Intermune, Inc.

Hoffmann-la Roche Inc.

Roche Palo Alto LLC

Pharmasset, Inc.

Williamson Ziegler Bradford

Javier Szwarcberg

Steven B Porter

Leonid Beigelman

Brad Owen Buckman

Scott D Seiwert

Antitsa Dimitrova Stoycheva

Vladimir Serebryany

Abel De La Rosa

Patrick F Smith

Ellen S Yetzer

Michael D Rogers

William T Symonds

The disclosure relates to improved methods of administering pirfenidone therapy when ciprofloxacin is administered concomitantly.

Methods of administering pirfenidone therapy

The present invention relates to methods involving avoiding adverse drug interactions with pirfenidone and CYP inducers, such as smoking.

Pirfenidone therapy and inducers of cytochrome P450

Embodiments disclosed in the present application relate to a composition that can include a hepatitis C viral polymerase inhibitor, or pharmaceutically acceptable salt or prodrug thereof and a hepatitis C viral protease inhibitor, or pharmaceutically acceptable salt or prodrug thereof. Additional embodiments disclosed relate to methods for treating a disease condition such as a hepatitis C virus infection, liver fibrosis and/or impaired liver function with a hepatitis C viral polymerase inhibitor, or pharmaceutically acceptable salt or prodrug thereof and a hepatitis C viral protease inhibitor, or pharmaceutically acceptable salt or prodrug thereof.

Therapeutic composition

Methods are provided for administering pirfenidone to a patient that has exhibited abnormal biomarkers of liver function in response to pirfenidone administration. The methods include administering to a patient pirfenidone at doses lower than the full target dosage for a time period, followed by administering to the patient pirfenidone at the full target dosage. The methods also include administering pirfenidone at the full target dose with no reduction and administering permanently reduced doses of pirfenidone.

Pirfenidone treatment for patients with atypical liver function

The invention relates to methods for decreasing adverse events associated with pirfenidone (5-methyl-1-phenyl-2-(1H)-pyridone) therapy. The invention discloses an optimized dose escalation scheme that results in the patient having increased tolerance to adverse events associated with the administration of pirfenidone. The invention also discloses a starter pack that may be used in conjunction with the dose escalation scheme.

Method of providing pirfenidone therapy to a patient

The present invention relates to methods involving avoiding adverse drug interactions with fluvoxamine and pirfenidone or other moderate to strong inhibitors of CYP enzymes.

The embodiments provide compounds of the general Formulae I, II, III, IV, V, VI, VII, and X, as well as compositions, including pharmaceutical compositions, comprising a subject compound. The embodiments further provide treatment methods, including methods of treating a hepatitis C virus infection and methods of treating liver fibrosis, the methods generally involving administering to an individual in need thereof an effective amount of a subject compound or composition.

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Ross, CA, United States of America

Williamson Ziegler Bradford