# US 2019/0167646 A1 · Treatment of hepatitis delta virus infection

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- Number: US 2019/0167646 A1
- Document ID: US20190167646A1
- Status: Published application
- Kind: A1
- Application number: 16/052,386
- Filed: 2018-08-01
- Published: 2019-06-06
- Earliest claimed: 2014-05-01
- Assignees: Eiger BioPharmaceuticals, Inc.
- Applicants: Eiger BioPharmaceuticals, Inc.
- Inventors: David A. Cory; Ingrid Choong; Jeffrey S. Glenn
- Web page: https://patentgrep.com/patent/US20190167646A1

## CPC

- A61K 31/427: not condensed and containing further heterocyclic rings
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/146: {with organic macromolecular compounds}
- A61K 31/4545: containing a six-membered ring with nitrogen as a ring hetero atom, e.g. pipamperone, anabasine
- A61K 38/21: Interferons {[IFN]}
- A61K 38/212: {IFN-alpha}
- A61K 47/60: the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## 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 further comprises treating the patient with an interferon.

## Claims

### Claim at position 1

1-31. (canceled)

### Claim 32

A method for inducing immune reactivation in a patient infected with hepatitis delta virus (HDV) and hepatitis B virus (HBV), the method comprising:
(i) administering lonafarnib and ritonavir co-therapy to the patient, wherein the lonafarnib is administered at a dose of 25 mg BID or 50 mg BID and the ritonavir is administered at a dose of 100 mg BID to 200 mg BID; and
(ii) detecting a hepatitis flare in the patient.

### Claim 33 (depends on 32)

The method of claim 32, wherein the detecting step comprises measuring serum alanine aminotransferase (ALT) levels in the subject.

### Claim 34 (depends on 32)

The method of claim 32, wherein the lonafarnib and ritonavir co-therapy is administered for a period of 2 to 12 weeks.

### Claim 35 (depends on 32)

The method of claim 32, wherein after a hepatitis flare is detected, the method comprises administering the lonafarnib at a lower dose for a period of at least 4 weeks.

### Claim 36 (depends on 32)

The method of claim 32, wherein after a hepatitis flare is detected, the lonafarnib and ritonavir co-therapy is discontinued for at least 4 weeks.

### Claim 37 (depends on 32)

The method of claim 32, wherein the method further comprises administering an interferon to the patient.

### Claim 38 (depends on 37)

The method of claim 37, wherein the interferon is administered at a dose of 120 micrograms QW or 180 micrograms QW.

### Claim 39 (depends on 37)

The method of claim 37, wherein the interferon is interferon lambda.

### Claim 40 (depends on 36)

The method of claim 36, wherein after the lonafarnib and ritonavir co-therapy is discontinued, the method further comprises administering to the patient a second course of lonafarnib and ritonavir co-therapy in which the lonafarnib is administered at a lower dose than the initial lonafarnib and ritonavir co-therapy.

### Claim 41

(canceled)

### Claim 42

A method for inducing immune reactivation in a patient infected with HDV and HBV, the method comprising administering to the patient lonafarnib at a first dose, followed by administering lonafarnib at a second dose, wherein the second dose is lower than the first dose.

### Claim 43 (depends on 42)

The method of claim 42, wherein the first dose is administered for at least 8 weeks and the second dose is administered for at least 4 weeks.

### Claim 44 (depends on 42)

The method of claim 42, wherein the first dose of lonafarnib is 50 mg BID and the second dose of lonafarnib is 25 mg BID.

### Claim at position 15

45-69. (canceled)

### Claim 70

A unit dose form comprising lonafarnib and ritonavir, wherein the unit dose form is formulated for oral administration.

### Claim 71 (depends on 70)

The unit dose form of claim 70, wherein the lonafarnib and ritonavir are present in a ratio of about 1:2 (w/w) or about 1:4 (w/w).

### Claim 72 (depends on 70)

The unit dose form of claim 70, wherein the lonafarnib is amorphous lonafarnib.

### Claim 73 (depends on 70)

The unit dose form of claim 70, comprising lonafarnib in an amount from about 25 mg to about 100 mg and ritonavir in an amount from about 50 mg to about 100 mg.

### Claim 74 (depends on 70)

The unit dose form of claim 70, comprising 25 mg or 50 mg amorphous lonafarnib and 100 mg ritonavir.

### Claim 75

(canceled)

### Claim 76 (depends on 70)

The unit dose form of claim 70 that comprises an admixture of lonafarnib and ritonavir, a multiparticulate formulation, or a bilayer formulation.

### Claim 77 (depends on 70)

The unit dose form of claim 70, further comprising povidone.

### Claim 78 (depends on 70)

The unit dose form of claim 70, wherein the unit dose form is formulated as a capsule or a tablet.

### Claim at position 25

79-86. (canceled)