Treatment of Alcoholic Hepatitis
Methods of treating alcoholic hepatitis (AH) are provided. For instance, the methods may comprise administering 5-cholesten-3,25-diol, 3-sulfate (25HC3S) or a salt thereof.
1 . A method of treating alcoholic hepatitis in a human subject in need thereof, the method comprising administering to the subject 5-cholesten-3,25-diol,3-sulfate (25HC3S) or salt thereof in a total amount of about 10 mg to about 400 mg in a period of one month, wherein:
the total amount is sufficient to treat the alcoholic hepatitis;
the total amount is administered in one or more separate doses comprising at least a first dose; and
the period of one month is measured from the beginning of administration of the first dose.
2 - 4 . (canceled)
5 . The method of claim 1 , wherein the total amount is administered in one dose or in two separate doses, preferably as a single dose.
6 . The method of claim 1 , wherein at least one of the one or more separate doses comprises from about 10 mg to about 200 mg of 25HC3S or salt thereof.
7 . The method of claim 1 , wherein at least one of the one or more separate doses comprises from about 20 mg to about 100 mg of 25HC3S or salt thereof.
8 . The method of claim 1 , wherein the total amount is administered in two or more separate doses that are administered at a dose frequency ranging from daily to once every week.
9 . The method of claim 1 , wherein:
the total amount is administered in one dose or in two separate doses;
the one dose comprises from about 10 mg to about 200 mg of 25HC3S or salt thereof;
each of the two separate doses comprises from about 10 mg to about 200 mg of 25HC3S or salt thereof; and
the two separate doses are administered at a dose frequency ranging from once every two days to once every four days.
10 . The method of claim 1 , wherein the administering is performed parenterally, intravenously, intramuscularly, or subcutaneously.
11 . The method of claim 1 , wherein the administering is performed by injection.
12 . The method of claim 1 , wherein the 25HC3S or salt thereof is administered in a formulation comprising the 25HC3S or salt thereof and a pharmaceutically acceptable carrier.
13 . The method of claim 1 , wherein the 25HC3S or salt thereof comprises sodium salt of 25HC3S.
14 - 15 . (canceled)
16 . The method of claim 1 , wherein the total amount of 25HC3S is administered in from one to five separate doses.
17 . The method of claim 1 , wherein the total amount of 25HC3S is administered in a single dose.
18 . The method of claim 1 , wherein each of the separate doses comprises from 10 mg to 100 mg of 25HC3S or salt thereof.
19 . The method of claim 1 , wherein each of the separate doses comprises from 20 mg to 100 mg of 25HC3S or salt thereof.
20 . The method of claim 1 , wherein the total amount of 25HC3S or salt thereof is not more than 200 mg.
21 . The method of claim 1 , wherein:
the total amount is administered in one dose or in two separate doses;
the one dose comprises from 20 mg to 40 mg of 25HC3S or salt thereof;
each of the two separate doses comprises from 20 mg to 40 mg of 25HC3S or salt thereof; and
the two separate doses are administered at a dose frequency ranging from once every two days to once every four days.
22 . The method of claim 1 , wherein:
the total amount is administered in one dose or in two separate doses;
the one dose comprises from 80 mg to 100 mg of 25HC3S or salt thereof;
each of the two separate doses comprises from 80 mg to 100 mg of 25HC3S or salt thereof; and
the two separate doses are administered at a dose frequency ranging from once every two days to once every four days.
23 . The method of claim 1 , wherein the human subject has a Model for End-stage Liver Disease (MELD) score of at least 11.
24 . The method of claim 1 , wherein the human subject has a Maddrey's discriminant function (MDF) of at least 32.