Combination of direct acting antiviral agents and ribavirin for treating HCV patients

An antiviral agent, patient technology, applied in the direction of antiviral agents, drug combinations, medical preparations containing active ingredients, etc., can solve problems such as incomplete elimination of viruses

Inactive Publication Date: 2015-10-28
ABBVIE INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Significant limitations in efficacy and tolerability remain as many users suffer from side effects and elimination of virus from the body is often incomplete

Method used

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  • Combination of direct acting antiviral agents and ribavirin for treating HCV patients
  • Combination of direct acting antiviral agents and ribavirin for treating HCV patients
  • Combination of direct acting antiviral agents and ribavirin for treating HCV patients

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0082] Example 1. Clinical modeling of DAA combination therapy without interferon

[0083] The treatment regimen comprising administration of Compound 1 and Compound 2 was described using U.S. Patent Application Publication No. 2013 / 0102526, filed October 19, 2012 and entitled "Methods for Treating HCV," which is incorporated herein by reference in its entirety. clinical model for evaluation. These treatment regimens included the administration of Compound 1 and Compound 2, but not the administration of interferon or ribavirin. However, similar SVR rates were expected when ribavirin was added to these regimens.

[0084] figure 1 Shown are the predicted median SVR percentages and 90% for the 2-DAA regimen consisting of Compound 1 (400 mg once daily) and Compound 2 (120 mg once daily) to treat genotype 1 naïve subjects. % SVR confidence interval. Different treatment durations were evaluated. The predicted SVR rate for 12-week treatment was approximately 95%. As used in all...

Embodiment 2

[0090] Example 2. Combination of Compound 1 and Compound 2 in vitro

[0091] Figure 7 It was shown that the combination of Compound 1 and Compound 2 exhibited a significant synergistic effect on HCV inhibition as tested in HCV GT 1b Con-1 replicating cells. Results were generated using the Prichard and Shipman model (Prichard et al. Antiviral Research 14:181-205 (1990)).

[0092] Compound 1 inhibits the replication of HCV stable subgenomic replicons containing the NS3 gene from GT 1a, 1b, 2a, 3a, 4a or 6a, where EC 50 Values ​​range from 0.85 to 2.8 nM. Notably, compound 1 is potent against replicon containing GT3a protease, in which EC 50 The value is 1.6 nM. Compound 1 retained its activity against common GT1a and 1b variants at NS3 amino acid positions 155 and 168 that confer resistance against other HCV protease inhibitors (Pis). Resistant colony selection studies in GT1a and 1b subgenomic replicon cells identified A156T in GT1a and A156V in GT1b as the most common v...

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Abstract

The present invention features interferon-free therapies for the treatment of HCV. Preferably, the treatment is over a shorter duration of treatment, such as no more than 12 weeks. In one aspect, the treatment comprises administering at least two direct acting antiviral agents and ribavirin to a subject with HCV infection, wherein the treatment lasts for 12 weeks and does not include administration of interferon, and said at least two direct acting antiviral agents comprise (a) Compound 1 or a pharmaceutically acceptable salt thereof and (b) Compound 2 or a pharmaceutically acceptable salt thereof.

Description

[0001] This application claims the benefit of US Provisional Application No. 61 / 783,437, filed March 14, 2013, which is hereby incorporated by reference in its entirety. field of invention [0002] The present invention relates to an interferon-free treatment for hepatitis C virus (HCV). Background of the invention [0003] HCV is an RNA virus belonging to the Hepacivirus genus in the Flaviviridae family. The enveloped HCV virion contains a positive-sense RNA genome that encodes all known virus-specific proteins in a single uninterrupted open reading frame. The open reading frame comprises about 9500 nucleotides and encodes a single large protein of about 3000 amino acids. The polyprotein comprises core protein, envelope proteins E1 and E2, membrane-bound protein p7, and nonstructural proteins NS2, NS3, NS4A, NS4B, NS5A and NS5B. [0004] Chronic HCV infection is associated with progressive liver pathology including cirrhosis and hepatocellular carcinoma. Chronic hepatiti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/454A61K31/4985A61K31/7056A61K45/06A61P31/22
CPCA61K31/7056A61K31/454A61K31/4985A61K45/06A61P1/16A61P31/14A61K2300/00
Inventor B.M.伯恩斯坦S.杜塔刘巍T.J.波萨德基A.L.坎贝尔R.M.梅农林志威王恬力W.M.奥尼
Owner ABBVIE INC
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