ONCE DAILY TREATMENT OF HEPATITIS C WITH RIBAVIRIN AND TARIBAVIRIN
Hepatitis C is treated by administering once daily ribavirin, taribavirin, other derivatives or pharmaceutically acceptable salts thereof. Hepatitis C may also be treated by administering any of the foregoing compounds once daily in combination with interferon and/or direct-acting antivirals. Once daily dosage forms administered for treating hepatitis C may comprise between 800 mg and 1400 of ribavirin. Once daily dosage forms administered for treating hepatitis C may also comprise between 800 mg and 4000 mg of taribavirin.
1 . A method of treating HCV infection, comprising administering ribavirin, or a pharmaceutically acceptable salt thereof, in combination with a direct-acting antiviral agent to a subject in need of such treatment, wherein the ribavirin, or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of between 800 mg and 1400 mg.
2 . The method of claim 1 , wherein the dose of ribavirin, or a pharmaceutically acceptable salt thereof, is administered in one dosage unit.
3 . The method of claim 1 , wherein the dose of ribavirin, or a pharmaceutically acceptable salt thereof, is administered in two or three dosage units and wherein each dosage unit comprises 400, 500 or 600 mg of ribavirin, or a pharmaceutically acceptable salt thereof.
4 . The method of claim 2 , wherein the dosage unit of ribavirin, or a pharmaceutically acceptable salt thereof, is an immediate release dosage unit.
5 . The method of claim 2 , wherein the dosage unit of ribavirin, or a pharmaceutically acceptable salt thereof, is an extended release dosage unit or a combination of an immediate release dosage unit and an extended release dosage unit.
6 . The method of claim 3 , wherein at least one of the two or three dosage units of ribavirin, or a pharmaceutically acceptable salt thereof, is an immediate release dosage unit.
7 . The method of claim 3 , wherein at least one of the two or three dosage units of ribavirin, or a pharmaceutically acceptable salt thereof, is an extended release dosage unit or a combination of an immediate release dosage unit and an extended release dosage unit.
8 . The method as in one of claims 1 - 7 , wherein ribavirin, or a pharmaceutically acceptable salt thereof, is administered in the form of a tablet.
9 . The method as in one of claims 1 - 7 , wherein ribavirin, or a pharmaceutically acceptable salt thereof, is administered in the form of a capsule.
10 . The method as in one of claims 1 - 7 , wherein the direct-acting antiviral agent is telaprevir.
11 . The method as in one of claims 1 - 7 , wherein the direct-acting antiviral agent is boceprevir.
12 . The method as in one of claims 1 - 7 , wherein the direct-acting antiviral agent is a HCV protease inhibitor.
13 . The method as in one of claims 1 - 7 , wherein the direct-acting antiviral agent is a HCV helicase inhibitor.
14 . The method as in one of claims 1 - 7 , wherein the direct-acting antiviral agent is an inhibitor of HCV nonstructural protein 4B.
15 . The method as in one of claims 1 - 7 , wherein the direct-acting antiviral agent is an inhibitor of HCV nonstructural protein 5A.
16 . The method as in one of claims 1 - 7 , wherein the direct-acting antiviral agent is a HCV polymerase inhibitor.
17 . The method as in one of claims 1 - 7 , wherein the direct-acting antiviral agent is an inhibitor of HCV viral ion channel forming protein p7.
18 . The method as in one of claims 1 - 7 , wherein the subject is coinfected with HIV.
19 . The method as in one of claims 1 - 7 , wherein the subject is additionally administered interferon.
20 . The method of claim 19 , wherein the interferon is selected from the group consisting of interferon alfa-2α, interferon alfa-2β and alfacon-1, as well as pegylated interferon alfa-2α, interferon alfa-2β and alfacon-1.
21 . A method of treating HCV infection, comprising administering ribavirin, or a pharmaceutically acceptable salt thereof, in combination with interferon to a subject in need of such treatment, wherein between 800 mg and 1400 mg of ribavirin, or a pharmaceutically acceptable salt thereof, are administered once daily in a single unit.
22 . The method of claim 21 , wherein the single unit is an immediate release dosage unit.
23 . The method of claim 21 , wherein the single unit is an extended release dosage unit or a combination of an immediate release dosage unit and an extended release dosage unit.
24 . The method as in one of claims 21 - 23 , wherein the interferon comprises interferon alfa-2α or interferon alfa-2β.
25 . The method of claim 24 , wherein the interferon is pegylated.
26 . The method as in one of claims 21 - 23 , wherein the interferon comprises interferon alfacon-1.
27 . The method of claim 26 , wherein the interferon is pegylated.
28 . A method of treating HCV infection, comprising administering ribavirin, or a pharmaceutically acceptable salt thereof, to a subject in need of such treatment, wherein ribavirin, or a pharmaceutically acceptable salt thereof, is administered once daily in an immediate release single unit comprising between 800 mg and 1400 mg of ribavirin, or a pharmaceutically acceptable salt thereof.
29 . The method of claim 28 , wherein the immediate release single unit comprises 800 mg of ribavirin, or a pharmaceutically acceptable salt thereof.
30 . The method of claim 28 , wherein the immediate release single unit comprises 1000 mg of ribavirin, or a pharmaceutically acceptable salt thereof.
31 . The method of claim 28 , wherein the immediate release single unit comprises 1200 mg of ribavirin, or a pharmaceutically acceptable salt thereof.
32 . The method as in one of claims 28 - 31 , wherein the immediate release single unit is a tablet.
33 . The method as in one of claims 28 - 31 , wherein the immediate release single unit is a capsule.
34 . A pharmaceutical dosage unit comprising between 800 mg and 1400 mg of ribavirin, or a pharmaceutically acceptable salt thereof, wherein the dosage unit is an immediate release dosage form.
35 . The pharmaceutical dosage unit of claim 34 , comprising 800 mg of ribavirin, or a pharmaceutically acceptable salt thereof.
36 . The pharmaceutical dosage unit of claim 34 , comprising 1000 mg of ribavirin, or a pharmaceutically acceptable salt thereof.
37 . The pharmaceutical dosage unit of claim 34 , comprising 1200 mg of ribavirin, or a pharmaceutically acceptable salt thereof.
38 . The pharmaceutical dosage unit as in one of claims 34 - 37 , wherein the dosage unit is a tablet.
39 . The pharmaceutical dosage unit as in one of claims 34 - 37 , wherein the dosage unit is a capsule.
40 . A method of treating HCV infection, comprising administering taribavirin, or a pharmaceutically acceptable salt thereof, in combination with a direct-acting antiviral agent to a subject in need of such treatment, wherein the taribavirin, or a pharmaceutically acceptable salt thereof, is administered once daily at a dose of between 800 mg and 1600 mg.
41 . The method of claim 34 , wherein the dose of taribavirin, or a pharmaceutically acceptable salt thereof, is administered in one dosage unit.
42 . The method of claim 34 , wherein the dose of taribavirin, or a pharmaceutically acceptable salt thereof, is administered in more than one dosage units and wherein each dosage unit comprises 200 mg of taribavirin, or a pharmaceutically acceptable salt thereof.
43 . The method of claim 41 , wherein the dosage unit of taribavirin, or a pharmaceutically acceptable salt thereof, is an immediate release dosage unit.
44 . The method of claim 41 , wherein the dosage unit of taribavirin, or a pharmaceutically acceptable salt thereof, is an extended release dosage unit or a combination of an immediate release dosage unit and an extended release dosage unit.
45 . The method of claim 42 , wherein at least one of the dosage units of taribavirin, or a pharmaceutically acceptable salt thereof, is an immediate release dosage unit.
46 . The method of claim 42 , wherein at least one of the dosage units of taribavirin, or a pharmaceutically acceptable salt thereof, is an extended release dosage unit or a combination of an immediate release dosage unit and an extended release dosage unit.
47 . The method as in one of claims 40 - 46 , wherein taribavirin, or a pharmaceutically acceptable salt thereof, is administered in the form of a tablet.
48 . The method as in one of claims 40 - 46 , wherein taribavirin, or a pharmaceutically acceptable salt thereof, is administered in the form of a capsule.
49 . The method as in one of claims 40 - 46 , wherein the direct-acting antiviral agent is telaprevir.
50 . The method as in one of claims 40 - 46 , wherein the direct-acting antiviral agent is boceprevir.
