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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 drug therapy

Active Publication Date: 2017-03-22
EIGER BIOPHARMLS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Hepatitis delta virus (HDV) causes the most severe form of viral hepatitis and has no effective drug 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

Embodiment 1

[0194] Example 1. Treatment of HDV patients with BID administration of 100 mg lonafarib

[0195] This example demonstrates the efficacy of lonafarib in reducing HDV RNA levels in chronic HDV patients. Eight Group 1 patients (all with chronic HDV) were treated according to the following: six patients (patients 1, 2, 4, 5, 6, and 8) with chronic hepatitis D (HDV) received lonafarib, two Patients (Patients 3 and 7) were administered placebo for 28 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 active-treated lonafarib group and -0.24 log HDV RNA copies / mL in the placebo group.

[0196] Patients 4, 5, 6, and 8 responded to treatment, as defined by a quantitative serum HDV RNA level decline from baseline to nadir of greater than or equal to 0.5 log HDV RNA copies / mL during active treatment. See Table 5 (showing the change i...

Embodiment 2

[0205] Example 2. Treatment of HDV patients with BID administration of 200 mg and 300 mg lonafarib

[0206] Six human subjects known to be infected with HDV were treated at 200 mg BID or 300 mg BID for 84 days; these subjects had documented baseline HDV RNA viral titers ranging from 5.8 log HDV RNA copies / mL to 8.78 log HDV RNA copies / mL.

[0207] The effect of 28 days treatment

[0208] At the end of the 28-day treatment period, among the six subjects, the mean change in viral load from baseline to Day 28 was -1.63 log copies / mL for the 200 mg BID group and -2.00 log for the 300 mg BID group copies / mL. See Table 6 and image 3 .

[0209] Table 6

[0210]

[0211] The Day 28 results demonstrate superior efficacy of the 200 mg BID and 300 mg BID dosing schedules over the 100 mg BID dosing schedule. However, additional efficacy is required for significant therapeutic benefit. Based on the results of BID administration of 200 mg and 300 mg lonafarib in HDV patients, we ...

Embodiment 3

[0214] Example 3. Use Combination of 100mg BID lonafarib and interferon in HDV patients

[0215] Three human subjects known to be infected with HDV were treated with lonafarib at a dose of 100 mg BID in combination with 180 μg Pegasys (peg interferon alfa-2a) weekly for 56 days (2 months); these subjects had been Baseline HDV RNA viral titers were recorded ranging from 4.34 log HDV RNA copies / mL to 5.15 log HDV RNA copies / mL, and ALT values ​​ranged from 155-174 IU / L.

[0216] At the end of day 28, 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, and the The mean decline in three patients was -1.8 log HDV RNA copies / mL. At the end of day 56, HDV RNA viral titers continued to decline in all three patients, with a mean viral load reduction of 3 log copies / mL at day 56. In addition, ALT values ​​decreased from baseline until Day 56 in all three patients, continued to decline after ces...

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Abstract

The prenyltransferase inhibitor lonafarnib and the CYP3A4 inhibitor ritonavir are used in combination to treat hepatitis delta virus (HDV) infection. HDV infection is treated by orally administering to the patient a therapeutically effective amount of lonafarnib and a therapeutically effective amount of a CYP3A4 inhibitor for at least 30 days. Optionally the treatment includes prophylactic administration of one or more GI modifying agents.

Description

[0001] Cross References to Related Applications [0002] This application claims U.S. provisional applications US62 / 151,349 (filed April 22, 2015), US61 / 987,315 (filed May 1, 2014), US62 / 044,766 (filed September 2, 2014), and US62 / 073,413 (filed priority interest on October 31, 2014. The entire content of each of the foregoing provisional applications is incorporated herein by reference. technical field [0003] 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 [0004] Hepatitis delta virus (HDV) causes the most severe form of viral hepatitis and has no effective drug therapy (see Lau, 1999, Hepatology 30:546-549). HDV is frequently co-infected with HBV, and co-infected patients are more likely to die from complications of viral infection than HBV-only patients. Currently...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4545
CPCA61K31/4545A61K45/06A61K31/4178A61K31/426A61K31/427A61K31/451A61K31/46A61P1/04A61P1/08A61P1/12A61P31/00A61P31/12A61P31/14A61P43/00A61K2300/00
Inventor 大卫·克里英格丽德·松杰弗里·S·格伦
Owner EIGER BIOPHARMLS
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