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Treatment of hepatitis delta virus infection

A hepatitis D virus technology, applied in the field of treatment of viral hepatitis caused by hepatitis D virus infection, can solve the problem of no effective medical therapy

Pending Publication Date: 2018-08-03
EIGER BIOPHARMLS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Hepatitis D virus (HDV) causes the most severe form of viral hepatitis and has no effective medical therapy (see Lau, 1999, Hepatology 30:546-549)

Method used

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  • Treatment of hepatitis delta virus infection
  • Treatment of hepatitis delta virus infection
  • Treatment of hepatitis delta virus infection

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0309] Example 1. Treatment of HDV patients with 100 mg lonafarib administered BID

[0310] This example illustrates the efficacy of lonafarib to reduce HDV RNA levels in patients with chronic HDV. Eight Group 1 patients (all with chronic HDV) were treated as follows: six patients (patients 1, 2, 4, 5, 6 and 8) with chronic hepatitis B (HDV) were treated with lonafarib, And placebo was administered to 2 patients (Patients 3 and 7) for a duration of twenty-eight days. Six patients in the active treatment group were dosed at 100 mg BID (oral administration) for 28 days. The mean change from baseline to nadir in HDV RNA levels was -0.74 log HDV RNA copies / mL in the lonafarib active-treated group and -0.24 log HDV RNA copies / mL in the placebo group.

[0311] Patients 4, 5, 6, and 8 responded to therapy, as defined by a greater than or equal to 0.5 log HDV RNA copy / mL decline in quantitative serum HDV RNA levels from baseline to nadir during active treatment. See Table 6 (duri...

example 2

[0320] Example 2. Treatment of HDV patients with 200 mg and 300 mg lonafarib administered BID

[0321] Six human subjects known to be infected with HDV were treated with 200 mg BID or 300 mg BID doses of lonafarib treatment continued for a period of 84 days.

[0322] The effect of 28 days treatment

[0323] At the end of the 28-day treatment period, the mean change in viral load from baseline to Day 28 for the 6 subjects was -1.63 log copies / mL for the 200 mg BID group and -2.00 log copies / mL for the 300 mg BID group . See Table 7 and image 3 .

[0324] Table 7

[0325]

[0326] Results at day 28 showed that the 200 mg BID and 300 mg BID dosing regimens were superior to the 100 mg BI dosing regimen in efficacy. However, additional efficacy with fewer side effects is believed to be required for significant therapeutic benefit.

[0327] Effect of 56-84 days of treatment

[0328] When the administration of 200mg BID and 300mg BID continued for 56 days (days 29-56 ma...

example 3

[0329] Example 3. Treatment of HDV patients with combination of 100 mg BID lonafarib and interferon

[0330] As recorded by baseline HDV RNA viral titers (ranging from 4.34 log HDV RNA copies / mL to 5.15 log HDV RNA copies / mL, and ALT values ​​ranging from 155-174 IU / L), three HDV-infected Human subjects were treated with lonafarib at a dose of 100mg BID with Combination treatment with (pegylated interferon alpha-2a) 180 μg / week lasted for a period of 56 days (2 months).

[0331] At the end of 28 days, all three patients had decreased HDV RNA viral titers from baseline, ranging from -1.04 log HDV RNA copies / mL to -2.00 log HDV RNA copies / mL of HDV-RNA, at three The mean reduction in subjects was -1.8 log HDV RNA copies / mL. At the end of 56 days, HDV RNA viral titers continued to decline in all three patients, with mean viral loads declining to 3 log copies / mL on day 56. In addition, ALT values ​​decreased from baseline to day 56 in all three patients, continued to decline...

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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 comprises treating the patient with lonafarnib-interferon lambda co-therapy.

Description

technical field [0001] The present invention provides methods for the treatment of viral hepatitis caused by hepatitis D virus (HDV) infection, and thus relates to the fields of chemistry, medicinal chemistry, medicine, molecular biology, and pharmacology. Background technique [0002] Hepatitis delta virus (HDV) causes the most severe form of viral hepatitis and has no effective medical therapy (see Lau, 1999, Hepatology 30:546-549). HDV invariably manifests as co-infection with hepatitis B virus (HBV), and co-infected patients are more likely to die from complications of viral infection than patients infected with HBV alone. [0003] The HDV large delta antigenic protein contains a CXXX box that is passed through prenyl lipid farnesyltransferase (see Glenn et al., 1992, Science [Science] 256:1331-1333, and Otto and Casey, 1996, J.Biol.Chem.[Biological Chemistry Journal] 271:4569-4572) make it become the substrate of prenylation (referring to Zhang and Casey, 1996, Annu.Re...

Claims

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Application Information

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IPC IPC(8): A61K31/4545A61K31/4178A61P31/12
CPCA61K31/4545A61K38/21A61K9/0053A61K9/0095A61K9/1635A61K9/1652A61K9/2004A61K9/48A61K31/427A61P31/12A61P31/14A61P31/20A61P43/00A61K2300/00A61K31/4178A61K31/4439A61K31/451A61K31/46
Inventor 大卫·A·克里英格丽德·宋杰弗里·S·格伦
Owner EIGER BIOPHARMLS
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