The present invention relates to, inter alia, methods of treatment and combinations of (R)-2-(7-(4-cyclopentyl-3-(tri-fluoromethyl)benzyloxy)-1,2,3,4-tetrahydrocyclopenta[b]indol-3-yl)
acetic acid (Compound 1) useful for the treatment of primary biliary cholangitis (PBC). In some embodiments, the methods further comprise administering Compound 1, or a pharmaceutically salt, solvate, or
hydrate thereof, in combination with a compound selected from the group consisting of: an
antihistamine (
diphenhydramine), cholestyramine (questran, prevalite), rifampin, an
opioid antagonist (naloxone),
pilocarpine (isopto carpine, salagen), cevimeline (evoxac),
calcium and / or
vitamin D supplement, and
vitamin A, D, E and / or K supplement. Other embodiments, relate to
titration packages for enabling compliance with a
regimen of changing dosage of a medication over a period of time for the treatment of primary biliary cholangitis (PBC).