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Placebo - OSTI GOV

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Last Updated: 26 April 2022

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Oral prenylation inhibition with lonafarnib in chronic hepatitis D infection: a proof-of-concept randomised, double-blind, placebo-controlled phase 2A trial

Background: Therapies for persistent hepatitis delta virus infections are unsatisfactory. Methods: Patients aged 18 years or older with persistent HDV infection were randomly selected to receive lonafarnib 100 mg or lonafarnib 200 mg twice daily for 28 days in this phase 2A double-blind, randomized, placebo-controlled trial, as well as the 6 months' follow-up. As group 2 participants, a placebo group of patients received lonafarnib on an open-label basis. A decrease in HDV viral titre in serum was the primary therapeutic endpoint, and the primary safety endpoint was the ability to tolerate the drug in the full 4-week duration, defined as drug discontinuation due to intolerance or grade 3/4 adverse events. In group 1 and -154 log IU/mL, respectively, on day 28, log HDV RNA declines from baseline were -0-7 log IU/mL, compared to placebo, and group 2's -154 log IU/mL. Lonafarnib serum levels were correlated with HDV RNA change, according to HDV RNA change. After a brief pharmacological delay, lonafarnib's effectiveness in blocking HDV production in group 2 was greater than in group 1; the HDV half-life was 162 days. Patients with diarrhoea in three patients and nausea in two patients and in group 2 were mainly mild to moderate, with no patient suffering nausea, diarrhoea, abdominal bloating, and weight loss greater than 2 kg were present. Interpretation: HIV vaccine treatment with lonafarnib effectively reduces virus levels in the long run.

Source link: https://www.osti.gov/biblio/1454990

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions