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144 Weeks of bulevirtide monotherapy for chronic hepatitis D: Final and posttreatment results from a Phase 3 randomized trial
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Highlights
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Bulevirtide is well tolerated and effective through 144 weeks of treatment
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Virologic and biochemical response rates decreased posttreatment
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Some patients sustained undetectable HDV RNA through up to 2 years of follow-up
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These patients maintained improvements in biochemical response posttreatment
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Duration of continuous HDV RNA undetectability at EOT predicts sustained posttreatment undetectability
Abstract
Background & Aims
Bulevirtide 2 mg/day is approved in Europe, Australia, Russia, and Canada for treatment of compensated chronic hepatitis D (CHD). However, long-term outcomes after treatment discontinuation are unknown.
Methods
Patients with CHD (n=150) were randomized to immediate treatment with bulevirtide 2 mg/day (n=49) or 10 mg/day (n=50) for 144 weeks (W), or 48W of delayed treatment (DT; n=51) followed by bulevirtide 10 mg/day for 96W (DT/10 mg; n=50), and 96W of posttreatment follow-up (FU96) in the MYR301 study. Efficacy endpoints included virologic response (VR; undetectable hepatitis D virus [HDV] RNA or ≥2 log10 IU/mL decline from baseline), combined response (CR; VR and alanine aminotransferase [ALT] normalization), ALT normalization, and undetectable HDV RNA.
Results
At the end of treatment (EOT), response rates in the 2, 10, and DT/10 mg groups were: VR, 73%, 76%, and 92%; ALT normalization, 59%, 60%, and 58%; CR, 57%, 54%, and 56%; HDV RNA undetectability, 29%, 50%, and 52%. At FU96, VR rates declined to 33%, 30%, and 32%, respectively; CR rates were 24% across all groups. HDV RNA undetectability rates were 20%, 22%, and 20% at FU96. Sustained undetectability through follow-up was observed in 23/64 (36%) patients with undetectable HDV RNA at EOT, with weeks continuously undetectable at EOT being the most important predictor of sustained undetectability. Posttreatment hepatic serious adverse events occurred in 20/142 (14%) patients and resolved in 17/20 (85%).
Conclusions
Bulevirtide treatment for CHD for up to 144W was safe and effective. Response rates decreased after treatment discontinuation; however, some patients had sustained undetectable HDV RNA throughout 2 years of follow-up. (Funded by Gilead Sciences; MYR301 ClinicalTrials.gov number, NCT03852719).
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