Bulevirtide HDV therapy has shown remarkable promise in Gilead’s final results from the Phase 3 MYR301 study. The findings indicate that longer bulevirtide monotherapy for chronic hepatitis delta virus (HDV) leads to sustained virologic suppression after stopping treatment. Notably, 36% of adults who achieved undetectable HDV RNA at the end of treatment maintained this suppression for nearly two years post-therapy. Furthermore, among those undetectable for at least 96 weeks during treatment, a striking 90% continued to show undetectability after therapy cessation, with no late relapses. These findings highlight bulevirtide’s potential for durable off-treatment virologic control in chronic HDV patients.

Key Insights on Bulevirtide’s Effectiveness

• Durable Virologic Response: The MYR301 data show that patients achieving sustained undetectability of HDV RNA during treatment can maintain this response after therapy cessation, especially those undetectable for ≥96 weeks.
• No Late Relapses Observed: No relapses were recorded during the second year of follow-up among patients who sustained undetectability for a year post-treatment.
• Monotherapy Efficacy: Bulevirtide, as a standalone therapy, has shown significant efficacy and tolerability, alongside normalization of liver inflammation markers.
• Novelty with HBV Co-infection: Achieving sustained HDV RNA undetectability while HBV surface antigen remains present is a clinical breakthrough.

The Urgent Need for Effective HDV Treatments

Chronic HDV is the most severe form of viral hepatitis, linked to rapid progression to liver cancer and mortality. Coinfection with HBV affects ~12 million globally. Effective therapies for chronic HDV have been lacking. Bulevirtide’s approval in the EU, UK, and Australia marks a breakthrough. Bulevirtide has received breakthrough designation in the US, with a biologics license application set for FDA review in 2025.

Health Economics and Outcomes Considerations

Bulevirtide’s durable response may improve cost-effectiveness by reducing long-term complications and hospitalizations. Payers may advocate for shorter treatment durations if durable off-treatment control is demonstrated. The findings suggest improved quality of life and slowed disease progression. Bulevirtide’s high sustained response rate sets a new benchmark for HDV therapy.

Conclusion: A Paradigm Shift in HDV Management

The MYR301 results show bulevirtide provides durable treatment for chronic HDV patients, especially those maintaining undetectable HDV RNA long-term. This marks a turning point in HDV management, with implications for patient outcomes and market access. Ongoing analysis will refine patient selection and optimize treatment duration. For more details, refer here.