51 . The method as in one of claims 40 - 46 , wherein the direct-acting antiviral agent is a HCV protease inhibitor.
52 . The method as in one of claims 40 - 46 , wherein the direct-acting antiviral agent is a HCV helicase inhibitor.
53 . The method as in one of claims 40 - 46 , wherein the direct-acting antiviral agent is an inhibitor of HCV nonstructural protein 4B.
54 . The method as in one of claims 40 - 46 , wherein the direct-acting antiviral agent is an inhibitor of HCV nonstructural protein 5A.
55 . The method as in one of claims 40 - 46 , wherein the direct-acting antiviral agent is a HCV polymerase inhibitor.
56 . The method as in one of claims 40 - 46 , wherein the direct-acting antiviral agent is an inhibitor of HCV viral ion channel forming protein p7.
57 . The method as in one of claims 40 - 46 , wherein the subject is coinfected with HIV.
58 . The method as in one of claims 40 - 46 , wherein the subject is additionally administered interferon.
59 . The method of claim 58 , wherein the interferon is selected from the group consisting of interferon alfa-2α, interferon alfa-2β and alfacon-1, as well as pegylated interferon alfa-2α, interferon alfa-2β and alfacon-1.
60 . A method of treating HCV infection, comprising administering taribavirin, or a pharmaceutically acceptable salt thereof, in combination with interferon to a subject in need of such treatment, wherein between 800 mg and 1600 mg of taribavirin, or a pharmaceutically acceptable salt thereof, are administered once daily in a single unit.
61 . The method of claim 60 , wherein the single unit is an immediate release dosage unit.
62 . The method of claim 60 , wherein the single unit is an extended release dosage unit or a combination of an immediate release dosage unit and an extended release dosage unit.
63 . The method as in one of claims 60 - 62 , wherein the interferon comprises interferon alfa-2α or interferon alfa-2β.
64 . The method of claim 63 , wherein the interferon is pegylated.
65 . The method as in one of claims 60 - 62 , wherein the interferon comprises interferon alfacon-1.
66 . The method of claim 65 , wherein the interferon is pegylated.
67 . A method of treating HCV infection, comprising administering taribavirin, or a pharmaceutically acceptable salt thereof, to a subject in need of such treatment, wherein taribavirin, or a pharmaceutically acceptable salt thereof, is administered once daily in a single unit comprising between 800 mg and 1600 mg of ribavirin, or a pharmaceutically acceptable salt thereof.
68 . The method of claim 67 , wherein the single unit comprises 800 mg of taribavirin, or a pharmaceutically acceptable salt thereof.
69 . The method of claim 67 , wherein the single unit comprises 1200 mg of taribavirin, or a pharmaceutically acceptable salt thereof.
70 . The method of claim 67 , wherein the single unit comprises 1600 mg of taribavirin, or a pharmaceutically acceptable salt thereof.
71 . The method as in one of claims 67 - 70 , wherein the single unit is a tablet.
72 . The method as in one of claims 67 - 70 , wherein the single unit is a capsule.
73 . The method as in one of claims 67 - 70 , wherein the single unit is an immediate release dosage unit.
74 . The method as in one of claims 67 - 70 , wherein the single unit is an extended release dosage unit.
75 . A pharmaceutical dosage unit comprising between 800 mg and 1200 mg of taribavirin, or a pharmaceutically acceptable salt thereof.
76 . The pharmaceutical dosage unit of claim 75 , comprising 800 mg of taribavirin, or a pharmaceutically acceptable salt thereof.
77 . The pharmaceutical dosage unit of claim 75 , comprising 1200 mg of taribavirin, or a pharmaceutically acceptable salt thereof.
78 . The pharmaceutical dosage unit of claim 75 , comprising 1600 mg of taribavirin, or a pharmaceutically acceptable salt thereof.
79 . The pharmaceutical dosage unit as in one of claims 75 - 78 , wherein the dosage unit is a tablet.
80 . The pharmaceutical dosage unit as in one of claims 75 - 78 , wherein the dosage unit is a capsule.
81 . The pharmaceutical dosage unit as in one of claims 75 - 78 , wherein the dosage unit is an immediate release dosage unit.
82 . The pharmaceutical dosage unit as in one of claims 75 - 78 , wherein the dosage unit is an extended release dosage unit.