Randomized clinical trial: Combination antiretroviral therapy with tenofovir-emtricitabine and lopinavir-ritonavir in patients with primary biliary cholangitis.

ABSTRACT:

Background

Prior studies using reverse transcriptase inhibitors to treat a human betaretrovirus (HBRV) in patients with primary biliary cholangitis (PBC) resulted in a 21% reduction in alkaline phosphatase (ALP). Herein, we studied the safety and efficacy of combination tenofovir-emtricitabine (TDF/FTC) and lopinavir-ritonavir (LPRr) in PBC patients unresponsive to ursodeoxycholic acid (UDCA).

Methods

A double-blind randomized controlled trial was performed in patients on UDCA for 6 months or more with ALP levels greater than two-fold the upper limit of normal or bilirubin greater than the upper limit of normal. Patients were randomized to daily TDF/FTC 300/200 mg and LPRr 800/200 mg versus identical placebo for 6 months. The primary endpoint was reduction of ALP below 1.67

SUBMITTER: Lytvyak E 

PROVIDER: S-EPMC8112609 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature