Method for improving pharmacokinetics

Abstract

The object of the present invention is to elevate the blood levels of a compound of formula I by co-administration with a cytochrome P450 inhibitor.

Description

CROSS REFERENCE TO PRIOR APPLICATIONS[0001]This application claims the benefit of priority to U.S. Provisional Application 61 / 172,722 filed Apr. 25, 2009 the contents of which is incorporated herein by reference in its entirety.FIELD OF THE INVENTION[0002]The present invention relates to a an improved method or administering a compound according to formula I for treating HCV by co-administration with ritonavir. The invention further relates to a pharmaceutical compositions containing the compound of formula I and ritonavir.BACKGROUND[0003]Hepatitis C virus (HCV) is the leading cause of chronic liver disease throughout the world. (Boyer, N. et al., J. Hepatol. 2000 32:98-112). The World Health Organization (WHO) estimates that more than 170 million people worldwide (or about 3% of the world's population) are infected with the single-stranded ribonucleic acid (RNA) HCV. (G. M. Lauer and B. D. Walker, N. Engl. J. Med. 2001 345:41-52) Approximately one-fifth of chronically infected pati...

AI Technical Summary

Benefits of technology

[0014]In one aspect of the present invention there is provided a method for increasing the bioavailability and or blood level of a Hepatitis C virus NS3 protease inhibitor according to formula I in a patient comprising co-administering to the patient the compound of formula I and a cytochrome P450 monooxygenase inhibitor.

Problems solved by technology

Currently a limited number of approved therapies are available for the treatment of HCV infection.

Ribavirin also exhibits significant toxicity and is known to induce anemia.

Unfortunately, the effects of IFN are temporary.

(Walker, supra) Furthermore, PEG-IFN is given by injection, and the hematologic and constitutional toxicities of PEG-IFN and of RBV are difficult for many patients to tolerate for the long (up to 48 weeks) duration of treatment required.

Currently, there is no SOC treatment for patients who either relapsed or did not respond to (nonresponders) PEG-IFN / RBV therapy.

Given the high prevalence of CHC disease worldwide, the high treatment failure rate with the current SOC, and tolerability issues with the current SOC, there is a substantial unmet medical need to improve and expand therapeutic options for these patient populations.

The effectiveness of the host defenses is hampered by the ability of HCV to disrupt, evade, and antagonize the host immune response, not only ensuring continued viral infection, but also quite often resisting the antiviral action of IFN therapy (M. Gale, Jr. and E. M. Foy, Nature 2005.436:939-945).

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