Publications by authors named "T Iu Stepanova"
Background And Aim: Bulevirtide (BLV) leads to beneficial virologic and biochemical responses when given alone to treat hepatitis delta virus (HDV) infection, which causes the most severe form of chronic viral hepatitis. We evaluated 48 weeks of BLV monotherapy, BLV + tenofovir disoproxil fumarate (TDF) and BLV + pegylated interferon alfa-2a (Peg-IFNα-2a), with 24-week follow-up.
Methods: Ninety patients were enrolled into six arms of 15 each (A-F); 60 patients were included in the main randomisation (arms A-D), and 30 patients (arms E-F) were randomised to the extension phase: (A) Peg-IFNα-2a 180 μg once weekly (QW); (B) BLV 2 mg once daily (QD) + Peg-IFNα-2a 180 μg QW; (C) BLV 5 mg QD + Peg-IFNα-2a 180 μg QW; (D) BLV 2 mg QD; (E) BLV 10 mg QD + Peg-IFNα-2a 180 μg QW and (F) BLV 10 mg (5 mg twice daily) + TDF QD.
Article Synopsis
- The study assessed the safety and tolerability of bulevirtide (BLV), a new treatment for chronic hepatitis delta (CHD), by analyzing data from three clinical trials involving 269 patients.
- The findings indicated that certain adverse events, such as increased bile acid levels and injection-site reactions, were more common with BLV compared to a control group, but serious side effects were minimal and did not lead to treatment discontinuation.
- Overall, BLV was deemed safe and well tolerated over 48 weeks of therapy in patients with CHD, showing promise as an effective treatment option.
Background & Aims: Once-daily treatment of chronic hepatitis delta (CHD) with bulevirtide is well tolerated and associated with significant reductions in HDV RNA in the blood and in biochemical liver disease activity. This study explored the effects of 48-week bulevirtide treatment on health-related quality of life (HRQoL) in patients with CHD.
Methods: In an open-label, randomised, phase III trial, 150 patients with CHD and compensated liver disease were stratified by cirrhosis status and randomised 1:1:1 to no treatment (control), bulevirtide 2 mg/day, or bulevirtide 10 mg/day for 48 weeks.
Article Synopsis
- A phase 2b trial tested the effectiveness of bulevirtide combined with peginterferon alfa-2a compared to peginterferon alone and bulevirtide alone in treating chronic hepatitis D over 48 weeks, with follow-up for an additional 48 weeks.* -
- Results showed that 46% of patients receiving the 10 mg bulevirtide and peginterferon had undetectable levels of the hepatitis D virus 24 weeks after treatment, compared to only 17% in the peginterferon alone group.* -
- The combination therapy indicated a statistically significant improvement in viral response, suggesting that bulevirtide and peginterferon could be a beneficial treatment strategy
Background & Aims: Bulevirtide (BLV), a first-in-class entry inhibitor, is approved in Europe for the treatment of chronic hepatitis delta (CHD). BLV monotherapy was superior to delayed treatment at week (W) 48, the primary efficacy endpoint, in the MYR301 study (NCT03852719). Here, we assessed if continued BLV therapy until W96 would improve virologic and biochemical response rates, particularly among patients who did not achieve virologic response at W24.
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