Virologic Response to Interferon-Free Therapy.” Hepatology (Baltimore, MD.) vol. 71, I…
[cited by applicant]
Masci, P., et al. “New and modified interferon alfas: Preclinical and clinical data”, Current Oncology Reports, vol. 5, Apr. 2003, p. 108-113, DOI:https://doi.org/10.1007/s11912-003-0097-4.
[cited by applicant]
Miller, M.M., et al. “The role of dolutegravir in the management of HIV infections”, Infection and Drug Resistance, vol. 8, Feb. 19, 2015, p. 19-29, DOI:https://doi.org/10.2147/IDR.S58706.
[cited by applicant]
Myler, H., et al., “Anti-PEG antibody bioanalysis: a clinical case study with PEG-IFN-λ-1a and PEG-IFN-α2a in naive patients”, Bioanalysis, vol. 7, Issue 9 (2015): 1093-1106. DOI:10.4155/bio.15.36.
[cited by applicant]
Ning, L., “Pharmaceutics”, Planned Textbook for Pharmacy and Bioengineering in Colleges and Universities, No. 186643, Dec. 31, 2007, p. 273-276.
[cited by applicant]
Noureddin, M., et al., “Hepatitis delta: epidemiology, diagnosis and management 36 years after discovery”, Curr Gastroenterol Rep., vol. 16, Issue 365, Jan. 2014, 8 pages, DOI:10.1007/s11894-013-0365-x.
[cited by applicant]
Osborn, B. L., et al. “Pharmacokinetic and Pharmacodynamic Studies of a Human Serum Albumin-Interferon-α Fusion Protein in Cynomolgus Monkeys”, The Journal of Pharmacology and Experimental Therapeutics, vol. 303, No. 2,…
[cited by applicant]
Otto, J.C., et al. “The Hepatitis Delta Virus Large Antigen Is Farnesylated Both in Vitro and in Animal Cells”, The Journal of Biological Chemistry, vol. 271, No. 9, Mar. 1, 1996, p. 4569-4572, DOI:10.1074/jbc.271.9.456…
[cited by applicant]
Piyachaturawat, P. et al. “Changes in transient elastography in early cirrhotic patients after receiving nonselective B-blocker for primary variceal bleeding prophylaxis: Three-month follow up.” JGH open : an open acces…
[cited by applicant]
Saldanha, J., et al. “An international collaborative study to establish a World Health Organization international standard for hepatitis B virus DNA nucleic acid amplification techniques”, Vox Sanguinis, vol. 80, Issue …
[cited by applicant]
Tho, I., et al. “Formation of nano/micro-dispersions with improved dissolution properties upon dispersion of ritonavir melt extrudate in aqueous media”, European Journal of Pharmaceutical Sciences, vol. 40, Issue 1, Apr…
[cited by applicant]
Tong, W., et al., “Identification of unstable metabolites of Lonafarnib using liquid chromatography-quadrupole time-of-flight mass spectrometry, stable isotope incorporation and ion source temperature alteration”, Journ…
[cited by applicant]
Velasco, M., et al. “Resolution of Chronic Hepatitis B after Ritonavir Treatment in an HIV-Infected Patient,” The New England Journal of Medicine, vol. 340, No. 22, 1999, p. 1765-1766.
[cited by applicant]
Wang, X., et al. “Derivation of Phase 3 dosing for peginterferon lambda-1a in chronic hepatitis C, Part 1: Modeling optimal treatment duration and sustained virologic response rates”, The Journal of Clinical Pharmacolog…
[cited by applicant]
Wedemeyer, H., et al.,“Epidemiology, pathogenesis and management of hepatitis D: update and challenges ahead”, Nature Reviews Gastroenterology and Hepatology, vol. 7, Jan. 2010, p. 31-40, DOI:https://doi.org/10.1038/nrg…
[cited by applicant]
Yang et al., “Different alterations of cytochrome P450 3A4 isoform and its gene expression in livers of patients with chronic liver diseases,” World Journal of Gastroenterology 2003;9(2): 359-363; www.wjgent.com.
[cited by applicant]
Yardeni, D., et al., Regression of Liver Fibrosis Following 48 Weeks of Therapy with Peginterferon Lambda in Patients with Chronic Hepatitis Delta Virus (HDV) Infection, American Association for the Study of Liver Disea…
[cited by applicant]
Yu, L., et al., “Amorphous pharmaceutical solids: preparation, characterization and stabilization”, Advanced Drug Delivery Reviews, vol. 48, 2001, p. 27-42.
[cited by applicant]
Yurdaydin, C., et al., “Optimizing The Prenylation Inhibitor Lonafarnib Using Ritonavir Boosting in Patients with Chronic Delta Hepatitis” Journal of Hepatology, vol. 62, Supplement 2, Apr. 2015, p. S252, DOI:https://do…
[cited by applicant]
Zhang, F.L., et al. “Protein Prenylation: Molecular Mechanisms and Functional Consequences”, Annual Review of Biochemistry, vol. 65, Jul. 1996, p. 241-269, DOI:10.1146/annurev.bi.65.070196.001325.
[cited by applicant]